24 Amendments of Stelios KYMPOUROPOULOS related to 2023/0132(COD)
Amendment 196 #
Proposal for a directive
Recital 30
Recital 30
(30) Regulatory decision-making on the development, authorisation and supervision of medicines may be supported by access and analysis of health data, including real world data i.e. health data generated outside of clinical studies, where appropriate, and/or data generated via in silico methods, such as computational modelling and simulation, molecular modelling, mechanistic modelling, digital twin and artificial intelligence (AI). The competent authorities should be able to use such data, including via the European Health Data Space interoperable infrastructure.
Amendment 200 #
Proposal for a directive
Recital 31
Recital 31
(31) Directive 2010/63/EU of the European Parliament and of the Council43 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico toolsmethods, or read-across models. _________________ 43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
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 248 #
Proposal for a directive
Recital 52
Recital 52
(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment or an undertaking to generate real world evidence, including patient reported outcomes that compare the new active substance to the existing treatment, should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.
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 489 #
Proposal for a directive
Article 4 – paragraph 1 – point 11
Article 4 – paragraph 1 – point 11
(11) ‘non-clinical’ means a study or a test conducted in vitro, ex vivo, in silico, or in chemico, or a non-human in vivo test related to the investigation of the safety and efficacy of a medicinal product. Such test may include simple and complex human cell-based assays, microphysiological systems including organ-on-chip, computer modelling and other in silico methods, other non-human or human biology-based test methods, and animal-based tests;
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 1247 #
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 usstudies, trials and other activities are conducted for the purposes of:
Amendment 1258 #
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:(i) obtaining for a marketing authorisation and subsequent variations; (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282; (iii) obtaining for pricing and reimbursement approval; (iv) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate; (v) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.
Amendment 1267 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
Amendment 1278 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
Amendment 1291 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
Amendment 1323 #
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 the submission of the application for a marketing authorisation andinclude 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.
Amendment 1335 #
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 1347 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article 85a 1. Applications, procedures, and decisions to regulate marketing authorisations, the prices of medicinal products, or to decide on their inclusion within the scope of public helath insurance or public and private precurement, shall be considered by the Member States as administrative or regulatory precedures independent from the enforcement of intellectual propoerty (IP) rights. 2. The protection of IP rights shall not be used unjustifiably as a reason to refuse, suspend, delay, withdraw, or revoke decisions on the regulatory or administatives procedures outlined in paragraph 1. 3. The applications, decisions, and procedures reffered to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the IP rights. 4. All paragraphs of this article shall apply without prejudice to the Union and national law relating to the protection of IP.
Amendment 1394 #
Proposal for a directive
Article 108 – paragraph 6 a (new)
Article 108 – paragraph 6 a (new)
6 a. The Agency and the Member States shall work together to achieve high standards of safety in public health delivery, by supporting the digital transition of health systems together with healthcare professionals and service providers.
Amendment 1459 #
Proposal for a directive
Article 172 – paragraph 1 – introductory part
Article 172 – paragraph 1 – introductory part
1. Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance after prescription to the public by means of services as defined in Directive (EU) 2015/1535 of the European Parliament and of the Council78 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services under the following conditions: _________________ 78 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
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.