Why it matters for patients?
The European Medicines Agency (EMA) is a decentralised agency of the European Union. They are responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use within the European Union. It approves cancer drugs for market entry in the EU/EEA by granting them marketing authorisation on behalf of the European Commission. Since its foundation in 1995, they have been engaged in dialogue with patients and consumers to ensure that they have access to high-quality, effective and safe medicine. With this, the EMA recognises the central role that cancer patients play as co-creators of their own health. Patients’ contribution is crucial at all steps of medicine development as well as for pharmacovigilance, the monitoring of medicines after their introduction to the market. This also includes monitoring adverse drug reactions reported by patients and ensuring that national authorities implement all rules of the Pharmacovigilance Directive.
“All suspected side effects that are reported by patients and healthcare professionals must be entered into EudraVigilance, the EU web-based information system operated by EMA that collects, manages and analyses reports of suspected side effects of medicines.”
What ECPC does
ECPC has collaborated with the EMA since 2013 when it became a member of the Consumers’ Working Party of the Committee for Medicinal Products for Human Use (CHMP). Cancer patients provide the EMA with unique real-life experiences and patients’ perspective to scientific committees. ECPC President, Kathi Apostolidis, is the ECPC representative in the CHMP, ensuring the interests of patients are met and strongly involved in all possible procedures within the EMA including benefit and risk assessment in scientific advice procedures, package leaflet assessments and participation in Scientific Advisory Groups. Patient involvement helps ensure the safety of medicines and the quality of information provided to patients. Their involvement in benefit and risk deliberations further contribute by providing transparency and trust.