Brussels, 11 June 2026
Europe has the ambition and the industrial base to lead in biotechnology. Turning that ambition into deployable manufacturing capability requires a strategy that sees the full value chain, including the companies that make biomanufacturing possible.
LSMA’s position on the European Biotech Act II sets out what it will take to get there. LSMA calls on the Commission to RECOGNISE life sciences manufacturers as innovation actors, DEFINE life sciences to lay the basis for proportionate regulation, and BRIDGE the regulatory gap between industrial biotechnology and regulated manufacturing, which Europe’s biotech strategy has yet to address.
“The Biotech Act II is a unique opportunity to ensure that Europe’s biotechnology strategy addresses not only downstream biotech products and production capacity, but also the enabling manufacturing layer, without which that capacity cannot be built. Europe’s competitiveness needs to be built on the entire life sciences value chain, from the cell line to the advanced therapy, and everything in between.” Adrien Samson, Secretary General.
LSMA will continue to engage constructively with the institutions and other stakeholders in the ecosystem to ensure that the final text fully delivers on Europe’s biotechnology strategy. The full position paper is available here.
About LSMA
The Life Science Manufacturers Association (LSMA) is the European trade association representing companies that develop and supply the materials, consumables, equipment, technologies, and specialised services that enable the research, development, and industrial production of medicines, vaccines, diagnostics, and advanced therapies. LSMA advocates at the EU level to ensure that life sciences manufacturers are recognised as the innovation actors and strategic enablers they are. For more information, visit lsma.org.