On 14-15 November, our Director of Research & Policy, Angela Bradshaw, attended meetings of the European Medicines Agency (EMA) Patients’ and Consumers’ and Healthcare Professionals Working Parties (PCWP/HCPWP). Alzheimer Europe is a member of the PCWP, which includes over 40 civil society organisations representing patients and consumers, and provides a platform for exchange of information and discussion of key topics for EMA, patients and the general public. On 14 November, the PCWP meeting addressed the availability and accessibility of medicines, with presentations from EMA and European Commission experts on the interface between European regulators and health and technology assessment (HTA) bodies, the EMA critical medicines list, and updates on medicines repurposing activities.
Bela Dajka (European Commission) provided an update on the European HTA Stakeholder Network, which is being established by the EMA as part of its responsibilities under the new HTA Regulation. This pan-European group are working on implementation of the HTA Regulation, Bela explained, with regular meetings planned in the coming year. Another topic was the COVID-19 pandemic, with a presentation from Melanie Carr of the EMA on lessons learned, and discussions on generating clinical evidence for treatment and prevention of Long COVID. On 15 November, the PCWP and HCPWP met, bringing together both EMA Working Parties in a meeting co-Chaired by Juan Garcia Burgos (EMA), Marko Korenjak (PCWP co-Chair) and Rosa Giuliani (HCPWP co-Chair). This meeting was focused on updates from the different EMA committees; EMA data-related initiatives and digitalisation; regulatory science and innovation; and communications.
EMA speakers representing the COMP, CAT, CHMP and PDCO Committees, which review orphan medicinal products, advanced therapies, human medicinal products, and medicines for children. Each Committee involves representatives of patients, consumers and healthcare professionals in their work, asking for their views on medicines in different disease areas. Moving on to data-related initiatives, EMA experts provided updates on the Big Data Steering Group, DARWIN initiative, patient experience data and AI-based methods for evidence generation. Following an interactive discussion on accessible communications, members of the PCWP and HCPWP spoke about new initiatives from their organisations in the “Member’s Voice” section.
Francois Houyez of EURORDIS (European Organisation for Rare Diseases) presented new research on Goal Attainment Scaling, a new approach for identifying and measuring individualised, patient-centred outcomes. Finally, Marcin Rodzinka-Verhelle of the Standing Committee of European Doctors (CPME) presented a recent national survey that assessed antimicrobial resistance stewardship programmes, prescribing guidelines and awareness campaigns, concluding that more action is needed to coordinate, engage and educate stakeholders within and across countries. The next PCWP and joint PCWP/HCPWP meetings will be organised in March 2024.
