One Europe, Many Patients: A Call to Action to Make EU HTAR More Inclusive in Practice

The European Union (EU) Health Technology Assessment Regulation (HTAR) centralizes clinical evaluation of new health technologies via joint clinical assessment (JCA). At its core, HTAR aims to promote more equal and timely access to evidence-based healthcare. However, without structured, resourced, and transparent mechanisms to incorporate diverse patient perspectives, particularly during scoping and evidence interpretation, the HTAR risks perpetuating existing health inequities across the EU. Although the value of patient involvement in EU JCAs is widely recognized, most discussions stop short of addressing patient diversity. Diverse patient involvement is a critical driver for closing health inequalities, provided it moves from past tokenism into genuine evidence co-production and impact on decision-making. Thus, diverse patient involvement must be treated as an ethical and methodological necessity rather than a box-ticking exercise. This has already been recommended by patient organizations as one of their recommendations to ensure meaningful patient input in the JCA process. To achieve the required level of patient diversity in EU JCAs, we propose five system-level actions: (1) make patient groups that represent the interests of diverse populations an integral part of PICO scoping methodology; (2) provide resources to address language and literacy challenges; (3) standardize patient evidence templates and quality criteria aligned with existing guidance; (4) publish patient outcomes and context data with the JCA report; and (5) add patient impact statements to the JCA report. We acknowledge the need for a level of investment to overcome logistical barriers to this effort, and observable indicators to measure whether patient perspectives truly shape JCA processes. This blueprint for action provides an opportunity for the HTAR’s principles to fully reflect Europe’s diversity.