Text · Opinion parliamentary committee
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
Full title
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
Document SANT-AD-787758 · 10643/2025 – C100075/2026 – 2025/0162(NLE)
- Kind
- Opinion parliamentary committee SANT-AD-787758
- Date
- 7 May 2026
- Committee
- Committee on Public Health
- Rapporteur
- Adam Jarubas
- Dossier
- 2025-0162
More facts (3)
- Formats
- Official page PDF Word
- Subject matter
- c_6f402b92
- Reference
- 10643/2025 – C100075/2026 – 2025/0162(NLE)
In short
A summary of the text written by AI; ¶ opens the paragraph it rests on.
AI: In short Written by AI from the official text — check the source · deepseek-flash · 25 Sept 2026
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.
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
- The Committee on Public Health gives its consent to the broad package of agreements with the Swiss Confederation.
- 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.
- The health agreement integrates Switzerland as a full rights user of the EU's Early Warning and Response System for surveillance.
- It includes Switzerland in the EU's joint procurement procedures for medical countermeasures during health crises.
- It grants Switzerland full participation in the EU Health Security Committee, without voting rights.
- 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.
- 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.
- The protocol grants Switzerland observer status in the Committee on Medical Devices and the Medical Device Coordination Group established under Regulation (EU) 2017/745.
- 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.
- It makes an exception for Switzerland's participation as an observer in the meetings of 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.
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.
Text
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Short justification
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.
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.
Back matter, 1
Parts that accompany the text rather than belong to it: explanatory statement, annexes, opinions appended by other committees. Collapsed.
Annex: declaration of input 1 block
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.
Procedure pages and committee votes
How the committees handled the text and how their members voted on it. Collapsed.
Procedure – committee asked for opinion 1 block
| Title | 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 |
| References | 10643/2025 – C10-0075/2026 – 2025/0162(NLE) |
| Committee(s) responsible Date announced in plenary | AFET 25.3.2026 |
| Opinion by Date announced in plenary | SANT 25.3.2026 |
| Rapporteur for opinion Date appointed | Adam Jarubas 24.9.2025 |
Final vote by roll call by the committee asked for opinion 3 blocks
31 · For
- ECR
- Ondřej Krutílek, Aurelijus Veryga
- No group
- Ondřej Dostál, Kateřina Konečná
- EPP
- Bartosz Arłukowicz, Jens Gieseke, Michalis Hadjipantela, Adam Jarubas, Radan Kanev, András Tivadar Kulja, Norbert Lins, Lukas Mandl, Jessica Polfjärd, Manuela Ripa, Tomislav Sokol
- Patriots
- Laurent Castillo, Viktória Ferenc
- Renew
- Stine Bosse, Veronika Cifrová Ostrihoňová, Andreas Glück, Irena Joveva
- S&D
- Vytenis Povilas Andriukaitis, Biljana Borzan, Christophe Clergeau, Vivien Costanzo, Nikos Papandreou, Marta Temido
- The Left
- Catarina Martins
- Greens
- Martin Häusling, Ignazio Roberto Marino, Tilly Metz
Connections
The dossier, the decisions on this text and its other versions.
No connections found for this item.
Sources & citation
Where the facts on this page come from, and how to cite it.
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “OPINION 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”. Text, 7 May 2026. docId SANT-AD-787758. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/SANT-AD-787758 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/SANT-AD-787758 (CC BY 4.0).
BibTeX
@misc{epw-text-sant-ad-787758,
author = {{European Parliament}},
title = {{OPINION 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}},
year = {2026},
date = {2026-05-07},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/SANT-AD-787758}},
url = {https://news.eu-parl.st-solutions.dev/texts/SANT-AD-787758},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId SANT-AD-787758. Data: EP Open Data API: document record (CC BY 4.0)}
}