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Ottawa's Cheshire cat grin to the global AIDS pandemic will vanish in September when the last, small shipment of drugs produced under Canada's Access to Medicines Regime leaves the country for Rwanda.

Virtually no one outside the federal government expects there will be more - a gloomy backdrop to the indictments of the world's wealthiest nations at this week's international AIDS conference in Cape Town, South Africa, for a chain of broken promises on helping poorer countries to obtain life-saving treatment.

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In the five years that the Canadian legislation, CAMR - initially dubbed the Jean Chrétien Pledge to Africa Act - has been in place, only one allotment of low-cost medicine has been arranged: for 21,000 Rwandans for one year. The first shipment went last year; the last lot will go at the summer's end.

The consensus among AIDS activists and generic drug manufacturers is that CAMR is so overwhelmingly flawed and cumbersome that no developing country will use it again to apply for assistance, and no generic pharmaceutical company will use it to manufacture anti-retroviral drugs.

"We're still where we were five or six years ago, and the system needs to get fixed," said Elie Betito, director of public and government affairs for Apotex Inc. in Toronto, which made the Rwandan anti-retroviral product at cost after long and expensive legal negotiations with three pharmaceutical companies holding patents on components of the medication.

"But I don't think this government wants to change [CAMR] because it's not their legislation," he added. It was introduced by a Liberal government, although passed unanimously by Parliament.

Apotex, one of the world's largest generic drug manufacturers, has said its one and only experience working under CAMR was so bad that it won't seek a new licensing agreement using the legislation, although it's ready to produce a desperately needed pediatric formulation that it says would both meet high Canadian standards and be globally cost competitive.

The CAMR legislation was designed to allow generic pharmaceutical companies to produce and export affordable drugs that are under patent to developing countries facing public health emergencies.

But it requires countries on an approved list to go through a mountain of red tape to apply for assistance and tender for manufacturers, and generic manufacturers to negotiate new licensing agreements with patent holders on each contract and with each country.

Thus, if Apotex was to have won a contract from Rwanda for another year of supplying drugs to the same 21,000 patients, it would have had to go through the same negotiations as before with the patent holders.

"You're looking at 65-page contracts," Mr. Betito said.

Tony Clement, while national health minister in 2006, told the international AIDS conference, held that year in Toronto, that the legislation was flawed. But since becoming Minister of Industry - with responsibility for the legislation - in 2008, he has not given any intention of amending it.

A government review concluded in 2007 that it would be premature to change the legislation. The patent-holding pharmaceutical manufacturers have said there's nothing wrong with the legislation as it stands, and have lobbied strenuously against changes.

A Senate bill being shepherded by Manitoba Liberal Senator Sharon Carstairs and a House of Commons private member's bill introduced by Manitoba New Democrat Judy Wasylycia-Leis would require only a single licence.

Apotex would prefer the government take over the whole process and simply hand compulsory licences to generic manufacturers.

Laura Esmail, a University of Toronto doctoral candidate in pharmacy whose academic research is on CAMR and affordable AIDS drugs, said the one-licence proposal would allow Canadian companies, such as Apotex, to develop affordable global drugs using economies of scale.

She also said developing countries find themselves pressured by international corporations and other governments not to apply for drugs under legislation such as CAMR, and they need wealthy countries like Canada to make it easier for them to do so.

 

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