Report from European Medicines Agency Meeting and Elections in Amsterdam, 21-22 September 2022

WONCA Europe is represented by our delegate and past president Prof Mehmet Ungan.

Short Information: EMA mainly works with two networks. The PCWP (Patients, Consumers) and HCPWP (Health Care Professionals)  which are formal working parties of EMA, composed of representative organisations of patients, consumers and healthcare professionals as well as representatives from EMA’s human scientific committees. They support and monitor the involvement of patients, consumers, healthcare professionals and their organisations in Agency activities. They identify opportunities and challenges that may need special attention, particularly in the context of their respective frameworks for interaction and engagement. The working parties (WPs) serve as platforms for exchange and discussion between regulators and organisations on issues of common interest related to medicines. The WPs do not cover medicines- specific discussions or confidential aspects of ongoing regulatory procedures.

The PCWP and HCPWP participate at key stages of EMA initiatives, policy development and implementation as well as in other EMA activities including those aimed at supporting the implementation of EU legislation (e.g. EMA’s extended mandate, ACT EU, DARWIN, patient preferences, antimicrobial resistance, vaccines). PCWP and HCPWP identify topic co-leads and organisations’ topic-specific interest, where needed.

Elections: EMA’s Patients' and Consumers' Working Party (PCWP) has elected Marilena Vrana of the European Heart Network (EHN) as new co-chair.

The two network chair elections were performed in separate sessions. UEMO, EFPC and WONCA Europe were represented and voted as GP/FP & PC member organizations who signed a MoU in 2019 with EMA. UEMO proposed a co-chair for HCPWP as one of the three candidates. The Healthcare Professionals' Working Party (HCPWP) in which WONCA Europe is a member, and represented by Prof Mehmet Ungan, has elected Rosa Giuliani of the European Society for Medical Oncology (ESMO) as new co-chair. Together with Juan Garcia Burgos, Head of Public Engagement at EMA, they will co-chair the meetings of their respective working parties for the next three years. The vote took place during the September 2022 meeting of both working parties.

The joint 2022-2025 workplan for the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP) was endorsed by EMA’s scientific committees during the September 2022 meeting. The work plan sets out the areas of work common to both working groups and it is subject to annual reviews to enable refinement of the proposed actions. Particular attention will be paid to the revision of the EU general pharmaceuticals legislation and its implications for stakeholders.

HCP Policy Officers’ Group updated us about Draft statement on Frailty and older adults. Following the discussion a 3-week consultation was launched after the meeting. WONCA Europe Executives prepared a feedback.

Update on COVID-19 and Monkeypox:   Marco Cavaleri (EMA) made a presentation briefly and here below are the conclusions:


  • Three adapted COVID mRNA vaccines approved to better match current VOCs: two bivalent original/Omicron BA. 1 and one bivalent original/Omicron BA. 4-5
  • EMA -ECDC recommended additional booster doses in elderly above 60 years of age, immunocompromised subjects, individuals with underlying conditions and pregnant women.
  • Health Care Workers should also be vaccinated with adapted vaccines
  • Other vaccines in the pipeline may come to rapid approval to enlarge our portfolio of options
  • Additional safe and effective therapeutics will help in the fight against COVID-19,
  • Monkeypox outbreak in Europe is now slowing down and plateauing in many countries
  • Effectiveness data with Imvanex are needed to understand the impact RCTs with tecovirimat to be started soon in the EU