By Shawn Buckley

You should worry whenever the government does something in secret. When the government hides things it is because they do not want you to know. The government definitely does not want you to know that they have changed to law to have more control during the next pandemic. The changes are both scary and unbelievable.

In June 2024, major changes were made to the Food and Drugs Act that Health Canada wanted to keep secret. In order to keep them secret, Health Canada snuck them into the 2024 Budget Bill (Bill C-69). If you want to keep changes to our drug safety laws secret, the only way to do so is to sneak them into a Budget Bill. Bill C-69 was 668 pages long. The length made the changes invisible. Budget bills are about government spending. The public does not generally read them because they only address government spending. Budget bills are also passed quickly, so they are not before Parliament for long.

I can see why Health Canada wanted to hide these changes from you.

They are scary. The first change gives the Minister of Health the power to prevent drugs being used off-label. Off-label-use refers to the use of a drug in circumstances where Health Canada has not approved the drug. Clinical trials for drug approval usually exclude elderly persons, children, and pregnant women as trial participants. As a result, most drugs are not approved for these groups, which means that all drug use for them is off-label-use.

Doctors learn through experience that a drug approved for one condition may work for a different condition, which, when prescribed, is off-label-use. Until now, health care practitioners have been free to recommend drugs they believe are best for the patient for whatever conditions they have. Now, Health Canada can interfere with the doctor-patient relationship.

Another change is that Health Canada can make it a crime for anyone to promote a drug for off-label-use. Such a crime is punishable with $5-million-dollar-a-day fines and jail. These first two changes made me think of Ivermectin. During the Covid-19 pandemic, Health Canada did not want doctors to use Ivermectin or to speak publicly about it. Now, Health Canada can make it a crime to both use Ivermectin for things like Covid-19 and to truthfully speak about it.

What is also chilling is that Health Canada could make it a crime for the media to speak about Ivermectin for things like Covid-19. So, for example, if Druthers ran an article written by Dr. Pierre Kory [with FLCCC Alliance] about using Ivermectin for Covid-19, Druthers could be liable for $5-million-dollar-a-day fines and jail for every day the story is on their website. Since such publications would be a “crime,” Health Canada could also get court injunctions to remove them from the public.

The next change is that Health Canada can prevent humans from accessing veterinary drugs for human use. Again, I think about Ivermectin. During Covid-19, Canadians who wanted to use Ivermectin could not access the human supply. Many obtained veterinary Ivermectin instead. This loophole can now be closed.

Another change is truly shocking. If I didn’t see it with my own eyes, I would not believe it.

There are three fundamental safety lines for drugs that the Government of Canada has never previously compromised on. They are hard safety lines that can never be crossed because people die when they are crossed. The first is that no one can lie to the public about a drug. The second is that no one can sell or market a drug that is adulterated with a dangerous substance. The third is that no one can sell or market a drug that is manufactured under unsanitary conditions.

Now, Health Canada can exempt a drug from these fundamental safety provisions. This is not to protect the public. There is no circumstance where it is safe to lie to the Canadian public about a drug. Clearly, it is not safe to permit Canadians to take a drug adulterated with a dangerous substance. There is no circumstance where this is in the public interest. There are no circumstances where permitting drugs that have been manufactured under unsanitary conditions should be allowed.

The ability to exempt drugs from these fundamental safety provisions appears to be designed to further protect Health Canada and pharmaceutical companies from liability if they use mRNA vaccines for the next pandemic. Health Canada and the pharmaceutical companies cannot be liable under the Food and Drugs Act for Covid-19 vaccines that were not proven to be safe and effective. This is because the law was changed to permit the approval of these vaccines without safety and efficacy being proven—Canada’s version of an Emergency Use Authorization, known as an Interim Order.¹ But there could be liability for fraudulent marketing by both Health Canada and the pharmaceutical companies. There could be liability for adulteration of the vaccines and for unsanitary production.

For the next pandemic, all potential liability for both Health Canada and the pharmaceutical companies can be avoided by exempting new vaccines from the safety provisions meant to protect us from fraud, adulteration, and unsanitary manufacturing conditions.

Indeed, Health Canada now has the power to exempt drugs from any of our drug safety regulations.

For the next pandemic, it would not even be necessary for pharmaceutical companies to apply to Health Canada for approval. Now, if a foreign regulatory authority has approved a vaccine, Health Canada could rely on the foreign approval to justify approval in Canada. So, if a third-world country, without the expertise of Health Canada, approved a vaccine, the vaccine could be approved for use in Canada without Health Canada approval.

Of equal interest is that the term foreign regulatory authority is defined so broadly that it could apply to non-governmental bodies, such as the World Health Organization (WHO) or the United Nations (UN). In other words, if the WHO or the UN approved a vaccine, it could be approved of in Canada, based on the WHO or UN approval without even an approval application made to Health Canada.

Even more troubling, is that Health Canada can exempt a drug from any part of the Food and Drugs Act, or our drug regulations, based on “portions” of documents provided to a foreign regulatory authority. So, another country could have refused to approve a vaccine, but Health Canada can approve it based on portions of the approval application provided to the foreign country.

As unbelievable as it is, it is true.

All of these changes are truly scary. To add insult to injury, the government gave what I consider to be fraudulent justifications for the changes.

The first explanation was the changes were needed to protect youth from flavoured nicotine vaping products and from nicotine pouches. Later, we were told the changes could be necessary to allow the import of baby formula. I consider these explanations to be fraudulent:

1. There are already powers in the Food and Drugs Act to enable restrictions on nicotine products and to permit the importation of baby formula that does not meet Canadian standards.
2. Allowing drugs to be fraudulently marketed to Canadians has nothing to do with nicotine pouches or baby formula.
3. Allowing drugs that are adulterated with dangerous substances to be given to Canadians has nothing to do with nicotine pouches or baby formula.
4. Allowing unsanitary drugs has nothing to do with nicotine pouches or baby formula.
5. Allowing drugs to be approved for use in Canada and/or exempted from Canadian safety provisions based on “portions” of documents provided to foreign entities has nothing to do with nicotine pouches or baby formula.
6. Interfering with the doctor-patient relationship by prohibiting off-label-use of drugs has nothing to do with nicotine pouches or baby formula.
7. Criminalizing the media from truthfully reporting on the off-label-use of drugs has nothing to do with nicotine pouches or baby formula.

To learn more about these changes, please read the Natural Health Products Protection Association (NHPPA) Discussion Paper at nhppa.org/discussion-paper-alarm-bells-in-health-policy

I appreciate that this encroachment on health protections is unbelievable. If I was writing a fictional novel, any editor would make me change the story because it is unbelievable!

1. nhppa.org/discussion-paper-changes-to-drug-approval-test

Shawn Buckley is a lawyer with expertise in the regulation of drugs and natural health products and is President of the Natural Health Product Protection Association. nhppa.org