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

Sven Bostyn; Thyra De Jong; Bregtje Kamphuis; Alfred  Radauer

doi:10.2861/836176

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

Sven Bostyn, Thyra De Jong, Bregtje Kamphuis, Alfred Radauer

Faculty of Law Research Centres

Research output: Book/Report › Report › peer-review

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.

Original language	English

Place of Publication	Brussels
Publisher	European Union
Number of pages	87
ISBN (Print)	9789284811243
ISBN (Electronic)	9789284811236
Commissioning body	European Parliament
DOIs	https://doi.org/10.2861/836176
Publication status	Published - 2023

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Cite this

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title = "The potential impact of the unitary Supplementary Protection Certificate on access to health technologies: Analysis of regulatory proposals",

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.",

author = "Sven Bostyn and {De Jong}, Thyra and Bregtje Kamphuis and Alfred Radauer",

year = "2023",

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TY - RPRT

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T2 - Analysis of regulatory proposals

AU - Bostyn, Sven

AU - De Jong, Thyra

AU - Kamphuis, Bregtje

AU - Radauer, Alfred

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

U2 - 10.2861/836176

DO - 10.2861/836176

M3 - Report

SN - 9789284811243

BT - The potential impact of the unitary Supplementary Protection Certificate on access to health technologies

PB - European Union

CY - Brussels

ER -