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Regulation (EU) 2025/26452023/0129(COD)COM(2023)224JURI

Compulsory licensing of patents in crisis situations

Compulsory licensing for crisis management and amending Regulation (EC) 816/2006

Stage
In force, reached 30 Dec 2025
In force
In force since 19 Jan 2026 · CELEX 32025R2645
Procedure
Regulation · Ordinary legislative procedure
Rapporteur
Adrián Vázquez Lázara (EPP)
Lead DG
DG GROW
Commissioner
Stéphane Séjourné
Council configuration
Competitiveness Council
Last activity
30 Dec 2025
Legal basis
TFEU Art. 294; TFEU_2016 Art. 114; TFEU_2016 Art. 207; TFEU_2016 Art. 294
56 entries · record as of 14 Sept 2026

Where it stands

Latest: Published in the Official Journal, 30 Dec 2025.

Show the earlier record: 38 dates, 29 Apr 2022 to 27 Oct 2025
  1. 29 Apr 2022
    • Call for evidence closed: Compulsory licensing of patents, 57 responses · Commission
  2. 29 Sept 2022
    • Public consultation closed: Compulsory licensing of patents, 74 responses · Commission
  3. 27 Apr 2023
    • Adoption of legislative proposal by the Commission
  4. 2 May 2023
    • Discussions within the Council or its preparatory bodies
  5. 12 Jun 2023
    • Referred to committee
  6. 14 Jul 2023
    • Discussions within the Council or its preparatory bodies
  7. 25 Jul 2023
    • Discussions within the Council or its preparatory bodies
  8. 31 Jul 2023
    • Feedback on adopted proposal closed: Compulsory licensing of patents, 38 responses · Commission
  9. 11 Sept 2023
    • Discussions within the Council or its preparatory bodies
  10. 25 Sept 2023
    • Discussions within the Council or its preparatory bodies
  11. 2 Oct 2023
    • Committee opinion tabled
  12. 16 Oct 2023
    • Committee report tabled
    • Discussions within the Council or its preparatory bodies
    • EP committee draft report
  13. 14 Nov 2023
    • Committee amendments tabled
    • Tabling of amendments in the EP committee responsible
  14. 28 Nov 2023
    • Committee opinion adopted
  15. 1 Feb 2024
    • Discussions within the Council or its preparatory bodies
  16. 13 Feb 2024
    • Committee report adopted
  17. 19 Feb 2024
    • Tabled for plenary
  18. 12 Mar 2024
    • Debate in plenary
  19. 13 Mar 2024
    • EP position at first reading
    • Plenary amended the proposal
    • Plenary vote
  20. 26 Jun 2024
    • Adoption of negotiating mandate by Coreper
  21. 3 Jul 2024
    • Discussions within the Council or its preparatory bodies
  22. 11 Jul 2024
    • Discussions within the Council or its preparatory bodies
  23. 13 Nov 2024
    • Referred to committee
  24. 10 Dec 2024
    • Interinstitutional negotiations
  25. 11 Dec 2024
    • Deliberations in Coreper
  26. 26 Mar 2025
    • Interinstitutional negotiations
  27. 2 Apr 2025
    • Deliberations in Coreper
  28. 10 Apr 2025
    • Deliberations in Council working party
  29. 28 Apr 2025
    • Deliberations in Council working party
  30. 8 May 2025
    • Deliberations in Council working party
  31. 14 May 2025
    • Deliberations in Coreper
  32. 21 May 2025
    • Interinstitutional negotiations
  33. 22 May 2025
    • Deliberations in Council
  34. 28 May 2025
    • Deliberations in Coreper
  35. 2 Jun 2025
    • Deliberations in Council working party
  36. 13 Jun 2025
    • Endorsement of the provisional agreement by Coreper
  37. 24 Jun 2025
    • Committee approved the provisional agreement
  38. 27 Oct 2025
    • Council’s position at first reading and statement of reasons
  1. 29 Oct 2025
    • Adoption of a Commission’s communication on Council’s position at 1st reading
  2. 13 Nov 2025
    • Announcement of the Council’s first reading position in EP plenary
    • Referred to committee
  3. 1 Dec 2025
    • Committee report tabled
    • EP committee draft recommendation for second reading
  4. 3 Dec 2025
    • Committee report adopted
  5. 4 Dec 2025
    • Tabled for plenary
  6. 10 Dec 2025
    • Tabled for plenary
  7. 16 Dec 2025
    • Approval of the Council’s first reading position by the EP (adoption of the legislative act)
    • Plenary vote
    • Plenary approved the Council position
    • Signed
  8. 30 Dec 2025
    • Published in the Official Journal
12 people

Who is on it

The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.

RoleNameGroupCountryCommittee
RapporteurAdrián Vázquez LázaraEPPESJURI
Shadow rapporteurGeoffroy DidierEPPFRJURI
Shadow rapporteurKosma ZłotowskiECRPLJURI
Shadow rapporteurLaurence FarrengRenewFRJURI
Shadow rapporteurMario FuroreThe LeftITJURI
Shadow rapporteurSergey LagodinskyGreens/EFADEJURI
Shadow rapporteurTiemo WölkenS&DDEJURI
Rapporteur for opinionHelmut ScholzThe LeftDEINTA
Shadow rapporteur for opinionDominik TarczyńskiECRPL
Shadow rapporteur for opinionHeidi HautalaGreens/EFAFI
Shadow rapporteur for opinionKathleen Van BremptS&DBE
Shadow rapporteur for opinionSamira RafaelaRenewNL
13 documents

Documents

Newest first. Each opens at its source.

1 consultation

Consultations on it

The Commission's Have Your Say consultations linked to this file. Where we publish the positions filed, the title opens them here.

ConsultationFeedback deadlineFeedback received
31 Jul 2023169

Summary

Generated

This regulation creates a compulsory licensing mechanism for pharmaceutical products to ensure supply security and health protection during crises, allowing use or sale of patented medicines without patent holder consent. It amends Regulation (EC) 816/2006 and directly affects patent holders, pharmaceutical firms, and EU member states.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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