Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795
A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.
Where it stands: Parliament’s committee approved the deal reached with the Council on 14 July 2026; the plenary vote on it is still to come.
- ✓ Referred to committee 21 May 2025
- ✓ Committee work Report adopted 15 December 2025
- ✓ Tabled for plenary 19 December 2025
- ✓ Plenary vote Adopted 20 January 2026
- 5 Negotiations with the Council Deal approved in committee 14 July 2026
- 6 Published as law
How a file moves through Parliament
A file is referred to one lead committee (others may give an opinion). Its rapporteur writes a draft report, committee members table amendments, and the committee votes to adopt the report. The report is then tabled for all MEPs; political groups can table further amendments, which are voted on before the final vote in plenary. For a law, Parliament’s adopted text is its first-reading position; Parliament and the Council then negotiate a common text (trilogues) which both must approve before it is published as law.
Who is working on it
- Lead committee
- SANT — Public Health
- Rapporteur
- Tomislav SOKOL PPE
- Shadow rapporteurs
- Tiemo WÖLKEN S&DOndřej KNOTEK PfEAurelijus VERYGA ECRVlad VASILE-VOICULESCU RenewTilly METZ Verts/ALECatarina MARTINS The LeftChristine ANDERSON ESN
- For opinion
- ENVI — Environment, Climate and Food Safety · rapporteur Michele PICARO ECRIMCO — Internal Market and Consumer Protection · rapporteur Marion WALSMANN PPEITRE — Industry, Research and Energy · rapporteur Oliver SCHENK PPE
The rapporteur drafts and negotiates the text for the lead committee; each other political group names a shadow rapporteur to follow the file.
The text, version by version
Latest Tabled for plenary → Adopted by Parliament: Adds provisions on contraceptives and abortifacients, defining them as medicinal products of common interest and requiring Member States to ensure their supply. Extends strategic project criteria to include reserving manufacturing capacity and adds requirements for financial support to ensure availability and affordability. Defines 'systemic wholesaler' and adds conditions for determining significant Union manufacture, including thresholds for active substance production. Lowers the threshold for joint procurement requests from five Member States and adds health security aspects to strategic partnerships. The other changes are formal or wording: typo fixes, terminology alignment, and removal of the report's justification section. see the changes →
Committee opinions: Draft opinion (ITRE),Draft opinion (ENVI),Opinion (ITRE),Draft opinion (IMCO),Opinion (IMCO),Opinion (ENVI)
Newest version first. Open a version to read it in full. “What changed” shows the differences paragraph by paragraph; ✦ lines are AI-written from the texts themselves.
Timeline
- Negotiations with the Council
- 14 July 2026 Committee approved the deal reached with the Council
The provisional agreement from the trilogues goes to the whole Parliament for a vote.
- 11 May 2026 Trilogue meeting
Negotiation between Parliament, Council and Commission on a common text.
- 16 March 2026 Trilogue meeting
Negotiation between Parliament, Council and Commission on a common text.
- 2 February 2026 Trilogue meeting
Negotiation between Parliament, Council and Commission on a common text.
- 20 January 2026 Parliament opened negotiations with the Council
After its vote Parliament sent the file back to committee, so that its negotiators can seek a compromise text with the Council (in “trilogues”).
- Plenary stage
- 20 January 2026 Plenary voteAdopted Adopted by a large majorityFor 503 Against 57 Abstained 108
Final vote at 12:51 · 75% of votes cast in favour · every MEP’s position →
Show all 43 ballots in voting order
1. Proposal to reject the text 12:43 A10-0272/2025 – Tomislav Sokol – Proposal for rejection – Am 258Rejected2. Amendments by the committee responsible — put to the vote collectively Amendments by the committee responsible – put to the vote collectivelyAdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded3. Amendments by the committee responsible — separate vote Amendments by the committee responsible – separate voteAdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded4. Amendment 158 12:43 A10-0272/2025 – Tomislav Sokol – Amendments by the committee responsible – separate vote – Am 158Adopted5. Amendment 159 12:43 A10-0272/2025 – Tomislav Sokol – Amendments by the committee responsible – separate vote – Am 159Adopted6. Amendment 162 12:44 A10-0272/2025 – Tomislav Sokol – Amendments by the committee responsible – separate vote – Am 162Adopted7. Amendment 163 12:44 A10-0272/2025 – Tomislav Sokol – Amendments by the committee responsible – separate vote – Am 163Adopted8. Amendment 164 12:46 A10-0272/2025 – Tomislav Sokol – Amendments by the committee responsible – separate vote – Am 164Adopted9. Amendment 257 to Article 3, paragraph 1, point 5 12:46 A10-0272/2025 – Tomislav Sokol – Article 3, § 1, point 5 – Am 257Adopted10. Separate vote on Article 3, paragraph 1, point 5Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded11. Separate vote on Article 3, paragraph 1, point 5RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded12. Vote on text inserted after Article 12RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded13. Separate vote on Article 16, paragraph 1AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded14. Separate vote on Article 16, paragraph 1Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded15. Amendment 250 to Article 16, after paragraph 2 12:47 A10-0272/2025 – Tomislav Sokol – Article 16, after § 2 – Am 250Rejected16. Separate vote on Article 21AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recordedAdopted18. Separate vote on Article 21Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded19. Separate vote on Article 22AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded20. Separate vote on Article 22Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded21. Separate vote on Article 22AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recordedAdopted23. Separate vote on Article 22Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded24. Separate vote on Article 23RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded25. Separate vote on Article 23AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded26. Separate vote on Article 23AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recordedAdopted28. Separate vote on Article 23Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded29. Separate vote on Article 24AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded30. Separate vote on Article 24Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded31. Separate vote on Article 30, after paragraph 2RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded32. Separate vote on Article 30, after paragraph 3RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded33. Vote on text inserted after recital 1RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded34. Amendment 244, adding text after recital 3 12:49 A10-0272/2025 – Tomislav Sokol – After recital 3 – Am 244RejectedRejected36. Vote on text inserted after recital 12RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded37. Amendment 256, adding text after recital 12 12:50 A10-0272/2025 – Tomislav Sokol – After recital 12 – Am 256Adopted38. Separate vote on recital 22AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded39. Separate vote on recital 22Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded40. Amendment 247, adding text after recital 22 12:50 A10-0272/2025 – Tomislav Sokol – After recital 22 – Am 247Rejected41. Vote on text inserted after recital 42RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recordedAdopted43. Referral back to committee Request for referral back (Rule 60(4))AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded - 19 January 2026 Debated in plenary
MEPs debated the text in the chamber ahead of the vote.
- 13 January – 19 January 2026 260 amendments tabled for the plenary vote
Groups propose changes to the tabled text; each is voted on before the final vote.
- 19 December 2025 Report tabled for plenary
This is the text all MEPs vote on. Political groups can still table amendments to it.
- Committee stage
- 15 December 2025 Committee vote: report adopted
SANT (Public Health) voted on the amendments and adopted the report that goes to plenary.
- 11 November 2025 ITRE (Industry, Research and Energy) adopted its opinion
The opinion is attached to the report for the lead committee to consider.
- 11 November 2025 IMCO (Internal Market and Consumer Protection) adopted its opinion
The opinion is attached to the report for the lead committee to consider.
- 4 November 2025 ENVI (Environment, Climate and Food Safety) adopted its opinion
The opinion is attached to the report for the lead committee to consider.
- 26 September – 13 October 2025 Amendments tabled in committee (3 batches)
Members of SANT (Public Health) proposed changes to the draft.
- 18 July 2025 Draft report published
The rapporteur’s first text in SANT (Public Health). Members can table amendments before the committee votes.
- 21 May 2025 Referred to the SANT (Public Health) committee
The lead committee prepares the report; ENVI (Environment, Climate and Food Safety), IMCO (Internal Market and Consumer Protection), ITRE (Industry, Research and Energy) give an opinion.