EU Commission plans to strengthen the biotechnology sector.

EU Health Commissioner Olivér Várhelyi is planning to present a ‘Biotech Act’ in 2026. The aim of the act is to create simple, fast and transparent authorisation procedures for the biotechnology sector in Europe. Commission President Ursula von der Leyen has also declared such a legislative proposal to be one of her political priorities. She sees the impending biotechnology revolution as a strategic opportunity for Europe.

It is still unclear what specific content the Biotech Act will contain. The European Parliament is using the time until a draft is presented to put forward its ideas. This is currently taking place in two committees - the Committee on Public Health (SANT) and the Committee on Industry, Research and Energy (ITRE). This dichotomy shows: It is not only about issues of healthcare through biologics and biosimilars, but also about strengthening a competitive European biotech sector.

What are biotechnologies?

Biotechnologically produced drugs (biologics) are playing an increasingly important role in the treatment of autoimmune diseases such as rheumatoid arthritis or in cancer therapy - not only medically, but also in terms of their share of the costs of pharmaceutical expenditure. The active ingredients of biological drugs are obtained, for example, from living animal and plant cells or genetically modified organisms. Most biological drugs such as insulin, antibodies or coagulation factors are now produced using biotechnology. As with drugs with chemically produced active ingredients, a distinction is made between originator drugs (reference drugs) and imitation drugs (biosimilars).

Political context

In March 2024, the European Commission published a communication on strengthening biotechnology and bioproduction in Europe. This outlined measures to promote research and innovation and simplify the regulatory processes for a variety of biotechnologies in the EU. In November 2024, Denmark and Finland, supported by Germany and others, presented information in which they called on the Commission to tackle regulatory hurdles for biotechnology across sectors.

In January 2025, the Commission presented the ‘Compass for Competitiveness’, which emphasises the potential of biotechnologies and life sciences for the competitiveness of the EU. In particular for the pharmaceutical industry, agriculture, the energy sector and for food and animal feed.

The new European legal act for biotechnology is intended to provide a future-oriented framework that favours innovation in areas such as the assessment of health technologies and clinical trials and generally exploits the potential that biotechnology offers for the EU economy.

Discussion in the European Parliament

Two committees in the European Parliament are currently working on the preparation of the planned Biotech Act. In the Committee on Industry, Research and Energy (ITRE), Hildegard Bentele (EPP, DE) is responsible for the report on the initiative. According to the report, the aim is to strengthen the EU's innovation and competitiveness in this sector, remove regulatory hurdles and better translate research findings into practice. Proposals include a ‘Chief Biotechnology Officer’, a standardised framework for clinical trials, regulatory sandboxes and a biotech omnibus to simplify legal requirements.

At the same time, the SANT Committee, chaired by Margarita de la Pisa Carrión (PfE, ES), is preparing its own own-initiative report on biotechnological and health-related aspects. In a debate on 9th April, the importance of research and training in the field of mRNA technologies was emphasised in particular. Europe must maintain its leading role in research, but at the same time catch up in terms of application. Economic interests should be harmonised with ethical standards and social benefits.

Outlook

From the perspective of the German Social Insurance, the EU's endeavours to promote biotechnology in order to improve medical care and ensure security of supply are understandable. In addition to industrial policy objectives, central principles such as availability, accessibility and affordability as well as a patient-orientated concept of innovation must take centre stage. The DSV will accompany the political process with this in mind.