The European Society of Cardiology (ESC) has published a statement about the Reform of the EU Pharmaceutical Legislation adopted by the European Commission and currently under negotiation in the European Parliament and the Council.
The ESC has endorsed the overarching goal of the draft legislation to improve the availability and accessibility of medicines in the European Union, tackling the existing disparities and affordability issues, and has praised the European Commission for introducing measures aimed to enhance security of supply and address environmental concerns in the sector.
At the same time, the ESC has urged policymakers to develop a framework which is supportive of innovation and has highlighted some remaining concerns, including declining pharmaceutical research in cardiovascular disease (CVD). Although CVD remains the leading cause of death and morbidity in Europe, research and development is far out of proportion to its burden and lagging behind with respect to other therapeutic areas1. Out of 89 positive opinions for the authorisation of new medicines issued by the European Medicines Agency (EMA) in 2022, none were in the CVD area2.
The organisation has suggested some possible improvements to the draft Reform in order to contribute to the ongoing legislative debate. Among key points:
- Modulation of Incentives: The ESC appreciates the Commission's efforts while raising concerns about the possible, unintended, further slowdown of cardiovascular research. Targeted incentives for highly prevalent chronic conditions are proposed.
- Unmet Medical Needs: The ESC calls for a broader definition, which encompasses chronic conditions and dimensions such as quality of life and reduction in the severity of side-effects. Healthcare professionals' and patients' organisations shall be involved in its development.
- EMA & Regulatory Streamlining: The ESC supports efforts to streamline the regulatory process and recommends increased involvement of medical societies in regulatory decisions.
- Transparency and Affordability: The ESC supports the proposed measures aimed at improving affordability of medicinal products, including disclosure of public funding received, with the suggestion to further improve transparency on research and development costs.
- Supply Security and Shortages Control: The ESC praises actions to enhance supply security and control shortages and recommends the consultation of healthcare professionals' organisations for the development of the Union list of critical medicines.
As remarked by the Chairman of the ESC Regulatory Affairs Committee, Piotr Szymański, "Legislative efforts should address diseases where development of medicines is unmistakably out of proportion to their burden. Therefore, we urge policymakers to constitute a base to support declining pharmaceutical research in cardiovascular diseases, which remain the leading cause of death. ESC calls for the revised definition of unmet medical needs for the good of patients across the EU, in order to avoid possible unintended downturn of research and innovation."
The ESC remains committed to collaborating with regulators and other stakeholders to improve the pharmaceutical landscape in Europe, benefiting patients and public health.
