- Ganapati Mudur
India’s controller of patents has granted the country’s first compulsory licence on a patented drug, allowing a domestic drug company to manufacture a generic version of Bayer’s sorafenib tosylate (marketed as Nexavar), used in chemotherapy for hepatic and renal cancers.
Natco Pharma asked for the right to manufacture sorafenib tosylate, saying that it would make available a generic version that would cost patients 8800 rupees (£110; €135; $175) a month rather than the 280 000 rupees a month it costs for Bayer’s product. The controller granted the licence and ruled that Natco Pharma should pay Bayer a royalty fee of 6% on sales of the generic version.
Experts in public health who have been campaigning for better access to inexpensive generic drugs have hailed the controller’s decision, but sections of the pharmaceutical industry have said that compulsory licensing should be invoked only in public health emergencies and not to reduce the prices of drugs.
Bayer, which has the right to appeal, has said it is disappointed by the decision.
However, patient support groups are looking forward to more compulsory licences in other therapeutic areas. Yogendra Sapru, chief executive of the Cancer Patients Aid Association, said in a statement released after the controller’s decision this week, “Many other cancer medicines are sold at exorbitant prices in India.”
A single vial of patented trastuzumab (Herceptin), which is used in combination with paclitaxel to treat metastatic breast cancer, costs about 132 000 rupees in India, says a report from the Centre for Trade and Development, a policy think tank in New Delhi.
Malluparambil Santhosh, associate fellow at the think tank, said, “Herceptin chemotherapy in India is currently beyond the reach of the vast majority of patients who need it.”
A patented version of interferon used to treat hepatitis C virus infection is another example of a drug that most patients can’t afford, he said.
A senior health economist said that India will need to use all available tools to reduce prices of drugs given the government’s plans to introduce universal healthcare, including free drugs, announced last year (BMJ 2011;343:d6774, doi: 10.1136/bmj.d6774).
Sakthivel Selvaraj, an economist with the Public Health Foundation of India, New Delhi, said, “Compulsory licensing fits in with the goal of government procurement of drugs and distribution of free medicines for inpatient and outpatient healthcare.”
India changed its patent laws in 2005 to allow product patents on drugs, including the provision of compulsory licensing—as have other countries, as this is allowed under World Trade Organization rules. Brazil and Thailand have already used compulsory licences to make available antiretrovirals and anticancer drugs to their populations.
“India has been lagging behind on compulsory licensing despite huge expenses on drugs,” Dr Selvaraj told the BMJ. A nationwide survey of healthcare spending has shown that expenditure on drugs had accounted for about 68% of total personal spending on healthcare in India between April 2009 and March 2010.
The Organisation of Pharmaceutical Producers of India, which mainly represents international drug companies, has said that it has no objection to the use of compulsory licensing in a national emergency but believes that broadening its scope for “affordability” could result in the abuse of this provision.
India’s Association of Biotechnology Led Enterprises has said that it supports strong protection of intellectual property and opposes compulsory licences on “frivolous” grounds. “The government should clearly specify the criteria for issuing compulsory licences,” said Nandita Chandavarkar, its director of operations.
But health groups say that such reactions are predictable. “The idea that compulsory licensing should be limited only to emergencies is a myth promoted by multinational companies,” said Anand Grover, a director of Lawyers Collective, a non-government organisation that has represented cancer and HIV patients’ groups in court.
Mr Grover said that members of the World Trade Organization, including the United States and the European Union, had signed the Doha Declaration in 2001, which recognises the right to grant compulsory licences and the freedom to determine the grounds on which such licences are granted.
“India is likely to experience intense pressure from the developed countries and multinational corporations in the coming weeks to go slow on compulsory licensing,” said the Centre for Trade and Development’s Mr Santhosh.
Cite this as: BMJ 2012;344:e2132
Friday, March 16, 2012
Indian health groups welcome country’s first compulsory licence | BMJ