Bangkok Post - February 7, 2007

This provision enabled India to become the undisputed generics manufacturing centre of the world, much to the displeasure of Western pharmaceutical companies.

Since April 2005, Indian patent law has been modified to adhere to TRIPS provisions that recognise international patents on drug products for a period of 20 years, unless it can be shown that the patents don't involve any "innovative molecular research" _ a provision fully within TRIPS guidelines.

Since the passage of the 2005 law, many generic drugs manufactured in India have been shut down. Yet India, like Thailand, is also being pressured to implement measures which it feels go beyond WTO guidelines. In a landmark case, the Swiss drug giant Novartis AG is appealing in an Indian court over the rejection of a patent for its modified leukaemia drug Gleevac on the grounds that it is not sufficiently innovative. The treatment costs for Gleevac and the generic copy per month are about US$2,000 and $175, respectively (about 70,000 and 6,125 baht). There are signs that the Indian parliament is bending to corporate pressure. It has introduced a report for court consideration which recommends a lessening of the degree of innovation required for a new patent. The worry is that a patent for most drugs could be extended merely by making minor modifications, as happens routinely in the US and other Western countries. This would represent a significant threat to accessibility of generic drugs not only in India, but throughout the developing world.

Another legal obstacle to generic drugs in India is looming. Multinational companies want to forbid generics manufacturers from using their data from clinical trials in proving the safety of drugs coming off-patent. This would make the licensing process for the generics much more time-consuming and expensive.

It is too simple to demonise multinational pharmaceutical companies. Some of them, including Novartis, have in some cases been willing to make life-sustaining drugs available to those most in need at little or no cost. As long as profit remains the bottom line, however, it is a sure thing that choices will be made which limit access to essential drugs, and diseases that affect mostly poor people, such as TB and malaria, will continue to be underfunded.

Perhaps what is really needed is a system that is driven by global health needs rather than by profit. Preliminary efforts toward this objective were begun at the World Health Organisation's World Health Assembly 2006. An inter-governmental working group was set up to develop a global strategy to address TRIPS-plus disputes. The working group was also charged with coming up with proposals on how to "ensure an enhanced and sustainable basis for health research" and direct research to address diseases that affect mostly developing countries, something that would require large increases in R&D spending by governments and international organisations.

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