Proposals for the Pharmaceutical Strategy for Europe
In response to the European Commission consultation, The Guild’s Health Deans advocate for the development of a framework that would facilitate the pursuit of multinational clinical studies within the EU.
Clinical studies are of paramount importance for investigating the safety and efficacy of drugs and interventions, and for supporting more personalised decision-making in health care. Yet, as the covid-19 pandemic has even further highlighted, there are many challenges in initiating, coordinating and evaluating industry-independent multinational studies within the EU. Some of the existing barriers include the absence of a regulatory framework fully aligned with the rapidly developing innovations in medicine, and the lack of interest among industrial shareholders to develop or evaluate new strategies for some innovative treatments, the latter demonstrating the importance of public funding in this area.
As a solution to the current challenges, The Guild calls for the development of a European Framework for Multinational Clinical Studies -“EU-CLIN”. Such a framework, coupled with appropriate research funding in this area under Horizon Europe, would help to tackle existing unmet needs. It would also foster cutting-edge biomedical and clinical research, which is a crucial stage in the pharmaceutical value chain and paramount to boosting Europe’s competitiveness.
In particular, The Guild calls on the European Commission to use the opportunity offered by the future Pharmaceutical Strategy for Europe to:
Create a platform where researchers from all EU countries can express an interest in joining multinational clinical studies.
Provide a simplified process, easier access and a more user-friendly interface to databases such as EudraCT and Eudravigilance, as this would greatly benefit investigator-initiated clinical trials.
Provide the swift adoption of guidelines and solve issues related to the interpretation of GDPR rules regarding the sharing of health data for scientific purposes.
Devote funding for the conduction of multinational clinical studies, via the Horizon Europe programme.
Enhance a dialogue with the scientific community on emerging questions related to regulatory science. The European Medicines Agency’s (EMA) framework for collaboration with academia could represent the right platform to deepen such engagement.