On November 15, the European Medicines Agency (EMA) convened a meeting of its Patient and Consumer’s (PCWP) and Healthcare Professionals Working Parties (HCPWP). The meeting was attended by all eligible patient organisations and professional bodies, and was chaired by Juan Garcia Burgos (EMA) and Rosa Giuliani (HCPWP). The first session kicked off after opening remarks from Emer Cooke (Executive Director of the EMA), and was focused on patient involvement in medicines development and regulation.
Rosa Gonzalez-Quevedo (EMA) delivered a presentation that summarised the outcomes of a recent EMA multi-stakeholder workshop on patient experience data. Patient experience data is defined as data that are intended to provide information about patients’ experience of their health status, symptoms, disease course, quality of life, and other parameters. Rosa highlighted challenges related to lack of alignment among decision-makers, insufficient regulatory guidance, increasing digitalisation of collection methodologies, and the need for better resources and support.
Next, Francois Houyez (Eurordis) and Lembit Rägo (CIOMS) presented the recent CIOMS consensus report on patient involvement in the development, regulation and safe use of medicines. The report was developed in consultation with a working group composed of patient representatives, regulators, researchers and policymakers, and provides case studies and guiding principles for patient involvement at all stages of the medicines development pipeline. The second session was focused on availability and accessibility of medicines, and included a series of presentations and discussions on this wide-ranging topic. The EMA Taskforce on the availability of authorised medicines (TF AAM) presented updates on their activities and the reporting of medicines shortages by organisations, and discussed preparations for a 2023 multi-stakeholder workshop as well as updates to EU guidance on shortage prevention and communication to the public.
Speakers including Michael Berntgen (EMA), Stephanie Said (EunetHTA21) and Daniel Ritter (EunetHTA21) provided a health technology assessment (HTA) perspective, explaining how regulatory and HTA activities intersect under the new HTA regulation, how this affects access to medicines, and identifying how and where involvement of patients and healthcare professionals is incorporated. Lively discussions with attendees revolved around improving and enhancing these involvement processes, and ensuring that the patient experience of challenges in accessing or obtaining medicines are accurately captured and fed back to the relevant authorities.
The final session of the meeting addressed the important topic of antimicrobial resistance (AMR) and other emerging health threats. In his presentation, Radu Botgros (EMA) explained that AMR occurs when microorganisms such as bacteria become increasingly resistant to antimicrobial drugs, such as antibiotics. AMR has become a critical threat to global health, with thousands of people in Europe dying each year due to infections with antibiotic-resistant bacteria – a number that is projected to grow to over 10 million by 2050, if we do not find new ways to address this threat. Radu outlined the ways in which EMA is combating AMR, by developing guidance for developers and HCPs, adapting regulatory tools to accelerate the development of new antimicrobials, and new human and veterinary medicines regulations promoting the responsible use of antibiotics. He emphasised, however, that there is a long way to go to effectively address AMR.
Continuing the theme of emerging health threats, Melanie Carr (EMA) spoke about the impacts of COVID-19 on the EMA, and the way the agency addressed this health crisis – and highlighted learnings and good practices from this challenging period. Juan Burgos (EMA) then closed the meeting after a short wrap-up, thanking all attendees for their active engagement, and looking forward to the next PCWP/HCPWP meetings in 2023.
