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November 10 2023

European Commission Calls for Patient Organization Representatives in EMA’s Committee for Orphan Medicinal Products

The Rare disease community unites in an open letter for continued support of European Reference Networks

The European Commission has initiated a call for expressions of interest to identify candidates representing patients’ organizations within the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP).

The call seeks to appoint three COMP members nominated by the European Commission to advocate for patient organizations. The selected members will serve a three-year term starting from July 1, 2024, with the possibility of renewal. The deadline for submitting applications to the European Commission is 12:00 CET on December 7, 2023. Existing members are eligible for reapplication.

For detailed information on the application process and assessment criteria, please click here.

The COMP has a longstanding commitment to involving patient representatives in its activities. Its primary responsibility is to review applications from companies and determine whether their medicines qualify for ‘orphan’ designation. Orphan medicines are those used in the diagnosis, prevention, or treatment of life-threatening or chronically debilitating conditions that are rare, affecting no more than five in 10,000 people in the European Union (EU).

The role of a patient organization representative within the COMP is to advocate for patients, ensuring their perspectives are considered in the Committee’s decision-making process. While a medical background is not mandatory, candidates may benefit from a solid understanding of medical and regulatory issues related to medicines in the EU.

Patient organization representatives actively participate in COMP procedures, attending monthly Committee meetings at EMA. They contribute to scientific discussions, review documents, and provide comments, focusing specifically on the patient groups they represent.

These representatives also become members of EMA’s Pharmacovigilance Risk Assessment Committee, Paediatric Committee, and Committee for Advanced Therapies.

Appointment of patient organization members will be made by the European Commission following consultation with the European Parliament.

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