[Ip-health] Empirical Paper on ARVs in Sub-Saharan Africa

[Colleen Chien]

http://www.plosone.org/article/fetchArticle.action?articleURI=info:doi/10.1371/journal.pone.0000278

HIV/AIDS Drugs for Sub-Saharan Africa: How Do Brand and Generic Supply Compare?
Colleen V. Chien*

Fenwick & West LLP, Oakland, California, United States of America
(*The author is Incoming Assistant Professor of Law at Santa Clara Law School)

Background
Significant quantities of antiretroviral drugs (ARVs) to treat
HIV/AIDS have been procured for Sub-Saharan Africa for the first time
in their 20-year history. This presents a novel opportunity to
empirically study the roles of brand and generic suppliers in
providing access to ARVs.

Methodology/Principal Findings
An observational study of brand and generic supply based on a dataset
of 2,162 orders of AIDS drugs for Sub-Saharan Africa reported to the
Global Price Reporting Mechanism at the World Health Organization from
January 2004-March 2006 was performed. Generic companies supplied 63%
of the drugs studied, at prices that were on average about a third of
the prices charged by brand companies. 96% of the procurement was of
first line drugs, which were provided mostly by generic firms, while
the remaining 4%, of second line drugs, was sourced primarily from
brand companies. 85% of the generic drugs in the sample were
manufactured in India, where the majority of the drugs procured were
ineligible for patent protection. The remaining 15% was manufactured
in South Africa, mostly under voluntary licenses provided by brand
companies to a single generic company. In Sub-Saharan African
countries, four first line drugs in the dataset were widely patented,
however no general deterrent to generic purchasing based on a patent
was detected.

Conclusions/Significance
Generic and brand companies have played distinct roles in increasing
the availability of ARVs in Sub-Saharan Africa. Generic companies
provided most of the drugs studied, at prices below those charged by
brand companies, and until recently, almost exclusively supplied several
fixed-dose combination drugs. Brand companies have supplied almost all
second line drugs, signed voluntary licenses with generic companies,
and are not strictly enforcing patents in certain countries. Further
investigation into how price reductions in second line drugs can be
achieved and the cheapest drugs can actually be procured is warranted.