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DRAFT 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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The Committee on Public Health gives its consent to a broad package of agreements between the EU and the Swiss Confederation. It focuses on the Agreement on health and the Amending Protocol on mutual recognition in relation to conformity assessment. The health agreement makes Switzerland a full user of the Early Warning and Response System, includes it in joint procurement of medical countermeasures, and gives it participation in the Health Security Committee without voting rights. Switzerland joins the European Centre for Disease Prevention and Control, contributing financially and taking part in its Advisory Forum, networks and Management Board, without a vote on the Board. The mutual recognition protocol grants Switzerland observer status in the Committee on Medical Devices and the Medical Device Coordination Group, and observer participation in the Good Manufacturing and Distribution Practice Inspectors Working Group, while excluding it from the European Medicines Agency and from drafting EU medicinal product legislation. The committee calls on the Committee on Foreign Affairs to recommend approval of the draft Council decision concluding the package.

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

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 creates a binding framework for cooperation on cross-border health crisis preparedness, disease prevention and regulatory oversight of medical devices and pharmaceuticals.
  3. Switzerland becomes a full rights user of the EU's Early Warning and Response System for surveillance.
  4. Switzerland is included in EU joint procurement procedures for medical countermeasures during health crises.
  5. Switzerland participates fully in the EU Health Security Committee, without voting rights.
  6. Switzerland participates structurally in the European Centre for Disease Prevention and Control, contributes financially, and takes part in its Advisory Forum, operational networks and Management Board, without a vote on the Board.
  7. The Amending Protocol on mutual recognition in relation to conformity assessment updates mutual recognition mechanisms to avoid duplication of procedures for products placed on the market.
  8. Switzerland receives observer status in the Committee on Medical Devices and the Medical Device Coordination Group established under Regulation (EU) 2017/745.
  9. Switzerland does not get the right to participate in the European Medicines Agency or in drafting EU medicinal product legislation.
  10. Switzerland may participate 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 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, and participation in the Health Security Committee and ECDC without votes.
  • EU and Swiss pharmaceutical and medical device sectors: benefit from updated mutual recognition and observer roles in relevant committees.
  • European Centre for Disease Prevention and Control: receives financial contributions from Switzerland and includes it in its bodies.
  • European Medicines Agency: Switzerland is excluded from participation.