Commission presents industry-policy-driven legislative proposal.

As part of the EU Health Package presented on 16 December, the European Commission published a comprehensive proposal for a Biotech Act. The aim is to strengthen the biotechnology and biomanufacturing sector in the EU and to position Europe as a globally competitive biotech hub. The proposal focuses on the health biotech sector and seeks to expand research and production capacities in the EU while accelerating innovation. At the same time, the Commission promises a more modern, efficient and resilient European health ecosystem.

Strategic health biotech projects

At the core of the proposal is the introduction of strategic health biotech projects. Biotechnological projects of particular relevance for health, security of supply and innovation are to be specifically recognised – either at Member State level or, additionally, at EU level as so-called high-impact projects. These projects are intended to benefit from simplified and accelerated regulatory procedures in order to shorten the time to market for new biotech products. As a financial instrument, an EU Health Biotechnology Investment Pilot is envisaged in cooperation with the European Investment Bank.

This approach shows clear parallels to the Critical Medicines Act. Targeted support for biotechnological production capacities can in principle contribute to strengthening both innovation and security of supply. From the DSV’s perspective, however, the development of such capacities remains an industrial policy task that should be designed transparently and financed from public funds.

Extension of the Supplementary Protection Certificate (SPC)

The legislative proposal provides for a twelve-month extension of the Supplementary Protection Certificate (SPC) for biotechnologically produced medicinal products – including advanced therapy medicinal products (ATMPs) – provided that they are manufactured in Europe. This would extend patent protection beyond the currently possible maximum SPC duration of five years.

From the DSV’s point of view, this approach is highly critical. Only recently, regulatory protection periods and the SPC system were renegotiated as part of the EU pharmaceutical reform and the EU patent package. Given the already extensive IP protection mechanisms in the EU, any further extension would entail significant additional costs for healthcare systems.

Streamlining and acceleration of clinical trials

The proposal also foresees streamlining and accelerating clinical trials through amendments to the EU Clinical Trials Regulation. Authorisation timelines for multinational trials are to be reduced from 106 to 75 days; where no questions are raised to the sponsor, the decision period is to be shortened to 47 days. In addition, closer cooperation between Member States, simplified procedures for multinational and combined trials, and regulatory sandboxes for atypical trials are envisaged.

Industrial policy momentum, unresolved questions in healthcare provision

With the Biotech Act, the European Commission aims to secure Europe’s position as a biotech hub. This clearly industry-policy-driven orientation runs throughout the extensive legislative proposal. The DSV broadly welcomes efforts to strengthen biotechnology in order to promote innovation and security of supply. However, availability, accessibility and affordability, as well as a patient-centred concept of innovation, must remain at the core. In the further legislative process, it will therefore be crucial to assess where the perspectives of healthcare provision and patients are genuinely anchored – or where they need to be more firmly re-established by Parliament and Council. It is critical that the proposal was presented without a robust impact assessment, despite potentially significant financial and structural implications for healthcare systems.

Outlook

The draft Biotech Act will now be discussed in the Council and the European Parliament. Both institutions will develop their positions before trilogue negotiations begin. The conclusion of the legislative process is currently not expected before summer 2026.