Almost 40 European, national, and regional industry organizations have signed a joint position paper to support the European Union’s Biotech Act II, an initiative to boost capacity and innovation in biomanufacturing in the EU. What does it mean for the bio/pharma industry?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Focus on biomanufacturing
Almost 40 European, national, and regional industry organizations have signed a joint position paper to highlight the need for dedicated legislation to deliver biomanufacturing scale‑up and market deployment in Europe.

“Europe remains the only major global region without a dedicated biomanufacturing initiative,” said EuropaBio, an industry association representing the European biotechnology industry, in an April 2, 2026, release. “At a time when global competitors such as the United States, India, and China are prioritizing biomanufacturing at the highest strategic level, the signatories call for a growth and market‑focused EU Biotech Act II to strengthen competitiveness, resilient value chains, and high‑quality employment across Europe.”

The call for measures relating to biomanufacturing is part of a larger policy proposal by the European Commission to boost the biotechnology industry in Europe. In December 2025, the European Commission published its proposal for the European Biotech Act as part of a broader strategy to position the European Union (EU) as a global leader in biotechnology. It is part of the EU’s efforts to close the so-called “innovation gap” in the biotechnology/life sciences sector in Europe.

Key measures of the European Commission’s policy proposal involve increasing funding for biotech companies in the EU, simplify and accelerate the regulatory process for biopharmaceuticals, as well as measures for boosting biomanufacturing.

On the funding side, the proposed policy includes boosting access to funding to help EU biotech companies grow and scale-up, with economic incentives to facilitate the biotech sector’s access to capital in the EU. Already in 2026 and 2027, in cooperation with the European Investment Bank (EIB), the European Commission will run a health biotech pilot to complement the EIB’s Biotech initiative that will mobilize up to EUR 10 billion ($11.6 billion) in investment in the sector. This initiative will stream into the EU health biotechnology investment pilot, established for an initial period of two years with the option to renew.

The policy also seeks to reinforce EU industrial capabilities and support for innovation to deliver high-impact biotechnology developments, including centers of excellence for advance therapy medicinal products, testing and training environments for biomanufacturing, data quality accelerators, and biodefense capability projects. The proposed policy also seeks to reward key EU innovation in health and veterinary biotech with a targeted extension of patent rights, along with support for strategic areas such as biosimilar development and production.

In addition, the policy calls for better applying artificial intelligence (AI), data, and digital solutions in the biotech sector by implementing the European Health Data Space to create trusted AI testing environments, facilitate data-sharing, and support small and medium enterprises, start-ups and scale-ups in using high-performance technologies.

It also seeks to simplify and accelerate regulatory procedures to reduce time-to-market for biotech products, for example, with harmonized requirements and the use of regulatory sandboxes, as controlled environments for companies to experiment and trial innovative solutions, regulatory procedures, and technologies. In addition, it seeks to provide biosecurity safeguards to protect against the misuse of biotechnologies and boost the EU’s biodefense capabilities.

Actions, including the EU Biotech Act Part I, primarily targets health, but the second part of that focus, the EU Biotech Act Part II, seeks to address critical gaps in translating innovation into industrial scale in all sectors, including bio/pharmaceuticals.

“A Biotech Act II dedicated to biomanufacturing is the missing piece of the puzzle for the EU’s global competitiveness from this vital technology,” said Dr. Claire Skentelbery, Director General of EuropaBio, in an April 2, 2026, statement. “It is essential that we empower all sectors with a thriving EU market, cutting-edge capability and ensuring that it is the logical next investment for companies in our champion sectors. We must create our own destiny for biomanufacturing, rather than watching it being delivered elsewhere, and the job is not yet done.”

The joint position paper calling for a Biotech Act II with a focus on biomanufacturing seeks to address “a critical gap remain[ing] in the transition from innovation to industrial scale across all sectors. The EU continues to experience regulatory fragmentation and duplication across sectors and Member States. This slows deployment and scaling of modern biomanufacturing, weakens the single market, and limits regional and export performance.”

In addition to EuropaBio, signatories to the joint position paper include the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents bio/pharmaceutical companies and national bio/pharmaceutical associations in Europe, the Swiss Biotech Association, which represents the biotechnology industry in Switzerland, the National Institute for Bioprocessing Research and Training, based in Dublin, Ireland, a training and research center for bioprocessing, and the Council of European Bioregions, an European association of nearly 50 cluster organizations from 17 countries, representing regional ecosystems specialized in biotechnology, medtech, digital health, and other life-sciences sectors, as well as industry groups representing the food and other industries.