Although the world’s pharmaceutical giants welcomed media rumblings indicating India would do away with its controversial policy, officials in New Delhi promptly quashed the rumors and reiterated its view that the compulsory licenses complied with the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS.
“There have been recent media reports that the Government of India has privately assured that it will not issue any more compulsory license,” the Commerce Ministry said. “It is hereby clarified that such reports are factually incorrect. India has a well-established TRIPS compliant legislative, administrative and judicial framework to safeguard IPRs.”
India’s compulsory licenses have drawn fire from the world’s leading drugmakers, which claim the country abuses the practice in a way that stifles innovation. On the other side, public health advocates have applauded the licenses for helping improve access to crucial medicines in impoverished areas.
The Indian government maintains it tackles compulsory licensing issues with its WTO obligations fully in mind.
“Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted,” the ministry said. “ Even as the government of India is conscious of the need to spur innovation and protect individual rights, it retains the sovereign right to utilize the flexibilities provided in the international IPR regime.”
According to the WTO, compulsory licenses are typically issued when negotiations for the patent holder to issue a voluntary license have failed. The patent holder still retains its rights, including the right to be paid for the authorized copies of its products.
Tensions have been running high between the U.S. and India over intellectual property for years, and the compulsory license issue has been among the chief bilateral irritants. The two nations even forged a high-level dialogue devoted exclusively to IP in 2014, but that has done little to quiet the criticism from industry.
In comments to the U.S. Trade Representative’s Office for this year’s Special 301 report on global IP barriers, the Pharmaceutical Research and Manufacturers of America tabbed India as one country that it believes is abusing the issuance of compulsory licenses, referred to as CLs in the comments.
“PhRMA members urge USTR and other federal agencies to closely monitor the consideration and use of CLs and to encourage decisions on public health grounds and through fair and transparent procedures that involve participation by all stakeholders,” the group said.
--Editing by Jill Coffey.