33 Amendments of Marian-Jean MARINESCU related to 2023/0132(COD)
Amendment 149 #
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure equal access to innovative and established medicines for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.
Amendment 157 #
Proposal for a directive
Recital 6
Recital 6
(6) The regulatory framework for medicinal products use should also take into account the needs of the undertakings in the pharmaceutical sector and trade in medicinal products within the Union, without jeopardising the quality, safety and efficacy of medicinal products products and without jeopardising patients` access to medicines.
Amendment 165 #
Proposal for a directive
Recital 11
Recital 11
(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs and to ensure an increased access to innovative, quality medicines. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.
Amendment 190 #
Proposal for a directive
Recital 21
Recital 21
(21) Marketing authorisation decisions should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic or any other considerations including the status of intellectual property rights. . However, Member States should be able exceptionally to prohibit the use in their territory of medicinal products.
Amendment 243 #
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 285 #
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 relevant product, without this being considered patent or SPCupplementary Protection Certificate (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 conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 304 #
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 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 540 #
Proposal for a directive
Article 4 – paragraph 1 – point 70
Article 4 – paragraph 1 – point 70
(70) ‘public service obligation’ means to guarantee permanently an adequate range and the necessary quantity of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.
Amendment 558 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1
Article 6 – paragraph 7 – subparagraph 1
The marketing authorisation applicant shall demonstrate that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted in support of the application. Where appropriate the marketing authorisation applicant shall not carry out animal testing to meet the requirements of this legislation where non-animal methods that are acceptable to the competent authorities, are available.’
Amendment 700 #
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days after the submission of a valid application from the date of validation of a marketing authorisation application, according to Council Directive 89/105/EEC.
Amendment 803 #
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.
Amendment 1208 #
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 as well as the stakeholders referred to in Article 162 of [revised Regulation (EC) No 726/2004].
Amendment 1220 #
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 indication not previously authorised in the Union, provided that:
Amendment 1250 #
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 1277 #
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 for subsequent variations;
Amendment 1286 #
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 1297 #
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 1304 #
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 1309 #
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 and the subsequent practical requirements associated with such activities.
Amendment 1319 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) tThe activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation andfalling within the first subparagraph include 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 1339 #
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 1343 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Amendment 1369 #
Proposal for a directive
Article 97 – paragraph 1 – point e a (new)
Article 97 – paragraph 1 – point e a (new)
(e a) Facilitate harm reduction from adverse events through developing and implementing corrective patient safety plans for safe medicinal product administration and handling which can include the deployment of digital medication safety systems in hospitals and ambulatory care settings.
Amendment 1389 #
Proposal for a directive
Article 106 – paragraph 5
Article 106 – paragraph 5
5. Member States shall ensure that reports of suspected adverse reactions arising from an error, including those associated with the use, administration, and dispensation of a medicinal product, by professionals, that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations or institutions, responsible for patient safety within that Member State concerned. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 102 of [revised Regulation (EC) No 726/2004].
Amendment 1390 #
Proposal for a directive
Article 106 – paragraph 5 a (new)
Article 106 – paragraph 5 a (new)
5 a. Competent Authorities of the Member States, members of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the coordination group by means of a repository referred to in Article in 104 of [revised Regulation (EC) No726/2004) shall ensure that reports of adverse reactions arising from medication errors associated with the incorrect administration and dispensation of a medicinal product available in the Eudravigilance database are included in periodic safety update reports, and cooperate with healthcare professionals to define, if needed, corrective action to achieve high standards of medication safety in healthcare settings, such as the implementation of digital medication safety systems.
Amendment 1395 #
Proposal for a directive
Article 112 – paragraph 1 – point 1 (new)
Article 112 – paragraph 1 – point 1 (new)
(1) Upon receipt of a periodic assessment report that records adverse reactions arising from a medication error decide whether any corrective action is required to achieve high standards of medication safety in hospitals and ambulatory care settings.
Amendment 1405 #
Proposal for a directive
Article 123 – paragraph 1 – point b a (new)
Article 123 – paragraph 1 – point b a (new)
(b a) scientific guidance on post- authorisation treatment optimisation studies.
Amendment 1449 #
Proposal for a directive
Article 166 – paragraph 1 – point l
Article 166 – paragraph 1 – point l
(l) continuously guarantee the appropriate and continued supply of an adequate range and the necessary quantity of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;
Amendment 1450 #
Proposal for a directive
Article 166 – paragraph 1 – point m
Article 166 – paragraph 1 – point m
(m) cooperate with marketing authorisation holders and competent authorities of the Member States on the security of supply., according to the principels of Public Service Obligations;
Amendment 1451 #
Proposal for a directive
Article 166 – paragraph 1 – point m a (new)
Article 166 – paragraph 1 – point m a (new)
(m a) comply with the provisions of Public Service Obligations.
Amendment 1456 #
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 contractual 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.
Amendment 1542 #
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 for 3 months 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. If, after the 3 months suspension, the serious risk to the environment or public health has not been sufficiently addressed by the marketing authorisation holder, the competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may revoke the marketing authorisation.
Amendment 1556 #
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, within 3 months since the serious risk to the environment or to public health via the environment has been identified.