PhRMA speaks out against compulsory licensing in India Posted 13/04/2012

The decision by the Indian government to issue a compulsory licence for the first time has led the research-based pharmaceutical industry to raise concerns regarding research and innovation.

The 2005 Indian Patents Act provides broad grounds for issuing a compulsory licence including: a) the reasonable requirements of the public with respect to the patented invention have not been satisfied or; b) it is not available to the public at a reasonably affordable price and; c) the patent is not being worked. The recent issuing of Natco with a compulsory licence for sorafenib by the Indian government is a rare instance globally where a general compulsory licence has been issued, not bound by ‘government use’ provisions or those allowed only in cases of ‘extreme urgency’ or ‘national emergency’.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the industry group representing innovator companies, said that ‘While India has not routinely issued compulsory licenses, PhRMA believes it is not an appropriate tool even if granting compulsory licenses may be a legal option. Assessments of particular compulsory licensing policies and decisions need to be made on a case-by-case basis, taking into account a number of factors. Legitimate health emergencies that require making exceptions to intellectual property rights can and should be accommodated under the international framework, but only after exhausting all other efforts and under extraordinary circumstances.’

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