HEALTH CANADA’S PROPOSED REGULATIONS Aim to Remove Our Access to Natural Health Products
In early 2018, Health Canada introduced a new “Regulatory Initiative: Self-Care Framework Plan for 2018-2020.” According to their website, the government’s new “Self-Care Framework” will update its approach to regulating self-care products in phases:
- Phase I – Fall 2018: Introduce, for consultation, targeted amendments to the Natural Health Products Regulations to improve labelling of natural health products. This includes: a facts table, requirements for risk information, which will be clearly displayed and expressed in plain language. These changes are intended to better support consumers in selecting and safely using a product.
- Phase II – Early 2019: Introduce, for consultation, targeted amendments to the Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for non-prescription drugs. These include: expedited pathways for lower-risk products. These changes are intended to align the oversight for non-prescription drugs with other self-care products of comparable level of risk
- Phase III – 2020: Introduce, for consultation, regulatory amendments to address: evidence standards for similar health claims, extending risk-based regulatory oversight, seeking additional powers for Health Canada, such as the ability to require a recall or label change for all self-care products.
Commentary by Lawyer Shawn Buckley
“The Self-Care Framework is the natural health community’s Pearl Harbor.”
The attack on the U.S. fleet at Pearl Harbor on December 7, 1941, was devastating because the fleet had not been warned about the imminent attack. The ships in the harbour were therefore sitting ducks for the planes that found them “safely” anchored. This is similar to the situation facing the natural health community. We are about to be attacked, and we are acting as if there is nothing wrong.
In February of this year, I went from booth to booth at the Calgary Health Show asking if anyone was aware of the impending ‘Self-Care Framework’ proposed regulations. To my surprise only one exhibitor knew about it. I was surprised because Health Canada claims to have toured the country to educate the Canadian public about the ‘Self-Care Framework’.
I was also surprised because this is the biggest threat to natural health products in my lifetime, and I would expect exhibitors at a health show to know about the threat and to be taking action to prevent it. Instead, like the fleet at Pearl Harbor, the natural health community is taking no action to defend itself from attack by a government regulatory body.
What Does This Mean for Consumers of Natural Health Products?
Health Canada’s plan with the ‘Self Care Framework’ is to regulate natural health products under the same regulations as chemical non-prescription drugs. Natural products and chemical drugs would then both be called ‘Self-Care’ products. The outcome of this new regulatory structure would work to:
– drive the prices of natural products higher;
– restrict truthful health claims;
– increase censorship of truthful health information;
– force many natural products off of the market.
Under the ‘Self-Care’ framework, the traditional uses of a particular herb or vitamin or other supplement will no longer be allowed to support most claims of its effectiveness. Several healing traditions have accumulated hundreds or even thousands of years of evidence through traditional use. This evidence would now be meaningless. For example, it will be illegal for the product’s traditional folklore uses to be shared to educate consumers about its therapeutic benefits. This is expected to have a major impact on the big healing traditions such as Ayurvedic Medicine, Traditional Chinese Medicine, and Western Herbal Medicine, not to mention the publications (such as Vitality) that share this information with the public.
Currently, anyone in the natural health community who breaches a provision of the Food and Drugs Act or Regulations faces a maximum fine of $5,000. But under the Self-Care Framework, fines will be increased to $5,000,000 a day for any transgression. Not only will the ‘offending’ company be liable for these $5,000,000 a day fines, every director, officer, and employee who participated in committing the offence could be personally liable for additional $5,000,000 a day fines.
Under the current Natural Health Product Regulations, there is no restriction on the type of condition for which a natural product can be used, providing there is sufficient evidence to support the use. Under the new Self-Care Framework, claims will be restricted to uses for which a person would not need to seek the advice of a healthcare practitioner licensed by a province. In other words, if it is a condition for which you would seek the advice of a nurse, nutritionist, naturopath, etc., it is not a condition which is appropriate to use a natural product for. It will happen gradually, but this is a clear signal that professional lines of natural health products used by practitioners will be restricted.
This restricting of claims, and new powers to censor truthful health information, will compel more and more people into the chemical drug model. That is the intention. We have structured our drug laws so that the “effect” of our drug laws is to make it illegal to treat serious health conditions with natural products. Now it will be illegal to treat anything but the most minor of conditions with natural products.
What Does This Mean for Manufacturers and Distributors of Natural Health Products?
Under the new ‘Self-Care Framework’ manufacturers of natural products will for the first time have to pay licensing fees. This is called ‘cost recovery’, and will lead to a loss of products currently on the market. During a conference call with a group of manufacturers in early February, one manufacturer explained to me that they do not make a profit on a number of their products, but they still make the products because people rely on them. However, once the manufacturers have to pay yearly licensing fees they will have to stop making anything but their bestsellers.
Costs to manufacturers, distributors, stores, and practitioners will also increase with new administrative penalties. Health Canada inspectors will be able to issue fines for any violation found during an inspection. And these fines cannot be disputed in court. (In other industries, administrative penalties are used as a source of revenue for the bureaucracy, paying for the inspectors and for their managers. We have no reason to believe Health Canada will be any different.)
Most troubling is the fact that Health Canada will be able to issue these fines for sharing truthful health information. This will be a powerful tool to ensure that such information is not shared with consumers.
Eventually, natural products will have to provide the same type of evidence to be sold as chemical drugs. Because natural products do not have meaningful intellectual property rights, this will be the final death knell to innovation. This is truly upsetting. I know of several innovative natural products created in Canada that have saved thousands of lives and/or have brought tremendous relief to suffering. Under the new regulatory regime, this type of innovation will be stopped.
New Self-Care Framework Created with No Public Consultation
For many in the natural health community, the prospect of regulating natural products under the same set of regulations as chemical non-prescription drugs is a step backwards. Not long ago we only had one set of regulations. The result was that Health Canada restricted our access to innovative natural products and we rebelled. On October 4, 1997, former Health Minister Allan Rock publically backed down and asked the Standing Committee on Health to hold consultations and to advise the Government on how to regulate natural products. The Committee held the broadest consultations in its history.
After these consultations, the Committee concluded that it was inappropriate to regulate natural products in the same way as chemical drugs. The Committee also found that it was inappropriate to impose the chemical drug standards of evidence on natural products.
It might be truthful to say that more citizen input, expert input and political will went into arriving at the Natural Health Product Regulations than any other set of regulations in Canada. But the opposite is true of the ‘Self-Care Framework’ which was created out of thin air by four Health Canada bureaucrats.
Industry advisor Deane Parkes made requests under the Access to Information Act to find out who came up with the Self- Care Framework, and what evidence was relied upon. According to Health Canada’s response, four bureaucrats are identified as the source. They are Simon Kennedy, Paul Glover, Anil Arora, and Pierre Sabourin. There were no public consultations on whether natural products should be regulated under the same set of regulations as chemical drugs. Indeed, in the only call for public feedback, Health Canada made it clear that the proposed regulatory change would not apply to natural health products. Because the call for public consultation specifically stated that natural health products were not included in the proposed changes, the public did not comment on whether natural products should be regulated with chemical drugs.
So that I am clear, the most sweeping changes to the regulation of natural health products ever, are being imposed without any public consultation. Nor is there expert evidence to justify the changes. A Discussion Paper with links to the documents relied on by Health Canada can be found at nhppa.org/STOPHC. When you review the documents you will see that the Self-Care Framework was literally created out of thin air.
Time to Take Action
In effect, we are facing the biggest challenge to our access to natural products, and to truthful information about natural products, in generations. This may be our last opportunity to act. If the Self-Care Framework becomes law, our right to decide how we wish to prevent disease and treat ourselves when we are ill will be lost.
The Natural Health Product Protection Association (NHPPA) is calling on everyone to get involved to protect our health freedom. There is a three-part plan which includes:
- Stopping the Self-Care Framework;
- Putting the definition of natural health product into the Food and Drugs Act, and
- Having the Charter of Health Freedom enacted as law.
Now is the time for you to take action. This is too important for you to assume that others will take action for you. You will need to:
– Write and speak to your MP, the Health Minister, and the Prime Minister;
– Attend rallies and activities (or better yet set them up);
– Financially contribute to groups taking action (as nothing happens without resources);
– Get your network involved. Even if you only manage to get 5% of your network to take action, that 5% will get 5% of their network involved, and so on and so on. Before long, your network will have produced meaningful action.
To access resources to educate yourself, and to equip yourself to take action, visit nhppa.org/STOPHC
Stand up and be counted. Be proud to look in the mirror.