Indian generics makers have supplied over 80% of donor-funded HIV/AIDS drugs to developing countries in the last seven years, but this supply is threatened by new trade deals now under negotiation, warns a new report.
Already, the World Trade Organization (WTO) Trade Related Aspects of Intellectual Property (TRIPS) agreement, which has required India to apply product patents since 2005, has begun to curtail the country's ability to produce cheaper generic versions of newer medicines, says the study, which is published by the Journal of the International AIDS Society. New Free Trade Agreements (FTAs) currently being discussed may further reduce India’s vital role as provider of life-saving treatments, it adds.
Since 2006, Indian-made generic antiretrovirals (ARVs) have accounted for over 80% of the donor-funded developing country market and in 2008 they represented 87% of ARV purchases by volume, says the study. Their market share is even higher in some areas; for example, in 2008 they accounted for 91% of paediatric ARV sales by volume.
By 2008, Indian generics accounted for 65% of the total value (US $463 million) of reported ARV purchases, while non-Indian generic and innovator ARVs represented 13% and 22% of market value, respectively. The number of Indian generics makers supplying ARVs to low- and middle-income countries increased from four to 10 during 2003-8, while the number of Indian-produced generic ARVs rose from 14 to 53 in the same period, the researchers note.
However, they warn that FTAs which may create new intellectual property (IP) obligations for India can increase ARV prices, impede the development of acceptable dosage forms and delay access to newer and better ARVs, all of which will undermine international agreements on achieving universal access to HIV/AIDS treatment.
The study’s findings raise grave concerns for international aid agency UNITAID because it relies heavily on Indian generic firms to supply “quality-assured, patient-friendly, low-cost AIDS medicines in over 50 countries," said UNITAID executive secretary Jorge Bermudez. “What we need today is a more flexible approach to scale up treatment and not the opposite,” he added.
Moreover, the World Health Organization (WHO)’s new recommendation that people living with HIV/AIDS should begin treatment earlier and switch to newer medicines - which are more robust and less toxic but also much more expensive - means that more people than foreseen will need treatment today and in the coming years. However, the cost of treatment could skyrocket if the new products cannot be made available at 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,” said Mr Bermudez.