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Drug makers don’t oppose generic drug legislation

An August 2010 file photo shows Drug manufacturing at GlaxSmithKline Canada's Mississauga facility.

Fred Lum/The Globe and Mail

Canada's brand-name drug companies say they do not object to an NDP private-member's bill aimed at unblocking efforts to make cheap generic versions of lifesaving drugs available to the world's poor.

In a letter sent last week to all parties in the House of Commons, Russell Williams, the president of Canada's Research-Based Pharmaceutical Companies (R&D), said his organization "will not oppose the amendments proposed in Bill C-398," provided that any reforms to Canada's Access to Medicines Regime (CAMR) comply with World Trade Organization rules.

That is good news to Hélène Laverdière, the New Democratic sponsor of the bill, who says international legal experts agree that there is nothing in her proposed legislation that would contravene WTO agreements.

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Mr. Williams's letter spells out a number of requirements that he would like to see imposed on any generic company that copies a brand-name drug with the intention of selling it to impoverished countries.

But "what it means to me is that R&D is ready to see the bill go to committee and be studied there," Ms. Laverdière said. "They are ready to sit down and discuss and make this thing work, which is fantastic."

Meanwhile, Jack Kay, the chief executive officer of Apotex Inc., a generic drug manufacturer, has written his own letter to MPs in support of the bill.

"We urge you to consider some simple, fundamental changes to the existing CAMR that would immediately make it more workable and attractive for a company like Apotex to utilize in a sustainable manner," Mr. Kay wrote. "Important simple changes are before you again in Bill C-398."

The proposed legislation is, in all practical ways, identical to a bill that was passed by the House of Commons in the final days of the previous government. The earlier bill died in the Senate when the election was called in the spring of 2011.

The new bill will be put to a vote in the Commons on Wednesday. If it fails, the initiative will die, at least until after the next election in 2015.

Like its predecessor, Bill C-398 is an attempt to untie the knots in CAMR, which came into law under a Liberal government. The regime is so fraught with red tape that, in eight years of existence, it has been used to send just two batches of one generic drug to one country.

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Ms. Laverdière is counting on the support of her own party, the Liberals, the four Bloc Québécois MPs and Green Party Leader Elizabeth May. There are also a number of Conservative MPs who are in favour, she said, "some because it's a moral imperative and others because they are actually quite knowledgeable about the bill."

It is expected to be a free vote. But the numbers for and against will be close and the outcome could depend upon who is in their seats at the time.

The Conservative government has made it clear that it doesn't approve of the proposed legislation and has sent out members of the Tory caucus to say the bill would violate Canada's international obligations.

Supporters of the bill say that is simply not true.

"It changes the sequencing of events that happens in order to get the compulsory licence in the hands of generic manufacturers to supply the eligible countries," said Richard Elliott, the executive director of the Canadian HIV/AIDS Legal Network. "But all of the parameters that are required in WTO law to ensure transparency of the process and to ensure that medicines get to where they are supposed to get are respected."

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About the Author
Parliamentary reporter

Gloria Galloway has been a journalist for almost 30 years. She worked at the Windsor Star, the Hamilton Spectator, the National Post, the Canadian Press and a number of small newspapers before being hired by The Globe and Mail as deputy national editor in 2001. Gloria returned to reporting two years later and joined the Ottawa bureau in 2004. More

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