Banking on flawed drug voluntary licences

The Medicines Patent Pool is pushing for more VLs, but its bad deal with Novartis on a cancer drug shows the pitfalls

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IN DECEMBER, there was a sense of triumph in Geneva when it was announced that Hetero Drugs of Hyderabad had received the green light from the US Food and Drug Administration (FDA) for its generic version of nilotinib, a patented medicine of Swiss pharma giant Novartis that is used to treat chronic myeloid leukaemia. Hailing the FDA approval as "a landmark achievement" was the Medicines Patent Pool (MPP), a UN-backed public health organisation that is tasked with increasing access to life-saving medicines in low- and middle-income countries (LMICS). It was MPP that had given Hetero and three other selected drug companies a sub-licence to produce generic nilotinib through its voluntary licensing and patent pooling system. The irony is that nilotinib had ceased to be a patented drug 18 months earlier. So what was the celebration about?

Hetero was first off the blocks to get approval from the US drug regulator, and MPP was chuffed because it is the first time the agency got into oncology treatment. The UNsupported agency's initial mandate was to provide low-cost drugs to treat infectious diseases like HIV, hepatitis C and tuberculosis, but it had decided to expand its operations to non-communicable diseases (NCDS) such as cancer, diabetes and heart ailments. That might explain why FDA approval for Hetero's nilotinib was described as a milestone for the global health community, since it paved the way "for broader distribution of essential cancer medication under the VL [voluntary licence] mechanism".