How Europe can support its biotech sector

The European Economic and Social Committee (EESC) has adopted a new opinion calling on the EU to accelerate biotechnology development, warning that Europe risks falling behind global competitors while patients face delays in accessing new treatments.

The opinion responds to the European Commission’s recent proposals under the European Biotech Act, which aims to streamline biotech regulation, promote large-scale investment, and support innovation. 

Biotechnology, which is covering areas such as vaccines, gene therapies and advanced medicines, is expanding rapidly worldwide. However, while Europe has strong research capacity, much of the investment and large-scale production in this sector is taking place in the United States and China. 

According to the EESC, this gap is the result of long-standing structural weaknesses. Fragmented national rules, slower approval processes and limited access to funding make it difficult for companies to scale up. As a result, many European firms develop their innovations at home but have to move abroad to grow. 

“We must address gaps in venture capital and speed up clinical trials to ensure patients benefit sooner from innovative medicines. Our approach is clear: protect citizens while strengthening European innovative businesses, with full respect for workers’ health, environmental safeguards and meaningful dialogue with civil society,” said the EESC rapporteur of the opinion, Joan Roget Alemany.

The impact goes beyond industrial competitiveness. Dependence on external suppliers for key medicines and technologies creates risks for supply and resilience and delays in innovation mean that patients in Europe may wait longer to access life-saving treatments.

Strengthen the full biotech value chain in Europe

To address this, the Committee calls for a stronger European biotech ecosystem linking research, investment and production so that innovation developed in Europe is also delivered in Europe.

A central issue is funding. European biotech companies often struggle to secure the large-scale investment needed to grow, particularly at later stages. The EESC supports the two-year 'capital booster' financial pilot to attract private investment and want to see it become a permanent tool.  

At the same time, it calls for closer links between universities, research centres and industry to ensure scientific breakthroughs reach the market. Stronger support for these biotech clusters necessary to help European firms scale up.

Simplify and align rules to support innovation

On regulation, the EESC identifies to complexities and inconsistencies across Member States as a major obstacle. It proposes clearer and more harmonised procedures, including a central role for the European Medicines Agency in pharmaceutical approvals, to reduce delays and make the EU more attractive for innovation. 

“Biotechnology is a strategic sector at the heart of Europe’s industrial future. The European Biotech Act should create the right conditions to bring innovation from the lab to the market, but simplification must not come at the expense of safety or standards. We need clearer, more coherent rules that support investment and competitiveness while upholding Europe’s high ethical, social and environmental values,” said Co-Rapporteur Thomas Student.

Targeted incentives for innovation, including simplified rules for new medicines developed and produced in the EU, should further support investment. The Committee also backs regulatory sandboxes to test new technologies in a controlled setting, provided they are aligned across the EU and take into account ‘social acceptability’ . 

Speed up access while maintaining safeguards

The EESC stresses that speeding up innovation must not weaken safeguards. Biotech applications should continue to undergo strict checks before reaching the market, particularly in the case of genetically modified microorganisms. Stronger traceability and measures to prevent misuse are also needed.

Digital tools will play a growing role. The Committee supports a digital by default approach, which includes the use of artificial intelligence in clinical trials, as long as clear rules are in place and human oversight is maintained.

It also highlights the need to strengthen clinical trials in Europe, especially for rare diseases and children, with faster and more proportionate pathways. Prevention, including vaccines, should also play a larger role, alongside more inclusive approaches to ensure access for all patient groups.

Ensure trust, protection and policy coherence

Throughout, the Committee is clear that simplification must not become deregulation. Protections for workers, the environment and health and safety must be maintained, with strict and independent checks in place before biotech products reach the market.

The EESC underlines the importance of public trust. Biotechnology can raise concerns, particularly around genetic technologies, and the Committee calls for better communication and dialogue to ensure citizens understand both the benefits and the risks. 

The opinion also emphasizes that the European Biotech Act should be implemented in coordination with EU industrial, health, and innovation policies to fully integrate biotechnology into Europe’s wider strategy, ensuring that scientific breakthroughs, production capacity, and patient access advance together. (gb)