News | Bureaucracy bars children’s access to meds

Large pharmaceutical companies expected to oppose reforms to flawed legislation

After nearly five years of calling for reform of Canada’s Access to Medicines Regime (CAMR) – legislation intended to facilitate access to affordable, essential medicines in developing countries – Canadian civil society organizations may have reason to believe change is near.

Speaking on Parliament Hill last Thursday at a panel to launch the reform campaign, Senator Yoine Goldstein indicated that amendments to the legislation had already been drafted, and that plans to table the initiative in Senate by the end of April were underway.

CAMR was originally meant to allow generic Canadian drug manufacturers to approach the Commissioner of Patents and request a compulsory license – a scheme which permits the manufacturer to bypass the patent holder’s rights under exceptional circumstances. In so-called developed countries like Canada, HIV/AIDS has become a difficult, chronic condition. Yet, in developing countries with high rates of HIV/AIDS and low access to essential medicines, millions are in need, and the conditions are certainly exceptional. However, only one shipment of drugs has left the country thus far, and the legislation is widely recognized as flawed.

“[The regime] has not put lives before patents – precisely what this groundbreaking legislation was intended to do,” said Marek Krasula, counsel for Senator Goldstein. “No generic manufacturer is willing to go through the CAMR process in its current form.”

Under the current system, manufacturers are required to apply for a separate compulsory license for each country it wants to export to, and for each quantity of medication it wants to export.

According to Richard Elliott, Executive Director of the HIV/AIDS Legal Network, the main aim of the proposed reform implementing what he terms a “one-license solution” – a system that would allow generic manufacturers to apply for a single license authorizing the export of a lower-cost drug to any of the eligible countries without predetermining the quantity, and with the requirement that the generic manufacturer periodically disclose the contracts that they land and pay the applicable royalty.

“I think it is not at all premature, contrary to what the government says, to actually revisit this and come up with a much better, simpler process of getting medicines at lower prices to developing countries,” Elliott said.

At the panel, Elliott highlighted the need for government to act immediately. He announced that generic drug manufacturer Apotex – the first and only company to export drugs under CAMR – has committed to making a lower-cost version of an important paediatric AIDS medication, but only once CAMR is streamlined.

Citing problems with current paediatric formulas, including unpleasant tasting syrups, the requirement for refrigeration, and the need for children to take multiple doses, Elliott said that millions of children are in need.

“[A] paediatric formulation is incredibly needed to treat children with HIV around the world, particularly in Sub-Saharan Africa, when so few children have access to practicable treatment,” Elliott said, adding that the proposed formulation would only have to be taken once or twice per day.

Apotex’s Director of Public and Government Affairs, Eli Betito, also told The Daily that this would be the first and only medicine of its kind in the world.

Once the bill is tabled in the Senate, however, it is likely to face major obstacles. Though Elliott has been meeting with MPs from all political parties to discuss the proposed reform, history does not show promise: in December 2007, the government tabled a review of CAMR that recommended no changes be made. Elliott speculates that much of the resistance will come from large pharmaceutical companies who have a stake in maintaining the status quo.

“Big pharma has always opposed compulsory licensing as a policy tool to get lower priced medicines, an opposition which is particularly obnoxious and offensive and really damaging when we’re talking about opposing the use of compulsory licensing by developing countries who are facing millions of people who need affordable medicine,” Elliott said.

The Minister of Industry, Tony Clement, did not respond to The Daily’s request for a comment.

Krasula felt that the issue of reform should move beyond partisanship, calling it “apolitical.”

“Even though it is a private member’s bill, all-party support would surely expedite the entire process and give this issue the attention it deserves,” he said.

Elliott agreed, noting that all members of Parliament and the Senate should have an interest in making the legislation work, as they voted unanimously for the original CAMR plan in 2004.

“As more time goes by it just becomes even more and more of an embarrassment that we haven’t got this right. That’s why we’re saying: it is in your hands, Parliament,” Elliott said.


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