Luxembourg, 16 June 2026
European Biotech Act I: Directive
The Council agreed its negotiating position on the European Biotech Act I directive, which updates the rules on genetically modified micro-organisms (GMMs) and the processing of organs.
The proposed directive forms part of the European Biotech Act I, which seeks to strengthen the competitiveness of the EU’s biotechnology sector, particularly in the area of health.
Overall, today’s Council marks an important milestone for Europe’s health agenda. The progress we achieved will strengthen the EU’s competitiveness, resilience and capacity to act in the field of health. These achievements reflect the vision of the Cyprus presidency: ‘An Autonomous Europe, Open to the World’. A Europe that invests in innovation, strengthens its resilience, secures its strategic interests, and delivers for its citizens while remaining open to cooperation.
Neophytos Charalambides, Minister for Health, Republic of Cyprus
- Council agrees mandate on measures to advance biotech innovation in the EU (press release)
- European Biotech Act directive (Council’s general approach)
- EU health policy (background information)
- Watch the public session
European Biotech Act I: Regulation
Ministers held a policy debate on the European Biotech Act I regulation, which seeks to establish a framework of measures to strengthen the EU’s biotechnology and biomanufacturing sectors, particularly in the area of health.
In particular, they shared their countries’ priorities for the Biotech Act I, and discussed ways that the act could be effective in helping to improve competitiveness in the EU and ensure greater access for patients and citizens to innovative products.
- The European Biotech Act I Regulation: how to boost health biotechnology in the EU? (presidency steering note)
- European Biotech Act regulation (Commission proposal)
- Watch the public session
Medical and in vitro devices
The Cyprus presidency presented a progress report on the proposed regulation simplifying the rules on medical and in vitro diagnostic devices.
The aim of the proposal is to address ongoing issues in the existing legislation, including excessive regulatory burden and uncertainty for companies, as well as unavailability of certain medical devices.
The presidency’s progress report takes stock of the discussions carried out at the technical level during the Cyprus presidency.
- Presidency progress report
- Draft regulation on medical and in vitro diagnostic devices
- Watch the public session
Other business
Under “other business”, EU health ministers received information on the recent Ebola Bundibugyo virus (BVD) outbreak in Central Africa; the critical medicines act; health conferences organised during the Cyprus presidency; the pandemic agreement; the urban waste water treatment directive; and the work programme of the incoming Irish presidency.
- Recent Ebola Bundibugyo virus (BVD) outbreak in Central Africa
- Critical medicines act (Commission proposal)
- Health conferences organised during the Cyprus presidency
- Impact of the extended producer responsibility under the urban waste water treatment directive on the supply of medicinal products
- Watch the public session
Informal lunch debate
Over lunch, ministers took part in an informal discussion on the topic of “Strengthening Europe’s pharmaceutical resilience and strategic autonomy”.
Meeting files
- List of A items, non-legislative activities
- Provisional list of A items
- Provisional list of A items, REV 1
- Provisional agenda
- Background brief
Outcome documents
Press releases
Source – EU Council