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OPINION (10643/2025 – C100075/2026 – 2025/0162(NLE))

On the draft Council decision on the conclusion of a broad package of agreements between the European Union, of the one part, and the Swiss Confederation, of the other part, to consolidate, deepen and expand their bilateral relations, and amending Decisions 2011/51/EU and 2011/738/EU

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Committee on Public Health · Rapporteur: Adam Jarubas

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✦ In short · AI summary of this text, generated 25 Sept 2026

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The Committee on Public Health gives its consent to the broad package of agreements between the EU and the Swiss Confederation, focusing on the Agreement on health and the Amending Protocol on mutual recognition in relation to conformity assessment. It welcomes the health agreement, which sets up a binding framework for cross-border health security, makes Switzerland a full user of the Early Warning and Response System, includes it in joint procurement of medical countermeasures and gives it full participation in the Health Security Committee without voting rights. The committee also welcomes Switzerland's structural participation in the European Centre for Disease Prevention and Control, with financial contributions and full involvement in its Advisory Forum, operational networks and Management Board, but no vote in the latter. It supports the mutual recognition protocol, which updates recognition mechanisms to avoid duplication and grants Switzerland observer status in the Committee on Medical Devices and the Medical Device Coordination Group. The protocol protects EU legislative autonomy on medicinal products: Switzerland gets no right to participate in the European Medicines Agency or in drafting EU medicinal product legislation, except as an observer in the Good Manufacturing and Distribution Practice Inspectors Working Group. The committee calls on the Committee on Foreign Affairs, as the committee responsible, to recommend approval of the draft Council decision concluding the package.

Committee position. The Committee on Public Health gives its consent to the package and calls on the Committee on Foreign Affairs to recommend approval of the draft Council decision.

Key points

  1. The Committee on Public Health gives its consent to the broad package of agreements with the Swiss Confederation.
  2. The Agreement on health establishes a legally binding framework for cooperation on cross-border health crisis preparedness, disease prevention and regulatory oversight of medical devices and pharmaceuticals.
  3. The health agreement integrates Switzerland as a full rights user of the EU's Early Warning and Response System for surveillance.
  4. It includes Switzerland in the EU's joint procurement procedures for medical countermeasures during health crises.
  5. It grants Switzerland full participation in the EU Health Security Committee, without voting rights.
  6. Switzerland will participate structurally in the European Centre for Disease Prevention and Control, contribute financially, and take part in its Advisory Forum, operational networks and Management Board, without the right to vote in the Management Board.
  7. The Amending Protocol on mutual recognition in relation to conformity assessment updates recognition mechanisms to avoid duplication of procedures for products placed on the market.
  8. The protocol grants Switzerland observer status in the Committee on Medical Devices and the Medical Device Coordination Group established under Regulation (EU) 2017/745.
  9. The protocol stipulates that Switzerland does not get the right to participate in the European Medicines Agency or in the drafting of EU medicinal product legislation.
  10. It makes an exception for Switzerland's participation as an observer in the meetings of the Good Manufacturing and Distribution Practice Inspectors Working Group.
  11. The committee calls on the Committee on Foreign Affairs, as the committee responsible, to recommend approval of the draft Council decision concluding the package.

Who is affected

  • Switzerland: gains full use of the Early Warning and Response System, joint procurement participation, and ECDC involvement, but no votes in the Health Security Committee or ECDC Management Board.
  • EU and Switzerland: cooperate on cross-border health crisis preparedness, disease prevention and medical product safety.
  • Medical device and pharmaceutical sectors: benefit from updated mutual recognition and observer status in relevant committees.
  • European Medicines Agency: Switzerland does not get the right to participate, except as an observer in the GMDP Inspectors Working Group.