E-DRUG: India's central role in AIDS medicines supply could be threatened by trade agreements, new study says
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*Geneva, 14 September 2010* — A new study to be published today reveals that Indian generic manufacturers have supplied more than 80% of donor-funded AIDS medicines to developing countries in the last seven years. However, it warns that upcoming trade agreements India is currently negotiating may close the tap on affordable medicines for AIDS patients. The news coincides with a global funding crisis in the area of AIDS while at the same time new clinical evidence demonstrates that greater investments are needed to address the disease.
"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," said Jorge
Bermudez, UNITAID Executive Secretary. "What we need today is a more
flexible approach to scale up treatment and not the opposite."
*A lifeline to treatment: the role of Indian generic manufacturers in
supplying antiretroviral medicines to developing countries,* published today 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.
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% of the donor-funded developing country market, and
comprised 87% 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% of paediatric
ARV volume.
By 2008, Indian generic ARVs accounted for 65% of the total value (US $463
million) of ARV purchases reported, while non-Indian generic and innovator
ARVs accounted for 13% and 22% 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.
The report concludes that "Free Trade Agreements that may create new
intellectual property obligations for India can increase 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."
*A lifeline to treatment: the role of Indian generic manufacturers in
supplying antiretroviral medicines to developing countries* is co-authored
by Brenda Waning, Coordinator of Market Dynamics, UNITAID; Ellen
Diedrichsen, Boston University School of Medicine; and Suerie Moon,
Sustainability Science Program, Center for International Development,
Harvard Kennedy School of Government; and can be found at:
http://www.jiasociety.org/content/13/1/35