Skip to content
OPINION (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

ITRE-AD-754772

Committee on Industry, Research and Energy · Rapporteur: Henna Virkkunen

Official HTML ↗ PDF DOCX
✦ In shortFull textProcedure & committee votes
✦ In short · AI summary of this text, generated 25 Sept 2026

Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

The Committee on Industry, Research and Energy gives its opinion on the proposed regulation on authorising and supervising medicines for human use and on the European Medicines Agency. It proposes amendments to support competitiveness, innovation and medicine availability. It backs transferable exclusivity vouchers for priority antimicrobials but asks to reconsider the strict conditions, and proposes a Union push and pull incentives scheme. It wants the regulatory sandbox widened beyond pharmaceuticals to medical devices, diagnostics and digital tools, with easier access for small and medium-sized enterprises and startups. On shortages, it asks to limit mandatory shortage prevention plans to critical medicines, to use data and digital tools, and to set up an EU Critical Medicines Act. It proposes changes to orphan medicine incentives, including longer market exclusivity periods and a dedicated framework for rare diseases.

Committee position. The committee supports the pharmaceutical package and proposes amendments to improve competitiveness, innovation and medicine availability, including on transferable exclusivity vouchers, unmet medical needs, regulatory sandboxes, shortages and orphan incentives.

Key points

  1. The committee calls on the Committee on the Environment, Public Health and Food Safety to take its amendments into account.
  2. It supports the pharmaceutical reform's objectives: a competitive and innovation-friendly research environment, strategic autonomy, action on antimicrobial resistance and better medicine access.
  3. It asks for legislation that is predictable, transparent, stable and clear to keep the EU attractive for research, development and production of medicines.
  4. It supports transferable exclusivity vouchers for new antimicrobials but asks to reconsider the strict conditions, which extend only regulatory data protection.
  5. It proposes a Union push and pull incentives scheme for novel antimicrobials, with research grants, milestone prizes and voluntary joint procurement with subscription payments or market entry rewards.
  6. It warns that restricting incentives to a narrow definition of unmet medical needs could hinder future therapies and reduce predictability for companies.
  7. It wants the regulatory sandbox expanded beyond pharmaceuticals to cover medical devices, diagnostics and digital tools, and to be easily accessible to small and medium-sized enterprises and startups.
  8. It asks to limit mandatory shortage prevention plans to critical medicines and to focus on transparency of demand and use of data and digital tools.
  9. It calls for an EU Critical Medicines Act to support European manufacturing of key medicines and ingredients for which the Union depends on one country or few manufacturers.
  10. It proposes longer market exclusivity periods for orphan medicines, including ten, twelve and six years depending on the criteria, and a maximum of fifteen years.
  11. It asks the Commission to develop a dedicated framework for rare diseases, in consultation with Member States and patient organisations.
  12. It wants the Agency to assess national measures to mitigate shortages for their impact on other Member States and to inform the MSSG and the Commission.

Who is affected

  • Pharmaceutical industry: would face amended rules on incentives, exclusivity and shortage prevention.
  • Patients: would benefit from better availability, access and information on shortages.
  • Member States: would monitor shortages and may introduce more robust supply measures.
  • European Medicines Agency: would gain tasks on sandboxes, shortage monitoring and assessment of national measures.
  • Small and medium-sized enterprises and startups: would have easier access to regulatory sandboxes.

Figures and deadlines

  • Notification period for temporary shortages extended from two to six months.
  • Voucher gives an additional period of data protection, replacing 12 months.
  • Voucher usable only if the product has at least two years of regulatory data protection remaining.
  • Market exclusivity for orphan medicines: ten years, twelve years, six years, and a maximum of fifteen years.
  • Prolongation of market exclusivity by 18 months or 24 months or 36 months in specific cases.
  • Commission to propose an EU Critical Medicines Act by 24 months after entry into force.
  • Commission to develop the push and pull incentives scheme by one year after entry into force and report after seven years.
  • Commission to issue guidelines on regulatory sandboxes by 12 months after entry into force.