This is the first time any manufacturer in any country has used such a licensing framework to get essential medicine to people in the developing world, the Ottawa Citizen reported Monday.
But Apotex, the drug manufacturer that produced the pills, says the Canadian legislation – and the World Trade Organization regulations it's based on – has created such a complicated, costly system, the company won't be doing it again unless the regulations are changed.
"It took us more than four years just to get to this point," Elie Betito, director of public affairs for Apotex, the generic-drug manufacturer supplying the pills told Ottawa Citizen newspaper. "It's a huge process, with huge costs involved.
"We will not be doing this again."
The process began when humanitarian organization Medecins Sans Frontieres asked Apotex to produce a generic version of several costly, brand-name antiretroviral medications – treatments easily accessible to patients in the developed world and proven to prolong the life of most AIDS patients for years.
But in poorer countries, particularly some in Africa, the brand-name drugs are far too expensive and most go without treatment.
In Rwanda some 290.000 people are living with HIV/Aids with about 54.000 on antiretroviral treatment. The United Nations estimates that there are more than 30 million people infected with HIV-AIDS, 95 per cent of whom live in developing countries.
Apotex combined three medications into one pill, called Apo TriAvir, and received Health Canada approval.
The cost for one TriAvir pill is 19.5 cents US, two-thirds less than the cost of buying the brand-name medications separately, according to the Canadian HIV-AIDS Legal Network.
Critics say the CAMR legislation contains several serious flaws. It covers a limited number of medicines, and does not apply to poor countries that have not joined the WTO.
It also creates a process completely backwards from the normal business model.
CAMR requires generic drug companies to negotiate royalty agreements with the patent-holding pharmaceuticals, a process Apotex says dragged on for two years.
The importing country then has to formally notify the World Trade Organization it intends to issue a "compulsory licence" – essentially, suspending a company's patent over a specific medication and allowing another company to produce it at far lower cost.
This what Rwanda actually did early this year. (End)