Health Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products (Draft Guidance), which is intended to replace the current 1996 policy entitled The Distinction Between Advertising and Other Activities (Current Policy). Copies of the Draft Guidance are available from Health Canada on request; comments can be submitted until September 3, 2019.
As with the Current Policy, the Draft Guidance is intended to outline the factors that contribute to rendering a message or activity non-promotional, in order to determine if it is subject to the advertising provisions of the Food and Drugs Act and Food and Drug Regulations. Health Canada developed the Draft Guidance, in collaboration with advertising pre-clearance agencies, with the intention of making it more up to date, accurate, and relevant given significant evolution in the advertising landscape.
Highlights of changes
The scope of the Draft Guidance is broader than the Current Policy. While the Current Policy applies to drugs for use in humans, the Draft Guidance applies to drugs, medical devices, natural health products, biologics, and vaccines for human use as well as veterinary health products.
Like the Current Policy, the Draft Guidance sets out factors that contribute to a non-promotional determination, followed by some examples of non-promotional messages and activities. These factors have been reorganized into two overarching categories:
- Content and context, which includes accuracy, objectiveness, consistency with the terms of market authorization, sponsor/manufacturer influence, layout and design, focus of the message, linkages to other messages, and cautions/disclaimers.
- Sponsorship and dissemination, which includes frequency and breadth of delivery, intended audience, type of staff delivering the message, and the willingness of a competitor to fund the same message.
Other notable changes include:
- Technology updates. The Draft Guidance now accounts for the dissemination of information through technology such as web sites, social media, digital applications, and email. It outlines certain factors that need to be taken into consideration in this context such as the use of links, the “sharing” options, the duration of the availability of an announcement on a health product manufacturer’s website, and whether a social media web site or platform is unbranded.
- New examples. New examples have been added to the Draft Guidance, such as Medical Condition and Treatment Awareness Related Materials. The Draft Guidance also introduces Other Learning Activities and Risk Management Plans and provides guidance as to when these activities will be considered non-promotional. Meanwhile, other examples from the Current Policy have been omitted from the Draft Guidance, such as Help Seeking Announcements, Consumer Brochures, and 1-800 Telephone Numbers.
- Definition of “general public”. Various terms have been defined. For example, “general public” has been defined as “ordinary people, especially all the people who are not members of a particular organization or who do not have any special type of medical/scientificknowledge [sic]”. Notably, this definition does not appear to exclude patients prescribed a drug. Health Canada’s stance on the meaning of the “general public” is important, as the Food and Drugs Act and Regulations place limits on advertising to the general public.
- Clinical Trial Recruitment. The Draft Guidance indicates that the manufacturer’s name should be included in clinical trial recruitment messages. This reverses the position in the Current Policy, which indicates that a manufacturer’s name should be excluded from these messages.
- Patient Information. Under the Current Policy, Patient Information Booklets that accompanied the drug product were considered part of the labelling, and labelling requirements applied. Under the Draft Guidance, Patient Information Materials and Packages is defined more broadly as information in the form of a website, application, leaflet, brochure, or booklet published by the manufacturer concerning a health product. The Draft Guidance does not include a requirement that these materials accompany a drug in order to be considered part of the label (i.e., it implies that they will always be considered part of the label), and labelling requirements will apply. If the materials pertain only to a health product that is being, or has already been, prescribed to a patient (or is contained on a gated website), they will not be considered promotional.
- Press releases and conferences. New considerations are introduced for Press Releases and Press Conferences. Any announcement posted on a manufacturer’s website can be posted for a maximum of 30-days. However, the Draft Guidance now clarifies that statements regarding the degree of safety or efficacy and comparison to other treatments may be included when limited to factual and observed information.
- Unsolicited requests for information. The Draft Guidance explicitly states that in order for responses to inquiries to be considered non-promotional, they cannot be communicated by sales and/or marketing personnel.