cover image: The potential impact of the unitary supplementary protection certificate on access to health technologies :Executive summary

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The potential impact of the unitary supplementary protection certificate on access to health technologies :Executive summary

26 Feb 2024

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.
pharmaceutical legislation european patent market approval codification of eu law health technology medicinal product

Authors

Directorate-General for Internal Policies of the Union, European Parliament, De Jongh, Thyra, Kamphuis, Bregtje, Bostyn, Sven, Radauer, Alfred

Catalogue number
QA-05-24-144-EN-N QA-05-24-144-EN-C
Citation
European Parliament, Directorate-General for Internal Policies of the Union, De Jongh, T., Kamphuis, B., Bostyn, S. et al., The potential impact of the unitary supplementary protection certificate on access to health technologies – Executive summary , European Parliament, 2024, https://data.europa.eu/doi/10.2861/928246
DOI
https://data.europa.eu/doi/10.2861/928246
ISBN
978-92-848-1648-4
Pages
8
Published in
Belgium
Themes
Law and justice , Pharmaceutical and cosmetics industry