CPE Response to the European Commission’s Consultation on Cooperation with the European Medicines Agency

CPE Response to the European Commission’s Consultation on Cooperation with the European Medicines Agency

This Position Paper sets out Cancer Patients Europe’s formal response to the European Commission’s consultation on the third Implementing Act relating to cooperation and exchange of information between the European Medicines Agency (EMA) and EU HTA bodies under Regulation (EU) 2021/2282. CPE welcomes the clarification of rules for identifying patient experts to participate in Joint Clinical Assessments but raises concerns about potential duplication of effort between EMA and HTA processes. Key recommendations include: expanding expert identification to include patient organisations and carers, aligning Declaration of Interest procedures between EMA and HTA frameworks, and establishing safeguards for patient information confidentiality.