Activities of Henna VIRKKUNEN related to 2023/0131(COD)
Opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Amendments (6)
Amendment 46 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) The pharmaceutical framework should be consistent with overarching EU industrial policy, including the Council Conclusions from 23 March 2023 which stressed the importance of strengthening incentives for investment in innovation and the 2016 Council Conclusions which stress any revision, including to the incentive framework, should not discourage the development of medicinal products needed for the treatment of rare diseases; increased innovation will further support patient outcomes and public health;
Amendment 103 #
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentiviseze investment and innovation, research and development of orphan medicinal products addressing high unes where either no other treatment needs, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; orphan medicinal products addressing high unmet medical needs benefit from the longest market exclusivity, whileexists or, if other treatments already exist, they would constitute a significant benefit to the target population, a modulation of market exclusivity has been introduced. Such modulation is science-driven and informed by the principles that guide research, with incentives based on the concrete barriers, unique attributes, and needs for development of novel therapies that address patient needs; four main incentive archetypes are foreseen by the Regulation, each addressing unique needs and knowledge gaps in research; market exclusivity for well-established use orphan medicinal productes, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
Amendment 130 #
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. 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 of critical medicinal products 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 186 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the envirconmtental 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; or timelines of post- authorisation studies to further clarify environmental risk assessment, as required in article 20(c), cannot be agreed.
Amendment 485 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c) and Marketing Authorisation Holders, ensure the following:
Amendment 489 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities and availability of alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;