# The new European regulation on Health Technology Assessment: what changes for Advanced Therapy Medicinal Products ?

Blanka Bartos, Joséphine Juët, Florence Taboulet, Aurélie Mahalatchimy

► To cite this version:

Blanka Bartos, Joséphine Juët, Florence Taboulet, Aurélie Mahalatchimy. The new European regulation on Health Technology Assessment: what changes for Advanced Therapy Medicinal Products?. European Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom. halshs-03901269

HAL Id: halshs-03901269

https://shs.hal.science/halshs-03901269

Submitted on 15 Dec 2022

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# The new European regulation on Health Technology Assessment: what changes for Advanced Therapy Medicinal Products?

Blanka Bartos¹, Joséphine Juët², Florence Taboulet³, Aurélie Mahalatchimy⁴

¹PhD Student in law, CREDIMI, Univ. of Burgundy, Dijon, 27877, France, ²Student in Pharmaceutical Sciences, Univ. of Paul Sabatier- Toulouse 3, Toulouse, 31062, France., ³Professor in Pharmaceutical Law and Health Economics, CERPOP (Center for Epidemiology and Research in POPulation health), UMR 1295 Inserm, Univ. of Paul Sabatier- Toulouse 3, Toulouse, 31062, France., ⁴Permanent Researcher in law at the French National Centre for Scientific Research (CNRS), Faculty of Law, UMR 7318 International, Comparative and European law (DICE) CERIC, CNRS, Aix Marseille Univ., Toulon Univ. Pau & Pays de l'Adour Univ., Aix-en-Provence, 13628, France

**Acknowledgement:** This work has been supported by ANR-funded I-BioLex project (ANR-20-CE26-0007-01, coord. A. Mahalatchimy).

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## Remaining challenges:

* Building EU processes from national HTA experiences and feedback from experts

* Training more external expert / organisations on HTA in general, and on EU procedure(s)

* Organising HTA registries, raising awareness, collecting experiences

* Identifying / involving clinicians or patients (organisations' membership list, social networks, European Reference Networks, clinics in Pubmed...)

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