On 9 June 2026, the European Medicines Agency (EMA) published a joint work plan for 2025-2028 covering its Patients' and Consumers' Working Party (PCWP) and the Healthcare Professionals' Working Party (HCPWP). The document sets out the strategic priorities and planned activities for these two advisory bodies over the next three years, aiming to strengthen the involvement of patients, consumers, and healthcare professionals in EMA's regulatory processes.
The work plan, which covers the period from 2025 to 2028, outlines key areas of focus including enhancing patient and healthcare professional engagement in scientific committees, improving communication of regulatory decisions, and fostering collaboration on real-world evidence and digital health tools. The PCWP and HCPWP will also work on developing guidance for patient and healthcare professional involvement in benefit-risk assessments and clinical trial design.
No prior coverage of this document exists in the public record. The plan is a non-binding strategic document that guides the activities of the two working parties, which are composed of representatives from patient organisations, consumer groups, and healthcare professional associations across the EU. The working parties provide advice to EMA's scientific committees and contribute to the agency's transparency and public trust objectives.
Policy orientations and trade-offs The work plan reflects a push for greater inclusivity and transparency in EMA's decision-making, but it also implies a trade-off between broadening stakeholder input and maintaining regulatory efficiency. Increased engagement activities may require additional resources and could slow down certain processes, though the plan does not quantify these impacts. The document emphasises the value of diverse perspectives in improving the quality of regulatory assessments, particularly in areas such as paediatric medicines, rare diseases, and antimicrobial resistance.
Impact on stakeholders - Patients and consumers: The plan promises more systematic involvement in regulatory discussions, potentially leading to medicines that better address patient needs. However, the actual influence of their input will depend on how recommendations are integrated into final decisions. - Healthcare professionals: The HCPWP's focus on communication and education may improve the dissemination of safety updates and prescribing information, but the plan does not guarantee changes to labelling or clinical guidelines. - Pharmaceutical industry: Companies may face new expectations to engage with patient and professional groups during drug development, which could add complexity to trial design and market access strategies. - EMA itself: The agency will need to allocate staff and budget to support the expanded work plan, which may compete with other priorities such as regulatory science innovation.
Expected institutional follow-up The work plan will be implemented through annual operational plans and progress reports. EMA's Management Board is expected to review the outcomes at the end of the period. The document does not propose legislative changes, but its recommendations could inform future revisions of EMA's framework for stakeholder engagement.
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