HOW WILL MEMBER STATES USE IT? NATIONAL UPTAKE AND THE "DUE CONSIDERATION" OF JOINT CLINICAL ASSESSMENT
Author(s)
Hend Jdidi, DMD1, Mahbouba Boualleg, Bioengineer1, Lylia Chachoua, PharmD2, Mondher Toumi, MSc, PhD, MD3.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3Aix-Marseille University, Marseille, France.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3Aix-Marseille University, Marseille, France.
OBJECTIVES: A joint assessment only matters if national systems actually use it. The Regulation requires Member States to give due consideration to JCA reports while leaving final conclusions to them. This study examined what that duty requires, how uptake can be observed, and what could undermine it.
METHODS: A legal and policy analysis used Regulation (EU) 2021/2282 (notably Article 13 on due consideration and documentation, and Recital 31 on the non-binding character of reports), the Article 31 reporting obligations, and comparative experience from voluntary HTA cooperation. The analysis examined the documentation and transparency duties through which uptake is to be demonstrated.
RESULTS: The review found that due consideration is a duty of process, not of outcome: Member States must take the JCA report into account and document how, but may still reach different conclusions. This design preserves national competence yet leaves uptake difficult to verify and easy to satisfy formally. Several factors may weaken effective use, including divergent national appraisal methods, the multi-PICO structure of reports (only part of which is nationally relevant), and the tension between confidentiality and transparent documentation of how a report was considered. Because reporting templates were not yet standardised, early uptake evidence risks being heterogeneous and hard to compare across Member States, limiting the framework's central promise of reduced duplication.
CONCLUSIONS: Reduced duplication depends on genuine, not nominal, uptake. Standardised reporting on how JCA reports are used, and why national conclusions diverge, would let the Article 31 review distinguish real adoption from box-ticking.
METHODS: A legal and policy analysis used Regulation (EU) 2021/2282 (notably Article 13 on due consideration and documentation, and Recital 31 on the non-binding character of reports), the Article 31 reporting obligations, and comparative experience from voluntary HTA cooperation. The analysis examined the documentation and transparency duties through which uptake is to be demonstrated.
RESULTS: The review found that due consideration is a duty of process, not of outcome: Member States must take the JCA report into account and document how, but may still reach different conclusions. This design preserves national competence yet leaves uptake difficult to verify and easy to satisfy formally. Several factors may weaken effective use, including divergent national appraisal methods, the multi-PICO structure of reports (only part of which is nationally relevant), and the tension between confidentiality and transparent documentation of how a report was considered. Because reporting templates were not yet standardised, early uptake evidence risks being heterogeneous and hard to compare across Member States, limiting the framework's central promise of reduced duplication.
CONCLUSIONS: Reduced duplication depends on genuine, not nominal, uptake. Standardised reporting on how JCA reports are used, and why national conclusions diverge, would let the Article 31 review distinguish real adoption from box-ticking.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR94
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas