The 2025–2026 period marked a year of intense legislative activity for EuropaBio, the European association representing the biotechnology industry, with a strong focus on the development of the EU Biotech Act. The organisation has recently published its Annual Report 2026, providing an overview of its advocacy efforts and the main policy developments shaping the European biotech landscape.
Over the past year, EuropaBio has continued to expand its membership, which now includes more than 100 direct members, among them over 30 national, regional and sectoral associations representing more than 6,000 innovative SMEs across Europe. New members also include representatives from European contract research organisations (CROs) and consumer food companies, reflecting the growing role of biotechnology across multiple industrial sectors.
Biotech Act takes centre stage
Part I of the proposed EU Biotech Act, published in December 2025, focuses on health biotechnology and introduces measures covering clinical trials, incentives for breakthrough biotech innovation and a new framework for collaborative research and development across Europe. Part II extends the scope to industrial biotechnology, microorganisms and food and non-food applications, while proposing an expanded role for the European Food Safety Authority (EFSA).
Alongside the Biotech Act, European institutions reached a political agreement in March 2026 on the revision of the EU pharmaceutical legislation. Meanwhile, negotiations continue on the Critical Medicines Act, aimed at strengthening pharmaceutical supply chains and improving the availability of critical medicines throughout the European Union. EuropaBio’s Healthcare Biotechnology Council contributed technical expertise to the development of both legislative initiatives. On the regulatory front, the seventh bilateral meeting between EMA and EuropaBio took place in January 2026, while EuropaBio Director General Claire Skentelbery participated in the EMA CEO Round Table in April.
Industrial biotechnology and European collaboration
EuropaBio’s Industrial Biotechnology Council has been actively involved in discussions on Part II of the Biotech Act, the Food and Feed Safety Omnibus package and the upcoming EU Bioeconomy Strategy, with particular attention to genetically modified microorganisms and the need for a regulatory framework better suited to microbial technologies. These topics were also at the centre of the European Forum for Industrial Biotechnology (EFIB), held in June 2026.
The organisation’s Council of National Associations welcomed seven new members, bringing the total to 32 associations from across Europe. The report also highlights the third and fourth editions of the Biotech & Biomanufacturing Policy Summit, held in October 2025 and July 2026 respectively. During the latest edition, EuropaBio presented a preview of the updated EuropaBio–WifOR study assessing the economic impact of the biotechnology sector in the European Union. EuropaBio is also involved in several EU-funded initiatives, including PRIMED, APROVALS and BIOLEAD, supporting regional bio-based value chains, alternative proteins and Europe’s leadership in biomanufacturing.
On the communications side, the association coordinated a joint initiative bringing together more than 40 European, national and regional organisations to advocate for a dedicated Biotech Act II focused on biomanufacturing. Additional awareness campaigns were carried out in connection with World Cancer Day, Rare Disease Day and European Biotech Week. Looking ahead, EuropaBio identifies the implementation of the revised pharmaceutical legislation, the continuation of negotiations on the Critical Medicines Act and the Biotech Act, as well as growing attention to biosecurity and biodefence, among its main priorities. The latter will also be supported by the organisation’s newly established national Biosecurity Task Force.