UNITAID, the world organisation that was launched in 2006 as an innovative mechanism for scaling up access to treatment for HIV/AIDS, tuberculosis and malaria, has expressed concern over the Free Trade Agreements that India is negotiating with European Union and Japan as that "may create new intellectual property obligations for India to increase antiretroviral (ARV) prices, impede the development of acceptable dosage forms, and delay access to newer and better ARVs.

Such measures can undermine the international goal to achieve universal access to HIV/AIDS interventions and the 2001 WTO Doha Declaration on TRIPS and Public Health. Rather than agreeing to inappropriate IP obligations, India and its trade partners - along with international organizations, donors, national governments, civil society, and pharmaceutical manufacturers - should ensure that there is sufficient policy space for the Indian generic industry to continue its central role in supplying developing countries with low-cost, quality-assured generic medicines, UNITAID said.

Expressing the global organisation's grave concern, especially in the wake of a global funding crisis in the area of AIDS, UNITAID executive secretary Jorge Bermudez has said that a new study reveals that Indian generic manufacturers have supplied more than 80 per cent of donor-funded AIDS medicines to developing countries in the last seven years. "The findings of this study raise grave concerns for us because UNITAID relies heavily on Indian generic manufacturers to supply quality-assured, patient-friendly, low cost AIDS medicines in over 50 countries," he said and added that "What we need today is a more flexible approach to scale up treatment and not the opposite."

The role of Indian generic manufacturers in supplying ARV medicines to developing countries, published by the Journal of the International AIDS Society, explains that a global trade agreement - known as Trade Related Aspects of Intellectual Property (TRIPS) - which has bound India to apply product patents since 2005 - has already begun to curtail the country's ability to produce low-cost generic versions of newer medicines. New trade agreements being currently discussed may further reduce India's vital role as provider of life-saving treatments, Bermudez said.

The study comes at a time when the World Health Organization (WHO) has introduced new recommendations for people living with HIV/AIDS to begin treatment earlier and to switch to newer medicines that are more robust and less toxic but also much more expensive. This means that more people than foreseen will need treatment today and in the next years and that the cost of treatment could skyrocket if the new products cannot be made available at the more affordable generic prices.

"If Indian manufacturers cannot meet these demands, a lot of the progress we have made in the last seven years will be reversed," added Jorge Bermudez.

AIDS treatment has experienced startling progress over recent years, with about four million people starting treatment between 2003 and 2008, largely due to India's ability to produce low-cost quality medicines and to healthy competition among India's producers. For instance, the Indian generic version of the most commonly used first-line adult regimen (lamivudine/nevirapine/stavudine) dropped from $414/person/year in 2003 to $74/person/year in 2008.

Since 2006, Indian-produced generic antiretrovirals (ARVs) have accounted for more than 80 per cent of the donor-funded developing country market, and comprised 87 per cent of ARV purchase volumes in 2008. The proportion of ARVs produced by Indian manufacturers is even higher within certain market niches. In 2008, Indian-produced generics accounted for 91 per cent of paediatric ARV volume.

By 2008, Indian generic ARVs accounted for 65 per cent of the total value (US $463 million) of ARV purchases reported, while non-Indian generic and innovator ARVs accounted for 13 per cent and 22 per cent of market value, respectively. The number of Indian generic manufacturers supplying ARVs to low- and middle-income countries increased from four to 10 from 2003 to 2008, while the number of Indian-produced generic ARV products increased from 14 to 53 over the same time period.