Mario Draghi’s report, ″The Future of European Competitiveness″, identified biotechnology as one of the ten strategic industries for the EU, but concluded that Europe is losing ground to competitors such as the US and China. It therefore calls for a more targeted industrial policy for the strategic sectors, with streamlined regulation and more closely aligned research and investment frameworks. Consequently, the two-part Biotech Act is not only on the competitiveness agenda but also a key initiative of the Strategy for European Life Sciences. Part one will primarily concentrate on health, while part two is expected to cover the further areas of biotechnology and is scheduled for publication in the third quarter of 2026.
Biotechnology is one of Europe’s fastest‑growing high‑tech industries, expanding at twice the pace of the overall EU economy. It is dominated by health‑related applications, which account for roughly 82% of the sector, while industrial biotechnology has emerged as its fastest‑growing segment. To build on this momentum, the Commission intends to use the Biotech Act to foster an ecosystem that speeds the journey of biotech innovation from the lab to the market, while maintaining rigorous safety standards for people and the environment. To this end, the forthcoming Act aims to propose measures to simplify and streamline existing regulations, thereby reducing costs and lowering bureaucratic barriers. It is anticipated to leverage economies of scale within the Single Market, improve access to investment, enhance Europe’s investment attractiveness and support the development of key technologies, including AI. The Act is also likely to envisage efforts to enhance European biomanufacturing networks and to promote trustworthy AI through better data access and secure computing infrastructure. Furthermore, the initiative could pave the way for greater mobilisation of public and private capital, helping to drive innovation and expand venture capital financing across Europe.
The Commission also plans to build on other legislation, such as the Pharmaceutical Package, and to link the Act to further measures, including the Veterinary Medicinal Products Regulation and the Clinical Trials Regulation.
In its own‑initiative report to the Commission, the European Parliament’s Committee on Public Health has recently published its ″wish list″ for the sector. Just like the Commission, it envisions Europe as a leading global destination for biotechnology investment—spanning research and development, manufacturing and clinical trials. It calls for increased public and private investment and stresses the need to align the Biotech Act with existing and forthcoming legislation to ensure coherent policies. BPI shares this vision but also advocates for a Europe where Member States view healthcare and pharmaceuticals as strategic investments rather than mere costs. Our vision also includes promoting local biomanufacturing, securing essential raw materials and creating an EU Biotech and Biomanufacturing Agency. We welcome the Commission’s recognition of the importance of supporting SMEs and hope for the introduction of bespoke, tiered definitions for biopharmaceutical SMEs and mid‑caps, which would more effectively promote innovation and boost competitiveness over the coming years.
It seems that the Biotech Act has a few positive surprises in store for the pharmaceutical industry. Companies may see improved production conditions, faster regulatory approvals and quicker access to clinical trials. These changes could help turn research into therapies more rapidly, making it easier for biotech firms in Germany to scale up and compete at both European and international level. Despite our most inquisitive rattling of the wrapped Biotech Act box, it remains unclear what concrete initiatives lie in store for the industry before its big reveal – though perhaps it will turn this year’s wish list into next year’s reality.
Contact: Cara Rogers, (BPI office Brussels), bpi.brussels@bpi.de
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