recommendations for the upcoming negotiations in the European Parliament on the EU Biotech Act

As negotiations on the EU Biotech Act move forward in the European Parliament, the European Patients’ Forum (EPF) is calling on policymakers to ensure that patient needs, public health and equitable access remain central to the final legislation.

Following an analysis of the more than 2,000 amendments tabled by MEPs, EPF has identified five priorities:

• Strengthening the scrutiny and oversight of strategic health biotechnology projects;

• Ensuring transparency and accountability when public funding and support are provided;

• Deleting the proposed extension of supplementary protection certificates (SPCs), or limiting its duration and applying strict eligibility criteria;

• Securing meaningful and structured patient involvement throughout the implementation of the Act;

• Protecting the quality of clinical trials, patient safety and patients’ rights, while strengthening patient participation in clinical research.

EPF welcomes amendments that would strengthen oversight, improve transparency and give patients a more meaningful role in the Act’s governance and in clinical research.

However, we remain strongly opposed to the proposed SPC extension because of its potential impact on timely access to medicines and the sustainability of healthcare systems. We also recommend maintaining the clinical trial timelines proposed by the European Commission rather than introducing further reductions that could undermine robust assessment, ethical standards and patient safety.

The fast pace of negotiations makes meaningful engagement with patients and civil society particularly important. Getting legislation adopted quickly should not come at the expense of getting it right.

Read our full statement here.