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Generic AIDS drugs: still not getting from Canada to the world

UNICEF, Stephen Lewis, Senator Yoine Goldstein make the case for new laws

When it was first passed in May of 2004, Canada’s Access to Medicines Regime (CAMR) was ground-breaking.

It came the heels of a 2003 World Trade Organisation agreement that there needed to be an “expeditious solution” to providing low-cost generic versions of anti-retroviral drugs to developing countries.

However, the regime has only been accessed once since its passing, says Liberal Senator Yoine Goldstein.

Goldstein organised an expert panel of NGOs to address the need to reform CAMR. At the National Press Theatre on Mar 26, they made their case.

“A key component of this battle shamefully, I say frankly, remains mired in red tape, preventing inexpensive drugs from flowing from Canada,” Goldstein says. “Canada, with its wealth and its international reputation has the obligation to encourage and facilitate the flow of drugs to the almost 30 million people who have no access at all to those drugs.”

“The current mechanism consists of a country-by-country, drug-order-by-drug-order process of licensing,” says Richard Elliott, Executive Director of the Canadian HIV/AIDS Legal Network. “The results: inefficiency, waste, disincentives, and pressure on countries to refrain from using compulsory licensing to obtain more affordable medicines, and a process that does not mesh with the practical reality in how countries proceed in procuring medicines.”

Elliott proposes a streamlined single-license solution that would allow a generic drug manufacturer to obtain a single license for the manufacture of an anti-retroviral drug, while allowing it to negotiate with various countries to allow for economies of scale and have the approvals ready at the bidding process.

“We have secured a commitment from Apotex that if the licensing process is streamlined and simplified, it will make a version of a key AIDS medication that is suitable for children that could be exported to multiple developing countries,” Elliott says.

Apotex is the only company to have accessed the CAMR provisions to provide a three-in-one AIDS drug to Rwanda, and even though several other countries have similar laws to Canada’s, no others have been accessed.

Nigel Fisher, the President and CEO of UNICEF Canada, Peggy Edwards, the Co-Chair of the National Advocacy Committee of the Grandmothers to Grandmothers Campaign, and Stephen Lewis of the Stephen Lewis Foundation urged Parliamentarians to act on streamlining CAMR.

The government position is it needs more time to fix the legislation — something the panel finds unacceptable.

“When we hear the government is monitoring the situation, waiting for enough evidence to accumulate to justify changing CAMR [and] does not rule out future amendments if they prove warranted, I and my co-workers in the field have to ask — what is the evidence that’s being waited for?” Fisher asks. “What are the circumstances required for change to be instituted?”

In the absence of amending legislation coming from the government, Goldstein will be bringing forward a private members’ bill in the Senate within the next month to make the changes.

“One would have hoped that the government in place would present its own bill, because that would make the process all the more speedy,” Goldstein says. “But that has not happened.”

Elliott stresses that the changes would not cost the government a single penny.

“It is something that is a matter of changing the legislative framework, and then it will be up to private parties to make use of that framework, to get medicines for patients at lower cost.”

And while the government has not yet offered official support, it was noted that the original bill passed with unanimous support in both Houses, and that there is a willingness among current MPs to make the changes.

“It’s a question of whether enough Parliamentarians will see the light and come on board and see that this is the thing that needs to be done,” Elliott says.