The evolving self-care framework: A work in progress and the questions it raises

20 December 2017

This article was originally published in NOC Fall 2017 and has been republished with permission.

As most health care product regulatory professionals are now aware, Health Canada is looking at changing the way cosmetics, over-the-counter drugs ("OTCs"), and natural health products ("NHPs") are regulated in Canada.

This is the culmination of many years of on-and-off proposals for one regulatory change or another that have mostly failed to come to fruition. This time, Health Canada is taking a bold and aggressive approach in its attempt to change the way multiple product categories are regulated by grouping them together under a single, proposed regulatory framework. Health Canada's stated goal is to change the way such products are classified from a current "formulation or indication" basis to a "risk" basis. Health Canada refers to this new and evolving proposal as the Self-Care Framework.

Over the past year, Health Canada has held a series of public and stakeholder consultations to inform Canadians about the proposed Self Care Framework. Industry response has varied significantly, often depending upon the current category of product an industry member sells. Companies selling primarily cosmetics and personal care-type products, which to date, may technically fall into other regulatory categories, appear to be more vocally supportive of the Self-Care Framework. The fundamental reason cited for this support is that this proposal can solve many of the longstanding challenges faced by such companies. For example, many toothpastes and mouthwashes may currently be regulated as a cosmetic, NHP, or OTC, depending on the indication or formula. Despite this patchwork of product categorizations, each product poses no meaningful difference in overall risk to the consumer. Similarly, companies primarily selling OTCs are also generally supportive of the Self-Care Framework, as it may relax certain regulatory and quality requirements for those OTCs regarded as being lower risk (i.e. by providing a regulatory framework more akin to the current approach to the regulation of NHPs).

Companies primarily selling NHPs are generally opposed to the proposed Self Care Framework, largely due to an absence of detail regarding the proposal. Perhaps most significant is the lack of information on the fate of over 100,000 currently-licensed NHPs. This industry has voiced opposition to the proposed changes, largely stemming from concerns that the gains made by this sector under the Natural Health Products Regulations will be lost. NHPs are currently regulated under the most modern regulatory framework of the three product categories proposed to be regulated under the new Self Care Framework. Beginning in 2004, companies selling NHPs made significant financial investments to comply with the newly enacted Natural Health Products Regulations. There is an added concern from this industry sector that such companies may effectively have to start over under a new framework – bringing uncertainty with respect to products they sell and a question mark as to whether past financial investments would be lost.

Characteristics of the Current System

Under the current system, cosmetics, OTCs and NHPs are subject to different regulations under the umbrella of the Food and Drugs Act. These various regulations have different evidentiary requirements for product licencing and notification, different approaches to the regulation of quality, and provide Health Canada with varying powers and authorities when it comes to enforcement. The latter is one of the reasons that Health Canada has emphasized as the impetus for revisiting the current regulatory framework. Health Canada is looking to strengthen, clarify, and align its post-market, licensing, and administrative powers across the various product categories.

  1. Over-the-Counter Drugs
    OTCs require a licence (market authorization) from Health Canada. Unless an OTC is consistent with either a Category IV monograph or Labelling Standard, as published by Health Canada, evidence must be provided to demonstrate the safety and efficacy of an OTC. Manufacturers and importers of OTCs require an Establishment Licence, are subject to regular inspections by Health Canada and Health Canada maintains the power to demand a recall or a label change.
  2. Natural Health Products
    Legally a subset of drugs, manufacturers of NHPs must obtain a licence (market authorization) from Health Canada. Unless an NHP is the subject of a monograph or Labelling Standard, as published by Health Canada, evidence must be provided to demonstrate the safety and efficacy of an NHP. In general, the level of proof of safety and efficacy is regarded as less onerous for NHPs than for OTCs. For example, clinical evidence in the public domain on individual medicinal ingredients can be used to support a combination product. The level of evidence required in support of an NHP product licence application varies based upon the nature of the natural health product as well as the proposed health claims. Manufacturers and importers of NHPs require a Site Licence, however, there is no formal Health Canada inspection as information is self-reported. Health Canada does not have the authority to force the recall of a natural health product. It should be noted that the current regulatory system acknowledges that patents are much less likely to be issued in the context of a natural health product, which can impact the incentive to financially invest in new clinical trials.
  3. Cosmetics
    Cosmetics are a unique category of self-care products, as there is no licencing requirement for cosmetics in Canada. These products are regulated through a post-market registration system whereby manufacturers and importers must notify Health Canada within 10 days of the first sale in Canada. This notification must contain information about the nature and quantity of the ingredients, and the purpose for which the cosmetic is meant to be used. Thus, it is not the case that Health Canada is unaware, or does not review the cosmetic products in the marketplace — Health Canada may reject the sale of a cosmetic product if it has any concern regarding the safety of the product or its ingredients. This is an important aspect of the cosmetic notification process, since cosmetics include a broad range of largely similarly formulated products ranging from soaps and toothpastes to moisturizers and make-up. Health Canada maintains authority to request safety data for these products, and can require manufacturers to cease sales in Canada should any product be deemed unsafe.

Proposed Changes

It is imperative to establish that while Health Canada has been somewhat consistent about the principles of the Self-Care Framework, the details, even at a high level, have either been lacking or continuously evolving. As a positive note, Health Canada seems to be reacting to the consultation process and the details regarding the proposed changes, outlined below, may have already evolved by the time you read this article.

The theme of the proposed Self-Care Framework is that of a "risk-based approach." Health Canada has indicated that a risk classification system was proposed in order to ensure that the level of oversight corresponds with the risks posed by a particular health product. The intent is that products of similar risk profiles would be treated in a similar manner notwithstanding their current classification as a cosmetic, NHP, or OTC drug. It should be noted that Health Canada has been revising what it considers to be risk throughout the consultation process, but at this time it is primarily focussed on the health risk of the ingredients (e.g. limited safety data or known safety risks) and risk of failed efficacy.

While the proposed product classes have been continuously changing throughout the consultation, it seems that this risk-based approach would include a number of risk categories or classes (either 2 or 3 classes, based upon recent Health Canada communications). Products currently regulated as OTC drugs and NHPs that do not conform to a current Labelling Standard or monograph would be funneled into a higher risk category. Homeopathic remedies, cosmetics, and NHPs with pre-cleared claims, authored by Health Canada, would be placed in a lower risk category. Lower-risk category products would not be licensed but would undergo a registration process, perhaps comparable to the current requirements for cosmetics. What remains fundamentally unclear is how many classes or subclasses will exist, how the spectrum of risk will be divided into those classes, and what many of the fundamental differences will be across the different classes and subclasses, including levels of evidence and quality requirements, including site licensing.

With respect to the low risk product group, it appears that Health Canada's current position is that either no health claims or very limited health claims would be permitted. Health Canada has also consulted on the concept of either a disclaimer or proclaimer to communicate that the product in question has not been reviewed for its effectiveness. Thus, under this proposed system, homeopathic products, for example, would still be permitted for sale; however, it is possible that Health Canada would require a statement making it clear that Health Canada has not reviewed the safety or efficacy of the product.

With respect to the higher risk group of products, which includes those products making health claims, these would have to be reviewed, licensed, and given a product number by Health Canada in order to gain market access. As part of licensing, scientific evidence would be needed to support any claims made by a product in this category. The review process for these higher risk self-care products would be more thorough than those considered a lower class of risk. We expect that products containing new claims for conditions with a high risk associated with failed efficacy, new ingredients, and new uses for susceptible subgroups (like children and pregnant or breastfeeding women), as well as those aimed at heart health, would likely be considered as higher risk. It remains to be seen how products that overlap both low and high-risk categories will be regarded. For example, fish oils are a source of omega-3 fatty acids, presumably a low-risk claim, yet have been actively studied for heart health -- presumably, a higher risk claim. In this instance, Homeopathic remedies, cosmetics, and NHPs with pre-cleared claims, authored by Health Canada, would be placed in a lower risk category. Lower-risk category products would not be licensed but would undergo a registration process, perhaps comparable to the current requirements for cosmetics. feature would a license or registration be required? Furthermore, can products normally considered low risk use scientific evidence to add claims?

It should also be noted that Health Canada has so far made it clear that products can move down and up classes. New evidence and information gained from market experience can change the risk profile of a product. It remains to be seen how such switching of categories would accomplished.

What Next?

If Health Canada chooses to go forward with the proposed changes, the current legislative framework will have to be remodeled. This process could easily take many years. While Health Canada has outlined its willingness to move forward at an expedited pace, there continues to be much uncertainly. This uncertainty relates to the fact that, while there has been much consultation on the principles of the proposed Self-Care Framework at a high level, there remains very limited to no consultation on many of the finer details that would be necessary for the Self-Care Framework to come into existence. The lack of information regarding the finer details of product classification, quality licence requirements, and the fate of the wealth of currently-licensed products on market is causing anxiety amongst industry members. It is paramount that Health Canada address these concerns such that a complete impact analysis may be performed.

From a legal perspective, Health Canada has not yet shared any information as to how it intends to accomplish the Self- Care Framework. It has also not confirmed whether it intends to move all products under a single regulation, use multiple regulations, or accomplish its goals under the regulations that exist today. That being said, we think it would be a significant challenge to achieve a Self-Care Framework, as it has been explained to date, without amending the Food and Drugs Act and, at least to an extent, restructuring the regulations currently under the Food and Drugs Act. This unknown is extremely significant. Opening the door to any legislative amendments has the potential to invite additional changes that have not yet been considered through any of the proposals to date. Certainly, if there are amendments proposed to the Food and Drugs Act, it will provide an opportunity for Parliament to serve a more active role in the process and the nuances may be the subject of increased scrutiny and public debate.

Overall, after a year of consultation, key details continue to remain absent from the consultation process. In effect, how will the proposed framework impact each company's approach to its day-to-day business? Will it be easier for a company to bring a product to market or more difficult? Will more or less evidence be required? Will companies be able to clearly convey to the consumer what the product is intended for? Will all products currently permitted on the market continue to be permitted on the market? Will products already on the market have an advantage over products not yet on the market? Will quality licences require third party auditing? In other words: what are the fundamental details that will determine how a product falls into a class and the practical impact of that class? How will the Selfcare Framework address incident reporting requirements across the various classes? We believe that if Health Canada can meaningfully and positively address all these questions in a clear and detailed manner, it would facilitate productive discussions and possible cooperation from industry.

When we were initially asked to write this article, we were hopeful we would have more clarity on the proposed framework, however, this has not been the case. It is human nature to fear the unknown and if Health Canada believes the Self Care Framework is the best way to regulate these products for Canadians, then we hope Health Canada will soon release the details needed so that all stakeholders, including Canadian consumers, can truly begin to understand how the proposed Self Care Framework would impact them and the products they use.


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