16 Amendments of Philippe JUVIN related to 2012/0035(COD)
Amendment 50 #
Proposal for a directive
Recital 4
Recital 4
(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’ 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.
Amendment 70 #
Proposal for a directive
Recital 14
Recital 14
(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.
Amendment 85 #
Proposal for a directive
Article 1 – paragraph 3 a (new)
Article 1 – paragraph 3 a (new)
3a. This Directive may not call into question granted as per the procedure referred to in Article 6 of Directive 2001/83/EC.
Amendment 105 #
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
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 690 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 145 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.
Amendment 116 #
Proposal for a directive
Article 3 – paragraph 5
Article 3 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of thewhat detailed additional information is required and take their final decision within 690 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 145 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.
Amendment 134 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
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 690 days of its receipt.
Amendment 140 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.
Amendment 149 #
Proposal for a directive
Article 4 – paragraph 4 – subparagraph 2
Article 4 – paragraph 4 – subparagraph 2
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 thewhat detailed additional information is required and take their final decision within 690 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.
Amendment 163 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 690 days of the receipt of the application. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of thewhat detailed additional information is required and take their final decision within 690 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.
Amendment 170 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
If there isn case of an exceptional number of applications, the relevant time limit set out in this paragraph 3 may be extended once only for a further 690 days. The applicant shall be notified of such extension before the expiry of the time limit set out in paragraph 3.
Amendment 191 #
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
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 690 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 145 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.
Amendment 199 #
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of thewhat detailed additional information is required and take their final decision within 690 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 145 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.
Amendment 208 #
Proposal for a directive
Article 7 – paragraph 6
Article 7 – paragraph 6
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 390 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).
Amendment 238 #
Proposal for a directive
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (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’s response to its proposals.
Amendment 245 #
Proposal for a directive
Article 13
Article 13
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 or the criteria for orphan designation.
Amendment 258 #
Proposal for a directive
Article 15
Article 15
Where a Member State intends to adopt or amendrecast 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.