REVISITING THE CASE FOR REFORM: THE IMPACT ASSESSMENT BEHIND THE EU HTA REGULATION
Author(s)
Asma Jouini, Biology Engineer1, Souha Zarai, Biology Engineer2, Lylia Chachoua, PharmD, PhD1, Pascal Auquier, PhD3, Mondher Toumi, MD, MSc, PhD3.
1Clever Access, Paris, France, 2Clever Access, Tunis, Tunisia, 3Aix-Marseille University, Marseille, France.
1Clever Access, Paris, France, 2Clever Access, Tunis, Tunisia, 3Aix-Marseille University, Marseille, France.
OBJECTIVES: Mandatory Joint Clinical Assessment (JCA) replaced voluntary EUnetHTA cooperation on the strength of one document: the European Commission's 2018 Impact Assessment (SWD(2018)41). This study reassessed the assumptions, evidence, and causal reasoning behind it to ask whether the expected benefits of making cooperation mandatory were adequately substantiated.
METHODS: A retrospective policy analysis was conducted using the European Commission's Impact Assessment, supporting studies, legislative documents, EUnetHTA outputs, and published evaluations of voluntary cooperation. The analysis focused on four policy assumptions: duplication reduction, administrative burden reduction, improved patient access, and enhanced consistency of clinical assessments. A theory-of-change framework was applied to examine whether the evidence presented supported the transition from voluntary to mandatory cooperation.
RESULTS: The review identified significant asymmetries between the evidence presented and the policy conclusions reached. Evidence supporting duplication of assessments was substantial; however, evidence demonstrating that mandatory cooperation would necessarily reduce delays in patient access was limited. Much of the observed variation in access originated from national pricing, reimbursement, and budgetary decisions rather than from clinical assessment duplication alone. Similarly, evidence that methodological divergence represented a systemic failure requiring regulatory intervention was mixed. The analysis suggests that the Impact Assessment relied heavily on assumptions regarding behavioural change by Member States following centralisation of clinical assessment activities. Several anticipated benefits therefore depended on causal pathways that were not empirically demonstrated at the time of adoption.
CONCLUSIONS: The case for cooperation is sound; the case for making it mandatory rested on less evidence than often assumed. The Article 31 review should test those original assumptions directly, and check whether the promised benefits have materialised.
METHODS: A retrospective policy analysis was conducted using the European Commission's Impact Assessment, supporting studies, legislative documents, EUnetHTA outputs, and published evaluations of voluntary cooperation. The analysis focused on four policy assumptions: duplication reduction, administrative burden reduction, improved patient access, and enhanced consistency of clinical assessments. A theory-of-change framework was applied to examine whether the evidence presented supported the transition from voluntary to mandatory cooperation.
RESULTS: The review identified significant asymmetries between the evidence presented and the policy conclusions reached. Evidence supporting duplication of assessments was substantial; however, evidence demonstrating that mandatory cooperation would necessarily reduce delays in patient access was limited. Much of the observed variation in access originated from national pricing, reimbursement, and budgetary decisions rather than from clinical assessment duplication alone. Similarly, evidence that methodological divergence represented a systemic failure requiring regulatory intervention was mixed. The analysis suggests that the Impact Assessment relied heavily on assumptions regarding behavioural change by Member States following centralisation of clinical assessment activities. Several anticipated benefits therefore depended on causal pathways that were not empirically demonstrated at the time of adoption.
CONCLUSIONS: The case for cooperation is sound; the case for making it mandatory rested on less evidence than often assumed. The Article 31 review should test those original assumptions directly, and check whether the promised benefits have materialised.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA314
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas