Compulsory Licensing of Pharmaceutical Patents

Five years have gone by since the reintroduction of the product patent regime for pharmaceuticals and it is time public policy reckoned with the implications of local firms being debarred from producing and selling a patented drug even if they develop the processes of manufacturing the same, unless they are granted a compulsory licence (CL). The latter is a right granted by the government that allows parties other than the patent holder to produce and sell a patented product or use a patented process, without the consent of the patent holder. Even the Government of the United Kingdom, where neoliberalism was first conceived, takes advantage of CLs in order to reduce costs in the National Health Service, but the Government of India, which can also avail of CLs for non-commercial purposes, for example, to authorise the production of patented medicines for free or subsidised distribution in government hospitals, has not done so. The interests of the transnational pharmaceutical companies holding the patents seem more important than the public interest.

Indeed, in the aftermath of the “Doha Declaration on the TRIPS [Trade-Related Aspects of Intellectual Property Rights] Agreement and Public Health” of November 2001, a number of countries have issued CLs, some of them in the context of the HIV/AIDS crisis. For instance, Brazil, Ecuador, Kenya, Malaysia, South Africa, and Thailand have issued CLs for anti-HIV/AIDS drugs. India has around 25 lakh persons suffering from HIV/AIDS, but only 12% of them are being treated. The first generation drugs are now less effective, and it is time they are all administered the second and third generation drugs. The National AIDS Control Organisation can distribute these patented drugs to many more of those affected if the government takes advantage of CLs for non-commercial use. (Of course, a CL can also be granted for commercial purposes upon a potential licensee not being able to obtain a voluntary licence on reasonable terms and within a definite time frame.) Surprisingly, it is still not sufficiently clear, though there should have been no ambiguity on this count after the Doha Declaration (mentioned above), that “Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted”. The government now seems to be waking up to the implications of this Section 5(b) of the Doha