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DRAFT REPORT (COM(2023)0193 – C90144/2023 – 2023/0131(COD))

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

ENVI-PR-753550

Committee on the Environment, Public Health and Food Safety · Rapporteur: Tiemo Wölken

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The rapporteur's draft report sets out Parliament's first-reading position on the proposed regulation on authorising and supervising human medicines and on the European Medicines Agency. It amends many provisions and deletes the transferable data exclusivity voucher for priority antimicrobials, replacing it with a new European Medicines Facility. It deletes the regulatory sandbox chapter, tightens rules on shortages and security of supply, and strengthens transparency, conflict-of-interest and patient-organisation involvement. It changes marketing authorisation validity to five years, renewable for ten, and sets new rules for conditional and temporary emergency authorisations. It revises orphan and paediatric incentives, environmental risk assessment duties, and the Agency's data, scientific advice and working-party structures.

Committee position. The rapporteur proposes to amend the Commission proposal by deleting the transferable data exclusivity voucher and the regulatory sandbox chapter, establishing a European Medicines Facility, and strengthening rules on shortages, transparency, conflicts of interest and patient involvement.

Key points

  1. Parliament adopts its first-reading position on the Commission proposal for a regulation on human medicines and the European Medicines Agency.
  2. The Commission must refer the matter to Parliament again if it replaces or substantially amends its proposal.
  3. Antimicrobials are to be authorised at Union level in the interest of patients' health.
  4. Member States may exceptionally prohibit use of a human medicine on their territory but must give due justification to the Agency.
  5. The Agency should engage in early and continuous dialogue on real-world data with the Member State Coordination Group on Health Technology Assessment, payers, healthcare professionals, patient and consumer organisations and developers.
  6. The transferable data exclusivity voucher for priority antimicrobials is deleted, along with its recitals and articles.
  7. A European Medicines Facility is established as an independent agency to run purpose-led research and development projects, including priority antimicrobials and unmet medical needs.
  8. The regulatory sandbox chapter is deleted.
  9. A marketing authorisation is valid for five years and, once renewed, for an additional period of 10 years.
  10. Conditional marketing authorisations are subject to specific obligations, annual review for the first three years and penalties for non-compliance; the Commission may suspend, revoke or vary them.
  11. Temporary emergency marketing authorisations require robust transparency measures and cease to be valid when the public health emergency ends or sufficient data allow a conditional authorisation.
  12. Member States may introduce or maintain more robust measures on security of supply than those in the regulation, and the Commission shall adopt implementing acts to improve security of supply.

Who is affected

  • Marketing authorisation holders: new obligations on shortages, post-authorisation studies, penalties and transparency.
  • Member States: may prohibit medicines, maintain stronger supply measures and must set penalties.
  • Patients and consumer organisations: greater involvement in Agency consultations and access to shortage information.
  • Wholesalers: must transmit product availability and service level information for early detection of shortages.
  • The European Medicines Agency: new tasks on data, scientific advice, working groups and transparency.

Figures and deadlines

  • A marketing authorisation is valid for five years.
  • Once renewed, a marketing authorisation is valid for an additional period of 10 years.
  • An initial conditional marketing authorisation is valid for one year, renewable for the first three years and every two years thereafter.
  • A prevalence of not more than five affected persons per 10 000 is generally regarded as the appropriate threshold for orphan designation.
  • Market exclusivity is eight years for most orphan medicinal products, five years for a new orphan therapeutic indication of already authorised products, and three years for well-established use orphan products.
  • The period of market exclusivity is prolonged by an additional 12 months if the holder obtains a marketing authorisation for a new therapeutic indication for a different orphan condition at least three years before the end of the exclusivity period.
  • The Agency has 20 days to accept or refuse a justified request to use the procedure for an incomplete paediatric development plan.
  • Member States shall lay down penalties by six months after the date of entry into force of the regulation.

Legal basis: Article 294(2), Article 114 and Article 168(4), point (c), of the Treaty on the Functioning of the European Union.