
Biotechnology
EU Commission plans to strengthen the biotechnology sector.
CC – 04/2025
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.