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, says Karin Timmermans of the World Health Organization (WHO) in an Essay in PLoS Medicine.
Writing in a personal capacity, Ms Timmermans says that data 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.
AdvertisementBefore 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. It is unlikely that withholding medicines in this way this would pass the scrutiny of ethical review committees, which renders it de facto impossible for generic companies to repeat the clinical trials."
Alternatively, generic manufacturers would have to postpone the launch of their product until the end of the exclusivity period. "Thus, data exclusivity can delay generic competition and the ensuing price reductions," says Ms Timmermans.
"More 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," she says, otherwise we will lose the battle for access to essential medicines.