OBLIGATIONS WITHOUT REMEDIES? APPEAL AND REVIEW PATHWAYS IN EU JOINT CLINICAL ASSESSMENT
Author(s)
Ines Abdelghani, Phd1, Meriem Fadhel, engineer1, Aleksandra Caban, Phd2, Pascal Auquier, Phd, MD3, Mondher Toumi, MSc, PhD, MD3.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Cracow, Poland, 3Aix-Marseille University, Marseille, France.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Cracow, Poland, 3Aix-Marseille University, Marseille, France.
OBJECTIVES: The JCA framework imposes heavy obligations and produces outputs that shape national decisions but offers almost no way to contest them. This study examined whether developers have meaningful redress, internal or external, against assessment reports and the procedural decisions behind them.
METHODS: A legal-policy analysis used Regulation (EU) 2021/2282, Commission Implementing Regulation (EU) 2024/1381, the Charter of Fundamental Rights (notably the right to an effective remedy), and the framework's procedural architecture. The availability and practical effectiveness of redress mechanisms were assessed across the assessment lifecycle, from scoping decisions to the final report, and compared with arrangements in other EU regulatory regimes.
RESULTS: The analysis identified a structural redress gap. The framework provides no internal administrative-review mechanism for procedural decisions (for example, scope determinations or completeness findings) and offers developers only a narrow factual-accuracy check on the draft report. Although the formal outputs are designated non-binding, they condition national appraisal and access in practice, so the absence of redress is operationally consequential. The availability of external judicial challenge against such outputs is doctrinally unsettled. The result is a system in which significant duties are imposed and influential outputs produced without a clearly articulated, practically accessible route to contest them raising predictability and legitimacy concerns relevant to developers and national authorities alike.
CONCLUSIONS: An internal review route with binding timelines, plus clarity on external challenge, would restore the balance between obligation and remedy. Accessible redress is a prerequisite for confidence in the framework independent of how good its methods are.
METHODS: A legal-policy analysis used Regulation (EU) 2021/2282, Commission Implementing Regulation (EU) 2024/1381, the Charter of Fundamental Rights (notably the right to an effective remedy), and the framework's procedural architecture. The availability and practical effectiveness of redress mechanisms were assessed across the assessment lifecycle, from scoping decisions to the final report, and compared with arrangements in other EU regulatory regimes.
RESULTS: The analysis identified a structural redress gap. The framework provides no internal administrative-review mechanism for procedural decisions (for example, scope determinations or completeness findings) and offers developers only a narrow factual-accuracy check on the draft report. Although the formal outputs are designated non-binding, they condition national appraisal and access in practice, so the absence of redress is operationally consequential. The availability of external judicial challenge against such outputs is doctrinally unsettled. The result is a system in which significant duties are imposed and influential outputs produced without a clearly articulated, practically accessible route to contest them raising predictability and legitimacy concerns relevant to developers and national authorities alike.
CONCLUSIONS: An internal review route with binding timelines, plus clarity on external challenge, would restore the balance between obligation and remedy. Accessible redress is a prerequisite for confidence in the framework independent of how good its methods are.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR158
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling, Coverage with Evidence Development & Adaptive Pathways, Insurance Systems & National Health Care, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas