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India Plans Another Round of Compulsory Licenses
India’s Department of Pharmaceuticals has begun the process of issuing compulsory licenses to three more drugs.
This time targeting Roche’s breast cancer med Herceptin (trastuzumab) as well as the leukemia treatment Sprycel (dasatanib) and breast cancer drug Ixempra (ixabepilone) from Bristol Myers-Squibb.
This is the second time India has pursued compulsory licensing in order to make a drug more widely available to its citizens, the first being in March when it awarded a compulsory license to Natco Pharma to manufacture Bayer’s liver cancer drug, Nexavar. Since then the generics firm Cipla has also begun manufacturing the drug, cutting the price by nearly 75 percent.
Compulsory licensing is legal in India under sections 84 and 92 of the Indian Patents Act, 1970, in cases where the drug is either unavailable or unaffordable to the general population. Roche have been accused of “predatory pricing” of trastuzumab by the Campaign for Affordable Trastuzumab, who wrote an open letter to the Prime Minister in November, signed by cancer survivors, women’s groups, human rights and health rights activists, calling for the breast cancer treatment to be made more widely available.
Roche had taken some steps to increase access to Herceptin, arranging a deal in March with Indian manufacturer Emcure Pharmaceuticals to produce the drug for sale at a lower price. However, consultant oncologist at Sir Ganga Ram Hospital Dr. Shyam Aggarwal hailed the government’s move, remarking that “even after the recent cut in the prices of trastuzumab and dasatinib, they are still way too expensive for the common man. It is a very good move that will not just benefit Indians but possibly bring down cancer drug prices in countries where the pharma market is not controlled by the US or western European nations”.
This is not the only setback big pharma has had to endure in the last year from an increasingly hostile Indian government: the Indian Health Ministry announced in October that its states will no longer issue new licenses for the manufacture or sale of branded drugs, and there have been a slew of patent revocations on medications such as Pfizer’s cancer med Sutent, Roche’s Hep C drug Pegasys, and Merck’s asthma treatment.
India may not be the only country to be considering compulsory licenses; China recently amended its own intellectual property laws in order to facilitate compulsory licensing in cases of state emergencies, unusual circumstances, or when it is in the public interest. What pharma will be wondering now is, where will the axe fall next?
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