Changes to India's patent law will impact prices of life-saving drugs

India's trade and investment policies, particularly balancing right to health with intellectual property and public health safeguards, are being questioned in a US investigation. With the threat of potential trade sanctions, Rohit Malpani, director of policy and analysis at Médecins Sans Frontières (MSF) - Access Campaign, an international humanitarian organization, made a case for access to treatment before the US International Trade Commission recently.He tells Rupali Mukherjee how pressure tactics may push up prices of generic medicines
What is at the centre of the growing trade dispute between India and US?
Much of the controversy surrounds the rejection or revocation of patents on medicines by the Indian patent offices and courts. The patented medicines at issue tend to be the ones priced far out of reach for most Indians (and developing countries). It highlights the tension between the commercial interests of big pharmaceutical companies, and the Indian patent office and judicial system's efforts to safeguard public interest by not blindly granting patents and injunctions that undermine access to low cost generic versions of medicines. Granting frivolous patents introduces monopoly rights on the medicine, restricting the entry of affordable versions, hence denying treatment to patients.
How is the US pressurizing India over its patent system?
It is a well-planned and well-orchestrated lobbying campaign led by big pharmaceutical companies with an intention to influence India's existing drug patent policies, which include a strict standard patentability criteria and provision for compulsory licenses. Compulsory licenses are a legally recognized means to overcome barriers in accessing affordable medicines, where a government allows a generic competitor to market a more affordable version of a patented drug on payment of royalties to the originator company.
This concerted effort has resulted in the launch of an investigation by the United States International Trade Commission against India looking at recent changes in trade and investment policies, and particularly on intellectual property (IP) enforcement. There is also a push by US industry associations to designate India as a "priority foreign country" under the Special 301 provision of the US Trade Act of 1974, with the aim of using the threat of trade sanctions to exert undue pressure on India.
What are the points in favour of India?
We firmly believe that the US pressure is unjustified. India's actions are fully compliant with the WTO agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Contrary to what the US pharmaceutical companies are claiming about very few patents on medicines being granted, MSF's own patent searches reveal that the country has granted patents on a number of new essential TB, HIV and Hepatitis C medicines that are in the pipeline.
Evergreening of patents is now a global crisis and India should not be targeted for initiating a long-awaited reform - the establishment of an independent patent examination system that addresses this problem. It is a common abusive patenting practice followed by pharmaceutical industry to extend patent terms by claiming separate patents relating to different aspects of the same medicine to gain further monopolies and block entry of generic versions. In the absence of such a system, patented medicines in South Africa, for example, can cost up to 35 times more than in countries like India.
Measures taken by India send a clear signal that the industry is too focused on business models to extend monopolies on existing medicines to discourage competition. By not rewarding these strategies, India will hopefully push companies to refocus energies on developing new medicines.
It has been established that India's patent regime is fully compliant with international trade laws. So why is the US still targeting India?
At the behest of the pharmaceutical industry, the US government is pushing countries to adopt tough US-style IP rules. Whether or not a rule like compulsory licensing is TRIPScompliant and is effective in bringing down drug prices by nearly 97% is not relevant for many US policy-makers.
In the US itself the high domestic cost of patented cancer drugs such as imatinib (marketed as Gleevec) is being described by oncologists as "simply too high." There is also considerable debate over the use of parallel importation - even from just Canada - to reduce medicine prices.
What are the implications for India and the rest of the developing world, if India rolls back the public interest provisions in its IP laws under US pressure?
India is a critical producer of affordable medicines, and competition among generic drug manufacturers here has brought down the price of medicines for HIV, TB and cancer by over 90%. Treatment providers like MSF rely heavily on generic medicines manufactured in India, known as the pharmacy of the developing world. Over 80%of all HIV medicines used by us are produced in India. Any changes that erode the safeguards included in India's patent law would keep medicine prices too high.