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Questions and answers on the European Biotech Act
Why is the Commission proposing a Biotech Act?
Biotechnology is essential to the EU's competitiveness, strategic autonomy and economic security. It is one of the fastest growing innovative industries, growing at twice the speed of the EU economy in the last 10 years, whilst contributing close to €40 billion to the EU's gross domestic product, and creating more than 900,000 jobs.
Biotech can deliver ground-breaking medicines and treatments to patients, such as the pioneering work in gene therapies and personalised medicine, and the creation of numerous life-saving biopharmaceuticals, such as synthetic insulin. It can also accelerate medical breakthroughs and help address unmet medical needs. For example, recent successful examples of biotech in health are CAR-T cells, which are engineered from a patient's own immune cells, to precisely target and destroy cancer cells when other treatments fail. Similarly, mRNA therapies, built on decades of research, teach the body to fight or prevent disease and are now being developed for a wide range of uses, from cancer vaccines to rare genetic conditions.
Despite its strong scientific base, Europe is trailing its competitors when it comes to advancements in biotechnology. For example, the EU is lagging behind in venture capital investment in health biotech, with a global share of 7%. At the same time the EU/EEA global share of commercial clinical trials fell from 22% to 12% in just 10 years. A combination of structural barriers, issues accessing capital and overly complex regulation is prompting innovative European start-ups and scientist increasingly to move abroad.
What is the scope of this Biotech Act?
Today's Biotech Act is focussed particularly on health biotech, although it also includes provisions on food and feed. Health biotech currently accounts for more than 80% of the value of the entire sector, and 75% of all jobs in this sector in Europe. Biotechnology also represents around one quarter of the EU's pharmaceutical sector, in terms of value.
The Biotech Act also proposes to amend specific parts of EU health and food regulations, to adapt the whole ecosystem to the needs of modern society and this fast-growing sector. Today's proposals include revising EU rules on clinical trials, advanced therapy medicinal products, substances of human origin, veterinary medicinal products, general food law, human organs and genetically modified organisms.
What are the main features of the proposal?
The Biotech Act aims to turn Europe into a biotech powerhouse, bringing top-notch medicines to the market, closing its global competitiveness gap and retaining global leadership in biotechnology and biomanufacturing.
The Act focuses on industrial policy measures and simplification. In particular, it will:
- Boost access to funding to help EU biotech companies grow and scale-up, with economic incentives to facilitate the biotech sector's access to capital in the EU. Already in 2026 and 2027, in cooperation with the European Investment Bank Group, the Commission will run a health biotech pilot to complement the EIB's BiotechEU initiative that will mobilise up to €10 billion investment in the sector. This initiative will stream into the EU health biotechnology investment pilot, established for an initial period of 2 years with the option to renew.
- Reinforce EU industrial capabilities and support for innovation, to deliver high impact biotechnology developments including centres of excellence for advance therapy medicinal products, testing and training environments for biomanufacturing, data quality accelerators and biodefence capability projects.
- Reward key EU innovations in health and veterinary biotech with a targeted extension of patent rights, along with support for strategic areas such as biosimilar development and production.
- Harness the use of artificial intelligence, data and digital solutions in the biotech sector, by implementing the European Health Data Space, creating trusted AI testing environments, facilitating data-sharing, and supporting small and medium enterprises, start-ups and scale-ups in using high performance technologies.
- Simplify and accelerate regulatory procedures to reduce time-to-market for biotech products; for example, with harmonised requirements and the use of regulatory sandboxes, as controlled environments for companies to experiment and trial innovative solutions, regulatory procedures and technologies.
- Provide biosecurity safeguards to protect against the misuse of biotechnologies and boost the EU's biodefence capabilities.
These measures, each of which is interconnected and mutually reinforcing, will make the EU a more attractive place for innovation and development in the biotech sector.
Can you give examples of how costs and administrative burdens will be reduced with this proposal?
The proposal aims to reduce costs and administrative burdens by simplifying regulatory frameworks and streamlining procedural timelines.
For example, concerning multinational clinical trials, the end-to-end authorisation timelines will be shortened from 75 to 47 days if there is no need to request further information, and from 106 days to 76 days where there is such a request. Additionally, the assessment period for substantial modifications will be reduced from 64 to 33 days when there is no request for additional information from the sponsor and from 96 days to 47 days when there is.
In addition, accelerated procedures (including for clinical trials) and frameworks adapted to innovative companies' needs, such as regulatory sandboxes, will reduce procedural timelines and regulatory burdens, ultimately lowering costs for companies.
Why is there such a strong focus on clinical trials and what improvements have been proposed?
Clinical trials are crucial to delivering innovative, cutting-edge treatments and millions of people have been able to access treatments by participating in clinical trials. Currently, around 6,500 advance phase trials in the EU are testing medicines that hold huge promise for patients, while around 20% of all trials focus on treatments for rare diseases.
Europe, however, faces significant challenges in conducting clinical trials, which deter researchers. These obstacles include lengthy and complicated approval processes, restricted access to capital, sub-optimal infrastructure and an insufficiently skilled workforce, which in turn delays patient access to promising new treatments.
The Biotech Act seeks to address these challenges through substantial amendments to the EU Clinical Trials Regulation:
- streamlining and accelerating authorisation procedures, with a voluntary initiative by 23 member States, FAST EU, piloting the new authorisation procedure as early as January;
- strengthening collaboration among Member States and simplifying multi-country trials;
- introducing regulatory sandboxes to facilitate atypical clinical trials, while securing safety of patients;
- introducing a single authorisation process for combined clinical trials and reinforce risk-based approaches.
These revisions aim to rapidly transform innovative ideas into safe, effective treatments, benefitting millions of patients across the EU.
What is the concept of health biotech ‘high impact strategic projects' and how will this help health biotech companies?
The Biotech Act will boost industrial biomanufacturing in the EU and support high impact health biotech initiatives, designating 'strategic projects', based on specific criteria. Once designated, these projects will benefit from easier access to EU funding and fast-tracked administrative, regulatory and scientific support.
The aim is to strengthen competitiveness of the EU's high impact health biotech companies and provide them with the support needed to innovate and grow. These include centres of excellence for advanced therapies, trusted testing environments, data quality accelerators, biodefence capability projects, biotech development accelerators and late-stage capital booster pilots, among other things.
How will the new health biotech investment pilot work in providing access to funding for biotech companies?
The new health biotech investment pilot will be implemented in partnership with the European Investment Bank. The pilot will provide a toolbox of financial products to support biotech companies, including start-ups and small and medium-sized companies. The pilot aims to mobilise private investments, strengthen the availability of long-term risk finance, and anchor growth and manufacturing activities in the EU. The pilot is established for an initial period of two years, after which it shall be reviewed.
The Commission, in cooperation with the EIBG, is already kick-starting this support to the sector from today by cooperating on a new BioTechEU initiative. BioTechEU will attract new private investors and act as a market catalyst. The pilot takes a full lifecycle approach to biotech finance, supporting European innovators from discovery to industrial scale
Why are biosecurity measures included in the Biotech Act?
Biosecurity measures are crucial to safeguard against the misuse of biotechnologies and ensure public safety, especially given the rapid pace at which biotech innovation is progressing. The Biotech Act includes proportionate biosecurity measures to protect human health from potential risks. These provisions establish clear, harmonised rules across the EU to prevent biological misuse by:
- establishing a requirement to verify that buyers of biotechnology products with high misuse potential, such as the DNA of dangerous pathogens, have a legitimate need for them;
- strengthening sequence screening requirements; and
- including measures to strengthen biodefence capabilities, such as early detection of novel biological threats.
For more information
Factsheet: The EU Safe Hearts Plan
Factsheet: The European Biotech Act