Canadian medicine to fight HIV/AIDS left for Rwanda yesterday, reviving criticism of the complex federal legislation that allows generic producers to export patented, life-saving drugs to developing countries.
Civil society organizations and generic manufacturers are lauding the delivery, but say that unless the legislation – called the Canada Access to Medicines Regime (CAMR) – is modified, this first shipment will also be the last.
Wednesday’s delivery of 7-million three-in-one antiretrovirals manufactured by generic pharmaceutical producer Apotex Inc. and expected to save the lives of 21,000 people is the first shipment of generic drugs to leave Canada in the four years since the legislation has been in place.
Apotex has been working since 2004 to produce inexpensive drugs for export to the developing world – a process they describe as long and unnecessarily bureaucratic.
“There is a reason no other company has tried to provide medicines under this regime,” said Jack Kay, Apotex’s president. “It is too complex and has to be repeated for every request that comes in from a country.”
Currently, generic manufactures must conduct what they say are typically lengthy and unfruitful negotiations with patent-holders to ask them for a voluntarily license to produce the drugs. Should patent-holding manufacturers not wish to grant a voluntary licence, as happened to Apotex, the generic manufacturer must then file for a compulsory license with the government. This process must be repeated for each recipient country and for each quantity of drugs intended for export.
With generic manufacturers unwilling to repeat the process under the current Regime, Richard Elliott, Executive Director of the Canadian HIV/AIDS Legal Network, was concerned that Canada’s regime would do little to alleviate the health problems facing the developing world.
“People are not getting medicines that they need…and it is clearly not because [of a lack of need]. It is because the process is unnecessarily time consuming and cumbersome,” he said. “[CAMR] has worked once…. Our concern is that it won’t get used again. It’s not good enough.”
Intended to facilitate the export of inexpensive generic drugs to treat diseases like HIV/AIDS, malaria, and tuberculosis that affect the least-developed countries, the CAMR was created to exempt generic pharmaceutical companies who produce these drugs for the least-developed countries from patent laws that grant long-term monopolies to the research-based pharmaceutical companies that develop the drugs.
Many groups have asked for a “one-license solution,” which would allow generic pharmaceutical companies to produce the licensed drug without having to reapply for a separate license for each shipment and country, paying a royalty based on the quantity produced. While Industry Canada reviewed the system, it concluded that more time was needed before a proper assessment of the Regime could occur.
Canadian Grandmothers for Africa: A National Advocacy Network demonstrated last night at Union Station in downtown Toronto to show support for Apotex’s efforts, and to try to mobilize support for CAMR reform prior to the October federal election.
“[This demonstration] is a call to action to fix this system and to fix it now,” said Carole Holmes, spokesperson for the Grandmothers. “If the political will was there, we know that it would have been fixed in weeks, not years.”
According to Elliott, the Canadian HIV/AIDS Legal Network has submitted questions to all five federal parties, and responses will be made available to the public on the Canadian HIV/AIDS Legal Network’s web site on Monday.
Elliott suspected that the government may try to trumpet Tuesday’s drug delivery as evidence that CAMR is functional.
“I would assume that now that the drugs are finally leaving that [the government] will reiterate their position. I didn’t think it was convincing then, and I don’t think that it’s convincing now,” said Elliott.
Elliot seemed to be correct. While Industry Canada will continue to monitor the effectiveness of the program, it has said that CAMR does seem to be working.
“This [Tuesday’s drug shipment] demonstrates that CAMR can help deliver generic drugs to help combat disease in the developing world,” Industry Canada’s senior media-relations advisor Annie Trepanier, wrote in an email to The Daily.
Holmes said that Canada has an obligation to fix CAMR so that it can live up to its commitment to provide access to essential medicines for developing countries.
“I think that for Grandmothers, who tend to keep their promises, this just doesn’t do it,” Holmes said.