[e-drug] New study demonstrates India's central role in ARV supply to developing countries

E-DRUG: New study demonstrates India's central role in ARV supply to developing countries
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[See also press release from UNITAID Communications. Moderator]

Dear all,

The Journal of the International AIDS Society today published a new study demonstrating the central role Indian generic manufacturers play in supplying antiretroviral medicines to developing countries. A better understanding of India's role is of particular importance given ongoing negotiations for bilateral or regional trade agreements that may introduce new IP obligations that could constrain or restrict generic supply. Please find the abstract pasted below, and full article available open access at: http://www.jiasociety.org/content/13/1/35

Your comments are most welcome,

-Suerie Moon
suerie_moon@yahoo.com

A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. Brenda Waning, Ellen Diedrichsen and Suerie Moon. Journal of the International AIDS Society 2010, 13:35doi:10.1186/1758-2652-13-35

Published: 14 September 2010

Abstract (provisional)

Background
Indian manufacturers of generic antiretroviral (ARV) medicines
facilitated the rapid scale up of HIV/AIDS treatment in developing
countries though provision of low-priced, quality-assured medicines. The legal framework in India that facilitated such production, however, is
changing with implementation of the World Trade Organization Agreement
on Trade-Related Aspects of Intellectual Property Rights, and
intellectual property measures being discussed in regional and bilateral free trade agreement negotiations. Reliable quantitative estimates of
the Indian role in generic global ARV supply are needed to understand
potential impacts of such measures on HIV/AIDS treatment in developing
countries.

Methods
We utilized transactional data containing 17,646 donor-funded
purchases of ARV tablets made by 115 low- and middle-income countries
from 2003 to 2008 to measure market share, purchase trends and prices of
Indian-produced generic ARVs compared with those of non-Indian generic
and brand ARVs.

Results
Indian generic manufacturers dominate the ARV market, accounting for
more than 80% of annual purchase volumes. Among paediatric ARV and adult
nucleoside and non-nucleoside reverse transcriptase inhibitor markets,
Indian-produced generics accounted for 91% and 89% of 2008 global
purchase volumes, respectively. From 2003 to 2008, the number of Indian
generic manufactures supplying ARVs increased from four to 10 while the
number of Indian-manufactured generic products increased from 14 to 53.
Ninety-six of 100 countries purchased Indian generic ARVs in 2008,
including high HIV-burden sub-Saharan African countries. Indian-produced
generic ARVs used in first-line regimens were consistently and
considerably less expensive than non-Indian generic and innovator ARVs.
Key ARVs newly recommended by the World Health Organization are three to
four times more expensive than older regimens.

Conclusions
Indian generic producers supply the majority of ARVs in developing
countries. Future scale up using newly recommended ARVs will likely be
hampered until Indian generic producers can provide the dramatic price
reductions and improved formulations observed in the past. Rather than
agreeing to inappropriate intellectual property obligations through free trade agreements, India and its trade partners - plus international
organizations, donors, civil society and pharmaceutical manufacturers -
should ensure that there is sufficient policy space for Indian
pharmaceutical manufacturers to continue their central role in supplying developing countries with low-priced, quality-assured generic
medicines.