Vanessa's Law: When is a Therapeutic Product not a Therapeutic Product?

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Jun 8 2014

Bill C-17, the Protecting Canadians From Unsafe Drugs Act, also known as Vanessa's Law, is no small undertaking.  The Bill amends Canada's Food and Drugs Act, an exceedingly rare event in Canadian legislative history.  In fact, Vanessa's Law is probably the most extensive set of changes to the Act since 1953.

That's right.  Despite all of the changes in science, technology and the pharmaceutical industry over the past sixty years, the last time Parliament dove this deeply into the laws governing these matters, most Canadians didn't even own televisions. With that history in mind, it wouldn't be unreasonable to look at Vanessa's Law not only as a long-overdue update to the Food and Drugs Act, but one with which we will likely live for a very long time.

So what does Vanessa's Law do? The Bill's provisions can be divided into two groupings. The first of these deal with enforcement powers.  Vanessa's Law updates fines and penalties to make them relevant in the 21st century. For example, the maximum fines for offenses under the Act go from a rather quaint $5000, to as much as $5 million per day for the worst transgressors.  The Bill also gives the Minister of Health the authority to order the recall of products governed under the Act, bringing her powers in this area into line with those she has under the Canada Consumer Product Safety Act, the law governing the sale of virtually all other consumer products.

The second group of provisions gives the Minister new powers to deal with safety concerns that might arise after a drug or medical device is initially approved for sale. These include making the reporting of adverse reactions mandatory for institutions (hospitals), authorizing the Minister to order new safety studies and authorizing the Minister to order changes to the labels of drugs and devices.  All of these provisions recognize the science of post-marketing surveillance, which addresses safety issues too rare or complex to be picked up in the clinical trials that necessarily form the basis of pre-market approvals.

Together, these provisions have been the focus of the debate around Vanessa's Law.  That debate, incidentally, has been remarkably free of rancour, at least in Parliament.  This is no doubt due to the fact that virtually everyone recognizes the need for the modernization of our aging food and drug legislation. But Vanessa's Law has a glaring flaw that goes directly to the heart of the matter.  The Bill proposes a new definition for "therapeutic products" in the Food and Drugs Act that sets out the products that will be subject to the above new powers.  That definition includes all drugs and medical devices or combinations thereof, but expressly excludes natural health products (NHPs).  What this means is that, while the Minister of Health will now have modern enforcement and recall powers for virtually all other products on the Canadian market, from cancer drugs and pacemakers to window blinds and children's toys, she will not have those powers for NHPs.

In some corners of the public imagination, natural health products are inherently low-risk "supplements," like vitamins, herbs and homeopathic remedies that may or may not offer some health benefit to users.  The reality is both simpler and far more complex.  Legally, NHPs are drugs whose active ingredients occur in nature.  Of course, there are all sorts of naturally occurring substances that can be beneficial to health, many that can be harmful and many that can be both, depending on how they are used. In fact, a surprising number of prescription drugs, from powerful heart drugs like digoxin to narcotic pain relievers like morphine, are naturally occurring molecules.  To ensure that NHPs can be safely used by the public, Health Canada uses safety criteria in the Food and Drug Regulations to identify those substances that can only be used by prescription from a doctor or other authorized health professional.

And here is where the proposed definition of "therapeutic product" gets even more difficult to understand.  The safety criteria that separate NHPs from prescription drugs in the Food and Drug Regulations are also what separate over-the-counter medicines (OTCs) from prescription drugs. In fact, the only thing separating OTCs from NHPs is the fact that the latter must contain active ingredients that occur in nature, which is why thousands of OTC medicines, from decongestants like pseudoephedrine to steroid creams like hydrocortisone, became NHPs when the NHP regulations were created in 2004.

So, when is a therapeutic product not a therapeutic product? It's a head-scratcher.  Under Vanessa's Law, disinfectant toilet bowl cleaners and hand sanitizers will be "therapeutic products," while some cold medicines and, potentially, even low-dose statin cholesterol-reducing drugs, will not. (Health Canada has just proposed switching red yeast rice containing up to 1mg lovastatin from prescription to NHP status.)

Consumer Health Products Canada believes that arming Canadians with the tools they need to take more control over their own health is vitally important to public health and to the sustainability of our health care system.  Our member companies produce and sell the vast majority of the OTCs and NHPs that Canadians use in their own self-care. We embrace the provisions of Vanessa's Law because they are entirely consistent with the law-abiding, safety-first way our members conduct business. But, if passed with the currently proposed, lop-sided definition of "therapeutic products," we fear that Vanessa's Law will distort the marketplace for consumer health products and could undermine consumer confidence in the roughly 50% of our member's products that fall under the Natural Health Products Regulations.

On Tuesday, June 10th, the House of Commons Standing Committee on Health will hear from witnesses and begin considering potential amendments to Vanessa's Law. There are indications that the process will move quickly, with a view to returning the Bill to the House before it rises for the summer. CHP Canada fervently hopes that, in their haste, they do not lose sight of the importance of patient safety to all users of all therapeutic products. If history tells us anything, it is likely that the implications of their decision will be with us for a very long time.