On 1–2 April 2025, the European Medicines Agency (EMA) convened the first joint meeting of the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP) for 2024. Held in a hybrid format in Amsterdam and online, the meeting was co-chaired by Juan Garcia-Burgos (EMA), Rosa Giuliani (European Society for Medical Oncology), and Marko Korenjak (European Liver Patients’ Association). The event welcomed over 70 participants, including our Director for Research, Angela Bradshaw, together with representatives from other patient organisations, medical societies, and EMA scientific committees.
Opening the meeting, EMA Executive Director Emer Cooke welcomed participants and outlined key activities for EMA’s 30th anniversary year. She emphasised the Agency’s ongoing commitment to stakeholder collaboration, transparency, and patient engagement. The first session focused on innovation in regulatory science and support for clinical trials under the Accelerating Clinical Trials in the EU (ACT EU) initiative. Updates were presented on the ACT EU 2025–2026 workplan, including the launch of the EU Clinical Trials Map. Participants provided feedback on the tool, discussing how it might help patients and healthcare professionals access and enrol in clinical studies. The meeting also reviewed the latest developments from the recent ACT EU workshop on ICH E6(R3) and received an update on the Multistakeholder Platform Advisory Group (MSP-AG), with the EMA committing to provide greater preparatory support for patient and HCP representatives in advance of future MSP meetings.
In the area of pharmacovigilance, Priya Bahri (EMA) provided an overview of recent research and engagement on risk minimisation in healthcare, outlining plans to develop new educational materials. Attention was also given to the upcoming implementation of the revised EMA policy on competing interests, which will take effect from 1 May 2025. Monica Dias (EMA) then introduced the next focus area for the meeting: medicine shortages. She provided a brief overview of ongoing activities on shortages across the EU, highlighting transitions in how shortage management and mitigation is coordinated. EMA announced a public report on the shortage taskforce’s eight-year legacy and shared updates on the European Shortages Monitoring Platform (ESMP). A webinar on shortages for patients and HCPs is planned for 4 November 2025. Product information was another key agenda item. Elisabeth Scanlon (EMA) presented the results of the electronic product information (ePI) pilot and encouraged contributions to the open consultation on linking ePI to EU medicine packages. The European Patients’ Forum and the Standing Committee of European Doctors also presented their respective statements on improving the accessibility and clarity of patient information.
On day two, digitalisation and data innovation were in focus, with EMA staff including Peter Arlett and Andrej Segec providing an update on the Data Analysis and Real World Interrogation Network (DARWIN EU). The network, now three years into its operation, has delivered several studies supporting regulatory decision-making through real-world evidence. Kaisa Immonen (EMA) then informed members about the upcoming consultation on a reflection paper on patient experience data and discussed how to facilitate public and stakeholder interventions during the evaluation of medicines. As the current mandate (2022–2025) draws to a close, co-chairs Rosa Giuliani and Marko Korenjak reflected on the working parties’ accomplishments and their own experiences in co-chairing the HCPWP and PCWP, respectively, thanking members for their contributions and EMA colleagues for their support.
Day two concluded with the “Member’s Voice” section, where members of the two working parties can share ongoing initiatives and activities of relevance for the EMA. Elisabeth Vroom and Dimitrios Athanasiou of the World Duchenne Organisation presented insights from a decade of engagement with the EMA, highlighting key achievements but also identifying ongoing challenges in ensuring meaningful involvement. This opened up several discussion topics, with other organisations also sharing their experiences of involvement in regulatory processes, identifying potential areas where the EMA and Working Parties could work together to enhance patient engagement. Finally, the Pharmaceutical Group of the European Union (PGEU) raised important concerns about the misuse of medicines, underlining the need for enhanced pharmacovigilance and public education to protect patient safety. Read more about the Joint meeting: https://www.ema.europa.eu/en/events/european-medicines-agency-ema-patients-consumers-pcwp-healthcare-professionals-hcpwp-working-parties-joint-meeting-3
