Fédération nationale des centres de lutte contre le cancer
Unicancer
Unicancer est la seule fédération hospitalière dédiée à la cancérologie en France, qui regroupe les 18 Centres de lutte contre le cancer (CLCC).
ID: 336378742561-89
Lobbying Activity
Response to Evaluation and revision of the general pharmaceutical legislation
8 Nov 2023
Unicancer, the French hospital federation of comprehensive cancer centers, expresses its gratitude to the European Commission for the opportunity to provide feedback in the public consultation on the legislative proposal for revising the EUs legislation on pharmaceuticals. While we welcome the proposal, we have five specific comments which we have integrated in the attached contribution: 1. Access to quality oncology drugs: we endorse the proposal to streamline drug development and repurposing of existing medicines, strengthen the security of drug supply, and create an EU-wide list of essential medicines. However, we regret the exclusion of treatment optimization studies and recommend requiring marketing authorization holders to submit such data; 2. Unmet medical needs: we welcome incentives for developing innovative drugs targeting unmet medical needs, including incentives for pediatric and AYA cancer treatments. However, we emphasize the need for clarity in defining "Unmet Medical Need"; 3. Advanced Therapy Medicinal Products (ATMPs): we appreciate the preservation of the hospital exemption for ATMPs. We suggest adapting regulatory provisions to facilitate ATMP development and recommend a specific framework for autologous therapies. Moreover, we propose establishing a regulatory sandbox and early dialogues with stakeholders to enhance the development of ATMPs; 4. Interplay with other health products and technologies: Unicancer seeks clarity in coordinating EU rules on medicines, medical devices, and in vitro diagnostic devices. We highlight the challenges related to companion diagnostics and propose addressing the transition to the new CE mark procedure. We emphasize the importance of enabling the development of multiple companion tests; 5. Accelerate innovation and research: We support a flexible regulatory framework for oncology research and development, to reduce administrative burden, and an increased representation of healthcare professionals and patients in the development and approval of medicines. Unicancer remains ready to collaborate with EU institutions for a swift adoption to accelerate innovation in cancer drug development for the benefit of all patients.
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