Response to claim by USIBC on reported assurances given by Ministry on drug patents.

The National Human Rights Commission has served a notice on the Union Commerce Ministry over “private assurances” that were reported to have been given by it to a business advocacy group representing U.S. interests that India would go slow in granting Compulsory Licences (CLs) allowing domestic pharma companies to override patents held by Western drug-makers and make corresponding generic drugs that would be sold at cheaper prices.

The NHRC notice comes after reports that came in March that the United States-India Business Council (USIBC) had been verbally assured that India’s patent offices would take a restrained approach in handing out licences to produce cheaper, generic versions of drugs patented by American companies. It had also been reported that at least two applications for CLs to domestically produce generic versions of drugs patented in the U.S. were rejected in India last year.

The comments were revealed in a submission earlier this year by USIBC to the U.S. Trade Representative (USTR), which was in the process of reviewing global intellectual property laws for an annual report identifying trade barriers to U.S. companies. The USTR has placed India on its “priority watch list” for two years now, saying its patent laws favour the local drug industry in an unfair manner. “The NHRC is spot on; the Ministries are going slow [on clearing applications],” said Leena Menghaney, a lawyer campaigning for access to affordable medicines in India for cancer.

“The government’s decision… was hugely disappointing,” she added, pointing out that even after the high prices of the drug Dasatinib were documented the government did not act on the issue.

Dasatinib, the patent for which is held by the U.S.-based Bristol-Myers Squibb, is used to treat certain types of leukaemia. It was one of the drugs that the Ministry of Health and Family Welfare had recommended for the grant of CL.

“Health Ministry experts had been shown data from cancer hospitals — including army hospitals — to show that patients needed it. But the recommendation for CM was denied on the grounds that the patient cohort was too small,” Ms. Menghaney said.

The Commission has sought reports within two weeks from the Ministry of Commerce and Industry as well as of Health. In the notice, the NHRC states that the reported verbal assurances raise questions on issues that impinge on the right to health of citizens in India.

The notice points out that if the government, by invoking the provisions of the Indian Patents Act, grants CLs to manufacture particular drugs, that would increase access to affordable generic versions of the same drugs, bringing solace to thousands.

“Providing an affordable healthcare system is a basic [and] bounden duty of any government. It is a matter of concern that two applications for grant of compulsory licence to manufacture generic medicines for treatment of diabetes and cancer were rejected last year,” the Commission says.

In 2012, India denied a patent to German pharma giant Bayer for Nexavar, a “blockbuster” cancer drug for kidney and liver cancer. India granted a CL — it was the country’s first — to Natco Pharma, one of India’s leading generic producers, to manufacture Nexavar at a price that was 97 per cent less than what Bayer’s version cost, and the decision sent shock waves across the pharma industry worldwide.