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Industry and drug regulators disagree on which data should remain confidential

BMJ 2013; 347 doi: (Published 03 September 2013) Cite this as: BMJ 2013;347:f5390
  1. Nigel Hawkes
  1. 1London

Sharp differences of opinion have emerged over how much clinical trial data some drug companies are willing to release as the clock ticks down to the transparency deadline of 1 January 2014 set by the European Medicines Agency (EMA).

A meeting in Brussels late last month showed that the industry itself is split, despite the publication of a draft policy by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) which outlined the principles their members should follow.1

At the meeting one drug company representative, Neal Parker, of the US company AbbVie, broke ranks by asserting that some data on adverse drug reactions should be treated as commercially confidential.

AbbVie, a research based biopharmaceutical company which split off from Abbott at the beginning of this year, has already taken action in the courts to prevent the European Medicines Agency from releasing to …

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