Back in December 2019, when Commission President Ursula von der Leyen was putting together her College of Commissioners, the mission letter she sent to the Health Commissioner Stella Kyriakides highlighted the renewed impetus she wanted to give to the Health portfolio. The letter stated that S. Kyriakides should “look at ways to help ensure Europe has the supply of affordable medicines to meet its needs [while supporting] the European pharmaceutical industry to ensure that it remains an innovator and world leader”. For this, a roadmap for a Pharmaceutical Strategy for Europe was planned to be released in February 2020.The sanitary crisis that hit the entire world, pushed back its timeline to November 2020, bringing a new priority to the forefront of the Commission’s health agenda. As the Commission is closing in on its mid-mandate mark, there is no better occasion than now to reflect on how the Commission has tackled both those priorities and look towards what the institution aims to achieve during the second part of its mandate.
A health agenda disrupted by the pandemic
While pandemic preparedness was not part of S. Kyriakides’ initial mission letter, the COVID-19 crisis disrupted her agenda. It made it clear that a coordinated approach to the pandemic was necessary, with hopes of avoiding unilateral measures by Member States which would have impaired the global answer that was needed. While the Commission’s health competency is limited to supporting Member States’ endeavors in that field, when the opportunity to scale up its actions presented itself, the Commission did not shy away.
On November 11th 2020, it published a package of proposals for a so-called European Health Union which aimed at increasing the EU’s preparedness in light of the current and future sanitary crisis. Its proposals ranged from extending the European Medicines Agency’s (EMA) mandate to give it the ability to better manage shortages of medicines and medical devices, to increasing the European Centre for Disease Prevention and Control’s (ECDC) role by developing a framework for the prevention of communicable diseases and special issues. While the EMA proposal officially entered into force in March 2022, the ECDC one is still awaiting a formal adoption. The third proposal stemming from this package focused on serious cross-border health threats and aimed at giving the EU the power to declare a public health emergency, granting it the ability to react swiftly and develop a pandemic plan. It is currently being discussed between EU institutions. Finally, the EU set up the Health Emergency Response Authority (HERA) early 2022 to anticipate potential future health crises and ensure the development and distribution of health products necessary to face them. The sheer number of proposals highlights the will of the Commission to increase its ability to react swiftly to future pandemics and enhance its preparedness. While it was not initially foreseen in its priorities, the Commission rose to the occasion.
A Pharmaceutical Strategy essential for the future of Europe’s pharmaceutical industry
Though the COVID-19 crisis derailed the original timeline of the Pharmaceutical Strategy for Europe, the initial plan to enhance access to medicines while preserving the competitiveness of the industry was not cast aside. On the contrary, the swift reaction from the European Commission gave more legitimacy to its pharmaceutical strategy. In addition, lessons drawn from the pandemic were integrated in the Strategy, through initiatives to strengthen supply chain resilience among other complementing proposals to work on access to medicines and the industry’s competitiveness. Most of the legislative proposals are expected at the end of 2022, which will make for an intense end of mandate on the health front.
While the industry, including Servier, has taken serious steps towards ensuring that the Commission’s access concerns are answered early on, including through a commitment to file pricing and reimbursement applications within two years after receiving a marketing authorization, it cannot act alone. Access delays are the result of a vast combination of factors, among which the length of regulatory and pricing processes. The industry, regulators and payers must therefore work hand in hand in order to accelerate access to medicines.
Furthermore, improving access to medicines will not be sufficient if the framework does not adequately support the research and development of new medicinal treatments. The Pharmaceutical Strategy is a unique opportunity to work jointly with all stakeholders to ensure that the legislation creates an environment conducive to R&D. The industry and Servier rely on several factors to be able to strive: incentivizing innovation through robust intellectual property rights, enabling a collaborative research ecosystem where public-private partnerships thrive and implementing a flexible and predictable regulatory framework.
By integrating those elements in its Pharmaceutical Strategy and working with the industry, the European Commission will achieve its twin objective of improving access to medicines and ensuring Europe remains a world leader in life sciences. At the end of its mandate, it will have brought about many changes in health, going far beyond its 2019 objectives. The European Union will have the tools to anticipate and manage sanitary crises, while continuing to foster innovation for the benefits of patients, which will have access to the medicines they need. Servier and the industry stand ready to play its part in fulfilling this vision for the future