Health Canada moves to put natural remedies in checkmate
by Shawn Buckley
We all have defining moments when it becomes clear that what we believe is simply not true. In the area of the regulation of natural health products (NHPs), I have had two defining moments that made it clear my beliefs were false. Prior to these two defining moments, I actually believed Health Canada wanted to protect us. I also believed the wishes of the people meant something to the government.
My first defining moment happened during a trial where I was defending an NHP company from Health Canada charges, such as selling their product without a licence. At the time, only the chemical drug regulations existed and such a product could not be licensed. A Health Canada inspector was in the witness box. I suggested to her that the purpose of Health Canada was to protect the health of Canadians. I thought this was a no-brainer suggestion. I fully expected her to say yes. She did not. Rather, she explained that the purpose of Health Canada was to enforce the Food and Drugs Act and Regulations. People in the courtroom were stunned. We all believed that the purpose of Health Canada was to protect us. This was a false belief.
The purpose of Health Canada is to enforce the law as it is currently written, not to protect our health. Fortunately, in that case, the court acquitted the company of all charges finding it was legally necessary for the company to protect people rather than be in strict compliance with the law. This was a case in which I asked the Court to rule that Health Canada caused deaths by restricting access to a natural remedy.
My second defining moment happened when I was lobbying in Washington DC concerning proposed changes to how their dietary supplements were regulated. We had just finished meeting with a Senator. While we were packing up, the Senator’s aid asked if he could speak to us. This aid was around 50 years old and had been an aid to senators and congressmen his entire working life. In short, he was a Washington insider. He explained to us that, at that time, there were one and a half full-time pharmaceutical lobbyists for every senator and congressman. He went on to explain that the influence of the pharmaceutical lobby is so great that most senators and congressmen are aware of the share prices of the pharmaceutical companies. He was, in effect, trying to make it clear to us that we would in no way have any influence on government policy, as we could not compete with the pharmaceutical lobby. I knew that there was a strong pharmaceutical lobby in both the US and Canada. I simply did not appreciate how pervasive it was. In my defence, this was before the release of Dr. Shiv Chopra’s book Corrupt to the Core, which gave an inside view of corruption within Health Canada. Dr. Chopra’s book should be required reading for anyone who thinks Health Canada can currently be trusted to protect us.
These two defining experiences made it clear to me that:
- Health Canada is not there to protect my health. They are there to enforce the law (regardless of the flaws in the law) and
- I could not count on the law being drafted to protect my health where my interest in health conflicted with the interests of the pharmaceutical lobby.
My dealings with Health Canada over the years have strengthened my belief that Health Canada is not there to protect us. In every instance where I have been involved as a lawyer and Health Canada is seeking to take an NHP away, Health Canada has never taken into account the risk of removing the NHP from Canadians who may depend on it. In the court case I referred to earlier, I led evidence of deaths caused by Health Canada restricting access to a NHP. Despite warnings that restricting access to the NHP could lead to deaths, Health Canada never took into account the danger of removing the product. Health Canada was only concerned with enforcing the law, regardless of the law causing harm and death. I have never seen Health Canada do a balanced risk analysis (i.e. one that balances a risk posed by a product against the risk of removing the product) to ensure that the safest course of action is taken. Health Canada is only concerned with strict compliance with the law, even if strict compliance will lead to harm.
Because Health Canada always demands strict compliance with the law, you should be very concerned about any moves to strengthen Health Canada’s ability to take natural remedies away.
Currently, Health Canada is signalling they want to change how natural remedies are regulated. These changes may signal the endgame for any practitioner or company that is more concerned with good health outcomes than the over-regulation of natural remedies.
Currently, NHPs are regulated as a special type of drug. Much of our knowledge of natural remedies comes from experience. For example, the British Navy learned that the vitamin C in limes prevented scurvy. Limes or lime extract could be licensed as an NHP based on this learned experience. It would not be necessary to run expensive clinical trials to prove limes treat scurvy. Indeed, if it were necessary to run expensive clinical trials for a lime scurvy remedy, we would never have access to limes to treat scurvy. This is because of our intellectual property right laws.
If a chemical drug company invented a new drug they wanted to use to treat scurvy, they would have a patent on the new drug. Their patent would prevent any other company from selling a copy of the drug until the patent expired. The patent, in effect, creates a monopoly. Because there is a monopoly on the drug, the company can afford to go through the expensive clinical trial process. If they are successful, they can recover the costs of the clinical trials by charging a high price for the drug. They have a monopoly so the high price has to be paid. This is why new drugs are so expensive until after the patent expires.
An NHP company wanting to sell a lime extract for scurvy would not have a monopoly on their product. They did not invent limes and will have no intellectual property rights to limes or lime extract. In short, they cannot patent limes or lime extract. They would not be able to raise funds to go through the clinical trial process, as they would not be able to recover the cost by charging high prices. This is because they would not have a monopoly on the remedy. Any other company could copy the product and sell it at a lower price because there is no patent.
If you want to maintain your access to natural remedies, it is essential that NHPs are not subjected to the same types of evidence as is required for chemical drugs. Unfortunately, Health Canada is currently proposing subjecting NHPs to the same evidence standards imposed on chemical drugs. Not only does this ignore the differences in intellectual property rights, but it also ignores the risks of further restricting our access to natural remedies.
It is important to understand that there has never been a death caused by a NHP in Canada. Years ago, I made an Access to Information Act request of Health Canada asking for evidence of any deaths caused by NHPs going back to confederation in 1867. Health Canada could not point to a single death caused by a NHP. When our current NHP Regulations were introduced, the Regulatory Impact Statement made it clear it was inappropriate to regulate NHPs the same as chemical drugs because the NHPs had such a low risk profile.
Unfortunately chemical drugs do not share the low risk profile of natural remedies. Indeed, chemical drugs are one of the leading causes of death in Canada. Even over-the-counter chemical drugs like common painkillers and cold remedies cause a number of deaths each year. It is because chemical drugs are so dangerous that restricting our access to natural remedies will lead to death and harm.
Let me use nattokinase as an example. Nattokinase is a naturally occurring enzyme that can thin the blood. It is freely sold in the US. It used to be freely sold in Canada. Then Health Canada decided to restrict our access to nattokinase saying it was risky. I searched Health Canada’s Adverse Reaction Database and could not find a single harm event, let alone a death, caused by nattokinase in Canada. When I searched the same database for harm and death caused by the chemical drug blood thinners, there were many reports.
When Health Canada is demanding a natural product be removed and it is unsafe to follow Health Canada’s direction, the current penalties under the Food and Drugs Act are fines of up to $5,000 and/or three years of jail. Most persons or companies who have put a natural remedy on the market can survive such penalties. This enables them to act responsibly when following Health Canada’s direction would put Canadians at risk. If Health Canada’s directions are not followed, Health Canada can apply to a Superior Court for an injunction or other orders to ensure the law is followed. However, a Court will also have the opportunity to hear about the risk of removing a product, and will try to steer the safest course.
Health Canada is wanting to change the status quo. They want to be able to order recalls for NHPs without involving a Court. They also want to increase the penalties to fines of $5,000,000 a day for any violation, including for not following Health Canada recall orders. In addition, any management or employees involved in the violation could also be personally subjected to the $5,000,000 a day fines. I cannot think of a single NHP company that could withstand such fines. In effect, resisting Health Canada directions when it would be unsafe to follow them will be at an end.
Anyone who is concerned about giving a regulatory body the absolute say about what remedies are available should be concerned about the proposed changes. When new regulations and/or amendments to the Food and Drugs Act are introduced, we are all going to have to be ready for action. This is the most threatening proposal since the infamous Bill C-51. I am inviting all readers to do three things to prepare: 1) For a more thorough understanding of the proposed changes, visit www.nhppa.org and read my Discussion Paper on them; 2) Visit www.charterofhealthfreedom.org to familiarize yourself with the Charter of Health Freedom, which is a solution to the over-regulation of natural products, and 3) Financially support groups that will be resisting these changes. Advocacy for your health rights does not happen in a financial vacuum. You will either support groups such as the NHPPA or they will not have the resources to work on your behalf.
We are entering a time where unless we stand up and be counted, we will forever lose the right to decide for ourselves how we will treat ourselves or our loved ones when we/they are sick. Will you be counted?
Originally published in Vitality magazine, December 2016 (www.vitalitymagazine.com) Excerpted from the article “Freedom of choice threatened – again.” Shawn Buckley is president of the National Health Products Protection Association (www.nhppa.org).