As European Union governments continue critical negotiations on the revision of the EU Pharmaceutical Package, the Association of European Cancer Leagues (ECL), the European Consumer Organisation (BEUC), and the International Association of Mutual Benefit Societies (AIM) are urging Member States to ensure that access to affordable, safe, and effective medicines remains at the heart of the reform.
According to a joint statement, the high prices of innovative medicines continue to limit access for many patients across Europe, undermining both equity and the sustainability of national healthcare systems. The organisations are calling on EU governments to adopt patient-centred, demand-driven reforms, rather than profit-oriented approaches.
The statement highlights three main recommendations. The first is to reduce the baseline regulatory data protection (RDP) period from the current 8 years to enable earlier market entry of generics and biosimilars — a measure that could save European health systems €1.13 billion annually.
In this context, they also propose introducing a modulated incentive system with additional RDP periods capped at 8 years, to reward pharmaceutical innovation that delivers high societal and healthcare value.
Finally, they call for the promotion of competition and equitable access to improve the availability and affordability of medicines across all EU countries, thereby reducing territorial disparities.
This approach would strike a fair balance between supporting pharmaceutical innovation that meets societal needs and promoting affordable access for patients in Europe, while preserving the sustainability of healthcare systems.
“Incentives must be carefully designed to serve public health, not block it. We call on EU policymakers to ensure the Pharmaceutical Package truly delivers for patients — by promoting timely access to affordable, effective medicines and safeguarding the sustainability of our health systems,” stated Loek Caubo, President of the International Association of Mutual Benefit Societies (AIM).
