A patent problem called anthrax

HARINDER SIKKA

 THE Canadian governments decision to manufacture the generic version of the antibiotic drug, Ciprofloxacin, has expectedly met with no voice of dissent from the patent holding MNC. Even the US government is understood to be considering inviting pharma companies from the third world in order to ensure availability of stocks of Cipro, for the simple reason that it accords the highest priority to the safety of its people and therefore deems it fit to overlook patent regulations.

Ironically, similar concerns have been regularly raised by India, Brazil and select African nations. In Africa, over 4.5 million people suffering from HIV/AIDS had to fight in unison against the draconian patent law in order to obtain a generic version of the anti-AIDS cocktail. Brazil, too, saved over US $450 million towards costs of treatment thanks to cheaper HIV-related drugs. The ground reality is that while anthrax could be a version of threat to life in one country, HIV/AIDS could be the cause of havoc in the second and malaria in the third.

The anthrax scare has only vindicated the stand of developing countries that the patents embargo on lifesaving drugs should be reviewed afresh by the WTO at the Doha summit later this week. Trade-related intellectual property rights (TRIPS), considered to be a brainchild of mighty US pharma-business lobbies, is currently under review. Under the hammer is the future of hundreds of companies as well as availability of life-saving drugs to the poor at affordable prices. Protection of Intellectual Property Rights (IPR) ideally should allow productive research and the free flow of ideas rather than put a cork on the bottle. In the past 30 years, the Indian pharma sector has grown from a mere Rs 200 crore to over Rs 12,000 crore through nearly 25,000 units.

This has been possible because each was allowed to bring out its own generic product while maintaining Good Manufacturing Practices (GMP). The competition thus generated, forced companies to lower their costs thereby making their products more affordable. It did have its ills but served the purpose to a great extent. Successful research in genomics and gene-based drugs brought out some harsh realities in the open, when it was found that many players were patenting what otherwise belonged to a nations inherited wealth. The resultant in-fighting among multinationals made both USA and UK admit that protection of its inherited wealth was a countrys moral right.

TRIPS, too, recognised this vital aspect but left too many loopholes in Article 31 for gene pirates to exploit. To start with India must seek a separate chapter on pharmaceuticals in the TRIPS agreement at Doha. This chapter must negotiate all the vital aspects and apprehensions of developing nations. Secondly, it should insist on reducing the life of a product patent from the existing 20 years and, third, it should support the idea of creation of a global fund under the aegis of WHO or World Bank, that could work out a system to compensate the expenses related to research.

There are other important issues, which could harm the long-term interests of developing nations like India and need to be reviewed. Article 27.3 (b) of the TRIPS Agreement, which is about exemption from the patentability, designed along the international convention for protection for planted variety. This article does not recognise the farmers rights to seeds but only the breeders right. India, therefore, should stand firm that the convention on bio-diversity resources that recognises farmers rights to be the basis of the article. Similarly, microorganisms and microbiological processes should be exempted from patentability. Issues related to technology transfer have not been adequately dealt with and is tilted in favour of patent holders something that does not serve the interest of poor nations.

Whether biotechnology and genetically modified organism (GMO) should be brought within the preview of discussions under WTO and TRIPS is yet another matter that needs to be addressed. The WTO must give due weightage to ethics. While there is no third umpire, its decisions as a referee would be closely viewed by millions of affected people in developing nations. India too must play its part with extreme caution to protect the interests of its people.

The writer is corporate president, Nicholas Piramal India Limited