Last month, the European Medicines Agency (EMA) hosted an online 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), Kaisa Immonen (EPF; PCWP) and Ulrich Jaeger (HCPWP). Angela Bradshaw (Project Officer) represented AE at the meeting.
The first half of the meeting was focused on updates from the EMA on new regulations, guidelines and directives, specifically the recently-proposed HTA (Health Technology Assessment) regulation, the Clinical Trials Regulation (which will come into force in January 2022) and the ICH E8 Guideline on general considerations for clinical studies. Michael Bertgen of the EMA explained how the EMA has worked closely with EUNetHTA, the European Network for HTA, since 2010, developing a workplan for activities between 2017 and 2021. Areas with specific needs for collaboration included scientific advice, patient and clinician engagement, and therapeutic innovations. Peter Vankeerberghen (EMA) then reminded the audience of how the Clinical Trials Regulation will be implemented, with the launch of the new Clinical Trial Information System (CTIS) on 31 January 2022. The CTR aims to streamline clinical trials conduct and increase efficiencies and transparency.
After a brief break, Mavris Mavria (EMA) explained to attendees how patient organisations and advocates participate in EMA scientific committees, describing the decision-making process and showing how civil society representatives are included in committees such as the CHMP (Committee for Medicinal Products for Human Use). She emphasised that they can be involved either as representatives of the PCWP, representatives of their own organisations or as individual experts by experience. At the end of the meeting, the co-Chairs moderated an interactive discussion with feedback from the audience via sli.Do polling, asking the attendees to identify the key challenges preventing active engagement with the EMA (e.g. lack of funding or resources) and what their priorities are going forwards. Among the priorities identified by attendees were understanding the impact of COVID-19 on the conduct of clinical trials; digital biomarkers; inclusion and accessibility; and areas of unmet need, particularly non-communicable diseases that have been overlooked due to the pandemic. The next PCWP/HCPWP will be held at the beginning of March 2022.