Government Moves to Restrict Access to Natural Health ProductsShawn Buckley April 1, 2014
Exploring the Federal Prejudice Against Natural Health Products
Are we moving out of the eye of the hurricane and into the storm? ~ Shawn Buckley
There are many reasons for those concerned about access to natural health products (“NHPs”) to be complacent. Indeed, a case could be made that there is clear sailing ahead. Most companies have completed the transition brought about by the Natural Health Product Regulations. Health food stores are bursting with products. Rather than not having enough choices, consumers enjoy a broad diversity of product choices. Indeed, some could criticize writers like myself who – even before the Regulations came into force ten years ago – warned about a bleak future for natural health products.
So, were the nay-sayers wrong? The answer to that question depends upon what is coming next. It could be clear sailing. Or it could be that we are simply in the eye of the hurricane and will soon be moving back into the storm.
Why the Regulations in the First Place?
To understand the prior warning about the NHP Regulations it is important to understand what the changes were and whether they were necessary.
Prior to January 1, 2004, natural health products were largely unregulated. We only had drug regulations designed for dangerous chemical drugs. For several reasons, it was impractical for NHPs to comply with the drug regulations. This meant that before 2004, by and large almost all NHPs were technically illegal.
Following a consumer rebellion wherein Canadians reacted to the disappearance of natural products under the drug regulations, Health Canada was tasked with drafting regulations that were appropriate for natural products. There were two main philosophical assumptions that Health Canada had to choose from. Both would dramatically affect access to natural products. One would restrict access, the other would, as demanded by Canadians, increase access. Health Canada could assume that natural products are dangerous, or Health Canada could assume that natural products are safe.
For example, in the U.S. after a citizen rebellion against losing access to natural products, a law was passed called the Dietary Supplement Health and Education Act, 1994. Under this law natural remedies were deemed to be safe. Therefore, the U.S. government is not allowed to remove a natural remedy from the market unless it has evidence that the remedy is harmful. Because natural remedies are presumed to be safe in the U.S., there is no need to seek government pre-approval in the form of a licence to sell them. The consequence for the U.S. consumer is that natural remedies are abundant and inexpensive.
In Canada, our government did the opposite and assumed that natural products are dangerous. Because NHPs are presumed to be dangerous, they are in effect all illegal. To become legal, a company has to convince Health Canada to grant a licence permitting sale.
Was the Assumption of Harm Correct?
If you are going to regulate in any area based on an assumption, it is proper to ask if the assumption is correct. So is the assumption that natural remedies are dangerous correct?
In assessing the risk of anything, it is important to put the risk into context. This is necessary because everything carries some risk. I recall listening to a CBC Radio program during which a medical doctor was explaining how every year some long distance runners die because they drink too much water. Drinking water while long distance running can be fatal. At the same time, most of us would not tolerate paying for a Bottled Water Directorate at Health Canada to regulate the use of bottled water. Most of us would not tolerate this even though it would probably save some lives. We would not tolerate this because although there are some deaths, they are too few in number for us to see bottled water as a risk that needs further regulation. The same could be said for peanut butter and shellfish, both of which cause deaths every year.
By contrast, in all of Canadian history the government has not been able to point to a single death caused by a NHP. I made an Access to Information Act request for such information which came up blank. I am simply not aware of a single death caused by a NHP.
Does Restricting Access to NHPs Put Public Health at Risk?
Before the NHP Regulations came into force I testified in front of the Standing Committee on Health. At issue was a Bill that would have made the NHP Regulations irrelevant. I asked the Committee – if we came back in 10 years, how many lives would be saved by the NHP Regulations. The answer of course would be zero. If natural health products had never caused a death in Canada, then it was statistically unlikely that one would be caused in a 10 year period that would see them restricted by new regulations. I also asked the Committee how many lives would be lost if they permitted the NHP Regulations to go ahead, which would restrict access to NHPs.
For example, I believe that taking nattokinase off of the market has caused, or will cause, deaths. Nattokinase has many uses, one of which is to act as a natural blood thinner. In a strange coincidence, just when doctors were complaining that a new prescription blood thinner, Pradaxa, was causing deaths, Health Canada took nattokinase off the market. When people who were being safely managed on nattokinase are then transitioned to drugs like Pradaxa that have a much higher risk profile, in my opinion we can expect deaths. These will not be reported as deaths caused by the removal of nattokinase and consequently are difficult to track.
Nattokinase is a single example. I am of the opinion that our Regulations have caused death and suffering by restricting access to other products as well.
Storm Clouds on the Horizon
The store shelves are full, but are things truly rosy? If you depend on a product that is no longer available, or if you depend on a product that was more effective before Health Canada required a formulation change, then things are not rosy. If you are poor and can no longer afford NHPs which have gone up in price due to the additional costs the Regulations have caused, then no. Indeed, for the poor the Regulations have made natural remedies beyond reach.
There are also some storm clouds on the horizon. One of these is cost recovery. Health Canada will eventually impose fees for applying for licences and for renewing licences. The last time they proposed a fee schedule for this, some companies were concerned the fees would make their businesses no longer sustainable. If similar fees are enforced, we will lose more providers. The increased costs and the reduced competition will lead to higher prices which will further reduce access for the poor. Low volume products are also likely to be dropped, harming those who depend upon them.
Another storm cloud on the horizon is the threat of the Comprehensive Economic Trade Agreement announced between Canada and the European Union (“CETA”). Although CETA was announced with great fan-fare in October 2013, the details are still being worked out. It is not clear whether the Agreement will affect how NHPs are regulated in Canada. The European Union has much stricter regulations governing natural remedies, so adopting their rules might dramatically reduce the number of NHPs available to us. We do not know if CETA will include NHPs, but if it does we may be looking back at the NHP Regulations as the “good old days”.
There are still so called “illegal” products on the market. So far Health Canada has not aggressively enforced the NHP Regulations because we have been in a transition period. That period is now coming to an end, and it is likely that there will be a step-up in enforcement this year. This will further deprive us of products freely available in the U.S. but no longer available here.
The Trojan Horse of Bill C-17
In December 2013, Bill C-17 was introduced. This Bill amends the Food and Drugs Act in many negative ways. On its face, the Bill does not affect NHPs; it applies to a new class of products called “therapeutic products.” The term “therapeutic product” is defined so that it does not include NHPs as they are described in the NHP Regulations.
The danger is that the way Bill C-17 is written may create a Trojan horse that permits the Bill’s provisions to be applied to NHPs. This could occur if the government changed the definition of NHP in the NHP Regulations. Such a change could be made without any vote by Parliament. Indeed, even an unpopular minority government could easily make this change. This Trojan horse danger could easily be fixed by adding the definition of NHP to the Food and Drugs Act.
Bill C-17 is another proposed Act which undermines the rule of law. Under the rule of law, the government cannot take control over your person or property without supervision by an impartial court. Under Bill C-17, the Minister can order a party to recall a product or to transport it to a place of the Minister’s choosing (i.e. having the Minister take possession of your property). There is a potential penalty of a $5,000,000 fine and/or two years of jail for each day the Minister’s order is not complied with. There is no court or parliamentary supervision of these orders. In effect, the proposed Act would give the Minister complete discretion (which is the classic definition of tyranny).
I have been involved in cases where the Minister has requested a recall and I am hired to advise the company. Often we have a professional risk assessment done so that we know the safest course of action. If the risk assessment tells us that complying with the recall would be dangerous, then other legal obligations kick in. In such a case my client could be convicted of criminal negligence causing death or causing harm if they comply with the Minister and death or harm results. If death or harm ensued, the client is likely to be sued. Before Bill C-17 my clients could refuse to recall if it was unsafe to do so. Now, because of the draconian penalties, anyone who dares to defy the Minister will be bankrupted and imprisoned. There is no safe course where the Minister gets it wrong.
Bill C-17 also enables the Minister to make regulations which incorporate by reference any other document. This would enable, for example, the Minister to adopt European Union regulations, or standards set by a trade association. Once adopted, they are law. These groups would then be able to change their documents, and the changes are automatically changes to our law. This undermines our parliamentary system where parliament has control of our laws. For example, if the Minister adopted European Union regulations and you wanted a change, you would not lobby Parliament, you would lobby the European Union.
Courts May No Longer Be Listening
Anyone who has consulted a lawyer about taking the government to court to enforce a right will know that such proceedings are very expensive. Indeed, I feel confident in saying that the poor generally do not have access to the courts in such situations. However, even for those who can afford court, there may no longer be a remedy. Two cases stand out which should cause the entire natural health community concern.
A) The first concerns Truehope Nutritional Support which makes a product to treat bi-polar disorder and major depressive disorder. In 2003, Health Canada seized a shipment of the product and began turning other shipments away at the border. When the shipment was seized in 2003, Truehope and a person whose product for his children was seized started court proceedings. They were not seeking financial damages. Rather, they were seeking a declaration that when the government seizes vital medication two things must happen. First the person must be told their vital medication is seized. Second, there must be an accessible way for them to argue that their medical need for the medication exceeds the state’s need in enforcing the law.
At the court hearing I presented evidence to show that Health Canada’s actions had led to deaths. I invited the court to make a finding of fact that Health Canada had caused death. Rather than make this finding, the court said that we did not have what is called “standing” to present this evidence. The evidence was excluded and no violation of rights was found. Usually when challenging the constitutional validity of legislation, a party must present broad evidence of the effect of the legislation. In the Truehope case we were prevented from doing so.
B) The second case that causes us concern is that of NorthRegentRX. NorthRegent sold a natural remedy for erectile dysfunction. Health Canada demanded they recall and stop selling because it allegedly contained sildenifel, the chemical name for Viagra. According to NorthRegent, Health Canada’s lab was simply wrong. Independent labs could not find sildenifel. NorthRegent sued Health Canada for damages. The court threw their case out, finding that Health Canada did not owe them a duty of care. In other words, Health Canada can destroy a business with faulty lab work, and there is no recourse.
If we have no recourse to the courts when the government takes away remedies that we rely on, then we become sitting ducks at the mercy of Health Canada.
The Charter of Health Freedom
The steady erosion of our right to access natural remedies needs to be reversed. And our basic right to treat ourselves as we choose needs to be respected. Indeed, our very sovereignty over our own bodies is being threatened. The best remedy that I see is for Canadians to continue to push for the adoption of the Charter of Health Freedom (see http://www.charterofhealthfreedom.org).
For more details, visit the Natural Health Products Protection Association website at: http://www.nhppa.org
Shawn Buckley is a lawyer with expertise in the Food and Drugs Act and Regulations. Mr. Buckley is also President of the Natural Health Products Protection Association, an association dedicated to protecting access to NHPs. The NHPPA is also one of the founding groups supporting the Charter of Health Freedom. Visit www.nhppa.org