Patents and public health concerns

Siddharth Narrain

THE WTO AND INDIA'S PHARMACEUTICALS INDUSTRY — Patent Protection, TRIPS, and Developing Countries: Sudip Chaudhuri; Oxford University Press, YMCA Library Building, Jai Singh Road, New Delhi-110001. Rs. 650.

THE WTO AND INDIA'S PHARMACEUTICALS INDUSTRY — Patent Protection, TRIPS, and Developing Countries: Sudip Chaudhuri; Oxford University Press, YMCA Library Building, Jai Singh Road, New Delhi-110001. Rs. 650.  

The Patents Act, passed by Parliament in March 2005, brought into sharp focus the debate around the patents regime in India. The relatively low cost of drugs in India is a result of the Indian Government's replacement of the British drafted Patents and Designs Act by the Patents Act, 1970.

The Act, which created favourable conditions for the growth of the generic pharmaceutical industry in India by providing for a process patent regime, was a farsighted legislation that changed the landscape of India's pharmaceuticals industry and helped to bring down the cost of drugs drastically. However, after TRIPS (Agreement on Trade Related Intellectual Property Rights) was made part of the World Trade Organisation (WTO) negotiations, India was under an obligation to switch to the product patent regime by January 2005.

Opposition to the inclusion of TRIPS in the WTO process erupted in the form of protests at the WTO's Seattle Ministerial Conference in 1999. The gravity of public health concerns of the developing world was finally acknowledged in the Doha Ministerial in 2001 in the form of the Doha Declaration, which recognised the effects of intellectual property protection on rising drug prices.

Stressing that the TRIPS agreement does not prevent members from taking measures to protect public health, the Doha Declaration reaffirmed the right of WTO members to use flexibilities within TRIPS to promote access to medicines for all.

However, developing countries have continued to exert pressure on individual countries to prevent them from using mechanisms that TRIPS provides to meet their public health concerns.

Thus, people all over the world were carefully following the debate in Parliament around the Patents Act of 2005, especially since the legislation would have an enormous impact on the future of Indian generic manufacturers who had become one among the largest producers of low cost drugs in the world.

Emphasising that it is the patent system and marketing power that are at the root of the worldwide dominance of multinational pharmaceutical companies, Chaudhuri looks at the impact of the Indian Patents Act on the future of the Indian pharmaceuticals industry.

The book highlights the role of the public sector in India in aiding indigenous efforts in the private sector. After the changes in the patent law, the indigenous sector spurred large-scale production of bulk drugs, which peaked in the 1990s. Indian pharmaceutical companies began producing drugs at a fraction of their international prices, thus becoming recognised as low-cost producers of quality drugs.

The book looks at the problems with the Patents Act especially at crucial aspects like compulsory licensing provisions that the Act does not address. Evaluating the design of the new law, the author concludes that the framers of the legislation have not done enough to take advantages of TRIPS' flexibilities.

The author looks at how the Free Trade Agreements that the U.S. is negotiating with a number of developing countries to limit the use of compulsory licences to national emergencies and `to public no commercial use', thus narrowing the scope of the flexibilities that the Doha Declaration allows for.

The United States Trade Representative, through Section 301 of the United States Trade Act of 1974, issues a yearly report putting countries on a watch list and threatens them with trade sanctions for their failure to protect intellectual property rights of U.S. companies.

The book looks at the pressure on the Indian Government to implement data exclusivity measures, a development that has taken place post the patents legislation. If India succumbs to this pressure and implements these measures, it will mean that generic companies can be prevented from using data related to the safety and efficacy of products that are submitted by the innovator company, thus preventing generic companies from using this data till the data exclusivity period ends.

Though drug price control mechanisms in India have contributed to keeping drug prices at an affordable rate, Chaudhuri says that price control is not a substitute for generic competition and a price control mechanism alone is unlikely to keep prices down in a product patent regime.

The book examines the crucial question of whether developing countries should provide product patent protection for pharmaceuticals at all. The book looks at TRIPS as a political instrument enacted by the developed world — an agreement that needs to be fundamentally altered, if not totally abolished to stop developing countries from being forced into providing product patent protection.

The author touches upon alternative models that governments could use to promote Research and Development (R&D) while keeping the prices of drugs at an affordable rate. One wishes that the author had gone into some detail about these alternatives.

But what the author has done successfully is to approach the debate on patents from a public health perspective; a viewpoint that was missing from most media reports around the time the Patents Act was debated and passed.

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