On 21 September, the EMA convened a multistakeholder workshop with patients, healthcare professionals, academia, regulators, and industry to discuss ways to improve the collection and use of patient experience data to achieve patient-centred medicine development and regulation. During this workshop, which was organised into five sessions, attendees listened to short presentations by expert speakers from patient organisations, EMA committees, data initiatives and industry, contributing their views and discussing gaps and priorities. Sessions addressed the following topics: patient engagement in medicines development, patient preference elicitation, patient-reported outcomes, digitalisation for patient-generated health data, and guidance on collection and use of patient data. Feedback from workshop attendees included the need to involve and engage more diverse and representative patient populations, and the importance of end user involvement in the development and validation of patient-reported outcomes and digital methodologies. Meetings of the EMA patients’ and consumers’ working party (PCWP) and healthcare professionals’ working party (HCPWP) were held the next day, on 22 September. These meetings were the first to be held face-to-face since the start of the COVID-19 pandemic in 2020, and represent the first meetings of the new EMA mandate (2022-2025).
The morning sessions were dedicated to electing new co-Chairs for the PCWP and HCPWP, with Marilena Vrana (European Heart Network) and Rosa Giuliani (European Society for Medical Oncology) elected to this role in the PCWP and HCPWP, respectively. Marilena and Rosa will co-Chair the PCWP and HCPWP together with the EMA co-Chair, Juan Garcia Burgos. In the afternoon, the joint meeting of the PCWP and HCPWP was held. Marco Cavaleri provided a detailed situation report of vaccines and treatments for COVID-19 and monkeypox, highlighting recent developments showing that dual boosters using the original COVID-19 were able to effectively protect against severe disease caused by the new Omicron variants, BA.4 and BA.5. Next, attendees discussed recent progress on the PCWP/HCPWP contribution to the ICH guidance on good clinical practice. This guidance document lays out quality standards for designing, conducting, recording and reporting clinical trials. Maria Mavris (EMA) then provided feedback on a recent webinar on advanced therapy medicinal products (ATMPs; medicines based on genes, tissues or cells), followed by an update from Priya Bhari (EMA) on new EMA initiatives for risk minimisation and pharmacovigilance, including PRISMA, the PRAC risk minimisation alliance. The final session was dedicated to the “members’ voice”, with presentations from Ancel-la Santos of the European Consumer Organisation (BEUC) and Isabel Proano Gomez of the European Lung Health Group (EFA). Ancel-la spoke about a recent survey carried out by BEUC on drug shortages, highlighting this as a real issue for many EU citizens with a significant impact on their day-to-day lives. Isabel presented the recent EFA policy brief on medicines for rare disease and children, which calls for greater investment in basic research and improved frameworks for medicines development, and also outlined the results of a recent survey on digital technology use in patients with asthma and COPD. The PCWP and HCPWP co-Chairs, Marilena, Rosa and Juan, drew the meeting to a close by thanking all attendees for their contributions.
