Highlights from the ISPOR 2022 Patient Representative Roundtable - Europe

Published Feb 10, 2023

On 30 November 2022, 33 representatives from patient organizations, payers, HTA organizations, regulatory bodies, government, industry, and research/academia convened virtually for the 10th annual ISPOR Patient Representatives Roundtable (PRR) – Europe to discuss the evolving role of patient involvement in health technology assessment (HTA) in Europe.  

ISPOR’s Commitment to Patient Engagement and Contributions Made by the Patient Representatives Roundtables – Europe Over the Last 10 Years

The meeting started with Roundtable chairperson, Derick Mitchell of Irish Platform for Patient Organisations, Science & Industry (IPPOSI), leading a review of ISPOR patient engagement initiatives over the last 10 years. With ISPOR’s continual commitment to amplifying the patient voice in health economics and outcomes research (HEOR) and decision making, patient engagement has become a key part of the ISPOR fabric and continues to be supported by a wide range of activities. Roundtables were highlighted as a mainstay of ISPOR’s patient activities and as one of the only efforts run by the patients for the patients. Importantly, these roundtables have provided value and over the last 10 years, and the PRR - Europe has helped drive the conversation on patient engagement in HTA. While early roundtables focused on the importance of patient engagement in HTA and just getting the patient in the room, subsequent roundtable topics included criteria for engagement, specific roles, and collaboration, moving more recently to the impact of patient involvement and inclusion of patient-reported outcomes and patient-generated evidence.

Presentations Outlining the Current Status and Continued Evolution of Patient Involvement in HTA in Europe

Three speakers gave presentations reviewing the current state of patient involvement in HTA in Europe, training initiatives to support improved patient involvement in HTA in Europe, and a look towards the continued evolution of patient involvement with the introduction of the new European Union (EU) HTA regulation.

The first speaker, Anke-Peggy Holtorf, provided an overview of an initiative to assess current stakeholder experiences with patient involvement in HTA in Europe, led by the HTA International (HTAi) Interest Group for Patient and Citizen Involvement in HTA (PCIG). PCIG is a multistakeholder group including over 300 representatives of patients/patient groups, health technology developers, researchers, HTA bodies and government, together working to continue patient involvement in HTA. This initiative, the 360o Project on Stakeholder Experiences with Patient Involvement in HTA, will employ a comprehensive analysis of HTA practices in Europe to ascertain how these practices are experienced and perceived by stakeholders with the goal of providing clear, actionable, evidence-based recommendations for valued patient involvement in HTA. A 2-track approach will be employed using (1) interviews with key stakeholders to better understand patient involvement processes across Europe and (2) surveys of all relevant stakeholders to more broadly capture Europe-wide experiences and perspectives. Preliminary results from this initiative were presented, offering a somewhat clearer picture of patient involvement in HTA in Europe as well as areas for improvement to better support the patient. Several challenges with patient involvement have also been identified at both the HTA agency/government and patient levels, and PCIG is working to address these barriers through a broad range of activities and with multistakeholder collaboration.

The second speaker, Maria Dutarte, reviewed current training efforts led by European Patients’ Academy on Therapeutic Innovation (EUPATI) to support capacity building and increased patient involvement in HTA in Europe. The free online training platform and toolbox have supported learners from many different disease areas and communities across Europe, offering materials to equip patients/patient representatives with the right knowledge, skills, and competencies to be equal actors in medicines R&D and other health technologies. The HTA training module includes how the process works and how patients can be involved, with over 75% of fellows reporting that the training made a difference in patient involvement in HTA. However, only 38% of fellows are now involved in HTA in some way and highlighted barriers to involvement include lack of trust in patient ability to contribute despite the course and fear of missing the ordinary patient who would have not received such training. Going forward, there are efforts to identify additional training needs and the speaker discussed the HTA4Patients project, which will update EUPATI’s current HTA training program to align with the new EU HTA regulation. During the group discussion it was noted that not all European countries are currently served by HTA, and so attendance of individuals from such countries in these training programs may be low. In addition, there may be political, societal, or cultural challenges that limit patient involvement in HTA, and so there may be a need to not only further patient involvement but also to support with best practices where patient involvement does not occur. The roundtable also discussed conflict of interest (COI) requirements and associated limitations and that other financial sources for patient support may reduce dependency on industry.

The third speaker gave an overview of the new EU HTA regulation. Despite efforts starting in the 1990s, a sustainable European HTA framework and regulation are only now being developed, slowed by national variation in systems and processes. The new EU HTA regulation builds on the work of EUnetHTA21 and EUnetHTA Joint Action (JA)3 and will focus on joint clinical assessment of medicinal products, joint scientific advice to manufacturers, identification of new health technology, and cooperation in other non-clinical areas. The EU HTA regulation will require member state commitment, cooperation, and adoption of the mandatory mechanism for data submission at the EU level. Given this integration, patient/patient representatives will require a broader viewpoint that takes into consideration the various member states, and the group discussion highlighted the need for further clarification around these requirements.

Participant Poll Regarding Confidence in HTA Systems in Europe

Polls were launched during the roundtable session to capture the level of confidence around the current and future systems for HTA (assessment + appraisal stages only) in Europe. While most of the 26 responders were confident to very confident in the current systems for HTA in Europe (11 confident, 9 somewhat confident, 1 very confident), 5 responders were only slightly confident in this system. Regarding confidence in future systems for HTA in Europe, the majority of the 14 responders were confident to very confident (6 confident, 6 somewhat confident, 1 very confident) and only 1 responder was slightly confident. None of the responders were not confident at all for either current or future systems for HTA. When asked about what would increase levels of confidence through a Mentimeter exercise, top responses included participatory processes, more meetings and discussions like this, political agreement, and understanding how patients and patient groups will be involved. Participants also agreed that more coherence between different assessments, more interactions between patients and HTA bodies, and increased sharing of good practices in patient and public involvement would all increase their level of confidence in HTA in Europe. In addition, participants favored the comment, “Trust is something to mutually work on. Starting from the conflicts of interest assumption is a difficult start (it is actually appearance-based prejudice). Trust is built as we work together. You cannot ask for trust.”

Additional Considerations for the Roundtable Going Forward

In consideration of the continued role of the PRR – Europe in supporting patient involvement, participants suggested several areas for roundtable evolution and further topics of discussion:

  • Assign Co-Chairs for the PRR  - Europe with a patient representative serving as a co-chair
  • Need for further efforts to leverage the work of the roundtables and work off meeting outcomes
  • Increased interconnectivity between the regional roundtables and with other ISPOR initiatives
  • Support for broadening the group of patients involved in HTA beyond the more articulate or more experienced patients
  • Better understanding and communication around the impact of patient involvement on decisions
  • Communication on best practices in terms of patient/patient group contributions to the field
  • Continued support for evidence development and helping to further patient engagement in research at appropriate junctures
  • Further consideration of challenges to patient involvement, such as conflict of interest (COI)
  • Demonstrating the value of European patient organizations as a source of informed patient cohorts


The efforts to support patient involvement in HTA over the last 10 years have allowed for considerable progress, moving from consideration of whether patients should be engaged in HTA to present day where patients serve as informed HTA stakeholders in Europe. Further initiatives and efforts will be needed given the continued role and evolution of patient involvement in HTA with the novel EU regulation and beyond. 


This summary was developed by Brittany Carson, BSc, MCom, PhD. We would like to thank the Chair of the ISPOR PRR – Europe for his direction and leadership – Derick Mitchell, PhD, Chief Executive Officer of IPPOSI. We thank all speakers and attendees for their participation and valuable contributions. 

Additional Information

The ISPOR Patient Representatives Roundtable provides a platform for patient representatives to discuss issues and challenges of patient involvement in the health care research and decision-making processes with other key stakeholders such as researchers, HTA bodies, payers, decision and policy makers, as well as representatives from the pharmaceutical industry. To learn more about ISPOR's Patient Initiative, visit our website and the specific topic pages: 

-        ISPOR Patient Representative Membership

-        ISPOR Patient Centered Special Interest Group

-        ISPOR Patient Representatives Conference Travel Grants

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