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Open Access Highly Accessed Commentary

Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data

Daniel Strech12* and Jasper Littmann3

Author Affiliations

1 CELLS – Centre for Ethics and Law in the Life Sciences, Hannover Medical School, Carl-Neuberg Str. 1, 30625, Hannover, Germany

2 Institute of Biomedical Ethics, University of Zurich, Switzerland

3 University College London, London, UK

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Trials 2012, 13:100  doi:10.1186/1745-6215-13-100

Published: 2 July 2012

Abstract

For the protection of commercial interests, licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence. Their respective policies on data transparency, however, lack a systematic account of (1) what kinds of commercial interests remain relevant after market approval has been granted, (2) what the specific types of public interest are that may override these commercial interests post approval, and, most importantly, (3) what criteria guide the trade-off between public interest and legitimate measures for the protection of commercial interest. Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.