Position Paper on the Biotech Act proposal
The European Patients’ Forum welcomes the European Commission’s proposal for a EU Biotech Act, recognising its potential to strengthen Europe’s leadership in biotechnology and support the development of innovative treatments, particularly in areas of unmet medical need such as rare diseases and rare cancers.
While EPF supports the ambition to boost innovation and biomanufacturing capacity, it emphasises that public health, equitable access, and patient-centred policies must remain at the core of the Act. It also raises important concerns regarding transparency, patient involvement, and the lack of robust evidence underpinning key measures.
To address these issues, EPF puts forward several key priorities:
- Enforcing greater scrutiny and oversight of health biotechnology strategic projects;
- Promoting transparency in access to funding tools;
- Urgently assessing the impacts of SPC extensions;
- Expanding actions to support biosimilars;
- Involving patients and patient organisations in clinical trials;
- Addressing the lack of a comprehensive and high-quality impact assessment.
Reaffirming its commitment to a patient-centred approach, EPF stands ready to work with EU institutions to ensure that the Biotech Act delivers meaningful innovation while guaranteeing equitable access for all patients across Europe.
Read the full position paper for more details.