The Distinction Between Advertising and Other Activities

Guidance on distinction between advertising and other activities for health products

Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks.

?galement disponible en fran?ais sous le titre : Document d'orientation sur la distinction entre les activit?s publicitaires et les autres activit?s pour les produits de sant? To obtain additional information, please contact:

Health Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613-957-2991 Toll free: 1-866-225-0709 Fax: 613-941-5366 TTY: 1-800-465-7735 E-mail: hc.publications-publications.sc@canada.ca

? His Majesty the King in Right of Canada, as represented by the Minister of Health, 2023 Publication date: August 2023

This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged.

Cat.: H164-353/2023E-PDF ISBN: 978-0-660-49497-5 Pub.: 230238

Foreword

Guidance documents provide assistance on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a health product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of other applicable guidance documents and policies. This guidance document supersedes the 2005 policy The Distinction Between Advertising and Other Activities.

Guidance on distinction between advertising and other activities for health products

| i

Table of contents

Overview ................................................................................................................................................................. 1

Purpose ................................................................................................................................................................ 1 Scope ................................................................................................................................................................... 1 Background .......................................................................................................................................................... 1 General principles ................................................................................................................................................ 3 Factors that contribute to a promotional determination ......................................................................................... 3

What is the context in which the message is disseminated? ............................................................................... 3 Who are the primary and secondary audiences? ................................................................................................ 3 Who delivers the message (the provider)?......................................................................................................... 3 Who sponsors the message and how? ............................................................................................................... 4 What influence does a health product manufacturer have on the message?........................................................ 4 What is the content of the message?.................................................................................................................. 4 How frequently is the message delivered? ........................................................................................................ 4 Content and context factors .............................................................................................................................. 4 Sponsorship* and dissemination factors ............................................................................................................ 5

Promotional examples ............................................................................................................................................ 7

Clinical trial and investigational testing recruitment material................................................................................ 7 Corporate messages .............................................................................................................................................. 7 Medical condition and treatment awareness materials ........................................................................................... 8 Electronic tools and technology ............................................................................................................................ 8

Social media..................................................................................................................................................... 8 Other interactive tools ...................................................................................................................................... 9 Formulary kits or packages................................................................................................................................... 9 Educational activities............................................................................................................................................ 9 Continuing medical education, scientific/medical exhibits and conferences ...................................................... 9 Canadian and international medical/scientific conferences .............................................................................. 10 Other learning activities.................................................................................................................................. 10 Publication supplements ..................................................................................................................................... 11 Medical procedure and health service messages.................................................................................................. 12 Patient information materials.............................................................................................................................. 12 Patient support group activities and literature ..................................................................................................... 12 Patient support group activities....................................................................................................................... 12 Patient support group literature....................................................................................................................... 12 Press releases and press conferences ............................................................................................................... 13 Risk management plans ...................................................................................................................................... 13 Reference texts, peer-reviewed journal articles ................................................................................................... 14 Responses to inquiries ........................................................................................................................................ 14

Definitions............................................................................................................................................................. 15

Relevant legislative and regulatory sections ........................................................................................................ 21

Sections of the Food and Drugs Act.................................................................................................................... 21 Sections of the Food and Drug Regulations under the Food and Drugs Act......................................................... 21 Sections of the Medical Device Regulations under the Food and Drugs Act........................................................ 22 Sections of the Natural Health Products Regulations under the Food and Drugs Act........................................... 22 Section of the Controlled Drugs and Substances Act........................................................................................... 22 Sections of the Narcotic Control Regulations under Controlled Drugs and Substances Act ................................. 22 Section of the Benzodiazepines and Other Targeted Substances Regulations under Controlled Drugs and Substances Act ................................................................................................................................................... 23

Guidance on distinction between advertising and other activities for health products

| iii

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download