February 25, 2011

The Other Drug Trade

New bill could make cheap HIV meds easier to access

by Steph Law

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

Student activists raised awareness around Canada's Access to Medicine Regime (CAMR) last March in downtown Montreal. Critics say CAMR is too complicated to use. Photo: Steph Law

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HALIFAX—On March 9, Members of Parliament will have a very simple choice to make, according to Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network. They can vote for Bill C-393, and make it easier for people in the developing world to access affordable HIV medication.

“When you could do something with the most minimal of efforts to prevent these [HIV related] deaths from happening, to not [do so] is profoundly immoral,” says Elliott.

Despite Elliott’s confidence in the importance of the Bill, its passing on March 9 in the House of Commons is far from certain.

Advocates for Bill C-393 rallied last March outside Liberal MP Marc Garneau's office, urging him to support the bill. Photo: Steph Law

Bill C-393 seeks to amend a piece of legislation enacted in 2005, known as Canada’s Access to Medicine Regime (CAMR). CAMR was created to help Canadian generic companies produce and export generic medicines at reasonable prices to the countries that need them most.

In 2009, almost 15 million people in low- to middle-income countries were living with HIV, and only five million of them received treatment, according to the World Health Organization (WHO).

Despite these numbers, CAMR has been used only once. Advocates for Bill C-393 argue that CAMR is too complicated and must be fixed to make it easier to export affordable medication.

Apotex, a Canadian generic drug company, successfully shipped anti-HIV drug Apo-TriAvir to Rwanda in 2008 and 2009 under CAMR. The shipments contained enough medication to treat 21,000 people living with HIV for one year.

Turns out, this feat was a one-hit wonder.

“We're not likely to repeat the process under [CAMR],” said Bruce Clark, Apotex’s Senior Vice-President, Medical and Regulatory affairs. Clark says CAMR is not easy to use. “It’s a practical reality that no second country has made a request under the regime because it’s so complicated.”

Many steps are required before a shipment of drugs can be made. It took four years for Apotex to complete the process and get their shipment authorized by the Canadian government.

Four years is a long time to wait, considering approximately two million people died from AIDS in 2009, according to the WHO.

Despite this, the pharmaceutical industry insists Apotex’s process was “extremely quick” and CAMR is working well.

“There was tremendous co-operation on the industry’s part because we support the intention of CAMR,” said Wendy Zatylny, Vice President of Government Affairs at Rx&D, the association of research-based pharmaceutical companies in Canada.

Rx&D represents the interests of 50 drug companies, including GlaxoSmithKline (GSK), Shire and Boehringer Ingelheim, which were the three patent holders for the drugs that Apotex needed to produce Apo-TriAvir.

Apotex requested voluntary licenses from the three companies in July 2007. Within a month, all three responded and granted permission to manufacture the drugs royalty-free, according to Rx&D’s records.

Many conditions were attached to the voluntary licenses.

“Two of the patentees went so far as to expressly reserve all rights with respect to their trademark rights, effectively threatening suit,” Clark said.

In the end, after fruitless negotiations, the patent holders retracted the voluntary licenses and Apotex applied for a compulsory license in September 2007 under CAMR, he added.

It took 68 days from the time Apotex asked for voluntary licenses to when the government granted the compulsory license. But the entire process took four years because of the details Apotex needed in order to start the process in the first place.

“We were turned back as the request was, in their words, 'premature' as no country had confirmed an order,” Clark said

The developing country has to put forward a request for an exact quantity of drugs to be produced and exported in order for the process to begin. It is difficult for a country to accurately estimate the amount of medicine it needs at any given time. This is particularly true for infectious diseases like HIV, where predicting how many people are infected, and will be infected in the near future, is difficult.

In addition to the barriers to getting permission for exporting generic drugs, CAMR mandates an expiry date of two years on the compulsory license.

Once Apotex had delivered medication to Rwanda, the country wanted to order more. In order to do this, however, both Rwanda and Apotex would have had to go through the entire process again.

So they didn’t.

After this one and only experience working with CAMR, its advocates started discussing how to improve it. The outcome was Bill C-393, which former NDP MP Judy Wasylycia-Leis introduced as a private member’s bill in 2009.

The bill proposes a “one-license solution.” If passed, a generic company would be able to distribute drugs anywhere in the developing world simply by getting a single license from the brand-name companies. This would eliminate the daunting task of having to negotiate a separate license for each country that makes a request.

Furthermore, the bill wants to expand the list of drugs that qualify for compulsory licenses. CAMR only allows the export of certain drugs for certain diseases. Advocates of the bill argue that this list is too restrictive.

“That’s an unnecessary and unjustifiable restriction to the [CAMR] regime,” said Elliott. “It is both unethical and bad public health policy for Canada to tell developing countries that CAMR can only be used to get certain medicines for certain public health problems.”

A parliamentary committee gutted these two provisions from the bill in November 2010. The Conservative MPs in the committee and Liberal Marc Garneau took the position that CAMR works in its current form, a stance shared by Rx&D.

The removal of these provisions from the bill did not come as a shock to Elliott.

“I think there is of course tremendous pressure from Big Pharma,” said Elliott. “They're all over Parliament Hill arguing against the bill.”

During the second vote on the bill in 2009, the liberal MPs who voted against it sat in ridings where many pharmaceutical companies reside. For example, Abbott Laboratories, AstraZeneca and GSK operate within the ridings of Liberal MPs Marc Garneau and Stephane Dion.

In January this year, NDP MP Megan Leslie re-introduced the provisions as amendments to the bill in hopes of salvaging it. These amendments will be voted on in March.

While parliament continues to fight out this battle around reforming CAMR, the developing world faces a cruel reality. There is currently a global deficit of anti-HIV drugs suitable for children and many countries don't have the manufacturing capacity to develop and produce them.

"Unless Apotex or any of the other generic companies see a potential market, they're not going to go ahead on their own to produce the pediatric formulas," said Joel Lexchin, professor at York University. "And there's no market without a reformulation of CAMR."

Apotex has already committed to making and delivering infant and children-suitable HIV drugs if parliament votes to fix CAMR.

“It’s hard to imagine why there’s so much resistance to making this bill more workable and I think we continue to say whose interest[s] we’re protecting in the way the bill currently stands,” Clark from Apotex said. “It’s clearly not those of the developing world and not those [of people] suffering from AIDS.”

Steph Law is a freelance journalist, health rights activist and an epidemiologist. @lawsteph

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