On July 1, 2025, Denmark assumed the Presidency of the Council of the European Union, stepping into its role as part of the current presidency trio alongside Poland and Cyprus. Under the overarching theme “A strong Europe in a changing world,” the Danish Presidency set out an ambitious and forward-looking programme aimed at strengthening Europe’s capacity to respond to geopolitical, economic, social and environmental challenges.
The programme is built around two central priorities. Firstly, a ‘secure Europe’, emphasising the need to reinforce the EU’s capacity to defend itself, respond to crises, manage migration and protect democracy. Secondly, a ‘competitive and green Europe’ focuses on advancing economic prosperity through investment, regulatory simplification, innovation and the green and digital transitions.
Economic resilience and access to medicines drive the Danish health priorities
Health is recognised as a pillar of European resilience, preparedness and long-term competitiveness. The Danish Presidency has outlined four key priorities/action areas within the health and well-being area to improve access to medicines and boost health security and resilience:
- Finalising the EU’s General Pharmaceutical Legislation (GPL) – a proposal which aims to improve patient access to medicines, encourage innovation and streamline approval processes for new treatments.
- Review the proposal on the Critical Medicines Act (CMA) – a proposal which aims to enhance the security of European supply chains for essential medicines, reduce reliance on other regions and prevent medicine shortages.
- Strengthen EU innovation and healthcare system resilience against man-made crises and natural disasters by focusing on the European Commission’s strategies for life science and medical countermeasures
- Conduct negotiations on the Framework Convention on Tobacco Control and the Pandemic Convention
Ensuring the General Pharmaceutical Legislation delivers for all patients
As the Danish Presidency works to finalise negotiations on the GPL, it is vital that the final legislation reflects the needs of people living with chronic conditions, including people living with diabetes (PwD). Two elements within the legislation are particularly important in the current trilogue negotiations: how unmet medical needs are defined, and how patients are involved in regulatory decision-making.
Current proposals in the Council risk narrowing the definition of unmet medical needs to focus only on a limited set of therapies, with a heavy emphasis on comparative clinical evidence. This approach could exclude PwD from benefiting from future innovations that improve quality of life, lower the risk of complications or support earlier diagnosis. It fails to recognise the reality of living with chronic conditions and the kind of innovation that can truly improve their lives. A more inclusive, patient-centred definition – one that recognises the value of improving quality of life, slowing disease progression and supporting personalised care, is essential to ensure future therapies truly address the evolving needs of PwD.
The GPL negotiations also include a proposal from the Council to remove voting rights of patient representatives in the Committee for Medicine Products for Human Use (CHMP) and reducing the number of patient representatives in the Pharmacovigilance Risk Assessment Committee (PRAC). For people living with chronic conditions like diabetes, it is essential that regulatory decisions are not only informed by evidence-based science but also shaped by real-world patient experience. Removing or weakening patient involvement risks sidelining the lived experiences of those most affected by regulatory decisions. To ensure future policies reflect real-world needs and deliver better outcomes, patient voices must be meaningfully included and formally safeguarded in the final legislation.
As negotiations continue, IDF Europe calls on the Danish Presidency and all co-legislators to deliver legislation that is not only fit for purpose, but also inclusive and patient-centred.
