On November 25th 2020, the European Pharmaceutical strategy was published and presented by Commission Vice President Margaritis Schinas and Health Commissioner Stella Kyriakides. When presenting it, M. Schinas stated that the aim is to completely overhaul the entire legislative framework for medicines and pharmaceuticals. This set of rules being 20 years old, it requires modernization which will be a long-term process, with concrete proposals presented throughout the mandate of the current Commission.
This Strategy is divided in 4 main pillars:
“Delivering for patients: fulfilling unmet medical needs and ensuring accessibility and affordability of medicines”
This first pillar focuses on providing new tools to face unmet medical needs through the creation of new pull incentives for novel antimicrobials and the revision of the Paediatric and Orphan Medicines Regulations. It seeks to review the system of incentives and obligations in the pharmaceutical legislation to support innovation, access and affordability of medicines across the EU. The Commission is also looking to foster transparency of price information between national P&R authorities.
“Supporting a competitive and innovative European pharmaceutical industry”
Through this second pillar, the Commission wants to provide a fertile environment for Europe’s industry by providing balanced and fair incentives to reward and protect innovation. To do so, it will rely on the IP Action Plan, published on the same day and which will simplify and streamline the EU pharma IP system, notably with SPCs. It will also seek to enable digital transformation and a better use of data through the establishment of a European Health Data Space. Lastly, it will explore new and more flexible approaches to assess scientific evidence for the safety and efficacy of medicines.
“Enhancing resilience: Diversified and secure supply chains; environmentally sustainable pharmaceuticals; crisis preparedness and response mechanism”
This pillar aims to secure the supply of medicines across the EU and avoid shortages by building the EU’s open strategic autonomy in the area of medicines. This could lead to a stronger coordinating role for the EMA and stronger obligations on the industry to ensure the supply of medicines, earlier notification of shortages and enhance transparency of stocks across the supply chain. Moreover, it wants to ensure high quality, safe and environmentally sustainable medicines. Finally, it will focus on enhancing Europe’s health crisis response mechanism. To do so, the Commission has published its European Health Union package which extends the EMA mandate, increases EU’s preparedness and resilience to cross-border health threats, strengthens the ECDC mandate and creates the new EU HERA.
“Ensuring a strong EU voice globally”
Lastly, the fourth pillar will see the Commission continue its open dialogue with other regions and countries to work towards enhanced regulatory cooperation and, where possible, towards convergence. It will continue working to promote common international standards to implement a level-playing field and a regulatory environment conducive to innovation and competitiveness.
As stated in the document, the strategy is only “the beginning” of a “multi-year vision … [to] ensure that the EU’s pharmaceutical policy delivers and serves public health in an economically, environmentally and socially sustainable manner.” It could also trigger a larger discussion on the shared competencies in Health, with treaty changes being called by several heavyweights of European politics in a Manifesto published just a day before the Pharmaceutical Strategy.