EU-Biotech Act I focused on important measures
EU-Biotech Act I focused on important measures
Berlin (December 17, 2025) – The first part of the EU Biotech Act, which the EU Commission published yesterday, brings together numerous measures to improve the framework conditions for research and development in medical biotechnology in Europe, such as the approval of clinical trials, the expansion of bioproduction, and access to capital. The regulations for feed and food and genetically modified microorganisms are also to be adapted in order to strengthen the highly innovative biotechnology industry in Europe in international competition. The biotechnology industry association BIO Deutschland e. V. welcomes the package of measures and is now pushing for its rapid implementation.
Roland Sackers, CEO of BIO Deutschland, comments: "We welcome the fact that the EU Commission is pushing ahead with improving the framework conditions for the biotechnology industry. We consider the first part of the EU Biotech Act to be positive for medical biotechnology and medical technology. We must accelerate market access for biotech innovations, simplify regulatory procedures, and facilitate financing and scale-up. The latter is addressed in the first part of the Biotech Act with the EU Health Biotechnology investment pilot and a "capital booster" for later development phases. It is now important to implement this quickly and, of course, not to lose sight of the entire biotechnology ecosystem. After all, biotechnology is a platform technology. The second part of the Biotech Act should therefore follow swiftly.”
Viola Bronsema, Managing Director of BIO Deutschland, adds: "With the European Biotech Act, we are finally creating a framework for strategic health biotechnology projects in the EU and specifically strengthening start-ups, SMEs, and scale-ups. These can now, for example, use the EU Health Biotechnology Support Network and learn from the expertise of other companies. Accelerated procedures, administrative support, and improved access to financing can make innovations from Europe competitive. Although the first part of the Act focuses on the health industry, improvements in the approval of food and feed and the regulation of genetically modified microorganisms are also planned. This is right and necessary. We are optimistic that the establishment of a European Health Biotechnology Steering Group will enable the Act to be implemented quickly and successfully."
Further information to the Biotech Act can be found here: https://health.ec.europa.eu/document/download/ec1475b7-e3f9-409e-b927-fc7e69306a8c_en?filename=biotech_reg-com2025-1022_act_en.pdf
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About BIO Deutschland:
BIO Deutschland e. V. is an independent biotechnology organization. The association represents the interests of its members at national, European, and global level. Biotechnology translates biology into industrial applications. It has already demonstrated widely visible benefits in medicine, for example. Innovative bio-based economic systems can enable Germany and Europe to achieve long-term sovereignty and prosperity. The association's network is interdisciplinary and unique. Its members conduct research, development, production, and marketing on a global scale. BIO Deutschland is a strong community. It is committed to diversity, openness, and equal opportunities, and is dedicated to the free democratic basic order. Roland Sackers is the Chairman of the Board of BIO Deutschland.
Further information is available at; www.biodeutschland.org
BIO Deutschland's supporting members and industry partners are:
AGC Biologics, Avia, Baker Tilly, Bayer, BioSpring, Boehringer Ingelheim, BüchnerBarella, Citeline, CMS Hasche Sigle, Deutsche Bank, Ernst & Young, Evotec, IDT Biologika, ITM, KPMG, Lonza, Miltenyi Biotec, Novartis, PricewaterhouseCoopers, QIAGEN, Rentschler Biopharma, Roche Diagnostics, Sanofi Aventis Deutschland, Thermo Fisher Scientific, Vertex Pharmaceuticals, Vibalogics, ZETA.
Contact:
BIO Deutschland e. V.
Dr. Claudia Englbrecht
Schützenstraße 6a
10117 Berlin
Tel.: +49 30 2332 164-32
Mobile: +49 151 14067326
E-Mail: englbrecht@biodeutschland.org
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