19 Amendments of Marian-Jean MARINESCU related to 2023/0131(COD)
Amendment 472 #
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems to parallel trade . In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.
Amendment 485 #
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation and to identify the cause or causes of the respective critical shortage. If the critical shortage is triggered by a marketing authorisation holder, wholesale distributor or other legal entity, the Commission should be able to impose sanctions. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 532 #
Proposal for a regulation
Article 2 – paragraph 2 – point 7 a (new)
Article 2 – paragraph 2 – point 7 a (new)
(7 a) 'adverse reaction' means a response to a medical that is noxious and includes medication errors and uses outside of the terms of the marketing authorisation, including the misuse and abuse of the medication product;
Amendment 660 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
Amendment 683 #
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 2 – point c
Article 16 – paragraph 4 – subparagraph 2 – point c
(c) a potential or actual shortage in that Member State in accordance with Article 116(1), point (d); and its reasons for such action under points (a) and (b) in accordance with Article 24 and the cause of shortage under point (c) , as well as any other reason relating to precautionary actions with regard to quality, safety, efficacy and the environment.
Amendment 735 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point c a (new)
Article 20 – paragraph 1 – subparagraph 1 – point c a (new)
(c a) submits Treatment optimisation (TO) data to the EMA within certain time limit.
Amendment 736 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point c b (new)
Article 20 – paragraph 1 – subparagraph 1 – point c b (new)
(c b) performs a Treatment optimisation( TO) clinical trial in collaboration with an independent not- for-profit research organisation able to develop and peer-review the clinical trial protocol, and to collect and analyse independently the clinical trial data. The marketing authorisation holder shall provide all relevant information regarding the drug and financial support to the independent non-profit research organisation.
Amendment 743 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f
Article 24 – paragraph 1 – subparagraph 2 – point f
Amendment 842 #
Proposal for a regulation
Article 40 – paragraph 2
Article 40 – paragraph 2
2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product, if the medicinal product is released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in all Member States in which the marketing authorisation is valid.
Amendment 1141 #
Proposal for a regulation
Article 70 – paragraph 1 – point b
Article 70 – paragraph 1 – point b
(b) the use of the orphan medicinal product results in a meaningful reduction in disease morbidity, acute or long-term toxicity or mortality for the relevant patient population.
Amendment 1144 #
Proposal for a regulation
Article 70 – paragraph 1 – point b a (new)
Article 70 – paragraph 1 – point b a (new)
(b a) the use of the medicinal product results in a substantial improvement of patients' quality of life.
Amendment 1207 #
Proposal for a regulation
Article 71 – paragraph 2 – point c a (new)
Article 71 – paragraph 2 – point c a (new)
(c a) twelve years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70 in the paediatric population;
Amendment 1372 #
Proposal for a regulation
Article 101 – paragraph 1 – subparagraph 3
Article 101 – paragraph 1 – subparagraph 3
The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.
Amendment 1389 #
Proposal for a regulation
Article 111 – paragraph 1
Article 111 – paragraph 1
The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse events including medication errors, processes and standards for medication safety, and implement digital technologies in healthcare settings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.
Amendment 1463 #
Proposal for a regulation
Article 116 – paragraph 1 – introductory part
Article 116 – paragraph 1 – introductory part
1. The marketing authorisation holder of a medicinal product in possession of a centralised marketing authorisation or a national marketing authorisation (‘the marketing authorisation holder’) shall notify and explain the reasons for the competent authority of the Member State where the medicinal product has been placed on the market and, in addition, the Agency for a medicinal product covered by a centralised marketing authorisation (these are referred to in this Chapter as ‘the competent authority concerned’) of the following:
Amendment 1527 #
Proposal for a regulation
Article 120 – paragraph 1 a (new)
Article 120 – paragraph 1 a (new)
1 a. When a marketing authorisation holder notifies a temporary disruption in supply of a medicinal product, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products shall provide information requested in a timely manner to the Agency, the competent authority in a Member State, and the relevant marketing authorisation holder to confirm that the temporary disruption in supply of the product in a Member State was not caused by parallel distribution to another Member State.
Amendment 1548 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) in order to avert or mitigate an imminent or existing supply shortage relevant to the supply of a medication product request pharmacies supplying hospitals and hospital pharmacies, to communicate electronically data on available stock of the respective medicinal product.
Amendment 1578 #
Proposal for a regulation
Article 122 – paragraph 4 – point e a (new)
Article 122 – paragraph 4 – point e a (new)
(e a) specify the systems and procedures to ensure the European Shortages Monitoring Platform (ESMP) includes accurate information on available critical medicinal stocks in legal entities that are authorised or entitled to supply medicinal products to the public including pharmacies supplying hospitals and hospital pharmacies.
Amendment 1706 #
Proposal for a regulation
Article 134 – paragraph 2
Article 134 – paragraph 2
2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decide toshall adopt an implementing act to improve security of supply. The implementing act may impose contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities.