AIDS drugs flow after 4-year mess
September 23, 2008
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Tanya Talaga
HEALTH REPORTER
It started off as a brilliant idea.
Pass a law to help put cheaper medicine into the hands of people suffering from AIDS and other diseases in the poorest countries.
But what began as an international gesture of goodwill four years ago has become a nightmare, bogged down in red tape, with Canada's generic drug makers now saying they don't want anything to do with the program until the law is fixed.
Canadian generic drug giant Apotex Inc. signed on to the initiative in 2004. It quickly got caught in red tape and months of delays, and became embroiled in endless negotiations with developing nations and brand-name firms. They blame the law for creating this quagmire.
Apotex's first shipment of anti-AIDS medication finally leaves tomorrow for an African nation, en route to Rwanda. Apotex will send another shipment at the same time next year – but it is likely their last. Apotex officials say they don't want to be involved again until better legislation is brought in.
Critics condemn the government for a missed opportunity.
"We could have been seen as the breakthrough Western government," said Stephen Lewis, former United Nations special envoy for HIV/AIDS in Africa. "And all we get out is one batch? This is awful."
Canada's Access to Medicines Regime was passed in 2004 with much fanfare and heralded internationally as an opportunity for Canada to be a major player in the global fight against disease in poor countries. The government promised access to first-world therapies at reduced prices, by getting brand-name pharmaceutical firms to negotiate with generic drug makers and allow the generics to manufacture cheaper AIDS drugs.
Lewis said Ottawa has allowed the brand-name drug companies to "artfully delay things, tie things up in knots and persuade people they shouldn't do this quickly."
As long as the Conservatives are in power, Lewis feels the legislation is dead.
"Somebody needs to decide what the objective of this legislation is," said Bruce Clark, vice-president of Apotex's regulatory and medical affairs.
"If the objective is to get needed medication into the hands of patients, then it isn't the needs of industry you need to balance and protect, it is of the individuals in need.
"(The legislation) is so laborious and convoluted it is almost a waste for us to go through the process."
After what Apotex has been through, Jeff Connell of the Canadian Generic Pharmaceutical Association doubts any other generic firm will step up to the plate.
Tomorrow's shipment of 7 million anti-AIDS pills will treat 21,000 patients for one year. Next year, another shipment will go out to Rwanda. Apotex says it spent more than $3 million to make and ship the drugs to Kigali.
"If you are a public company, your shareholders would revolt," Clark said. "But this has been the right thing to do. I hope the next step is meaningful legislation."
Two years ago, when Toronto hosted the international AIDS conference, Health Minister Tony Clement promised to review the legislation that countries in need and drug makers said was too cumbersome and bureaucratic to work. The review was held, but activists say nothing came out of it.
Clement could not be reached for comment yesterday.
Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network in Toronto feels all hope is not lost. The network suggests a one-licence process where the government gives an authorization licence to a generic company from the beginning. This would streamline the process for producers and purchasers, doing away with separate negotiations and licensing for every single order of medicines by individual countries.
So far, Rwanda is the only country that has approached Canada for help.
Last May, Apotex won a contract to supply Rwanda with Apo-TriAvir, a triple combination anti-AIDS medication. It costs about 39 cents a day for the Apotex product.
Dr. Olufemi Owoeye, director of health and HIV, World Vision Rwanda, said he is happy to hear the drugs are finally on their way.
"It is good Apotex is doing this because the drug supply is few and there are gaps," he said from Kigali.
Rwanda recently received about $135 million (U.S.) from The Global Fund to fight AIDS, tuberculosis and malaria, but it takes time for money to be released and medication to be bought, Owoeye added.
But what is really needed is medication for children. Some 250,000 Rwandan children have HIV/AIDS and access to pediatric drugs is slim.
Ideally, kids must be given drugs in syrup or powder form because they can't swallow pills.
Toronto Star
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