100 Amendments of Cristian-Silviu BUŞOI related to 2023/0132(COD)
Amendment 56 #
Proposal for a directive
Recital 41
Recital 41
(41) In the case of products with well- known molecules, generic medicinal products of which the reference medicinal product has been granted a marketing authorisation under the centralised procedure, hybrid medicinal products, well established and products with fixed dose combinations of known molecules, applicants seeking marketing authorisation should be able to choose either of the two procedures, on certain conditions. Similarly, the mutual- recognition or decentralised procedure should remain available as an option for certain medicinal products, even if they represent a therapeutic innovation or are of benefit to society or to patients. Since generic medicines account for a major part of the market in medicinal products, their access to the Union market should be facilitated in the light of the experience acquired, therefore, the procedures to include other Member States concerned to such procedure should be further simplified.
Amendment 77 #
Proposal for a directive
Recital 51 a (new)
Recital 51 a (new)
(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentived as it can expand access to patients and reduce health inequalities.
Amendment 109 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of th, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is limited exemption is however fragmented across the Union and iportant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rel, on day one a reference medicinal product,fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process, health technology assessment ands, obtaining pricing and reimbursement request, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicants and by third party suppliers or service providers. During the term of protection in a MS of the patent or SPC ofor the referencelevant medicinal product or process, there can be no commercial usplacing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 117 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursementregulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toaforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 122 #
Proposal for a directive
Recital 65
Recital 65
(65) The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal productAvoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions and a resolution of the European Parliament. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.
Amendment 147 #
Proposal for a directive
Recital 79
Recital 79
(79) As a general rule, risk management plans for generic and biosimilar medicinal products should not be developed and submitted, considering that the reference medicinal product has such a plan, except in specific cases, where a risk management plan should be provided. Furthermore, given that the marketing authorisation holder has to forthwith submit any new data that might impact the benefit-risk balance of its products and given that national competent authorities have several tools available to continuously monitor the benefits and risks of authorised medicines, such as assessment of PSURs, signal detection and referrals, regulatory action will be taken as needed throughout the lifecycle of the product. Therefore, as a general rule a marketing authorisation should be granted for an unlimited period; exceptionally, one renewal may be decided only on justified grounds related to the safety of the medicinal product.
Amendment 205 #
Proposal for a directive
Recital 41
Recital 41
(41) In the case of products with well- known molecules, generic medicinal products of which the reference medicinal product has been granted a marketing authorisation under the centralised procedure, hybrid medicinal products, well established and products with fixed dose combinations of known molecules, applicants seeking marketing authorisation should be able to choose either of the two procedures, on certain conditions. Similarly, the mutual- recognition or decentralised procedure should remain available as an option for certain medicinal products, even if they represent a therapeutic innovation or are of benefit to society or to patients. Since generic medicines account for a major part of the market in medicinal products, their access to the Union market should be facilitated in the light of the experience acquired, therefore, the procedures to include other Member States concerned to such procedure should be further simplified.
Amendment 223 #
Proposal for a directive
Article 4 – paragraph 1 – point 28
Article 4 – paragraph 1 – point 28
(28) '‘vaccine’ means any medicinal product that is intended to elicit an immune responsecontaining antigen(s) or genetic information for antigen(s) that elicit an immune response and therefore are intended for prevention, including post -exposure prophylaxis, and f/or treatment of diseases caused by an infectious agents;
Amendment 230 #
Proposal for a directive
Article 4 – paragraph 1 – point 36 a (new)
Article 4 – paragraph 1 – point 36 a (new)
(36 a) ‘Quality master file’ means a document that contains a detailed description of the manufacturing process, quality control during manufacture and process validation of an active substance other than a chemical active substance, or of any other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, prepared in a separate document by the manufacturer of the substance or component.
Amendment 232 #
Proposal for a directive
Article 4 – paragraph 1 – point 36 b (new)
Article 4 – paragraph 1 – point 36 b (new)
(36 b) Platform technology’ means a collection of technologies used in the manufacturing process and/or the quality control of one or more medicinal products or their components that rely on shared prior knowledge and are established under the same underlying scientific principles. Platform technologies can encompass a variety of activities, including without being limited to similar formulations, manufacturing steps and analytical testing.
Amendment 233 #
Proposal for a directive
Article 4 – paragraph 1 – point 36 c (new)
Article 4 – paragraph 1 – point 36 c (new)
(36 c) ‘Platform technology master file’ means a document that contains all data relative to a platform technology for which there is reasonable certainty that the underlying scientific principles under which the platform technology is established will apply regardless of the active substance or other component of interest added to the platform as part of the manufacturing process of a medicinal product. The nature of the data to be included in the platform technology master file will be defined by the applicant depending on the type of platform technology. The platform technology master file needs to be supplied in a separate document by the platform technology owner.
Amendment 236 #
Proposal for a directive
Article 4 – paragraph 1 – point 48
Article 4 – paragraph 1 – point 48
(48) ‘common name’ means the international non-proprietary name recommended by the World Health Organization for an active substance, or, if one does not exist, the usual common name;
Amendment 245 #
Proposal for a directive
Recital 51 a (new)
Recital 51 a (new)
(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentived as it can expand access to patients and reduce health inequalities.
Amendment 254 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Where justified for preventive or therapeutic purposes, a marketing authorisation may be granted for a fixed dose combination medicinal product.
Amendment 256 #
Proposal for a directive
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
Where justified for preventive or therapeutic purposes, a marketing authorisation may, in exceptional circumstances, be granted for a medicinal product comprised of a fixed component and a variable component that is pre- defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients (‘platform technology’).
Amendment 257 #
Proposal for a directive
Article 15 – paragraph 2 – subparagraph 2
Article 15 – paragraph 2 – subparagraph 2
Amendment 258 #
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1
Article 15 – paragraph 3 – subparagraph 1
Where justified for public health reasons and when the active substances cannot be combined within a fixed dose combination medicinal productfor a preventive or therapeutic purposes, a marketing authorisation may, in exceptional circumstances, be granted to a multi- medicinal product package.
Amendment 259 #
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 2
Article 15 – paragraph 3 – subparagraph 2
Amendment 283 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of thwithout this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is limited exemption is however fragmented across the Union and iportant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rel,on day one a reference medicinal product,fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ands, obtaining pricing and reimbursement request, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a MS of the patent or SPC ofor the referencelevant medicinal product or process, there can be no commercial usplacing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 296 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursementregulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toaforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 300 #
Proposal for a directive
Recital 65
Recital 65
(65) The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal productAvoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions and a resolution of the European Parliament. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.
Amendment 335 #
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 2
Article 26 – paragraph 1 – subparagraph 2
Marketing authorisation applicants may only rely on an additional quality master file certificate if no certificate exists on the same additional quality master file.
Amendment 335 #
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 2
Article 26 – paragraph 1 – subparagraph 2
Marketing authorisation applicants may only rely on an additional quality master file certificate if no certificate exists on the same additional quality master file.
Amendment 336 #
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 2 a (new)
Article 26 – paragraph 1 – subparagraph 2 a (new)
Marketing authorisation applicants may also, instead of submitting the relevant data on a platform technology used in the context of the manufacturing process of a medicinal product, rely on a platform technology master file, or a platform technology master file certificate granted by the Agency in accordance with this Article. Marketing authorisation applicants may only rely on an additional platform technology master file if no certificate exists on the same additional platform technology master file.
Amendment 336 #
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 2 a (new)
Article 26 – paragraph 1 – subparagraph 2 a (new)
Marketing authorisation applicants may also, instead of submitting the relevant data on a platform technology used in the context of the manufacturing process of a medicinal product, rely on a platform technology master file, or a platform technology master file certificate granted by the Agency in accordance with this Article. Marketing authorisation applicants may only rely on an additional platform technology master file if no certificate exists on the same additional platform technology master file.
Amendment 337 #
Proposal for a directive
Article 26 – paragraph 2
Article 26 – paragraph 2
2. Article 25, paragraphs 1 to 5, 7 and 8 shall also apply mutadis mutandis to additional quality master file certification.
Amendment 337 #
Proposal for a directive
Article 26 – paragraph 2
Article 26 – paragraph 2
2. Article 25, paragraphs 1 to 5, 7 and 8 shall also apply mutadis mutandis to additional quality master file certification.
Amendment 340 #
Proposal for a directive
Article 26 – paragraph 3 – point b
Article 26 – paragraph 3 – point b
(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance present or used in the manufacture of a medicinal productreferred to in paragraphs 1 and 1a of this Article;
Amendment 340 #
Proposal for a directive
Article 26 – paragraph 3 – point b
Article 26 – paragraph 3 – point b
(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance present or used in the manufacture of a medicinal productreferred to in paragraphs 1 and 1a of this Article;
Amendment 341 #
Proposal for a directive
Article 26 – paragraph 3 – point b a (new)
Article 26 – paragraph 3 – point b a (new)
(b a) the rules governing the content and format of the application for an additional master file certificate;
Amendment 341 #
Proposal for a directive
Article 26 – paragraph 3 – point b a (new)
Article 26 – paragraph 3 – point b a (new)
(b a) the rules governing the content and format of the application for an additional master file certificate;
Amendment 342 #
Proposal for a directive
Article 26 – paragraph 3 – point c
Article 26 – paragraph 3 – point c
(c) the rules for the examination of an applications for making publicly available of additional quality master filan additional master file certificate and for the granting of the certificates;
Amendment 342 #
Proposal for a directive
Article 26 – paragraph 3 – point c
Article 26 – paragraph 3 – point c
(c) the rules for the examination of an applications for making publicly available of additional quality master filan additional master file certificate and for the granting of the certificates;
Amendment 343 #
Proposal for a directive
Article 26 – paragraph 3 – point d
Article 26 – paragraph 3 – point d
(d) the rules for introducing changes to the additional quality master file and the certificate;
Amendment 343 #
Proposal for a directive
Article 26 – paragraph 3 – point d
Article 26 – paragraph 3 – point d
(d) the rules for introducing changes to the additional quality master file and the certificate;
Amendment 344 #
Proposal for a directive
Article 26 – paragraph 3 – point e
Article 26 – paragraph 3 – point e
(e) the rules on access for competent authorities of the Member State to the additional quality master file and its assessment report;
Amendment 344 #
Proposal for a directive
Article 26 – paragraph 3 – point e
Article 26 – paragraph 3 – point e
(e) the rules on access for competent authorities of the Member State to the additional quality master file and its assessment report;
Amendment 345 #
Proposal for a directive
Article 26 – paragraph 3 – point f
Article 26 – paragraph 3 – point f
(f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on an additional quality master file certificate to the additional quality master file and to the assessment report.
Amendment 345 #
Proposal for a directive
Article 26 – paragraph 3 – point f
Article 26 – paragraph 3 – point f
(f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on an additional quality master file certificate to the additional quality master file and to the assessment report.
Amendment 432 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a package leaflet in paper format in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.
Amendment 432 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a package leaflet in paper format in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.
Amendment 440 #
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.
Amendment 440 #
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.
Amendment 449 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = fivone years following 18 months after the date of entering into force of this Directive].
Amendment 449 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = fivone years following 18 months after the date of entering into force of this Directive].
Amendment 458 #
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].
Amendment 458 #
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].
Amendment 463 #
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. The Agency shall make available a system to accommodate the electronic product information in the database provided in Article 138(1)(n) and 138(2) of the Revised Regulation … after consultation with Member States and the relevant stakeholders. The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].
Amendment 463 #
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. The Agency shall make available a system to accommodate the electronic product information in the database provided in Article 138(1)(n) and 138(2) of the Revised Regulation … after consultation with Member States and the relevant stakeholders. The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].
Amendment 494 #
Proposal for a directive
Article 74 – paragraph 4 a (new)
Article 74 – paragraph 4 a (new)
4 a. By derogation, when dully justified (eg. health emergencies), the official language obligation as mentioned in Article 74.1 shall not apply when the product is not intended to be delivered to the patient for self-administration.
Amendment 494 #
Proposal for a directive
Article 74 – paragraph 4 a (new)
Article 74 – paragraph 4 a (new)
4 a. By derogation, when dully justified (eg. health emergencies), the official language obligation as mentioned in Article 74.1 shall not apply when the product is not intended to be delivered to the patient for self-administration.
Amendment 573 #
Proposal for a directive
Article 83 – paragraph 1 – introductory part
Article 83 – paragraph 1 – introductory part
1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening or severely debilitating or chronic disease and the following conditions are met:
Amendment 573 #
Proposal for a directive
Article 83 – paragraph 1 – introductory part
Article 83 – paragraph 1 – introductory part
1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening or severely debilitating or chronic disease and the following conditions are met:
Amendment 583 #
Proposal for a directive
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high, morbidity or mortality, mortality or impacting the quality of life;
Amendment 583 #
Proposal for a directive
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high, morbidity or mortality, mortality or impacting the quality of life;
Amendment 587 #
Proposal for a directive
Article 83 – paragraph 1 – point b
Article 83 – paragraph 1 – point b
(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.:
Amendment 587 #
Proposal for a directive
Article 83 – paragraph 1 – point b
Article 83 – paragraph 1 – point b
(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.:
Amendment 590 #
Proposal for a directive
Article 83 – paragraph 1 – point b – point i (new)
Article 83 – paragraph 1 – point b – point i (new)
i) a meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population; or
Amendment 590 #
Proposal for a directive
Article 83 – paragraph 1 – point b – point i (new)
Article 83 – paragraph 1 – point b – point i (new)
i) a meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population; or
Amendment 591 #
Proposal for a directive
Article 83 – paragraph 1 – point b – point ii (new)
Article 83 – paragraph 1 – point b – point ii (new)
ii) a meaningful positive impact on quality of life; or
Amendment 591 #
Proposal for a directive
Article 83 – paragraph 1 – point b – point ii (new)
Article 83 – paragraph 1 – point b – point ii (new)
ii) a meaningful positive impact on quality of life; or
Amendment 592 #
Proposal for a directive
Article 83 – paragraph 1 – point b – point iii (new)
Article 83 – paragraph 1 – point b – point iii (new)
iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.
Amendment 592 #
Proposal for a directive
Article 83 – paragraph 1 – point b – point iii (new)
Article 83 – paragraph 1 – point b – point iii (new)
iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.
Amendment 601 #
Proposal for a directive
Article 83 – paragraph 3
Article 83 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004] representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.
Amendment 601 #
Proposal for a directive
Article 83 – paragraph 3
Article 83 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004] representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.
Amendment 603 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 603 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 613 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 613 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 614 #
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and does not fall in the same global marketing authorization as a medicinal product that has has not previously benefitted from data protection or market exclusitvity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 614 #
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and does not fall in the same global marketing authorization as a medicinal product that has has not previously benefitted from data protection or market exclusitvity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 617 #
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product shall be designated as a value added medicinal product.
Amendment 617 #
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product shall be designated as a value added medicinal product.
Amendment 621 #
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is usedstudies, trials and other activities are conducted and the subsequent practical requirements associated with such activities, for the purposes of:
Amendment 621 #
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is usedstudies, trials and other activities are conducted and the subsequent practical requirements associated with such activities, for the purposes of:
Amendment 626 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities conducted to generate data for an application, for:deletion
Amendment 626 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities conducted to generate data for an application, for:deletion
Amendment 634 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and forand subsequent variations;
Amendment 634 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and forand subsequent variations;
Amendment 638 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 644 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement approval.
Amendment 651 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;
Amendment 655 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere;
Amendment 657 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
Amendment 665 #
Proposal for a directive
Article 85 – paragraph 1 a (new)
Article 85 – paragraph 1 a (new)
The activities falling within the first subparagraph may include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.
Amendment 667 #
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activitiin a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manufactured for the aforementioned purposes.
Amendment 1219 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, incuding a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 1223 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 1232 #
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 1240 #
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product shall be designated as a value added medicinal product.
Amendment 1245 #
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is usedstudies, trials and other activities are conducted and the subsequent practical requirements associated with such activities, for the purposes of:
Amendment 1260 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities conducted to generate data for an application, for:deletion
Amendment 1272 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and forand subsequent variations;
Amendment 1284 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 1293 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement approval.
Amendment 1303 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;
Amendment 1312 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii c (new)
Article 85 – paragraph 1 – point a – point iii c (new)
(iii c) complying with any other regulatory or administrative requirement in the Union or elsewhere;
Amendment 1315 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
Amendment 1332 #
Proposal for a directive
Article 85 – paragraph 1 a (new)
Article 85 – paragraph 1 a (new)
The activities falling within the first subparagraph may include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.
Amendment 1336 #
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activitiin a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manufactured for the aforementioned purposes.