Position paper 2025
Unleashing therapeutic innovation
With a projected growth of the cancer burden in Europe in a chronically budget-constrained healthcare environment, maximizing the patient and societal benefits of medical innovation is a priority for patients, the medical community, and policy makers.
Overcoming hurdles to new uses of authorized drugs
Every year, a vast amount of knowledge and expertise is generated through European and national research grants. Yet too often, the results of that research remain confined to high-quality scientific publications and off-label use, without ever reaching clinical practice.
To truly benefit patients—especially those with limited treatment options—we need to ensure that research outcomes from non-traditional developers are valorized and effectively translated into accessible treatments.
That’s why a complementary regulatory pathway is essential.
The proposed EU Pharmaceutical Regulation, and in particular Article 48, could be a game changer in making this happen.
Given the importance of this article, we’ve joined forces with peers and other stakeholders to clearly explain why this framework matters—and why action is needed now.
Please read our full position paper to learn more.