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Life Saving AIDS Drug for Africa Gets Final Clearance
TORONTO, Canada, September 20 /PRNewswire/ -- The Federal Commissioner of Patents issued today a compulsory licence for ApoTriavir under Canada's Access to Medicines Regime Program (CAMR) allowing Apotex to proceed with manufacturing of the product. This drug, a triple combination AIDS therapy, was the first product to be approved by Health Canada under the provisions of the CAMR. ApoTriavir was approved by Health Canada in August 2006 and is pre-qualified by the World Health Organization. The CAMR was designed to help developing countries that have little or no pharmaceutical manufacturing capacity in their fight against HIV/AIDS, tuberculosis, malaria and other diseases. Rwanda was the first African country to request ApoTriavir under this established process and the licence today opens the way for us to provide quality medicine at an affordable price to the Government of Rwanda. The delay between approval by Health Canada and issuance of the compulsory license highlights the problems with the process as it exists. It is unnecessarily complex and does not adequately represent the interests of those who require treatment. As it now stands the process is voluntary and controlled by the multinational pharmaceutical companies who hold patents for drugs like Apo-Triavir. In this case, Glaxo Smith Kline (GSK), Shire and Boehringer Ingelheim were the three patent holders and each put forward numerous conditions for issuing a voluntary license. In the end, GSK and Shire did not oppose the application, but chose not to grant a voluntary licence, requiring Apotex to navigate the complexities of the CAMR. Boehringer Ingelheim was also not prepared to freely grant a licence. This process of obtaining a license to produce a product has to be restarted every time a new country makes a request. There is no assurance that the patent holders will not attempt to once again delay the process and the supply of these vital medicines to developing countries in the future. "We are doing this on a not-for-profit basis and hope that this life-saving drug gets to the thousands of patients in Africa dying every month; the Canadian Federal Government must change the process to get quality affordable medicines to those who have no access", stated Jack Kay, President and COO of Apotex. Apotex is Canada's largest pharmaceutical company with over 300 medicines exported to 115 countries and its planned R&D expenditures over the next 10 years are CND$2 Billion.
