19 Amendments of Massimiliano SALINI related to 2023/0132(COD)
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 434 #
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 chooses to provide the package leaflet in an electronic format, there is always the option to voluntarily offer a paper version of the package leaflet in addition to the electronic one. 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 442 #
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. By derogation from paragraph 3, if the medicinal product is not meant to be directly administered to the patient, the package leaflet can be provided electronically exclusively.
Amendment 451 #
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 eliminating the requirement to include a printed package leaflet within the packaging. 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 459 #
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 461 #
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. Following consultation with Member States and pertinent stakeholders, the Agency will make a system available to accommodate the electronic product information in the database specified in Article 138(1)(n) and 138(2) of the Revised Regulation. By [30 months after publication], at the latest, the Agency will have the system operational and all Member States will be using it.
Amendment 501 #
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the ultimate decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licencse requires, and during the duration period of the compulsory licencefor the indication pertaining to the public health emergency, solely during the compulsory license's period, and, if applicable, exclusively within the Member State where the compulsory license is authorized. The competent authority relevant to the suspension of data and market protection shall notify the marketing authorization holder of the medicinal product prior to the effective date of such suspension.
Amendment 529 #
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 comprehensive document provided by the manufacturer of an active substance, excluding chemical active substances. This document includes a thorough description of the manufacturing process, quality control procedures throughout production, and the validation process. It is mandated by Annex II and is prepared as a distinct document, encompassing details about the active substance or any other substances utilized in the production of a medicinal product.
Amendment 1218 #
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 medical product may be used, not previously authorised in the Union, provided that:
Amendment 1224 #
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 1235 #
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 authorisation as a medical 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 1238 #
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 appointed 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 1548 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder via conditions specified in Articles 44(h) or 87(c).
Amendment 1557 #
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions specified in Articles 44(h) or 87(c).