title: Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data.
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licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence.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.
authors: CELLS - Centre for Ethics and Law in the Life Sciences, Hannover Medical School, Carl-Neuberg Str, 1, 30625, Hannover, Germany. strech.daniel@mh-hannover.de
authors: Daniel
authors: D
authors: Strech
authors: Jasper
authors: J
authors: Littmann
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D016265:Conflict of Interest; D003257:Consumer Product Safety; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence* / Q000592:standards; D033161:Government Regulation; D017408:Guidelines as Topic; D019981:Health Care Sector / Q000331:legislation & jurisprudence* / Q000592:standards; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D061214:Patient Safety; D018570:Risk Assessment