EFPIA & VE welcome the European Commission’s initiative to develop the Biotech Act II and supports the objective of strengthening Europe’s industrial biotechnology and biomanufacturing ecosystem. The Biotech Act II should primarily focus on improving framework conditions that enable advanced biomanufacturing and manufacturing innovation in Europe, helping to translate scientific excellence into commercial success. Pharmaceutical manufacturing is already governed by one of the most stringent regulatory systems globally, and overlapping frameworks can unintentionally slow the adoption of innovative approaches.

In this context, EFPIA/VE is particularly concerned by the recent significant reduction in scope of decentralised manufacturing in the final text of the General Pharmaceutical Legislation (Directive Article 26b). Limiting decentralised manufacturing to niche applications, such as certain ATMPs with very short shelf-life, contradicts the EU’s ambition to create an innovation-friendly biotechnology ecosystem and risks placing Europe behind developments already underway in the UK and the US. In the longer term, this may also negatively impact supply chain resilience, manufacturing flexibility and future onshoring capacity. The Biotech Act II should therefore support future-oriented regulatory frameworks that enable the broader deployment of innovative manufacturing approaches, including decentralised and modular manufacturing models.

The EU should also prioritise removal of unnecessary regulatory burdens that no longer reflect modern pharmaceutical manufacturing and quality systems. Repeating batch release testing upon importation into the EU, unless waived under a Mutual Recognition Agreement, creates unnecessary waste, administrative burden and complexity for products already tested and released under GMP standards. These requirements were introduced in the 1970s, before the development of today’s global regulatory enforcement systems and advanced quality oversight mechanisms. The current framework no longer reflects modern manufacturing realities and leads to duplication without additional public health benefit.

EFPIA/VE therefore supports extending the waiver of import testing provisions to medicinal products manufactured in third countries with equivalent GMP standards and regulatory oversight. This would reduce unnecessary duplication, improve supply chain efficiency and support exports from EU manufacturers and strengthen international regulatory cooperation, while fully maintaining product quality and patient safety.

 A stable, predictable, and enforceable IP framework is a prerequisite for sustained innovation within a given market. As the expanded Bolar exemption allows generic and biosimilar companies to conduct HTA and P&R activities during the patent and SPC term, ensuring clarity around "day one" competition entry is more critical than ever to safeguard the robustness of the IP system. A reliable mechanism is needed to balance necessary IP protection and timely granting of generic or biosimilar marketing authorisations. This should include: (i) transparent and accessible listing of patents covering innovative products; and (ii) timely granting of generic or biosimilar marketing authorisations, the effectiveness of which is conditioned on the expiry or successful challenge of such patents/SPCs.

Policies that strengthen Europe’s clinical research ecosystem, regulatory predictability, data infrastructure, digitalisation and IP framework will naturally reinforce advanced manufacturing investment and scale-up within the EU. Europe’s competitiveness depends not on localisation requirements, but on creating the systemic conditions that enable innovation, scale-up and investment across globally interconnected value chains, including support for sustainable biomanufacturing and access to bio-based inputs for pharmaceuticals. To succeed, the framework should prioritise regulatory simplification, innovation enablement, investment predictability rather than restrictive localisation approaches.