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

Wording as published by the EP, in English.

1. Amendment 368Rejected

   Recital 5 a (new)

   Tabled by Anders Vistisen, Christine Anderson, Aurélia Beigneux · ID

   Added: (5 a) Health policy is an exclusive competence of the Member States. The track record of the Union in dealing with health crises and the acquistion of pharmaceutical products during the COVID-19 crisis emphasises the importance of Member States remaining sovereign on these issues.

2. Amendment 373Rejected

   Article 33 – paragraph 3

   Tabled by Anders Vistisen, Aurélia Beigneux · ID

   … A time limit for the submission of those studies shall be set. Added: The Eudravigilance database shall remain updated and accessible to the public at all times.

3. Amendment 377Rejected

   Recital 3 a (new)

   Tabled by Marina Mesure · The Left

   Added: (3 a) Treating health as a commodity has proven to be both costly and inefficient, as pharmaceutical companies have not addressed the crucial issue of shortages of medicinal products, despite receiving windfall profits at the expense of European citizens' right to healthcare. Enhanced public control over medical research and medicines production is urgently needed to ensure that treatments are not developed according to their profitability, and are affordable for all patients.

4. Amendment 378Rejected

   Article 134 – paragraph -1

   Tabled by Marina Mesure · The Left

   Added: -1. The Commission shall implement a long-term strategic reserve for medicinal products, at European level via the European Medicines Agency, as well as at national level within each Member State, to prevent the emergence of shortages of medicinal products, particularly the most critical ones.

5. Amendment 379Rejected

   Article 40 a (new)

   Tabled by Alessandra Moretti, Brando Benifei, Patrizia Toia +47 · Members

   Added: Article40a Article 40a Establishment and role of the European Medicines Facility 1.⁠ ⁠The European Medicines Facility ( ‘EMF’) is hereby established. 2.⁠ ⁠The main missions and responsibilities of the EMF shall be: (a) setting out a long-term vision of health priorities in the public interest at a Union level in the form of a strategic roadmap with a number of specific purpose-led R&D projects; in the elaboration of the strategic roadmap, the EMF shall engage in transparent consultation with relevant stakeholders, including scientific communities, Union public health authorities, patient and consumer organisations as well as the relevant agencies established at Union level; (b) establishing, as a priority, a portfolio of priority pharmaceutical R&D projects addressing at least the following therapeutic areas: (i) the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level; (ii) the development of medicinal products for high unmet medical needs as referred to in Article 70(1) of this Regulation and unmet medical needs as referred to in Article 83 of [revised Directive 2001/83/EC], in particular for conditions not sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therapies; (iii) the development of medicinal products for which the private sector charges excessive prices and for which alternatives or generic alternatives are non-existent or unaffordable.