March 23, 2005 - The Indian Parliament has passed a new law to become compliant with the World Trade Organization (WTO)'s Agreement on Trade-related Aspects of Intellectual Property Rights. Doctors Without Borders/Médecins Sans Frontières (MSF) is deeply concerned that the new law will result in people in the developing world being cut off from the vital source of affordable generic versions of essential medicines produced in India.
To date, the supply of affordable medicines from India has only been possible because Indian law previously had no product patent constraints. This has been particularly important for the antiretroviral (ARV) medicines for the treatment of HIV. Of the 700,000 people estimated to be on ARV treatment in developing countries, approximately 50% rely on Indian generic production.
The new law makes it easy for multinational pharmaceutical companies to get patents granted, while making it difficult for generic companies to get compulsory licenses to override patents when necessary for public health or other reasons. Although a "worst-case scenario" was averted in the passage of this law due to widespread civil society pressure within India and around the world - for example, generic medicines already on the market in India will still be able to be produced, even if patents are granted, although generic producers will be required to pay licensing fees to the patent owner - the law is deeply worrying for all new drugs that will be subject to patentability in India in the future. Especially concerning are provisions on scope of patentability, the period of examination of patent applications, and compulsory licensing.
Today, MSF treats more than 25,000 people living with HIV/AIDS worldwide, and roughly 70% of our patients take Indian generic medicines. The low cost and user-friendliness of these WHO-recommended combination pills has allowed MSF to increase the numbers of people on treatment dramatically over the past three years. We fear that once these patients, and hundreds of thousands of others like them in developing countries, need second-line treatment, the restrictions in the law will create unnecessary hurdles and delays in the production and export of affordable generic versions of new medicines, putting much-needed treatments out of reach for individuals and communities who need them.
MSF will continue to work with those in India and elsewhere in order to minimize and document the negative consequences of this new law on the affordability and availability of medicines for our patients and millions of other poor people with HIV/AIDS and other illnesses.