Attempts to revive an “unusable” Canadian law passed in 2004 to enable generic versions of patented drugs to be exported to developing countries have all but failed, to the fury of health activists.
Last week, a majority of the Canadian House of Commons Standing Committee on Industry, Science and Technology destroyed the core reforms proposed by Bill C-393 to fix Canada’s moribund Access to Medicines Regime (CAMR), which was originally passed in 2004 as the Jean Chretien Pledge to Africa Act to facilitate the export of generic drugs to eligible developing countries. However, the law has proved over-complex and bureaucratic, and in the six years since it was passed it has been used only once, to issue a licence authorising the export of a single order of one HIV/AIDS drug to one country, Rwanda.
Bill C-393’s supporters had sought to amend CAMR with a number of reforms aimed at making it more workable, including introducing a so-called “one-licence” mechanism to streamline the law and replace its current requirement that, in seeking a licence to export, a generic drugmaker needs to identify in advance a single developing country and a fixed “maximum” quantity of a medicine for that country, and then repeat a lengthy licencing process each time.
The proposed amendment would have enabled generics makers to obtain a single licence authorising exports of a medicine to any of the eligible countries listed under the current law, and to supply the quantities of medicines required as the nations’ needs evolved over time.
While this amendment and other key clauses aimed at improving the bill’s usability had the backing of activist groups, civil society organizations and health experts, they were rejected last week by the five Conservative Members of Parliament (MPs) sitting on the Industry Committee, plus one Liberal.
Critics on the panel had expressed concerns over the proposed reforms’ implications for intellectual property rights and incentives for R&D, and the potential for drugs exported under the scheme to find their way onto the black market. However, the Canadian HIV/AIDS Legal Network, which has long campaigned for reforms to CAMR to remove the obstacles preventing its use, described the vote as “a shameful display of putting the interests of the extraordinarily profitable brand-name pharmaceutical industry ahead of the lives of millions of poor people who need low-priced, affordable medicines.”
The current regime is not economically viable for generic manufacturers or procedurally user-friendly for developing countries,” said the Network’s executive director, Richard Elliott. “The generic manufacturer that has tried to use CAMR has indicated it won’t try again unless the system is changed. Humanitarian organization Medecins Sans Frontieres tried for months to use CAMR to purchase medicines, but ultimately abandoned the effort. No other developing country has sought to use CAMR,” he added.
Since Bill C-393’s author, New Democratic Party (NDP) MP Judy Wasylycia-Leis, left Parliament at the end of April, the bill has been sponsored on an unofficial basis by her NDP colleague and Industry Committee member Brian Masse, who described the vote as “shameful and embarrassing” for Canada and “an insult to all of the thousands of Canadians across the country who have worked so hard for this bill to fix the broken CAMR.”
“With 14,000 lives lost every day to treatable infectious diseases such as HIV, malaria and tuberculosis,” it was “unfortunate,” he added, that the Committee members “chose to side with large foreign pharmaceutical corporations rather than sick children in poor countries.”