Building on the European Commission’s Roadmap for the EU Pharmaceutical Strategy

EFPIA welcomes the European Commission’s recognition of the importance of the pharmaceutical sector in the Pharmaceutical Strategy and looks forward to working with the EU institutions and Member States to building Europe’s health research eco-system, increasing our resilience to global health threats and driving our economic recovery.
In her Mission letter to Health Commissioner Kyriakides, President von der Leyen asked to “look at ways to help ensure Europe has the supply of affordable medicines to meet its needs. In doing so, you should support the European pharmaceutical industry to ensure that it remains an innovator and world leader.” Since the publication of this Commission’s Health priorities, the coronavirus pandemic and its terrible human and economic cost across Europe has brought these two objectives into even sharper focus.
Commenting on the roadmap, EFPIA Director General, Nathalie Moll said. “Our aim is to work with the Commission and all relevant health stakeholders to learn the lessons of the COVID-19 crisis together and work collaboratively to achieve the aims set out in the Mission letter, in support of EU global competitiveness. Now is the time to work together to build Europe’s resilience, from the scientist’s bench to the patient’s bedside, from medical innovation through to ensuring patients get access to the treatments and vaccines they need.” 
It is crystal clear to all that the only way out of the shadow of COVID-19 is through medical innovation – by rapidly developing diagnostics, treatments and ultimately vaccines that can enable life in Europe to return to normal. The crisis has underlined the need for an infrastructure and policy environment that supports medical research in Europe. Our research eco-system is an essential part of the region’s resilience to this pandemic, future health threats and our ongoing health challenges and should be clearly addressed in the EU Pharmaceutical Strategy.
The Pharmaceutical strategy and the EU Industrial Strategy can be catalysts to ensure the research-based industry in Europe “remains an innovator and world leader” as aspired to in the Mission letter. The search for diagnostics, treatments and vaccines for use in the fight against COVID-19 underline the strategic importance of Europe being able to compete with other regions like China and the US in the development and manufacture of new medical technologies, bringing real innovation to meet the challenges faced by patients and our health systems. As the roadmap outlines, the technological and scientific developments, such as use of digital technologies and enhanced evidence generation through increased acceptance of real world data and complex clinical trials in the authorization of medicines, may challenge the regulatory framework. On the other hand, EFPIA believes that much can and should be done already now within the existing framework by recognition and efficient implementation of the lessons learned from the COVID-19 crises.
In EU Industrial and Pharmaceutical Strategy: An Opportunity to Drive Europe’s Health and Growth published by EFPIA in March 2020, we have outlined the steps we can take together which we believe Europe can take to build our research eco-system, our resilience and our economic recovery.
Our industry shares the goal of fast, equitable access to vaccines and treatments for patients across Europe and believes this requires immediate action rather than waiting for the implementation of the Pharmaceutical Strategy.  To that end, we call on the Commission to create a High-Level Forum on Better Access to Health Innovation as proposed by the European Health Coalition so as to develop concrete, multi-stakeholder solutions to introducing new technologies into health systems in a way that is sustainable, widely available and accessible to European citizens. A High-Level Forum would furthermore enable a comprehensive discussion and analysis of the root causes of unequal patient access and supply of medicines, also taking into consideration the fragmentation of the EU single market and different national approaches to pricing and reimbursement as well as healthcare investment and organisation. Such an analysis will show that an effective, targeted response to the access and availability challenges does not lie in a reduction of incentives for innovation or in wholesale changes to the pharmaceutical legislation but rather requires a structured dialogue with relevant stakeholders, Member States and the European Commission in light of their respective competence areas. 
We acknowledge the EU’s focus on enhancing its strategic autonomy in a number of specific areas, including in strategic value chains. Ensuring the supply of medicines to the patients who need them, remains a top priority for EFPIA and its members during the COVID-19 crisis and beyond.  The experience of the crisis has underlined that, from the perspective of the innovative medicines industry, companies have been able to increase supply to meet the needs of patients across Europe. Europe’s innovative pharmaceutical industry already has a strong in-built resilience with 76% 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% coming from the US. Only 9% are sourced from Asia including South Korea and Japan. The data underlines the need for a nuanced, evidenced-based dialogue identifying all the root causes of medicines shortages so that collaborative solutions that work for patients can be identified and implemented without jeopardising supply chains designed to work across borders and over €400 billion in European exports of medicines.
Nathalie Moll went on to say. “The COVID-19 crisis has underlined the importance of medical innovation as an essential component in tackling Europe’s health challenges. Discovering and developing new treatments, diagnostics and vaccines is the first step to access to medicines. Following the publication of the Roadmap, we look forward to an open and constructive dialogue to find shared and concrete solutions to address issues of supply, access and availability of new medicines for citizens and patients as well as to create the conditions in which Europe can re-establish itself as a world leader in bringing transformative treatments to patients”.