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

The Committee on Public Health gives its consent and supports the broad package of agreements to consolidate, deepen, and expand bilateral relations with the Swiss Confederation. Within this extensive package, two specific documents bear legal effect and form the basis for this committee's opinion: the Agreement on health, and the Amending Protocol to the Agreement on mutual recognition in relation to conformity assessment. These texts establish binding institutional frameworks, rules, and mutual obligations, explicitly governing EU-Swiss cooperation on cross-border health crisis preparedness, disease prevention, and the rigorous regulatory oversight of medical devices and pharmaceuticals.

Forming the primary basis for our endorsement is the Agreement on health. The Committee welcomes this dedicated agreement because it establishes a robust, legally binding framework for health security cooperation to prepare for, and respond to, serious cross-border threats to health. Crucially, it ensures a consistently high level of surveillance by integrating Switzerland as a full rights user of the EU's Early Warning and Response System (EWRS). Furthermore, it strengthens our collective supply chain during health crises by including Switzerland in the EU's joint procurement procedures for medical countermeasures, and it grants them full participation in the EU Health Security Committee, albeit without voting rights.

Additionally, this core agreement secures Switzerland’s structural participation in the European Centre for Disease Prevention and Control (ECDC), which is a core agency under this committee's remit. Switzerland will contribute financially to the agency and participate fully in its Advisory Forum and operational networks, as well as its Management Board, though explicitly without the right to vote in the latter. This deep integration ensures that both the Union and Switzerland can effectively prevent and respond to shared health threats.

The other central pillar of our endorsement is the Amending Protocol on mutual recognition in relation to conformity assessment. This protocol directly relates to the Committee on Public Health's competences regarding pharmaceuticals and medical devices. The committee welcomes this protocol because it updates mutual recognition mechanisms to avoid the duplication of procedures while certifying conformity to respective requirements for products placed on the market. Specifically, it formally grants Switzerland observer status in the Committee on Medical Devices and the Medical Device Coordination Group (MDCG), established under Regulation (EU) 2017/745 on medical devices.

Finally, the mutual recognition protocol carefully protects the Union's legislative autonomy regarding medicinal products. It explicitly stipulates that Switzerland does not get the right to participate in the European Medicines Agency (EMA) or in the drafting of EU medicinal product legislation. However, it makes an exception for Switzerland's participation as an observer in the meetings of the Good Manufacturing and Distribution Practice (GMDP) Inspectors Working Group. This allows for appropriate cross-border cooperation and consistent oversight on pharmaceutical manufacturing standards.

Considering these provisions, the structural integration of these public health policies and medical product safety standards warrants the full support of the Committee on Public Health, serving as the basis for our recommendation to give consent to the broad package of agreements.

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The Committee on Public Health calls on the Committee on Foreign Affairs, as the committee responsible, to recommend approval of 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.

The Chair in his capacity as rapporteur for opinion declares under his exclusive responsibility that he did not include in his opinion input from interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from representatives of public authorities of third countries, including their diplomatic missions and embassies, to be listed in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.