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Canada's empty pledge to Africa

[PoliticsWatch updated 6:30 p.m. August 16, 2006]

OTTAWA  — On November 6, 2003, five Liberal cabinet ministers held a press conference at the National Press Theatre to make a major announcement.

It was a feel-good news day as cabinet ministers Pierre Pettigrew, Anne McLellan, Allan Rock, Bill Graham and Susan Whelan all declared a small victory in the worldwide battle against AIDS.

Canada would became the first country in the world to introduce legislation that would allow generic drug companies to sell drugs currently under patent protection in Canada to developing nations facing epidemics. 

"We are proud of this giant step forward," said Pettigrew, who was trade minister at the time. 

Bill C-9 was viewed as a landmark piece of legislation and then prime minister Paul Martin named it the Jean Chretien Pledge to Africa Act in honour of the outgoing prime minister. It's recently been renamed Canada's Access to Medicines Regime. 

The bill was eventually supported by all parties in the House of Commons. 

Almost three years later, Health Minister Tony Clement has drawn attention to something that has been known in the drug industry, but not widely known to the general public. 

Like a UN resolution, the legislation has turned into just another empty promise with no results.

The Chretien Pledge to Africa Act has so far pledged not a single pill to a developing nation in the world. 

At a news conference at the International AIDS Conference in Toronto this week, Clement spoke about the bill in almost scandalous tones. 

"Exhibit A is the fact that not a single pill has flowed through the system and got to the people who need it," he said. "It's time to review whether there is something that is not working."

Clement said stakeholders will be part of this "top-to-bottom" review that will begin next year. 

Not only have pills not been delivered, but in the over two years since the bill was passed, only one Canadian generic drug company has made an application to obtain a licence to sell a brand-name drug. 

In the highly acrimonious and litigious world of the generic and brand name drug companies Clement's review is expected to create finger-pointing from both sides. 

But so far both sides are being careful not to get involved in a war of words with each other. 

In an interview with PoliticsWatch, Jack Kay, president of generic drug manufacturer Apotex, was careful not to lay blame on his brand-name competitors, but largely found fault with the previous Liberal government and the bureaucracy for creating hurdles that are slowing the process to deliver the drugs. 

"They didn't listen to us," he said of the Liberals and the mandarins. "They were trying so hard to protect the brand companies that they've almost killed the possibility of any Canadian company to take advantage of the bill the way it is structured."

Kay welcomes Clement's initiative, but describes himself as  "guardedly optimistic." 

While he believes Clement is "sincere" in wanting to fix the problem, he notes that no one from the minister's office or the government has approached him yet. 

"Politically it was the right thing to say. Will he have the courage of his convictions? Or will the bureaucracy not allow it to happen?" 

Kay alleges the bureaucracy, primarily Industry Canada officials, is pro brand-name drug and they are the real problem for his industry on this issue. "They're there forever and the politicians come and go."

He said the necessary changes do not require the legislative review Clement is calling for and could be completed by regulatory change. 

"I have an order, I have raw material. If I get a licence tomorrow, in two weeks I have the product made, shipped and we save lives."

According to Kay the primary problem with the bill is a clause that requires generic firms to approach patent holders -- brand-name drug companies -- to receive a voluntary licence to sell the drugs. 

However, pharmaceutical industry sources say the primary problem with drugs not getting to the developing world and the lack of interest by Canadian companies is Canadian generic drugs cannot compete price wise with other producers in countries like Indian. 

"The generics are trying to shift the debate into a patent case and that is not the case," an industry source told PoliticsWatch. 

But Kay begs to differ and suggests the legislation allows the brand-name drug companies to set up roadblocks. 

In 2005, Apotex was approached by the aid group Medecins Sans Frontiers to create a cocktail anti-viral AIDS drug, which Apotex has called Apo-triAvir. 

The drug is a mixture of three drugs -- zidovudine, lamivudine and nevirapine. 

The patent has expired on one of these drugs, but Apotex has had to approach two brand-name drug companies to receive permission to sell the drug to the aid group for distribution in the developing world. 

However, that has launched a complex negotiation between lawyers for Apotex and the brand-name companies that Kay says is delaying the process. And there is no limit on how long negotiations can proceed before the government can intervene.

Complicating the matter is that Medecins Sans Frontiers says the countries that are interested in buying Apo-triAvir do not want to be identified for a variety of reasons. 

The lawyers for the patent holders, including GlaxoSmithKline, wants Apotex to disclose what country the drug are destined for. They also are demanding that Apotex provides assurances the new drug, which is not currently being sold in Canada, does not get resold on the Canadian market.

Under the law the drugs sold cannot  resemble drugs sold in Canada in order to prevent cheaper drugs being sold on the black market domestically. 

Kay calls concerns about Apo-triAvir being resold in Canada "ludicrous" because there is no brand-name equivalent of its three-drug combination currently on the market in Canada.

Another problem with the process, according to Kay, is an application for a licence cannot be made until the drug is developed and approved by Health Canada. That may pose a time-consuming and costly gamble for any drug company attempting obtain a licence. 

Kay says Apotex has invested $2 million so far in the process. The drugs will be sold at 38 cents a tablet and Kay says the company will not make any money on the product which it's selling at direct cost -- raw material and overhead. Kay says this also does not include research and development and legal expenses. 

After being approached by Medecins Sans Frontiers to make the drug in 2005, Kay says Apotex has spent 15 months developing the new drug, running clinical trials and getting Health Canada approval of the drug. Apotex lawyers did not approach the patent holders until early this year. 

Clement has not ruled out his review could result in the government forcing the brand-name companies to give up their patents to allow generics to sell certain drugs to developing countries. 

The group representing the brand-name drug industry, Rx&D, issued a statement to PoliticsWatch on the issue. 

“Canada’s Research Based Pharmaceutical Companies (Rx&D) supports Canada's Access to Medicine Regime (CAMR) formerly known as the Jean Chretien Pledge to Africa Act as a tool to provide treatment to the developing world," said Jacques Lefebvre, vice president of communications for Rx&D.

"We believe that if all partners work together, the CAMR will achieve its objectives of providing affordable medicines to the developing world. Our community is doing its share to make the regime work."

: Related Links

> Government task force looking at high cost of generic drugs in Canada 

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