18 Amendments of Elżbieta Katarzyna ŁUKACIJEWSKA related to 2023/0132(COD)
Amendment 280 #
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 thewithout this being considered patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of thinfringement. 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 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 conduct studies and trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment and, obtaining pricing and reimbursement requestdecisions, the public and private procurement of medicinal products to be supplied immediately after ex piry 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 Member State of the patent or SPC ofor the reference medicinal product, there can be no commercial uslevant product or or process, there can be no placing on the market in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01).
Amendment 295 #
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 302 #
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 Council1a and the European Parliament1b. 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. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31) Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02) 1b European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI))
Amendment 1217 #
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 1222 #
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 1230 #
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 1246 #
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 usednecessary studies, trials and other activities are conducted exclusively for the purposes of:
Amendment 1262 #
(a) studies, trials and other activities conducted to generate data for an application, for:obtaining a marketing authorisation and subsequent variations;
Amendment 1268 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
Amendment 1279 #
Amendment 1289 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
Amendment 1316 #
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 and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 1328 #
Proposal for a directive
Article 85 – paragraph 1 – point b a (new)
Article 85 – paragraph 1 – point b a (new)
(b a) obtaining pricing and reimbursement approval;
Amendment 1329 #
Proposal for a directive
Article 85 – paragraph 1 – point b b (new)
Article 85 – paragraph 1 – point b b (new)
(b b) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;
Amendment 1330 #
Proposal for a directive
Article 85 – paragraph 1 – point b c (new)
Article 85 – paragraph 1 – point b c (new)
(b c) complying with any other regulatory or administrative requirement in the Union or elsewhere;
Amendment 1331 #
Proposal for a directive
Article 85 – paragraph 1 a (new)
Article 85 – paragraph 1 a (new)
The activities falling within the first subparagraph include the offering, manufacturing, selling, suppling, storing, importing, exporting, using and purchasing of products or processes, including by third party suppliers and service providers.
Amendment 1338 #
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 1342 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)