Canada: The Evolving Self-Care Framework: A Work In Progress And The Questions It Raises

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.

Originally published in NOC Fall 2017

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Events from this Firm
23 Jan 2018, Seminar, London, UK

Join Gowling WLG's pensions team as they explain some of the biggest challenges facing trustees and employers in the coming year and provide practical ways of dealing with them.

25 Jan 2018, Seminar, Birmingham, UK

2018 is set to be another big year in employment, with employers set to face new challenges and responsibilities. At our event, looking ahead to next year, we will be discussing four key issues you might face in 2018, providing useful tips and answering your questions.

2 Feb 2018, Seminar, London, UK

2018 is set to be another big year in employment, with employers set to face new challenges and responsibilities. At our event, looking ahead to next year, we will be discussing four key issues you might face in 2018, providing useful tips and answering your questions.

 
In association with
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

    Disclaimer

    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

    Registration

    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

    Cookies

    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

    Links

    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

    Mail-A-Friend

    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

    Emails

    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

    Security

    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions