On 16 June 2026, the Council of the European Union (Employment, Social Policy, Health and Consumer Affairs) adopted a general approach on the European Biotech Act I Directive, affecting all EU Member States. The decision, formalised in draft minutes published on 3 July 2026, marks a key step in the legislative process for the directive, which aims to streamline regulatory frameworks for biotechnology products. Austria abstained from the vote, while Bulgaria supported the text, with both countries submitting statements included in the annex of the minutes.
The Council also held a policy debate on the European Biotech Act I Regulation (doc. 9454/26) and took note of a progress report on the Regulation to simplify rules on medical and in vitro diagnostic devices (doc. 9801/26). Under 'Any other business', the Presidency provided information on current legislative proposals, including the Critical Medicines Act (doc. 6872/25), an update on the recent Ebola Bundibugyo virus outbreak in Central Africa (doc. 10271/26), Presidency conferences (doc. 9173/26), and negotiations for an international agreement on pandemic prevention, preparedness and response (doc. 9406/26).
Germany, supported by Austria, Croatia, the Czech Republic, Estonia, Finland, Latvia, Lithuania, Malta, the Netherlands, Portugal, Romania, Slovakia and Slovenia, raised concerns about the impact of extended producer responsibility under the Urban Waste Water Treatment Directive on the supply of medicinal products (doc. 10272/1/26 REV 1). Ireland also presented the work programme of the incoming Presidency.
The general approach on the Biotech Act Directive represents a significant policy development for the EU biotech sector, which includes pharmaceutical companies, medical device manufacturers, and agricultural biotech firms. The directive is expected to reduce administrative burdens and accelerate market access for innovative products, potentially boosting competitiveness. However, the abstention by Austria signals unresolved concerns, possibly related to environmental or safety standards. The impact on national regulatory authorities will be moderate, as they will need to align domestic rules with the new EU framework. Consumer and patient groups may benefit from faster access to new therapies, but environmental NGOs have raised questions about long-term ecological effects. The Council's next step is to enter negotiations with the European Parliament, which will shape the final text.