This article has been corrected. See But observers say that the investment, announced in July 2008, falls far short of what is needed. A business plan produced for the proposed network last year estimated annual operating costs to be $20.6 million.
Parliament's Standing Committee on Health called on the government in June 2008 to “immediately” establish the network, which would link researchers around the country to produce timely reports that track the impact of drug use in the “real world” and hence help protect Canadians from the unanticipated adverse effects of prescription drugs.
Dr. Carolyn Bennett, Member of Parliament for St. Paul's, Toronto and a committee member, was “thrilled” the network is being acknowledged, but dismissed the $1-million investment as a “pittance… just a little nod, with no assurance that another $20 million will be forthcoming.”
Post-Market Surveillance of Pharmaceuticals (June 2008), the Parliamentary committee's 54-page report, noted that Health Canada's proposed new “life cycle” approach to regulating prescription drugs (Bill C51) would ramp up the need for scrutiny of how drugs are actually used after they are approved for marketing.
Drugs are now assessed for safety and efficacy before they are approved for marketing, but the assessment is based on clinical trials conducted with limited numbers and types of patients. It is widely acknowledged that once on the market, drugs are taken by patients and disease groups that were never assessed, leaving them at risk for unexpected risks. A modern regulatory system is one that “continuously assesses a product's risks and benefits, both before and after it reaches the market,” states the federal Food and Consumer Product Safety Action Plan.
Around the world, countries are moving to establish systems to track the safety and effectiveness of drugs after they are marketed, but a key stumbling block is “sheer political will, because you have to put money towards this,” says internationally renowned drug researcher Dr. David Henry, who is now the president of the Institute of Clinical Evaluative Sciences in Toronto, Ontario.
“This is such an important issue. A lot of drugs seem okay and are later found to have serious adverse effects, like [rofecoxib] Vioxx [which was withdrawn from the Canadian market in 2005] and the diabetes drug [rosiglitazone] Avandia,” he says. “You need a system that is capable of detecting an increase in adverse reactions that are not, like sudden fatal liver disease, well recognized,” he says. For example, heart attacks and strokes could be drug reactions, but would be recognized as such only through formal large-scale surveillance, not through reports on individual patients, he said.
Henry, who moved from Australia to Canada this year, says Health Canada's announced investment is “necessary but not sufficient…. I can only take it as an article of faith that more money will follow, that this represents an enduring commitment.” The $1 million is to support a “detailed implementation plan,” Health Canada spokesperson Stéphane Shank stated in an email interview. It's not yet clear whether the provinces will kick in monies but Shank noted that the 2008 federal budget allocated about $119 million over 5 years for health product safety.
Canada is in a very good position internationally to set up the proposed drug safety network because detailed data sets that are available from provinces can be linked; the high quality of researchers in epidemiology, pharmacology and methodology; and Canada's success in addressing privacy concerns through the use of anonymized data, Henry said.
Canadians now spend about $22.5 billion annually on prescription drugs, with public drug plans picking up about half the tab. In 2004, about $38 million was spent on the premarket drug approval process (a substantial portion of that contributed by user fees paid by pharmaceutical companies), while the budget for the Marketed Health Products Directorate, charged with postmarket surveillance for all health products (including drugs), was just $8 million.
Canadian researchers, many of whom have been working together for several years on issues related to creating such a network, are heartened by this week's announcement. Sustained and predictable funding will be essential for the network to be attractive to the best scientists and research staff, notes Prof. Steve Morgan, who heads the program on pharmaceutical policy at the University of British Columbia's Centre for Health Services and Policy. “It can't be done in a series of one-off, 1-year projects. It has to be 5 years or more to create a community of practice that is going to be engaged in this in a meaningful way.”
Henry says that key to the success is for provinces to make data available to researchers, and if that takes place “something can happen quite quickly.” A backgrounder from Health Canada notes that “coordinated national collaboration and progress in addressing this important issue [postmarket surveillance] was difficult.” — Ann Silversides, CMAJ
