When Coordinators Legislate: The HTA Coordination Group’s Guiding Principles on Data Transparency and the Limits of Institutional Self-Empowerment

Mondher Toumi, Aurélie Mahalatchimy (), Tamara K. Hervey (), Frank-Ulrich Fricke (), Laurent Boyer, Pascal Auquier (), Maarten Postma (), Anna Kapuśniak, Juergen Wasem, Jaime Espin (), Borislav Borissov, David Danko, Renato Bernardini and Stefano Capri
Additional contact information
Mondher Toumi: AMU - Aix Marseille Université
Aurélie Mahalatchimy: DICE / CERIC - Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC) - DICE - Droits International, Comparé et Européen - AMU - Aix Marseille Université - UTLN - Université de Toulon - CNRS - Centre National de la Recherche Scientifique
Tamara K. Hervey: University of London [London]
Frank-Ulrich Fricke: TH Nürnberg - Technische Hochschule Nürnberg Georg Simon Ohm = Georg Simon Ohm University of Applied Sciences Nuremberg [Germany]
Laurent Boyer: Hôpitaux Sud - Département Universitaire de Psychiatrie - [Hôpital Sainte Marguerite - APHM] - AMU - Aix Marseille Université - APHM - Assistance Publique - Hôpitaux de Marseille - Hôpitaux Sud - Hôpital Sainte-Marguerite [CHU - APHM], Fondation FondaMental [Créteil]
Pascal Auquier: CEReSS - Centre d'études et de recherche sur les services de santé et la qualité de vie - AMU - Aix Marseille Université
Maarten Postma: University of Groningen [Groningen]
Borislav Borissov: Prescriptia Ltd, Sofia, Bulgaria;
David Danko: Weill Cornell Medicine [Cornell University] - CU - Cornell University [Ithaca, NY, USA]
Renato Bernardini: Unict - Università degli studi di Catania = University of Catania

Working Papers from HAL

Abstract: On 14 May 2026, the Member State Coordination Group on Health Technology Assessment (HTA Coordination Group) adopted Guiding Principles on Data Transparency under Article 3(7), points (c) and (h), of Regulation (EU) 2021/2282. The document opens with a disclaimer of legal force; its operational architecture, a self-authored definition of ‘commercially confidential information', a categorical declaration that broad classes of clinical data are in general non-confidential, and a recourse procedure run by the same family of actors that produced the rule, has consequences that the disclaimer cannot dissolve. We argue that the Guiding Principles sit uneasily with EU lex specialis on commercial confidentiality and with case-by-case jurisprudence on disclosure; that, in producing them, the HTA Coordination Group has concentrated rulemaking, executive and quasi-judicial functions in a manner that engages the principle of conferred powers, the Meroni doctrine, and Articles 41 and 47 of the Charter; and that the corrective is institutional rather than substantive: the problem lies in how the rules were made and by whom, not only in their content.

Keywords: EU HTA regulation; joint clinical assessment; commercially confidential information; institutional balance; Meroni doctrine; soft law; charter of fundamental rights (search for similar items in EconPapers)
Date: 2026-06-30
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Persistent link: https://EconPapers.repec.org/RePEc:hal:wpaper:halshs-05723038

DOI: 10.20944/preprints202607.0096.v1

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