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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

A-9-2024-0141

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

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Parliament's amended version of the Commission proposal for a regulation on authorising and supervising human medicines and on the European Medicines Agency. It adds rules on medicine shortages, environmental risk assessment, antimicrobial incentives, orphan and paediatric medicines, transparency and regulatory sandboxes. It requires marketing authorisation holders to keep shortage prevention plans and to notify supply disruptions, and gives the Agency and member states tasks to monitor and manage shortages and critical shortages. It sets up milestone payments, a subscription model for joint procurement and a transferable data exclusivity voucher for priority antimicrobials, and creates an ad hoc Environmental Risk Assessment working party. It changes orphan medicine rules, including market exclusivity periods, and requires the Commission to propose a Union Framework for Rare Diseases. It strengthens transparency, independence and conflict-of-interest rules for the Agency, and allows regulatory sandboxes for innovative products.

Committee position. The committee adopts its first-reading position with amendments to the Commission proposal. It adds rules on shortages, environmental risk assessment, antimicrobial incentives and transparency, and deletes the Commission's provisions on regulatory sandboxes.

Key points

  1. The regulation lays down Union procedures for authorisation, supervision and pharmacovigilance of human medicines and rules on shortages, security of supply and the Agency's governance.
  2. Marketing authorisation holders must keep an up-to-date shortage prevention plan for each product placed on the market and make it available on request.
  3. Holders must notify the competent authority and the Agency of suspensions, withdrawals and foreseeable supply disruptions, generally at least six months in advance.
  4. Wholesale distributors must report shortages and submit regular information on available stocks; other suppliers must provide information on request.
  5. Member states must monitor shortages, publish information on national websites and may activate a Voluntary Solidarity Mechanism to redistribute stocks.
  6. The Agency must assess whether national measures to mitigate a shortage harm supply in other member states and inform the MSSG and the Commission.
  7. The Commission must develop guidelines on stockpiling and on public procurement, including remedies against single-winner, price-only tenders.
  8. Milestone payments and a subscription model for voluntary joint procurement of antimicrobials are set up to reward priority antimicrobials.
  9. A transferable data exclusivity voucher gives 6, 9 or 12 months of extra data protection, may be transferred once, and the scheme ends after 15 years or 10 vouchers.
  10. The Agency must set up an ad hoc Environmental Risk Assessment working party, and environmental risk assessments must cover the product's lifecycle including manufacturing.
  11. Orphan medicinal products get market exclusivity of eleven years for high unmet need and four years for well-established use, and the Commission must propose a Union Framework for Rare Diseases.
  12. The Commission may set up regulatory sandboxes for innovative products lacking adapted rules, with derogations limited to what is necessary and patient safety upheld.

Who is affected

  • Marketing authorisation holders: must keep shortage prevention plans, notify disruptions and report financial support.
  • Wholesale distributors and suppliers: must report shortages and provide stock information.
  • Member states: must monitor shortages, publish information and may join joint procurement or the Voluntary Solidarity Mechanism.
  • Developers of priority antimicrobials: can receive milestone payments, subscription contracts or a transferable voucher.
  • Patients and healthcare professionals: get representation in Agency bodies and information on shortages and alternatives.

Figures and deadlines

  • 20 days for the Agency to check a marketing authorisation application for validity.
  • 90 days for the Committee to terminate an assessment if data are insufficient.
  • Six months' notice for temporary suspension or foreseeable supply disruption.
  • Two weeks: expected duration of a temporary supply disruption triggering notification.
  • 18 months from entry into force for marketing authorisation holders to have shortage prevention plans.
  • 12 months, 9 months or 6 months of extra data protection depending on pathogen ranking.
  • 15 years or 10 vouchers: duration of the transferable data exclusivity voucher scheme.
  • Five years from entry into force for the Commission's evaluation report on antimicrobial incentives.

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