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Data exclusivity for clinical trial data slows the development of generic drugs Karin Timmermans, Monopolizing Clinical Trial Data: Implications and Trends, PLoS Medicine, February 13, 2007. From the PLoS press release:
From the paper itself: [M]ore countries should resist demands that monopolize the use of clinical trial data and blur the boundaries between the intellectual property regime and regulatory requirements for pharmaceuticals. And the health sector should pay more attention to these developments outside its immediate purview, wake up to the far-reaching implications of these developments, and voice its concerns more widely and more effectively. Failing that, the battle for access to medicines will be lost on these new and little-known fronts. |