Are sources of affordable generic medicines drying up?

India should ensure global access to medicines when implementing its patent law.

India's obligation, under WTO law, to grant 20-year patents on pharmaceutical products may place their reputation as a leader in the debates on patent barriers to access to medicines at risk unless Indian politicians use their power wisely. The lives of millions of people worldwide using affordable Indian medicines depend on India's future policies with regard to medicines patents. Nowhere is this more visible than in the case of HIV/AIDS treatment.

"Any amendments to the country's new patent law must safeguard not only the citizens of India, but also the millions of children, women and men in the developing world whose lives depend on access to affordable generic medicines," said Ellen 't Hoen.

As the Indian Parliament prepares to tackle the country's implementation of the World Trade Organization's (WTO) agreement regulating patents on medicines, Médecins Sans Frontières (MSF) is urging Indian decision makers to ensure that patients in developing countries will continue to have access to affordable medicines .

"MSF has examined the proposed amendments to India's Patents Act of 1970. We believe they will drastically restrict, perhaps even prevent, the production and supply of vital therapies by Indian pharmaceutical companies to other developing countries," said Ellen 't Hoen, Director of Policy Advocacy and Research with MSF's Campaign for Access to Essential Medicines.

In the past few years, India has played a pivotal role in supplying affordable generic versions of medicines used throughout the developing world. It has also been a leader in the debates on patent barriers to access to medicines at the WTO, fighting for measures in international patent rules that protect public health. But the country's obligation under WTO law to grant 20-year patents on pharmaceutical products may be putting this reputation at risk unless Indian politicians use their power wisely.

The lives of millions of people worldwide using affordable Indian medicines depend on India's future policies with regard to medicines patents. Nowhere is this more visible than in the case of HIV/AIDS treatment.

Of the 700,000 people currently receiving antiretroviral treatment in developing countries, an estimated 50% rely on Indian generic production. MSF now treats 25,000 people with antiretrovirals in 27 countries around the world, and roughly 70% of the patients in those programmes use medicines that originate in India.

Before generic drugs became widely available in 2001, similar treatments cost over US$10,000 per patient per year - 40 times more than the average price of ARV treatment in MSF programmes today (US$250). The availability of affordable fixed-dose combination therapy, or three-in-one pills, manufactured in India has revolutionised AIDS treatment in developing countries.

But providing this user-friendly form of treatment has only been possible because there are no patent constraints in India on combining these medicines in one tablet. After India and other developing countries with manufacturing capacity start granting patents, generic drug manufacturers can no longer produce generic versions of patented drugs. Most new drugs are likely to be patented, so sources of new low-cost medicines will dry up globally.

It is crucial that India allows production and export of generic versions of new medicines in the future. MSF urges the Indian policy makers to ensure that the proposed amendments to the 1970 Patent Act incorporate the full flexibilities and safeguards of the TRIPS Agreement and reflect the hard-fought outcome of the Doha Declaration on TRIPS and Public Health, which affirmed that "the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' rights to protect public health and, in particular, to promote access to medicines for all."

"MSF hopes that India will continue to demonstrate the kind of international leadership it has shown with the WTO Doha Declaration on TRIPS and Public Health thus far," 't Hoen said. "Any amendments to the country's new patent law must safeguard not only the citizens of India, but also the millions of children, women and men in the developing world whose lives depend on access to affordable generic medicines."