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DRAFT REPORT (COM(2023)0222 – C90148/2023 – 2023/0127(COD))

On the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013

JURI-PR-753703

Committee on Legal Affairs · Rapporteur: Tiemo Wölken

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This is the rapporteur's draft report on the Commission proposal for a regulation on the unitary supplementary certificate for medicinal products. It adopts Parliament's first-reading position with 62 amendments to the Commission text. The amendments add new recitals on administrative streamlining, timely entry of generics and biosimilars, and the export and day-one entry exception. They also amend the definition of 'medicinal product' and add a definition of 'economically linked'. The amendments require electronic filing and communication with the Office, add applicant responsibility for accuracy, and require the Office to publish and notify decisions without undue delay. The amendments restrict the use of register information for patent linkage and require the Commission to evaluate the regulation, with special emphasis on opposition effects and delays.

Committee position. The rapporteur proposes that Parliament adopt its first-reading position with 62 amendments to the Commission proposal, covering definitions, the export and storage exception, electronic procedures, register use, and evaluation.

Key points

  1. Adds a recital noting it is difficult to establish a direct link between favourable pharmaceutical rules and Union competitiveness, as medicines from third countries are equally eligible for Union incentives.
  2. Adds a recital on streamlining measures, including electronic applications and the 'digital by default' principle for applications to the Office.
  3. Amends Recital 21 to replace 'therapeutically equivalent products' with 'biosimilars' for protection extending to products with the same International Nonproprietary Name.
  4. Adds a recital on the timely entry of generics and biosimilars to increase competition, reduce prices and ensure access to affordable medicines.
  5. Amends Recital 22 to specify the export exception applies to third-country markets where protection does not exist or has expired, and to storage for EU day-one entry.
  6. Adds a recital on restricting protection to allow making for export to third countries and related acts, including by third parties in a contractual relationship with the maker.
  7. Amends recitals on examination panels and Boards of Appeal to require relevant expertise and sufficient experience in supplementary protection certificates and patents.
  8. Amends Recital 33 on fees for applications and extensions for paediatric medicinal products, to be in accordance with Article 86 of Directive (EU) ... [2023/0132 (COD)].
  9. Amends Recital 35 to state that register information should not be used for patent linkage or as a basis for regulatory decisions on generics or biosimilars.
  10. Amends Article 2 to redefine 'medicinal product' and add a definition of 'economically linked' for holders of basic patents.
  11. Amends Article 5(3) to align the exception for export and storage with Regulation (EU) 2019/933, including related acts and acts under Article 85 of Directive (EU) ... [2023/0132 (COD)].
  12. Amends Articles 8, 9, 10, 12, 13, 14, 15, 16, 17, 18, 19, 22, 23, 28, 29, 32, 34, 35, 36, 40, 42, 46 and 56 to require electronic submissions, add applicant responsibilities, and set new procedural rules.

Who is affected

  • Applicants for unitary supplementary certificates, who must file electronically and are responsible for the accuracy of their submissions.
  • The pharmaceutical industry, including makers of generics and biosimilars, affected by the export and storage exception and patent linkage restrictions.
  • National patent offices and their examiners, who must have relevant expertise and sufficient experience in supplementary protection certificates.
  • The Office, which must publish and notify decisions without undue delay and handle oppositions jointly.
  • Public authorities, which shall not use register information for patent linkage or as a basis for regulatory decisions on generics or biosimilars.

Figures and deadlines

  • 6 months before the expiry of the certificate, for making for storage.
  • 6 months, within which the Office shall issue a decision on opposition unless complexity requires longer.
  • 2 months of the date of notification of the decision, for filing notice of appeal.
  • 4 months of the date of notification of the decision, for filing a written statement of grounds of appeal.
  • 1 month, minimum period of notice for a summons to give evidence orally.
  • 2 months of the removal of the obstacle, for filing an application for re-establishment.
  • one year immediately following the expiry of the unobserved time limit, for admissibility of re-establishment.
  • five years after the date of application, and every five years thereafter, for Commission evaluation.

Legal basis: Article 294(2) and Article 118, first paragraph, of the Treaty on the Functioning of the European Union.