Source: India Times, By: ET Bureau
NEW DELHI: The government has not closed the option of compulsory licensing, the ministry of commerce and industry has clarified in a press statement.
“India has a well-established TRIPS-compliant legislative, administrative and judicial framework to safeguard IPRs. Under the Doha Declaration on the TRIPS Agreement Public Health, each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted,” the statement said.
Compulsory licensing is when a government authorises a party other than the patent owner to produce the patented product or process, without the patent owner’s consent. This is largely resorted to in the case of public health emergency to make an expensive patented drugs available. India has issued its first compulsory licence in 2014 to NATCO for a cancer drug, ending the monopoly of German pharmaceutical company Bayer AG over the drug.
The commerce ministry also said that even though the government is conscious of the need to spur innovation and protect individual rights, it retains the sovereign right to utilise the flexibilities provided in the international IPR regime.
“It may be noted that to date, there has been only one case of compulsory licence in India and that too after a well-thought out and laid down process which was subsequently upheld right up to the highest Court of the land,” the ministry’s statement said.
The US-India Business Council (USIBC) in a report has said that India had given verbal assurance that it would not use compulsory licences for commercial purposes. Such a move would make it difficult for domestic pharma players to make cheap versions of patented drugs.
The pharmaceutical sector is one of the 25 focus areas of the government for its Make in India programme. India accounts for 20% of global exports in generics and it is the largest provider of generic medicines globally.Tags: compulsory licences, government, India, IP News, patent, WTO