The European Medicines Agency (EMA) and patients have been actively interacting since the creation of the Agency in 1995. This cooperation was extended to include consumer groups with an interest in medicines. Both of these stakeholder groups bring a ‘real-life’ experience as well as specific knowledge and expertise to scientific discussions on medicines and on the impact of regulatory decisions. Collaborating with these groups supports transparency and improves regulatory processes.
Key milestones of EMA interaction with patients and consumers
Framework for interaction
The framework for interaction between EMA and patients and consumers and their organisations outlines the basis for involving patients and consumers in Agency activities. EMA's Management Board endorsed a revised framework in 2014:
- Revised framework on the interaction of the Agency with patients and consumers and their organisations
The framework aims at:
- supporting the Agency to access experiences of diseases, their management and information on current use of medicines;
- contributing to more efficient and targeted communication to patients and consumers;
- enhancing understanding of the role of the EU medicines regulatory network.
This framework is in line with EMA's overarching framework for stakeholder relations management, which the EMA Management Board adopted in June 2016:
Activities of patients and consumers
Patients and consumers are involved in a wide range of activities at the Agency, including:
- as members of the Management Board;
- as members of scientific committees;
- being consulted on disease-specific requests by the scientific committees and working parties;
- taking part in discussions on the development and authorisation of medicines;
- reviewing written information on medicines prepared by the Agency;
- being involved in the preparation of guidelines;
- taking part in the Agency's conferences and workshops.
2015 Annual Report of EMA interactions with patients, consumers, healthcare professionals and their organisations
EMA publishes an annual report on its interactions with patients, consumers and healthcare professionals, incorporating both quantitative and qualitative data.
For previous reports, see Key documents.
- Getting involved
- Eligible patients' and consumers' organisations
- Patients' and Consumers' Working Party
- Training and support for patients and consumers
- Key documents
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