July 6, 2011

Global Safety Monitoring Of HIV Drugs Is Essential

With increasing numbers of people worldwide"”5 million in 2010"”on antiretroviral drugs for the treatment of HIV, the International Forum for Collaborative HIV Research recommends that improved and sustained global drug safety monitoring, including monitoring for substandard products, drug diversion, inappropriate use, and toxicity, is critical.

Writing in this week's PLoS Medicine, the Forum reports on a meeting in which key stakeholders from the UN and government agencies, donors, industry, academia, multilateral organizations, and implementers discussed the creation of a sustainable global pharmacovigilance system for antiretroviral drugs.

While all participants claimed that they were dedicated to establishing global pharmacovigilance, important contrasting priorities and values among stakeholders, such as national sovereignty versus regional and international collaboration, confidentiality of safety data versus need for transparency and public access, and generic versus innovator antiretroviral manufacturers remain barriers to progress.

The Forum authors state: "Many stakeholders with substantial interests are still not routinely at the table. Most prominently, the pharmaceutical industry, both innovator and generic, are not included, although both sets of institutions have substantial investment in global infrastructure, personnel, data management, databases, and other resources that could be purposed, at least in part, to sustaining global pharmacovigilance systems in [resource-limited settings]."

The Forum concludes: "Recognition, understanding, and respect for these contrasts is a pathway for increased collaboration and cooperation that will then lead to a sustainable system involving all stakeholders including industry and experienced regulatory agencies."


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