On 16 December 2025, the European Commission took an important step in defining the future of biotechnology in Europe by publishing the first part of the European Biotech Act (“Act”). This is a regulatory measure, developed mainly under the guidance of DG SANTE, and designed first and foremost to strengthen the healthcare sector.
Although the Act was created to support the evolution of biotechnology, its impact will not be limited to biological therapies: some of the planned changes, particularly those concerning clinical trials, will also affect non-biological therapies. This is a sign that the EU intends to modernise more broadly the regulatory framework that supports the development of medicines.
The Act seeks to overcome several obstacles that have long held back innovation and the development of new therapeutic solutions, while not yet addressing all the structural challenges that characterise the sector. Some proposals, in particular those relating to the Clinical Trials Regulation, represent a significant change: shorter timelines, simpler procedures and greater harmonisation among Member States could substantially facilitate clinical research, especially in multinational studies. The introduction of a limited extension of the Supplementary Protection Certificate (SPC) also opens the way to greater incentives for innovative therapies, although the measure remains very limited.
Beyond these more immediate measures, the Biotech Act looks to the long term. The underlying idea is to build a European ecosystem capable of supporting biotechnological research from its earliest stages through to the first phases of development. If the proposed tools prove effective, they could strengthen the link between academia, start-ups and already established players, creating a more fertile environment for the emergence of new technologies and new products.
One of the cornerstones of the Act is the creation of new structures designed to guide the evolution of the sector. Among these, the (High Impact) Health Biotechnology Strategic Projects stand out, broad initiatives aimed at supporting different stages of the biotechnology life cycle through administrative and financial incentives. This is a form of ‘strategic acceleration’ intended to give the sector a coordinated boost, focusing on the entire ecosystem, and it could have positive effects in the medium and long term.
Alongside these tools, the creation of a Foresight Panel and a Biotech Support Network is proposed, with the task of helping authorities and developers prepare for emerging technologies. In particular, the Network should facilitate interaction with existing regulatory frameworks, guiding developers towards the most appropriate pathways. Also significant is the emphasis placed on the role of artificial intelligence in the process of developing and authorising medicines, a clear sign of the intention to integrate digital technologies into decision-making mechanisms.
The Act also includes a series of complementary measures:
• significant simplifications for developers of advanced therapies in the field of genetically modified organisms;
• an expansion of Regulatory Sandboxes, to test innovations in a protected environment;
• new measures aimed at strengthening access to funding and consolidating a more dynamic public-private investment ecosystem, especially for start-ups, non-profit organisations and SMEs;
• new guidelines on biosafety and tools designed to prevent the misuse of biotechnology.
Biosimilars also find space in the Act, with the aim of making their assessment and authorisation pathway smoother. However, many of the Act’s broader ambitions – especially those linked to funding and the administrative support of Member States – will require further action, including future legislative updates (at national and European level) or measures within the next Multiannual Financial Framework.
Stefano Romanelli, EUCOPE
