Complexity Of Canadian Law Hindering Shipments Of Generic Antiretrovirals To Developing Countries, Company Says

Main Category: HIV / AIDS
Also Included In: Public Health;  Pharma Industry / Biotech Industry
Article Date: 25 Sep 2008 - 9:00 PDT

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Canadian generic drug company Apotex on Wednesday is scheduled to send Canada's first shipment of generic antiretrovirals to developing countries, but the company said it will not ship the drugs next year because of the complexity of the 2004 law allowing production of cheaper medications, the Toronto Star reports.

According to the Star, the Canadian government guaranteed low-income countries access to industrialized country medications at reduced prices through negotiations between brand-name and generic pharmaceutical companies for manufacturing rights for cheaper drugs. However, the complexity of the law has hindered many drugmakers from participating, the Star reports. Apotex said that it will ship seven million antiretroviral pills to Rwanda to treat 21,000 patients for one year but added that it will not participate in the program in the future unless the government corrects the law to alleviate some of the problems with its implementation. Bruce Clark, vice president of Apotex's regulatory and medical affairs, said that the law is "laborious and convoluted" and that it is "almost a waste for us to go through the process."

Stephen Lewis, former United Nations special envoy for HIV/AIDS in Africa, said, "We could have been seen as the breakthrough Western government, and all we get out is one batch? This is awful." Clark said that the objective of the legislation needs to be clarified before more companies will participate, adding that "[i]f the objective is to get needed medication into the hands of patients, then it isn't the needs of industry you need to balance and protect, it is of the individuals in need." Health Minister Tony Clement in 2006 promised to conduct a review of the law. According to some advocates, the review was conducted but nothing resulted from it.

According to the Star, more than $3 million was spent by Apotex to make and ship the drugs. The contract for Apotex to supply the drugs to Rwanda -- the only country to approach Canada for assistance -- was granted in May of 2007. Olufemi Owoeye, director of health and HIV for World Vision Rwanda, said, "It is good Apotex is doing this because the drug supply is few and there are gaps" (Talaga, Toronto Star, 9/23).

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