Canada: IT'S HERE: Health Canada's New Draft Guidance On Advertising Versus Other Activities Is Now Available

Life Sciences Bulletin

On July 5, 2019 Health Canada opened consultation on its draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products ("Draft Guidance"), which, when finalized is intended to replace the current policy entitled The Distinction Between Advertising and Other Activities. While the Draft Guidance is not available online, interested stakeholders can request a copy by emailing MHPD_DPSC-Advertising_Reg_Publicite@hc-sc.gc.ca

Significantly, the Draft Guidance is proposed to apply to "health products", versus only drugs per the current policy. Products governed by the Draft Guidance are: prescription drugs (including controlled substances), non-prescription drugs, medical devices, natural health products, biologics, vaccines and veterinary health products.

The Draft Guidance mirrors the current policy in both form and content, but includes important differences. The Draft Guidance maintains an introductory section on the general principles and factors to be applied when determining whether a message is promotional, followed by examples of non-promotional messages and activity types. Some of the examples remain very similar, with updates to reflect recent technological advances for the exchange of both promotional and non-promotional messages and related activities via social media platforms and websites. New examples have been added. The following is our selection of key changes:

New Sections

Electronic Tools and Technology

Deals with information disseminated through social media and similar technologies (in addition to interactive tools, which is also dealt with in the current policy). Such information may be considered non-promotional in the following circumstances:

  • the social media website, platform or tool remains unbranded (e.g., no specific product is mentioned);
  • the content, user-generated comments, hyperlinks and/or other interactive features do not place additional focus or emphasis on a specific health product and its benefits;
  • the available "sharing" options (e.g., email, "like", "tweet", etc.) do not modify the context by which the content is disseminated (e.g., different audience, emphasis on a specific product, etc.); and
  • a person or organization and/or its representatives may sponsor the social media activity or message, but is not engaged in discussions except in a monitoring capacity (e.g., removal of inappropriate comments, etc.).

Other Learning Activities

There is a new subsection under Educational Activities for "Other Learning Activities" (in addition to continuing medical education, which is also covered by the current policy). Other learning activities are defined as unaccredited programs, events or activities where medical/scientific information is presented to health care professionals, by health care professionals, where the primary focus is the exchange of scientific and clinical information and issues.

According to the Draft Guidance, information disseminated at OLAs may be considered non-promotional in the following circumstances:

  • the need for such an activity has been clearly and systematically identified through a needs assessment in collaboration with relevant health care professionals;
  • the objectives of the program have been clearly outlined and the activities are meant to address an identified gap between the current situation and the desired situation;
  • only health care professionals are invited or are in attendance;
  • all materials for the program or activity have been developed in accordance with program objectives and are only distributed to health care professional attendees;
  • any product discussions are fair and balanced, and consistent with the Canadian terms of market authorization; and
  • evaluations are collected to assess whether program objectives have been met.

Additionally, for an OLA event to be considered non-promotional, a speaker/presenter must:

  • appropriately disclose any conflict of interest(s) and funding;
  • disclose that the safety and efficacy/effectiveness are still under investigation in the case of unauthorized health products and unauthorized uses – this implies that non-promotional off-label discussions are permitted by Health Canada ; and
  • have complete editorial control of the content being presented.

New Examples of Non-Promotional Messages

The Draft Guidance contains a few new examples of non-promotional messages. One that is significant for many industry members is Patient Information Material, i.e. information in the form of a web site, application, leaflet, brochure, or booklet published by the manufacturer concerning a health product (e.g. patient support materials). Such information is considered non-promotional if it pertains only to the health product that is being, or has already been, prescribed to a patient by a health care professional and in the case of a web site, the access is gated to ensure that information is only accessible by patients. Other examples are Medical Procedure and Health-Service Related Messages issued by healthcare professionals ("HCPs") and Risk Management Plans, i.e. dynamic, stand-alone documents required or requested by Health Canada which describe a set of pharmacovigilance activities and interventions.

Other Notable Changes

Other notable changes to the Draft Guidance include the following:

Press Releases: There are new important requirements to be considered non-promotional, including that these communications must be posted on the website of the manufacturer or press release distributor for 30 days. It is also now permissible to include safety and efficacy information (previously not permitted).

Clinical trial announcements: It is now permissible to refer to the health product manufacturer's name in a clinical trial announcement and still be considered non-promotional.

Corporate messages (institutional messages under the current policy): Information about the health product being marketed/developed/researched must be included in the "investor information section" of the communication to be considered non-promotional.

Medical condition and treatment awareness related materials (consumer brochures under the current policy): There are two new requirements to be considered non-promotional:

  1. in the case of a disease where there is only one treatment available, the treatment must not be not alluded to, referred to, or mentioned in any way; and
  2. the material must emphasize the need for patients to consult a health care professional for complete information on the disease, and the available treatment options, or if they suspect they are experiencing any symptoms related to the disease.

Formulary Kits or Packages: As under the current policy, there is recognition that information about a health product provided to formulary committees may be non-promotional; the Draft Guidance makes it clear that such committees may be formed by public or private payers.

Educational Activities: It is no longer a requirement that continuing medical education (CME) events be restricted to HCPs to be considered non-promotional (just a statement that they are "generally" so restricted). International events are to be governed by the same rules as domestic conferences.

Responses to Inquiries (unsolicited requests for information under the current policy): It is now expressly stated that the response cannot be communicated by sales and marketing personnel.

Next Steps

The consultation is open for 60 days ending on September 3, 2019.

The purpose of this consultation is to obtain input on the revised guidance document from all relevant stakeholders (e.g., industry associations, health product manufacturers, advocacy groups, healthcare professionals, consumers, the advertising industry, provincial/territorial authorities, etc.).

The Fasken Life Sciences team has extensive experience in this area and is available to consult with stakeholders interested in commenting on the Draft Guidance.

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
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

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