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Low-cost AZT/3TC/NVP generic Fixed Dose Combination gets OK
  Thu, August 9, 2007
TORONTO -- Three years after Ottawa passed legislation to bolster access to low-cost medications desperately needed by developing countries, a Canadian generic pharmaceutical company appears to have the go-ahead to start producing the first drug under the program.
Pharma giant GlaxoSmithKline announced yesterday that it has given permission for generic drug maker Apotex to use two of its patented molecules to produce an antiretroviral medication to treat HIV-AIDS in Rwanda. Apotex agreed to make the AIDS medication, which it has dubbed Apo-triAvir, after the Rwandan government requested the drug under Canada's Access to Medicines Regime, a program enacted in May 2004 that has yet to produce even one pill for export. Boehringer Ingelheim Canada Ltd. has already given Apotex approval to use one of its compounds for the triple-combination medication.
Rwanda: Drug Giant Allows Production of HIV Medication
Rwanda News Agency/Agence Rwandaise d'Information (Kigali)
9 August 2007
Posted to the web 9 August 2007
GlaxoSmithKline PLC (GSK) has said it has given consent to Canadian company Apotex to manufacture a generic fixed dose combination of antiretrovirals for the treatment of HIV/AIDS in Rwanda, RNA has established.
The drug giant announced yesterday that its decision to allow Apotex to manufacture the drug through Canada's Access to Medicines Regime is part of its broad commitment to tackle the AIDS crisis.
Rwanda plans to import 260,000 packs of TriAvir from Canada. The drug is a fixed-dose combination of widely used anti-AIDS drugs lamivudine, zidovudine and nevirapine. The generic product is manufactured in Canada by Apotex Inc.
On July 20, the World Trade Organisation (WTO) said Rwanda had submitted a notification about its intention to import the generic drugs.
This essentially means Rwanda has invoked a never-before-used August 2003 waiver to WTO's intellectual property rules, meant to allow poor countries with public health problems to import generics when they cannot manufacture the drugs themselves.
The trade body said Rwanda on July 19 2007 became the first country to inform the WTO that it is using the 2003 decision designed to ease the way for countries with public health problems to import cheaper generics.
These drugs can be made under compulsory licensing elsewhere when they are unable to manufacture the medicines themselves.
However, the WTO also said as a least-developed country, Rwanda did not have to notify that it wants to be an "eligible importing member" of the 2003 decision (and 2005 amendment decision).
Under a multi million dollar program supported by US Presidents HIV/Aids plan, the Global Fund, and the World Bank, up to 30.000 people receive ARVs and this has been increasing. Estimates put the figure of those that need the drugs at about 90.000. (End)
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