FEAM Position Statement on the new Pharmaceutical Strategy for Europe

Brussels, 15 September 2020 

Timely patient access to affordable medicines

FEAM welcomes the opportunity to respond to the open consultation on the Pharmaceutical Strategy for Europe. The COVID-19 pandemic has illustrated the importance of strengthening the EU’s health research and biomedical R&D landscape. While biomedical innovation has now received an additional boost in the EU’s pandemic recovery strategy,^[1] carrying the European health research enterprise forward will require addressing challenges across the life cycle of health technologies – from basic research to commercialization^[2] and eventually to access for patients. As we have learned during the past few months, an important degree of flexibility to define and update priorities, and a sound regulatory system for approval of medicines, including a rapid and robust mechanism to approve drugs in emergency situations -for example in pandemics- will be essential to address future crises.

The EU Pharmaceutical Strategy Roadmap’s focus on a wide range of issues is commendable. This includes strengthening Europe’s biomedical R&D capabilities, redirecting health research towards unmet medical needs, addressing shortages of medicines and vaccines as well as the EU’s increasing dependence on medicines and active pharmaceutical ingredients manufactured in non-EU countries, and enhancing timely and equal access to affordable medicines for patients. Many of these challenges, including the increasing dependence on non-EU countries and shortages of critical medicines, have been particularly emphasised during the COVID-19 crisis. FEAM also welcomes the emphasis on enabling EU cooperation on these and other related areas, such as health technology assessment (HTA), for the benefit of patients and citizens.

Ideally,  EU innovation should address the needs of the public by developing a comprehensive health research strategy. While all the areas mentioned above deserve careful consideration,  in this short statement, FEAM outlines its vision for the improvement of Europe’s biomedical R&D ecosystem and includes the following recommendations for strategic priority-setting in health research, public investment in underserved disease areas, and capacity building for health research across EU Member States:

1. Set up a European Health Research Council to coordinate and steer the European health research agenda;
2. Break silos and foster trans-disciplinary and cross-border collaboration (including with the UK post-Brexit), as well as collaboration between the public and private sectors;
3. Engage with all stakeholders and particularly with patients to improve the priority setting process and ensure that research matches societal needs;
4. Identify areas lacking sufficient industry-driven innovation to respond to public health needs, provide public funding for research in these areas, and foster publicly-funded clinical trials;
5. Address inequalities in health research capacity, which often translate into health inequalities;
6. Foster the synergistic use of public funds such as European Structural Funds and Horizon Europe to address inequalities in health research in a sustainable way that reflects the spirit of the EU Green Deal;
7. Improve access to novel medicines based on molecular targets and immunotherapy and to the required molecular testing for these treatments throughout EU;
8. Streamline data sharing capabilities while safeguarding privacy and security, including through the development of a sound framework for the proposed European Health Data Space.

Across the EU, funding and capacity for health research remain fragmented, potentially leaving key disease areas unaddressed.[3] It is imperative that the EU research community strive to ensure that future innovation can both advance Europe’s contribution to biomedical science, and improve the value of healthcare for citizens. Addressing these topics in the new Pharmaceutical Strategy for Europe – and its subsequent implementation— would greatly support the EU’s leadership in biomedical innovation, and would also be in the interest of its strategic autonomy in the global value chain for health technologies.

Read the full statement here

^[1] The Role of Research and Innovation in Europe’s Recovery. European Commission. (2020).

^[2] Workshop Summary Report: Working Together for the Future of European Health Research. Federation of European Academies of Medicines and Biomedical Alliance in Europe. EU Parliament, Brussels. (2020).

[3] Sipido, Karin R., et al. Overcoming fragmentation of health research in Europe: lessons from COVID-19. The Lancet. (2020).

EU ongoing actions related to this paper

• Pharmaceutical Strategy for Europe
• EU Green Deal 
• A European Strategy for Data and the EU Health Data Space