According to EFPIA and Vaccines Europe, the health package announced by the Commission in December 2025, which include the Biotech Act, is a positive step towards making Europe more attractive for cutting-edge science, clinical research, and biotech innovation. The research-based industry particularly welcomed the proposed reduction in clinical trial approval timelines to 75 days. The two associations also expressed positive views on the EU health biotech investment pilot and the targeted extension of the SPC regime. However, they have some concerns that the incentive would apply only to a limited subset of products, as well as the proposed “manufactured in the EU” criterion for IP protection.
According to Medicines for Europe, which represents the generics and biosimilar industry, the Biotech Act’s focus on competitiveness needs to be recalibrated, as intellectual property extensions have not stimulated R&D in Europe. Conversely, pro-biosimilar policies have encouraged R&D, scientific leadership and manufacturing investment across Europe. Key deliverables for a competitive industry should include industrial incentives, fit-for purpose Bolar exemptions, adaptation of the SPC manufacturing waiver to biosimilar timelines, predictable and pro-competitive markets, and regulatory simplification and harmonisation.
EuropaBio positively reacted to the proposed Biotech Act on behalf of the biotech industry. Key interventions planned in the health sector include the additional extension of SPCs, shorter clinical trials approval timelines, and a more efficient regulatory pathway for ATMPs. EuropaBio also expressed a positive opinion on the Health Biotech Investment Pilot.