(Editor’s note: Shawn Buckley is a lawyer with decades of experience in assisting natural health companies to deal with Health Canada. He has been called as an expert witness in both the House of Commons and the Senate concerning the regulation of natural products and constitutional rights. He is currently president of the NHPPA, a non-profit organization dedicated to protecting health rights.)
Several years ago I was defending a natural health company charged with selling a natural product without a licence. When I was in Court cross-examining one of the Health Canada inspectors, I put to her the statement that the purpose of Health Canada was to protect the health of Canadians. Because I was still naive about the purpose of our drug laws, I was surprised by the answer. The answer was “no”. She then explained that the purpose of Health Canada was not to protect the health of Canadians. Rather, the purpose of Health Canada is to enforce the law, specifically the Food and Drugs Act and Regulations.
I am no longer as naive. I now accept that although Health Canada uses safety language to support their actions, they are in reality the drug police whose job it is to uphold the law, regardless of the health consequences.
It took me much longer to figure out what the true purpose of our drug laws are. In fact, the purpose of our drug laws is not to protect our health, the purpose is to protect intellectual property rights. And the mechanism used to protect intellectual property rights is to censor truthful health information.
More specifically, the laws governing drugs effectively make every treatment illegal. Permission to sell a treatment must be obtained from Health Canada in the form of a licence. Once a licence is granted, all that can legally be stated is that the claim, if any, is approved of by Health Canada. In the area of serious health conditions, chemical drugs must go through the new drug approval process. This process costs roughly a billion dollars per drug. Because of the cost, only products with years left on their patent go through the process. If successful, because of the patent the drug company can charge high fees to recover the billion dollars and to subsequently make profits.
Now consider that there are no intellectual property rights for natural health products (NHPs). Because of this, none have ever gone through the new drug approval process to get approval to treat a serious health condition. Indeed, none have ever gone through the new drug submission process at all. And going forward, none ever will. No natural health product will go through the new drug approval process because they do not have patent rights and consequently cannot charge high prices to recover the prohibitive cost of the process.
Health Information Censored – Patients Making Uninformed Choices
So now we begin to understand that the purpose of our drug laws, to protect intellectual property rights, would fail unless there is censorship of truthful health information.
Let me explain how this works. Imagine you come down with a serious health condition. Your doctor explains that you are to take a patented chemical drug which has been approved for your condition. You will have to take this drug every day for the rest of your life. The doctor makes it clear that there are serious side effects, including death, and that you will never be healthy again. Because this is the only choice you are given, you dutifully take the drug for the rest of your life. You do this because the complete information about all possible treatment options has not been shared with you. The whole truth has been censored.
If you were told that there was a natural product that treated your condition as well or better than a drug, that the natural product did not have side effects, and that it was a fraction of the cost because there were no intellectual property rights, likely you would choose the natural product. But if you chose the natural product, the drug company would not recover the billion dollar cost of the drug approval process. If this became a trend, drug companies would stop going through the process and Health Canada would have to fire employees due to loss of revenue. (Health Canada depends on the large fees charged to the chemical drug companies for part of its budget.)
As our drug laws currently stand, the Natural Health Products Regulations permit health claims for serious conditions, but Health Canada has administered the Regulations to only allow structure function claims. A structure function claim is a milk-toast claim like “good for vascular health,” or “supports mental and physical well being.” It is not a treatment claim. In effect, Health Canada is ensuring that no natural health products are approved to treat serious health conditions under the current Regulations.
New Regulations Coming for Natural Health Products
Recently, Health Canada has signalled that there are significant changes coming in regards to how natural products will be regulated. In effect, Health Canada is going to repeal or amend the Natural Health Products Regulations so that natural products become regulated under the same regulations as chemical drugs.
It is our understanding that Health Canada will create a new category of drugs called self-care products. These products will have a single set of regulations for both chemicals and natural products. Health Canada has made it clear that self-care products are not to be used to treat serious health conditions. With the repeal of the Natural Health Product Regulations, the only avenue left to get approval to treat serious health conditions will be the new drug approval process which a natural product will never go through. In effect, this government body is institutionalizing a situation wherein the only drugs that will ever be approved in Canada to treat serious health conditions are patented chemicals. Parliament likely would not amend the Food and Drugs Act to expressly state that no natural product will ever be legal to treat a serious health condition. Yet, this is where the changes to the Regulations will lead us.
Harsh Penalties for Those Using NHPs
Even worse, this harmonization of regulations will subject natural health companies and practitioners to the same harsh penalties that we all fought against in 2008 in the Bill C-51 fight. Currently, any violation of the Food and Drugs Act and Regulations concerning a natural health product subjects the violating company to a fine of up to $5,000 per offence. With the changes, the fine will be dramatically increased to up to $5,000,000 per day if there is any violation of the Act or Regulations. In addition, every director, manager, and employee involved in the offence will also be personally liable for the $5,000,000 a day fines.
This drastic change will mean that any resistance to Health Canada directions, even if compliance will cause death, will be futile. No natural health company or practitioner can survive such penalties. In addition, for the first time natural companies and practitioners will be subject to the Health Canada powers that were in Bill C-51, such as recalls, and testing orders, regardless of whether such orders would bankrupt the company, are superfluous, or will cause harm or death.
Currently, traditional use evidence can be used to support a treatment claim. Health Canada has signalled that this will cease. This change would drastically reduce the uses for which natural products will be allowed. It may be that the compounding exemption which allows practitioners such as Herbalists and Traditional Chinese Doctors to prepare remedies for individual patients will be removed.
These are just some of the proposed changes.