Nick Kadysh: This budget hack is insane

Hidden in the omnibus budget is a change that threatens to politicize drug regulation.

By: Nick Kadysh

It was not so long ago that the Liberals used to rage against omnibus bills. In 2015, in fact, this little nugget appeared in the Liberal platform: "We will not resort to legislative tricks to avoid scrutiny."

And rightly! No doubt the previous Conservative government under Stephen Harper resorted to legislative tomes, jam packed with regulatory changes and budgetary measures, absolutely intended to slide potentially controversial amendments into law without much scrutiny or notice.

Of course, the Liberal promise lasted only a few years in office before they were engaging in identical behaviour. The recently tabled omnibus budget bill contains another whopper of a “legislative trick.”

Folded into line 326, Supplementary Rules, is hidden a new measure that will allow the Minister of Health to completely overturn the regulatory drug approval process. The measure allows the Minister of Health to ban import, control conditions of sale, advertising, manufacture, preparation, packaging, labelling, or storage of any Therapeutic Product, at any time, in any way, anytime he feels like it — just by signing a ministerial order. Therapeutic products are a broad category encompassing Drugs, Medical Devices, and Natural Health Products.

The creation of this new rule is a dramatic departure from how advanced rules-based countries govern medical products. Canada, like the rest of the western world, generally leaves drug product regulation to the trained bureaucrats at Health Canada. Pharmaceutical and Medical Device companies must meet stringent standards, and prove both efficacy and safety, prior to being allowed on the market.

There are good reasons for this: some drugs are politically sensitive, and we want decisions based on science and evidence to rule the day, not the political whims of a given Minister of Health. How long would a drug like Mifepristone, used for pharmaceutical abortions, last if it can be removed from the market instantly by ministerial order? What about puberty blockers or other drugs used in the treatment of Gender Dysmorphia?

There are strong public health arguments against these dangerous changes as well. Drug development is a difficult and costly enterprise. Pharmaceutical companies must spend hundreds of millions of dollars in research and development costs in order to bring a new product to market, and spend years on clinical trials. They do this because they have certainty in a regulatory process, free from political interference: if your drug works and is safe, it gets approved.

But the proposed changes to the Food and Drugs Act are a clear sign: if we don’t like the way the process works, the Minister of Health can just ban your drug anyways. He can ban its importation, or sale, or even storage. He doesn’t have to play by the established rules of the game, he can just turn the table over. Pharmaceutical and medical devices companies simply will not bring their products to Canada if they are at risk of becoming a political football; they need regulatory certainty based in scientific fact. If they don’t bring their drugs to market, the health of Canadians will suffer.

This type of political interference has played out many times. In the 1970s and 80s, Psychedelic drugs such as MDMA and Psilocybin — a field in which I am currently conducting business — were designated as Schedule 1 controlled substances through what many now admit were political machinations. This smothered initial research into their use as treatments for a range of mental and neurological disorders. It took nearly 50 years for research to restart — research that now shows significant promise.

Careful readers will note that this is not a demand for special treatment: psychedelic drug developers don’t want a special set of rules, just for the same established set of rules as all pharmaceutical companies. It’s up to the companies themselves to prove that their drugs are appropriate for approval. But no company can succeed when the rules can be changed anytime, and for any reason. The lesson here is clear: politics can, and does, kill science — and hurts our ability to care for people in the process.

The stated intention of these changes is to allow the Minister to restrict the use of nicotine replacement therapies, but they are far too overbroad and dangerous for such a minor purpose. The Minister has many tools at his disposal to regulate nicotine products. He doesn’t need more. The amendments to the Food and Drugs Act proposed in the budget amount to a loaded gun being carelessly tossed about by the federal government. They should not be passed.

Nicholas Kadysh is the CEO of PharmAla Biotech and the Board Chair of PsyCan, the Psychedelics Industry Trade Association

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