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Wednesday, February 14, 2007

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:

Data exclusivity —the granting of exclusive rights to commercial companies over clinical and preclinical trial data— could jeopardize efforts to create generic versions of life-saving medicines and harm public health....[D]ata exclusivity could impede efforts to produce generic versions of the "flu drug" oseltamivir in the event of a global flu pandemic, and data exclusivity is already preventing patients from getting access to generic HIV medicines.

Before registering a pharmaceutical product and allowing it on the market, regulatory authorities verify its quality, safety, and efficacy. In the case of a new medicine, safety and efficacy are established via preclinical and clinical trials; hence submission of the trial data is an important prerequisite for registration. Because of data exclusivity, regulatory agencies cannot rely on clinical data from the company that originally registered the drug to approve the marketing of the generic, and so these generic manufacturers must carry out their own safety and efficacy studies.

Generic manufacturers are thus obliged to repeat clinical and preclinical trials —something that takes time and is costly. More importantly, says Ms Timmermans, "the repetition of clinical trials raises serious ethical questions, since it would imply withholding medicines that are already known to be effective from some patients (the control group), solely for commercial purposes...."

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.