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DRAFT REPORT (COM(2023)0231 – C90146/2023 – 2023/0130(COD))

On the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)

JURI-PR-753704

Committee on Legal Affairs · Rapporteur: Tiemo Wölken

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This is the rapporteur's draft report on the Commission's proposal for a regulation on the supplementary protection certificate for medicinal products (recast). It adopts Parliament's position at first reading and sets out 44 amendments to the proposal. The amendments delete several recitals, add a new recital on timely entry of generics and biosimilars, and restrict the export and stockpiling exception to making for export and related acts. They also add rules on the register, including a ban on using register information for patent linkage, and require applicants to disclose direct public financial support for research. Other changes concern the definition of medicinal product, economically linked holders, examination and opposition procedures, appeals, and a Commission evaluation every five years.

Committee position. The rapporteur proposes that Parliament adopt its first reading position with 44 amendments to the Commission proposal, including changes to recitals, definitions, the scope of the export and storage exception, register rules, and procedural deadlines.

Key points

  1. Parliament adopts its position at first reading and calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal.
  2. Amendment 1 moves text on favourable rules and Union competitiveness from Recital 3 into Recital 2, and Amendments 2 and 3 delete Recitals 3 and 5.
  3. Amendment 4 replaces 'therapeutically equivalent products' with 'biosimilars' in Recital 13 on protection for biological medicinal products identified by International Nonproprietary Name.
  4. Amendment 5 adds a reference to Article [86] of Directive (EU) .../... [2023/0132(COD)] for fees for centralised applications and paediatric extensions.
  5. Amendment 6 adds a new Recital 41a stating that timely entry of generics and biosimilars is important to increase competition, reduce prices and ensure sustainability of national healthcare systems and better access to affordable medicines.
  6. Amendment 7 restricts the exception to certificate protection to making for the exclusive purpose of export to third countries and related acts, in accordance with Regulation (EU) 2019/933.
  7. Amendment 8 adds to Recital 60 that register information should not be used for patent linkage and no regulatory or administrative decisions on generics or biosimilars should be based on it.
  8. Amendments 9 and 10 define 'medicinal product' and add a definition of 'economically linked' for holders of basic patents protecting the same product.
  9. Amendments 11 to 17 amend Article 5 on the rights conferred by the certificate and the derogation for making for export or storage, including a new point (iva) referring to Article [85] of Directive (EU) .../... [2023/0132(COD)].
  10. Amendments 18 to 23 add applicant responsibility for accuracy, consent of third parties, information on direct public financial support, publication without undue delay, and a new ground for lapse if the marketing authorisation is withdrawn or revoked.
  11. Amendments 24 to 32 require the Office to assess applications against Article 3(1) and (3) and Article 6(2), publish negative opinions, and give detailed reasoning in opposition decisions, which must be issued within 6 months unless complexity requires longer.
  12. Amendments 33 to 44 set requirements for examiners' expertise, appeal deadlines and evidence, third-party observations on extensions, register information on public financial support and opposition or appeal status, conflict-of-interest checks for experts, and a Commission evaluation every 5 years.

Who is affected

  • Applicants for supplementary protection certificates must ensure accuracy of information and disclose direct public financial support for research.
  • Holders of certificates and third parties are affected by the restricted export and storage exception and by opposition and appeal procedures.
  • National authorities and the Office must publish information, assess applications against additional conditions, and avoid using register information for patent linkage.
  • Makers of generics and biosimilars benefit from the ban on using register information for patent linkage and from the timely entry provisions.

Figures and deadlines

  • 6 months before the expiry of the certificate: earliest time for making for storage.
  • 2 months of the date of notification of the decision: deadline to file notice of appeal.
  • 4 months of the date of notification of the decision: deadline to file written statement of grounds of appeal.
  • 6 months: deadline for the Office to issue a decision on opposition unless complexity requires longer.
  • 1 month: minimum period of notice for a summons to give evidence orally.
  • five years after the date of application, and every 5 years thereafter: Commission evaluation of Chapter III.

Legal basis: Article 294(2) and Article 114(1) of the Treaty on the Functioning of the European Union.