OTTAWA - Canadians who suffer harmful side effects from the new swine-flu shot can take the vaccine maker to court - but the federal government would be on the hook for any damages.
The chief public health officer, Dr. David Butler-Jones, said Wednesday that Canada has agreed to shield drug companies from lawsuits over the H1N1 pandemic vaccine.
That means the federal government, not the vaccine manufacturers, would have to pay any damages awarded in court. That doesn't apply to cases of malpractice.
"That's quite normal," Butler-Jones said.
"It is about the issue of the vaccine. We're not obviously anticipating problems with it, but having indemnification for a vaccine is important.
"If someone does malpractice - I mean basically injects somebody the wrong way in the wrong place, or causes harm because of their practice - that is a different issue and there are other mechanisms for that."
Quebec is the only province with a no-fault compensation plan for harmful side-effects resulting from immunizations.
The Public Health Agency of Canada initially wouldn't say if Canada would protect drug companies from H1N1 flu vaccine lawsuits, as the U.S. and other countries have done.
The Obama administration has extended sweeping legal protection to anyone who makes, distributes, prescribes or administers the H1N1 pandemic vaccine.
That follows a long-standing practice in the U.S. of protecting drug companies from lawsuits over the use of childhood vaccines. It instead falls to a federal court to handle claims and to decide who will be paid from a special fund.
The decision to protect vaccine makers in the U.S. came after the 1976 swine flu outbreak, when 40 million Americans were vaccinated in a national campaign.
But that scare never morphed into the deadly pandemic officials feared.
Instead it touched off a flurry of injury claims from Americans who suffered side effects from the vaccine - including about 500 people who developed a temporary paralysis called Guillain-Barre syndrome.
However, that syndrome was never conclusively linked to the 1976 swine flu shot, and experts don't think a repeat is likely.
Pharmaceutical giant GlaxoSmithKline has a contract to produce 50.4 million doses of pandemic vaccine at its facility in Ste-Foy, Que.
But there are concerns about the new vaccine, which contains adjuvants, or compounds that boost the immune system's response to vaccine, allowing smaller doses to be used.
There are no data on the use of adjuvanted flu vaccine in pregnant women, which may add to the already high degree of reluctance many pregnant women feel about taking any medication or therapy.
So Ottawa has ordered 1.8 million doses of vaccine that does not contain adjuvants for pregnant women and young children.
