Patients and consumers
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
EMA's Management Board endorsed an updated framework in 2022:
Engagement framework: European Medicines Agency and patients, consumers and their organisations
The framework aims at:
- supporting access to patients’ real-life experiences of living with a condition, its management and the current use of medicines complementing the scientific evidence provided during the evaluation process;
- promoting the generation, collection and use of evidence-based patient experience data for benefit-risk decision-making;
- enhancing patients and consumers understanding of medicines regulation and their role in the process;
- contributing to efficient and targeted communication to patients and consumers to support their role in the safe and rational use of medicines and to foster trust in 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:
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.
Stakeholder engagement report
EMA publishes an biennial report on its interactions with patients, consumers, healthcare professionals, academics and their organisations, incorporating both quantitative and qualitative data.
For previous reports, see Key documents.
Clinical Trials Transformation Initiative (CTTI): ICH E6 Guideline for good clinical practice – Update on progressEMA is helping ICH to ensure that the perspectives of European patients, healthcare professionals and clinical researchers are taken into account in the ongoing revision of its International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 good clinical practice (GCP) guideline, by coordinating the stakeholder engagement process in Europe on the behalf of ICH.
As a first step, EMA held a workshop with its Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties in June 2020 to gather their views and experiences. The workshop summary report is available:
ICH is revising this guideline to make it more responsive to advances in clinical trial design and conduct. It has committed itself to engaging stakeholders from the outset of the revision process, particularly patient representatives and academic clinical researchers. This is to ensure that the revised guideline will meet the needs of those conducting or participating in clinical trials.
For more information on the ICH E6 revision process, see:
