Global Policy Forum

By Heather Scoffield

It will likely take many months before Canada's generic-drug companies can start shipping medicine to AIDS-stricken countries, even if the federal government succeeds in rushing through provisions allowing the companies to copy and export the patented drugs. Manufacturers will probably need 18 to 24 months to apply for approvals from Health Canada, find raw materials and set up production lines, said Jack Kay, president of Toronto-based Apotex Inc., one of Canada's largest generic-drug companies. And that's only if government regulators agree to fast-track their approval systems, he said, adding that the scope of the legislation is still up for debate and it's difficult to tell now how co-operative Canadian drug regulators will be under the new rules.

The exception is the antiretroviral drug AZT. Apotex already has Health Canada's stamp of approval to make that drug and has experience producing it. The Supreme Court told Apotex and Novopharm Ltd. to stop producing the drug last year, saying the generic companies had infringed on a patent. But it would probably take only six weeks for Apotex to get its system up and running again, Mr. Kay said. "I could, if all the material is available, turn it around in six weeks," he said in an interview.

Industry Minister Allan Rock said yesterday the government will aim to implement amended patent laws before Christmas, although he cautioned that reaching the goal won't be easy. "That's very ambitious," he said in an interview. "It's a lot to do but we'll certainly do our very best." He said he did not know when developing countries would begin to see generic drugs from Canada.

AZT used to be the drug of choice to treat AIDS, and is still important in the cocktail of medicine that is more frequently used against the disease now, said Julie Tam, vice-president of professional and scientific affairs for the Canadian Generic Pharmaceutical Association. Critics, mainly brand-name pharmaceutical companies, of the plan to allow generic-drug companies to produce and export patented drugs for consumption in poor countries suggest that the marketplace has no room for Canadian companies, since generic drugs from India and Brazil will undercut their rock-bottom prices.

Indeed, Mr. Kay said he was not sure his company could compete on price, but would take the lead on quality. Canadian drugs have a reputation for safety, and could set a standard for the world market of generic drugs to treat AIDS, he said. Mr. Kay said that the initiative may improve the reputation of Canadian generic drugs, but he agreed that no business case can be made for exporting drugs at cost to poor countries. "It's the right thing to do. If we can save lives, then we have a responsibility to do it," he said. "We're only doing this because someone's got to belly up to the bar."

The generic-drug industry in Canada hopes to gain profile, enhance its reputation for quality and build goodwill but doesn't expect to profit from the AIDS plan, added Jim Keon, president of the generic pharmaceutical association. "Are our companies going to get rich from this? I don't think so."

The multinational brand-name industry has said the Canadian plan is "window-dressing" that will do little to change anything in poor countries and will hurt Canada as a destination for international research and development. Drug companies view patent protection, several years in which their product cannot be duplicated by another company, as the reward for years of expensive research and testing on new treatments.

If the Canadian plan is just symbolic but encourages other countries to produce more AIDS drugs at low prices, then the effort is worthwhile, responded Mark Fried, spokesman for Oxfam Canada. But former Canadian politician Stephen Lewis, the United Nations' special envoy for AIDS in Africa, said the demand for cheap AIDS drugs is rising quickly and Brazil and India soon won't be able to supply enough.

The World Health Organization hopes to see three million people in treatment programs by 2005, including two million in Africa, up from between 50,000 and 75,000 people in treatment in Africa now, Mr. Lewis said recently. "No one has the capacity to meet demand over the next few years," he said.

But much work remains in figuring out how the generic drugs produced in Canada and elsewhere will be paid for. The WHO and the UN Global AIDS Fund may pay for some, while national aid agencies such as the Canadian International Development Agency and non-governmental organizations may be called upon to chip in too, say Mr. Lewis and the generic companies.

FAIR USE NOTICE: This page contains copyrighted material the use of which has not been specifically authorized by the copyright owner. Global Policy Forum distributes this material without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. We believe this constitutes a fair use of any such copyrighted material as provided for in 17 U.S.C § 107. If you wish to use copyrighted material from this site for purposes of your own that go beyond fair use, you must obtain permission from the copyright owner.