The Life Science Manufacturers Association (LSMA) represents the companies that supply the tools, equipment, and technologies enabling Europe’s biotech and biomanufacturing ecosystem.
LSMA welcomes the Biotech Act I and its ambition to strengthen Europe’s biotechnology ecosystem, enhance competitiveness, and increase manufacturing capacity within the EU. To fully realise these objectives, however, Europe must also address the regulatory and structural barriers that limit the development and uptake of advanced manufacturing technologies.
While the Biotech Act supports infrastructure, strategic projects, and innovation ecosystems, it does not yet establish a dedicated mechanism to actively recognise and accelerate the integration of innovative manufacturing technologies into commercial production. Enabling the rapid adoption of advanced, high-quality and cleaner manufacturing technologies is essential if Europe is to translate its scientific excellence into scalable, resilient and globally competitive production capacity.
LSMA proposes the creation of an Advanced Biomanufacturing Technology (ABT) Designation to fill this gap. The designation serves three purposes: it provides a clear, EU-level signal identifying which technologies qualify for support avoiding the fragmented national approaches; it creates incentives for technology developers to invest in innovation; and it incentivises uptake by giving manufacturers a concrete basis on which to adopt new technologies. Together, these effects translate policy intent into industrial reality.
LSMA therefore proposes targeted amendments to the EU Biotech Act to give the ABT Designation operative effect by aligning the relevant provisions on strategic projects, regulatory sandboxes, funding, and the Union regulatory repository.
About LSMA
The Life Science Manufacturers Association (LSMA) is the unified voice of diverse companies powering the life science industry, dedicated to fostering a thriving ecosystem where innovation flourishes and critical technologies are accessible globally. As the industry’s advocate, LSMA engages with policymakers to shape supportive policies that contribute to healthcare, sustainability, and the European economy.
For further information and inquiries, please get in touch with the LSMA at secretariat@lsma.org.
You can download the LSMA position using the following link.