
The potential impact of the unitary Supplementary Protection Certificate on access to health technologies
28 September 2023
Summary
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.
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coronavirus public health eu law: legal system and acts evaluation of law and policy in practice eu member states