Published on October 20, 2009 at 7:23 AM
GlaxoSmithKline Inc. (GSK) As part of its broad commitment to improving access to medicines and its ongoing support for Canada's Access to Medicines Regime (CAMR), GlaxoSmithKline confirms it will not object - through CAMR - to allow Canadian company (Apotex) to continue manufacturing their drug for the treatment of HIV/AIDS in Rwanda. Apotex currently manufactures a fixed dose combination (FDC) antiretroviral (ARV), containing two molecules over which GSK has patent rights (zidovudine and lamivudine).
GSK believes that CAMR is simple, straightforward and efficient. It enables the government to authorise the production of certain patented medicines for export, and includes controls which are designed to ensure that these essential medicines reach the intended patients. At the time of the previous request, it took only 26 days for GSK to give its consent to Apotex to manufacture FDC.
On expiry of an authorization granted by the Commissioner of Patents, should the product still be required by the importing country, the Commissioner of Patents may grant a new authorization. GSK reconfirmed that if Apotex makes a new application to the Commissioner of Patents which meets CAMR's requirements, GSK will not object to Apotex supplying Rwanda with FDCs containing two GSK HIV molecules. This is reflective of GSK's support for the humanitarian goals of CAMR.
Canadian generic firm Apotex was first granted authorization to export the FDC containing two GSK patented molecules by the Commissioner of Patents on September 19, 2007, two months following Rwanda's request for assistance. This further demonstrates that in its current form CAMR operates effectively and efficiently.
Source: GLAXOSMITHKLINE