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This study investigates the legal implications of the EU Health Technology Assessment (HTA) regulation, specifically focusing on disparities in patient population, intervention, comparator, and outcomes (PICOs) across member states and the management of conflicts of interest (CoIs) in joint clinical assessments (JCAs). The analysis suggests that PICO disparities can justify non-consideration of JCA reports at the national level, while strict CoI management may disadvantage member states with fewer experts. These issues could increase the workload for developers and national HTA bodies, potentially delaying patient access.
Disparities in PICOs across EU member states and strict conflict of interest management in JCAs may lead to increased workload for health technology developers and national HTA bodies, potentially delaying patient access to new technologies.
Joint clinical assessments (JCAs) under the European Union (EU) Regulation 2021/2282 on health technology assessment (HTA-R) and its implementing regulations have been linked to various implementation challenges. However, legal implications of practically relevant issues have mostly remained unexplored. This study investigated potential legal implications of disparities regarding patient population, intervention, comparator, and outcomes (PICOs) in JCAs from respective member states (MSs), and of managing conflicts of interest (CoIs) of experts involved in a JCA. Moreover, we discussed potential consequences for patient access. JCA reports are not legally binding for MS; PICO disparities can underpin the required justification for their non-consideration at national level. Legal action against negative reimbursement decisions due to unjustified non-consideration falls under national jurisdiction. Furthermore, too strict CoI management might leave perspectives of MSs with fewer experts and thus a higher chance of CoI occurrence unheard, requiring corresponding expert elicitation at national level. These implications might lead to an increased workload for health technology developers and national HTA bodies, potentially fostering marketing strategies and access delays. Thorough scoping processes and prioritising the need for a JCA's scientific excellence could facilitate more streamlined national HTA procedures and accelerated patient access.
