Abstract 

Patient involvement in medicines research, development, regulation and safety monitoring is increasingly recognised as essential. Patients offer unique insights into the challenges of living with conditions, which provides regulators with better awareness when making decisions about medicinal product approval or rejection and how to improve the clarity of medical information. 

The European Medicines Agency (EMA) and national competent authorities (NCAs) now involve patients more actively, supported by initiatives such as the European Patients’ Academy on Therapeutic Innovation (EUPATI), which provides training for patients and patient representatives to engage in regulatory processes.

While the EMA’s patient involvement processes are now well documented, less is known about the practices of the NCAs across the different EU Member States. To address this, in 2023 and 2024, EUPATI conducted a European-wide survey, with support from the Heads of Medicines Agencies (HMA). The survey explored patient involvement in regulatory steps such as scientific advice (SA) and marketing authorisation (MA), including training and compensation policies. Responses from 15 NCAs, including Switzerland and the UK, were recorded and analysed. 

This article aims to provide an overview of the survey findings to better understand the different levels of patient involvement among European NCA regulatory processes. It also highlights good practice and makes recommendations to further enhance patient involvement in national level regulatory decision-making.