The European Medicines Agency (EMA) has established interactions with its stakeholders since its creation in 1995. Engagement has evolved and adapted as experience has been gained, taking into consideration new legislations, advances in science and crisis situations.
This framework describes the objectives and methodologies for EMA’s engagement with patients and consumers and their organisations in relation to medicines for human and veterinary use. It describes the overarching principles developed from experience gained to date and establishes a roadmap for the future.
EMA is committed to ensuring that the patient voice is included in the different regulatory activities of a medicine’s lifecycle, which improves the quality of and trust in the regulatory decisions and in new medicines placed onto the EU market.
The framework establishes the basis for:
• supporting access to individual patients’ real-life experiences of living with a condition, its management and the current use of medicines. This complementary perspective provides context and understanding of the value of 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.
• integrating animal owners (consumers) perspectives, where relevant. While to date the majority of EMA’s engagement has focused on human medicines, the principles described in this framework also apply to engagement with veterinary stakeholders.
Relevant legislation calls for the inclusion of patients and consumers as members of the EMA
Management Board and certain scientific committees. It also foresees consultation of individual experts and organisations in the evaluation of medicines and other Agency activities.
The framework relies on EMA’s broad network of patients and consumers organisations, its Patients and Consumers Working Party (PCWP) and the pool of disease-specific individual patient experts. It also acknowledges the necessity to further develop patients’ capacities, including training and other support measures, which facilitate integration in the Agency’s work while raising awareness about EMA
and the European Regulatory Network.
A Stakeholder Engagement report will be presented biennially to the EMA Management Board.