In a recent exclusive conversation with PharmaBoardroom, Nathalie Moll, director general of the European Federation of Pharmaceutical Industries & Associations (EFPIA), laid out the ways in which the European innovative pharma industry has come together to solve some of the most pressing issues around COVID-19, and how a more inter-connected and collaborative European industry could emerge from the crisis.
The crisis has underlined the need for a research ecosystem that can respond to global health threats. Medical innovation, through the development of treatments and ultimately a vaccine, is the only way out from under the shadow of the coronavirus
The EFPIA and its members had to work quickly at the beginning of the crisis to identify key areas in which it could contribute. Moll explains, “The first [key area] is quickly partnering and supporting organisations on the ground to fight against COVID-19. This could be in terms of monetary donations, or donations in kind such as personal protective equipment (PPE).”
She continues, “The second area of focus is ensuring that the supply of medicines to the patients who need them in Europe is guaranteed. As lockdown measures have spread across Europe, different governments have implemented different procedures and some borders have shut. There is a vital need to ensure that medicines – whether COVID-19-related or not – can reach patients who need them.”
“The third area is the research and development of COVID-19-related treatments, vaccines, and diagnostics.” Moll concludes, “To achieve these goals, at the beginning of April we committed to 12 key actions such as sharing learnings from clinical trials to governments in real-time, ramping up manufacturing capacity and working with governments to ensure that any new treatments or vaccines are both available and affordable.”
With these priorities and areas of focus in place, Moll expanded on the potential long-term impact of the crisis for a European research-based pharmaceutical industry which has struggled to compete with those of the USA and Asia-Pacific in recent years. “Features of the crisis have been the speed of response by our industry together with an unprecedented level of partnership and collaboration in tackling the pandemic. These are areas that I hope we can take from the crisis and help to define action and relationships in the future,” she states.
“The crisis has underlined the need for a research ecosystem that can respond to global health threats. Medical innovation, through the development of treatments and ultimately a vaccine, is the only way out from under the shadow of the coronavirus. In Europe, building that research ecosystem means having the skills, collaborative vehicles, health-data infrastructure, regulatory and IP frameworks that can facilitate the kind of response needed for this pandemic, future outbreaks and our existing health challenges. It means working with the EU Commission and Member States to ensure that the EU pharmaceutical strategy can help drive Europe’s health resilience, build our research ecosystem, facilitate access to innovative medicines, and drive our economic recovery.”
Moll continues, “The crisis has led to a focus on health resilience which could have implications for how we manage our supply chain and source APIs. We need to ensure that we continue to have a global view. Europe’s innovative pharmaceutical industry already has a strong in-built resilience with 76 percent of the active pharmaceutical ingredients (APIs) used in the manufacture of innovative medicines in Europe now being sourced in the EU with a further 11 percent coming from the US.”
She concludes, “The scale and extent of the COVID-19 crisis has instigated some new ways of looking at regulatory issues to facilitate the rapid analysis of potential new treatments and vaccines as well as addressing issues caused by the crisis such as supply bottlenecks and the continuity of clinical trials. As a regulatory community, we need to explore together what lessons can be learned from the new approaches necessitated by the crisis that can have a positive impact going forward. Simplifying procedures, looking at how we regulate complex clinical trial designs, drug-device combinations, the use of real-world evidence and creating a more dynamic, iterative process can all benefit patients and the innovation ecosystem”