Public payers and HTA bodies call to safeguard competition and affordability in the EU Biotech Act (position paper)

28. May 2026

On 16 December 2025, the European Commission presented its proposal for a European Biotech Act, aimed at strengthening Europe’s biotechnology and biomanufacturing ecosystem, supporting innovation, and improving the conditions for research, development and manufacturing in the EU.

The European Social Insurance Platform (ESIP) together with the Medicine Evaluation Committee (MEDEV) acknowledge these objectives. Europe needs a strong, competitive and resilient biotechnology sector. At the same time, industrial policy objectives must remain fully compatible with timely patient access, affordable medicines, robust evidence standards and the long-term sustainability of solidarity-based healthcare systems.

In this context, ESIP and MEDEV welcome targeted measures to strengthen Europe’s biologic and biosimilar ecosystem, but call for a better balance between competitiveness, access and affordability:

  • Reject the expansion of intellectual property rights through a 12-month extension of supplementary protection certificates (SPCs);

  • Strengthen provisions supporting biosimilar competition, including through strategic projects and a more streamlined, yet evidence-based, approach to clinical data requirements;

  • Preserve clinical evidence standards while simplifying the legislative framework on clinical trials, ensuring that evidence remains clinically relevant for health technology assessment (HTA) bodies, pricing and reimbursement (P&R) authorities and healthcare payers;

  • Limit the scope of regulatory sandboxes to exceptional cases where standard regulatory pathways are demonstrably not practicable;

  • Ensure the early and meaningful involvement of HTA bodies, P&R authorities and public healthcare payers in the Foresight Panel for Emerging Health Innovation;

  • Optimise the conditions attached to the designation of strategic projects, including appropriate corrective measures where requirements are not met; and

  • Ensure that national social security budgets remain dedicated to need-based, high-quality and affordable healthcare and are not diverted to the pursuit of industrial policy and economic objectives.

Of particular concern is the proposed 12-month SPC extension, which would impose high costs on solidarity-based healthcare systems through continued expenditure on high-priced biological medicines. By delaying biosimilar competition, the measure would ultimately jeopardise timely and affordable patient access.

More effective levers are available to strengthen Europe’s biologics and biosimilars ecosystem, including targeted public and private funding to support research, development and manufacturing capacity in Europe for projects that deliver clear societal value. By contrast, IP extensions will increase pressure on healthcare budgets and delay patient access.

ESIP position paper on the proposal for a European Biotech Act.