April 9, 2010

A Pharm Reduction Approach

Canada’s Access to Medicines Regime barely workable

by Nikki Bozinoff

The Dominion - http://www.dominionpaper.ca

Red tape is continuing to fence in much needed, and less expensive, generic drugs. Photo: Heidi Haering

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MONTREAL—The city of Montreal is set to be centre-stage in the coming months as a battle is waged between brand-name pharmaceutical companies, MPs, and a host of civil society organizations.
 
At stake is Bill C-393 (or drugs for international humanitarian purposes), a bill supporters say will help make Canada’s Access to Medicines Regime (CAMR) more workable.
 
Passed in 2004, CAMR was intended to facilitate the export of life-saving, generic medicines to “developing” countries.

Under CAMR, if patent-holders will not grant a voluntary license to the generic manufacturer, the company can approach the Canadian Commissioner of Patents and request a compulsory license be issued. This would give the manufacturer the right to by-pass patent holder's rights and produce a given medication, and in theory, allow generic medicines to be produced for export in public health emergencies.

But some organizations, including the Canadian HIV/AIDS Legal Network and Canadian Grandmothers for Africa, say the legislation is unnecessarily bureaucratic and must be reformed; thus far, a single order of medications has left the country.

C-393 has passed its second reading in the House of Commons but is expected to continue to face opposition from several Montreal MPs including Liberal Science and Technology critic Marc Garneau and Liberal MP Stephane Dion. Dion’s riding, Saint Laurent-Cartierville, is home to such brand-name, research-based pharmaceutical companies as Abbott Laboratories, AstraZeneca and Glaxo Smith Kline. Russell Williams, President of Rx&D, the association that advocates on behalf of Canada’s research-based pharmaceutical companies, has repeatedly stated that CAMR does not need to be reformed.

A group of McGill students and Raging Grannies protest outside MP Marc Garneau's Montreal office to demand reform of the Canadian Access to Medicines Regime. Photo: Stephanie Law

Bureaucracy bars access

Shortly after CAMR was passed in 2004, Medecins Sans Frontieres (MSF) approached Canadian generic manufacturer Apotex Inc. and urged them to produce a much-needed generic AIDS medication.

As Rachel Kiddell-Munroe, then Coordinator of MSF’s Access to Essential Medicines Campaign describes, Apotex had to overcome a daunting series of hurdles to make use of CAMR. These included applying to have the drug added to a list of medications eligible for use under CAMR, getting it tested by Health Canada despite the fact that it was pre-qualified by the World Health Organization and attempting to negotiate a voluntary license with Canadian patent-holders, a license none of the brand-name pharmaceutical companies was willing to grant in terms Apotex found acceptable.

“CAMR is extremely complex. These processes took over two years,” says Kiddell-Munroe of the back-and-forth she witnessed between Apotex, Health Canada and the Canadian patent-holders.

Even after going through these steps, the long journey was not over. MSF and Apotex still had to wait for a country to request the medication.

In 2007, Rwanda became the first and only country to ask for Canada’s help when it told the World Trade Organization (WTO) that it wanted to buy 260,000 packages of a triple-drug antiretroviral therapy—enough to treat 21,000 HIV-positive people for one year.

It wasn’t until September 2007, three years after CAMR was first passed, that Apotex was granted a compulsory license—the main aim of CAMR—and could finally begin production of the life-saving medication to send to Rwanda.

Kiddell-Munroe says these delays are unacceptable.

“Ten million people die each year from diseases that have available cures. Nearly a third of the world’s population does not have regular access to essential medicines, and in the least developed countries of Africa and Asia, this figure is more than fifty per cent,” she says.

Barking up the wrong tree

As Richard Elliott, Executive Director of the Canadian HIV/AIDS Legal Network explains, CAMR is made much more complicated than it needs be. The generic manufacturer is required to apply for a separate compulsory license for each country to which it wants to export, and for each quantity it wants to export. Elliott is an advocate for the “one-license solution” proposed in Bill C-393, explaining how it would work.

“You instead give the generic manufacturer a license that’s not limited to supplying one country but is actually authorization to supply multiple countries already named in the legislation; and you don’t fix the quantity ahead of time, because obviously you need to actually discuss with those countries what their needs are and those needs will change over time,” says Elliott.

Critics of reform, including Montreal-area Liberal MP Bernard Patry, argue that changes proposed in Bill C-393 would stifle innovation and remove incentives for research and development in Canada.

“Recognizing intellectual property rights is crucial for the future discovery of drugs that will save lives,” said Patry in the House of Commons in November 2009, during the bill’s second reading.

“If we do not protect intellectual property rights, we will deprive ourselves of key research, not only in the pharmaceutical sector but in all sectors driven by research,” he said.

As Elliott explains, generic medications manufactured under CAMR can only be exported to a limited list of low-income countries, pre-determined by the WTO.

“CAMR excludes export to all of the countries that account for the vast majority of the profits made by the brand-name pharmaceutical industry,” says Elliott.

“In doing this [reforming CAMR], there is nothing that would in any way undermine the ongoing presence of the brand-name pharmaceutical industry in Canada, in Quebec, so he’s barking up the wrong tree.”

Garneau has repeatedly voiced concerns that reforming CAMR will do little to actually improve access to medicines.

“The reasons why CAMR does not work as we had hoped have to do with real problems in the field, in the countries that need these medicines,” he said in the House of Commons during debate on C-393.

“They have to do with access to properly trained medical staff. ... In short, they have to do with poverty.”

Elliott says that alleviating poverty and reforming CAMR are not mutually exclusive.

“We know from experience that having compulsory licensing regimes that work, and the competition by generics that they enable, is what brings the prices of medicines down for developing countries. ... If you can actually make the medicines affordable, then whatever resources you mobilize to actually buy the medicines will go that much further,” he says.

Kiddell-Munroe agrees. “You cannot have doctors and nurses in beautifully pristine clinics in the middle of Africa and they’ve got no drugs in their pharmacy,” she says. “It’s not one or the other. It's both.”

Garneau’s office did not respond to The Dominion’s request for a comment.

Nikki Bozinoff is a Montreal-based writer, agitator and health-enthusiast.

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