Critics say the government has missed a chance to streamline its vaunted system to supply cheap, generic drugs to poor countries, especially since it has yet to ship a single pill anywhere.
A review of Canada's Access to Medicines Regime, tabled just before Parliament recessed for Christmas, recommended sticking with the status quo, although it did say more analysis is needed.
Richard Elliott, executive director of the Canadian HIV-AIDS Legal Network, said the government is doing nothing.
``There is not much there,'' he said of the Industry Canada report.
``There doesn't seem to be the sense of urgency that one would like to think would be there, given the dire need.''
``Given that it's been over three years since the law was passed, and we still haven't yet seen any exports . . . and given what further delay in coming up with a workable regime means for people with HIV who need medicines _ we find this lack of interest in fixing the regime disappointing, to put it mildly.''
A spokeswoman for Industry Minister Jim Prentice said in a statement that quick changes to the medicines regime would not fix systemic problems which may be preventing developing countries from importing drugs, such as limited resources available for purchases.
Instead, the government will focus on measures that it says achieve results.
The government cites a new tax incentive in last year's budget to encourage pharmaceutical makers to more medicines to developing countries; its support of the Canadian HIV Vaccine Initiative in collaboration with the Bill and Melinda Gates Foundation; and the Canada-led Initiative to Save a Million Lives which included a contribution of $105 million over five years to train 40,000 health workers in Africa and Asia.
The drug regime was established amid great fanfare in 2004, with the idea of making it easier to get generic drugs for diseases such as AIDS and malaria to developing countries.
The only country to even begin the process is Rwanda, which signed on last July. It is dealing with Apotex, Canada's largest drug company, to buy a generic, triple-combination AIDS drug.
But Elliott said the system has too much red tape built in.
``We ought to be making it as simple and easy as possible for the drugs that we can make here cheaply to get to countries that need them,'' he said.
The system offers too many complications, he added. First, a country has to formally ask for a specific drug. A Canadian manufacturer wanting to supply the drug has to ask for a license from the patent holder.
If that is denied, the Commissioner of Patents can issue what is known as a compulsory license, allowing the production of a generic version of the medicine.
Once those hurdles are cleared, the company can sell the drug to the developing country, but the compulsory license is only good for two years and for the exact number of doses specified in the original agreement.
``If they want to place an additional order for more of the same product, you have to go through the process all over again, which doesn't seem terribly efficient,'' Elliott said.
Apotex has been issued a compulsory license for the drug. Now it remains to be seen whether it can produce the compound at a competitive price.
Elliott said it's time to make the system much simpler and get drugs flowing overseas.
But he says the federal government is leery of the whole system in the face of strong opposition from the big drug companies and from the United States.
The drug companies don't like the idea that their patented drugs can be copied _ some call it piracy _ at lower royalty rates specified in the legislation. The United States has long lobbied for tougher protections for intellectual property _ such as drug patents.
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