Flu shots can give a different kind of immunity

Swine flu vaccine makers may get a special gift from the federal government: immunity from civil negligence suits. You may not have heard about it because other swine flu news recently got much more spotlight. First, Ottawa spent five times as much on stimulus plan ads as on H1N1 awareness. And the federal Health Ministry shipped body bags to aboriginal communities to help them prepare for the epidemic. But the story about legal immunity for vaccine makers is equally deserving of national attention. Taxpayers will foot any bill for the government’s protection of pharmaceuticals, and vaccine users may bear an excessive risk of death or injury. Although the US already offers immunity to vaccine makers, Canada is different enough to require careful study and discussion of this issue.

Immunity from legal suits in this case means if the vaccine is a suspected cause of death or injury, the law will not allow victims to sue the vaccine manufacturer. They may have no recourse at all, or the government may compensate them from a special fund. The immunity shifts the risk of mistakes in vaccine making from the pharmaceutical industry to victims or to taxpayers. Under the common law, negligent companies are liable for injury or death caused by their products. But the government can protect a company from the common law liability by statute or executive decision. The main reason is to bring vital products to as many people as possible faster and at a lower cost. The government may need as many vaccine doses as possible sooner to prepare for a coming pandemic. Protecting themselves from legal liabilities can slow vaccine makers down or make the vaccine too expensive. To get a lot of vaccine fast, the government shifts the risk from pharmaceutical companies to taxpayers or vaccine users.

Unless the government compensates victims, the vaccine makers’ immunity shifts the whole burden and risk of injury or death to vaccine users. The US government has granted immunity to vaccine makers after the 1976 swine flu outbreak, but it has set up a fund to compensate victims. This is essentially a specialized public health insurance fund. For a victim to take advantage of it, a special federal court must approve the claim. It’s also an insurance fund for pharmaceuticals because taxpayers pay for their negligence. It’s not clear if vaccine makers have to pay any premiums to get the protection. And no immunity is available for wilful acts, such as intentional tainting of the vaccine.

What about Canada? Are we at the moment of truth before the epidemic hits? Are the demand for the vaccine and the threat of legal liability so high that they are bogging down pharmaceutical companies? Or are vaccine makers trying to maximize their profits at the expense of Canadian taxpayers? The federal government refuses to tell if it will shield pharmaceutical companies from liability. GlaxoSmithKline, which has already signed a contract to make 50.4 million vaccine doses at its plant in Quebec, says only that it’s talking to Ottawa. It’s already much more difficult to sue for medical or pharmaceutical malpractice in Canada than in the US. Any immunity will lower the incentive to make vaccines safer, although they will not necessarily be less safe. We don’t know if the Quebec facility can simply conveyor doses out, or if more R&D and testing are required. Neither do we know if the vaccine will be mandatory taking away our choice between the risks of the swine flu and vaccine side effects. But even if the shot is voluntary, the government should require warnings before the vaccine is administered—that is, of course, if it makes us bear the risk of vaccine makers’ negligence by offering them immunity.