GlaxoSmithKline this week announced that it has granted voluntary licenses for two of its antiretrovirals – AZT (zidovudine) and 3TC (lamivudine) – to the South African generic manufacturer Thembalami (a joint venture of the Indian company Ranbaxy and Adcock Ingram).
Thembalami will be able to market AZT (zidovudine) and 3TC (lamivudine) throughout sub-Saharan Africa.
However the announcement comes too late for the company to bid in the first round of antiretroviral procurement announced by the South African government in March. That bidding process, the Department of Health told manufacturers, was open only to companies with products already registered in South Africa or awaiting registration with the South African Medicines Control Council.
Voluntary licenses have already been granted by Glaxo SmithKline to Aspen Pharmacare and by Boehringer Ingelheim (manufacturer of nevirapine) to both Aspen Pharmacare and Thembalami. Merck & Co. has granted a voluntary license to Thembalami for efavirenz and Bristol Myers Squibb has granted a voluntary license to Aspen Pharmacare for didanosine tablets (not enteric coated capsules).
Voluntary licenses were granted as the result of a South African Competition Commission finding last year, in which Glaxo SmithKline and Boehringer Ingelheim were judged to have charged excessive prices in South Africa for their products. In a settlement negotiated with South Africa’s AIDS Law Project the companies agreed that they would grant voluntary licenses to South African companies and would require a royalty of 5% or less.
Further information on this website
South African drug deal bring $140 a year treatment within reach of African nations - news story, December 2003
GSK gives pan-Africa license to South African firm - news story, October 2003