Gilead’s License on Hepatitis C Drugs, Sofosbuvir and Ledipasvir: a Fool’s Bargain

On September 14, 2014, Gilead announced a voluntary license (VL) agreement with seven Indian drug manufacturers. The agreement will allow these companies to produce and sell generic versions of sofosbuvir (Sovaldi©) and ledipasvir, Gilead’s direct-acting antiviral (DAA) medications for hepatitis C virus (HCV), in 91 countries. But Gilead’s license excludes countries where 73 million people with HCV live, and prevents them from receiving more affordable generic treatment. Thus, Gilead’s licensing agreement leaves out 46% of people who need HCV treatment worldwide.

Globally, an estimated 185 million people have HCV. Each year, nearly 500,000 of them die from HCV-related complications, such as liver cancer and liver failure. But hepatitis C can be cured, which dramatically reduces the risk of liver-related illness and death. In clinical trials of sofosbuvir and ledipasvir, the combination has demonstrated high cure rates and improved safety and tolerability, compared to the previous standard of care.

Gilead claims their priority is to “increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means,” but their HCV license actually creates a barrier to universal access by excluding many middle-income countries (MICs) and high-income countries (HICs), by controlling generic competition and segmenting markets. Even in countries where generic sofosbuvir can be sold, if Gilead fails to register its drug and get regulatory approval in that market, the drug cannot be made available there. Therefore, the license does not guarantee access even in the countries included in the geographical scope of the license.

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