Canada needs to correct a fundamental injustice by creating a no-fault compensation plan for those who are severely harmed by vaccines, a study concludes.
The report, published in the Munk School Briefings, argues that because vaccination is a cornerstone of public health and strongly encouraged (even mandatory in some circumstances), there is an ethical obligation to compensate people in the rare instances when they suffer disability or death as a result.
Further, Canada is the only Group of Eight country, other than Russia, that has not adopted this "principle of reciprocity," by creating a national no-fault compensation plan, according to the authors.
The paper, written by Jennifer Keelan, an assistant professor at the University of Toronto's Dalla Lana School of Public Health and Kumanan Wilson of the Ottawa Hospital Research Institute at the University of Ottawa, notes that there are a handful of cases of "vaccine-damaged" individuals each year, but there has never been a successful vaccine injury case.
"The tort system is not an efficient way of adjudicating these issues," Dr. Wilson said in an interview. "It's just not a fair system we have now."
That reality has been highlighted by a number of judges who reluctantly dismissed lawsuits involving children who suffered harm from vaccines because there was no fault found.
In fact, it was one such observation by the Supreme Court of Canada in the case of Nathalie Lapierre, a five-year-old girl who received a measles vaccination and, subsequently, developed viral encephalitis and severe, permanent disabilities, that led Quebec to create a no-fault compensation plan in 1986.
Three other provinces - Manitoba, Saskatchewan and Ontario - have considered implementing a similar model, but have not yet done so.
Dr. Wilson said there has never been urgency to act in Canada because the legal system has not allowed class actions that threatened to bankrupt vaccine manufacturers in other countries, but that is changing.
He noted, for example, that GlaxoSmithKline, the manufacturer of the H1N1 vaccine, would not bring its product to market unless it was protected from potential lawsuits, a demand that was met by Canada. And, in the U.S., a compensation program was created after two-thirds of vaccine manufacturers threatened to quit the business because of the fear of legal action.
"This is the right time to act," Dr. Wilson said. "We shouldn't wait for a crisis and react; we should be pro-active.
In their paper, Dr. Keelan and Dr. Wilson argue that a national plan is the best approach, principally because recommendations on vaccines come from two national bodies, the National Advisory Committee on Immunization and the Public Health Agency of Canada.
Additionally, a single national plan would help to ensure consistent rules and awards, and help to spread costs.
In their paper, the authors offer up a blueprint for a no-fault plan that would blend the approaches used in Quebec and the U.S. It would mean that claimants could either opt for an award from a pre-established "table of claims" or appear before a tribunal adjudicated by a special master, a quasi-judicial official.
The researchers also recommend that there be a three-year statute of limitations on making claims (because most vaccine injuries occur shortly after immunization), that only permanent disability or death be compensated and that only uninsured damages be covered.
Dr. Wilson said a no-fault compensation plan would cost very little - "maybe a few million."
There are 13 jurisdictions in the world with no-fault vaccine compensation programs, including Japan, New Zealand, South Korea, Denmark, France, Germany, Switzerland and the U.S.
In some countries, a few pennies are set aside from the cost of each vaccine dose to fund the plans, while others pay out of general revenues.
Injuries caused by vaccines are extremely rare, occurring at rates from 1 in 40,000, as in thrombocytopenia (a blood disease characterized by low platelet counts) after a measles-mumps-rubella vaccination, to less than one serious event per million doses, as in Guillain-Barré syndrome (a form of paralysis) related to influenza vaccine.
The Canadian Pediatric Society estimates that, of the 400,000 or so children immunized each year in Canada, five will suffer some permanent injury.