Strengthening competition in line with patient benefits?

Whereas the European Parliament has already taken an early position on European biotechnology policy with two imitative reports from the Committee for Public Health (SANT) and the Committee for Industry, Research and Energy (ITRE), the European Commission is currently preparing an impact assessment. This will form the basis of a legislative proposal. Presentation of the Biotech Act is scheduled for 2026.

Commission's objectives

The overall objective of the planned Biotech Act is to improve the scope and competitiveness of the EU’s biotechnology sector, whilst still maintaining high safety standards. The new legislation aims to ensure that the EU maximises the advantages of the biotechnology revolution for the benefit of society, the environment and the economy. It should also become easier to develop and market products in all biotechnology sectors within the EU.

Biotechnology in the healthcare sector: Prospects

Biotechnological medicinal products – especially gene therapies – open up new prospects for treating previously incurable diseases. They are generally highly complex and therefore pose particular challenges regarding authorisation, evidence generation and reimbursement. Whereas the industry views the planned Biotech Act primarily in terms of competitiveness, accelerated market access and financial support, DSV is pursuing a more comprehensive approach: In order to integrate medical progress in Europe through the use of new therapies in healthcare, a regulatory framework is needed that will enable biotech companies to conduct research and development and also have market access in the EU, whilst simultaneously ensuring quality and safety of care for all patients as well as protecting the financial viability of national healthcare systems.

DSV’s call

In their feedback, DSV welcomes the industrial policy objectives of the Biotech Act in principle, but warns against a decoupling of industry support and actual patient benefits. From the DSV's perspective, the Biotech Act must not result in a lowering of regulatory standards at the expense of quality and patient safety. Therefore, it must be based on evidence-based medicine principles and the EU’s Health Technology Assessment (EU-HTA). For high-cost biotechnological medicines, demonstrable added therapeutic value is essential.

Many biotechnological innovations are also based on publicly funded research. This must be made transparent so that the payers can take it into account during pricing and reimbursement negotiations, and so that patients can have access to biotechnological medicinal products at fair prices.