Activities of Joanna KOPCIŃSKA related to 2023/0132(COD)
Shadow reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Amendments (38)
Amendment 175 #
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
(15 a) It would be valuable to map terms used in ICD 11 an MedDRA, to clearly identify indications and to harmonise terminology used in other healthcare systems.
Amendment 204 #
Proposal for a directive
Recital 39
Recital 39
(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure by recognising it after it has been closed.
Amendment 219 #
Proposal for a directive
Recital 47
Recital 47
(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory datamarket protection for market launch shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.
Amendment 224 #
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases. Joint procurement should not have detrimental impact on access to medicines for countries not taking part in the procurement. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 249 #
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 should be incentivisedrecommended, especially in regards to medicines for non rare diseases, 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 254 #
Proposal for a directive
Recital 54
Recital 54
(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to market a medicinal product in the Member States where the marketing authorisation is valid for the purposes of receiving additional regulatory datamarket protection.
Amendment 259 #
Proposal for a directive
Recital 56
Recital 56
(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of datamarket protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory datamarket protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later.
Amendment 261 #
Proposal for a directive
Recital 57
Recital 57
(57) The issuing of documentation from the Member States as regards the prolongation of datamarket protection for the purpose of supply of medicinal products in all Member States where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation, does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the datamarket protection period.
Amendment 291 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow, inter alia, to conduct studies to support pricing and reimbursement all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studies activities to support regulatory 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 of seeking marketing authorisations during that period, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one after of loss of the patent or SPC protection under fair competitive conditions.
Amendment 325 #
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused unless health benefits from authorisation of medicine outweight the enviromental risk. The ERA should be updated when new data or knowledge about relevant risks become available.
Amendment 498 #
Proposal for a directive
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antiprotozoals and antifungals;
Amendment 546 #
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 549 #
Proposal for a directive
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2 a. Developments lacking therapuetic contributions shall always be granted in accodrance with paragraph 1 and be considered as belonging to the same global marketing authorisation.
Amendment 571 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, or there was a reference medicinal product but it is not currently available, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature.
Amendment 575 #
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1
Article 15 – paragraph 3 – subparagraph 1
Where justified for public health reasons and when the active substances cannot be combined within a fixed dose combination medicinal product, a marketing authorisation may, in exceptional circumstances, be granted to a multi- medicinal product packageroduct.
Amendment 577 #
Proposal for a directive
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
3 a. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by amending Annexes IV to VI by specyfying additional requirements for multi- medicinal product package.
Amendment 604 #
Proposal for a directive
Article 20 – title
Article 20 – title
Combinations of medicinal products with products other than medical devices
Amendment 605 #
Proposal for a directive
Article 20 – paragraph 2 a (new)
Article 20 – paragraph 2 a (new)
Amendment 708 #
Proposal for a directive
Article 34 – paragraph 5
Article 34 – paragraph 5
5. Within 1290 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant.
Amendment 710 #
Proposal for a directive
Article 34 – paragraph 6
Article 34 – paragraph 6
6. Within 690 days of receipt of the assessment report, the competent authorities of the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the competent authority of the reference Member State for the decentralised procedure accordingly. The competent authority of the reference Member State for the decentralised procedure shall record the agreement of all parties, close the procedure and inform the applicant accordingly.
Amendment 717 #
Proposal for a directive
Article 36 – paragraph 5
Article 36 – paragraph 5
5. If the competent authorities of the Member States concerned so require, the marketing authorisation holder shall request the competent authority of the reference Member State for the mutual recognition procedure to perform or update the assessment report drawn on the medicinal concerned by the application. In that case, the reference Member State shall perform or update the assessment report within 90 days after validation of the application. If the competent authorities of the Member States concerned do not require the performance or the update of the assessment report, the reference Member State shall provide the assessment report within 30 days in case medicinal product was previously authorised in European procedure.
Amendment 741 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g
Article 44 – paragraph 1 – subparagraph 1 – point g
(g) in case of medicinal products for which there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit- risk balance, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 765 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, however with clear prioritization of human health benefits over risk to environment;
Amendment 772 #
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial; orf systemic administration;
Amendment 775 #
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 779 #
Proposal for a directive
Article 51 – paragraph 1 – point e a (new)
Article 51 – paragraph 1 – point e a (new)
(e a) is an antibiotic; or
Amendment 794 #
Proposal for a directive
Article 51 – paragraph 5 – point b
Article 51 – paragraph 5 – point b
Amendment 808 #
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, and any data in its possession relating to the volume of prescriptions 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.
Amendment 1210 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourtwo years shall be granted for a medicinal product with respect to a new and previously unknown therapeutic indication not previously authorised in the Union, provided that:
Amendment 1400 #
Proposal for a directive
Article 123 – title
Article 123 – title
Guidance to facilitate the performance of pharmacovigilance activities
Amendment 1479 #
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(b a) are antibiotics.
Amendment 1488 #
Proposal for a directive
Article 177 – paragraph 2
Article 177 – paragraph 2
2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a medical practithealth professioneral for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.
Amendment 1497 #
Proposal for a directive
Article 177 – paragraph 4
Article 177 – paragraph 4
4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
Amendment 1515 #
Proposal for a directive
Article 185 – paragraph 1 – point g
Article 185 – paragraph 1 – point g
(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.
Amendment 1536 #
Proposal for a directive
Article 193 – paragraph 1 – subparagraph 1
Article 193 – paragraph 1 – subparagraph 1
to submit samples from each batch of the bulk or the medicinal product for examination by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before release on to the market unless the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member States shall be directly recognised. Member States shall ensure that any such examination is completed within 360 days of the receipt of the samples.
Amendment 1546 #
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 with clear prioritatization of public health over risk to environment.
Amendment 1595 #
Proposal for a directive
Article 214 – paragraph 3
Article 214 – paragraph 3
Amendment 1603 #
Proposal for a directive
Article 219 – paragraph 1
Article 219 – paragraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive by [1824 months after the date of entering into force of this Directive]. They shall immediately communicate the text of those measures to the Commission.