GSK gives consent under Canada’s Access to Medicines Regime for generic version of HIV/AIDS medicine for use in Rwanda

As part of its broad commitment to improving access to medicines, GlaxoSmithKline today announced it has given consent through Canada’s Access to Medicines Regime to enable a Canadian company (Apotex) to manufacture a generic fixed dose combination (FDC) antiretroviral (ARV), containing two molecules over which GSK has patent rights (zidovudine and lamivudine) for the treatment of HIV/AIDS in Rwanda.


Canada’s Access to Medicines Regime reflects the WTO “31f” agreement of August 2003 and enables the government to authorise the production of certain patented medicines for export. The legislation includes controls which are designed to ensure that these essential medicines reach the patients for whom they are intended and the authorisation to be granted will be subject to these controls. GSK has agreed to waive royalties on the basis that Apotex’s triple combination generic ARV will be supplied on a no profit basis.


Paul Lucas, President and CEO, GSK Canadasaid, “Tackling the AIDS crisis is one of the greatest challenges the world faces. GSK continues to play its part to tackle this crisis through research and development, not-for-profit pricing and ongoing investment in dedicated community programmes. Our decision to allow Apotex to manufacture an FDC containing two GSK molecules is part of this broad commitment. It also shows that Canada’s Access to Medicines Regime operates effectively to enable supply of medicines from Canadaas envisaged under the 31f Agreement.”


About GlaxoSmithKline

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and health-care companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.


GSK has issued eight previously announced voluntary licences to produce generic versions of GSK’s patented HIV/AIDS medicines for patients across Sub-Saharan Africa. In 2006 alone, GSK supplied 86 million tablets of preferentially priced ARVs to developing countries, while over 120 million ARV generic tablets were supplied by companies licensed by GSK.