It's a historic milestone, to be sure – this shipment of seven million tablets, a new combination of three existing anti-retroviral drugs used in AIDS treatment manufactured by Apotex Inc., a generic manufacturer, will arrive in Rwanda's capital city of Kigali today.
The drugs will improve the lives of more than 21,000 Rwandans living with HIV/AIDS. Some 54,000 people of the 290,000 that are infected with the virus are on ARVs.
But considering Canadian Parliament unanimously passed the Canadian Access to Medicines Regime (CAMR) back in 2004 – legislation meant to make the export of generic drugs flow quickly to developing countries – the four-year response time does not match the situation's urgency, say campaigners with Canadian HIV/AIDS Legal Network. In the meantime, millions have died of the disease.
For those fighting on the frontlines in Canada and abroad, it's a bittersweet day, the campaign group notes.
"We have the products and they can be fairly and efficiently delivered for a very low cost," says Elie Betito, the director of public and government affairs for Apotex Inc.
"The travesty of all this is that we have the tools, capacity and desire to save lives, but not the willpower from government to help move them along."
Part of the problem, say critics, is that Canada's legislation, one of only a few in existence in the world, is based on an agreement hammered out by the WTO in 2003. The agreement loosens patent rules so that generic drug companies like Apotex Inc. can work with the compulsory licensing of patented medicines and proceed with legally producing and exporting lower-cost versions of brand-name medicines to developing countries. However, since the legislation's inception, this process has been cumbersome.
"The Canadian legislation is not likely to get used again unless it's made much more user-friendly for both developing countries and the generic drug manufacturers," argues Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network.
"It's an unnecessarily complicated process for the suppliers and the purchasers – and the people who end up paying the price are the patients, because this logjam doesn't end up getting broken."
Unnecessary bureaucracy
At present, no other generic drug company besides Apotex, Inc. has stepped up to the plate, and it remains unlikely Apotex would repeat the process again without serious changes to the Regime, says Betito.
"Our executive and employees worked on this project diligently and because it was the right thing to do. [But] the reality is that Apotex spent millions of dollars on developing this drug, at our cost. To go through a four-and-a-half-year process where there's no guarantee of an end result that's even somewhat predictable, that's just not sustainable," continues Betito.
"There needs to be a review of this legislation, it needs to be simplified and fixed. Then I believe that other Canadian companies will take up the challenge."
The current law requires a generic company to have separate negotiations with patent-holders and arrange a separate licence for each purchasing country – as well as each new order of medicines that follows.
This amounts to a ridiculous amount of paperwork, legal bills and layers of unnecessary negotiating, says Betito. Both Apotex and the Legal Network argue this part of the legislation has it backwards, and it doesn't serve the public good.
What's needed instead, argues Elliott, is a "one-licence solution" that authorizes manufacturers to produce the same drug for export to any number of approved countries, rather than go through a renewal process every time. This would allow faster, cheaper and ultimately more competitive pricing and markets for life-saving medicine, he says.
It's lobbying by brand-name pharmaceutical companies at the WTO and in Ottawa that has made this obvious solution impossible. "Big Pharma wants to contain that as much as possible and see as few instances of governments actually using compulsory licences to override patents to get cheaper medicines," says Elliott.
"Unfortunately, you've got politicians who are unwilling to put the interests of patients in the developing countries first, and are instead kowtowing to the position of Big Pharma."
It took until December 2007 for the Minister of Industry to table a long-overdue report in Parliament, which made clear the Canadian government had no plans to make any changes to the CAMR legislation, despite many attempts by health organizations and HIV/AIDS groups to put amendments on the table.
"We've repeatedly outlined for the Minister and his advisors what the problems are and what the solutions could be, but so far the government has refused to act," said Elliott.
"At a certain point you have to go beyond looking at this as patents and trade and just look at it as doing the right thing to save human lives. People are dying needlessly because they don't have access to drugs," says Betito.
Now that Betito and his company have seen that generic drugs can reach poorer countries, and know Canada is well positioned to help on this issue, it makes the lack of political will in Ottawa seem all the more egregious. He's shocked that no campaign leader wants to amend the CAMR and commit to delivering generic drugs and saving lives in poorer countries.
"At the end of the day, we just let thousands of people die. And this when we've proven we have the life-sustaining drugs and can deliver them."
Contract stands
In the midst of the looming controversy, government is Kigali says it has no cause to worry because it has a contract with Apotex for the $3million shipments.
"We signed a contract with Apotex and all we need from them is to meet the requirements in the contract. If they don't we will also act accordingly," Health Minister Dr. Jean Damascene Ntawukuliryayo told The New Times. (End)
Additional reporting from Canadian HIV/AIDS Legal Network published on www.aidslaw.ca