35 Amendments of Nathalie COLIN-OESTERLÉ related to 2023/0132(COD)
Amendment 168 #
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) This Directive should be in line with the EU’s industrial, digital and trade aspirations. The European life sciences sector, and the pharmaceutical industry in particular, are essential in ensuring EU’s competitiveness. Maintaining and strengthening robust R&D sectors are key pillars of the shared European sovereignty in an increasingly competitive geopolitical context.
Amendment 170 #
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11 b) This Directive should recognize that there is no trade-off between maintaining a competitive pharmaceutical industry in the EU and ensuring the affordability, accessibility, and availability of medicinal products in the EU.
Amendment 193 #
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) Patent protection creates a legal framework, which is important for pharmaceutical innovation as it provides companies with financial incentives to cover the research and development (R&D) costs of new medicinal products. The research-based pharmaceutical industry is an essential sector and contributor to ensuring quality manufacturing and supply of medicinal products, to ensuring future innovation to address outstanding, unmet needs, and to supporting the resilience, responsiveness and readiness of healthcare systems to address future challenges, including pandemics.
Amendment 242 #
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 incentivised as it can expand access in an affordable manner, providing significant benefits to patients;
Amendment 264 #
Proposal for a directive
Recital 58 a (new)
Recital 58 a (new)
(58 a) Small patient populations, especially paediatric or rare disease ones, are often the most disadvantaged when it comes to access to medicines. In this regard, Directive 2011/24/EU should be considered as an alternative pathway of making available medicinal products to patients, who need paediatric, orphan medicinal products or advanced therapy medicinal products. The medicines can be administered via a center of excellence, early access or compassionate use programs, or other cross-border healthcare services.
Amendment 279 #
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 this limited exemption is however fragmented across the Union and ithe 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 important 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 productfter 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, 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 Member State of the patent or SPC of the reference medicinal product, there can be no commercial usrelevant product or process, there can be no placing 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 292 #
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 reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toregulatory 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 aforementioned 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 303 #
Proposal for a directive
Recital 65
Recital 65
(65) Avoiding 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 conclusions1a and a resolution of the European Parliament2a. 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 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. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU 2a European Parliament resolution of 2 March 2017 on EU options for improving access to medicine
Amendment 340 #
Proposal for a directive
Recital 76
Recital 76
(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to placmake the product available for ordering for paediatric patients in the same markets within two years of the date of approval of the indication.
Amendment 368 #
Proposal for a directive
Recital 130 a (new)
Recital 130 a (new)
(130a) Medium-term harmonisation of the provisions on e-leaflets can be a tool to tackle the problem of shortages of medicinal products. The Commission should be empowered to swiftly harmonise requirements concerning paper or electronic formats. If the electronic format were made generally applicable, a single European system would have to ensure that patients had access to e- leaflets for their products.
Amendment 383 #
Proposal for a directive
Article premier – paragraph 1
Article premier – paragraph 1
1. This Directive lays down rules for thshall apply to medicinal products for human use intended to be placinged on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of medicinal products for human use in Member States and either prepared industrially or manufactured by a method involving an industrial process.
Amendment 393 #
Proposal for a directive
Article premier – paragraph 5 – point c a (new)
Article premier – paragraph 5 – point c a (new)
(ca) medicinal products prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital preparations’). Hospital preparations shall be dispensed on medical prescription to one or more patients by the pharmacy supplying the hospital.
Amendment 476 #
Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, including those prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility or developed in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.
Amendment 517 #
Proposal for a directive
Article 4 – paragraph 1 – point 31 – point a
Article 4 – paragraph 1 – point 31 – point a
(a) a method involving an industrial process which includes pooling of donations with a view to a future fractionation; or
Amendment 519 #
Proposal for a directive
Article 4 – paragraph 1 – point 31 – point b
Article 4 – paragraph 1 – point 31 – point b
(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties; where a process involves the pooling, concentration, separation or isolation of elements in the preparation of SoHOs, or any other method that increases the microbiological quality, it should not be considered a change in their inherent properties;
Amendment 704 #
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 706 #
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawnrefused.
Amendment 713 #
Proposal for a directive
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 715 #
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 30 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 773 #
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial for systemic use; or
Amendment 797 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its contractual responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure Marketing authorisation holders comply with their supply obligations.
Amendment 810 #
Proposal for a directive
Article 56 – paragraph 9
Article 56 – paragraph 9
9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, in the Union or Member State. The Marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub- paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product and any data in its possession relating to the volume of prescriptions.
Amendment 1215 #
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 1225 #
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 1233 #
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 1241 #
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 should be designated as a value added medicinal product.
Amendment 1257 #
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 are conducted to generate data for an application, for:the purpose of: (i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations; (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282; (iii) obtaining pricing and reimbursement approval; (iv) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.
Amendment 1317 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), may cover include the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers. This exception shall not cover the placing on the market in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products purposes.
Amendment 1346 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of generics, biosimilars, hibryds and biohibrids or to determine their inclusion within the scope of public health insurance system of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of generics, biosimilars, hibryds and biohibrids or its inclusion within the public health insurance system. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Amendment 1454 #
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure wholesale distributors comply with their supply obligations.
Amendment 1458 #
Proposal for a directive
Article 168 – paragraph 1 – introductory part
Article 168 – paragraph 1 – introductory part
1. For all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in the Member State concerned, the authorised wholesaler must enclosprovide a document, which may be submitted in electronic format, that makes it possible to ascertain the following:
Amendment 1583 #
Proposal for a directive
Article 207 – paragraph 1
Article 207 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.
Amendment 1618 #
Proposal for a directive
Annex III – point 2
Annex III – point 2
2. The qualified person shall have acquired practical full-time experience over at least two years, in one or more undertakings that are authorised manufacturers, obtaining sufficient knowledge of manufacture, testing, supply chains, good manufacturing practice and pharmaceutical quality systems as well as regulatory processes and dossier content for ensuring the quality of medicinal products. The length of practical experience required may be reduced by one year where the university course was longer than five years, and by one and a half years where the university course was longer than six years.
Amendment 1619 #
Proposal for a directive
Annex III – point 4
Annex III – point 4
4. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings or not-for-profit entities that are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products. The length of practical experience required may be reduced by one year where the university course was longer than five years, and by one and a half years where the university course was longer than six years.
Amendment 1635 #
Proposal for a directive
Annex VI – paragraph 1 – point 8 a (new)
Annex VI – paragraph 1 – point 8 a (new)
(8a) Further to the measures provided for in Article 64(2a), for medicinal products included in the list referred to in Article 112a of [Regulation (EC) No 726/2004 as amended], the following additional statement shall be added: ‘This medicinal product is subject to additional monitoring.’ This statement shall be preceded by the symbol referred to in Article 112 of [Regulation (EC) No 726/2004 as amended] and followed by an appropriate standardised explanatory sentence.