As a last resort in its patent tangle with Swiss pharma giant Novartis, India may take a clue from the Thai Government's successful intervention to make available life-saving drugs at affordable prices by issuing compulsory licensing.
Having conveyed open requests to Novartis to withdraw the case against Indian patent law over its cancer pill Gleevec pending in the Chennai High Court, the Union Health Ministry is closely watching the developments and does not rule out invoking compulsory licence.
Officials in the ministry are weighing the options in the wake of the widespread support from across the globe to Thailand's steps and pressure from the public interest groups in India, it is learnt.
Enshrined in Article 31 of the WTO agreement on TRIPS, a compulsory license allows a government, to either produce or authorize someone else to produce a patented drug without the consent of the patent holder in the event of a national emergency, extreme urgency or for non commercial public use. Compulsory licenses are a legally recognised means to overcome barriers in accessing affordable medicines.
Union Health Minister Dr Anbumani Ramadoss himself recently made it clear that the Government would be forced to resort to the step as the last choice. "Till now, India has not used compulsory licensing and we do have no immediate intention of using it. But, don't force us to use it," he said recently, while commenting on the possibility.
The 2001 WTO Doha declaration on TRIPS and Public Health extended support to any government to use TRIPS flexibilities to overcome the barriers posed by patents. All governments in the WTO, including the United States, agreed to as much at Doha, clearly stating that "Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted."
After two years of failed attempts to negotiate affordable prices on patented drugs with pharmaceutical companies, the Thai government issued compulsory licenses on three drugs in the last few months. This allowed Thailand to import affordable, safe and effective generic versions of the patented drugs from other countries or produce them on their own through their Government Pharmaceutical Company (GPO). The move has reportedly proved successful. Before the issuing of compulsory licence Thailand was spending 10 times more on first line drug regimen, it is assessed.
The first license was issued on November 29, 2006 for the HIV/AIDS medicine, efavirenz (patented by Merck and sold by the brand name of Storcin). This was followed by additional compulsory licenses on January 26, for the heart disease drug clopidogrel (patent holder is sanofi-aventis who sells it by the brand name of Plavix) and the HIV/AIDS drug, lopinavir/ritonavir (patent holder is Abbott who sells it by the brand name Kaletra).