{"change_dates":[],"dossier":{"amendments":[{"authors":"EPP, S&D, ALDE, GREENS/EFA, ECR, GUE/NGL","changes":{},"committee":["ENVI"],"compromise":["Compromise amendment replacing Amendments 15, 16, 92-96, 97, 98-107, 108-110, 111-","120, IMCO16, IMCO17, IMCO18"],"date":"2012-12-11T00:00:00","id":"PE498.122-1","location":[["Proposal for a directive","Article 3 \u2013 paragraphs 2, 3, 4 and 5"]],"meta":{"created":"2019-07-03T05:27:15"},"new":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder once the marketing","authorisation of the product has been","granted. Member States may also provide","the possibility for the applicant for","marketing authorisation to submit such","requests once the Committee for","Medicinal Products for Human Use","established by Regulation (EC) No","726/2004 or the national competent","authority has issued a positive opinion to","the granting of a marketing authorisation","for the medicinal product concerned. The","competent authorities shall provide the","applicant with an official","acknowledgement of receipt within 10","days of the receipt of the application.","3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities.","Where applicable, Member States shall","use health technology assessment as part","of their decision-making process on the","pricing of medicinal products.","4. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant.","5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be in all events 30 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities."],"old":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder at any point in time.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt.","3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the price of the reference","medicinal product has been approved by","","the competent authorities.","4. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant.","5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be in all events 15 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities. Member States","shall not request any additional","information which is not explicitly","required under national legislation or","administrative guidelines."],"orig_lang":"en","peid":"PE498.122v01-00","reference":"2012/0035(COD)","seq":"1","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.122+01+DOC+PDF+V0//EN&language=EN"},{"authors":" EPP, S&D, ALDE, GREENS/EFA, ECR, GUE/NGL","changes":{},"committee":["ENVI"],"compromise":[" Compromise amendment replacing Amendments Compromise amendment replacing"," Amendments 126-129, 130, 131-136, 137-142, 143-145, 146-151, IMCO19, IMCO20"],"date":"2012-12-11T00:00:00","id":"PE498.122-2","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 2 + paragraph 3 \u2013 subparagraph 1 + paragraph 3 \u2013 subparagraph 2 + paragraph 4 \u2013 subparagraph 1 + paragraph 4 \u2013 subparagraph 2"]],"meta":{"created":"2019-07-03T05:27:15"},"new":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the marketing","authorisation holder in accordance with","the respective provisions of national law.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt within 10","days of the receipt of the application.","3. Member States shall ensure that a","decision to approve or reject an application","submitted in accordance with the","requirements laid down in the Member","State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 90","days of its receipt.","In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph.","4. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant.","The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information."],"old":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the marketing","authorisation holder at any point in time.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt.","","","3. Member States shall ensure that a","decision on an application submitted in","accordance with the requirements laid","down in the Member State concerned, by a","marketing authorisation holder to increase","the price of a medicinal product is adopted","and communicated to the applicant within","60 days of its receipt.","In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph.","4. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant.","The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. Member States","shall not request any additional","information which is not explicitly","required under national legislation or","administrative guidelines."],"orig_lang":"en","peid":"PE498.122v01-00","reference":"2012/0035(COD)","seq":"2","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.122+01+DOC+PDF+V0//EN&language=EN"},{"authors":"EPP, S&D, ALDE, GREENS/EFA, ECR, GUE/NGL","changes":{},"committee":["ENVI"],"compromise":["Compromise amendment replacing Amendments Compromise amendment replacing","Amendments 156 - 159, 160-165, 166-171, IMCO22, IMCO23, IMCO24"],"date":"2012-12-11T00:00:00","id":"PE498.122-3","location":[[" Proposal for a directive","Article 5 - paragraph 2 + paragraph 3 \u2013 subparagraph 1 + paragraph 3 \u2013 subparagraph 2"]],"meta":{"created":"2019-07-03T05:27:15"},"new":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","introduced by the marketing authorisation","holder at any point in time. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt","within 10 days of the receipt of the","application.","3. Member States shall ensure that a","reasoned decision on an application","referred to in paragraph 2 is adopted and","communicated to the applicant within 90","days of the receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 90 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed.","If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3."],"old":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","introduced by the marketing authorisation","holder at any point in time. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt.","3. Member States shall ensure that a","reasoned decision on an application","referred to in paragraph 2 is adopted and","communicated to the applicant within 60","days of the receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 60 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed.","If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3."],"orig_lang":"en","peid":"PE498.122v01-00","reference":"2012/0035(COD)","seq":"3","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.122+01+DOC+PDF+V0//EN&language=EN"},{"authors":" EPP, S&D, ALDE, GREENS/EFA, ECR, GUE/NGL","changes":{},"committee":["ENVI"],"compromise":[" Compromise amendment replacing Amendments 19, 20, 21, 22, 175-180, 181-183, 184-193,"],"date":"2012-12-11T00:00:00","id":"PE498.122-4","meta":{"created":"2019-07-03T05:27:15"},"new":["(15b) The principle of transparency,","integrity and independence of the","decision-making process within the","national competent authorities should be","ensured by the public disclosure of the","names of experts participating in the","bodies responsible for pricing and","reimbursement decisions, together with","their declarations of interest and the","procedural steps leading to pricing and","reimbursement decisions."],"old":[""],"orig_lang":"en","peid":"PE498.122v01-00","reference":"2012/0035(COD)","seq":"4","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.122+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-134","location":[["Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:21"},"new":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 90","days of its receipt."],"old":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 60","days of its receipt."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"134","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-135","justification":"The new time limits are unrealistic and go well beyond what is required to achieve the\nCommission\u2019s aim, namely that of ensuring the prompt availability of new medicinal products\nfor which a \u2018normal\u2019 marketing authorisation has been granted.","location":[["Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:22"},"new":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 90","days of its receipt."],"old":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 60","days of its receipt."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"135","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-136","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:22"},"new":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 90","days of its receipt."],"old":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 60","days of its receipt."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"136","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-137","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:22"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"old":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"137","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-138","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:22"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"old":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"138","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-139","location":[["Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:22"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"old":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"139","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-140","location":[["Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:22"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"old":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","","expiry of the time limit set out in this","paragraph."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"140","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-141","justification":" The new time limits are unrealistic and go well beyond what is required to achieve the\n Commission\u2019s aim, namely that of ensuring the prompt availability of new medicinal products\n for which a \u2018normal\u2019 marketing authorisation has been granted.","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:22"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"old":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"141","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-142","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:22"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"old":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","","","paragraph."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"142","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-143","location":[["Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:23"},"new":["Member States shall establish the","categories of particulars and documents to","be submitted by the applicant."],"old":["Member States shall establish in detail the","particulars and documents to be submitted","by the applicant."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"143","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-144","location":[["Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:23"},"new":["Member States shall establish in detail the","particulars and the main documents to be","submitted by the applicant."],"old":["Member States shall establish in detail the","particulars and documents to be submitted","by the applicant."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"144","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-145","location":[["Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:23"},"new":["Member States shall establish in detail the","categories of particulars and main","documents to be submitted by the","applicant."],"old":["Member States shall establish in detail the","particulars and documents to be submitted","","by the applicant."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"145","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-146","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:23"},"new":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information."],"old":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. Member States","shall not request any additional","information which is not explicitly","required under national legislation or","administrative guidelines."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"146","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-147","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:23"},"new":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"147","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-148","location":[["Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:23"},"new":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"148","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-149","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:23"},"new":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of what detailed additional","information is required and take their final","decision within 90 days of receipt of this","additional information. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"149","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-150","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:23"},"new":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of what detailed additional","information is required and take their final","decision within 90 days of receipt of this","additional information. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","","information required and take their final","decision within 60 days of receipt of this","additional information. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"150","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-151","location":[["Proposal for a directive","Article 4 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:23"},"new":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information."],"old":["The applicant shall furnish the competent","authorities with adequate information,","including details of those events","intervening since the price of the medicinal","product was last determined which in his","opinion justify the price increase requested.","If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. Member States","shall not request any additional","information which is not explicitly","required under national legislation or","administrative guidelines."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"151","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-152","justification":" This provision goes well beyond the aim of the proposal, namely that of ensuring the prompt\n availability of new medicinal products, and is neither proportionate nor consistent with the\n subsidiarity principle. What is more, such a measure could undermine even further the\n already shaky budgetary situation of public health insurance systems.","location":[["Proposal for a directive","Article 4 \u2013 paragraph 5"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:23"},"new":["deleted"],"old":["5. In the absence of a decision within the","relevant time limit referred to in","paragraphs 3 and 4, the applicant shall be","entitled to apply the price increase","requested."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"152","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-153","justification":" The requirement that the competent authorities should provide a detailed statement of reasons\n for every reassessment decision which runs counter to the commercial interests of\n manufacturers is disproportionate.","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 6"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:23"},"new":["6. If the competent authorities decide not to","permit the whole or part of the price","increase requested, the applicant shall be","informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"old":["6. If the competent authorities decide not to","permit the whole or part of the price","increase requested, the decision shall","contain a statement of reasons based on","objective and verifiable criteria and the","applicant shall be informed of all remedies","available, including judicial remedies, and","of the time limits for applying for such","remedies."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"153","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-154","justification":"The requirement that the competent authorities should provide a detailed statement of reasons\nfor every re-assessment decision which runs counter to the commercial interests of\nmanufacturers is disproportionate.","location":[["Proposal for a directive","Article 5 \u2013 paragraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:23"},"new":["1. In the event of a price freeze or price","reduction imposed on all medicinal","products or on certain categories of","medicinal products by the competent","authorities of a Member State, that","Member State shall publish a statement of","reasons for its decision, including, if","applicable, a justification of the categories","of products subject to the price freeze or","price reduction."],"old":["1. In the event of a price freeze or price","reduction imposed on all medicinal","products or on certain categories of","medicinal products by the competent","authorities of a Member State, that","Member State shall publish a statement of","reasons for its decision based on objective","and verifiable criteria, including, if","applicable, a justification of the categories","of products subject to the price freeze or","price reduction."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"154","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-155","location":[["Proposal for a directive","Article 5 \u2013 paragraph 1"]],"meps":[1927],"meta":{"created":"2019-07-03T05:27:24"},"new":["1. In the event of a price freeze or price","reduction imposed on all medicinal","products or on certain categories of","medicinal products by the competent","authorities of a Member State, that","Member State shall publish a statement of","reasons for its decision based on objective","and verifiable criteria, including, if","applicable, a justification of the categories","of products subject to the price freeze or","price reduction. Member States shall carry","out an annual review."],"old":["1. In the event of a price freeze or price","reduction imposed on all medicinal","products or on certain categories of","medicinal products by the competent","authorities of a Member State, that","Member State shall publish a statement of","reasons for its decision based on objective","and verifiable criteria, including, if","applicable, a justification of the categories","","","of products subject to the price freeze or","price reduction."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"155","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-156","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:24"},"new":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","introduced by the marketing authorisation","holder at any point in time."],"old":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","introduced by the marketing authorisation","holder at any point in time. The competent","authorities shall provide the applicant","with an official acknowledgement of","receipt."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"156","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-157","justification":"Drafting clarification and deletion of the phrase \u2018at any point in time\u2019, which would be a\nsource of legal uncertainty.","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:24"},"new":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall guarantee the","marketing authorisation holder the right to","submit an application for a derogation.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"old":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","","introduced by the marketing authorisation","holder at any point in time. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"157","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-158","justification":"This proposal would considerably increase the administrative burden on the competent\nauthorities in the Member States, which would be submerged with applications following any\ndecision to turn down an application for a derogation, even if circumstances have not\nchanged.","location":[["Proposal for a directive","Article 5 \u2013 paragraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:24"},"new":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","introduced by the marketing authorisation","holder. The competent authorities shall","provide the applicant with an official","acknowledgement of receipt."],"old":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","introduced by the marketing authorisation","holder at any point in time. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"158","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-159","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 2"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:24"},"new":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. These reasons must be","drawn from a pre-defined list determined","and published in an appropriate","publication by the Member State. The","application shall contain an adequate","statement of reasons. Member States shall","ensure that applications for a derogation","can be introduced by the marketing","authorisation holder. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","introduced by the marketing authorisation","holder at any point in time. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"159","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-160","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:24"},"new":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 90 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 90 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"old":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 60 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"160","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-161","location":[["Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:24"},"new":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 90 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 90 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"old":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 60 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"161","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-162","location":[["Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:24"},"new":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 90 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 90 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"old":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","","detailed additional information required","and take their final decision within 60 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"162","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-163","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:24"},"new":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 90 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of what","detailed additional information is required","and take their final decision within 90 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"old":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 60 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"163","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-164","justification":"The requirement that the competent authorities should provide a detailed statement of reasons\nfor every re-assessment decision which runs counter to the commercial interests of\nmanufacturers is disproportionate.","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:24"},"new":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application."],"old":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities","shall forthwith notify the applicant of the","detailed additional information required","and take their final decision within 60","days of receipt of this additional","information. If the derogation is granted,","the competent authorities shall forthwith","publish an announcement of the price","increase allowed."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"164","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-43","justification":"The Commission proposal should be rejected as it is solely driven by the interests of the\npharmaceutical industry, at the expense of the rights of Member States, and ultimately at the\nexpense of the interests of patients. Member States are straitjacketed (shorter assessment\ndeadlines, disproportionate penalties, strict notification requirements), while pharmaceutical\ncompanies can achieve increases price via a tacit consent procedure. The Commission should\npresent a new and balanced proposal.","meps":[96743],"meta":{"created":"2019-07-03T05:27:22"},"new":["The European Parliament rejects the","Commission proposal."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"43","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-165","justification":" The 90-day time limit should be retained in order not to jeopardise the quality of assessments\n of medicinal products in the Member States and, therefore, the quality of the service provided\n to patients.","location":[["Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:24"},"new":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 90 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of what","detailed additional information is required","and take their final decision within 90 days","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"old":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities shall","forthwith notify the applicant of the","detailed additional information required","and take their final decision within 60 days","","","of receipt of this additional information. If","the derogation is granted, the competent","authorities shall forthwith publish an","announcement of the price increase","allowed."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"165","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-44","justification":"This proposal does not relate to the free movement of just any type of goods, but deals with\nthe free movement of medicinal products and the pricing thereof, and the latter falls within\nthe competence of Member States in the field of public health. Article 168 of the TFEU should\ntherefore be added to the legal basis.","location":[["Proposal for a directive","Citation 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:22"},"new":["Having regard to the Treaty on the","Functioning of the European Union, and in","particular Articles 114 and 168 thereof,"],"old":["Having regard to the Treaty on the","Functioning of the European Union, and in","particular Article 114 thereof,"],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"44","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-166","justification":" The new time limits are unrealistic and go well beyond what is required to achieve the\n Commission\u2019s aim, namely that of ensuring the prompt availability of new medicinal products\n for which a \u2018normal\u2019 marketing authorisation has been granted.","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:24"},"new":["deleted"],"old":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall","be notified of such extension before the","expiry of the time limit set out in","paragraph 3."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"166","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-45","location":[[" Proposal for a directive","Citation 1"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:22"},"new":["Having regard to the Treaty on the","Functioning of the European Union, and in","particular Articles 168(7) and 114 thereof,"],"old":["Having regard to the Treaty on the","Functioning of the European Union, and in","particular Article 114 thereof,"],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"45","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-167","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:24"},"new":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 90 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in paragraph","3"],"old":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3"],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"167","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-168","location":[["Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:24"},"new":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 90 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3"],"old":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3"],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"168","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-46","location":[[" Proposal for a directive","Recital 2"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:22"},"new":["(2) In order to take into account the","evolution of the pharmaceutical market and","of national policies to control public","expenditure on medicinal products,","substantive changes are necessary to all","major provisions of Directive 89/105/EEC.","Therefore, in the interest of clarity,","Directive 89/105/EEC should be replaced."],"old":["(2) In order to take into account the","evolution of the pharmaceutical market and","of national policies to control public","expenditure on medicines, substantive","changes are necessary to all major","provisions of Directive 89/105/EEC.","Therefore, in the interest of clarity,","Directive 89/105/EEC should be replaced."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"46","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-169","location":[["Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:24"},"new":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 90 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3"],"old":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3"],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"169","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-47","location":[[" Proposal for a directive","Recital 2"]],"meps":[28279],"meta":{"created":"2019-07-03T05:27:22"},"new":["(2) In order to take into account the","evolution of the pharmaceutical market and","of national policies to control public","expenditure on medicines, substantive","changes are necessary to all major","provisions of Directive 89/105/EEC.","Therefore, in the interest of clarity,","Directive 89/105/EEC should be amended."],"old":["(2) In order to take into account the","evolution of the pharmaceutical market and","","of national policies to control public","expenditure on medicines, substantive","changes are necessary to all major","provisions of Directive 89/105/EEC.","Therefore, in the interest of clarity,","Directive 89/105/EEC should be replaced;"],"orig_lang":"lt","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"47","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-170","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:24"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3."],"old":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"170","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-48","location":[["Proposal for a directive","Recital 4"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:22"},"new":["(4) Member States have been confronted","with a steady rise in pharmaceutical","expenditure over the last decades, leading","to the adoption of increasingly innovative","and complex policies to manage the","consumption of medicines in the","framework of their public health insurance","systems. In particular, Member States\u2019","authorities have implemented a broad","range of measures to control the","prescription of medicines, to regulate their","prices or to establish the conditions of their","public funding. Such measures mainly aim","at promoting public health by ensuring the","availability of adequate supplies of","medicinal products on equal terms to all","EU citizens at reasonable costs, while","ensuring the financial stability of public","health insurance systems. Medicines","classed as essential on the WHO list","should be available to patients in all","Member States, whatever the size of the","market."],"old":["(4) Member States have been confronted to","a steady rise in pharmaceutical expenditure","over the last decades, leading to the","adoption of increasingly innovative and","complex policies to manage the","consumption of medicines in the","framework of their public health insurance","systems. In particular, Member States\u2019","authorities have implemented a broad","range of measures to control the","prescription of medicines, to regulate their","prices or to establish the conditions of their","public funding. Such measures mainly aim","at promoting public health by ensuring the","availability of adequate supplies of","medicinal products at reasonable costs,","while ensuring the financial stability of","public health insurance systems."],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"48","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-49","location":[[" Proposal for a directive","Recital 4"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:22"},"new":["(4) Member States have been confronted to","a steady rise in pharmaceutical expenditure","over the last decades, leading to the","adoption of increasingly innovative and","complex policies to manage the","consumption of medicinal products in the","framework of their public health insurance","systems. In particular, Member States\u2018","authorities have implemented a broad","range of measures to control the","prescription of medicinal products, to","regulate their prices or to establish the","conditions of their public funding. Such","measures mainly aim at promoting public","health for all citizens by ensuring the","availability of adequate supplies of","effective medicinal products at reasonable","costs, while ensuring an equal access to","high quality healthcare for all."],"old":["(4) Member States have been confronted to","a steady rise in pharmaceutical expenditure","over the last decades, leading to the","adoption of increasingly innovative and","complex policies to manage the","consumption of medicines in the","framework of their public health insurance","systems. In particular, Member States\u2018","authorities have implemented a broad","range of measures to control the","prescription of medicines, to regulate their","prices or to establish the conditions of their","public funding. Such measures mainly aim","at promoting public health by ensuring the","availability of adequate supplies of","medicinal products at reasonable costs,","while ensuring the financial stability of","public health insurance systems."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"49","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-171","justification":" The 90-day time limit should be retained in order not to jeopardise the quality of assessments\n of medicinal products in the Member States and, therefore, the quality of the service provided\n to patients.","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:25"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3."],"old":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall be","notified of such extension before the expiry","of the time limit set out in paragraph 3."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"171","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate, Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-50","justification":"Innovation in the field of healthcare brings considerable advantages for patients and makes\nhealthcare systems more efficient and durable.","location":[[" Proposal for a directive","Recital 4"]],"meps":[2025,96884],"meta":{"created":"2019-07-03T05:27:22"},"new":["(4) Member States have been confronted to","a steady rise in pharmaceutical expenditure","over the last decades, leading to the","adoption of increasingly innovative and","complex policies to manage the","consumption of medicines in the","framework of their public health insurance","systems. In particular, Member States\u2019","authorities have implemented a broad","range of measures to control the","prescription of medicines, to regulate their","prices or to establish the conditions of their","public funding. Such measures mainly aim","at promoting public health by ensuring the","availability of adequate supplies of","medicinal products at reasonable costs,","while ensuring the financial stability of","public health insurance systems. These","measures should also aim to promote","research and development of new","medicinal products and to recognise","medical innovation."],"old":["(4) Member States have been confronted to","a steady rise in pharmaceutical expenditure","over the last decades, leading to the","adoption of increasingly innovative and","complex policies to manage the","consumption of medicines in the","framework of their public health insurance","systems. In particular, Member States\u2019","authorities have implemented a broad","range of measures to control the","prescription of medicines, to regulate their","","","prices or to establish the conditions of their","public funding. Such measures mainly aim","at promoting public health by ensuring the","availability of adequate supplies of","medicinal products at reasonable costs,","while ensuring the financial stability of","public health insurance systems."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"50","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Horst Schnellhardt, Thomas Ulmer, Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-172","justification":"Voluntary agreements such as discount agreements between producers of medicines and\nhealth insurance funds have become more common and apply to a large proportion of the\nmedicines dispensed. These agreements make it impossible for doctors and pharmacists to\nascertain the actual price, and the economically most advantageous medicament is not always\ndispensed.","location":[["Proposal for a directive","Article 5 \u2013 paragraph 3 a (new)"]],"meps":[1930,28221,28227],"meta":{"created":"2019-07-03T05:27:25"},"new":["3a. Member States shall ensure that","dispensaries possess information about","the sale price of the medicinal product","applicable to the insured person in order","to prevent possible distorting effects","caused by a lack of transparency in prices","displayed on the market."],"orig_lang":"de","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"172","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-51","location":[["Proposal for a directive","Recital 5"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:22"},"new":["(5) Disparities in national measures may","hinder or distort intra-Union trade in","medicinal products, thereby directly","affecting the functioning of the internal","market in medicinal products."],"old":["(5) Disparities in national measures may","hinder or distort intra-Union trade in","medicinal products and distort","competition, thereby directly affecting the","functioning of the internal market in","medicinal products."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"51","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-173","location":[["Proposal for a directive","Article 5 a (new)"]],"meps":[1927,39916],"meta":{"created":"2019-07-03T05:27:25"},"new":["Article 5a","Member States shall ensure that the","patient or the insured person also","genuinely has the benefit of the agreed","reimbursement prices. Any possible lack","of transparency at dispensaries which","results in distortion because of failure to","present prices transparently shall be","avoided."],"orig_lang":"de","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"173","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Horst Schnellhardt, Anja Weisgerber, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-52","location":[["Proposal for a directive","Recital 8"]],"meps":[1930,28227,28221],"meta":{"created":"2019-07-03T05:27:23"},"new":["(8) Due to diversity of national measures","managing the consumption of medicines,","regulating their prices or establishing the","conditions of their public funding it is","necessary to clarify Directive 89/105/EEC.","In particular this Directive should cover all","types of measures devised by Member","States and susceptible to impact the","internal market. Since the adoption of","Directive 89/105/EEC, the pricing and","reimbursement procedures have evolved","and have become more complex. While","some Member States have interpreted the","scope of Directive 89/105/EEC","restrictively, the Court of Justice ruled that","those pricing and reimbursement","procedures fall within the scope of","Directive 89/105/EEC given the objectives","of that Directive and the need to ensure its","effectiveness. Therefore, this Directive","should reflect the developments in national","pricing and reimbursement policies.","Despite the existence of specific rules and","procedures in the area of public","procurement and voluntary contractual","agreements, national measures involving","public procurement and voluntary","contractual agreements should only be","excluded from the scope of this Directive","to the extent that the voluntary","agreements also allow transparency about","the drug sales price which is of primary","concern to the insured person. It must be","clear to doctors and pharmacists as","distribution points for drugs which costs","are incurred by the patient and the health","care systems for a medicine in order to be","able to choose the most economically","rational drug regardless of the type of","agreement."],"old":["(8) Due to diversity of national measures","managing the consumption of medicines,","regulating their prices or establishing the","conditions of their public funding it is","necessary to clarify Directive 89/105/EEC.","In particular this Directive should cover all","types of measures devised by Member","States and susceptible to impact the","internal market. Since the adoption of","Directive 89/105/EEC, the pricing and","reimbursement procedures have evolved","and have become more complex. While","some Member States have interpreted the","scope of Directive 89/105/EEC","restrictively, the Court of Justice ruled that","those pricing and reimbursement","procedures fall within the scope of","Directive 89/105/EEC given the objectives","of that Directive and the need to ensure its","effectiveness. Therefore, this Directive","should reflect the developments in national","pricing and reimbursement policies. Given","that specific rules and procedures exist in","the area of public procurement and","voluntary contractual agreements, national","measures involving public procurement","and voluntary contractual agreements","should be excluded from the scope of this","Directive."],"orig_lang":"de","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"52","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-174","location":[[" Proposal for a directive","Article 6"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:25"},"new":["deleted"],"old":["Article 6","Controls on profits","Where a Member State adopts a system of","direct or indirect controls on the","profitability of persons responsible for","placing medicinal products on the market,","the Member State concerned shall publish","the following information in an","appropriate publication and communicate","it to the Commission:","(a) the method or methods used in the","Member State concerned to define","profitability: return on sales and/or return","on capital;","(b) the range of target profit currently","permitted to persons responsible for","placing medicinal products on the market","in the Member State concerned;","(c) the criteria according to which target","rates of profit are accorded to an","individual responsible for placing","medicinal products on the market,","together with the criteria according to","which they will be allowed to retain profits","above their targets in the Member State","concerned;","(d) the maximum percentage profit which","any person responsible for placing","medicinal products on the market is","allowed to retain above his target in the","Member State concerned.","The information referred to in the first","subparagraph shall be updated once a","year or when significant changes are","made.","Where, in addition to operating a system","","","of direct or indirect controls on profits, a","Member State operates a system of","controls on the prices of certain types of","medicinal products which are excluded","from the scope of the profit control","scheme, Articles 3, 4 and 5 shall, where","relevant, apply to such price controls.","However, those Articles shall not apply","where the normal operation of a system of","direct or indirect controls on profits","results exceptionally in a price being fixed","for an individual medicinal product."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"174","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-53","justification":"In its judgment in Case C-62/09 the Court of Justice authorised measures to monitor or\nencourage the prescription of certain medicinal products. What is more, those measures have\nno bearing on decisions to include medicinal products in the scope of national health\ninsurance systems. A proposal such as this would also enable the manufacturers of all\ncompeting medicinal products to submit appeals, creating an administrative and legal\nnightmare.","location":[["Proposal for a directive","Recital 9"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:23"},"new":["(9) Any measure to regulate, either directly","or indirectly, the prices of medicinal","products, as well as any measure to","determine their coverage by public health","insurance systems should be based on","objective and verifiable criteria that are","independent from the origin of the product.","These requirements should equally apply to","national, regional or local measures to","control or promote the prescription of","specific medicinal products as such","measures also determine their effective","coverage by health insurance systems."],"old":["(9) Any measure to regulate, either directly","or indirectly, the prices of medicinal","products, as well as any measure to","determine their coverage by public health","insurance systems should be based on","objective and verifiable criteria that are","independent from the origin of the product","and should provide adequate legal","remedies, including judicial remedies, to","affected companies. These requirements","should equally apply to national, regional","or local measures to control or promote the","prescription of specific medicinal products","as such measures also determine their","effective coverage by health insurance","systems."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"53","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-175","location":[["Proposal for a directive","Article 7 \u2013 paragraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:25"},"new":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder at any point in time. If","the public health insurance system","comprises several schemes or categories of","coverage, the marketing authorisation","holder shall be entitled to apply for the","inclusion of its product in the scheme or","category of its choice."],"old":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder at any point in time. If","the public health insurance system","comprises several schemes or categories of","coverage, the marketing authorisation","holder shall be entitled to apply for the","inclusion of its product in the scheme or","category of its choice. The competent","authorities shall provide the applicant","with an official acknowledgement of","receipt."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"175","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-176","justification":" A number of Member States already authorise applicants to submit a Price and\n Reimbursement Application once the Committee for Medicinal Products for Human Use or a\n competent national authority of a Member State has delivered a favourable opinion. In this\n way a dialogue is opened at an early stage, making it more likely that the time limits laid\n down in the directive will be complied with and thus facilitating patient access to new\n medicinal products.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 2"]],"meps":[2025],"meta":{"created":"2019-07-03T05:27:25"},"new":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder at any point in time or","by the applicant once the Committee for","Medicinal Products for Human Use (set","up by Regulation (EC) No 726/2004) or a","competent national authority has","delivered a favourable opinion. If the","public health insurance system comprises","several schemes or categories of coverage,","the marketing authorisation holder or the","applicant shall be entitled to apply for the","inclusion of its product in the scheme or","category of its choice. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder at any point in time. If","the public health insurance system","comprises several schemes or categories of","coverage, the marketing authorisation","holder shall be entitled to apply for the","inclusion of its product in the scheme or","category of its choice. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"176","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Karin Kadenbach","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-54","location":[["Proposal for a directive","Recital 9"]],"meps":[97014],"meta":{"created":"2019-07-03T05:27:23"},"new":["(9) Any measure to regulate, either directly","or indirectly, the prices of medicinal","products, as well as any measure,","including recommendations that may be","required, to determine their coverage by","public health insurance systems should be","based on objective and verifiable criteria","that are independent from the origin of the","product and should provide adequate legal","remedies, including judicial remedies, to","affected companies. These requirements","should equally apply to national, regional","or local measures to control or promote the","prescription of specific medicinal products","as such measures also determine their","effective coverage by health insurance","systems."],"old":["(9) Any measure to regulate, either directly","or indirectly, the prices of medicinal","","products, as well as any measure to","determine their coverage by public health","insurance systems should be based on","objective and verifiable criteria that are","independent from the origin of the product","and should provide adequate legal","remedies, including judicial remedies, to","affected companies. These requirements","should equally apply to national, regional","or local measures to control or promote the","prescription of specific medicinal products","as such measures also determine their","effective coverage by health insurance","systems."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"54","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-177","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 2"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:25"},"new":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder at any point in time.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to include a medicinal product","","","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder at any point in time. If","the public health insurance system","comprises several schemes or categories","of coverage, the marketing authorisation","holder shall be entitled to apply for the","inclusion of its product in the scheme or","category of its choice. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"177","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-55","location":[[" Proposal for a directive","Recital 9"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:23"},"new":["(9) Any measure to regulate, either directly","or indirectly, the prices of medicinal","products, as well as any measure to","determine their coverage by public health","insurance systems should be based on","objective and verifiable criteria that are","independent from the origin of the product.","These requirements should equally apply to","national, regional or local measures to","control or promote the prescription of","specific medicinal products as such","measures also determine their effective","coverage by health insurance systems."],"old":["(9) Any measure to regulate, either directly","or indirectly, the prices of medicinal","products, as well as any measure to","determine their coverage by public health","insurance systems should be based on","objective and verifiable criteria that are","independent from the origin of the product","and should provide adequate legal","remedies, including judicial remedies, to","affected companies. These requirements","should equally apply to national, regional","or local measures to control or promote the","prescription of specific medicinal products","as such measures also determine their","effective coverage by health insurance","systems."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"55","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-178","justification":"Drafting clarification and deletion of the phrase \u2018at any point in time\u2019, which would be a\nsource of legal uncertainty. Moreover, the decision as to whether or not to allow the holder of\nthe marketing authorisation to apply for the inclusion of a medicinal product in a specific\ncategory is a Member State matter.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:25"},"new":["2. Member States shall guarantee the","marketing authorisation holder the right to","submit an application to include a","medicinal product in the scope of the","public health insurance scheme. The","competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health","insurance system can be introduced by the","marketing authorisation holder at any point","in time. If the public health insurance","system comprises several schemes or","categories of coverage, the marketing","authorisation holder shall be entitled to","apply for the inclusion of its product in","the scheme or category of its choice. The","competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"178","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Andres Perello Rodriguez","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-56","location":[["Proposal for a directive","Recital 9 a (new)"]],"meps":[96989],"meta":{"created":"2019-07-03T05:27:23"},"new":["(9a) The criteria underlying any decision","directly or indirectly regulating the prices","of medicinal products, as well as any","measure determining the extent to which","they shall be covered by public health","insurance systems should include the","assessment of unmet medical needs,","clinical and social benefits and","innovation, as laid down in the European","Economic and Social committee opinion","on the proposal for a directive of the","European Parliament and of the Council","relating to the transparency of measures","regulating the prices of medicinal","products for human use and their","inclusion in the scope of public health","insurance systems, of 12 June 20121.","Such criteria should also include","protection for the most vulnerable groups","of the population.","_____________","1 OJ C 299, 4.10.2012 p. 83"],"orig_lang":"es","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"56","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-179","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 2"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:25"},"new":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder at any point in time.","If the public health insurance system","comprises several schemes or categories","of coverage, the marketing authorisation","holder shall be entitled to apply for the","inclusion of its product in the scheme or","category of its choice. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"179","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Karin Kadenbach","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-57","location":[["Proposal for a directive","Recital 10"]],"meps":[97014],"meta":{"created":"2019-07-03T05:27:23"},"new":["(10) Applications to approve the price of a","medicinal product or to determine its","coverage by the health insurance system","should not delay the placing on the market","of that product beyond what is necessary. It","is therefore desirable that this Directive","sets out mandatory time limits within","which national decisions should be made.","In order to be effective, the prescribed time","periods should run from the receipt of an","application until the entry into force of the","corresponding decision. They should","include all recommendations and expert","evaluations, including health technology","assessments where applicable, and all","administrative steps required for the","decision to be adopted and take legal","effect."],"old":["(10) Applications to approve the price of a","medicinal product or to determine its","coverage by the health insurance system","should not delay the placing on the market","","of that product beyond what is necessary. It","is therefore desirable that this Directive","sets out mandatory time limits within","which national decisions should be made.","In order to be effective, the prescribed time","periods should run from the receipt of an","application until the entry into force of the","corresponding decision. They should","include all expert evaluations, including","health technology assessments where","applicable, and all administrative steps","required for the decision to be adopted and","take legal effect."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"57","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-180","justification":"Contrary to the subsidiarity principle. The procedure concerning the choice of a category of\ncover should remain a Member State matter.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:25"},"new":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health insurance","system can be introduced by the marketing","authorisation holder at any point in time.","If the public health insurance system","comprises several schemes or categories","of coverage, the marketing authorisation","holder shall be entitled to apply for the","inclusion of its product in the scheme or","category of its choice. The competent","authorities shall provide the applicant with","","an official acknowledgement of receipt."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"180","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-58","location":[[" Proposal for a directive","Recital 11"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:23"},"new":["(11) The time-limits for the inclusion of","medicinal products in the health insurance","systems set out in Directive 89/105/EEC","are mandatory as clarified by the case-law","of the Court of Justice. Experience has","shown that those time limits are not always","respected and that there is need to ensure","legal certainty and improve the procedural","rules related to the inclusion of medicinal","products in the scope of health insurance","system. Therefore, effective rapid remedies","procedures should be encouraged."],"old":["(11) The time-limits for the inclusion of","medicinal products in the health insurance","systems set out in Directive 89/105/EEC","are mandatory as clarified by the case-law","of the Court of Justice. Experience has","shown that those time limits are not always","respected and that there is need to ensure","legal certainty and improve the procedural","rules related to the inclusion of medicinal","products in the scope of health insurance","system. Therefore, an effective and rapid","remedies procedure should be put in place."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"58","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-181","location":[["Proposal for a directive","Article 7 \u2013 paragraph 3"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:25"},"new":["3. Member States shall establish the","categories of particulars and documents to","be submitted by the applicant."],"old":["3. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"181","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-59","justification":"Remedies procedures, including judicial procedures, already exist in the Member States.\nWhat is more, these procedures are Member State matters which fall outside the scope of this\ndirective, which deals with administrative procedures for approving the price of medicinal\nproducts and authorising the reimbursement of their cost under health insurance systems.","location":[[" Proposal for a directive","Recital 11"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:23"},"new":["(11) The time-limits for the inclusion of","medicinal products in the health insurance","systems set out in Directive 89/105/EEC","are mandatory as clarified by the case-law","of the Court of Justice. Experience has","shown that those time limits are not always","respected and that there is need to ensure","legal certainty and improve the procedural","rules related to the inclusion of medicinal","products in the scope of health insurance","system. Therefore, effective and rapid","measures of redress should be","encouraged."],"old":["(11) The time-limits for the inclusion of","medicinal products in the health insurance","systems set out in Directive 89/105/EEC","are mandatory as clarified by the case-law","of the Court of Justice. Experience has","shown that those time limits are not always","respected and that there is need to ensure","legal certainty and improve the procedural","rules related to the inclusion of medicinal","products in the scope of health insurance","system. Therefore, an effective and rapid","remedies procedure should be put in","place."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"59","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-182","location":[["Proposal for a directive","Article 7 \u2013 paragraph 3"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:25"},"new":["3. Member States shall establish in detail","the particulars and the main documents to","be submitted by the applicant."],"old":["3. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"182","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-60","location":[["Proposal for a directive","Recital 12"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:23"},"new":["(12) In its Communication \u2018Executive","Summary of the Pharmaceutical Sector","Inquiry Report\u2019 the Commission","demonstrated that pricing and","reimbursement procedures often","unnecessarily delay the launch of generic","or biosimilar medicinal products in Union","markets. Approving the price of generic or","biosimilar medicinal products and their","coverage by the health insurance system","should not require any new or detailed","assessment when the reference product has","already been priced and included in the","health insurance system. It is therefore","appropriate to lay down shorter time limits","for generic or biosimilar medicinal","products in those cases."],"old":["(12) In its Communication \u2018Executive","Summary of the Pharmaceutical Sector","Inquiry Report\u2019 the Commission","demonstrated that pricing and","reimbursement procedures often","unnecessarily delay the launch of generic","medicines in Union markets. Approving","the price of generic medicinal products and","their coverage by the health insurance","system should not require any new or","detailed assessment when the reference","product has already been priced and","","included in the health insurance system. It","is therefore appropriate to lay down shorter","time limits for generic medicinal products","in those cases."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"60","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-183","justification":" The competent authorities must be granted at least some leeway so that they can respond to\n unexpected developments.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:25"},"new":["3. Member States shall establish in detail","the categories of particulars and main","documents to be submitted by the","applicant."],"old":["3. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"183","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-61","justification":" Although decision-making concerning generic medicines whose reference medicinal products\n have already been evaluated should be expedited, it should still be possible to assess generics\n\nwhich are not essentially similar to their reference product. Certain generics may differ from\ntheir reference product in respect of their packaging or therapeutic indications.","location":[[" Proposal for a directive","Recital 12"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:23"},"new":["(12) In its Communication \"Executive","Summary of the Pharmaceutical Sector","Inquiry Report\" the Commission","demonstrated that pricing and","reimbursement procedures often","unnecessarily delay the launch of generic","medicines in Union markets. Approving","the price of generic medicinal products and","their coverage by the health insurance","system should not require any new or","detailed assessment when the reference","product is essentially similar, within the","meaning of Directive 2001/83/EC, and has","already been priced and included in the","health insurance system. It is therefore","appropriate to lay down shorter time limits","for generic medicinal products in those","cases. If generic medicinal products","display differences by comparison with","the reference medicinal product, for","example as regards their packaging or","their therapeutic indications, Member","States may provide for their assessment."],"old":["(12) In its Communication \"Executive","Summary of the Pharmaceutical Sector","Inquiry Report\" the Commission","demonstrated that pricing and","reimbursement procedures often","unnecessarily delay the launch of generic","medicines in Union markets. Approving","the price of generic medicinal products and","their coverage by the health insurance","system should not require any new or","detailed assessment when the reference","product has already been priced and","included in the health insurance system. It","is therefore appropriate to lay down shorter","time limits for generic medicinal products","in those cases."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"61","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-184","justification":"The 15-day time limit proposed by the Commission would be difficult for the authorities to\ncomply with. An excessively short time limit would damage the quality of decision-making.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:25"},"new":["(4) Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 25 days, provided","that the reference medicinal product has","already been included in the public health","insurance system."],"old":["(4) Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the reference medicinal product has","already been included in the public health","insurance system."],"orig_lang":"hu","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"184","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-185","location":[["Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:25"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 90 days of its receipt. With respect","to medicines for which Member States use","health technology assessment as part of","their decision-making process, the time-","limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the reference medicinal product has","already been included in the public health","insurance system."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"185","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-62","location":[["Proposal for a directive","Recital 13"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:23"},"new":["deleted"],"old":["(13) The judicial remedies available in the","Member States have played a limited role","in ensuring compliance with the time","limits due to the often lengthy procedures","in national jurisdictions, which deter","affected companies from initiating legal","action. Therefore, effective mechanisms","are necessary to control and enforce","compliance with the time limits for","pricing and reimbursement decisions."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"62","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-63","justification":" Remedies procedures, including judicial procedures, are Member State matters which fall\n outside the scope of this directive, which deals with administrative procedures for approving\n the price of medicinal products and authorising the reimbursement of their cost under health\n insurance systems.","location":[["Proposal for a directive","Recital 13"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:23"},"new":["deleted"],"old":["(13) The judicial remedies available in the","Member States have played a limited role","in ensuring compliance with the time","limits due to the often lengthy procedures","in national jurisdictions, which deter","affected companies from initiating legal","action. Therefore, effective mechanisms","are necessary to control and enforce","compliance with the time limits for","pricing and reimbursement decisions."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"63","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-186","location":[["Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:25"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 90 days of its receipt. With respect","to generic medicinal products, that time","limit shall be 90 days, provided that the","reference medicinal product has already","been included in the public health","insurance system."],"old":["4. Member States shall ensure that a","decision on an application to include a","","","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","15 days, provided that the reference","medicinal product has already been","included in the public health insurance","system."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"186","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-187","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:26"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 90 days of its receipt. With respect","to generic medicinal products, that time","limit shall be 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","15 days, provided that the reference","medicinal product has already been","included in the public health insurance","","system."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"187","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-64","location":[[" Proposal for a directive","Recital 13"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:23"},"new":["deleted"],"old":["(13) The judicial remedies available in the","Member States have played a limited role","in ensuring compliance with the time","limits due to the often lengthy procedures","in national jurisdictions, which deter","affected companies from initiating legal","action. Therefore, effective mechanisms","are necessary to control and enforce","compliance with the time limits for","pricing and reimbursement decisions."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"64","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-188","justification":"The new time limits are unrealistic and go well beyond what is required to achieve the\nCommission\u2019s aim, namely that of ensuring the prompt availability of new medicinal products\nfor which a \u2018normal\u2019 marketing authorisation has been granted.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:26"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 90 days of its receipt. With respect","to generic medicinal products, that time","limit shall be 15 days, provided that the","reference medicinal product has already","been included in the public health","insurance system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the reference medicinal","product has already been included in the","public health insurance system."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"188","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-65","location":[[" Proposal for a directive","Recital 14"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:24"},"new":["(14) The quality, safety and efficacy of","medicinal products, including orphan","medicinal products and the bioequivalence","of generic or biosimilar medicinal products","with the reference product, are ascertained","in the framework of marketing","authorisation procedures."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the","framework of pricing and reimbursement","procedures, Member States should","therefore not re-assess the elements on","","which the marketing authorisation is","based, including the quality, safety,","efficacy or bioequivalence of the","medicinal product."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"65","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-189","justification":" The proposed 15-day time limit may be too short for authorities which could have adverse\n effects on the quality of the decision. Since biological medicinal products have lost or are\n about to lose their exclusivity rights, biosimilar medicines are a relatively new category of\n medicinal products, the timelines from submission to approval should therefore be 60 days\n maximum.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:26"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","25 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. With respect to biosimilar","medicinal products, that time limit shall","be 60 days, provided that the reference","medicinal product has already been","included in the public health insurance","system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","15 days, provided that the reference","medicinal product has already been","included in the public health insurance","system."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"189","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-66","location":[["Proposal for a directive","Recital 14"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:24"},"new":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","where legitimate reservations have arisen","from knowledge newly obtained, Member","States should therefore reassess the","elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the","marketing authorisation is based, including","the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"66","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-67","location":[["Proposal for a directive","Recital 14"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:24"},"new":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based (quality, safety,","efficacy or bioequivalence of the medicinal","product). Member States shall be","guaranteed full access to the data used by","the marketing authorisation authority in","assessing these elements, with a view to","evaluating the relative safety, efficacy and","effectiveness of the medicine in the","context of the health insurance scheme.","Competent authorities should also have","the right to request additional data for the","purpose of their evaluation."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"67","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-190","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[28126],"meta":{"created":"2019-07-03T05:27:26"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 90 days of its receipt. With respect","to generic medicinal products, that time","limit shall be 45 days, provided that the","reference medicinal product has already","been included in the public health","insurance system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","15 days, provided that the reference","medicinal product has already been","included in the public health insurance","system."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"190","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-68","justification":" The introduction of specific provisions for generic medicinal products is what provides the\n\nmain \u2018added value\u2019 of this recast. However, in order to cover all generic medicinal products,\nincluding biotherapies, it is necessary to introduce the concept of biosimilarity in addition to\nbioequivalence.","location":[[" Proposal for a directive","Recital 14"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:24"},"new":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product and","the similarity of biosimilar medicinal","products, are ascertained in the framework","of marketing authorisation procedures, and","Member States should have full access to","the data used in the marketing","authorisation procedure so that they can","assess the relative safety and efficacy of a","medicinal product in the context of pricing","and reimbursement procedures."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the","framework of pricing and reimbursement","procedures, Member States should","therefore not re-assess the elements on","which the marketing authorisation is","based, including the quality, safety,","efficacy or bioequivalence of the","medicinal product."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"68","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-191","location":[["Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:26"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 90 days of its receipt. With respect","to generic medicinal products, that time","limit shall be 45 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall","consider basing their decision on an","application to include a medicinal product","in the scope of the national health","insurance system on a health technology","assessment."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the reference medicinal","product has already been included in the","public health insurance system."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"191","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-192","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:26"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","30 days, provided that the generic product","is essentially similar to the reference","medicinal product, according to Directive","2001/83/EC and that the reference","medicinal product has already been","included in the public health insurance","system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","15 days, provided that the reference","medicinal product has already been","included in the public health insurance","system."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"192","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-69","justification":"Misinterpreting this recital could result in Member States being prevented from using data or\nrequesting additional data they need to assess the relative risk-benefit ratio and the relative\nefficacy of medicinal products by comparison with treatments already covered by their\nnational health insurance systems.","location":[["Proposal for a directive","Recital 14"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:24"},"new":["(14) Proof of the quality, safety and","efficacy of medicinal products, including","the bioequivalence of generic medicinal","products with the reference product, is","verified in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the essential elements (quality,","safety, efficacy or biosimilarity) on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product.","However, Member States must be","guaranteed full access to the data used by","the authorities responsible for granting","the marketing authorisation so that they","can assess the relative safety, efficiency","and efficacy of a medicinal product in the","context of its inclusion in the scope of the","mandatory health insurance system. The","competent authorities should also be able","to include or generate additional relevant","data for the purposes of assessing","medicinal products."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"69","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-193","justification":"Un seul r\u00e9gime de d\u00e9lai devrait \u00eatre fix\u00e9. Il devrait \u00eatre maintenu \u00e0 quatre-vingt-dix jours afin\nde ne pas mettre en danger la qualit\u00e9 de l\u2019\u00e9valuation des m\u00e9dicaments dans les Etats\nmembres et ainsi la qualit\u00e9 du service rendu au patient. En effet, la consultation publique\nr\u00e9alis\u00e9e par la commission europ\u00e9enne a montr\u00e9 que la majorit\u00e9 des parties prenantes, y\ncompris l\u2019industrie des princeps, consid\u00e8re les d\u00e9lais actuels satisfaisants. Ces d\u00e9lais sont\nn\u00e9cessaires \u00e0 une \u00e9valuation de qualit\u00e9, compte tenu de l\u2019existence de produits bas\u00e9s sur une\nrecherche de plus en plus complexe et innovante.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:26"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 90 days of its receipt. With respect","to generic medicinal products, that time","limit shall be 30 days, provided that the","reference medicinal product is essentially","similar, within the meaning of Directive","2001/83/EC, and has already been","included in the public health insurance","system. If generic medicinal products","display differences by comparison with","the reference medicinal product, for","example as regards their packaging or","their therapeutic indications, Member","States may provide for their re-","assessment."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the reference medicinal","product has already been included in the","public health insurance system."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"193","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-194","justification":" The 15-day time limit proposed by the Commission would be difficult for the authorities to\n comply with. An excessively short time limit would damage the quality of decision-making.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:26"},"new":["(5) If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 25 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["(5) If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 15 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"orig_lang":"hu","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"194","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate, Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-70","justification":" It would be unacceptable for the medical added value of these medicinal products to be called\n into question at national level, because that added value is the essential precondition for their\n authorisation at EU level. A clarification of this kind would in no way be at odds with the\n decision by the national authorities whether or not to reimburse the cost of an orphan\n medicinal product, but would in fact encourage national authorities to make greater use of\n the expertise acquired at European level.","location":[[" Proposal for a directive","Recital 14"]],"meps":[2025,96884],"meta":{"created":"2019-07-03T05:27:24"},"new":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product. Similarly, in the","case of orphan drugs, Member states shall","not re-assess the criteria of the orphan","designation."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"70","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-195","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:26"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall notify the applicant","without undue delay of the detailed","additional information required and take","their final decision within 60 days of","receipt of this additional information.","However, with respect to medicines for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","15 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Member States shall not request","any additional information which is not","explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","","","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 15 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"195","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-71","justification":"Clarification that this procedure refers only to generic medicines.","location":[[" Proposal for a directive","Recital 15"]],"meps":[2025],"meta":{"created":"2019-07-03T05:27:24"},"new":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic medicinal product, should not","request information concerning the patent","status of the reference medicinal product","and should not examine the validity of an","alleged violation of intellectual property","rights should the generic medicinal product","be manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and procedures for reimbursement","of generic medicines in the Member","States."],"old":["(15) In accordance with Directive","","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic medicinal product, should not","request information concerning the patent","status of the reference medicinal product","and should not examine the validity of an","alleged violation of intellectual property","rights should the generic medicinal product","be manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and reimbursement procedures in","the Member States."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"71","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-196","location":[["Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:26"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","medicinal products for which Member","States use health technology assessment as","part of their decision-making process, the","time limit shall likewise be 90 days. With","respect to generic medicinal products, that","time limit shall be 30 days, provided that","the reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 15 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"196","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-197","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:26"},"new":["5. If the information supporting the","application is inadequate, the time limit","shall be suspended and the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be 90 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the reference medicinal","product has already been included in the","public health insurance system. Member","States shall not request any additional","information which is not explicitly required","under national legislation or administrative","guidelines."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"197","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-72","location":[["Proposal for a directive","Recital 15"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:24"},"new":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","bioequivalent generic medicinal product,","should not request information concerning","the patent status of the reference medicinal","product, but they should be allowed to","examine the validity of an alleged violation","of intellectual property rights should the","bioequivalent generic medicinal product be","manufactured or placed on the market","subsequently to their decision. That","responsibility may not be removed from","Member States. Without prejudice to the","responsibility of Member States to","examine information, intellectual property","issues should neither interfere with nor","delay pricing and reimbursement","procedures in the Member States."],"old":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic medicinal product, should not","request information concerning the patent","status of the reference medicinal product","and should not examine the validity of an","alleged violation of intellectual property","rights should the generic medicinal product","be manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and reimbursement procedures in","the Member States."],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"72","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-198","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:26"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the reference medicinal","product has already been included in the","public health insurance system. Member","States shall not request any additional","information which is not explicitly","required under national legislation or","administrative guidelines."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"198","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-73","location":[[" Proposal for a directive","Recital 15 a (new)"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:24"},"new":["(15a) Member States should make the","relevant documents and information","publicly available in an appropriate","publication, in accordance with national","practice, which could include electronic","and online format. When publishing such","information, they should ensure that the","quantity of data supplied is reasonable","and not such as to jeopardise the","competitiveness of the EU."],"old":["",""],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"73","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-199","location":[["Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of what detailed additional","information is required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be 45 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be 15 days, provided that","the reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","","legislation or administrative guidelines."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"199","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-74","location":[["Proposal for a directive","Recital 15 a (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:24"},"new":["(15a) ) Member States should ensure the","public availability of documents and","information in an appropriate","publication, in accordance with national","practice, which should include electronic","and online formats."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"74","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-200","justification":" The proposed 15-day time limit may be too short for authorities which could have adverse\n effects on the quality of the decision. Since biological medicinal products have lost or are\n about to lose their exclusivity rights, biosimilar medicines are a relatively new category of\n medicinal products, the timelines from submission to approval should therefore be 60 days\n\nmaximum.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 25 days, provided","that the reference medicinal product has","already been included in the public health","insurance system. With respect to","biosimilars medicinal products, that time","limit shall be 60 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the reference medicinal product has","already been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"200","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-75","location":[["Proposal for a directive","Recital 15 b (new)"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:24"},"new":["(15b) The transparency, integrity, and","independence of decision-making within","national authorities should be ensured","through publication of the names of the","competent authorities and the procedural","steps leading to pricing and","reimbursement decisions."],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"75","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-201","location":[["Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[28126],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be 45 days, , provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the reference medicinal","product has already been included in the","public health insurance system. Member","States shall not request any additional","information which is not explicitly required","under national legislation or administrative","guidelines."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"201","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-76","location":[[" Proposal for a directive","Recital 15 b (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:24"},"new":["(15b) The principles of transparency,","integrity and independence of the","decision-making processes should be","carried out by national competent public","authorities, who are responsible for","pricing and reimbursement decisions."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"76","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-202","location":[["Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 30 days, provided","that the generic product is essentially","similar to the reference medicinal","product, according to Directive","2001/83/EC and that the reference","medicinal product has already been","included in the public health insurance","system."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the reference medicinal product has","already been included in the public health","insurance system. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"202","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-77","location":[[" Proposal for a directive","Recital 16"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:24"},"new":["deleted"],"old":["(16) Member States have frequently","amended their health insurance schemes","or adopted new measures falling within","the scope of Directive 89/105/EEC. It is","therefore necessary to establish","information mechanisms intended, on the","one hand, to ensure the consultation of","interested stakeholders and, on the other","hand, to facilitate preventive dialogue","with the Commission as regards the","application of this Directive."],"orig_lang":"cs","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"77","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-203","justification":"The 90-day time limit should be retained in order not to jeopardise the quality of assessments\nof medicinal products in the Member States and, therefore, the quality of the service provided\nto patients. The public consultation carried out by the Commission revealed that most\nstakeholders, including originator companies, regard the current time limits as satisfactory.\nThey are essential if proper assessments are to be carried out, given the existence of products\ndeveloped by means of ever more complex and innovative research.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of what detailed additional","information is required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the","reference medicinal product is essentially","similar, within the meaning of Directive","2001/83/EC of 6 November 2001, and has","already been included in the public health","insurance system."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be 15 days, provided that","the reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which","is not explicitly required under national","","legislation or administrative guidelines."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"203","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-78","location":[[" Proposal for a directive","Recital 16"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:24"},"new":["(16) Member States have frequently","amended their health insurance schemes or","adopted new measures falling within the","scope of Directive 89/105/EEC. It is","therefore necessary to establish","information mechanisms intended, on the","one hand, to ensure the consultation of","interested stakeholders including patient","and consumer organisations and, on the","other hand, to facilitate preventive dialogue","with the Commission as regards the","application of this Directive."],"old":["(16) Member States have frequently","","amended their health insurance schemes or","adopted new measures falling within the","scope of Directive 89/105/EEC. It is","therefore necessary to establish","information mechanisms intended, on the","one hand, to ensure the consultation of","interested stakeholders and, on the other","hand, to facilitate preventive dialogue with","the Commission as regards the application","of this Directive."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"78","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-204","justification":" The 30-day time limit proposed by the Commission would be difficult for the authorities to\n comply with. An excessively short time limit would damage the quality of decision-making.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:27"},"new":["(6) Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","50 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"old":["(6) Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","30 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5). ."],"orig_lang":"hu","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"204","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-79","location":[["Proposal for a directive","Recital 18"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:24"},"new":["deleted"],"old":["(18) In accordance with the Joint Political","Declaration of Member States and the","Commission on explanatory documents of","28 September 2011, Member States have","undertaken to accompany, in justified","cases, the notification of their","transposition measures with one or more","documents explaining the relationship","between the components of a directive and","the corresponding parts of national","transposition instruments. With regard to","this Directive, the legislator considers the","transmission of such documents to be","justified."],"orig_lang":"cs","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"79","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-205","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:27"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 180 days. With respect to","the medicinal products for which Member","States use health technology assessment as","part of their decision-making process, the","time limit shall likewise not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","60 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","30 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"205","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-80","justification":" In certain Member States, healthcare is managed simultaneously at national level and local\n level. So as to avoid creating unnecessary rises in waiting time and extra red tape, the\n Directive must ensure that there is no overlap in procedures at national, regional or local\n level.","location":[["Proposal for a directive","Article 1 \u2013 paragraph 1"]],"meps":[2025],"meta":{"created":"2019-07-03T05:27:25"},"new":["1. Member States shall ensure that any","national, regional or local measure,","whether laid down by law, regulation or","administrative action, to control the prices","of medicinal products for human use or to","determine the range of medicinal products","covered by public health insurance","systems, including the extent and","conditions of their coverage, complies with","the requirements of this Directive. Member","States shall ensure that these measures","are not duplicated at regional or local","level in their respective states."],"old":["1. Member States shall ensure that any","national, regional or local measure,","whether laid down by law, regulation or","administrative action, to control the prices","of medicinal products for human use or to","determine the range of medicinal products","covered by public health insurance","systems, including the extent and","conditions of their coverage, complies with","the requirements of this Directive."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"80","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-206","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:27"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 180 days, provided that","the reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5) or","suspended in accordance with the","provisions of the preceding paragraph."],"old":["6. Irrespective of the organisation of their","","","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time limit","shall not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"206","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-81","location":[[" Proposal for a directive","Article 1 \u2013 paragraph 1 \u2013 subparagraph 1a (new)"]],"meps":[28221],"meta":{"created":"2019-07-03T05:27:25"},"new":["This Directive shall also apply to","medicinal products which are available on","prescription, but are not refundable by the","national health insurance system."],"orig_lang":"de","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"81","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-207","location":[["Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:27"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 60 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time limit","shall not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"207","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-82","location":[["Proposal for a directive","Article 1 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:25"},"new":["(a) voluntary contractual agreements,","subject to verification of elements","concerning the efficacy and/or relative","efficacy or the proper use of the given","medicine, concluded between public","authorities and the holder of a marketing","authorisation for a medicinal product that","have as their object to enable the effective","provision of this medicine to patients under","specific conditions for the agreed period;"],"old":["(a) voluntary contractual agreements","concluded between public authorities and","the holder of a marketing authorisation for","a medicinal product that have as their","object to enable the effective provision of","this medicine to patients under specific","conditions;"],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"82","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-208","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:27"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 90 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time limit","shall not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"208","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Horst Schnellhardt, Anja Weisgerber, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-83","justification":"Even prices set under voluntary agreements should be notified to the distribution points to\nallow the sale of the cheapest medicines.","location":[["Proposal for a directive","Article 1 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[1930,28227,28221],"meta":{"created":"2019-07-03T05:27:25"},"new":["(a) voluntary contractual agreements","concluded between public authorities and","the holder of a marketing authorisation for","a medicinal product that have as their","object to enable the effective provision of","this medicine to patients under specific","conditions, provided that such","arrangements also meet the transparency","requirements of Article 5, paragraph 3 a","(new);"],"old":["(a) voluntary contractual agreements","concluded between public authorities and","the holder of a marketing authorisation for","a medicinal product that have as their","object to enable the effective provision of","this medicine to patients under specific","conditions;"],"orig_lang":"de","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"83","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-209","justification":"The proposed 30-day time limit may be too short for authorities which could have adverse\neffects on the quality of the decision. Since biological medicinal products have lost or are\nabout to lose their exclusivity rights, biosimilar medicines are a relatively new category of\nmedicinal products, the timelines from submission to approval should therefore be 120 days\nmaximum.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:27"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","50 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. With respect to biosimilar","medicinal products, that time limit shall","not exceed 120 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","30 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"209","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-84","location":[[" Proposal for a directive","Article 1 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:25"},"new":["deleted"],"old":["The provisions of this Directive shall","apply to measures intended to determine","which medicinal products may be","included in contractual agreements or","public procurement procedures."],"orig_lang":"cs","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"84","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate, Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-85","justification":" The Directive should govern decision-making procedures in respect of pricing and\n reimbursement of pharmaceutical products and not redefine processes for granting marketing\n authorisations. Marketing authorisations are governed by Directive 2001/83/EC, which lists\n the criteria applicable to the quality, safety and efficacy of a product.","location":[[" Proposal for a directive","Article 1 \u2013 paragraph 3 a (new)"]],"meps":[2025,96884],"meta":{"created":"2019-07-03T05:27:25"},"new":["3a. This Directive may not call into","question granted as per the procedure","referred to in Article 6 of Directive","2001/83/EC."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"85","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-210","location":[["Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[28126],"meta":{"created":"2019-07-03T05:27:27"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 90 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time limit","shall not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"210","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-86","location":[[" Proposal for a directive","Article 2 \u2013 point 3 a (new)"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:25"},"new":["(3a) \"biosimilar medicinal product\"","means a similar biological medicinal","product approved in accordance with","Article 10(4) of Directive 2001/83/EC;"],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"86","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-211","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:28"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","60 days, provided that the generic product","is essentially similar to the reference","medicinal product, according to Directive","2001/83/EC and that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","30 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","","Article or Article 3(5)."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"211","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-87","justification":"The introduction of specific provisions for generic medicinal products is what provides the\nmain \u2018added value\u2019 of this recast. However, in order to cover all generic medicinal products,\nincluding biotherapies, it is necessary to introduce the concept of biosimilarity in addition to\nbioequivalence.","location":[["Proposal for a directive","Article 2 \u2013 point 3 a (new)"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:25"},"new":["3a) \u2018biosimilar medicinal product\u2019 means","a similar biological medicinal product","approved in accordance with Article 10(4)","of Directive 2001/83/EC;"],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"87","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-212","justification":"Un seul r\u00e9gime de d\u00e9lai devrait \u00eatre fix\u00e9. Il devrait \u00eatre maintenu \u00e0 quatre-vingt-dix jours afin\nde ne pas mettre en danger la qualit\u00e9 de l\u2019\u00e9valuation des m\u00e9dicaments dans les Etats\nmembres et ainsi la qualit\u00e9 du service rendu au patient. En effet, la consultation publique\nr\u00e9alis\u00e9e par la commission europ\u00e9enne a montr\u00e9 que la majorit\u00e9 des parties prenantes, y\ncompris l\u2019industrie des princeps, consid\u00e8re les d\u00e9lais actuels satisfaisants. Ces d\u00e9lais sont\nn\u00e9cessaires \u00e0 une \u00e9valuation de qualit\u00e9, compte tenu de l\u2019existence de produits bas\u00e9s sur une\nrecherche de plus en plus complexe et innovante. M\u00eame s\u2019il est souhaitable d\u2019acc\u00e9l\u00e9rer la\n\n prise de d\u00e9cision pour les m\u00e9dicaments g\u00e9n\u00e9riques dont le m\u00e9dicament de r\u00e9f\u00e9rence a d\u00e9j\u00e0\n \u00e9t\u00e9 \u00e9valu\u00e9, l\u2019\u00e9valuation des m\u00e9dicaments g\u00e9n\u00e9riques devrait rester possible si le m\u00e9dicament\n concern\u00e9 n\u2019est pas essentiellement similaire au m\u00e9dicament de r\u00e9f\u00e9rence. En effet, certains\n m\u00e9dicaments g\u00e9n\u00e9riques peuvent diff\u00e9rer du m\u00e9dicament de r\u00e9f\u00e9rence quant au\n conditionnement ou encore aux indications th\u00e9rapeutiques. Par cons\u00e9quent, des d\u00e9lais\n suffisants devraient permettre aux autorit\u00e9s comp\u00e9tentes de r\u00e9aliser une \u00e9valuation de ces\n m\u00e9dicaments de qualit\u00e9.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:28"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 180 days. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the","reference medicinal product is essentially","similar, within the meaning of Directive","2001/83/EC, and has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time limit","shall not exceed 180 days. With respect to","generic medicinal products, that time limit","shall not exceed 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Those time-limits may","be extended in accordance with paragraph","5 of this Article or Article 3(5)."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"212","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-88","justification":" Setting a definition of health technologies is arbitrary and unjustified because there is\n currently no common interpretation of what is meant by this concept. Coupled with the\n introduction of two different systems governing deadlines for approving the price and\n authorising the reimbursement of non-generic medicinal products, setting such a definition\n would further complicate matters.","location":[["Proposal for a directive","Article 2 \u2013 point 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:25"},"new":["deleted"],"old":["4) \u201chealth technology\u201d means a health","technology as defined in point (l) of","Article 3 of Directive 2011/24/EU of the","European Parliament and of the Council;"],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"88","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-213","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 7 \u2013 subparagraph 2"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:28"},"new":["The decisions referred to in this paragraph","shall also include any evaluation, expert","opinion or recommendation on which they","are based. The applicant shall be informed","of all remedies available, including judicial","remedies, of the time limits for applying","for such remedies."],"old":["The decisions referred to in this paragraph","shall also include any evaluation, expert","opinion or recommendation on which they","are based. The applicant shall be informed","of all remedies available, including judicial","remedies, and the remedies procedure set","out Article 8, of the time limits for","applying for such remedies."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"213","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-89","justification":" Setting a definition of health technology assessment is arbitrary and unjustified because there\n is currently no common interpretation of what is meant by this concept. Coupled with the\n introduction of two different systems governing deadlines for approving the price and\n authorising the reimbursement of non-generic medicinal products, setting such a definition\n would further complicate matters.","location":[[" Proposal for a directive","Article 2 \u2013 point 5"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:25"},"new":["deleted"],"old":["5) \u201chealth technology assessment\u201d means","an assessment of the relative efficacy or of","the short- and long-term effectiveness of","the medicinal product compared to other","health technologies in use for treating the","associated condition."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"89","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-214","justification":"Remedies procedures, including judicial procedures, already exist in the Member States.\nWhat is more, these procedures are Member State matters which fall outside the scope of this\ndirective, which deals with administrative procedures for approving the price of medicinal\nproducts and authorising the reimbursement of their cost under health insurance systems.","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 7 \u2013 subparagraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:28"},"new":["Les d\u00e9cisions vis\u00e9es au pr\u00e9sent paragraphe","contiennent \u00e9galement toute \u00e9valuation,","tout avis d'expert ou toute recommandation","d'expert sur lesquels elles s'appuient. The","applicant shall be informed of all remedies","available, including judicial remedies, and","of the time limits for applying for such","remedies."],"old":["The decisions referred to in this paragraph","shall also include any evaluation, expert","opinion or recommendation on which they","are based. The applicant shall be informed","of all remedies available, including judicial","remedies, and the remedies procedure set","out Article 8, of the time limits for","applying for such remedies."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"214","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese, Zofija Mazej Kukovi\u010d, Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-90","justification":"The scope of the Directive needs to be clarified to be non-ambiguous. Although the term\n\u201cagreement\u201d implies that the parties freely accepted their contractual obligations, there may\nbe cases where marketing authorisation holders are at least factually forced to enter into an\nagreement in order to have access to the market. In such cases, the marketing authorisation\nholder\u2019s only other option would be to refrain from concluding the agreement and to accept\nto be barred from the market. In order to ensure that agreements are not used as a loophole\nto avoid the applicability of the Directive, a definition of \u201cvoluntary contractual agreements\u201d\nshould be included.","location":[[" Proposal for a directive","Article 2 \u2013 point 5 a (new)"]],"meps":[1927,39916,28227],"meta":{"created":"2019-07-03T05:27:25"},"new":["(5a) \"voluntary contractual agreement\"","as referred to in Article 1(2), point (a)","means an agreement concluded between","public authorities and the marketing","authorisation holder for a medicinal","product which is neither mandatory or","required by law nor is the agreement the","only alternative to be included in the","national pricing and reimbursement","scheme."],"old":[""],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"90","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Andres Perello Rodriguez","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-215","location":[["Proposal for a directive","Article 7 \u2013 paragraph 7 \u2013 subparagraph 2 a (new)"]],"meps":[96989],"meta":{"created":"2019-07-03T05:27:28"},"new":["The criteria governing the decisions","referred to in the previous paragraph","shall include assessments of unmet","medical needs and of the clinical benefits,","the social benefits, innovation and","protection of the most vulnerable groups","in the population."],"orig_lang":"es","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"215","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Andres Perello Rodriguez","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-91","location":[["Proposal for a directive","Article 2 \u2013 point 5 a (new)"]],"meps":[96989],"meta":{"created":"2019-07-03T05:27:25"},"new":["(5a) \u2018Vulnerable groups\u2019: those sections","of the population most sensitive to","measures determining the extent to which","medicinal products are covered by public","health insurance systems, such as","children, pensioners, the unemployed,","those reliant on orphan drugs, the","chronically ill, etc."],"orig_lang":"es","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"91","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-216","justification":" As the decision whether or not to include a medicinal product within the scope of the public\n health insurance system is a national matter, Member States should not be required to\n communicate their assessment criteria to the Commission.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 8"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:28"},"new":["deleted"],"old":["8. Member States shall publish in an","appropriate publication and communicate","to the Commission the criteria which the","competent authorities must take into","account when deciding whether or not to","include medicinal products within the","scope of the public health insurance","system."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"216","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-92","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:26"},"new":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder at any point in time."],"old":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder at any point in time.","The competent authorities shall provide","the applicant with an official","acknowledgement of receipt."],"orig_lang":"cs","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"92","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Andres Perello Rodriguez","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-217","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 8"]],"meps":[96989],"meta":{"created":"2019-07-03T05:27:28"},"new":["8. Member States shall publish in an","appropriate publication and communicate","to the Commission the criteria which the","competent authorities must take into","account when deciding whether or not to","include medicinal products within the","scope of the public health insurance","system.These criteria shall include","assessments of unmet medical needs and","of the clinical benefits, the social benefits,","innovation and the protection of the most","vulnerable groups of the population."],"old":["8. Member States shall publish in an","appropriate publication and communicate","to the Commission the criteria which the","competent authorities must take into","account when deciding whether or not to","include medicinal products within the","scope of the public health insurance","system."],"orig_lang":"es","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"217","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-93","justification":" A number of Member States already authorise applicants to submit a Price and\n Reimbursement Application once the Committee for Medicinal Products for Human Use or a\n competent national authority of a Member State has delivered a favourable opinion. In this\n way a dialogue is opened at an early stage, making it more likely that the time limits laid\n down in the directive will be complied with and thus facilitating patient access to new\n medicinal products.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 2"]],"meps":[2025],"meta":{"created":"2019-07-03T05:27:26"},"new":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder at any point in time or","by the applicant once the Committee for","Medicinal Products for Human Use (set","up by Regulation (EC) No 726/2004) or a","competent national authority has","delivered a favourable opinion. The","competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder at any point in time.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"93","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-94","justification":"Clarification of the wording and removal of the phrase \u2018at any point in time\u2019, which is a\nsource of legal uncertainty.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:26"},"new":["2. Member States shall guarantee that the","marketing authorisation holder has the","possibility to introduce an application to","approve the price of the product. The","competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the","marketing authorisation holder at any","point in time. The competent authorities","shall provide the applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"94","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-218","location":[[" Proposal for a directive","Article 8"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:28"},"new":["deleted"],"old":["Article 8","","","","","Remedies procedure in case of non-","compliance with the time limits related to","the inclusion of medicinal products in","health insurance systems","","1. Member States shall ensure that","effective and rapid remedies are available","to the applicant in case of non-","compliance with the time limits set in","Article 7.","2. For the purposes of the remedies","procedure Member States shall designate","a body and entrust it with the powers to:","","(a) take, at the earliest opportunity","and by way of interlocutory procedures,","interim measures with the aim of","correcting the alleged infringement or","preventing further damage to the interests","concerned;","(b) award damages to the applicant in","case of non-compliance with time limits","set in Article 7 where damages are","claimed, unless the competent authority","may prove that the delay is not imputable","to it;","(c) impose a penalty payment,","calculated by day of delay.","For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, the need to ensure that the","penalty itself is a deterrent to further","infringements.","","Member States may provide that the body","referred to in the first subparagraph may","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits.","","","","3. A decision not to grant interim measure","shall not prejudice any other claim of the","applicant seeking such measures.","4. Member States shall ensure that","decisions taken by bodies responsible for","remedies procedures can be effectively","enforced.","5. The body referred to in paragraph 2","shall be independent of the competent","authorities in charge of controlling the","prices of medicinal products for human","use or in charge of determining the range","of medicinal products covered by health","insurance systems.","6. The body referred to in paragraph 2","shall state reasons for its decision.","Furthermore, where that body is not","judicial in character, provision must be","made to guarantee procedures whereby","any allegedly illegal measure taken by the","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the","European Union and independent of both","the competent authority and the body","referred to in paragraph 2.","The members of the body referred to in","paragraph 2 shall be appointed and leave","office under the same conditions as","members of the judiciary as regards the","authority responsible for their","appointment, their period of office, and","their removal. At least the president of","that body shall have the same legal and","professional qualifications as members of","the judiciary. That body shall take its","decisions following a procedure in which","both sides are heard, and these decisions","shall, by means determined by each","Member State, be legally binding."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"218","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-95","location":[["Proposal for a directive","Article 3 \u2013 paragraph 2"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:26"},"new":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder at any point in time.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"95","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-96","justification":" This proposal would considerably increase the administrative burden on the competent\n authorities, who would be submerged with applications following any decision to turn down\n an application, even if circumstances have not changed.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:26"},"new":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the marketing","authorisation holder at any point in time.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"96","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-219","justification":"This proposal, in addition to being questionable in terms of compliance with the subsidiarity\nprinciple, adds complexity and redundancy by comparison with the existing arrangements. It\nwould impose an unnecessary administrative and financial burden, since remedies\nprocedures, including judicial procedures, already exist in the Member States. What is more,\nthese procedures fall outside the scope of this directive, which deals with administrative\nprocedures for approving the price of medicinal products and authorising the reimbursement\nof their cost under health insurance systems.","location":[["Proposal for a directive","Article 8"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:28"},"new":["deleted"],"old":["Article 8","Remedies procedure in case of non-","compliance with the time limits related to","the inclusion of medicinal products in","health insurance systems","1. Member States shall ensure that","effective and rapid remedies are available","to the applicant in case of non-","compliance with the time limits set in","Article 7.","2. For the purposes of the remedies","procedure Member States shall designate","a body and entrust it with the powers to:","(a) take, at the earliest opportunity and by","way of interlocutory procedures, interim","measures with the aim of correcting the","alleged infringement or preventing","further damage to the interests","concerned;","(b) award damages to the applicant in","case of non-compliance with time limits","set in Article 7 where damages are","claimed, unless the competent authority","may prove that the delay is not imputable","to it;","(c) impose a penalty payment, calculated","by day of delay.","","For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, the need to ensure that the","penalty itself is a deterrent to further","infringements.","Member States may provide that the body","referred to in the first subparagraph may","","","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits.","3. A decision not to grant interim measure","shall not prejudice any other claim of the","applicant seeking such measures.","4. Member States shall ensure that","decisions taken by bodies responsible for","remedies procedures can be effectively","enforced.","5. The body referred to in paragraph 2","shall be independent of the competent","authorities in charge of controlling the","prices of medicinal products for human","use or in charge of determining the range","of medicinal products covered by health","insurance systems.","6. The body referred to in paragraph 2","shall state reasons for its decision.","Furthermore, where that body is not","judicial in character, provision must be","made to guarantee procedures whereby","any allegedly illegal measure taken by the","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the","European Union and independent of both","the competent authority and the body","referred to in paragraph 2.","The members of the body referred to in","paragraph 2 shall be appointed and leave","office under the same conditions as","members of the judiciary as regards the","authority responsible for their","appointment, their period of office, and","their removal. At least the president of","that body shall have the same legal and","professional qualifications as members of","the judiciary. That body shall take its","","decisions following a procedure in which","both sides are heard, and these decisions","shall, by means determined by each","Member State, be legally binding."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"219","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-220","location":[["Proposal for a directive","Article 8"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:28"},"new":["deleted"],"old":["Article 8","Remedies procedure in case of non-","compliance with the time limits related to","the inclusion of medicinal products in","health insurance systems","1. Member States shall ensure that","effective and rapid remedies are available","to the applicant in case of non-","compliance with the time limits set in","Article 7.","2. For the purposes of the remedies","procedure Member States shall designate","a body and entrust it with the powers to:","(a) take, at the earliest opportunity and by","way of interlocutory procedures, interim","measures with the aim of correcting the","alleged infringement or preventing","further damage to the interests","","","concerned;","(b) award damages to the applicant in","case of non-compliance with time limits","set in Article 7 where damages are","claimed, unless the competent authority","may prove that the delay is not imputable","to it;","(c) impose a penalty payment, calculated","by day of delay.","For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, the need to ensure that the","penalty itself is a deterrent to further","infringements.","Member States may provide that the body","referred to in the first subparagraph may","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits.","3. A decision not to grant interim measure","shall not prejudice any other claim of the","applicant seeking such measures.","4. Member States shall ensure that","decisions taken by bodies responsible for","remedies procedures can be effectively","enforced.","5. The body referred to in paragraph 2","shall be independent of the competent","authorities in charge of controlling the","prices of medicinal products for human","use or in charge of determining the range","of medicinal products covered by health","insurance systems.","6. The body referred to in paragraph 2","shall state reasons for its decision.","Furthermore, where that body is not","judicial in character, provision must be","made to guarantee procedures whereby","any allegedly illegal measure taken by the","","","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the","European Union and independent of both","the competent authority and the body","referred to in paragraph 2.","The members of the body referred to in","paragraph 2 shall be appointed and leave","office under the same conditions as","members of the judiciary as regards the","authority responsible for their","appointment, their period of office, and","their removal. At least the president of","that body shall have the same legal and","professional qualifications as members of","the judiciary. That body shall take its","decisions following a procedure in which","both sides are heard, and these decisions","shall, by means determined by each","Member State, be legally binding."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"220","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-97","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 2 \u2013 subparagraph 1a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:26"},"new":["This Article shall not prevent Member","States to refuse repeated applications","following a negative decision if the","circumstances have not significantly","changed."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"97","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-221","location":[["Proposal for a directive","Article 8"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:28"},"new":["deleted"],"old":["Article 8","Remedies procedure in case of non-","compliance with the time limits related to","the inclusion of medicinal products in","health insurance systems","1. Member States shall ensure that","effective and rapid remedies are available","to the applicant in case of non-","compliance with the time limits set in","Article 7.","","","2. For the purposes of the remedies","procedure Member States shall designate","a body and entrust it with the powers to:","(a) take, at the earliest opportunity and by","way of interlocutory procedures, interim","measures with the aim of correcting the","alleged infringement or preventing","further damage to the interests","concerned;","(b) award damages to the applicant in","case of non-compliance with time limits","set in Article 7 where damages are","claimed, unless the competent authority","may prove that the delay is not imputable","to it;","(c) impose a penalty payment, calculated","by day of delay.","For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, and the need to ensure that the","penalty itself is a deterrent to further","infringements.","Member States may provide that the body","referred to in the first subparagraph may","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits.","3. A decision not to grant interim measure","shall not prejudice any other claim of the","applicant seeking such measures.","4. Member States shall ensure that","decisions taken by bodies responsible for","remedies procedures can be effectively","enforced.","5. The body referred to in paragraph 2","shall be independent of the competent","authorities in charge of controlling the","prices of medicinal products for human","use or in charge of determining the range","","","of medicinal products covered by health","insurance systems.","6. The body referred to in paragraph 2","shall state reasons for its decision.","Furthermore, where that body is not","judicial in character, provision must be","made to guarantee procedures whereby","any allegedly illegal measure taken by the","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the","European Union and independent of both","the competent authority and the body","referred to in paragraph 2.","The members of the body referred to in","paragraph 2 shall be appointed and leave","office under the same conditions as","members of the judiciary as regards the","authority responsible for their","appointment, their period of office, and","their removal. At least the president of","that body shall have the same legal and","professional qualifications as members of","the judiciary. That body shall take its","decisions following a procedure in which","both sides are heard, and these decisions","shall, by means determined by each","Member State, be legally binding."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"221","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-98","justification":"The 15-day time limit proposed by the Commission would be difficult for the authorities to\ncomply with. An excessively short time limit would damage the quality of decision-making.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:26"},"new":["(3) Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 25 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities."],"old":["(3) Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 15 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities."],"orig_lang":"hu","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"98","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-99","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:26"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","medicinal products for which Member","States use health technology assessment as","part of their decision-making process, the","time limit shall likewise be 90 days. With","respect to generic medicinal products, that","time limit shall be 30 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the price of the reference medicinal","product has been approved by the","competent authorities."],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"99","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-222","location":[["Proposal for a directive","Article 8"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:28"},"new":["Member States shall ensure that effective","and rapid remedies are available to the","applicant in case of non-compliance with","the time limits set in Article 7.","deleted"],"old":["1. Member States shall ensure that","effective and rapid remedies are available","to the applicant in case of non-compliance","","with the time limits set in Article 7.","2. For the purposes of the remedies","procedure Member States shall designate","a body and entrust it with the powers to:","(a) take, at the earliest opportunity and by","way of interlocutory procedures, interim","measures with the aim of correcting the","alleged infringement or preventing","further damage to the interests","concerned;","(b) award damages to the applicant in","case of non-compliance with time limits","set in Article 7 where damages are","claimed, unless the competent authority","may prove that the delay is not imputable","to it;","(c) impose a penalty payment, calculated","by day of delay.","For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, the need to ensure that the","penalty itself is a deterrent to further","infringements.","Member States may provide that the body","referred to in the first subparagraph may","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits.","3. A decision not to grant interim measure","shall not prejudice any other claim of the","applicant seeking such measures.","4. Member States shall ensure that","decisions taken by bodies responsible for","remedies procedures can be effectively","enforced.","5. The body referred to in paragraph 2","shall be independent of the competent","authorities in charge of controlling the","prices of medicinal products for human","","use or in charge of determining the range","of medicinal products covered by health","insurance systems.","6. The body referred to in paragraph 2","shall state reasons for its decision.","Furthermore, where that body is not","judicial in character, provision must be","made to guarantee procedures whereby","any allegedly illegal measure taken by the","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the","European Union and independent of both","the competent authority and the body","referred to in paragraph 2.","The members of the body referred to in","paragraph 2 shall be appointed and leave","office under the same conditions as","members of the judiciary as regards the","authority responsible for their","appointment, their period of office, and","their removal. At least the president of","that body shall have the same legal and","professional qualifications as members of","the judiciary. That body shall take its","decisions following a procedure in which","both sides are heard, and these decisions","shall, by means determined by each","Member State, be legally binding."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"222","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-100","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:26"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"100","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-101","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:26"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","generic medicinal products, that time limit","shall be 90 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"101","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-223","justification":"Although it is essential that the Member States should make provision for remedies\nprocedures, the Commission has exceeded its powers by laying down overly prescriptive\nimplementing arrangements. It is also difficult to accept that an authority should be required\nto pay damages to a pharmaceuticals firm as a result of its failure to comply with a time limit.","location":[["Proposal for a directive","Article 8"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:28"},"new":["Member States shall ensure that effective","and rapid remedies are available to the","applicant in case of non-compliance with","the time limits set in Article 7."],"old":["1. Member States shall ensure that","effective and rapid remedies are available","","to the applicant in case of non-compliance","with the time limits set in Article 7.","2. For the purposes of the remedies","procedure Member States shall designate","a body and entrust it with the powers to:","(a) take, at the earliest opportunity and by","way of interlocutory procedures, interim","measures with the aim of correcting the","alleged infringement or preventing","further damage to the interests","concerned;","(b) award damages to the applicant in","case of non-compliance with time limits","set in Article 7 where damages are","claimed, unless the competent authority","may prove that the delay is not imputable","to it;","(c) impose a penalty payment, calculated","by day of delay.","For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, the need to ensure that the","penalty itself is a deterrent to further","infringements.","Member States may provide that the body","referred to in the first subparagraph may","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits.","3. A decision not to grant interim measure","shall not prejudice any other claim of the","applicant seeking such measures.","4. Member States shall ensure that","decisions taken by bodies responsible for","remedies procedures can be effectively","enforced.","5. The body referred to in paragraph 2","shall be independent of the competent","authorities in charge of controlling the","","prices of medicinal products for human","use or in charge of determining the range","of medicinal products covered by health","insurance systems.","6. The body referred to in paragraph 2","shall state reasons for its decision.","Furthermore, where that body is not","judicial in character, provision must be","made to guarantee procedures whereby","any allegedly illegal measure taken by the","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the","European Union and independent of both","the competent authority and the body","referred to in paragraph 2.","The members of the body referred to in","paragraph 2 shall be appointed and leave","office under the same conditions as","members of the judiciary as regards the","authority responsible for their","appointment, their period of office, and","their removal. At least the president of","that body shall have the same legal and","professional qualifications as members of","the judiciary. That body shall take its","decisions following a procedure in which","both sides are heard, and these decisions","shall, by means determined by each","Member State, be legally binding."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"223","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-102","justification":" The new deadlines are unrealistic and go well beyond what is necessary to attain the\n objective pursued by the Commission, namely the rapid availability of new treatments that\n have a \u2018normal\u2019 marketing authorisation.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:26"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","","","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be 15 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"102","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-224","location":[[" Proposal for a directive","Article 8"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:29"},"new":["Member States shall ensure that effective","and rapid remedies are available to the","applicant in case of non-compliance with","the time limits set in Article 7.","deleted"],"old":["1. Member States shall ensure that","effective and rapid remedies are available","to the applicant in case of non-compliance","with the time limits set in Article 7.","2. For the purposes of the remedies","procedure Member States shall designate","a body and entrust it with the powers to:","(a) take, at the earliest opportunity and by","way of interlocutory procedures, interim","measures with the aim of correcting the","alleged infringement or preventing","further damage to the interests","concerned;","(b) award damages to the applicant in","case of non-compliance with time limits","set in Article 7 where damages are","claimed, unless the competent authority","may prove that the delay is not imputable","to it;","(c) impose a penalty payment, calculated","by day of delay.","For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, the need to ensure that the","penalty itself is a deterrent to further","infringements.","Member States may provide that the body","referred to in the first subparagraph may","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits.","","","","3. A decision not to grant interim measure","shall not prejudice any other claim of the","applicant seeking such measures.","4. Member States shall ensure that","decisions taken by bodies responsible for","remedies procedures can be effectively","enforced.","5. The body referred to in paragraph 2","shall be independent of the competent","authorities in charge of controlling the","prices of medicinal products for human","use or in charge of determining the range","of medicinal products covered by health","insurance systems.","6. The body referred to in paragraph 2","shall state reasons for its decision.","Furthermore, where that body is not","judicial in character, provision must be","made to guarantee procedures whereby","any allegedly illegal measure taken by the","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the","European Union and independent of both","the competent authority and the body","referred to in paragraph 2.","The members of the body referred to in","paragraph 2 shall be appointed and leave","office under the same conditions as","members of the judiciary as regards the","authority responsible for their","appointment, their period of office, and","their removal. At least the president of","that body shall have the same legal and","professional qualifications as members of","the judiciary. That body shall take its","decisions following a procedure in which","both sides are heard, and these decisions","shall, by means determined by each","Member State, be legally binding."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"224","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-103","justification":"The proposed 15-day time limit may be too short for authorities which could have adverse\neffects on the quality of the decision. Since biological medicinal products have lost or are\nabout to lose their exclusivity rights, biosimilar medicines are a relatively new category of\nmedicinal products, the timelines from submission to approval should therefore be 60 days\nmaximum.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:26"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 25 days, provided","that the price of the reference medicinal","product has been approved by the","competent authorities. With respect to","biosimilar medicinal products, that time","limit shall be 60 days, provided that the","price of the reference medicinal product","has been approved by the competent","authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the price of the reference medicinal","product has been approved by the","competent authorities."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"103","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-225","justification":" The requirement that the competent authorities should provide an expert opinion or\n recommendation in support of every decision which runs counter to the commercial interests\n of manufacturers is disproportionate.","location":[[" Proposal for a directive","Article 9 \u2013 paragraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:29"},"new":["1. Any decision to exclude a medicinal","product from the scope of the public health","insurance system, or to modify the extent","or the conditions of coverage of the","product concerned, shall contain a","statement of reasons based on objective","and verifiable criteria. The applicant shall","be informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"old":["1. Any decision to exclude a medicinal","product from the scope of the public health","insurance system, or to modify the extent","or the conditions of coverage of the","product concerned, shall contain a","statement of reasons based on objective","and verifiable criteria. Such decisions","shall include any evaluation, expert","opinion or recommendation on which","they are based. The applicant shall be","informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"225","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Andres Perello Rodriguez","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-226","location":[[" Proposal for a directive","Article 9 \u2013 paragraph 1"]],"meps":[96989],"meta":{"created":"2019-07-03T05:27:29"},"new":["1. Any decision to exclude a medicinal","product from the scope of the public health","insurance system, or to modify the extent","or the conditions of coverage of the","product concerned, shall contain a","statement of reasons based on objective","and verifiable criteria. Such decisions shall","include assessments of unmet medical","needs, the clinical impact and social costs,","the protection of the most vulnerable","groups of the population and any","evaluation, expert opinion or","recommendation on which they are based.","The applicant shall be informed of all","remedies available, including judicial","remedies, and of the time limits for","applying for such remedies."],"old":["1. Any decision to exclude a medicinal","product from the scope of the public health","insurance system, or to modify the extent","or the conditions of coverage of the","product concerned, shall contain a","statement of reasons based on objective","","and verifiable criteria. Such decisions shall","include any evaluation, expert opinion or","recommendation on which they are based.","The applicant shall be informed of all","remedies available, including judicial","remedies, and of the time limits for","applying for such remedies."],"orig_lang":"es","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"226","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-104","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[28126],"meta":{"created":"2019-07-03T05:27:26"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","generic medicinal products, that time limit","shall be 45 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"104","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-227","justification":"The requirement that the authorities should provide a detailed justification for any decision to\nexclude a medicinal product from the scope of the public health insurance system and which\nthus runs counter to the commercial interests of manufacturers is disproportionate.","location":[["Proposal for a directive","Article 9 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:29"},"new":["2. Any decision to exclude a category of","medicinal products from the scope of the","public health insurance system, or to","modify the extent or the conditions of","coverage of the category concerned, shall","contain a statement of reasons based on","objective and verifiable criteria."],"old":["2. Any decision to exclude a medicinal","product from the scope of the public health","insurance system, or to modify the extent","or the conditions of coverage of the","product concerned, shall contain a","statement of reasons based on objective","and verifiable criteria and be published in","an appropriate publication."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"227","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-105","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:26"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","generic medicinal products, that time limit","shall be 45 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities.","Member States shall consider basing their","decision on the price which may be","charged for a medicinal produce on a","health technology assessment."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be 15 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"105","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Andres Perello Rodriguez","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-228","location":[[" Proposal for a directive","Article 9 \u2013 paragraph 2"]],"meps":[96989],"meta":{"created":"2019-07-03T05:27:29"},"new":["2. Any decision to exclude a category of","medicinal products from the scope of the","public health insurance system, or to","modify the extent or the conditions of","coverage of the category concerned, shall","contain a statement of reasons based on","objective and verifiable criteria and be","published in an appropriate publication.","These criteria shall include assessments","of unmet medical needs, the clinical","impact and social costs and the protection","of the most vulnerable groups of the","population"],"old":["2. Any decision to exclude a category of","medicinal products from the scope of the","public health insurance system, or to","modify the extent or the conditions of","coverage of the category concerned, shall","contain a statement of reasons based on","objective and verifiable criteria and be","published in an appropriate publication."],"orig_lang":"es","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"228","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-106","justification":"Un seul r\u00e9gime de d\u00e9lai devrait \u00eatre fix\u00e9. Il devrait \u00eatre maintenu \u00e0 quatre-vingt-dix jours afin\nde ne pas mettre en danger la qualit\u00e9 de l\u2019\u00e9valuation des m\u00e9dicaments dans les Etats\nmembres et ainsi la qualit\u00e9 du service rendu au patient. En effet, la consultation publique\nr\u00e9alis\u00e9e par la Commission europ\u00e9enne a montr\u00e9 que la majorit\u00e9 des parties prenantes, y\ncompris l\u2019industrie des princeps, consid\u00e8re les d\u00e9lais actuels satisfaisants. Ces d\u00e9lais sont\nn\u00e9cessaires \u00e0 une \u00e9valuation de qualit\u00e9, compte tenu de l\u2019existence de produits bas\u00e9s sur une\nrecherche de plus en plus complexe et innovante.M\u00eame s\u2019il est souhaitable d\u2019acc\u00e9l\u00e9rer la\nprise de d\u00e9cision pour les m\u00e9dicaments g\u00e9n\u00e9riques dont le m\u00e9dicament de r\u00e9f\u00e9rence a d\u00e9j\u00e0\n\u00e9t\u00e9 \u00e9valu\u00e9, l\u2019\u00e9valuation des m\u00e9dicaments g\u00e9n\u00e9riques devrait rester possible si le m\u00e9dicament\nconcern\u00e9 n\u2019est pas essentiellement similaire au m\u00e9dicament de r\u00e9f\u00e9rence. En effet, certains\nm\u00e9dicaments g\u00e9n\u00e9riques peuvent diff\u00e9rer du m\u00e9dicament de r\u00e9f\u00e9rence quant au\nconditionnement ou encore aux indications th\u00e9rapeutiques. Par cons\u00e9quent, des d\u00e9lais\nsuffisants devraient permettre aux autorit\u00e9s comp\u00e9tentes de r\u00e9aliser une \u00e9valuation de ces\nm\u00e9dicaments de qualit\u00e9.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:27"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities and","that the generic product is essentially","similar to the reference product, within","the meaning of Directive 2001/83/EC of 6","November 2001."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","","","time limit shall be 15 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"106","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-229","location":[[" Proposal for a directive","Article 10"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:29"},"new":["deleted"],"old":["Article 10","Classification of medicinal products in","view of their inclusion in health","insurance systems","1. Paragraphs 2, 3 and 4 shall apply","where medicinal products are grouped or","classified according to therapeutic or","other criteria for the purpose of their","inclusion within the scope of the public","health insurance system.","2. Member States shall publish in an","appropriate publication and communicate","to the Commission the objective and","verifiable criteria according to which","medicinal products are classified in view","of their inclusion in the public health","","","insurance system.","3. For the medicinal products subject to","such grouping or classification, Member","States shall publish in an appropriate","publication and communicate to the","Commission the methodologies used to","determine the extent or conditions of their","inclusion in the public health insurance","system.","4. At the request of the holder of a","marketing authorisation, the competent","authorities shall specify the objective data","on the basis of which they have","determined the arrangements of coverage","for their medicinal product, in application","of the criteria and methodologies referred","to in paragraphs 2 and 3. In such a case,","the competent authorities shall also","inform the marketing authorisation","holder of all remedies available, including","judicial, and of the time limits for","applying for such remedies."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"229","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-107","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:27"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 30 days, provided","that the generic product is essentially","similar to the reference medicinal","product, according to Directive","2001/83/EC and that the price of the","reference medicinal product has been","approved by the competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","","that time limit shall be 15 days, provided","that the price of the reference medicinal","product has been approved by the","competent authorities."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"107","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-230","location":[["Proposal for a directive","Article 11"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:29"},"new":["deleted"],"old":["Article 11","Measures to control or promote the","prescription of specific medicinal","products","1. Paragraphs 2, 3 and 4 shall apply","where a Member State adopts measures","intended to control or promote the","prescription of specific named medicinal","products.","2. Measures referred to in paragraph 1","shall be based on objective and verifiable","","criteria.","3. Measures referred to in paragraph 1,","including any evaluation, expert opinion","or recommendation on which they are","based, shall be published in an","appropriate publication.","4. At the request of the holder of a","marketing authorisation whose interests","or legal position are affected by the","measures referred to in paragraph 1, the","competent authorities shall specify the","objective data and criteria on the basis of","which these measures have been taken","with respect to its medicinal product. In","such a case, the competent authorities","shall also inform the marketing","authorisation holder of all remedies","available, including judicial, and of the","time limits for applying for such remedies."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"230","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-108","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 4"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:27"},"new":["4. Member States shall establish the","categories of particulars and documents to","be submitted by the applicant."],"old":["4. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"108","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-231","location":[[" Proposal for a directive","Article 11 \u2013 paragraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:29"},"new":["1. Paragraphs 2 and 3 shall apply where a","Member State adopts measures intended to","control or promote the prescription of","specific named medicinal products."],"old":["1. Paragraphs 2, 3 and 4 shall apply where","a Member State adopts measures intended","to control or promote the prescription of","specific named medicinal products."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"231","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-109","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 4"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:27"},"new":["4. Member States shall establish in detail","the particulars and the main documents to","be submitted by the applicant."],"old":["4. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"109","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-232","justification":"The requirement that the competent authorities should provide an expert opinion or\nrecommendation in support of every decision which runs counter to the commercial interests\nof manufacturers is disproportionate.","location":[[" Proposal for a directive","Article 11 \u2013 paragraph 3"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:29"},"new":["deleted"],"old":["3. Measures referred to in paragraph 1,","including any evaluation, expert opinion","or recommendation on which they are","based, shall be published in an","appropriate publication."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"232","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-110","justification":"The competent authorities must be granted at least some leeway so that they can respond to\nunexpected developments.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:27"},"new":["4. Member States shall establish in detail","the categories of particulars and main","documents to be submitted by the","applicant."],"old":["4. Member States shall establish in detail","the particulars and documents to be","submitted by the applicant."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"110","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-233","location":[["Proposal for a directive","Article 11 \u2013 paragraph 3"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:29"},"new":["3. Measures referred to in paragraph 1,","including any evaluation, expert opinion or","recommendation on which they are based,","shall be published in an appropriate","publication and made available to public","view."],"old":["3. Measures referred to in paragraph 1,","including any evaluation, expert opinion or","recommendation on which they are based,","shall be published in an appropriate","publication."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"233","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-111","justification":" The 15-day time limit proposed by the Commission would be difficult for the authorities to\n comply with. An excessively short time limit would damage the quality of decision-making.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 25 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 15 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"hu","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"111","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-234","justification":" In its judgment in Case C-62/09 the Court of Justice authorised measures to monitor or\n encourage the prescription of certain medicinal products. What is more, those measures have\n no bearing on decisions to include medicinal products in the scope of national health\n insurance systems. A proposal such as this would also enable the manufacturers of all\n competing medicinal products to submit appeals, creating an administrative and legal\n nightmare.","location":[["Proposal for a directive","Article 11 \u2013 paragraph 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:29"},"new":["deleted"],"old":["4. At the request of the holder of a","marketing authorisation whose interests","","or legal position are affected by the","measures referred to in paragraph 1, the","competent authorities shall specify the","objective data and criteria on the basis of","which these measures have been taken","with respect to its medicinal product. In","such a case, the competent authorities","shall also inform the marketing","authorisation holder of all remedies","available, including judicial, and of the","time limits for applying for such remedies."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"234","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-112","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall notify the applicant","without undue delay of the detailed","additional information required and take","their final decision within 60 days of","receipt of this additional information.","However, with respect to medicines for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","in all events 15 days, provided that the","price of the reference medicinal product","has been approved by the competent","authorities. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 15 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"cs","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"112","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-235","justification":"Although it is normal that marketing authorisation holders should be informed of the reasons\nfor the introduction of measures to monitor or encourage the prescription of certain\nmedicinal products, such measures are the result of national decisions which are generally\ntaken with the aim of limiting health expenditure. It is paradoxical, therefore, that provision\nshould be made for financial compensation for such measures.","location":[[" Proposal for a directive","Article 11 \u2013 paragraph 4"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:29"},"new":["4. At the request of the holder of a","marketing authorisation whose interests or","legal position are affected by the measures","referred to in paragraph 1, the competent","authorities shall specify the objective data","and criteria on the basis of which these","measures have been taken with respect to","its medicinal product."],"old":["4. At the request of the holder of a","marketing authorisation whose interests or","legal position are affected by the measures","referred to in paragraph 1, the competent","authorities shall specify the objective data","and criteria on the basis of which these","measures have been taken with respect to","its medicinal product. In such a case, the","competent authorities shall also inform","the marketing authorisation holder of all","remedies available, including judicial,","and of the time limits for applying for","such remedies."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"235","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-113","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","medicinal products for which Member","States use health technology assessment as","part of their decision-making process, the","time limit shall likewise be 90 days. With","respect to generic medicinal products, that","time limit shall be in all events 30 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be in all events 15","days, provided that the price of the","reference medicinal product has been","approved by the competent authorities.","Member States shall not request any","additional information which is not","explicitly required under national","legislation or administrative guidelines."],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"113","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-236","location":[["Proposal for a directive","Article 12"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:29"},"new":["The time limits laid down in Articles 3, 4,","5 and 7 shall be construed as the period","between the receipt of an application or","additional information, as the case may be,","and the issuing of the decision. All expert","evaluations and administrative steps","necessary for taking the decision and","bringing it into effect shall be carried out","within the prescribed time limits."],"old":["The time limits laid down in Articles 3, 4,","5 and 7 shall be construed as the period","between the receipt of an application or","additional information, as the case may be,","and the effective entry into force of the","corresponding decision. All expert","evaluations and administrative steps","necessary for taking the decision and","bringing it into effect shall be carried out","within the prescribed time limits."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"236","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-114","location":[["Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be in all events 30 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be in all events 15 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities. Member States","shall not request any additional","","","information which is not explicitly","required under national legislation or","administrative guidelines."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"114","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-115","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be in all events 90 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be in all events 15 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"115","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-237","location":[["Proposal for a directive","Article 12 \u2013 paragraph 1 a (new)"]],"meps":[28126],"meta":{"created":"2019-07-03T05:27:29"},"new":["1a. With respect to generic medicinal","products, a certain period for application","and a certain period for entering into","effect shall, however, not be included in","the time limits, provided that neither of","these periods exceeds one calendar month","each and that those periods are explicitly","regulated by national legislation or","administrative guidelines."],"old":[""],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"237","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-116","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of what detailed additional","information is required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be in all events 45 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be in all events 15 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"116","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-238","location":[[" Proposal for a directive","Article 12 \u2013 paragraph 1 a (new)"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:29"},"new":["1a. If a decision-making process involving","negotiations between the requesting","laboratory and the competent authority is","required, the time limits laid down in","Articles 3, 4, 5 and 7 shall be suspended","until the competent authority has received","the requesting laboratory\u2019s response to its","proposals."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"238","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-117","justification":" M\u00eame s\u2019il est souhaitable d\u2019acc\u00e9l\u00e9rer la prise de d\u00e9cision pour les m\u00e9dicaments g\u00e9n\u00e9riques\n dont le m\u00e9dicament de r\u00e9f\u00e9rence a d\u00e9j\u00e0 \u00e9t\u00e9 \u00e9valu\u00e9, l\u2019\u00e9valuation des m\u00e9dicaments g\u00e9n\u00e9riques\n devrait rester possible si le m\u00e9dicament concern\u00e9 n\u2019est pas essentiellement similaire au\n m\u00e9dicament de r\u00e9f\u00e9rence. En effet, certains m\u00e9dicaments g\u00e9n\u00e9riques peuvent diff\u00e9rer du\n m\u00e9dicament de r\u00e9f\u00e9rence quant au conditionnement ou encore aux indications th\u00e9rapeutiques.\n Par cons\u00e9quent, des d\u00e9lais suffisants devraient permettre aux autorit\u00e9s comp\u00e9tentes de\n r\u00e9aliser une \u00e9valuation de ces m\u00e9dicaments de qualit\u00e9.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of what detailed additional","information is required and take their final","decision within 90 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 30 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines and that the generic product is","essentially similar to the reference","product, within the meaning of Directive","2001/83/EC of 6 November 2001."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","","","shall be in all events 15 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"117","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-239","location":[[" Proposal for a directive","Article 13"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:29"},"new":["deleted"],"old":["Article 13","Additional proof of quality, safety,","efficacy or bioequivalence","In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"239","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-118","justification":"The proposed 15-day time limit may be too short for authorities which could have adverse\neffects on the quality of the decision. Since biological medicinal products have lost or are\nabout to lose their exclusivity rights, biosimilar medicines are a relatively new category of\nmedicinal products, the timelines from submission to approval should therefore be 60 days\nmaximum.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 25 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. With respect to","biosimilar medicinal products, that time","limit shall be in all events 60 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities. Member States","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 15 days, provided that","the price of the reference medicinal","","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"118","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-240","justification":"The incorporation of specific provisions concerning generic medicinal products constitutes\nthe main added value of this recast. However, if all types of generic medicinal products,\nincluding biotherapies, are to be covered, reference should be made to the concept of\nbiosimilarity, as well as to that of bioequivalence.","location":[["Proposal for a directive","Article 13 \u2013 title"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:30"},"new":["Additional proof of quality, safety,","efficacy, bioequivalence or biosimilarity"],"old":["Additional proof of quality, safety, efficacy","or bioequivalence"],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"240","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-119","location":[["Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[28126],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 90 days of receipt of this","additional information. With respect to","generic medicinal products, that time limit","shall be in all events 45 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be in all events 15 days,","provided that the price of the reference","medicinal product has been approved by","the competent authorities. Member States","","shall not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"119","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-241","location":[["Proposal for a directive","Article 13 \u2013 title"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:30"},"new":["Proof of quality, safety, efficacy or","bioequivalence"],"old":["Additional proof of quality, safety, efficacy","or bioequivalence"],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"241","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-120","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:27"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 30 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 15 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States","shall not request any additional","information which is not explicitly","required under national legislation or","administrative guidelines."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"120","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-242","location":[["Proposal for a directive","Article 13"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:30"},"new":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based (the","quality, safety, efficacy or bioequivalence","of the medicinal product). Member States","shall be guaranteed full access to the data","used by the marketing authorisation","authority in assessing these elements, with","a view to evaluating the relative safety,","efficacy and effectiveness of the medicine","in the context of the health insurance","scheme. Competent authorities should","also have the right to request additional","data for the purpose of their evaluation."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"242","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-121","justification":"This provision goes well beyond the desired objective of the rapid availability of new\ntreatments and is neither proportionate nor in accordance with the principle of subsidiarity.\nIn addition, a measure of this type could upset the already delicate budget balance of public\nhealth insurance systems.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 6"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:27"},"new":["deleted"],"old":["6. In the absence of a decision within the","relevant time limit set out in paragraphs 3","and 5, the applicant shall be entitled to","market the product at the price proposed."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"121","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-243","justification":"It is essential that the authorities should be able to carry out re-assessments of the relative\ntherapeutic value of a medicinal product, since that relative value may be significantly\naffected by the arrival of new, competing products on the market or the discovery of a new\ntherapeutic property. What is more, the remit of the agencies which issue marketing\nauthorisations does not cover such comparative assessments. Finally, there is no need to re-\nassess bioequivalence.","location":[[" Proposal for a directive","Article 13"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:30"},"new":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the essential elements","(quality, safety, efficacy or biosimilarity)","on which the marketing authorisation is","based. Nevertheless, Member States shall","have access to all the data used by the","authority which granted the marketing","authorisation so that they can assess the","relative safety and efficacy of a medicinal","product in the context of the health","insurance system."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"243","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-122","justification":"The requirement to provide expert reports in support of any decision by the authorities that is\ncontrary to the commercial interests of manufacturers is disproportionate.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 7"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:28"},"new":["7. If the competent authorities decide not to","permit the marketing of the medicinal","product concerned at the price proposed by","the applicant, the decision shall contain a","statement of reasons based on objective","and verifiable criteria. The applicant shall","be informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"old":["7. If the competent authorities decide not to","permit the marketing of the medicinal","product concerned at the price proposed by","the applicant, the decision shall contain a","statement of reasons based on objective","and verifiable criteria, including any","evaluation, expert opinion or","recommendation on which it is based. The","applicant shall be informed of all remedies","available, including judicial remedies, and","of the time limits for applying for such","remedies."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"122","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-244","location":[["Proposal for a directive","Article 13"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:30"},"new":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product.","However, Member States shall have full","access to the data used by the marketing","authorisation authority in assessing these","elements for the purpose of evaluation.","Competent authorities should also have","the right to request additional data for the","purpose of evaluation."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"244","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-123","justification":" Given that the pricing of medicinal products is a national competence, Member States do not\n a priori have to communicate to the Commission their criteria for assessing the price of a\n medicinal product.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 8"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:28"},"new":["deleted"],"old":["8. Member States shall publish in an","appropriate publication and communicate","to the Commission the criteria which the","competent authorities must take into","account when approving the prices of","medicinal products."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"123","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate, Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-245","justification":" It would be unacceptable for the medical added value of these medicinal products to be called\n into question at national level, because that added value is the sine qua non for their\n authorisation at EU level. A clarification of this kind would in no way be at odds with the\n decision by the national authorities whether or not to reimburse the cost of an orphan\n medicinal product, but would in fact encourage national authorities to make greater use of\n the expertise acquired at European level.","location":[["Proposal for a directive","Article 13"]],"meps":[2025,96884],"meta":{"created":"2019-07-03T05:27:30"},"new":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the marketing","authorisation, including the quality, safety,","efficacy or bioequivalence of the medicinal","product or the criteria for orphan","designation."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","","","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"245","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-124","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 9"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:28"},"new":["9. If the competent authorities decide to","reduce the price of a specific named","medicinal product on their own initiative,","the decision shall contain a statement of","reasons based on objective and verifiable","criteria. The decision shall be","communicated to the holder of the","marketing authorisation, who shall be","informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies. The","decision and a summary justification shall","be made available to public view."],"old":["9. If the competent authorities decide to","reduce the price of a specific named","medicinal product on their own initiative,","the decision shall contain a statement of","reasons based on objective and verifiable","criteria, including any evaluation, expert","opinion or recommendation on which it is","based. The decision shall be communicated","to the holder of the marketing","authorisation, who shall be informed of all","remedies available, including judicial","remedies, and of the time limits for","applying for such remedies."],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"124","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-246","justification":"Misinterpreting this article could result in Member States being prevented from using data or\nrequesting additional data they need to assess the relative risk-benefit ratio and the relative\nefficacy of medicinal products by comparison with treatments already covered by their\nnational health insurance systems.","location":[[" Proposal for a directive","Article 13"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:30"},"new":["In the framework of pricing and","reimbursement decisions, Member States","should not be seeking to re-assess the","essential elements (quality, safety, efficacy","or bioequivalence) on which the marketing","authorisation is based.","However, Member States must be","guaranteed full access to the data used by","the authorities responsible for granting","the marketing authorisation so that they","can assess the relative safety, efficacy and","efficiency of a medicinal product in the","context of its inclusion in the scope of the","mandatory health insurance system. The","competent authorities should also be able","to include or generate additional relevant","data for the purposes of assessing","medicinal products."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"246","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-125","justification":"The requirement to provide expert reports in support of any decision by the authorities that is\ncontrary to the commercial interests of manufacturers is disproportionate.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 9"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:28"},"new":["9. If the competent authorities decide to","reduce the price of a specific named","medicinal product on their own initiative,","the decision shall contain a statement of","reasons based on objective and verifiable","criteria. The decision shall be","communicated to the holder of the","marketing authorisation, who shall be","informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"old":["9. If the competent authorities decide to","reduce the price of a specific named","medicinal product on their own initiative,","the decision shall contain a statement of","reasons based on objective and verifiable","criteria, including any evaluation, expert","opinion or recommendation on which it is","based. The decision shall be communicated","to the holder of the marketing","authorisation, who shall be informed of all","remedies available, including judicial","remedies, and of the time limits for","applying for such remedies."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"125","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Oreste Rossi, Giancarlo Scott\u00e0","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-247","location":[["Proposal for a directive","Article 14 \u2013 paragraph 1"]],"meps":[97196,96996],"meta":{"created":"2019-07-03T05:27:30"},"new":["1. Decision-making procedures and","decisions to regulate the prices of","medicinal products in accordance with","Article 3 or which determine their","inclusion within the scope of public health","insurance systems in accordance with","Articles 7 and 9 shall be considered by","Member States as administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights."],"old":["1. Applications, decision-making","procedures and decisions to regulate the","prices of medicinal products in accordance","with Article 3 or to determine their","inclusion within the scope of public health","insurance systems in accordance with","Articles 7 and 9 shall be considered by","Member States as administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights."],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"247","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-126","location":[["Proposal for a directive","Article 4 \u2013 paragraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:28"},"new":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the marketing","authorisation holder at any point in time."],"old":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the marketing","authorisation holder at any point in time.","The competent authorities shall provide","the applicant with an official","acknowledgement of receipt."],"orig_lang":"cs","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"126","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Paolo Bartolozzi, Sergio Berlato, Elisabetta Gardini","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-248","location":[["Proposal for a directive","Article 14 \u2013 paragraph 1"]],"meps":[21818,4746,58758],"meta":{"created":"2019-07-03T05:27:30"},"new":["1. Decision-making procedures and","decisions to regulate the prices of","medicinal products in accordance with","Article 3 or which determine their","inclusion within the scope of public health","insurance systems in accordance with","Articles 7 and 9 shall be considered by","Member States as administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights."],"old":["1. Applications, decision-making","procedures and decisions to regulate the","prices of medicinal products in accordance","with Article 3 or to determine their","inclusion within the scope of public health","insurance systems in accordance with","Articles 7 and 9 shall be considered by","","","Member States as administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights."],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"248","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-127","justification":" Clarification of the wording and removal of the phrase \u2018at any point in time\u2019, which is a\n source of legal uncertainty.","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:28"},"new":["2. Member States shall guarantee that the","marketing authorisation holder has the","possibility to introduce an application to","increase the price of a medicinal product.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the","marketing authorisation holder at any","point in time. The competent authorities","shall provide the applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"127","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-249","location":[[" Proposal for a directive","Article 14 \u2013 paragraph 2"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:30"},"new":["2. The protection of intellectual property","rights shall not be a valid ground to refuse,","suspend or revoke decisions relating to the","price of a medicinal product or its inclusion","within the public health insurance system.","Member States may not, however, under","any circumstances, be deprived of the","power to verify intellectual property."],"old":["2. The protection of intellectual property","rights shall not be a valid ground to refuse,","suspend or revoke decisions relating to the","price of a medicinal product or its inclusion","within the public health insurance system."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"249","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-128","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 2"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:28"},"new":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the marketing","authorisation holder. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the marketing","authorisation holder at any point in time.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"128","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Paolo Bartolozzi, Sergio Berlato, Elisabetta Gardini","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-250","location":[[" Proposal for a directive","Article 14 \u2013 paragraph 3"]],"meps":[21818,4746,58758],"meta":{"created":"2019-07-03T05:27:30"},"new":["3. Paragraphs 1 and 2 shall apply without","prejudice to the Union and national","legislation relating to the protection of","intellectual property. With a view to","ensuring that the provisions of this article","are properly applied, those provisions","shall not prevent applications submitted to","the competent authorities or decisions by","competent authorities regarding the","setting of the price of a given product or","the inclusion of that product in public","health insurance systems from being","considered objective and reasonable","factors that may be taken into account by","the competent judicial authorities when","determining whether an intellectual","property right is being or will be","infringed."],"old":["3. Paragraphs 1 and 2 shall apply without","prejudice to the Union and national","legislation relating to the protection of","intellectual property.",""],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"250","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-129","justification":"This proposal would considerably increase the administrative burden on the competent\nauthorities, who would be submerged with applications following any decision to turn down\nan application, even if circumstances have not changed.","location":[["Proposal for a directive","Article 4 \u2013 paragraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:28"},"new":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the marketing","authorisation holder. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the marketing","authorisation holder at any point in time.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"129","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Oreste Rossi, Giancarlo Scott\u00e0","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-251","location":[["Proposal for a directive","Article 14 \u2013 paragraph 3 \u2013 subparagraph 1 a (new)"]],"meps":[97196,96996],"meta":{"created":"2019-07-03T05:27:30"},"new":["With a view to ensuring that the","provisions of this article are properly","applied, those provisions shall not prevent","applications submitted to the competent","authorities or decisions by competent","authorities regarding the setting of the","price of a given product or the inclusion","of that product in public health insurance","systems from being considered objective","and reasonable factors that may be taken","into account by the competent judicial","authorities when determining whether an","intellectual property right is being or will","be infringed."],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"251","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-130","location":[["Proposal for a directive","Article 4 \u2013 paragraph 2 \u2013 subparagraph 1a (new)"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:28"},"new":["This Article shall not prevent Member","States to refuse repeated applications","following a negative decision if the","circumstances have not significantly","changed."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"130","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Oreste Rossi, Giancarlo Scott\u00e0","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-252","location":[["Proposal for a directive","Article 14 \u2013 paragraph 3 a (new)"]],"meps":[97196,96996],"meta":{"created":"2019-07-03T05:27:30"},"new":["3a. Paragraphs 1 and 2 may be waived in","Member States in which the issue of a","marketing authorisation or a","reimbursement authorisation for a","generic product results in a change in the","price of and/or reimbursement terms for","the relevant reference product."],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"252","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Paolo Bartolozzi, Sergio Berlato, Elisabetta Gardini","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-253","location":[[" Proposal for a directive","Article 14 \u2013 paragraph 3 a (new)"]],"meps":[21818,4746,58758],"meta":{"created":"2019-07-03T05:27:30"},"new":["3a. Paragraphs 1 and 2 may be waived in","Member States in which the issue of a","marketing authorisation or a","reimbursement authorisation for a","generic product results in a change in the","price of and/or reimbursement terms for","the relevant reference product."],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"253","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-131","location":[["Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:28"},"new":["Member States shall ensure that a decision","to approve or reject an application","submitted in accordance with the","requirements laid down in the Member","State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is discussed, adopted,","and communicated to the applicant within","90 days of receipt of the application."],"old":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 60","days of its receipt."],"orig_lang":"sl","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"131","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" K\u0101rlis \u0160adurskis","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-132","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[111033],"meta":{"created":"2019-07-03T05:27:28"},"new":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 90","days of its receipt."],"old":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 60","days of its receipt."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"132","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Oreste Rossi, Giancarlo Scott\u00e0","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-254","location":[[" Proposal for a directive","Article 14 \u2013 paragraph 3 b (new)"]],"meps":[97196,96996],"meta":{"created":"2019-07-03T05:27:30"},"new":["3b. Member States may adopt specific","measures and legal procedures to protect","intellectual property rights in cases where","the issue of a marketing authorisation or","a reimbursement authorisation for a","generic product results in a change in the","price of and/or reimbursement terms for","the relevant reference product."],"old":[""],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"254","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2012-10-22T00:00:00","id":"PE497.983-133","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[97076],"meta":{"created":"2019-07-03T05:27:28"},"new":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 90","days of its receipt."],"old":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 60","days of its receipt."],"orig_lang":"en","peid":"PE497.983v01-00","reference":"2012/0035(COD)","seq":"133","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.983+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Paolo Bartolozzi, Sergio Berlato, Elisabetta Gardini","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-255","location":[["Proposal for a directive","Article 14 \u2013 paragraph 3 b (new)"]],"meps":[21818,4746,58758],"meta":{"created":"2019-07-03T05:27:31"},"new":["3b. Member States may adopt specific","measures and legal procedures to protect","intellectual property rights in cases where","the issue of a marketing authorisation or","a reimbursement authorisation for a","generic product results in a change in the","price of and/or reimbursement terms for","the relevant reference product."],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"255","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-256","location":[["Proposal for a directive","Article 15"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["Article 15","Consultation of interested parties","Where a Member State intends to adopt or","amend any measure falling within the","scope of this Directive, it shall give","interested parties the opportunity to","comment on the draft measure within a","reasonable period. The competent","authorities shall publish the rules","applicable to consultations. The results of","consultations shall be made publicly","","available, with the exception of","confidential information in accordance","with Union and national legislation","regarding business confidentiality."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"256","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-257","location":[[" Proposal for a directive","Article 15"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:31"},"new":["Where a Member State intends to adopt or","amend any measure falling within the","scope of this Directive, it shall give","interested parties, including patient and","consumer organisations, the opportunity","to comment on the draft measure within a","reasonable period. The competent","authorities shall publish the rules","applicable to consultations. The results of","consultations shall be made publicly","available, with the exception of","confidential information in accordance","with Union and national legislation","regarding business confidentiality."],"old":["Where a Member State intends to adopt or","amend any measure falling within the","scope of this Directive, it shall give","interested parties the opportunity to","comment on the draft measure within a","reasonable period. The competent","authorities shall publish the rules","applicable to consultations. The results of","consultations shall be made publicly","available, with the exception of","confidential information in accordance","with Union and national legislation","regarding business confidentiality."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"257","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-258","location":[[" Proposal for a directive","Article 15"]],"meps":[96884],"meta":{"created":"2019-07-03T05:27:31"},"new":["Where a Member State intends to recast","substantively any measure falling within","the scope of this Directive, it shall give","interested parties the opportunity to","comment on the draft measure within a","reasonable period. The competent","authorities shall publish the rules","applicable to consultations. The results of","consultations shall be made publicly","available, with the exception of","confidential information in accordance","with Union and national legislation","regarding business confidentiality."],"old":["Where a Member State intends to adopt or","amend any measure falling within the","scope of this Directive, it shall give","interested parties the opportunity to","","comment on the draft measure within a","reasonable period. The competent","authorities shall publish the rules","applicable to consultations. The results of","consultations shall be made publicly","available, with the exception of","confidential information in accordance","with Union and national legislation","regarding business confidentiality."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"258","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers, Justas Vincas Paleckis","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-259","location":[["Proposal for a directive","Article 15 a (new)"]],"meps":[96603,28279],"meta":{"created":"2019-07-03T05:27:31"},"new":["Article 15a","Price transparency","1. At least once a year, the competent","authorities shall publish in an appropriate","publication and communicate to the","Commission, a complete list of the","medicinal products covered by their","health insurance systems, the prices of","which have been fixed during the relevant","period, together with the prices which may","be charged for such products.","2. The Commission and the Member","States shall examine how to continue to","co-operate on the functioning of the","EURIPID price information database,","which provides EU-wide added value in","terms of price transparency."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"259","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-260","location":[[" Proposal for a directive","Article 16"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["Article 16","Notification of draft national measures","1. Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based.","2. Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed.","3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation.","4. The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law.","5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"260","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Erik B\u00e1nki","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-261","justification":" We see cause for concern in the fact that the proposal provides for a preliminary notification\n requirement followed by a three-month waiting period before the deadline which the\n Commission must comply with. This provision would make it impossible for Member States to\n respond flexibly to macroeconomic circumstances which justify amending the subsidy rules.","location":[["Proposal for a directive","Article 16"]],"meps":[113883],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["Article 16","Notification of draft national measures","(1) Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based.","(2) Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed.","(3) Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation.","(4) The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law.","(5) When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"hu","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"261","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-262","location":[[" Proposal for a directive","Article 16"]],"meps":[113487],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["Article 16","Notification of draft national measures","1. Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based.","2. Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed.","3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation.","4. The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law.","5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"262","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Nessa Childers","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-263","location":[["Proposal for a directive","Article 16"]],"meps":[96603],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["Article 16","Notification of draft national measures","","","1. Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based.","2. Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed.","3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation.","4. The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law.","5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"263","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-264","justification":" The provisions of this article go beyond what is required to achieve the aims of the proposal\n and are not consistent with the subsidiarity principle.","location":[["Proposal for a directive","Article 16"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["Article 16","Notification of draft national measures","1. Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based.","2. Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed.","3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation.","4. The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law.","5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"264","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-265","justification":"This bureaucratic procedure would make it impossible for the Member States to respond\nquickly to new developments threatening the sustainability of their health systems. What is\nmore, this proposal is at odds with the right of Member States to organise their health systems\nand with the subsidiarity principle.","location":[[" Proposal for a directive","Article 16"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["Article 16","Notification of draft national measures","1. Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based.","2. Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed.","3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","","envisaged for implementation.","4. The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law.","5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"265","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-266","location":[["Proposal for a directive","Article 16 \u2013 paragraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:31"},"new":["1. Where Member States adopt or amend","any measure falling within the scope of this","Directive, they shall communicate the final","text to the Commission, together with the","reasoning on which the measure is based."],"old":["1. Where Member States intend to adopt or","amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","","together with the reasoning on which the","measure is based."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"266","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-267","location":[[" Proposal for a directive","Article 16 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"267","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-268","location":[[" Proposal for a directive","Article 16 \u2013 paragraph 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["4. The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"268","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Zofija Mazej Kukovi\u010d","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-269","location":[["Proposal for a directive","Article 16 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[39916],"meta":{"created":"2019-07-03T05:27:31"},"new":["The Commission may send its observations","to the Member State which has","communicated the draft measure within","two months."],"old":["The Commission may send its observations","to the Member State which has","communicated the draft measure within","three months."],"orig_lang":"sl","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"269","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-270","location":[["Proposal for a directive","Article 16 \u2013 paragraph 5"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:31"},"new":["deleted"],"old":["5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"270","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-271","location":[["Proposal for a directive","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:31"},"new":["1. Do 31. By 31 January of [\u2026] [insert a","date - the year following the date referred","to in the first subparagraph of Article","18(1)], and by 31 January of every year","thereafter, Member States shall","communicate to the Commission and","publish in an appropriate publication a","detailed report providing the following","information:"],"old":["1. By 31 January of [\u2026] [insert a date - the","year following the date referred to in the","first subparagraph of Article 18(1)], and by","31 January and 1 July of every year","thereafter, Member States shall","communicate to the Commission and","publish in an appropriate publication a","detailed report providing the following","information:"],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"271","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-272","location":[[" Proposal for a directive","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[28177],"meta":{"created":"2019-07-03T05:27:31"},"new":["1. By 31 January of [\u2026] [insert a date - the","year following the date referred to in the","first subparagraph of Article 18(1)], and by","31 January of every year thereafter,","Member States shall communicate to the","Commission and publish in an appropriate","publication a detailed report providing the","following information:"],"old":["1. By 31 January of [\u2026] [insert a date - the","year following the date referred to in the","first subparagraph of Article 18(1)], and by","31 January and 1 July of every year","thereafter, Member States shall","communicate to the Commission and","publish in an appropriate publication a","detailed report providing the following","information:"],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"272","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-273","justification":"The requirement should be for these reports to be published annually, in order to ensure that\nno excessive administrative burden is imposed on Member States and that the reports are\nbased on a broader range of data, and thus offer a more comprehensive overview.","location":[[" Proposal for a directive","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[96743],"meta":{"created":"2019-07-03T05:27:32"},"new":["1. By 31 January of [\u2026] [insert a date - the","year following the date referred to in the","first subparagraph of Article 18(1)], and by","31 January of every year thereafter,","Member States shall communicate to the","Commission and publish in an appropriate","publication a detailed report providing the","following information:"],"old":["1. By 31 January of [\u2026] [insert a date - the","","year following the date referred to in the","first subparagraph of Article 18(1)], and by","31 January and 1 July of every year","thereafter, Member States shall","communicate to the Commission and","publish in an appropriate publication a","detailed report providing the following","information:"],"orig_lang":"fr","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"273","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-274","location":[["Proposal for a directive","Article 17 \u2013 paragraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:32"},"new":["2. The Commission shall publish a report","once a year on the information submitted","by Member States according to","paragraph 1."],"old":["2. The Commission shall publish every six","months a report on the information","submitted by Member States according to","paragraph 1."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"274","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-275","location":[["Proposal for a directive","Article 18 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:32"},"new":["Member States shall adopt and publish, by","[last day of the 24th month following","publication of this Directive in the Official","journal of the European Union] at the","latest, the laws, regulations and","administrative provisions necessary to","comply with this Directive. They shall","forthwith communicate to the Commission","the text of those provisions."],"old":["Member States shall adopt and publish, by","[last day of the 12th month following","publication of this Directive in the Official","journal of the European Union] at the","","","latest, the laws, regulations and","administrative provisions necessary to","comply with this Directive. They shall","forthwith communicate to the Commission","the text of those provisions."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"275","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-276","location":[[" Proposal for a directive","Article 19"]],"meps":[28324],"meta":{"created":"2019-07-03T05:27:32"},"new":["deleted"],"old":["Article 19","Report on the implementation of this","Directive","1. Member States shall send a report to","the Commission on the implementation of","this Directive by [insert date - within two","years after the date referred to in the","second subparagraph of Article 18(1)]","and every three years thereafter.","2. By [insert date - within three years after","the date referred to in the second","subparagraph of Article 18(1)], the","Commission shall submit a report to the","European Parliament and the Council on","the implementation of this Directive. The","report may be accompanied by any","appropriate proposals."],"orig_lang":"cs","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"276","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Oreste Rossi, Giancarlo Scott\u00e0","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-277","location":[[" Proposal for a directive","Article 19 \u2013 paragraph 2"]],"meps":[97196,96996],"meta":{"created":"2019-07-03T05:27:32"},"new":["2. By [insert date - within three years after","the date referred to in the second","subparagraph of Article 18(1)], the","Commission shall submit a report to the","European Parliament and the Council on","the implementation of this Directive. The","report may be accompanied, where","appropriate, by proposals for the","amendment of this Directive."],"old":["2. By [insert date - within three years after","the date referred to in the second","subparagraph of Article 18(1)], the","Commission shall submit a report to the","European Parliament and the Council on","the implementation of this Directive. The","report may be accompanied by any","appropriate proposals."],"orig_lang":"it","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"277","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Zofija Mazej Kukovi\u010d, Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2012-10-25T00:00:00","id":"PE498.042-278","location":[["Proposal for a directive","Article 19 a (new)"]],"meps":[1927,39916,28227],"meta":{"created":"2019-07-03T05:27:32"},"new":["Article 19a","Monitoring and Reporting","1. Three years after entry into force of this","Directive the Commission shall submit a","report to the European Parliament and to","the Council assessing the enforcement of","this Directive.","2. The Commission shall be equipped with","sufficient resources to monitor the","enforcement of the Directive."],"orig_lang":"en","peid":"PE498.042v02-00","reference":"2012/0035(COD)","seq":"278","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-498.042+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-25","justification":"This proposal does not relate to the free movement of just any type of goods, but deals with\nthe free movement of medicinal products and the pricing thereof, and the latter falls within\nthe competence of Member States in the field of public health. Article 168 of the TFEU should\ntherefore be added to the legal basis.","location":[["Proposal for a directive","Citation 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:18"},"new":["Having regard to the Treaty on the","Functioning of the European Union, and in","particular Articles 114 and 168 thereof,"],"old":["Having regard to the Treaty on the","Functioning of the European Union, and in","particular Article 114 thereof,"],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"25","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-26","justification":" Member States should be encouraged to adopt a reasonable approach to the use of external\n reference pricing by including in their referencing system Member States with a comparable\n purchasing power. Otherwise producers would be reluctant at putting their products on the\n market of Member States where prices are lower, just to avoid a downward pressure on\n prices across the EU as a whole.","location":[["Proposal for a directive","Recital 4 a (new)"]],"meta":{"created":"2019-07-03T05:36:18"},"new":["(4 a) Ensuring patients' access to","medicinal products throughout the Union","and effective free movement of goods","requires that Member States make a","reasonable use of external reference","pricing, namely by referring to Member","States with a comparable income level.","The unconditional use of external","reference pricing has been proven to","reduce the availability of medicinal","products by encouraging shortages in","low-price Member States."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"26","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-27","location":[[" Proposal for a directive","Recital 5"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:18"},"new":["(5) Disparities in national measures may","hinder or distort intra-Union trade in","medicinal products, thereby directly","affecting the functioning of the internal","market in medicinal products."],"old":["(5) Disparities in national measures may","hinder or distort intra-Union trade in","medicinal products and distort","competition, thereby directly affecting the","functioning of the internal market in","medicinal products."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"27","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Louis Grech","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-28","location":[[" Proposal for a directive","Recital 6"]],"meps":[28123],"meta":{"created":"2019-07-03T05:36:18"},"new":["(6) In order to reduce the effects of the","disparities on the internal market, national","measures should comply with minimum","procedural requirements enabling the","parties concerned to verify that those","measures do not constitute quantitative","restrictions on imports or exports or","measures having equivalent effect thereto.","Those requirements are also intended to","ensure more predictability, transparency,","fairness and legal certainty to producers","of pharmaceutical products, to contribute","to encouraging research and development","and the placing on the market of","innovative medicinal products to the","benefit of patients and to increase patient","accessibility to medicinal products across","the board in general. However, those","requirements should not affect the policies","of those Member States which rely","primarily upon free competition to","determine the price of medicinal products.","They also should not affect national","policies on price setting and on the","determination of social security schemes,","except as far as it is necessary to attain","transparency within the meaning of this","Directive and to ensure the functioning of","the internal market."],"old":["(6) In order to reduce the effects of the","disparities on the internal market, national","measures should comply with minimum","procedural requirements enabling the","parties concerned to verify that those","measures do not constitute quantitative","restrictions on imports or exports or","measures having equivalent effect thereto.","However, those requirements should not","affect the policies of those Member States","which rely primarily upon free competition","","","to determine the price of medicinal","products. They also should not affect","national policies on price setting and on the","determination of social security schemes,","except as far as it is necessary to attain","transparency within the meaning of this","Directive and to ensure the functioning of","the internal market."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"28","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-29","location":[["Proposal for a directive","Recital 8"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:18"},"new":["(8) Due to diversity of national measures","managing the consumption of medicines,","regulating their prices or establishing the","conditions of their public funding it is","necessary to clarify Directive 89/105/EEC.","In particular this Directive should cover all","types of measures devised by Member","States and susceptible to impact the","internal market. Since the adoption of","Directive 89/105/EEC, the pricing and","reimbursement procedures have evolved","and have become more complex. While","some Member States have interpreted the","scope of Directive 89/105/EEC","restrictively, the Court of Justice ruled that","those pricing and reimbursement","procedures fall within the scope of","Directive 89/105/EEC given the objectives","of that Directive and the need to ensure its","effectiveness. Therefore, this Directive","should reflect the developments in national","pricing and reimbursement policies. Given","that specific rules and procedures exist in","the area of public procurement, national","measures involving public procurement","should be excluded from the scope of this","Directive."],"old":["(8) Due to diversity of national measures","managing the consumption of medicines,","regulating their prices or establishing the","conditions of their public funding it is","necessary to clarify Directive 89/105/EEC.","In particular this Directive should cover all","types of measures devised by Member","States and susceptible to impact the","internal market. Since the adoption of","Directive 89/105/EEC, the pricing and","reimbursement procedures have evolved","and have become more complex. While","some Member States have interpreted the","scope of Directive 89/105/EEC","restrictively, the Court of Justice ruled that","those pricing and reimbursement","procedures fall within the scope of","","Directive 89/105/EEC given the objectives","of that Directive and the need to ensure its","effectiveness. Therefore, this Directive","should reflect the developments in national","pricing and reimbursement policies. Given","that specific rules and procedures exist in","the area of public procurement and","voluntary contractual agreements,","national measures involving public","procurement and voluntary contractual","agreements should be excluded from the","scope of this Directive."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"29","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jorgo Chatzimarkakis","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-30","location":[[" Proposal for a directive","Recital 8"]],"meps":[28243],"meta":{"created":"2019-07-03T05:36:18"},"new":["(8) Due to diversity of national measures","managing the consumption of medicines,","regulating their prices or establishing the","conditions of their public funding it is","necessary to clarify Directive 89/105/EEC.","In particular this Directive should cover all","types of measures devised by Member","States and susceptible to impact the","internal market. Since the adoption of","Directive 89/105/EEC, the pricing and","reimbursement procedures have evolved","and have become more complex. While","some Member States have interpreted the","scope of Directive 89/105/EEC","restrictively, the Court of Justice ruled that","those pricing and reimbursement","procedures fall within the scope of","Directive 89/105/EEC given the objectives","of that Directive and the need to ensure its","effectiveness. Therefore, this Directive","should reflect the developments in national","pricing and reimbursement policies. In","addition to measures of direct and indirect","pricing policies in accordance with","objective criteria subject to evaluation,","price transparency should be ensured. A","distortion of competition can only be","avoided through price transparency.","Distorting effects in the perception of","prices created by different decision","making procedures in the Member States","for pricing and reimbursement between","manufacturer and insurance carrier can","be averted by more transparency of","pricing methods. Improved transparency","on prices leads to cost-effectiveness and","cost-efficiency, as intended by this","Directive. That again means cost savings","for health systems."],"old":["(8) Due to diversity of national measures","managing the consumption of medicines,","regulating their prices or establishing the","conditions of their public funding it is","necessary to clarify Directive 89/105/EEC.","In particular this Directive should cover all","types of measures devised by Member","States and susceptible to impact the","internal market. Since the adoption of","Directive 89/105/EEC, the pricing and","reimbursement procedures have evolved","and have become more complex. While","some Member States have interpreted the","scope of Directive 89/105/EEC","restrictively, the Court of Justice ruled that","those pricing and reimbursement","procedures fall within the scope of","Directive 89/105/EEC given the objectives","of that Directive and the need to ensure its","effectiveness. Therefore, this Directive","should reflect the developments in national","pricing and reimbursement policies. Given","that specific rules and procedures exist in","","the area of public procurement and","voluntary contractual agreements,","national measures involving public","procurement and voluntary contractual","agreements should be excluded from the","scope of this Directive."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"30","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-31","justification":" When standard coverage/reimbursement mechanisms are not deemed appropriate, in\n particular where higher than normal levels of uncertainty exist as regards the effect of a\n medicine on patients and society, the reimbursement authority and the manufacturer can\n agree on specific conditions regulated in contracts to ensure patient access to innovative\n medicines. These agreements, which deviate from standard administrative practices, operate\n outside of the scope of this Directive, provided that they are not imposed on the applicant.","location":[["Proposal for a directive","Recital 8 a (new)"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:18"},"new":["(8 a) In addition to conventional","measures laid down by law, regulation or","administrative action to regulate the","conditions of public funding of medicinal","products, public authorities are","increasingly engaging in agreements","which aim at providing patient access to","innovative treatments by including a","medicinal product in the scope of the","public health insurance system whilst","monitoring elements agreed upfront with","the marketing authorisation holder. Such","monitoring aims at addressing evidentiary","uncertainties related to the effectiveness","and appropriate use of the medicinal","product in clinical practice over time. The","level of coverage of the medicinal product","subject to such agreement is dependent on","the output of monitoring and is unknown","upfront. The terms and conditions of such","agreements are governed by contracts","concluded between the public authority","and the holder of a marketing","authorisation concerned. Where public","authorities make the decision on","including a medicinal product in the","scope of the public health insurance","system conditional upon the entry into","such agreement, the agreement should","not be considered to have been concluded","at the request of the holder of the","marketing authorisation."],"old":[""],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"31","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-32","location":[[" Proposal for a directive","Recital 14"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:18"},"new":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products and the similarity of biosimilar","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy, bioequivalence or","biosimilarity of the medicinal product. The","marketing authorisation of an orphan","medicinal product is also based on the","evaluation of several criteria, including","the significant benefit of the product over","any available existing alternatives in the","Union, in accordance with Regulation","(EC) No 141/2000, which should not be","re-assessed in the framework of pricing","and reimbursement procedures."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product.",""],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"32","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi, Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-33","location":[["Proposal for a directive","Recital 14"]],"meps":[40599],"meta":{"created":"2019-07-03T05:36:18"},"new":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products an the similarity of biosimilar","medicines with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"33","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-34","location":[["Proposal for a directive","Recital 14"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:18"},"new":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence and the biosimilarity of","medicinal products with the reference","product, are ascertained in the framework","of marketing authorisation procedures. In","the framework of pricing and","reimbursement procedures, Member States","should therefore not re-assess the elements","on which the marketing authorisation is","based, including the quality, safety,","efficacy, bioequivalence or biosimilarity","of the medicinal product."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the marketing","authorisation is based, including the","quality, safety, efficacy or bioequivalence","of the medicinal product."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"34","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-35","justification":" The introduction of specific provisions for generic medicinal products is what provides the\n\nmain \u2018added value\u2019 of this recast. However, in order to cover all generic medicinal products,\nincluding biotherapies, it is necessary to introduce the concept of biosimilarity in addition to\nbioequivalence.","location":[[" Proposal for a directive","Recital 14"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:18"},"new":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product and","the similarity of biosimilar medicinal","products, are ascertained in the framework","of marketing authorisation procedures and","may be re-assessed in the framework of","pricing and reimbursement procedures."],"old":["(14) The quality, safety and efficacy of","medicinal products, including the","bioequivalence of generic medicinal","products with the reference product, are","ascertained in the framework of marketing","authorisation procedures. In the framework","of pricing and reimbursement procedures,","Member States should therefore not re-","assess the elements on which the","marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"35","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-36","location":[["Proposal for a directive","Recital 15"]],"meps":[40599],"meta":{"created":"2019-07-03T05:36:18"},"new":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic or biosimilar medicinal product,","should not request information concerning","the patent status of the reference medicinal","product and should not examine the","validity of an alleged violation of","intellectual property rights should the","generic or biosimilar medicinal product be","manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and reimbursement procedures in","the Member States."],"old":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic medicinal product, should not","request information concerning the patent","status of the reference medicinal product","and should not examine the validity of an","alleged violation of intellectual property","rights should the generic medicinal product","be manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and reimbursement procedures in","the Member States."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"36","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-37","location":[[" Proposal for a directive","Recital 15"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:18"},"new":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic or biosimilar medicinal product,","should not request information concerning","the patent status of the reference medicinal","product and should not examine the","validity of an alleged violation of","intellectual property rights should the","generic or biosimilar medicinal product be","manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and reimbursement procedures in","the Member States."],"old":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic medicinal product, should not","request information concerning the patent","status of the reference medicinal product","and should not examine the validity of an","alleged violation of intellectual property","rights should the generic medicinal product","be manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and reimbursement procedures in","the Member States."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"37","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-38","location":[[" Proposal for a directive","Recital 15"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:18"},"new":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic or biosimilar medicinal product,","should not request information concerning","the patent status of the reference medicinal","product and should not examine the","validity of an alleged violation of","intellectual property rights should the","generic or biosimilar medicinal product be","manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and reimbursement procedures in","the Member States."],"old":["(15) In accordance with Directive","2001/83/EC, intellectual property rights do","not provide a valid ground to refuse,","suspend or revoke a marketing","authorisation. By the same token,","applications, decision-making procedures","and decisions to regulate the prices of","medicinal products or to determine their","coverage by health insurance systems","should be considered administrative","procedures which, as such, are independent","from the enforcement of intellectual","property rights. The national authorities in","charge of those procedures, when","examining an application with respect to a","generic medicinal product, should not","request information concerning the patent","status of the reference medicinal product","and should not examine the validity of an","alleged violation of intellectual property","rights should the generic medicinal product","be manufactured or placed on the market","subsequently to their decision.","Consequently, intellectual property issues","should neither interfere with nor delay","pricing and reimbursement procedures in","the Member States."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"38","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-39","justification":" When standard coverage/reimbursement mechanisms are not deemed appropriate, in\n particular where higher than normal levels of uncertainty exist as regards the effect of a\n medicine on patients and society, the reimbursement authority and the manufacturer can\n agree on specific conditions regulated in contracts to ensure patient access to innovative\n medicines. These agreements, which deviate from standard administrative practices, operate\n outside of the scope of this Directive, provided that they are not imposed on the applicant.","location":[["Proposal for a directive","Article 1 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:18"},"new":["This Directive shall apply to measures","intended to determine which medicinal","products may be included in contractual","agreements or public procurement","procedures.","This Directive shall not apply to the","following:"],"old":["This Directive shall not apply to the","following:",""],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"39","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jorgo Chatzimarkakis","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-40","location":[[" Proposal for a directive","Article 1 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[28243],"meta":{"created":"2019-07-03T05:36:18"},"new":["deleted"],"old":["(a) voluntary contractual agreements","concluded between public authorities and","the holder of a marketing authorisation","for a medicinal product that have as their","object to enable the effective provision of","this medicine to patients under specific","conditions;"],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"40","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-41","justification":"When standard coverage/reimbursement mechanisms are not deemed appropriate, in\nparticular where higher than normal levels of uncertainty exist as regards the effect of a\nmedicine on patients and society, the reimbursement authority and the manufacturer can\nagree on specific conditions regulated in contracts to ensure patient access to innovative\nmedicines. These agreements, which deviate from standard administrative practices, operate\noutside of the scope of this Directive, provided that they are not imposed on the applicant.","location":[[" Proposal for a directive","Article 1 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:18"},"new":["(a) agreements concluded at the written","request of the holder of a marketing","authorisation with public authorities","which aim at including a medicinal","product in the scope of the public health","insurance system whilst monitoring","elements agreed upfront with the holder","of a marketing authorisation to address","evidentiary uncertainties related to the","effectiveness and appropriate use of the","given medicinal product over time;"],"old":["(a) voluntary contractual agreements","concluded between public authorities and","","the holder of a marketing authorisation for","a medicinal product that have as their","object to enable the effective provision of","this medicine to patients under specific","conditions;"],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"41","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-42","justification":"When standard coverage/reimbursement mechanisms are not deemed appropriate, in\nparticular where higher than normal levels of uncertainty exist as regards the effect of a\nmedicine on patients and society, the reimbursement authority and the manufacturer can\nagree on specific conditions regulated in contracts to ensure patient access to innovative\nmedicines. These agreements, which deviate from standard administrative practices, operate\n\n\n outside of the scope of this Directive, provided that they are not imposed on the applicant.","location":[["Proposal for a directive","Article 1 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:19"},"new":["deleted"],"old":["The provisions of this Directive shall","apply to measures intended to determine","which medicinal products may be","included in contractual agreements or","public procurement procedures."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"42","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jorgo Chatzimarkakis","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-43","location":[[" Proposal for a directive","Article 1 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28243],"meta":{"created":"2019-07-03T05:36:19"},"new":["The provisions of this Directive shall apply","to measures intended to determine which","medicinal products may be included in","public procurement procedures."],"old":["The provisions of this Directive shall apply","to measures intended to determine which","medicinal products may be included in","contractual agreements or public","procurement procedures."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"43","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-44","justification":" The introduction of specific provisions for generic medicinal products is what provides the\n main \u2018added value\u2019 of this recast. However, in order to cover all generic medicinal products,\n including biotherapies, it is necessary to introduce the concept of biosimilarity in addition to\n bioequivalence.","location":[[" Proposal for a directive","Article 2 \u2013 paragraph 1 \u2013 point 3 a (new)"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:19"},"new":["3a. \u201cbiosimilar medicinal product\u201d means","a similar biological medicinal product","approved in accordance with Article 10(4)","of Directive 2001/83/EC;"],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"44","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-45","justification":"Clarification of the wording and removal of the phrase \u2018at any point in time\u2019, which is a\nsource of legal uncertainty.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:19"},"new":["2. Member States shall guarantee that the","marketing authorisation holder has the","possibility to introduce an application to","approve the price of the product. The","competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to approve the price of the","product can be introduced by the","marketing authorisation holder at any","point in time. The competent authorities","shall provide the applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"45","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nora Berra, Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-46","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[96947,40599],"meta":{"created":"2019-07-03T05:36:19"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 15 days, provided that the price of","the reference medicinal product has been","","","approved by the competent authorities."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"46","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-47","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:19"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 30 days, provided","that the price of the reference medicinal","product has been approved by the","competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the price of the reference medicinal","product has been approved by the","competent authorities."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"47","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Louis Grech","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-48","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[28123],"meta":{"created":"2019-07-03T05:36:19"},"new":["3. Member States shall ensure that a","reasoned and objectively justified decision","on the price which may be charged for the","medicinal product concerned is adopted","and communicated to the applicant within","60 days of the receipt of an application","submitted, in accordance with the","requirements laid down in the Member","State concerned, by the holder of a","marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the price of the reference medicinal","product has been approved by the","competent authorities. That decision","should be made available to the public in","a clear and transparent manner within a","reasonable time following adoption."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the price of the reference medicinal","product has been approved by the","competent authorities."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"48","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-49","justification":" The new deadlines are unrealistic and go well beyond what is necessary to attain the\n objective pursued by the Commission, namely the rapid availability of new treatments that\n have a \u2018normal\u2019 marketing authorisation.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 3"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:19"},"new":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 90 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the price of","the reference medicinal product has been","approved by the competent authorities."],"old":["3. Member States shall ensure that a","decision on the price which may be","charged for the medicinal product","concerned is adopted and communicated to","the applicant within 60 days of the receipt","of an application submitted, in accordance","with the requirements laid down in the","Member State concerned, by the holder of","a marketing authorisation. However, with","respect to medicines for which Member","States use health technology assessment","as part of their decision-making process,","the time-limit shall be 90 days. With","respect to generic medicinal products, that","time limit shall be 15 days, provided that","the price of the reference medicinal","","product has been approved by the","competent authorities."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"49","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-50","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 5"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:19"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 30 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be in all events 15 days, provided that","the price of the reference medicinal","product has been approved by the","competent authorities. Member States shall","not request any additional information","which is not explicitly required under","national legislation or administrative","guidelines."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"50","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-51","justification":"This provision goes well beyond the desired objective of the rapid availability of new\ntreatments and is neither proportionate nor in accordance with the principle of subsidiarity.\nIn addition, a measure of this type could upset the already delicate budget balance of public\nhealth insurance systems.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 6"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:19"},"new":["deleted"],"old":["6. In the absence of a decision within the","relevant time limit set out in paragraphs 3","and 5, the applicant shall be entitled to","market the product at the price proposed."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"51","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-52","justification":" The requirement to provide expert reports in support of any decision by the authorities that is\n contrary to the commercial interests of manufacturers is disproportionate.","location":[["Proposal for a directive","Article 3 \u2013 paragraph 7"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:19"},"new":["7. If the competent authorities decide not to","permit the marketing of the medicinal","product concerned at the price proposed by","the applicant, the decision shall contain a","statement of reasons based on objective","and verifiable criteria. The applicant shall","be informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"old":["7. If the competent authorities decide not to","permit the marketing of the medicinal","product concerned at the price proposed by","the applicant, the decision shall contain a","statement of reasons based on objective","and verifiable criteria, including any","evaluation, expert opinion or","recommendation on which it is based. The","applicant shall be informed of all remedies","available, including judicial remedies, and","of the time limits for applying for such","remedies."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"52","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-53","justification":" Given that the pricing of medicinal products is a national competence, Member States do not\n a priori have to communicate to the Commission their criteria for assessing the price of a\n medicinal product.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 8"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:19"},"new":["deleted"],"old":["8. Member States shall publish in an","appropriate publication and communicate","to the Commission the criteria which the","competent authorities must take into","account when approving the prices of","medicinal products."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"53","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-54","justification":"The requirement to provide expert reports in support of any decision by the authorities that is\ncontrary to the commercial interests of manufacturers is disproportionate.","location":[[" Proposal for a directive","Article 3 \u2013 paragraph 9"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["9. If the competent authorities decide to","reduce the price of a specific named","medicinal product on their own initiative,","the decision shall contain a statement of","reasons based on objective and verifiable","criteria. The decision shall be","communicated to the holder of the","marketing authorisation, who shall be","informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"old":["9. If the competent authorities decide to","reduce the price of a specific named","medicinal product on their own initiative,","the decision shall contain a statement of","reasons based on objective and verifiable","criteria, including any evaluation, expert","opinion or recommendation on which it is","based. The decision shall be communicated","","to the holder of the marketing","authorisation, who shall be informed of all","remedies available, including judicial","remedies, and of the time limits for","applying for such remedies."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"54","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-55","justification":"Clarification of the wording and removal of the phrase \u2018at any point in time\u2019, which is a\nsource of legal uncertainty.","location":[["Proposal for a directive","Article 4 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["2. Member States shall guarantee that the","marketing authorisation holder has the","possibility to introduce an application to","increase the price of a medicinal product.","The competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to increase the price of the","product can be submitted by the","marketing authorisation holder at any","point in time. The competent authorities","shall provide the applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"55","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-56","justification":" The new deadlines are unrealistic and go well beyond what is necessary to attain the\n objective pursued by the Commission, namely the rapid availability of new treatments that\n have a \u2018normal\u2019 marketing authorisation.","location":[["Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 90","days of its receipt."],"old":["Member States shall ensure that a decision","on an application submitted in accordance","with the requirements laid down in the","Member State concerned, by a marketing","authorisation holder to increase the price of","a medicinal product is adopted and","communicated to the applicant within 60","days of its receipt."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"56","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-57","justification":" The new deadlines are unrealistic and go well beyond what is necessary to attain the\n objective pursued by the Commission, namely the rapid availability of new treatments that\n have a \u2018normal\u2019 marketing authorisation.","location":[[" Proposal for a directive","Article 4 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 90 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"old":["In case of an exceptional number of","applications, the time limit set out in this","paragraph may be extended once only for a","further 60 days. The applicant shall be","notified of such an extension before the","expiry of the time limit set out in this","paragraph."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"57","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-58","justification":"This provision goes well beyond the desired objective of the rapid availability of new\ntreatments and is neither proportionate nor in accordance with the principle of subsidiarity.\nIn addition, a measure of this type could upset the already delicate budget balance of public\nhealth insurance systems.","location":[["Proposal for a directive","Article 4 \u2013 paragraph 5"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["deleted"],"old":["5. In the absence of a decision within the","relevant time limit referred to in","paragraphs 3 and 4, the applicant shall be","entitled to apply the price increase","requested."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"58","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-59","justification":" The requirement to provide a detailed justification in support of any decision by the\n authorities regarding price re-assessment that is contrary to the commercial interests of\n manufacturers is disproportionate.","location":[["Proposal for a directive","Article 4 \u2013 paragraph 6"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["6. If the competent authorities decide not to","permit the whole or part of the price","increase requested, the applicant shall be","informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"old":["6. If the competent authorities decide not to","permit the whole or part of the price","increase requested, the decision shall","contain a statement of reasons based on","objective and verifiable criteria and the","applicant shall be informed of all remedies","available, including judicial remedies, and","of the time limits for applying for such","remedies."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"59","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nora Berra, Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-60","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 1"]],"meps":[96947,40599],"meta":{"created":"2019-07-03T05:36:20"},"new":["1. In the event of a temporary price freeze","or price reduction imposed on all medicinal","products or on certain categories of","medicinal products by the competent","authorities of a Member State, that","Member State shall publish a statement of","reasons for its decision based on objective","and verifiable criteria, including, if","applicable, a justification of the categories","of products subject to the price freeze or","price reduction."],"old":["1. In the event of a price freeze or price","reduction imposed on all medicinal","products or on certain categories of","medicinal products by the competent","authorities of a Member State, that","Member State shall publish a statement of","reasons for its decision based on objective","and verifiable criteria, including, if","applicable, a justification of the categories","of products subject to the price freeze or","price reduction."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"60","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-61","justification":"The requirement to provide a detailed justification in support of any decision by the\nauthorities regarding price re-assessment that is contrary to the commercial interests of\nmanufacturers is disproportionate.","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["1. In the event of a price freeze or price","reduction imposed on all medicinal","products or on certain categories of","medicinal products by the competent","authorities of a Member State, that","Member State shall publish a statement of","reasons for its decision, including, if","applicable, a justification of the categories","of products subject to the price freeze or","price reduction."],"old":["1. In the event of a price freeze or price","reduction imposed on all medicinal","products or on certain categories of","medicinal products by the competent","authorities of a Member State, that","Member State shall publish a statement of","reasons for its decision based on objective","and verifiable criteria, including, if","","","applicable, a justification of the categories","of products subject to the price freeze or","price reduction."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"61","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-62","justification":"Clarification of the wording and removal of the phrase \u2018at any point in time\u2019, which is a\nsource of legal uncertainty.","location":[["Proposal for a directive","Article 5 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall guarantee that the","marketing authorisation holder has the","possibility to introduce an application for","a derogation. The competent authorities","shall provide the applicant with an official","acknowledgement of receipt."],"old":["2. Marketing authorisation holders may","apply for a derogation from a price freeze","or price reduction if this is justified by","particular reasons. The application shall","contain an adequate statement of reasons.","Member States shall ensure that","applications for a derogation can be","introduced by the marketing authorisation","holder at any point in time. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"62","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-63","justification":" The requirement to provide a detailed justification in support of any decision by the\n authorities regarding price re-assessment that is contrary to the commercial interests of\n manufacturers is disproportionate.","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application."],"old":["Member States shall ensure that a reasoned","decision on an application referred to in","paragraph 2 is adopted and communicated","to the applicant within 60 days of the","receipt of the application. If the","information supporting the application is","inadequate, the competent authorities","shall forthwith notify the applicant of the","detailed additional information required","and take their final decision within 60","days of receipt of this additional","information. If the derogation is granted,","the competent authorities shall forthwith","publish an announcement of the price","increase allowed."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"63","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-64","justification":"The new deadlines are unrealistic and go well beyond what is necessary to attain the\nobjective pursued by the Commission, namely the rapid availability of new treatments that\nhave a \u2018normal\u2019 marketing authorisation.","location":[[" Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["deleted"],"old":["If there is an exceptional number of","applications, the relevant time limit set out","in paragraph 3 may be extended once only","for a further 60 days. The applicant shall","be notified of such extension before the","expiry of the time limit set out in","paragraph 3."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"64","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-65","justification":"There has been an increase in the number of voluntary agreements such as discount contracts\nbetween pharmaceutical manufacturers and health insurance funds. As a result, the actual\nprice of the medicinal product is not clear to doctors and pharmacists and the patient is not\nalways prescribed the least expensive and therefore the most economical medicine.","location":[["Proposal for a directive","Article 5 \u2013 paragraph 3 \u2013 subparagraph 2 a (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:36:20"},"new":["Member States shall ensure that","dispensaries possess information about","the actual price of the medicinal product","in order to prevent possible distorting","effects caused by a lack of transparency in","prices displayed on the market."],"orig_lang":"de","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"65","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-66","justification":" Clarification of the wording and removal of the phrase \u2018at any point in time\u2019, which is a\n source of legal uncertainty.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:20"},"new":["2. Member States shall guarantee that the","marketing authorisation holder has the","possibility to introduce an application to","include a medicinal product in the scope","of the public health insurance system. If","the public health insurance system","comprises several schemes or categories of","coverage, the marketing authorisation","holder shall be entitled to apply for the","inclusion of its product in the scheme or","category of its choice. The competent","authorities shall provide the applicant with","an official acknowledgement of receipt."],"old":["2. Member States shall ensure that an","application to include a medicinal product","in the scope of the public health","insurance system can be introduced by the","","marketing authorisation holder at any","point in time. If the public health insurance","system comprises several schemes or","categories of coverage, the marketing","authorisation holder shall be entitled to","apply for the inclusion of its product in the","scheme or category of its choice. The","competent authorities shall provide the","applicant with an official","acknowledgement of receipt."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"66","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nora Berra, Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-67","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[96947,40599],"meta":{"created":"2019-07-03T05:36:20"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 30 days, provided","that the reference medicinal product has","already been included in the public health","insurance system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the reference medicinal product has","already been included in the public health","insurance system."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"67","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-68","location":[["Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:21"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","30 days, provided that the reference","medicinal product has already been","included in the public health insurance","system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicinal products for","which Member States use health","technology assessment as part of their","decision-making process, the time-limit","shall be 90 days. With respect to generic","medicinal products, that time limit shall be","15 days, provided that the reference","medicinal product has already been","included in the public health insurance","system."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"68","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-69","justification":" The new deadlines are unrealistic and go well beyond what is necessary to attain the\n objective pursued by the Commission, namely the rapid availability of new treatments that\n have a \u2018normal\u2019 marketing authorisation.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 4"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:21"},"new":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 90 days of its receipt. With respect","to generic medicinal products, that time","limit shall be 15 days, provided that the","reference medicinal product has already","been included in the public health","insurance system."],"old":["4. Member States shall ensure that a","decision on an application to include a","medicinal product in the scope of the","public health insurance system, submitted","","by the marketing authorisation holder in","accordance with the requirements laid","down in the Member State concerned, is","adopted and communicated to the applicant","within 60 days of its receipt. However,","with respect to medicines for which","Member States use health technology","assessment as part of their decision-","making process, the time-limit shall be 90","days. With respect to generic medicinal","products, that time limit shall be 15 days,","provided that the reference medicinal","product has already been included in the","public health insurance system."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"69","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nora Berra, Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-70","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[96947,40599],"meta":{"created":"2019-07-03T05:36:21"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 30 days, provided that the","reference medicinal product has already","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicines for which Member","States use health technology assessment as","part of their decision-making process, the","time-limit shall be 90 days. With respect to","generic medicinal products, that time limit","shall be 15 days, provided that the","reference medicinal product has already","","been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"70","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-71","location":[["Proposal for a directive","Article 7 \u2013 paragraph 5"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:21"},"new":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 30 days, provided","that the reference medicinal product has","already been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"old":["5. If the information supporting the","application is inadequate, the competent","authorities shall forthwith notify the","applicant of the detailed additional","information required and take their final","decision within 60 days of receipt of this","additional information. However, with","respect to medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time-limit shall be 90 days.","With respect to generic medicinal products,","that time limit shall be 15 days, provided","that the reference medicinal product has","already been included in the public health","insurance system. Member States shall not","request any additional information which is","not explicitly required under national","legislation or administrative guidelines."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"71","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nora Berra, Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-72","location":[["Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[96947,40599],"meta":{"created":"2019-07-03T05:36:21"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","60 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","30 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"72","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-73","location":[[" Proposal for a directive","Article 7 \u2013 paragraph 6"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:21"},"new":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","60 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"old":["6. Irrespective of the organisation of their","internal procedures, Member States shall","ensure that the overall period of time taken","by the inclusion procedure set out in","paragraph 5 of this Article and the price","approval procedure set out in Article 3","does not exceed 120 days. However, with","respect to the medicinal products for which","Member States use health technology","assessment as part of their decision-making","process, the time limit shall not exceed 180","days. With respect to generic medicinal","products, that time limit shall not exceed","","30 days, provided that the reference","medicinal product has already been","included in the public health insurance","system. Those time-limits may be extended","in accordance with paragraph 5 of this","Article or Article 3(5)."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"73","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-74","justification":"Given that the decision on whether or not to include a medicinal product within the scope of\nthe public health insurance system is a national competence, Member States do not a priori\nhave to communicate their assessment criteria to the Commission.","location":[["Proposal for a directive","Article 7 \u2013 paragraph 8"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:21"},"new":["deleted"],"old":["8. Member States shall publish in an","appropriate publication and communicate","to the Commission the criteria which the","competent authorities must take into","account when deciding whether or not to","include medicinal products within the","scope of the public health insurance","system."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"74","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-75","location":[["Proposal for a directive","Article 7 \u2013 paragraph 8"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:21"},"new":["8. Member States shall publish in an","appropriate publication and communicate","to the Commission the criteria which the","competent authorities must take into","account when deciding whether or not to","include medicinal products within the","scope of the public health insurance","system. The identity and statements of","interest of the experts involved in the","decision-making process shall also be","published."],"old":["8. Member States shall publish in an","","","appropriate publication and communicate","to the Commission the criteria which the","competent authorities must take into","account when deciding whether or not to","include medicinal products within the","scope of the public health insurance","system."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"75","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ildik\u00f3 G\u00e1ll-Pelcz","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-76","justification":" The part of the proposal which would impose a fine and the payment of compensation on a\n determining authority for not reaching a decision within the deadline is unacceptable. This\n also applies to possible interim measures. A medicinal product cannot be included in the\n support scheme by means of an interim measure. Nor is it clear what the basis for calculating\n the amount of the fine and compensation would be. Therefore the idea of a \u2018super-authority\u2019\n which would be created or appointed to implement the compensation should not be supported.","location":[[" Proposal for a directive","Article 8"]],"meps":[102886],"meta":{"created":"2019-07-03T05:36:21"},"new":["deleted"],"old":["[...]"],"orig_lang":"hu","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"76","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nora Berra","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-77","location":[[" Proposal for a directive","Article 8 \u2013 paragraph 2"]],"meps":[96947],"meta":{"created":"2019-07-03T05:36:21"},"new":["deleted"],"old":["2. For the purposes of the remedies","","","procedure Member States shall designate","a body and entrust it with the powers to:","a) take, at the earliest opportunity and by","way of interlocutory procedures, interim","measures with the aim of correcting the","alleged infringement or preventing","further damage to the interests","concerned;","b) award damages to the applicant in case","of non-compliance with time limits set in","Article 7 where damages are claimed,","unless the competent authority may prove","that the delay is not imputable to it;","c) impose a penalty payment, calculated","by day of delay.","For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, the need to ensure that the","penalty itself is a deterrent to further","infringements.","Member States may provide that the body","referred to in the first subparagraph may","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"77","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-78","location":[["Proposal for a directive","Article 8 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point b"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:21"},"new":["deleted"],"old":["(b) award damages to the applicant in","case of non-compliance with time limits","set in Article 7 where damages are","","claimed, unless the competent authority","may prove that the delay is not imputable","to it;"],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"78","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-79","location":[[" Proposal for a directive","Article 8 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point b a (new)"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:21"},"new":["(b a) refer any instances of non-","compliance with time limits set in Article","7 to the relevant body, in accordance with","national law, should the competent","authority have been unable to prove that","the delay is not imputable to it."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"79","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-80","location":[[" Proposal for a directive","Article 8 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point c"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:21"},"new":["deleted"],"old":["(c) impose a penalty payment, calculated","by day of delay."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"80","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-81","location":[[" Proposal for a directive","Article 8 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:21"},"new":["deleted"],"old":["For the purposes of point (c), the penalty","payment shall be calculated depending on","the seriousness of the infringement, its","duration, the need to ensure that the","penalty itself is a deterrent to further","infringements."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"81","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-82","location":[["Proposal for a directive","Article 8 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:22"},"new":["deleted"],"old":["Member States may provide that the body","referred to in the first subparagraph may","take into account the probable","consequences of potential measures taken","under the present paragraph for all","interests likely to be harmed, as well as","the public interest, and may decide not to","take such measures when their negative","consequences could exceed their benefits."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"82","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-83","location":[["Proposal for a directive","Article 8 \u2013 paragraph 6 \u2013 subparagraph 1"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:22"},"new":["The body referred to in paragraph 2 shall","state reasons for its decision. Furthermore,","where that body does not have judicial","authority, provision must be made to","guarantee procedures whereby any","allegedly illegal measure taken by the","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the European","Union and independent of both the","competent authority and the body referred","to in paragraph 2."],"old":["The body referred to in paragraph 2 shall","state reasons for its decision. Furthermore,","where that body is not judicial in","character, provision must be made to","","guarantee procedures whereby any","allegedly illegal measure taken by the","independent body or any alleged defect in","the exercise of powers conferred on it can","be subject to judicial review or review by","another body which is a court or tribunal","within the meaning of Article 267 of the","Treaty on the Functioning of the European","Union and independent of both the","competent authority and the body referred","to in paragraph 2."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"83","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-84","justification":" The requirement to provide expert reports in support of any decision by the authorities that is\n contrary to the commercial interests of manufacturers is disproportionate.","location":[[" Proposal for a directive","Article 9 \u2013 paragraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:22"},"new":["1. Any decision to exclude a medicinal","product from the scope of the public health","insurance system, or to modify the extent","or the conditions of coverage of the","product concerned, shall contain a","statement of reasons based on objective","and verifiable criteria. The applicant shall","be informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"old":["1. Any decision to exclude a medicinal","product from the scope of the public health","insurance system, or to modify the extent","or the conditions of coverage of the","product concerned, shall contain a","statement of reasons based on objective","and verifiable criteria. Such decisions","shall include any evaluation, expert","opinion or recommendation on which","they are based. The applicant shall be","informed of all remedies available,","including judicial remedies, and of the time","limits for applying for such remedies."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"84","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-85","justification":"The requirement to provide a detailed justification in support of any decision by the\nauthorities regarding the exclusion of a medicinal product from the scope of the public health\ninsurance system that is contrary to the commercial interests of manufacturers is\ndisproportionate.","location":[["Proposal for a directive","Article 9 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:22"},"new":["2. Any decision to exclude a category of","medicinal products from the scope of the","public health insurance system, or to","modify the extent or the conditions of","coverage of the category concerned, shall","contain a statement of reasons based on","objective and verifiable criteria."],"old":["2. Any decision to exclude a category of","medicinal products from the scope of the","public health insurance system, or to","modify the extent or the conditions of","coverage of the category concerned, shall","contain a statement of reasons based on","objective and verifiable criteria and be","published in an appropriate publication."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"85","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-86","location":[["Proposal for a directive","Article 9 \u2013 paragraph 2"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:22"},"new":["2. Any decision to exclude a category of","medicinal products from the scope of the","public health insurance system, or to","modify the extent or the conditions of","coverage of the category concerned, shall","contain a statement of reasons based on","objective and verifiable criteria and be","made publicly available."],"old":["2. Any decision to exclude a category of","medicinal products from the scope of the","public health insurance system, or to","modify the extent or the conditions of","coverage of the category concerned, shall","contain a statement of reasons based on","objective and verifiable criteria and be","published in an appropriate publication."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"86","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-87","location":[[" Proposal for a directive","Article 10 \u2013 paragraph 2"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:22"},"new":["2. Member States shall make publicly","available and communicate to the","Commission the objective and verifiable","criteria according to which medicinal","products are classified in view of their","inclusion in the public health insurance","system."],"old":["2. Member States shall publish in an","appropriate publication and communicate","to the Commission the objective and","verifiable criteria according to which","medicinal products are classified in view of","their inclusion in the public health","insurance system."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"87","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-88","location":[[" Proposal for a directive","Article 10 \u2013 paragraph 3"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:22"},"new":["3. For the medicinal products subject to","such grouping or classification, Member","States shall make publicly available and","communicate to the Commission the","methodologies used to determine the extent","or conditions of their inclusion in the","public health insurance system."],"old":["3. For the medicinal products subject to","such grouping or classification, Member","States shall publish in an appropriate","publication and communicate to the","Commission the methodologies used to","determine the extent or conditions of their","inclusion in the public health insurance","system."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"88","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-89","justification":"The requirement to provide expert reports in support of any decision by the authorities that is\ncontrary to the commercial interests of manufacturers is disproportionate.","location":[[" Proposal for a directive","Article 11 \u2013 paragraph 3"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:22"},"new":["deleted"],"old":["3. Measures referred to in paragraph 1,","including any evaluation, expert opinion","or recommendation on which they are","based, shall be published in an","appropriate publication."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"89","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-90","location":[["Proposal for a directive","Article 11 \u2013 paragraph 3"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:22"},"new":["3. Measures referred to in paragraph 1,","including any evaluation, expert opinion or","recommendation on which they are based,","shall be made publicly available."],"old":["3. Measures referred to in paragraph 1,","including any evaluation, expert opinion or","recommendation on which they are based,","shall be published in an appropriate","publication."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"90","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-91","justification":" The requirement to provide a detailed justification in support of any decision by the\n authorities regarding their prescription policy that would be contrary to the commercial\n interests of manufacturers is disproportionate.","location":[["Proposal for a directive","Article 11 \u2013 paragraph 4"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:22"},"new":["4. At the request of the holder of a","marketing authorisation whose interests or","legal position are affected by the measures","referred to in paragraph 1, the competent","authorities shall inform the marketing","authorisation holder of all remedies","available, including judicial, and of the","time limits for applying for such remedies."],"old":["4. At the request of the holder of a","marketing authorisation whose interests or","legal position are affected by the measures","referred to in paragraph 1, the competent","","authorities shall specify the objective data","and criteria on the basis of which these","measures have been taken with respect to","its medicinal product. In such a case, the","competent authorities shall also inform","the marketing authorisation holder of all","remedies available, including judicial, and","of the time limits for applying for such","remedies."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"91","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-92","location":[[" Proposal for a directive","Article 13 \u2013 title"]],"meps":[40599],"meta":{"created":"2019-07-03T05:36:22"},"new":["Additional proof of quality, safety,","efficacy, bioequivalence or biosimilarity"],"old":["Additional proof of quality, safety, efficacy","or bioequivalence"],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"92","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-93","justification":"The non reassessment of the elements on which the marketing authorisation is based should\nalso apply to biosimilar medicinal products approved according to Article 10.4 of Directive\n2001/83/EC.","location":[[" Proposal for a directive","Article 13 \u2013 title"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:22"},"new":["Additional proof of quality, safety,","efficacy, bioequivalence or biosimilarity"],"old":["Additional proof of quality, safety, efficacy","or bioequivalence"],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"93","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-94","justification":"The introduction of specific provisions for generic medicinal products is what provides the\nmain \u2018added value\u2019 of this recast. However, in order to cover all generic medicinal products,\nincluding biotherapies, it is necessary to introduce the concept of biosimilarity in addition to\nbioequivalence.","location":[["Proposal for a directive","Article 13 \u2013 title"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:22"},"new":["Additional proof of quality, safety,","efficacy, bioequivalence or biosimilarity"],"old":["Additional proof of quality, safety, efficacy","or bioequivalence"],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"94","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-95","justification":"The title should remain general and not be a list of everything that should not be subject to\nreassessment.","location":[["Proposal for a directive","Article 13 \u2013 title"]],"meta":{"created":"2019-07-03T05:36:22"},"new":["Non-reassessment of elements","underpinning the market authorisation"],"old":["Additional proof of quality, safety,","efficacy or bioequivalence"],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"95","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-96","location":[[" Proposal for a directive","Article 13 \u2013 title"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:22"},"new":["Additional proof of quality, safety,","efficacy, bioequivalence or biosimilarity"],"old":["Additional proof of quality, safety, efficacy","or bioequivalence"],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"96","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-97","justification":" The non reassessment of the elements on which the marketing authorisation is based should\n also apply to biosimilar medicinal products approved according to Article 10.4 of Directive\n 2001/83/EC.","location":[[" Proposal for a directive","Article 13 \u2013 paragraph 1"]],"meps":[96957],"meta":{"created":"2019-07-03T05:36:23"},"new":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence or biosimilarity of the","medicinal product."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"97","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-98","justification":"The authorities need to be able to re-assess the therapeutic value of a medicinal product. The\nrelative value of a medicinal product may in fact vary considerably depending on the\nappearance of new competing molecules on the market or the discovery of a new therapeutic\nproperty. In addition, these comparative assessments are not covered by the mandates of\nagencies issuing marketing authorisations. Finally, it is not necessary to re-assess\nbioequivalence.","location":[[" Proposal for a directive","Article 13 \u2013 paragraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:23"},"new":["In the framework of pricing and","reimbursement decisions, Member States","may re-assess the elements on which the","marketing authorisation is based, including","the quality, safety or efficacy of the","medicinal product."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"98","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristian Silviu Bu\u015foi","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-99","justification":" Adjustment of Amendment 19 to include also biosimilarity which is established by EMA at the\n marketing authorization stage.","location":[["Proposal for a directive","Article 13 \u2013 paragraph 1"]],"meta":{"created":"2019-07-03T05:36:23"},"new":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or,","where appropriate, the bioequivalence or","biosimilarity of the medicinal product or","the criteria for orphan designation.","However, this Directive shall not prevent","Member States from using the data","generated in the marketing authorisation","process for health technology assessment","or pharmaco-economic evaluation","purposes."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"99","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-100","location":[[" Proposal for a directive","Article 13 \u2013 paragraph 1"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:23"},"new":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy,","bioequivalence or biosimilarity of the","medicinal product."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"100","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-101","location":[[" Proposal for a directive","Article 13 \u2013 paragraph 1"]],"meps":[40599],"meta":{"created":"2019-07-03T05:36:23"},"new":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the criteria on which the","marketing authorisation is based."],"old":["In the framework of pricing and","reimbursement decisions, Member States","shall not re-assess the elements on which","the marketing authorisation is based,","including the quality, safety, efficacy or","bioequivalence of the medicinal product."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"101","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-102","location":[["Proposal for a directive","Article 15 \u2013 paragraph 1"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:23"},"new":["Where a Member State intends to adopt or","amend any measure falling within the","scope of this Directive, it shall give","interested parties, civil society","organisations and stakeholders the","opportunity to comment on the draft","measure within a reasonable period. The","competent authorities shall publish the","rules applicable to consultations. The","results of consultations shall be made","publicly available, with the exception of","confidential information in accordance","with Union and national legislation","regarding business confidentiality."],"old":["Where a Member State intends to adopt or","amend any measure falling within the","scope of this Directive, it shall give","interested parties the opportunity to","comment on the draft measure within a","reasonable period. The competent","authorities shall publish the rules","applicable to consultations. The results of","consultations shall be made publicly","available, with the exception of","confidential information in accordance","with Union and national legislation","regarding business confidentiality."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"102","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-103","location":[["Proposal for a directive","Article 16"]],"meps":[40599],"meta":{"created":"2019-07-03T05:36:23"},"new":["deleted"],"old":["Article 16","Notification of draft national measures","1. Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based.","2. Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","","necessary to assess the implications of the","measure proposed.","3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation.","4. The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law.","5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"103","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-104","justification":" The provisions of this Article go beyond what is necessary to attain the objective pursued and\n infringe the principle of subsidiarity.","location":[[" Proposal for a directive","Article 16"]],"meps":[28177],"meta":{"created":"2019-07-03T05:36:23"},"new":["deleted"],"old":["Article 16","Notification of draft national measures","1. Where Member States intend to adopt","","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based.","2. Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed.","3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation.","4. The Commission may send its","observations to the Member State which","has communicated the draft measure","within three months.","The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in","particular if the observations indicate that","the draft measure may be incompatible","with Union law.","5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If","observations have been made by the","Commission in accordance with","paragraph 4, this communication shall be","accompanied by a report on the actions","taken in response to the observations of","the Commission."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"104","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ildik\u00f3 G\u00e1ll-Pelcz","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-105","location":[[" Proposal for a directive","Article 16 \u2013 paragraph 1"]],"meps":[102886],"meta":{"created":"2019-07-03T05:36:23"},"new":["(1) Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","communicate to the Commission the draft","measure envisaged, together with the","reasoning on which the measure is based."],"old":["(1) Where Member States intend to adopt","or amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based."],"orig_lang":"hu","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"105","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Adam Bielan","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-106","location":[[" Proposal for a directive","Article 16 \u2013 paragraph 1"]],"meps":[23788],"meta":{"created":"2019-07-03T05:36:23"},"new":["1. Where Member States intend to adopt or","amend any measure falling within the","scope of this Directive, they should","communicate to the Commission the draft","measure envisaged, together with the","reasoning on which the measure is based."],"old":["1. Where Member States intend to adopt or","amend any measure falling within the","scope of this Directive, they shall","immediately communicate to the","Commission the draft measure envisaged,","together with the reasoning on which the","measure is based."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"106","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ildik\u00f3 G\u00e1ll-Pelcz","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-107","location":[["Proposal for a directive","Article 16 \u2013 paragraph 2"]],"meps":[102886],"meta":{"created":"2019-07-03T05:36:23"},"new":["deleted"],"old":["(2) Where appropriate, Member States","shall simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed."],"orig_lang":"hu","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"107","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Adam Bielan","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-108","location":[["Proposal for a directive","Article 16 \u2013 paragraph 2"]],"meps":[23788],"meta":{"created":"2019-07-03T05:36:23"},"new":["2. Where appropriate, Member States","should simultaneously communicate the","texts of the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed."],"old":["2. Where appropriate, Member States shall","simultaneously communicate the texts of","the basic legislative or regulatory","provisions principally and directly","concerned, if knowledge of such texts is","necessary to assess the implications of the","measure proposed."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"108","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ildik\u00f3 G\u00e1ll-Pelcz","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-109","location":[["Proposal for a directive","Article 16 \u2013 paragraph 3"]],"meps":[102886],"meta":{"created":"2019-07-03T05:36:23"},"new":["deleted"],"old":["(3) Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft","that have the effect of significantly","altering its scope or substance, or","shortening the timetable originally","envisaged for implementation."],"orig_lang":"hu","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"109","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Adam Bielan","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-110","location":[[" Proposal for a directive","Article 16 \u2013 paragraph 3"]],"meps":[23788],"meta":{"created":"2019-07-03T05:36:23"},"new":["3. Member States should communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft that","have the effect of significantly altering its","scope or substance, or shortening the","timetable originally envisaged for","implementation."],"old":["3. Member States shall communicate the","draft measure referred to in paragraph 1","again if they make changes to the draft that","have the effect of significantly altering its","scope or substance, or shortening the","timetable originally envisaged for","implementation."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"110","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nora Berra","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-111","location":[[" Proposal for a directive","Article 16 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[96947],"meta":{"created":"2019-07-03T05:36:23"},"new":["The Commission shall send its","observations to the Member State."],"old":["The Commission may send its observations","to the Member State which has","communicated the draft measure within","three months."],"orig_lang":"fr","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"111","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ildik\u00f3 G\u00e1ll-Pelcz","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-112","location":[["Proposal for a directive","Article 16 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[102886],"meta":{"created":"2019-07-03T05:36:23"},"new":["The Commission may send its observations","to the Member State which has","communicated the draft measure within","three months, and the Member State will","then publish these in the form of an on-","line database."],"old":["The Commission may send its observations","to the Member State which has","communicated the draft measure within","three months."],"orig_lang":"hu","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"112","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Adam Bielan","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-113","location":[["Proposal for a directive","Article 16 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[23788],"meta":{"created":"2019-07-03T05:36:23"},"new":["The observations of the Commission","should be taken into account by the","Member State concerned."],"old":["The observations of the Commission shall","be taken into account as far as possible by","the Member State concerned, in particular","if the observations indicate that the draft","measure may be incompatible with Union","law."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"113","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ildik\u00f3 G\u00e1ll-Pelcz","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-114","location":[["Proposal for a directive","Article 16 \u2013 paragraph 5"]],"meps":[102886],"meta":{"created":"2019-07-03T05:36:23"},"new":["(5) When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If observations","have been made by the Commission in","accordance with paragraph 4, this","communication shall be accompanied by a","report on the actions taken in response to","the observations of the Commission, which","will publish it in the form of a public on-","line database."],"old":["(5) When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If observations","have been made by the Commission in","accordance with paragraph 4, this","communication shall be accompanied by a","report on the actions taken in response to","the observations of the Commission."],"orig_lang":"hu","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"114","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Adam Bielan","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-115","location":[[" Proposal for a directive","Article 16 \u2013 paragraph 5"]],"meps":[23788],"meta":{"created":"2019-07-03T05:36:24"},"new":["5. When the Member State concerned","definitively adopts the draft measure, it","should communicate the final text to the","Commission without delay."],"old":["5. When the Member State concerned","definitively adopts the draft measure, it","shall communicate the final text to the","Commission without delay. If observations","have been made by the Commission in","accordance with paragraph 4, this","communication shall be accompanied by","a report on the actions taken in response","to the observations of the Commission."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"115","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Phil Prendergast","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-116","location":[[" Proposal for a directive","Article 17 a (new)"]],"meps":[107386],"meta":{"created":"2019-07-03T05:36:24"},"new":["Article 17 a","The Commission shall establish and","maintain a publicly accessible online","database containing comparative","information on procurement prices for all","medicines purchased by Member States."],"orig_lang":"en","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"116","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ildik\u00f3 G\u00e1ll-Pelcz","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-117","justification":"Price transparency and comparability of the price of medicinal products between the Member\nStates are important. The ongoing EURIPID project, which is jointly funded by the\nCommission and the Member States, aims to provide a comparison of the prices of medicinal\nproducts between the Member States. The project should be continued for the purpose of price\ntransparency. In terms of communicating the prices to the Commission, there is therefore a\nneed for the contents of the \u2018Transparency Directive\u2019 in force (89/105/EEC) to appear in the\nnew Directive. This explains the suggested addition to the first paragraph.","location":[["Proposal for a directive","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c a (new)"]],"meps":[102886],"meta":{"created":"2019-07-03T05:36:24"},"new":["c a) a list of those medicinal products","whose prices were registered during the","period in question and the prices which","can be obtained for these products;"],"orig_lang":"hu","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"117","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ildik\u00f3 G\u00e1ll-Pelcz","changes":{},"committee":["IMCO"],"date":"2012-10-10T00:00:00","id":"PE497.814-118","justification":" Price transparency and comparability of the price of medicinal products between the Member\n States are important. The ongoing EURIPID project, which is jointly funded by the\n Commission and the Member States, aims to provide a comparison of the prices of medicinal\n products between the Member States. The project should be continued for the purpose of price\n transparency. In terms of communicating the prices to the Commission, there is therefore a\n need for the contents of the \u2018Transparency Directive\u2019 in force (89/105/EEC) to appear in the\n new Directive. This explains the suggested addition to the first paragraph.","location":[["Proposal for a directive","Article 17 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point c b (new)"]],"meps":[102886],"meta":{"created":"2019-07-03T05:36:24"},"new":["c b) a list of those medicinal products","whose prices were authorised to rise","during the period in question and the new","prices which can be obtained for these","products;"],"orig_lang":"hu","peid":"PE497.814v01-00","reference":"2012/0035(COD)","seq":"118","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-497.814+01+DOC+PDF+V0//EN&language=EN"}],"changes":{"2012-03-14T10:34:25":[{"data":[{"body":"EP","date":"2012-03-01T00:00:00","type":"EP officialisation"},{"body":"EC","commission":[],"date":"2012-03-01T00:00:00","docs":[{"celexid":"CELEX:52012PC0084:EN","title":"COM(2012)0084","type":"Legislative proposal published","url":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84"},{"title":"SWD(2012)0030","type":"Document attached to the procedure"}],"type":"Legislative proposal"}],"path":["activities"],"type":"added"},{"data":[],"path":["other"],"type":"added"},{"data":[{"body":"EP","committee":"EMPL","committee_full":"Employment and Social Affairs","responsible":false},{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","responsible":true},{"body":"EP","committee":"IMCO","committee_full":"Internal Market and Consumer Protection","responsible":false},{"body":"EP","committee":"ITRE","committee_full":"Industry, Research and Energy","responsible":false},{"body":"EP","committee":"JURI","committee_full":"Legal Affairs","responsible":false}],"path":["committees"],"type":"added"},{"data":{"European Commission":{"title":"PreLex","url":"http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2012&DocNum=0035"},"National parliaments":{"title":"IPEX","url":"http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2012&number=0035&appLng=EN"}},"path":["links"],"type":"added"},{"data":{"instrument":"Directive","legal_basis":["Treaty on the Functioning of the EU TFEU 114-p1"],"reference":"2012/0035(COD)","stage_reached":"Preparatory phase in Parliament","subject":["2.10 Free movement of goods","2.60.03 State aids and interventions","4.20.04 Pharmaceutical products and industry","4.20.06 Health services, medical institutions","4.60.06 Consumers' economic and legal interests","8.50.01 Implementation of Community law"],"subtype":"Legislation","summary":["Repealing Directive 89/105/EEC"],"title":"Medicinal products for human use: transparency of measures regulating the prices and their inclusion in the scope of public health insurance systems","type":"COD - Ordinary legislative procedure (ex-codecision)"},"path":["procedure"],"type":"added"}],"2012-03-22T00:11:58":[{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"deleted"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"deleted"},{"data":{"Commissioner":"TAJANI Antonio","DG":{"title":"Enterprise and Industry","url":"http://ec.europa.eu/enterprise/"}},"path":["activities",1,"commission",0],"type":"added"},{"data":{"body":"EP","committees":[{"body":"EP","committee":"EMPL","committee_full":"Employment and Social Affairs","responsible":false},{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","responsible":true},{"body":"EP","committee":"IMCO","committee_full":"Internal Market and Consumer Protection","responsible":false},{"body":"EP","committee":"ITRE","committee_full":"Industry, Research and Energy","responsible":false},{"body":"EP","committee":"JURI","committee_full":"Legal Affairs","responsible":false}],"date":"2012-03-13T00:00:00","type":"Committee referral announced in Parliament, 1st reading/single reading"},"path":["activities",2],"type":"added"},{"data":{"body":"EC","commissioner":"TAJANI Antonio","dg":{"title":"Enterprise and Industry","url":"http://ec.europa.eu/enterprise/"}},"path":["other",0],"type":"added"},{"data":"ENVI/7/08978","path":["procedure","dossier_of_the_committee"],"type":"added"},{"data":["Preparatory phase in Parliament","Awaiting Parliament 1st reading / single reading / budget 1st stage"],"path":["procedure","stage_reached"],"type":"changed"}],"2012-03-23T10:11:45":[{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"added"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"added"},{"data":{"title":"IPEX","url":"http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2012&number=0035&appLng=EN"},"path":["links","National parliaments"],"type":"deleted"}],"2012-03-26T15:28:17":[{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"deleted"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"deleted"}],"2012-03-27T16:43:45":[{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"added"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"added"},{"data":{"title":"IPEX","url":"http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2012&number=0035&appLng=EN"},"path":["links","National parliaments"],"type":"added"}],"2012-03-29T00:27:07":[{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"deleted"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"deleted"}],"2012-03-29T15:02:12":[{"data":[{"group":"EPP","mepref":"4f1ac4bdb819f25896000030","name":"MAZEJ KUKOVI\u010c Zofija"}],"path":["activities",2,"committees",1,"shadows"],"type":"added"},{"data":[{"group":"EPP","mepref":"4f1ac4bdb819f25896000030","name":"MAZEJ KUKOVI\u010c Zofija"}],"path":["committees",1,"shadows"],"type":"added"}],"2012-04-02T15:16:15":[{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"added"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"added"}],"2012-04-04T00:56:42":[{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"deleted"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"deleted"}],"2012-04-04T16:11:10":[{"data":"2012-03-20T00:00:00","path":["activities",2,"committees",2,"date"],"type":"added"},{"data":[{"group":"ALDE","mepref":"4de1836b0fb8127435bdbc10","name":"BU\u015eOI Cristian Silviu"}],"path":["activities",2,"committees",2,"rapporteur"],"type":"added"},{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"added"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"added"},{"data":"2012-03-20T00:00:00","path":["committees",2,"date"],"type":"added"},{"data":[{"group":"ALDE","mepref":"4de1836b0fb8127435bdbc10","name":"BU\u015eOI Cristian Silviu"}],"path":["committees",2,"rapporteur"],"type":"added"},{"data":{"title":"PreLex","url":"http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2012&DocNum=0035"},"path":["links","European Commission"],"type":"deleted"}],"2012-04-05T21:18:41":[{"data":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=84","path":["activities",1,"docs",0,"url"],"type":"deleted"},{"data":{"title":"SWD(2012)0030","type":"Document attached to the procedure"},"path":["activities",1,"docs",1],"type":"deleted"},{"data":{"title":"PreLex","url":"http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2012&DocNum=0035"},"path":["links","European Commission"],"type":"added"}],"2012-04-10T20:06:07":[{"data":["
PURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Antonyia PARVANOVA (ALDE, BG) on\nthe proposal for a Directive of the European Parliament and of the\nCouncil relating to the transparency of measures regulating the\nprices of medicinal products for human use and their inclusion in\nthe scope of public health insurance systems.
\nIt recommends that the European Parliaments\nposition at first reading, under the ordinary legislative\nprocedure, should amend the Commissions proposal as\nfollows:
\nLegal base: Members\nconsider that because this proposal deals specifically with the\nfree movement of medicinal products and the pricing thereof (a\nmatter that falls within the competence of Member States in the\nfield of public health), Article 168 of the TFEU should\ntherefore be added to the legal basis.
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Members\ndefine a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which as\na minimum includes the relative efficacy or the short- and\nlong-term effectiveness of the medicinal product compared to other\nhealth technologies or interventions in use for treating the\nassociated condition.
\nInnovative treatments: competent authorities and marketing authorisation\nholders increasingly engage in contractual agreements to provide\npatients with access to innovative treatments by including a\nmedicinal product in the scope of public health insurance systems\nwhilst monitoring elements agreed upfront and for a defined period\nof time in order, in particular, to address evidentiary\nuncertainties relating to the effectiveness and/or relative\nefficacy or the appropriate use of a specific medicinal\nproduct.
\nCriteria underlying decisions regulating prices of\nmedicinal products: the criteria\nunderlying any decision directly or indirectly regulating the\nprices of medicinal products, as well as any measure determining\nthe extent to which they shall be covered by public health\ninsurance systems, should include the assessment of unmet\nmedical needs, clinical and societal benefits and innovation.\nSuch criteria should also include the protection of the most\nvulnerable groups of the population.
\nMembers consider that in the framework of pricing and\nreimbursement decisions, the competent authorities responsible for\nthese decisions should not reassess the essential elements on which\nthe marketing authorisation is based, including the quality,\nsafety, efficacy, bioequivalence or biosimilarity of the medicinal\nproduct.
\nTime-periods: the\nCommittee extended a number of the deadlines in the\nCommissions proposal. For example, Member States shall ensure\nthat a decision on the price which may be charged for the medicinal\nproduct concerned is adopted and communicated to the applicant\nwithin 90 days (60 days in Commission proposal) of the\nreceipt of an application submitted. Members recommended a\n60-day time limit to decide on the pricing and reimbursement of\ngeneric medicines.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Members consider\nthat a yearly report collecting Member States data and\ninformation would be more appropriate than a six-monthly report, as\nproposed by the Commission, in order to allow an accurate overview\nand relevant trends analysis on the implementation of time\nlimits.
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level, should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Antonyia PARVANOVA (ALDE, BG) on\nthe proposal for a Directive of the European Parliament and of the\nCouncil relating to the transparency of measures regulating the\nprices of medicinal products for human use and their inclusion in\nthe scope of public health insurance systems.
\nIt recommends that the European Parliaments\nposition at first reading, under the ordinary legislative\nprocedure, should amend the Commissions proposal as\nfollows:
\nLegal base: Members\nconsider that because this proposal deals specifically with the\nfree movement of medicinal products and the pricing thereof (a\nmatter that falls within the competence of Member States in the\nfield of public health), Article 168 of the TFEU should\ntherefore be added to the legal basis.
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Members\ndefine a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which as\na minimum includes the relative efficacy or the short- and\nlong-term effectiveness of the medicinal product compared to other\nhealth technologies or interventions in use for treating the\nassociated condition.
\nInnovative treatments: competent authorities and marketing authorisation\nholders increasingly engage in contractual agreements to provide\npatients with access to innovative treatments by including a\nmedicinal product in the scope of public health insurance systems\nwhilst monitoring elements agreed upfront and for a defined period\nof time in order, in particular, to address evidentiary\nuncertainties relating to the effectiveness and/or relative\nefficacy or the appropriate use of a specific medicinal\nproduct.
\nCriteria underlying decisions regulating prices of\nmedicinal products: the criteria\nunderlying any decision directly or indirectly regulating the\nprices of medicinal products, as well as any measure determining\nthe extent to which they shall be covered by public health\ninsurance systems, should include the assessment of unmet\nmedical needs, clinical and societal benefits and innovation.\nSuch criteria should also include the protection of the most\nvulnerable groups of the population.
\nMembers consider that in the framework of pricing and\nreimbursement decisions, the competent authorities responsible for\nthese decisions should not reassess the essential elements on which\nthe marketing authorisation is based, including the quality,\nsafety, efficacy, bioequivalence or biosimilarity of the medicinal\nproduct.
\nTime-periods: the\nCommittee extended a number of the deadlines in the\nCommissions proposal. For example, Member States shall ensure\nthat a decision on the price which may be charged for the medicinal\nproduct concerned is adopted and communicated to the applicant\nwithin 90 days (60 days in Commission proposal) of the\nreceipt of an application submitted. Members recommended a\n60-day time limit to decide on the pricing and reimbursement of\ngeneric medicines.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Members consider\nthat a yearly report collecting Member States data and\ninformation would be more appropriate than a six-monthly report, as\nproposed by the Commission, in order to allow an accurate overview\nand relevant trends analysis on the implementation of time\nlimits.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Antonyia PARVANOVA (ALDE, BG) on\nthe proposal for a Directive of the European Parliament and of the\nCouncil relating to the transparency of measures regulating the\nprices of medicinal products for human use and their inclusion in\nthe scope of public health insurance systems.
\nIt recommends that the European Parliaments\nposition at first reading, under the ordinary legislative\nprocedure, should amend the Commissions proposal as\nfollows:
\nLegal base: Members\nconsider that because this proposal deals specifically with the\nfree movement of medicinal products and the pricing thereof (a\nmatter that falls within the competence of Member States in the\nfield of public health), Article 168 of the TFEU should\ntherefore be added to the legal basis.
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Members\ndefine a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which as\na minimum includes the relative efficacy or the short- and\nlong-term effectiveness of the medicinal product compared to other\nhealth technologies or interventions in use for treating the\nassociated condition.
\nInnovative treatments: competent authorities and marketing authorisation\nholders increasingly engage in contractual agreements to provide\npatients with access to innovative treatments by including a\nmedicinal product in the scope of public health insurance systems\nwhilst monitoring elements agreed upfront and for a defined period\nof time in order, in particular, to address evidentiary\nuncertainties relating to the effectiveness and/or relative\nefficacy or the appropriate use of a specific medicinal\nproduct.
\nCriteria underlying decisions regulating prices of\nmedicinal products: the criteria\nunderlying any decision directly or indirectly regulating the\nprices of medicinal products, as well as any measure determining\nthe extent to which they shall be covered by public health\ninsurance systems, should include the assessment of unmet\nmedical needs, clinical and societal benefits and innovation.\nSuch criteria should also include the protection of the most\nvulnerable groups of the population.
\nMembers consider that in the framework of pricing and\nreimbursement decisions, the competent authorities responsible for\nthese decisions should not reassess the essential elements on which\nthe marketing authorisation is based, including the quality,\nsafety, efficacy, bioequivalence or biosimilarity of the medicinal\nproduct.
\nTime-periods: the\nCommittee extended a number of the deadlines in the\nCommissions proposal. For example, Member States shall ensure\nthat a decision on the price which may be charged for the medicinal\nproduct concerned is adopted and communicated to the applicant\nwithin 90 days (60 days in Commission proposal) of the\nreceipt of an application submitted. Members recommended a\n60-day time limit to decide on the pricing and reimbursement of\ngeneric medicines.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Members consider\nthat a yearly report collecting Member States data and\ninformation would be more appropriate than a six-monthly report, as\nproposed by the Commission, in order to allow an accurate overview\nand relevant trends analysis on the implementation of time\nlimits.
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level, should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level, should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nThe Commission presents an amended proposal for the\nDirective on the transparency of measures regulating the prices of\nmedicinal products for human use and their inclusion in the scope\nof public health insurance systems. The European Parliament will\nbe consulted again on this proposal.
\nBackground: the\nCommission presented its initial legislative proposal on 1st March\n2012 (please refer to the summary of the same date).\nNegotiations in the Council Working Party on Pharmaceuticals and\nMedical Devices proved to be difficult. The main concerns of\nMember States were related to: (i) the principle of subsidiarity;\n(ii) the remedies procedure; (iii) the creation of a system of\npre-notification of draft national measures to the Commission; (iv)\nthe shortening of the time limits for taking decisions on pricing\nof medicines and their inclusion in the scope of health insurance\nsystems; (v) the distinction between originator medicinal products\nsubject to health technology assessment (HTA) and those not subject\nto HTA; (vi) the obligation to consult the interested\nparties.
\nAs the result of the European Parliaments\nposition in 1st reading on 6 February 2013 (please refer to the\nsummary of that date) and taking into consideration the\nposition of Member States in the Council, the Commission decided to\namend its proposal.
\nIt took into account the amendments of the European\nParliament voted in plenary: 50 were\nacceptable (16 as such and 34 acceptable in principle, even if, a\nfew of them were acceptable only in part) and only 7 were\nunacceptable.
\nThe main amendments to\nthe initial proposal are as follows:
\nMinimum procedural requirements: these should ensure legal certainty and\ntransparency for all the parties involved in the process of\npricing of medicinal products and inclusion in the health insurance\nsystems, while promoting the production of medicinal products,\naccelerating the entry into the market of generic medicinal\nproducts and encouraging research and development of new medicinal\nproducts.
\nDefinitions: the amended\nproposal inserted a definition for biosimilar medicinal\nproduct which means a biological medicinal product that\nis similar to a reference biological medicinal product.
\nThe concept of health technology\nassessment is clarified: it means an assessment which as\na minimum includes the assessment of the relative efficacy or of\nthe short- and long-term effectiveness of the medicinal product\ncompared to other health technologies or interventions in use for\ntreating the associated condition.
\nPrice approval: a\ndecision on the price which may be charged for the medicinal\nproduct concerned is adopted and communicated to the applicant\nwithin 90 days (rather than 60 days as stated in the initial\nproposal) of the receipt of an application submitted. With respect\nto generic medicinal products, that time limit shall be 30\ndays (15 days in the initial proposal), provided that the price\nof the reference medicinal product has been approved by the\ncompetent authorities.
\nWhere Member States decide to include health\ntechnology assessment as part of their decision-making process\non the pricing of medicinal products, such assessment shall be\ncarried out within these time limits.
\nPrice increase: a\ndecision to approve or reject on an application to increase the\nprice of a medicinal product must be adopted and communicated to\nthe applicant within 90 days of its receipt.
\nPrice freeze and price reduction: once a year Member States shall assess whether the\nprice freeze or the price reduction is still justified taking into\naccount the macro-economic conditions and adopt necessary changes\nwhere appropriate.
\nInclusion of medicinal products in health insurance\nsystems: the amended proposal states\nthat a decision must be adopted and communicated to the applicant\nwithin 90 days of its receipt. With respect to generic\nmedicinal products, that time limit shall be 30 days, provided\nthat the reference medicinal product has already been included in\nthe public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days,\nprovided that the reference medicinal product has already been\nincluded in the public health insurance system.
\nFurthermore, information on information on the\ncriteria which the competent authorities must take into account\nwhen deciding whether or not to include medicinal products within\nthe scope of the public health insurance system must be made\npublic, as must information regarding decision-making bodies at\nnational or regional level.
\nAdditional proof of quality, safety, efficacy or\nbioequivalence: in the framework of\npricing and reimbursement decisions, Member States shall not\nre-assess the elements on which the marketing authorisation is\nbased, including the quality, safety, efficacy, or bioequivalence,\nor biosimilarity of the medicinal product or the criteria for\norphan designation which have already been assessed during\nthe marketing authorisation procedure.
\nConsultation of interested parties: where a Member State intends to adopt or amend any\nlegislative measure falling within the scope of the Directive, it\nshall give civil society organisations, including patient and\nconsumer groups, and other interested parties, the opportunity to\ncomment on the draft measure within a reasonable period.
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level, should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level, should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level, should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level, should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nThe Commission presents an amended proposal for the\nDirective on the transparency of measures regulating the prices of\nmedicinal products for human use and their inclusion in the scope\nof public health insurance systems. The European Parliament will\nbe consulted again on this proposal.
\nBackground: the\nCommission presented its initial legislative proposal on 1st March\n2012 (please refer to the summary of the same date).\nNegotiations in the Council Working Party on Pharmaceuticals and\nMedical Devices proved to be difficult. The main concerns of\nMember States were related to: (i) the principle of subsidiarity;\n(ii) the remedies procedure; (iii) the creation of a system of\npre-notification of draft national measures to the Commission; (iv)\nthe shortening of the time limits for taking decisions on pricing\nof medicines and their inclusion in the scope of health insurance\nsystems; (v) the distinction between originator medicinal products\nsubject to health technology assessment (HTA) and those not subject\nto HTA; (vi) the obligation to consult the interested\nparties.
\nAs the result of the European Parliaments\nposition in 1st reading on 6 February 2013 (please refer to the\nsummary of that date) and taking into consideration the\nposition of Member States in the Council, the Commission decided to\namend its proposal.
\nIt took into account the amendments of the European\nParliament voted in plenary: 50 were\nacceptable (16 as such and 34 acceptable in principle, even if, a\nfew of them were acceptable only in part) and only 7 were\nunacceptable.
\nThe main amendments to\nthe initial proposal are as follows:
\nMinimum procedural requirements: these should ensure legal certainty and\ntransparency for all the parties involved in the process of\npricing of medicinal products and inclusion in the health insurance\nsystems, while promoting the production of medicinal products,\naccelerating the entry into the market of generic medicinal\nproducts and encouraging research and development of new medicinal\nproducts.
\nDefinitions: the amended\nproposal inserted a definition for biosimilar medicinal\nproduct which means a biological medicinal product that\nis similar to a reference biological medicinal product.
\nThe concept of health technology\nassessment is clarified: it means an assessment which as\na minimum includes the assessment of the relative efficacy or of\nthe short- and long-term effectiveness of the medicinal product\ncompared to other health technologies or interventions in use for\ntreating the associated condition.
\nPrice approval: a\ndecision on the price which may be charged for the medicinal\nproduct concerned is adopted and communicated to the applicant\nwithin 90 days (rather than 60 days as stated in the initial\nproposal) of the receipt of an application submitted. With respect\nto generic medicinal products, that time limit shall be 30\ndays (15 days in the initial proposal), provided that the price\nof the reference medicinal product has been approved by the\ncompetent authorities.
\nWhere Member States decide to include health\ntechnology assessment as part of their decision-making process\non the pricing of medicinal products, such assessment shall be\ncarried out within these time limits.
\nPrice increase: a\ndecision to approve or reject on an application to increase the\nprice of a medicinal product must be adopted and communicated to\nthe applicant within 90 days of its receipt.
\nPrice freeze and price reduction: once a year Member States shall assess whether the\nprice freeze or the price reduction is still justified taking into\naccount the macro-economic conditions and adopt necessary changes\nwhere appropriate.
\nInclusion of medicinal products in health insurance\nsystems: the amended proposal states\nthat a decision must be adopted and communicated to the applicant\nwithin 90 days of its receipt. With respect to generic\nmedicinal products, that time limit shall be 30 days, provided\nthat the reference medicinal product has already been included in\nthe public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days,\nprovided that the reference medicinal product has already been\nincluded in the public health insurance system.
\nFurthermore, information on information on the\ncriteria which the competent authorities must take into account\nwhen deciding whether or not to include medicinal products within\nthe scope of the public health insurance system must be made\npublic, as must information regarding decision-making bodies at\nnational or regional level.
\nAdditional proof of quality, safety, efficacy or\nbioequivalence: in the framework of\npricing and reimbursement decisions, Member States shall not\nre-assess the elements on which the marketing authorisation is\nbased, including the quality, safety, efficacy, or bioequivalence,\nor biosimilarity of the medicinal product or the criteria for\norphan designation which have already been assessed during\nthe marketing authorisation procedure.
\nConsultation of interested parties: where a Member State intends to adopt or amend any\nlegislative measure falling within the scope of the Directive, it\nshall give civil society organisations, including patient and\nconsumer groups, and other interested parties, the opportunity to\ncomment on the draft measure within a reasonable period.
\nThe Commission presents an amended proposal for the\nDirective on the transparency of measures regulating the prices of\nmedicinal products for human use and their inclusion in the scope\nof public health insurance systems. The European Parliament will\nbe consulted again on this proposal.
\nBackground: the\nCommission presented its initial legislative proposal on 1st March\n2012 (please refer to the summary of the same date).\nNegotiations in the Council Working Party on Pharmaceuticals and\nMedical Devices proved to be difficult. The main concerns of\nMember States were related to: (i) the principle of subsidiarity;\n(ii) the remedies procedure; (iii) the creation of a system of\npre-notification of draft national measures to the Commission; (iv)\nthe shortening of the time limits for taking decisions on pricing\nof medicines and their inclusion in the scope of health insurance\nsystems; (v) the distinction between originator medicinal products\nsubject to health technology assessment (HTA) and those not subject\nto HTA; (vi) the obligation to consult the interested\nparties.
\nAs the result of the European Parliaments\nposition in 1st reading on 6 February 2013 (please refer to the\nsummary of that date) and taking into consideration the\nposition of Member States in the Council, the Commission decided to\namend its proposal.
\nIt took into account the amendments of the European\nParliament voted in plenary: 50 were\nacceptable (16 as such and 34 acceptable in principle, even if, a\nfew of them were acceptable only in part) and only 7 were\nunacceptable.
\nThe main amendments to\nthe initial proposal are as follows:
\nMinimum procedural requirements: these should ensure legal certainty and\ntransparency for all the parties involved in the process of\npricing of medicinal products and inclusion in the health insurance\nsystems, while promoting the production of medicinal products,\naccelerating the entry into the market of generic medicinal\nproducts and encouraging research and development of new medicinal\nproducts.
\nDefinitions: the amended\nproposal inserted a definition for biosimilar medicinal\nproduct which means a biological medicinal product that\nis similar to a reference biological medicinal product.
\nThe concept of health technology\nassessment is clarified: it means an assessment which as\na minimum includes the assessment of the relative efficacy or of\nthe short- and long-term effectiveness of the medicinal product\ncompared to other health technologies or interventions in use for\ntreating the associated condition.
\nPrice approval: a\ndecision on the price which may be charged for the medicinal\nproduct concerned is adopted and communicated to the applicant\nwithin 90 days (rather than 60 days as stated in the initial\nproposal) of the receipt of an application submitted. With respect\nto generic medicinal products, that time limit shall be 30\ndays (15 days in the initial proposal), provided that the price\nof the reference medicinal product has been approved by the\ncompetent authorities.
\nWhere Member States decide to include health\ntechnology assessment as part of their decision-making process\non the pricing of medicinal products, such assessment shall be\ncarried out within these time limits.
\nPrice increase: a\ndecision to approve or reject on an application to increase the\nprice of a medicinal product must be adopted and communicated to\nthe applicant within 90 days of its receipt.
\nPrice freeze and price reduction: once a year Member States shall assess whether the\nprice freeze or the price reduction is still justified taking into\naccount the macro-economic conditions and adopt necessary changes\nwhere appropriate.
\nInclusion of medicinal products in health insurance\nsystems: the amended proposal states\nthat a decision must be adopted and communicated to the applicant\nwithin 90 days of its receipt. With respect to generic\nmedicinal products, that time limit shall be 30 days, provided\nthat the reference medicinal product has already been included in\nthe public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days,\nprovided that the reference medicinal product has already been\nincluded in the public health insurance system.
\nFurthermore, information on information on the\ncriteria which the competent authorities must take into account\nwhen deciding whether or not to include medicinal products within\nthe scope of the public health insurance system must be made\npublic, as must information regarding decision-making bodies at\nnational or regional level.
\nAdditional proof of quality, safety, efficacy or\nbioequivalence: in the framework of\npricing and reimbursement decisions, Member States shall not\nre-assess the elements on which the marketing authorisation is\nbased, including the quality, safety, efficacy, or bioequivalence,\nor biosimilarity of the medicinal product or the criteria for\norphan designation which have already been assessed during\nthe marketing authorisation procedure.
\nConsultation of interested parties: where a Member State intends to adopt or amend any\nlegislative measure falling within the scope of the Directive, it\nshall give civil society organisations, including patient and\nconsumer groups, and other interested parties, the opportunity to\ncomment on the draft measure within a reasonable period.
\nPURPOSE: to improve the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nPROPOSED ACT: Directive of the European\nParliament and of the Council.
\nBACKGROUND: Council\nDirective 89/105/EEC relating to the transparency of measures\nregulating the pricing of medicinal products for human use and\ntheir inclusion in the scope of national health insurance systems\nwas adopted so as to remove distortions to intra-Community trade in\nmedicinal products. Directive 89/105/EEC has never been amended\nsince its adoption. Its provisions reflect the pharmaceutical\nmarket conditions which prevailed more than twenty years ago.\nHowever, these conditions have fundamentally changed, for instance\nwith the emergence of generic medicines providing cheaper versions\nof existing products or the development of increasingly innovative\n(yet often expensive) research-based medicinal products. In\nparallel, the constant rise in public expenditure on\npharmaceuticals in the last decades has encouraged Member States to\ndevise more complex and innovative pricing and reimbursement\nsystems over time.
\nDespite the historically positive impact of Directive\n89/105/EEC on the internal market for medicines, there is evidence\nthat it does not fully achieve its objectives in the present\ncontext:
\n(1) A gap has emerged\nbetween the provisions of the Directive, which describe the main\ntypes of pricing and reimbursement procedures established in the\n1980s, and the much wider range of cost-containment measures\nadopted nowadays by Member States. Despite the extensive\ninterpretation of the Directive by the Court of Justice, the\nimplementation of its provisions in national law and the effective\nenforcement of its principles, in particular by the Commission,\nhave become particularly challenging. This situation not only\nresults in legal uncertainties but also in a reduced transparency\nof national pricing and reimbursement measures, which negatively\naffects the smooth functioning of the internal market to the\ndetriment of European patients and pharmaceutical\ncompanies.
\n(2) The time limits for\npricing and reimbursement decisions established by Directive\n89/105/EEC are regularly exceeded by Member States. This leads to\ndelays in the marketing of medicinal products, which in turn slows\ndown the availability of valuable treatments for\npatients.
\nIn order to take into account the evolution of the\npharmaceutical market and of national policies to control public\nexpenditure on medicines, substantive changes are necessary to all\nmajor provisions of Directive 89/105/EEC. Therefore, in the\ninterest of clarity, Directive 89/105/EEC should be\nreplaced. The fundamental objectives and principles of\nDirective 89/105/EEC remain fully valid in the present\ncontext.
\nIMPACT ASSESSMENT: the proposal to revise the\nDirective is based on the combination of options recommended in the\nframework of the impact assessment, namely:
\nThe possible extension of the Directive to include\nmedical devices was examined in the impact assessment but discarded\ndue to the specificities of this market.
\nFurthermore, in spite of the difficulty to conclude on\nthe overall cost-benefit balance of reducing the time limits\nwith respect to originator medicines, a reduction from the current\n90/180 days to 60/120 days is proposed in light of the positive\nimpact it would have on the swift availability of innovative\nmedicines to patients and on rewarding pharmaceutical innovation\nwhen medicines are approved for reimbursement.
\nLEGAL BASIS: Article 114 of the Treaty on the\nFunctioning of the European Union (TFEU).
\nCONTENT: the\noverall objective of the proposal is to clarify the procedural\nobligations incumbent upon Member State and to ensure the\neffectiveness of the Directive, both in avoiding delays in\npricing and reimbursement decisions and in preventing barriers\nto pharmaceutical trade. This shall be done without affecting\nnational social security policies, except as far as it is necessary\nto achieve the transparency of national procedures and the\neffectiveness of the internal market legislation.
\nThe proposal maintains the core principles of the\nexisting Directive but also puts forward a comprehensive adaptation\nof its legal provisions based on the following key\nelements:
\nClarification of the scope of the\nDirective: the transparency\nrequirements apply to all pricing and reimbursement measures\nunderstood in a broad sense, including demand side\nmeasures to control or promote the prescription of specific\nmedicines. Nevertheless, measures involving public procurement and\nvoluntary contractual agreements with individual companies are\nexcluded from the scope of the Directive in order to avoid\ninterference with other bodies of law.
\nComprehensive coverage of national measures and legal\nclarity: the provisions of the\nDirective are reworded in accordance with general principles\n(rather than on the basis of specific national procedures) and\nincorporate the case-law of the Court of Justice. Several key\nprovisions are clarified and updated to avoid interpretation\ncontroversies. In particular, it is made clear that the time limits\nfor pricing and reimbursement decisions include all procedural\nsteps leading to the decision, including health technology\nassessments where applicable.
\nAdaptation of the time limits for pricing and\nreimbursement decisions: the time\nlimits applicable to generic medicines are reduced to 15/30\ndays when the reference product has already been priced and\nincluded in the health insurance system. The time limits applicable\nto all other medicinal products are reduced to 60/120\ndays.
\nHowever, in cases where national authorities subject\nmedicinal products to health technology assessment procedures in\norder to assess the relative efficacy or the short- and long-term\neffectiveness, as an integral part of their decision-making\nprocess, the time-limits shall be 90/180 days.
\nNon-interference of patent and safety issues with\npricing and reimbursement procedures:\nthe proposal clarifies that intellectual property rights should not\ninterfere with pricing and reimbursement procedures, as is already\nthe case for marketing authorisation procedures. In addition,\nelements already assessed in the framework of the marketing\nauthorisation process (quality, safety and efficacy, including\nbioequivalence) may not be reassessed in the framework of pricing\nand reimbursement procedures.
\nDialogue and enforcement tools: different instruments are put in place to facilitate\ndialogue on the implementation of the Directive and to ensure its\neffective enforcement (consultation on draft measures at national\nlevel and pre-notification to the Commission, the creation of a\nremedies procedure in case of non-compliance with the time-limits\nrelated to the inclusion of medicinal products in health insurance\nsystems).
\nBUDGETARY IMPLICATION:\nthe Commission's proposal has no impact\non the European Union budget beyond what is already foreseen for\nthe years to come in the Multiannual Financial Framework. Total\nappropriations under headings 1 to 5 of\nthe multiannual financial framework are estimated at EUR 0.859\nmillion (2014); EUR 1.293 million (2015); EUR 1.143 million\n(2016-2017); EUR 1.093 (2018 action continued).
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Antonyia PARVANOVA (ALDE, BG) on\nthe proposal for a Directive of the European Parliament and of the\nCouncil relating to the transparency of measures regulating the\nprices of medicinal products for human use and their inclusion in\nthe scope of public health insurance systems.
\nIt recommends that the European Parliaments\nposition at first reading, under the ordinary legislative\nprocedure, should amend the Commissions proposal as\nfollows:
\nLegal base: Members\nconsider that because this proposal deals specifically with the\nfree movement of medicinal products and the pricing thereof (a\nmatter that falls within the competence of Member States in the\nfield of public health), Article 168 of the TFEU should\ntherefore be added to the legal basis.
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Members\ndefine a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which as\na minimum includes the relative efficacy or the short- and\nlong-term effectiveness of the medicinal product compared to other\nhealth technologies or interventions in use for treating the\nassociated condition.
\nInnovative treatments: competent authorities and marketing authorisation\nholders increasingly engage in contractual agreements to provide\npatients with access to innovative treatments by including a\nmedicinal product in the scope of public health insurance systems\nwhilst monitoring elements agreed upfront and for a defined period\nof time in order, in particular, to address evidentiary\nuncertainties relating to the effectiveness and/or relative\nefficacy or the appropriate use of a specific medicinal\nproduct.
\nCriteria underlying decisions regulating prices of\nmedicinal products: the criteria\nunderlying any decision directly or indirectly regulating the\nprices of medicinal products, as well as any measure determining\nthe extent to which they shall be covered by public health\ninsurance systems, should include the assessment of unmet\nmedical needs, clinical and societal benefits and innovation.\nSuch criteria should also include the protection of the most\nvulnerable groups of the population.
\nMembers consider that in the framework of pricing and\nreimbursement decisions, the competent authorities responsible for\nthese decisions should not reassess the essential elements on which\nthe marketing authorisation is based, including the quality,\nsafety, efficacy, bioequivalence or biosimilarity of the medicinal\nproduct.
\nTime-periods: the\nCommittee extended a number of the deadlines in the\nCommissions proposal. For example, Member States shall ensure\nthat a decision on the price which may be charged for the medicinal\nproduct concerned is adopted and communicated to the applicant\nwithin 90 days (60 days in Commission proposal) of the\nreceipt of an application submitted. Members recommended a\n60-day time limit to decide on the pricing and reimbursement of\ngeneric medicines.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Members consider\nthat a yearly report collecting Member States data and\ninformation would be more appropriate than a six-monthly report, as\nproposed by the Commission, in order to allow an accurate overview\nand relevant trends analysis on the implementation of time\nlimits.
\nThe European Parliament adopted by 559 votes to 54,\nwith 72 abstentions, a legislative resolution on the proposal for a Directive of the European\nParliament and of the Council relating to the transparency of\nmeasures regulating the prices of medicinal products for human use\nand their inclusion in the scope of public health insurance\nsystems.
\nParliament adopted its position at first reading under\nthe ordinary legislative procedure. Its amendments are as\nfollows:
\nScope: this Directive\nmay not call into question a marketing authorisation relating to a\nmedicinal product granted in accordance with the procedure referred\nto in Directive\n2001/83/EC.
\nDefinitions: Parliament\ndefines a voluntary contractual agreement as an\nagreement concluded between public authorities and the marketing\nauthorisation holder for a medicinal product which is neither\nmandatory nor required by law, nor the only alternative to being\nincluded in the national pricing and reimbursement scheme to ensure\nthat agreements are not used as a loophole to avoid the\napplicability of the Directive. A biosimilar medicinal\nproduct means a similar biological medicinal product\napproved in accordance with Directive 2001/83/EC. Health\ntechnology assessment (HTA) means an assessment which\nas a minimum includes the relative efficacy or the short-\nand long-term effectiveness of the medicinal product compared to\nother health technologies or interventions in use for treating the\nassociated condition.
\nCriteria underlying decisions regulating prices of\nmedicinal products: Parliament\nintroduces a new recital requiring that the criteria underlying any\ndecision directly or indirectly regulating the prices of medicinal\nproducts, as well as any measure determining the extent to which\nthey shall be covered by public health insurance systems, include\nthe assessment of unmet medical needs, clinical and societal\nbenefits and innovation. Such criteria should also include the\nprotection of the most vulnerable groups of the\npopulation.
\nThese criteria, as well as the information concerning\nthe decision-making bodies at national or regional level, should be\nmade publicly available.
\nDeadlines: Parliament\nproposes extending a number of the deadlines in the\nCommissions proposal. Member States\nshall ensure that a decision on the price which may be charged for\na medicinal product concerned is adopted and communicated to the\napplicant within 90 days of the receipt of an application\nsubmitted. With respect to generic\nmedicinal products, that time limit shall be 30 days,\nprovided that the reference medicinal product has been approved by\nthe competent authorities. Where appropriate, Member States shall\nuse health technology assessment as part of their\ndecision-making process on the pricing of medicinal\nproducts.
\nIn regard to a decision on the inclusion of a\nmedicinal product in the scope of the public health insurance\nscheme, a decision shall be adopted and communicated to the\napplicant within 90 days of its receipt. With respect to\ngeneric medicinal products, that time limit shall be 30\ndays, provided that the reference medicinal product has already\nbeen included in the public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days, provided that the reference\nmedicinal product has already been included in the public health\ninsurance system.
\nMediation and remedies procedures: Parliament amended the Commissions proposal\nrequiring Member States to ensure that effective and rapid\nmediation or remedies procedures are available to the applicant in\ncase of unjustified delays or non-compliance with the time\nlimits set in the Directive, and in accordance with their\nnational law.
\nTransparency of decision-making bodies and\nprices: Member States shall ensure\nthat the competent authorities controlling the prices of medicinal\nproducts or determining the coverage of medicinal products by\npublic health insurance systems make publicly available a\nregularly updated list of the members of their decision-making\nbodies, together with their declarations of interest. These\nauthorities shall also publish and communicate to the Commission,\nat least once a year, a complete list of the medicinal\nproducts covered by their public health insurance systems and the\nprices which have been set during the relevant period. Any decision\nto exclude a medicinal product or a category of medicinal\nproducts from the scope of the public health insurance system shall\nbe made publicly available, together with a summary of the\nstatement of reasons.
\nReport: Parliament\nconsiders that a yearly report collecting Member\nStates data and information would be more appropriate than a\nsix-monthly report, as proposed by the Commission, in order to\nallow an accurate overview and relevant trends analysis on the\nimplementation of time limits.
\nThe Commission presents an amended proposal for the\nDirective on the transparency of measures regulating the prices of\nmedicinal products for human use and their inclusion in the scope\nof public health insurance systems. The European Parliament will\nbe consulted again on this proposal.
\nBackground: the\nCommission presented its initial legislative proposal on 1st March\n2012 (please refer to the summary of the same date).\nNegotiations in the Council Working Party on Pharmaceuticals and\nMedical Devices proved to be difficult. The main concerns of\nMember States were related to: (i) the principle of subsidiarity;\n(ii) the remedies procedure; (iii) the creation of a system of\npre-notification of draft national measures to the Commission; (iv)\nthe shortening of the time limits for taking decisions on pricing\nof medicines and their inclusion in the scope of health insurance\nsystems; (v) the distinction between originator medicinal products\nsubject to health technology assessment (HTA) and those not subject\nto HTA; (vi) the obligation to consult the interested\nparties.
\nAs the result of the European Parliaments\nposition in 1st reading on 6 February 2013 (please refer to the\nsummary of that date) and taking into consideration the\nposition of Member States in the Council, the Commission decided to\namend its proposal.
\nIt took into account the amendments of the European\nParliament voted in plenary: 50 were\nacceptable (16 as such and 34 acceptable in principle, even if, a\nfew of them were acceptable only in part) and only 7 were\nunacceptable.
\nThe main amendments to\nthe initial proposal are as follows:
\nMinimum procedural requirements: these should ensure legal certainty and\ntransparency for all the parties involved in the process of\npricing of medicinal products and inclusion in the health insurance\nsystems, while promoting the production of medicinal products,\naccelerating the entry into the market of generic medicinal\nproducts and encouraging research and development of new medicinal\nproducts.
\nDefinitions: the amended\nproposal inserted a definition for biosimilar medicinal\nproduct which means a biological medicinal product that\nis similar to a reference biological medicinal product.
\nThe concept of health technology\nassessment is clarified: it means an assessment which as\na minimum includes the assessment of the relative efficacy or of\nthe short- and long-term effectiveness of the medicinal product\ncompared to other health technologies or interventions in use for\ntreating the associated condition.
\nPrice approval: a\ndecision on the price which may be charged for the medicinal\nproduct concerned is adopted and communicated to the applicant\nwithin 90 days (rather than 60 days as stated in the initial\nproposal) of the receipt of an application submitted. With respect\nto generic medicinal products, that time limit shall be 30\ndays (15 days in the initial proposal), provided that the price\nof the reference medicinal product has been approved by the\ncompetent authorities.
\nWhere Member States decide to include health\ntechnology assessment as part of their decision-making process\non the pricing of medicinal products, such assessment shall be\ncarried out within these time limits.
\nPrice increase: a\ndecision to approve or reject on an application to increase the\nprice of a medicinal product must be adopted and communicated to\nthe applicant within 90 days of its receipt.
\nPrice freeze and price reduction: once a year Member States shall assess whether the\nprice freeze or the price reduction is still justified taking into\naccount the macro-economic conditions and adopt necessary changes\nwhere appropriate.
\nInclusion of medicinal products in health insurance\nsystems: the amended proposal states\nthat a decision must be adopted and communicated to the applicant\nwithin 90 days of its receipt. With respect to generic\nmedicinal products, that time limit shall be 30 days, provided\nthat the reference medicinal product has already been included in\nthe public health insurance system.
\nIrrespective of the organisation of their internal\nprocedures, Member States shall ensure that the overall period\nof time taken by the inclusion procedure and the price approval\nprocedure does not exceed 180 days. With respect to generic\nmedicinal products, that time limit shall not exceed 60 days,\nprovided that the reference medicinal product has already been\nincluded in the public health insurance system.
\nFurthermore, information on information on the\ncriteria which the competent authorities must take into account\nwhen deciding whether or not to include medicinal products within\nthe scope of the public health insurance system must be made\npublic, as must information regarding decision-making bodies at\nnational or regional level.
\nAdditional proof of quality, safety, efficacy or\nbioequivalence: in the framework of\npricing and reimbursement decisions, Member States shall not\nre-assess the elements on which the marketing authorisation is\nbased, including the quality, safety, efficacy, or bioequivalence,\nor biosimilarity of the medicinal product or the criteria for\norphan designation which have already been assessed during\nthe marketing authorisation procedure.
\nConsultation of interested parties: where a Member State intends to adopt or amend any\nlegislative measure falling within the scope of the Directive, it\nshall give civil society organisations, including patient and\nconsumer groups, and other interested parties, the opportunity to\ncomment on the draft measure within a reasonable period.
\n