IDF Europe welcomes the long-awaited revision of the general pharmaceutical legislation (GPL) that is crucial to ensure access to affordable medicines and address unmet medical needs for people living with diabetes (PwD) and other conditions, while at the same time promoting innovation as well as the competitiveness and sustainability of the EU’s pharmaceutical industry.
On April 26, 2023, the European Commission adopted a proposal for a new Directive and a new Regulation, revising and replacing the existing legislation. The proposed Directive provides, inter alia, a definition of what constitutes “Unmet Medical Needs” (UMN). This definition is critical to ensure that PwD can benefit from the revision of the legislation, as the proposal also introduces the concept of variable incentives to reward innovation.
As it stands, the proposed definition does not acknowledge the burden of chronic diseases on citizens and their families and caregivers, nor does it consider the progressive nature of chronic conditions, where improvements in quality of life and health outcomes and disease-modifying treatments remain key unmet needs. It does not either reflect the need to take into account patients’ preferences.
To allow for an appropriate consideration of the numerous UMN still existing in diabetes and other chronic conditions, IDF Europe calls on the co-legislators to adapt the definition of unmet medical needs to reflect the burden, needs and preferences of Europeans living with these conditions. We also call on the EU institutions to define the notion of UMN (and the set of criteria therein) in a process of collaborative deliberation that has the perspectives of citizens at its heart, and to ensure that patient organisations are included as partners – and recognised as such in the Directive – in this process.