EU Biotech Act Talks
The European Patients’ Forum (EPF) called for patient access, affordability and safety to remain central to the EU Biotech Act during a meeting with Members of the European Parliament Vytenis Andriukaitis and Stine Bosse, as well as several Parliamentary Assistants and Groups’ advisors.
The discussions covered proposed changes to clinical trial rules, incentives for biotechnology companies, including a proposed 12-month extension of supplementary protection certificate (SPC) protection, patient and healthcare professionals’ involvement in the governance and support structures of the Act as well as aspects relating to strategic projects.
EPF welcomed the opportunity to share patients’ perspectives but remains concerned about NGOs’ ability to contribute meaningfully to the process. While civil society was not invited to previous roundtables organised by the European Parliament on this dossier, representatives of other stakeholder groups were invited to today's meeting without prior notice, and despite the meeting having been specifically requested by patient and healthcare professionals' organisations to present their positions and proposals as MEPs move towards finalising the Act.
While we have consistently been open to multistakeholder dialogue, we also believe that dedicated opportunities to present our perspectives are particularly important, especially as our concerns have so far been insufficiently reflected in the draft legislation. With negotiations nearing their conclusion, EPF stressed that the meeting must lead to substantive consideration of patients’ views.
EPF supports the Act’s ambition to strengthen biotechnology research and development, but measures to improve Europe’s competitiveness should not deepen inequalities in access to medicines or put further pressure on healthcare budgets. Across Europe, patients continue to face delays in accessing innovative medicines, high prices, and rising out-of-pocket costs, while many hospitals struggle with basic infrastructure and healthcare workforce shortages remain top of mind.
"Europe’s competitiveness should be measured not only by the investment it attracts, but by the improvements it delivers in patients’ lives", said Claudia Louati, Head of Policy and Capacity Building at EPF.
EPF reiterated its positions, and, in particular, its concern about the proposed 12-month extension of SPC. It could delay biosimilar competition, which can help widen access to treatment, while there is insufficient evidence that the extension would generate additional investment in Europe commensurate with its costs. While the rapporteurs see it as a signal to attract pharmaceutical industry, ultimately, it will contribute to increasing costs and exacerbating inequalities in access to medicines across Europe.
EPF also stressed that making Europe more attractive for clinical research requires more than faster regulatory procedures. To improve the quality of clinical trials in Europe, patients should be involved in trial design and governance; informed consent should be clear and accessible; and arrangements for access to treatments after trials should be more consistent. EPF also called for measures to address the concentration of clinical trial activity in Western Europe, particularly by facilitating cross-border access to clinical trials. Importantly, the legislation should also address barriers to participation faced by underserved groups and promote more inclusive clinical trials that better reflect the diversity of the European population.
As negotiations continue, EPF urges policymakers to ensure that the Biotech Act strengthens innovation and clinical research while safeguarding affordability, equitable access and patient safety.