2016 marks the 10th anniversary of the European Medicines Agency’s (EMA) Patients’ and Consumers’ Working Party (PCWP). The PCWP is a unique platform for exchange with patients and consumers on medicine-related issues.
Involving patients and consumers in the Agency’s activities brings 'real-life' experience as well as specific knowledge and expertise to scientific discussions on medicines and on the impact of regulatory decisions. Collaborating with these groups supports transparency and improves regulatory processes.
EMA formalised the PCWP following the success of the Working Group with Patients Organisation and the adoption of the framework of interaction in 2006. Key achievements of the working party in its first decade include:
- publication of information on medicines addressed to the general public. These documents are reviewed by patients to ensure that the information is clear and relevant. For more information, see How patients are involved in the review of documents;
- determination of eligibility criteria for patient and consumer groups working with the Agency;
- involvement of patients as experts in regulatory activities. For more information, see Getting involved;
- implementation of patient recommendations in the revision of the Pharmacovigilance legislation;
- involvement of patients in the assessment and safety monitoring of medicines as members of the Pharmacovigilance Risk Assessment Committee.
10th anniversary meeting
The working party celebrated its 10th anniversary with a dedicated meeting on 14 June 2016. This meeting reflected on how the involvement of patients in EMA activities has evolved since the creation of the Agency and discussed future priorities and challenges.
Isabelle Moulon, the EMA co-chair of the PCWP said: 'the PCWP has triggered most of the initiatives that are now being implemented and has helped the Agency to mature its reflection on how to involve patients and further reach civil society. The PCWP is now key in Agency life.'
A panel discussion with the PCWP stakeholders highlighted their different starting points that converged to address the need to collaborate and communicate on medicines. The patient representatives highlighted the importance of finding the right committed people and not being intimidated by the regulators or the acronyms they use. The EMA representatives emphasised that having clear and transparent eligibility criteria was key to successful cooperation.
The patient representative co-chairs presented the highlights and challenges encountered during their mandates, including the adoption of the reflection paper on further involvement of patients and consumers in EMA activities in 2009, input on pharmacovigilance and holding joint meetings with the healthcare professionals.
Participants highlighted future steps, including the need for patient interactions to continue to evolve, to broaden and strengthen cooperation with healthcare professionals, to systematically involve patients in the CHMP, to engage with young people and allow the general public to provide input to the PRAC through public hearings.
Noel Wathion, EMA's Deputy Executive Director explained that the EU Medicines Agencies Network Strategy to 2020 sets a clear vision on involving patients in the activities of not only EMA but also the national competent authorities until 2020. He said: 'the working party has been a success story – we could not have achieved this alone so thanks to all of the patients and consumers and their organisations.'
In these articles, working party members reflect on how, starting from a blank page, EMA and patients and consumers were able to design their own vision for working together. The PCWP quickly recognised the importance of working with the healthcare professionals and a framework of collaboration with academia is also underway:
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Co-chairs Frits Lekkerkerker and Isabelle Moulon on the beginnings and achievements of the PCWP
Members reflect on the working party and its first decade
Future role for patients in medicines development