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  Access-to-medicine bill is mired in Parliamentary red tape
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Date: 24 February 2011

A parliament battle currently raging gives the impression that the Conservative government isn`t keen on delivering affordable drugs to children dying from HIV in the rest of the world.

Of course, many members of the public disagree, especially the 30,261 signatories of a petition [2] calling for the government to support Bill C-393.

The bill seeks to amend a piece of legislation enacted in 2005 known as Canada`s Access to Medicine Regime (CAMR). This regime was the then government`s response to the need for low-cost drugs to save millions of lives in developing countries. It was meant to help by allowing Canadian generic companies to produce and export generic medicines at reasonable prices to those countries who needed it.

The World Health Organization (WHO) has estimated that almost 15 million people living in low- to middle-income countries had with HIV in 2009, but only five million of these people were receiving treatment.

The bill hasn`t been working and needs to be fixed.

"The government had erected a series of roadblocks that prevented the use of this piece of legislation in any effective way," said Joel Lexchin, a professor in the Faculty of Health at York University in Toronto. "Until they fix these problems, this piece of legislation would not be viable as an option for improving access to medication in developing countries."

The bill proposes amendments based on how the legislation has worked to date, but these amendments were watered down [3] when a parliamentary committee reviewed it last November.

So the bill, as it stands, will not improve the legislation. The House of Commons has an opportunity to re-introduce those amendments that would make a difference back into the bill on March 3. Failing that, the bill will be useless even if it passes its final vote on March 9.

Much of the resistance against reforming CAMR comes from the pharmaceutical industry, as represented by Rx&D, the association of 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, in an interview.

"The reality is that the attempt to reform CAMR is not necessary, it works."

But advocates of the bill challenge this.

"To claim that it`s working when it`s taken almost seven years to supply one drug, once, to one country, and any country that`s come out to use it has said they won`t use it again..." said Richard Elliott, executive director of the Canadian HIV/AIDS legal network. "Well, if that`s their definition of success, I`d hate to see what their definition of failure is."

Elliott was referring to the one and only time Canada used CAMR to export drugs. Apotex, a Canadian generic drug company, successfully made two shipments of anti-HIV drugs [4], Apo-TriAvir, to Rwanda in 2008 and 2009.

The shipment contained enough tablets to treat 21,000 people living with HIV for one year. But this feat was a one-hit wonder, with Apotex itself shying away from repeating the experience.

"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."

Getting authorization to export drugs under CAMR is a lengthy process. A developing country has to first come forward and request for the drugs. The country also has to specify the volume of drugs they wish to order.

A generic drug producer, like Apotex, then uses that information to request for a voluntary license from the brand-name drug companies. These companies hold the patents, or rights, to producing and selling the drugs.

If the brand-name producer doesn`t grant the voluntary license, then the generic producer can apply for a compulsory license under CAMR. A compulsory license gives governments the power to let a generic drug company produce and sell a drug, even without consent from the patent holder.

Once approved, the drugs are made and exported to the country that made the initial request.

The long road

It took four years for Apotex to work through all those steps in order to get their shipment authorized by the government.

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

Despite this, the pharmaceutical industry insists the regime is working expediently.

"It was an extremely quick process," said Zatylny, vice president of government affairs at Rx&D. "There was tremendous corporation on the industry`s part because we support the intention of CAMR."

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. And 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.

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 in total from the time Apotex asked for voluntary licenses to when the government granted the compulsory license. Which isn`t too long. But it took four years because of the details needed to approach brand-name companies in the first place.

Apotex had 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," he said.

The problem is created because a developing country has to put forward a request for an exact quantity of drugs 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.

"Needless to say, the usual response is they decide to go buy it directly from a catalogue of an Indian supplier," Clark said.
India supplies nearly 80 per cent of all HIV drugs available in developing countries, according to a study [5]published last year in the Journal of the International AIDS Society.

Opponents of the bill argue that countries aren`t coming to Canada for the drugs because they aren`t competitively priced, and not because of how complicated the process is.

"That`s just spreading misinformation," Clark said.

Apotex sold Apo-Triavir to Rwanda at 19.5 cents per tablet, according to Apotex records. This was lower than prices offered by Indian generic drug companies at the time, which were 20 cents per tablet.

One-license solution

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 that expires, the countries and the generic companies have to go through the entire process again.

Apotex faced this issue when Rwanda asked for the authorized amount of drugs to be shipped out in two installments, one in 2008 and another in 2009. By the time the second shipment was scheduled for, the compulsory license expired.

"The reality is that when Apotex came back and requested an extension, our member company granted the extension for the patent for the licence within seven days," said Zatylny.

Apotex doesn`t dispute this number. The problem lay in what happened after the authorized amount was delivered. Rwanda wanted to order more drugs from Apotex.

But this wasn`t possible unless the both Rwanda and Apotex went through the entire process dealing with the brand-name companies again, including first needing to ask for voluntary licenses again, and if that failed, applying for a compulsory license.

So Rwanda looked elsewhere.

Advocates for CAMR started discussing how to improve it. The outcome was Bill C-393 now before Parliament, which former NDP MP Judy Wasylycia-Leis introduced as a private member`s bill in 2009.

The bill originally proposed 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, if any, given how complicated this is.

Furthermore, the bill wanted to expand the list of drugs that qualify for compulsory licenses. This list currently limits the use of CAMR to specific drugs for specific diseases.

"[As it stands] that`s an unnecessary and unjustifiable restriction to the 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."

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

In January this year, NDP MP Megan Leslie, re-introduced these solutions as amendments to the bill, and this will be voted on in March.

The wait

While parliament continues to fight over this, 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 paediatric formulas," said Lexchin, "and there`s no market without a reformulation of CAMR. "

Apotex has already committed to making and delivering infant and child-suitable HIV drugs if parliament votes to fix CAMR. But until then, the likelihood Canadian companies can contribute in any meaningful way to this specific shortage is slim.

"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 said. "It`s clearly not those of the developing world and not those suffering from AIDS."

Clark raised good point. In fact, in 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, pharmaceutical companies such as Abbott Laboratories, AstraZeneca and GSK are within the ridings of Liberal MPs Marc Garneau and Stephane Dion.

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."

Stephanie Law [6] is a freelance journalist, health rights activist and epidemiologist.

Keywords: Medicines / Access / HIV/AIDS