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


Strech, Daniel; Littmann, Jasper (2012). Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data. Trials, 13:100.

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licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence.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.

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licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence.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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Biomedical Ethics and History of Medicine
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2012
Deposited On:11 Feb 2013 16:21
Last Modified:07 Aug 2017 05:28
Publisher:BioMed Central
ISSN:1745-6215
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1186/1745-6215-13-100
PubMed ID:22747684

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