[Ip-health] "Life-saving drug bill poised to pass" (Ottawa Citizen, 6 March 2011)

Richard Elliott relliott at aidslaw.ca
Sun Mar 6 08:39:37 PST 2011

March 6, 2011


Life-saving drug bill poised to pass
Advocates say legislation would reform system for supplying generic medicines to poor nations
MARCH 6, 2011
Parliamentarians appear poised to approve a private member's bill Wednesday that could reinvigorate Canada's system for supplying generic copies of life-saving drugs to developing nations.

Advocates say the bill contains reforms needed to make Canada's Access to Medicines Regime (CAMR), adopted unanimously by Parliament in 2004, actually function. But opponents insist it won't work, largely because Canadian generic drugs are too expensive to attract interest from impoverished developing nations.

The bill, known as C-393, was proposed nearly two years ago by now-retired MP Judy Wasylycia-Leis. It's now spon-sored by Ottawa Centre MP Paul Dewar. It aims to streamline CAMR to remove barriers that charities and NGOs say have effectively deterred developing nations and generic drug makers from using it.

The regime, one of the first of its kind in the world, is based on a 2003 World Trade Organization decision that allows WTO countries, through a process known as compulsory licensing, to authorize someone other than patent holders to manufacture generic copies of specified drugs and export them to a list of developing countries.

The legislation that created it was dubbed the Jean Chrétien Pledge to Africa Act. But in the nearly six years since CAMR's passage, that pledge has gone largely unfulfilled. All that CAMR has produced is two shipments of one generic AIDS drug to Rwanda.

Supporters of C-393 blame CAMR's cumbersome process, which requires generic drug companies to apply for separate compulsory licences for every order from a developing nation. Dewar's bill would replace that with a "one licence solution" that would permit generic manufacturers to export approved drugs to any eligible developing country.

The bill has already survived several near-death experiences. It might well have languished after Wasylysia-Leis retired, but was rescued when MPs, in a rare display of co-operation, agreed to let Dewar become its new sponsor.

In committee, the key one-licence provision was removed by Conservative MPs -most of whom oppose the bill -and Liberal MP Marc Garneau, who worries that it would infringe on intellectual property rights. That effectively gutted the bill, proponents say.

But MPs restored the critical provision, as well as one expanding the number of drugs subject to mandatory licensing, in voice votes on NDP amendments during final debate on the bill this past Thursday.

That caught even the bill's supporters by surprise, though civil society groups -ranging from faith leaders to grannies for Africa -have become vigorously engaged and may have influenced skittish politicians eyeing a spring election.

Supporters are now optimistic the bill will pass when it comes to a vote Wednesday. The New Democrats and Bloc Québécois are solidly in favour, as are most Liberals and even a handful of Conservatives.

That doesn't mean it will become law, however. MP Glen Pearson, the Liberal critic for international cooperation, says Conservatives have told him it will be killed in the government-controlled Senate. It could also die if there's an early election.

The bill has been divisive within Liberal ranks, with key figures such as Garneau, Pearson and former leader Stéphane Dion opposed. "It's one of those feel-good bills that actually has nothing in it," says Pearson. "I think we all know that it's bad legislation. It's not going to work any more than the first one did."

Still, Liberal leader Michael Ignatieff doesn't want the party to be seen as opposing the bill, Pearson said. As a result, "we'll make sure that the Liberals will get it passed."

To the bill's supporters, passage would offer new hope to millions of desperately ill people in developing nations, most notably those living with HIV/AIDS.
Worldwide, about 15 million people need antiretroviral drugs to control their HIV infections. About 5.2 million are currently getting them, mostly from Indian generic drug manufacturers.

The flow of generic drugs from India has slashed the cost of treatment for HIV from $10,000 per patient per year to $100 or less. That has enabled millions of HIV patients in Africa to get treatment, says Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network.

But the Indian drugs. which mostly date from before 2005, when India markedly expanded its patent law and adopted its own version of CAMR, are starting to fail as the virus mutates and develops resistance, Elliott says.

That means those on medication need to switch to newer "secondline" drugs to control their infections. But those, almost without exception, are only available from brand-name manufacturers.

"We're seeing a return to the bad old days of a decade ago, where the cost of treating people with the drugs they need is skyrocketing again," Elliott says. "It becomes unsustainable to keep those people on treatment, and without it, obviously they'll get sick and die."

Proponents say fixing CAMR can help save lives by making it easier for Canadian generic drug companies to manufacture and export lifesaving medicines.

But Amir Attaran, the Canada Research Chair in Law, Population Health and Global Development Policy at the University of Ottawa, says those who believe that are deluding themselves.

"Canadian generics are among the world's most expensive," Attaran says. "Canada is not the best place to go. We're actually about the bottom of the list."
Pearson agrees. "If you're a country or NGO in Africa and you're looking for generic drugs," he says, "you will never buy them from Canada because you can't afford it."

Not surprisingly, Bruce Clark, a senior vice-president at generic drug manufacturer Apotex, begs to differ. The pricing issue is "simply a convenient distraction being propagated by self-serving companies," he says.

Raw materials are the main driver of prices for generic firms, Clark says. Price is determined solely by volume, which makes the "one licence solution" and other reforms in C-393 critical. "With those changes, we can be assured of larger orders and sufficient time to manage lead times and inventory, which also drives down costs."

Attaran doesn't buy it. He says activists are being "profoundly immoral" by promoting C-393. "If they got their way, they would be contributing to the impoverishment of poor countries."

It would be "lamentable" if MPs pass the bill on Wednesday, he says. "It will leave Canadians with the impression that this country is doing something for the world's poor and sick that is significant. It is not.

"The law is a terrible amount of misspent effort at best," Attaran says. "At worst, it's a sort of misbegotten patriotism and possibly even damaging."

What Canada should do, he says, is increase foreign aid and use the money to buy medicines for developing nations from the cheapest top-quality source, Canadian or otherwise. "That to me is the only ethical course."

Russell Williams, president of Rx&D, which represents brandname pharmaceutical companies, doesn't agree that CAMR needs to be changed. "I think it was a good compromise," he says. When the regime's "straightforward" rules are followed, it works.

The law was supposed to be about HIV/AIDS drugs for Africa, Williams says. "Now it's all drugs for all countries on an unlimited basis. We're considering completely unbalancing the delicate balance that was created with unanimous consent when we passed CAMR." That could have serious consequences for drug safety and diversion to black markets, he says.

The rest of the world is moving toward "more voluntary ways" of providing needed medicines to developing nations, says Williams. Canada should help lead and expand those voluntary efforts by developing "creative partnerships."

Worldwide, 32 nations have adopted laws similar to CAMR. Yet to date, none has used its law to export a single pill to a developing nation.

That's because those laws, like CAMR, suffer from fatal flaws, says Elliott. "None of them is actually a good regime." And, he says, "none would be as good as what Bill C-393 would put in place."

That makes C-393 even more important, argues Dewar. "Everyone's looking to Canada here, because we were the first ones to bring it in. Now we're showing a way to innovate and update what we brought in."

dbutler at ottawacitizen.com

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Richard Elliott
Executive Director | Directeur général
Canadian HIV/AIDS Legal Network | Réseau juridique canadien VIH/sida 
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