The potential impact of the unitary Supplementary Protection Certificate on access to health technologies analysis of regulatory proposals

Open Access
Authors
  • T. De Jong
  • B. Kamphuis
  • S. Bostyn
  • A. Radauer
Publication date 09-2023
ISBN
  • 9789284811243
ISBN (electronic)
  • 9789284811236
Series Study
Number of pages 86
Publisher Brussels: European Parliament, Directorate-General for Internal Policies of the Union
Organisations
  • Faculty of Law (FdR) - Institute for Information Law (IViR)
Abstract In April 2023, the European Commission adopted regulatory proposals introducing a Unitary Supplementary Protection Certificate (SPC) and a centralised assessment procedure for SPCs for medicinal products. This study analyses the potential impacts of these proposals on access to medicines, the administrative burden to applicants and the cost to national health systems.This document was prepared by Policy Department for Citizens' Rights and Constitutional Affairs at the request of the JURI Committee.
Document type Report
Language English
Published at https://doi.org/10.2861/836176
Downloads
IPOL_STU(2023)753104_EN (Final published version)
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