Three years after Jean Chrétien said Canada would allow generic drug makers to send copies of brand-name medicines to poor countries to combat diseases such as AIDS and malaria, groups that follow the issue say not a single pill has left Canada.
The roadblock, they say, is red tape and a powerful brand-name pharmaceutical industry that opposes the generic reproductions.
But the groups argue that Canada's Access to Medicines Regime can be rewritten to get the drugs moving.
The Canadian HIV/AIDS Legal Network and Doctors Without Borders will ask the Commons industry, science and technology committee today to change the law to allow any pharmaceutical firm to produce generic versions of any drug patented in Canada for export to any eligible developing country.
"We are giving them concrete amendments that they could enact, if they wanted to, to simplify the legislation and increase the chances of it working." Richard Elliott, the deputy director of the HIV/AIDS Legal Network, said yesterday.
Shortly after Tony Clement took over the federal health portfolio last year, he said he realized that Mr. Chrétien's so-called Pledge to Africa was not being fulfilled. The minister attributed this to a lack of "take-up" by developing countries, where AIDS claims nearly 8,000 lives a day.
But Mr. Elliott said the problem is not that simple.
"There were discussions when the legislation was first being drafted [by the Liberal government]three years ago where we and a number of the other [organizations]raised concerns about the complexity of the process," Mr. Elliott said.
The industry committee is conducting a mandatory review of the drug regime and must table a report in mid-May. "So now is the time to go back to the drawing board and say this is too complicated," Mr. Elliott said.
Apotex, one of Canada's best-known generic drug manufacturers, has developed a treatment for people with HIV that uses three patent-protected drugs: AZT, 3TC and Navirapin.
Canada's law requires that the brand-name manufacturers be consulted to see whether they will let the generic company violate their patents by selling it to developing countries. If they won't, Apotex must obtain what is known as a "compulsory licence" that permits the sale of a specific quantity of the drug to a specific country for two years.
That means that "before there is any guarantee of actually being able to get that licence and therefore buy the product, the [developing]country actually has to step forward and be identified," Mr. Elliott said.
"And we have seen over the last decade that, any time countries contemplate using compulsory licensing to override patents to get cheaper medicines from generic producers, there is a great deal of pressure brought to bear by the big multinational pharmaceutical industry, which doesn't want to see this happen, and by the U.S. government, which goes to bat for its pharmaceutical industry."
Typically, he said, if a country says it wants to buy the generic drugs using the compulsory licence, the United States will threaten to cut off trade.
On the other hand, Mr. Elliott said, if a generic manufacturer is permitted to sell any quantity of a drug to any number of countries for an unlimited period, paying royalties to the brand-name company as is required, many of the barriers would come down.
"Countries that want to do this will still have to stand up to the pressure that they are under," he said. "But, at least with the process that we are describing, you could have any number of countries getting together and making a joint order for a large quantity of product from a generic manufacturer. That would bring the price down because it is achieving economies of scale and there would be a certain degree of safety in number."