CHALLENGES FOR RESEARCHERS AND REGULATORS FACING THE PANDEMIC CRISIS
23 October, 2020
Online
The COVID-19 health crisis exposed major limitations in the European Pharmaceutical System, revealing an urgent need for reform to ensure that patients could receive timely access to high-quality, safe, and affordable medicines—even under emergency conditions.
In response, the European Commission proposed a new pharmaceutical strategy, aiming to accelerate access to innovative treatments while supporting stronger collaboration among regulatory bodies, industry stakeholders, healthcare professionals, researchers, and patient advocacy groups.
These issues were explored during the XIII Foresight Training Course (FTC), Organized by Fondazione Gianni Benzi.
The first session featured insights from Fabio D’Atri of the European Commission’s Health and Food Safety Directorate, who introduced the new strategy. Viviana Giannuzzi and Enrico Bosone, members of the Fondazione Benzi Scientific Committee, emphasized the importance of the public consultation process initiated in June 2020. The perspectives of industry and patient communities were also shared—Ansgar Hebborn from La Roche AG highlighted the industry’s position, while François Houyez of EURORDIS addressed concerns related to access for patients with rare diseases.
Marco Cavaleri, Chair of the COVID-19 Task Force at the European Medicines Agency (EMA), presented how the agency adapted its regulatory processes for fast-tracking new drugs and vaccines. Martine Dehlinger-Kremer, President of EUCROF, discussed the pandemic’s impact on clinical trials and outlined new methodological approaches for future studies.
Further discussion was led by Andrea Gambotto (University of Pittsburgh) and Martin Ryser (Janssen), who provided academic and industrial perspectives on the development of COVID-19 vaccines.
Another key topic was the revision of two foundational EU regulations: the Orphan Medicines Regulation and the Paediatric Regulation. Viviana Giannuzzi and Violeta Stoyanova-Beninska from EMA’s Committee for Orphan Medicinal Products explored proposed changes, while Pirkko Lepola (EnprEMA) and Donato Bonifazi (EPTRI) discussed challenges in pediatric drug development.
Innovation through artificial intelligence was analyzed by Francesca Mazzi (Queen Mary University of London) and Fedele Bonifazi (Fondazione Benzi). The ethical dimensions of emergency health response, including patient rights and protections, were addressed by Annagrazia Altavilla and Marek Migdal.
The course fostered an interdisciplinary dialogue that highlighted both the achievements and the areas in need of reform within the EU pharmaceutical landscape, contributing meaningfully to shaping future policy and innovation.
Discover the event agenda
