Canadians are bombarded with near-daily news stories of an overburdened health-care system, increased wait times and are being advised to live less sedentary lifestyles, yet Health Canada is trying to take away the means for the public to care for itself say opponents of a new federal bill that would significantly change the current Food and Drugs Act.
On April 8, the federal health minister, Tony Clement introduced Bill C-51 to the House of Commons where it passed its first reading. According to the government, the bill is designed to improve the safety of food, consumer and health products in Canada.
“The proposed amendments to the Food and Drugs Act will modernize Canada’s regulatory regime for health products and food, which has been a core federal government responsibility for decades,” says Paul Spendlove, media relations officer for Health Canada. “These amendments will strengthen our current system and continue to require that regulated parties comply with Canadian regulatory requirements.”
However, alternative health advocates are concerned with a number of the proposed changes that could see up to 75 per cent of natural health products (NHP) declared illegal and pulled from shelves. Products like herbs and supplements would be lumped together in the same category as pharmaceutical drugs under the term “therapeutic product.” According to Health Canada, this term is an umbrella definition intended to capture all products that are used for therapeutic purposes, such as medical devices, drugs, cells, tissues, organs, vaccines and veterinary drugs, as well as natural health products.
On May 9, close to 300 people staged a rally in downtown Calgary decrying the proposed legislation, many fearful the health products they have used for years with no adverse effects would soon disappear from store shelves and concerned about the “insidious” powers Bill C-51 would grant Health Canada inspectors.
“From a strictly manufacturer and retail sense, the amendments propose some really tough restrictions on natural health products,” says Liam Muzichuk, manager of Community Natural Foods. “Considering that two-thirds of Canadians, at some point, are taking some sort of supplement that means most Canadians won’t be able to get their supplements. From that perspective, it’s ridiculous.”
If passed, Bill C-51 would also allow Health Canada inspectors to conduct a search and seizure of a manufacturer’s property without a warrant, time limitations or the obligation to report the seizure to a court. The owner of the product could also be forced to pay for transportation and storage of the seized goods and have their bank accounts frozen. In the case of a private residence, Health Canada would require a warrant. Fines for violating the Act are as high as $5 million and impose jail terms up to two years.
“For the average natural health product manufacturer, especially some of these smaller upstart companies that may have a great product, $5 million would kill them,” says Muzichuk. He points to the number of stories in the news about Canada’s failing health-care system and the increase in wait times to see a physician, which he believes has frustrated Canadians to the point where they will seek out alternative treatments to either prevent or cure their illnesses. An Ipsos-Reid survey found that over 75 per cent of Canadians purchased some type of natural health product in 2005. According to Canadian Health Food Association, the natural health product industry is currently worth $2.5 billion in Canada. “The whole idea of this industry is to not be a burden on the health-care system and is a way to prevent illness from happening as opposed to dealing with it after the fact of it occurring,” says Muzichuk.
Health Canada says that under Bill C-51 Canadians will continue to have access to natural health products, and will it not limit access to natural health products nor call for a change in their regulatory status from over-the-counter to prescription. “Bill C-51 is not focused on natural health products and will not affect the regulation of natural health products in Canada,” says Spendlove. “Under Bill C-51, natural health products will continue to be regulated under the Natural Health Products Regulations, which have been in force since January 1, 2004.”
On that date, the Natural Health Products Directorate was enacted in part because the government, consumers and some natural health product manufacturers felt the regulations that existed at the time were too lax. The regulations required manufacturers to adhere to good manufacturing practices, to properly label the product and to acquire a product licence. The Natural Health Products Protection Association reports that under current Health Canada safety standards, 60 per cent of single-ingredient natural health products have failed the licence application process. This number increases significantly with multi-ingredient products with up to 80 per cent of these expected to fail licensing applications. “According to [Health Minister] Tony Clement, [the failure rate] has more to do with paper work than anything else,” says Muzichuk. “He says it’s easy to fix and be fast. The reality is that the approvals haven’t been fast, and the failure rate is up to 60 per cent. Either way you look at it manufacturers can’t get things approved.”
According to Health Canada, the power to seize and detain a product exists under the current Food and Drugs Act and in a number of other legislations, and that the current authority to seize a product does not require a judge's warrant, and would not change under Bill C-51. “An inspector's power to seize is based on the authority to enter an establishment, which may only be exercised when the inspector has reasonable grounds to enter,” says Spendlove. “Inspectors are obligated to release anything seized if they are satisfied that the regulated party has come into compliance. Again, there is a consistency between the current Act and Bill C-51 in this regard.”
“I think that there’s a pharmaceutical interest here,” says Anthony Stephan, one of the co-founders of Truehope Nutritional Support Ltd. “I think that the fact that 74 per cent of Canadians are using these products is affecting the bottom line of the pharmaceutical interest, and they’ve got to try to control that.”
In 2003, Truehope’s operations in Raymond, Alberta were raided by Health Canada inspectors and the RCMP and charged it with violating a number of regulations within the Food and Drug Act, including the sale of a product without a drug identification number. The company had been selling a mineral and vitamin supplement called EM Power it claimed could be used to successfully treat a number of serious mental health and central nervous system disorders, including bipolar disorder, attention deficit disorder, schizophrenia and autism. Truehope argued that testimonial evidence by its clients should have allowed it to sell the product without it being approved for sale as a drug in Canada.
On July 28, 2006, Alberta Provincial Court Judge Gerald Meagher found the company not guilty of the charge. “I’m not anti-pharmaceutical, but when you get into the side-effects produced by drugs, we need to look at those very, very carefully and make sure that we protect the public,” says Stephan. “With a NHP, we have very few stated side effects. They have to be used prudently like everything. There are no reported deaths in Canada ever from a natural health product. Why do we want to regulate an industry that is safer than food additives that has no history of causing harm?
“I think they said this bill is to protect you, but they didn’t explain to us that you’re going to have to give away your section eight charter of rights,” says Stephan.
