Legal implications of joint clinical assessments under the EU HTA regulation

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.