By Shawn Buckley

Sabine struggled for consciousness. How long had it been since she had been aware? Time, like everything else, was lost in the drug-induced fog. Sabine’s children, husband, and former life were only shadows in the fog.

Sabine suffered from severe bipolar disorder. She wrestled with a powerful and constant desire to die. To prevent Sabine from killing herself, she would be involuntarily committed to the psych ward and doped up on drug cocktails. For three years she was confined to bed for 20 hours a day. When she grew accustomed to the drugs, she would become suicidal again and be committed to the psych ward. A new drug cocktail would envelop Sabine in the mental fog, buying her a little longer to live.

Persons as severe as Sabine do not live long. For Sabine and others like her, our Health Canadaapproved drugs are merely a tortuous interlude before death.

But Sabine learned about treating severe bipolar disorder with a combination of vitamins and minerals called EMPowerplus. She knew this was experimental but she tried it. And it saved her life. She resumed her life as a mother, a wife, a friend and a professional.

Sabine went from facing a death sentence to having a full life. She was free, or so she thought. But there was one last demon hiding in the shadows. This demon was hell-bent on ensuring that she and the thousands of others that were only alive because of EMPowerplus, would no longer be able to access it. This demon was Health Canada.

Sabine was about to learn a lesson in Canadian drug regulation. She was about to learn that our drug regulations are not about health, they are about money.

The effect of our drug regulations is that it is only legal to treat serious health conditions with chemical drugs. We require any drug for a serious health condition to go through the new-drug approval process. This process is so detailed and so onerous that even simple applications can cost hundreds of millions of dollars. It is so expensive that only chemical drugs with patents go through it. Only if you have a patent can you charge an inflated price to recover the cost of the application process.

So, we have deliberately structured our drug regulations to have the effect that it is only legal to treat serious health conditions with chemical drugs that had a patent when approved. This is not by accident, it is by design. Our drug regulations protect intellectual property rights, they do not protect health.

The problem facing Sabine was that there was no patent. You cannot patent vitamins and minerals. Because of this, you cannot raise the funds necessary to go through the new-drug approval process. The effect of our drug regulations is that vitamins and minerals cannot become licenced for serious health conditions and therefore are illegal for serious health conditions. Because EMPowerplus was illegal Health Canada removed it from the market.

Health Canada asked the company (Truehope) to stop selling. Truehope had psychiatrists, doctors, and patients write to Health Canada to explain there would be deaths if Truehope stopped selling. These pleas for mercy fell on deaf ears. Health Canada raided the company with armed police. Shipments from the U.S. were seized at the border. And then there were deaths. Ron LaJeunesse, the former President of the Alberta Branch of the Canadian Mental Health Association (the “CMHA”), held a press conference every time a CMHA member died. The deaths and suffering Health Canada was causing became public. So they backed down and allowed shipments to cross the border again.

But Health Canada was not done. They charged the company for selling without a licence. This also failed. The Court acquitted Truehope on the defence of necessity. In other words, the Court agreed that it was legally necessary for Truehope to continue selling EMPowerplus to avoid harm (R. v. Synergy Group of Canada Inc., 2006 ABPC 196). This is an exceptional case. We cannot expect the Courts to go against the law which effectively makes it illegal to treat serious health conditions with anything but chemical drugs. This brings us to a legal-philosophical question. Our law is paternalistic. The citizen has no right to decide to take a treatment that Health Canada does not approve. And, Health Canada drives unapproved treatments off of the market so the citizen has no choice. Health Canada decides what treatments you are allowed to take. They have complete control. In effect, our legal-philosophical position in Canada is:

Health Canada has the sole right to decide what treatments are available to you. If the “approved” treatments do not work, you have no right to try anything else. All non-approved treatments have been driven off the market.

I believe that people like Sabine, for whom the approved treatments were a death sentence, have the right to decide to do whatever they want to their body. I think we should have the right to decide how to treat ourselves in all situations, not just life and death ones.

Unfortunately, Health Canada is doubling down on its efforts to ensure that we only have access to chemical drugs. It is bringing in the Self-Care Framework (the “SCF”) which will remove our access to most natural health products (“NHPs”), our only alternative to chemical drugs. This is the second of a two-step process to ensure we only have access to chemical drugs. The first step happened in 2004 when our natural products were moved half-way into the chemical drug model. Before 2004, our natural products were unregulated. The drug regulations were meant for “chemical” drugs. Natural treatments we had effectively been using for hundreds or thousands of years were not subject to the drug regulations.

But as natural products became more popular in the late 1980s both Health Canada and the U.S. Food and Drugs Administration (“FDA”) started driving natural products off the market by applying the drug regulations to them. In the U.S. there was a citizen rebellion which resulted in NHPs being classed by law as foods, not drugs. In the U.S. NHPs are deemed by law to be safe and can be sold without any government pre-approval.

In Canada, we did the opposite. We classed NHPs as drugs, not foods. We deem NHPs to be unsafe and require government pre-approval to sell them.

This was a halfway move into the chemical drug model. We were only halfway as we could still use traditional use evidence to show a NHP worked (as opposed to expensive clinical trials). We also did not have to pay the licencing fees the chemical drug companies have to pay.

Under the SCF, Health Canada moves us entirely into the chemical drug model, intending to harmonize regulation for NHPs and over-the-counter chemical drugs. Harmonization highlights include losing the right to use traditional use evidence to prove efficacy, licencing fees, no licensing for conditions for which you would seek the advice of a health care practitioner, $5,000,000 a day fines (up from $5,000 per offence), increased regulatory burden (to match those of the chemical drugs), and increased inspections, with the censoring of truthful health information.

The effect of these changes will be to remove most of our NHPs. This will also remove the health practitioners who rely on NHPs to treat us. There will be lowdose vitamins, minerals and single-ingredient products. Our multi-ingredient life-saving products will be gone. Innovation will end. We will find ourselves with only one treatment modality: chemical drugs.

This is a freedom issue. This speaks to who controls your body. Is it you? Is it Health Canada?

This is also a propaganda issue. Health Canada consistently cites the “risk” of natural products to justify ever-stricter regulations. The truth is you are 14 times more likely to be struck by lightning than to be killed by a NHP. Peanut butter is dramatically more dangerous than the entire NHP industry. Would you accept any loss of freedom to be protected from lightning or peanut butter?

And what is the risk of restricting NHPs? For Sabine and the thousands of others relying on EMPowerplus for their lives, the risk is certain death. Health Canada never takes the risk of removing NHPs into consideration. But any risk analysis must be balanced if the goal is to protect health. A one-sided risk analysis by Health Canada is the sure signal that the SCF is meant to protect intellectual property rights rather than to protect health.

We can stop this. The Natural Health Product Protection Association (the “NHPPA”) is campaigning to end the SCF and to bring in the Charter of Health Freedom. Over 70% of Canadians regularly take NHPs. We can create a citizens’ movement to protect our access to NHPs. But we need your help. Go to nhppa. org and sign up for our newsletters. We use them to let you know about actions you can take. Support us financially. We need funding to run a successful campaign.

The SFC is part of an international movement to harmonize drug regulations. This is why the World Health Organization is now looking into the regulation of natural health products. If there is any issue we can use to inform the Canadian Public that our health regulations are being dictated to us from outside of Canada this is it. We have an opportunity to broaden awareness just as the campaign to peacefully re-take control of our institutions is being organized. Become a part, join the NHPPA.

Shawn Buckley is a lawyer with expertise in the regulation of drugs and natural health products and is also lead counsel for the NCI.