Health Canada’s smart regulations not so smart
UPdate spring 2005

It would seem obvious that the priority of Health Canada is to protect the health and safety of Canadians through evaluating and regulating products and technologies. But that obvious truth may soon be thrown out the window. In Health Canada’s opinion, the Food and Drug Act is out of date. Its focus on safety is “too narrow” for the modern world.

If health and safety aren’t the priority for Health Canada, what is? Efficiency, innovation and trade would become equally important to safety if Health Canada’s new approach becomes law. In a document misleadingly titled Health and Safety First, Health Canada proposes to revise the basic principles of health protection in Canada.

Health Canada’s new document is full of logical sounding phrases. The Food and Drug Act needs to be updated, HC claims. The changes proposed will make us safer, they say. But behind these soothing phrases, lies a very different reality.

If proposed changes are adopted, companies would no longer be responsible to prove their products are safe. New foods, drugs and technologies would be presumed safe by Health Canada unless proven otherwise. The burden of proving otherwise would rest on citizens. The most likely scenario is that this would only happen after harm had been done, very possibly irreversible harm.
Instead of preventing harm, the objective of Health Canada would be to “reduce risk” and “manage damage.”
Instead of precaution being the guideline for decision making, the precautionary principle would be used only “in extreme cases.” But the point of using a precautionary approach is that its impossible to know, especially in the early stages of scientific innovation, what harm may come from a new product or technology in the future.
The proposed changes also remove Canadians’ right to sue the government for regulatory negligence.

What’s behind the proposed changes are highly controversial issues. These are issues about which scientific experts have urged extreme caution, including biopharmaceuticals, genetically modified foods, animal to human transplants and cloning. What’s motivating the proposed changes is very effective lobbying by strong corporate interests. As the European Union is strengthening its precautionary approach, Canada is poised to leap in the opposite direction, joining its neighbor to the South in downplaying regulation in favour of helping companies get new products on the market.

Mike McBane, head of the Canadian Health Coalition, sums up the new direction. “Canada’s [proposed] strategy is that it is better for ten new products to be approved to the detriment of human and environmental health than that one safe product be erroneously restricted.”

There have been many reasons to criticize the effectiveness of health protection in Canada, in recent years. Think of Walkerton, drug recalls, the tainted blood scandal. Recently, a Canadian Medical Association Journal editorial blasted Health Canada for failing "miserably" to protect Canadians from harmful drugs and setting standards for approval so low that they have sanctioned medicine without adequate proof of safety.

The source of these problems has not been that the Food and Drug Act was inadequate. The problem has been inadequate application of the act and other protective regulations. Inside Health Canada, budget cuts, dissolution of independent scientific labs, passive monitoring, and weakened regulatory controls have been undermining health protection for years . Dedicated Health Canada scientists have been fired for publicly criticizing the shifting emphasis from public health protection to client service - as Health Canada defined its clients as companies seeking product approval, not the public needing protection. Until now, however, the legislative principles that enshrined health protection and a precautionary approach remained intact.

Changes to the Food and Drug Act don’t sound very exciting. But the legal basis for Canadian’s right to health protection is found in the Food and Drug Act. The principles in the Act are the grounds on which health protection is based. They also provide the legal bases for remedies when health and safety is not adequately protected.

Now Health Canada wants to rewrite the principles and the law. It’s called “legislative renewal’ and its being done in the name of “smart regulation’”. “Smart regulation” is shorthand for insuring that protective agencies of government fall in line with the needs of trade and development policies. A government committee on “smart regulations” indicates that environmental protection as well as health protection will soon be subject to “smart regulation.”

Public consultations on the proposed changes showed that Canadians overwhelmingly reject Health Canada’s proposed change of emphasis. They want Health Canada to stay in the business of health protection. They want that protection to be strengthened, not weakened.

Justice Horace Kreever, in his report on the tainted blood scandal, could have been predicting current events. “The relationship between a regulator and the regulated must never become one in which the regulator loses sight of the principle that it regulates only in the public interest and not in the interests of the regulated.”

Health Canada’s proposals, and the politicians who support them, have certainly lost sight of the public interest, and the health of all Canadians lies in the balance.
For more info www.healthcoalition.ca