Thank you very much.
Good morning, ladies and gentlemen of the committee. I thank you for this opportunity to appear before you today.
This is Robert White, a colleague of mine and our director of scientific and regulatory affairs.
I am David Skinner. l am president of NDMAC. Our association is dedicated to advancing Canadian self-care. From sunscreens to pain relievers, vitamins to herbals, and toothpastes to acne treatments, self-care health products are vital tools in the personal health management of virtually all Canadians.
Our industry supports the need for risk-based regulatory interventions with respect to safety, efficacy, and quality. We believe that all products with health claims of similar risk should attract the same regulatory requirements, not just for post-market monitoring, but also for pre-market authorization to sell. This means there should be differing regulatory standards for products with differing levels of risk. Sadly, Canadian regulations are confusing, inefficient, and often arbitrary in the way they differentiate between health products of similar risk.
Health products can be divided into two major categories. First there are drugs and devices with risk profiles that require the intervention of a health professional to ensure their safe and proper use. These include prescription drugs, vaccines, medical imaging tools, and controlled substances. The second category of health care products is for self-care, which have risk profiles that permit their safe use on the basis of label directions without requiring the intervention of a licensed professional. The regulation of this latter category is inconsistent, at best.
To illustrate the confusing nature of the current regulations and nomenclature, we need to look no further than the terms of reference for this study. The stated intent is to review the federal government's role in post-market surveillance of prescription and non-prescription drugs. While it is clear that the committee intends that prescription drugs be within the scope of this study, it is less clear regarding non-prescription drugs.
Does this mean the focus is on products such as vaccines, controlled substances, exempt narcotics, and other drugs such as digoxin, insulin, and nitroglycerin, all of which are non-prescription drugs that are regulated under part C of the food and drug regulations but not listed in the prescription drug schedule? Does the committee also wish to include other items that fall under the same set of regulations as prescription drugs, such as toothpastes and sunscreens? If the intent is to include such items as antacids, laxatives, and cold products, then the question arises as to whether natural health products are also included, and if so, why not health products in food form?
The dangers of casting a broad net can be illustrated by the gross error of omission with respect to the establishment of price controls for patented drugs. When these regulations were promulgated, there had never been a single word uttered by Parliament about the rules being applied to sunscreens, chewing gum, anti-dandruff shampoos, nor any other self-care health product for that matter. Yet the patented medicine regulations were, and continue to be, mute on a definition of the scope of these controls.
The consequence of this is that the common definition of drug as found in the Food and Drugs Act has been used, thereby capturing everything from toothpaste and gum to allergy medicines. It has been conclusively demonstrated that self-care products operate in a highly competitive, out-of-pocket consumer pricing environment that negates the need for government price controls. Although the intent of Parliament never was to capture these products, lack of clarity has created a two-tiered market and reduced consumer choice.
This kind of overregulation has encouraged non-compliance and added unnecessary costs to the government and consumers. Our sector needs clarity. We do not wish to repeat the errors of the past by having our members' products lumped into the same basket as new chemical entities.
NDMAC does believe that regulatory efficiency and clarity is one of the greatest tools to ensure public safety and competitiveness. We endorse the need for post-market monitoring of all products under the Food and Drugs Act that carry health claims. The level of complexity needs to be proportionate to the risk of products.
New chemical entities, by definition, have the least market experience and have the least well-characterized safety profile. So these products would most surely be prescription drugs; thus their requirements would be significantly higher than those requirements for self-care health products, such as natural products and non-prescription medicines, as well as cosmetics and foods making health claims.
The regulations for lower-risk products, such as those for self-care, should be consistent, regardless of the form the products take. For example, calcium carbonate, whether it's in a tablet, a syrup, a drink, or a snack bar, is still a biologically active substance being delivered to the body, regardless of the format chosen by the consumer. In fact, it is consumer choice and consumer preference that often determines how this product is placed on the market. If it's promoted for its health benefit, either as a calcium supplement or an antacid, it must be subject to the regulations that reach beyond its fitness for general consumption. From the marketer's standpoint, the business decision to enter the health products market brings with it certain regulatory obligations with respect to ensuring appropriate use and the prevention of health fraud. These obligations should not be something that can be sidestepped through the choice of product format.
As the safety profile of self-care health products must be well known, the adverse events profile is also well documented, which negates the need for extensive post-marketing monitoring and reporting that are required for higher-risk products such as new chemical entities. Manufacturers of self-care health products report all adverse reactions to Health Canada and, on an annual basis, prepare and maintain a summary report with a concise and critical analysis of all adverse reactions for every product on the Canadian market. NDMAC believes that such regulatory oversight is sufficient for self-care health products.
Currently, some self-care health products are captured by part C of the food and drug regulations, where they are regulated alongside higher-risk products such as prescription drugs and vaccines. Other self-care products are handled by part D of the regulations, the natural health product regulations, and still others by part B, the foods regulations.
NDMAC urges the committee to recommend that a simplified, consistent, and comprehensive system of regulation for self-care health products be created outside part C of the food and drug regulations. Within the self-care regulatory framework, post-market monitoring should be established based on well-known safety profiles of lower-risk products and the requirements be made proportionate to the risk.
Thank you for your attention, and I await your questions.