A Chance for Canada to Play Hero with Medicines

Canada is in a prime position to lessen death and suffering all over the world by exporting affordable medicines to developing countries in a timely manner.

So why isn't it happening?

That's the question long vexing public health experts focusing on the needs of people in the poorest countries.

Now those advocates are pinning their hopes on a bill making its precarious way to a vote in parliament.

There's no disputing the need is great.

For example, approximately 1.3 million children under 15 live with HIV in low and middle-income countries. And less than a third of them currently receive treatment, according to a WHO report released in 2010.

But the first attempt by Canada's parliament to create a regime for making more drugs cheaply and quickly available to poorer countries hasn't delivered.

Which is why people like Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, are urging members of Parliament to pass an intact version of Bill C-393 on March 9 to fix Canada's Access to Medicine Regime (CAMR).

"We have tremendous capacity to help address a particularly need," Elliott said. "To leave in place a regime that is not working would be harming millions of people who need access to medicines."

False start in 2005

The regime that Elliott says isn't working was introduced in 2005. It allows generic companies to export drugs to developing countries without consent from the brand-name companies that own the patents.

Despite good intentions, the regime has only been used once. Apotex got permission in 2007 under the regime to distribute enough HIV medication, Apo-TriAvir, to treat 21,000 patients in Rwanda. The final shipment went out in 2009. But Apotex found the whole experience too cumbersome.

"We're not likely to repeat the process under the current regime," said Bruce Clark, Apotex's senior vice-president, scientific and regulatory affairs. "And I think it's not just our decision, it's a practical reality that no second country has made a request under the regime because it's so complicated."

Apotex has committed to developing and exporting HIV treatment suitable for children if Parliament makes the changes to the legislation proposed in bill C-393. But a parliamentary committee reviewed the bill last November and voted to water down its proposed amendments.

"As it stands, the bill won't fix anything," said Elliott from the Canadian HIV/AIDS Legal Network.

Parliament will have the chance re-introduce those amendments back into the bill on March 3. Failing that, say Elliott and other developing world health advocates, the bill will be useless even if it passes the final vote on March 9.

Too much onus on developing countries

The problem with the legislation lies in the multiple steps required before the government can override brand-name companies' control over their drugs, Clark said.

The legislation mandates that the generic company has to first try and get a voluntary license from the brand-name companies. This means that companies like Apotex have to approach brand-name companies and ask for permission to make generic copies of their drugs.

And if that fails, the generic company can then apply for a compulsory license under CAMR. Once the government grants the license, the drugs can be developed and exported.

Apotex requested voluntary licenses in July 2007 from GlaxoSmithKline (GSK), Shire and Boehringer Ingelheim, which were the three patent holders for the drugs needed to produce Apo-TriAvir.

Within a month, all three responded and granted permission to manufacture the drugs royalty-free, according to Rx&D's records.

But there were many conditions 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," said Clark from Apotex.

The patent holders later retracted the voluntary licenses and Apotex applied for a compulsory license in Sept. 2007 under CAMR.

That process took a total of 68 days, which is a number that the opponents of the bill agree with.

Current approach 'works': Rx&D spokesperson

The strongest opposition comes from Rx&D, an association of over 50 research-based pharmaceutical companies in Canada.

"We are as committed as everybody else in solving the problems in the Third World," said Wendy Zatylny, vice president of government affairs at Rx&D. "The reality is that the attempt to reform CAMR is not necessary, it works."

The process was very quick the last time, she added.

But those two months do not include the time it took Apotex to get all the information needed before they could approach the brand-name companies. In reality, it took four years for Apotex to complete their shipment of drugs to Rwanda, said Clark from Apotex.

Four years is a long time to wait for countries to wait on drugs, particularly when approximately 2 million people died from AIDS alone in 2009, according to the WHO.

Apotex started negotiating licenses with the drug companies as early as May 2006.

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

The drug companies wanted Apotex to give them the name of a specific country that's requesting the drugs, as well as the exact quantity to be produced and exported. But it isn't easy for a resource-strapped country to figure out how many people they expect to be infected with HIV at any given time.

"The developing countries couldn't understand why there's so much onus on them to take all these steps," Clark said. "Needless to say, the usual response is they decide to go buy it directly from a catalogue of an Indian supplier."

One of the amendments proposed, known as the "one-license" solution, would fix that. Right now, drugs authorized under CAMR can only be exported to the one country that made the initial request. If this bill passes, a generic company would only need to get a drug licensed once. After that, it could export the drug to any developing country. This would reduce the burden on developing countries to estimate their drug needs. And it would offload the pressure on generic companies to negotiate with brand-name companies.

Opposition blocks the bill

Opponents of the bill have also argued that the regime doesn't work because Canadian generics aren't competitively priced. Not because the legislation is too complicated.

"The trouble is that through no fault of CAMR or those who worked for it, Canadian generics are possibly the most expensive generics in the world," said Amir Attaran, Law professor at University of Ottawa, at a Senate hearing in 2009. "Therefore, no poor country is eager to buy them."

In fact, Apotex sold Apo-Triavir to Rwanda at 19.5 cents per tablet, according to Apotex records. This was less than what an India manufacturer charged at the time, at 20 cents per tablet.

In addition to the price argument, Rx&D argue that drug shortages are not as big of a problem as lack of infrastructure in developing countries.

"The bill is targeting the wrong problem," said Zatynyl from Rx&D. "At the end of the day, the problems the developing countries are facing are lack of health and human resources to properly provide diagnostic and treatment facilities, and follow-up capabilities for these patients."

Supporters of the bill don't dispute that some developing countries might have inadequate resources. But they argue that strategies to improve infrastructure should go hand-in-hand with increasing the availability of affordable drugs.

"In fact, the more you make the price of medicines come down," said Elliott from the Canadian HIV/AIDS Legal Network, "the more of the limited resources you actually free up to invest in building up other parts of the health system."

Pharma worried about property rights: prof

Professor Joel Lexchin at York University suggested that there might be other reasons behind why the pharmaceutical industry is against the bill.

"The drug companies are worried that any crack in the intellectual property rights regime would threaten their market," Lexchin said.

But even if Parliament fixes the legislation, generic drug companies will only be selling in developing countries, where brand-name companies don't have a market, he added.

The opposition from the pharmaceutical industry translates into votes and debates seen in parliament.

"The Liberals, especially from the Quebec region where a lot of brand-name drug companies are, aren't interested in this bill," said Lexchin. "Supporting the bill would cost them votes in seats within the House of Commons."

In the second vote on the bill in 2009, the Liberal MPs who voted against it included Marc Garneau and Stephane Dion. The two sit in ridings where pharmaceutical companies such as Abbott Laboratories, AstraZeneca and GSK are found.

"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 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 suffering from AIDS."

The regime was created for a reason, and it is to deliver much needed, essential, affordable drugs to developing countries. If it's failing to do that, then it's not working, pointed out Elliott of the HIV/AIDS Legal Network. The longer the government stalls on fixing the regime, the longer the global community suffers without drugs Canada can provide.

"When you could do something with the most minimal of efforts to prevent these deaths from happening," Elliott said, "to not do so is profoundly immoral."