MEASURING ACTIVITY, NOT DELIVERY: RE-EXAMINING THE EU HTA REGULATION'S FOUNDING IMPACT ASSESSMENT
Author(s)
Mondher Toumi, MSc, PhD, MD1, Kamilia Ben Abdallah, Eng2, Anna Kapusniak, MSc3.
1Aix-Marseille University, Marseille, France, 2Clever-Access, Tunis, Tunisia, 3Clever-Access, Cracow, Poland.
1Aix-Marseille University, Marseille, France, 2Clever-Access, Tunis, Tunisia, 3Clever-Access, Cracow, Poland.
OBJECTIVES: A binding EU reform is only as sound as the impact assessment that justified it. The Joint Clinical Assessment (JCA) framework rests on the European Commission's 2018 Impact Assessment (SWD(2018) 41). This study examined whether that assessment was built to test whether the chosen instrument would work — or merely to confirm that it would operate.
METHODS: A retrospective policy analysis examined SWD(2018) 41 against the European Commission's Better Regulation requirements for impact assessment, focusing on the treatment of expected benefits, the analysis of risk, and the proposed monitoring framework. The Regulatory Scrutiny Board's opinions on the assessment were reviewed, and the proposed monitoring indicators were classified as activity-based or outcome-based.
RESULTS: The analysis identified a structural mismatch between what the assessment claimed and what it demonstrated. Expected benefits — earlier access, reduced duplication, lower developer costs, narrower access disparities — were asserted without articulating the causal mechanisms or the conditions on which they depended; several depend on national pricing and reimbursement decisions the framework does not touch. The risk analysis was inverted: it examined whether less-binding options would underperform, not whether the chosen instrument might itself fail, and it identified no remedial pathways or warning signals. Most consequentially, the proposed monitoring indicators were activity-based — assessments produced, reports published, meetings convened — rather than outcome-based, so an evaluation against them will conclude that the framework is operating regardless of whether it delivers. The Commission's own Regulatory Scrutiny Board flagged insufficient treatment of risks and uncertainties; clearance followed additional contextual text rather than substantive risk analysis.
CONCLUSIONS: An assessment that can only confirm activity cannot test delivery. The 2028 Article 31 review should rest on an independent, outcome-based ex-post study rather than the founding assessment's own activity metrics, since the analytical quality of that foundation also underpins the reform's proportionality case.
METHODS: A retrospective policy analysis examined SWD(2018) 41 against the European Commission's Better Regulation requirements for impact assessment, focusing on the treatment of expected benefits, the analysis of risk, and the proposed monitoring framework. The Regulatory Scrutiny Board's opinions on the assessment were reviewed, and the proposed monitoring indicators were classified as activity-based or outcome-based.
RESULTS: The analysis identified a structural mismatch between what the assessment claimed and what it demonstrated. Expected benefits — earlier access, reduced duplication, lower developer costs, narrower access disparities — were asserted without articulating the causal mechanisms or the conditions on which they depended; several depend on national pricing and reimbursement decisions the framework does not touch. The risk analysis was inverted: it examined whether less-binding options would underperform, not whether the chosen instrument might itself fail, and it identified no remedial pathways or warning signals. Most consequentially, the proposed monitoring indicators were activity-based — assessments produced, reports published, meetings convened — rather than outcome-based, so an evaluation against them will conclude that the framework is operating regardless of whether it delivers. The Commission's own Regulatory Scrutiny Board flagged insufficient treatment of risks and uncertainties; clearance followed additional contextual text rather than substantive risk analysis.
CONCLUSIONS: An assessment that can only confirm activity cannot test delivery. The 2028 Article 31 review should rest on an independent, outcome-based ex-post study rather than the founding assessment's own activity metrics, since the analytical quality of that foundation also underpins the reform's proportionality case.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA85
Topic
Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas