In June 2022, the European Commission Directorate General for Health and Food Safety organised an annual conference on the Health Technology Assessment (HTA). The conference set out to communicate publicly on “what’s next” on EU HTA, after the EU adoption of the new regulation in late 2021. HTA is a crucial evaluation for patients, as the decisions taken by regulatory bodies ultimately affect how and what health technologies patients can access in any given country.
During the full day event, the European Commission, national HTA bodies, and other representatives including patients received information on the current context and work to prepare for the entry into force of the new HTA Regulation (HTAR). During the meeting, EFA Susanna Palkonen and Isabel Proaño reflected on the best ways to involve patients in that work.
What’s new?
Partially because of the COVID pandemic and gaps in EU health coordination, the HTAR will deepen the existing HTA coordination in several ways:
1) establishing a centralised application that would make it easier for the applicant
2) setting up permanent expert assessment groups
3) granting clear roles for stakeholders such as European level patient groups, national groups, and individual patients to inform the future HTA regulatory decisions.
EU coordination for the HTA will ultimately improve regulatory transparency on health technology decisions, and equity across Member States.
Until the legislation enters into force in 2027, the structure to coordinate on HTA matters at EU level has taken the shape of EU-funded Joint Action (called EUnetHTA) gathering the European Commission and the more than 50 national and regional HTA authorities within Member States, who
What’s next?
The European Commission is currently working with HTA bodies to get ready to the entry into force of the HTAR. Although the setup is still far from a fully-fledged independent agency, such as the EMA, HTA will be able to count on a:
- a Coordination Group composed of Member States. It held its first meeting in June 2022
- a Stakeholder Network, to be created by the end of 2022
- several implementing and delegated acts to make the regulation operational
- a methodology for joint HTA work by the Coordination Group as required by the Regulation.
EFA contributed to the discussion by emphasising the importance of supporting patient groups to contribute in a meaningful way, which, like anything requires resources. We also highlighted, on the topic of conflict of interest, that EMA as an EU agency already has a well-developed and transparent way of handling conflict interest that can serve as a model. Patients can be involved as individuals, patient experts and organisations, all having different roles that can be managed and supported.
More information about the HTA Regulation in the Commission website.
Presentations and recording of the EC HTA What’s next conference in the Commission website.