[india-drug] ART voluntary license

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

(From Pharmabiz with thanks?..SS)
SA agreement on ART voluntary license to benefit Indian Cos

Saturday, December 13, 2003 08:00 IST 
Joe C Mathew, New Delhi

Indian anti-retroviral drug manufacturers who are part of Clinton
Foundation HIV/AIDS Initiative will be highly benefited due to a
landmark agreement signed by South African AIDS activists and two of
the patent holders of ARV drugs on December 10, 2003. As per the
agreement, GlaxoSmithKline and Boehringer Ingelheim will grant
voluntary licenses to generic companies to manufacture ARVs and market
it in 47 sub-Saharan countries. 

GSK will issue licenses to four generic companies (including Aspen
Pharmacare and Thembalami Pharmaceuticals) to produce and/or import,
sell and distribute the antiretroviral medicines AZT and lamivudine. BI
will grant licenses to three generic companies (including Aspen
Pharmacare) to produce and/or import, sell and distribute the
antiretroviral medicine, nevirapine. Previously, the patent holders had
voluntary license agreement only with Aspen Pharmacare. 

The effect of the agreements with GSK and BI is that the Clinton
Foundation deal that was announced on 23 October 2003 can be
implemented in South Africa and other 47 sub-Saharan African countries
immediately. 

The Clinton Foundation deal has ensured that four generic companies
will sell triple-drug antiretroviral therapy to governments in
sub-Saharan Africa at US $140 per patient per year. Ranbaxy
Laboratories Ltd, Cipla Ltd, Matrix Laboratories Ltd, and Hetero
Laboratories are the Indian ARV manufacturers who are part of the
Clinton initiative. Aspen Pharmacare Holdings Ltd of Johannesburg,
South Africa is the fifth company. 

While the first three have agreed to supply bulk ARVs at the agreed
rates, Hetero is willing to supply both bulk and formulations at a
reduced rate. The prospects of the agreement should be more promising
to Ranbaxy as the company received WHO pre-qualification for its
three-drug fixed dose Anti-retroviral (ARV) combination products in the
first week of December. 

The settlement agreements will open up the ARV market to generic
competitors. Including Aspen Pharmacare, four generic companies will be
licensed to manufacture and/or import generic AZT and lamivudine
products, with three companies being licensed to manufacture and/or
import generic nevirapine products. All licensees will be entitled to
combine AZT, 3TC and nevirapine, both with each other and with other 

ARVs. All licensees will be entitled to sell their products to both the
public and private sectors, with sales being subject to a maximum 5 per
cent royalty rate. The licensees will be able to manufacture AZT,
lamivudine and/or nevirapine in combination with each other and/or any
other medicines for which the licensees have licences thereby allowing
the entry of triple-drug fixed dose combinations, currently
manufactured by at least two generic producers. 

Licensees that manufacture the ARVs in South Africa will be entitled to
export their products to all countries in sub-Saharan Africa. The AIDS
activists involved in the agreement are the Treatment Action Campaign
(TAC), COSATU, CEPPWAWU, and the AIDS Consortium. TAC has called on
pharmaceutical companies such as Merck, Roche and Abbott to follow the
examples of GSK, BI and Bristol Myers Squibb by agreeing either not to
enforce their patents on antiretroviral medicines in sub-Saharan Africa
or by granting voluntary licenses to generic manufacturers on
reasonable terms.


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