The European Union’s Health Technology Assessment Regulation (EU-HTA R) Will Prosper Despite Major Setbacks

  1. Mondher Toumi
  2. Imen Soussi
  3. Bruno Falissard
  4. Steven Simoens
  5. Asma Jouini
  6. Marteen Postma
  7. Joergen Wasem
  8. Oriol Sola Morales
  9. Laurent Boyer
  10. Claude Dussart
  11. Boris Borislav
  12. Renato Bernadini
  13. Stefano Capri
  14. Jaime Espin
  15. Pascal Auquier
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Abstract

The European Parliament, in its resolution of March 2nd, 2017, on European Union (EU) options for improving access to medicines, called on the Commission to propose legislation on a European system for health technology assessment (HTA) to harmonize transparent HTA criteria to assess the added therapeutic value and relative effectiveness of health technologies compared with the best available alternative (1). In December 2021, the EU-HTA R, formally known as ‘Regulation (EU) 2021/2282 of the European Parliament and of the Council of December 15th, 2021’ (2), on HTA and amending Directive 2011/24/EU (3) was adopted. It entered into force with implementation starting in January 2022 for oncology products and advanced therapeutic medicinal products (ATMP) in January 2028 for orphan designated products and in January 2030 for all products.

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  1. Version published to 10.20944/preprints202508.0274.v1