PAAB Workshop Health Canada s Regulatory Advertising Oversight Key Recent Initiatives November 20 & 22, 2018 Alain Musende, PhD Manager, Section for Transparency and Advertising Regulatory Surveillance Health Canada
Purpose: To provide: An update on 3 key recent regulatory advertising initiatives: Update to the policy entitled The Distinction Between Advertising and Other Activities (Distinction policy) Proactive monitoring of health products advertising Opioid advertising actions An example of advertising complaint addressed by Health Canada An example of an emerging advertising trend of concern to Health Canada 2
INTRODUCTION Regulatory advertising in Canada Context: Applicable Federal Statutes: - F&DA and R - CDSA and NCR Health Canada Guidance Documents APA Codes Health Product Advertising Association Codes A P A Industry APA: Advertising Preclearance Agency F&DA and R: Food & Drugs Act and Regulations Healthcare Professionals/General Public 3
INTRODUCTION Why regulate health product advertising? To protect the health and safety of Canadians Mandated by law 4
INTRODUCTION Primary Legislative Provision: Section 2 Food and Drugs Act: Advertisement includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device. 5
INTRODUCTION Core legislative & regulatory provisions: Section 2 Food and Drugs Act: Advertisement includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device. Section 9(1) Food and Drugs Act: No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Think Inside the Box! Section C.08.002 Food and Drug Regulations: No person shall sell or advertise a drug unless it has received a notice of compliance. 6
INTRODUCTION Are all messages about drugs considered as advertising? NO! Health Canada uses the policy The Distinction Between Advertising and Other Activities to distinguish promotional activities from information. 7
INTRODUCTION Key aspects of the Distinction Policy: Purpose: To distinguish promotional activities from information i.e. not primarily intended to promote the sale of a drug Scope: Applies to all types of information disseminated in relation to drugs for use in humans Key limitations: Issued in January 1996 22 years ago! Did not consider: the Internet, Social Media etc 8
The Distinction Between Advertising and Other Activities Why determine if a message is advertising? Drug Message Advertising Information Legislation & Regulations Apply Legislation & Regulations Do Not Apply 9
Updating - The Distinction Between Advertising and Other Activities Update considerations: Expand scope to: All types of health products including vaccines, medical devices and veterinary drugs All types of audiences (general public, healthcare professionals, etc ) Update current sections such as: Press Releases / Press Kits Help-seeking Messages Patient materials (e.g. access to patient Web sites) Continuing Medical Education / Conferences 10
Update considerations(continued): Include activities such as: Social media platforms and other online interactive communications / activities: Static content, dynamic content, user-generated comments, monitoring, linking, search engine techniques, banner ads, apps, QR codes, etc. Patient Web sites for products with risk management plans Link between Consumer Brochures & Help-Seeking Announcements (Disease Awareness Campaigns) Sales representatives activities / materials 11
Help-Seeking Announcements Current text: Help-seeking announcements are defined as announcements that ask patients among the general public having a particular medical disorder, or that experience a given set of symptoms, to consult a physician for discussion of treatment, or to call a 1-800 telephone number for further information. Such an announcement may be a non-promotional activity in the following circumstances: No specific drug is identified, There is no implication that a drug is the sole treatment available for the disease or condition, and No drug manufacturer's name is included. Such an activity may be advertising where any of the aforementioned conditions are not met, or where other factors indicate that the primary purpose is to promote the sale or disposal of a drug. 12
Issue Conflict with Canada's Anti-Spam Legislation Section 6 (2) Anti-Spam Legislation: The message must be in a form that conforms to the prescribed requirements and must (a) (b) (c) set out prescribed information that identifies the person who sent the message and the person if different on whose behalf it is sent; set out information enabling the person to whom the message is sent to readily contact one of the persons referred to in paragraph (a); and set out an unsubscribe mechanism in accordance with subsection 11(1). 13
Updating - The Distinction Between Advertising and Other Activities Overall process & timelines: Consultation with APAs Target Date: Completed Broad Stakeholders Consultation Target Date: Winter 2019 Webinar Target Date: Spring 2019 Posting on Health Canada s Website Target Date: Spring 2019 14
PROACTIVE MONITORING OF ADVERTISING Drivers: House of Commons Standing Committee on Health Government s Role in Addressing Prescription Drug Abuse Recommendation # 5: Health Canada review, in cooperation with stakeholders, inappropriate marketing practices that have an effect on prescribing practices. 15
PROACTIVE MONITORING OF ADVERTISING Drivers (continued): Minister s Announcement Opioid Crisis A dedicated team to proactively monitor opioid marketing 16
PROACTIVE MONITORING OF ADVERTISING Proposed approach: Proactive monitoring of multiple media/venues: - Television - Newspapers - Radio - Internet - Social media - Medical journals - Continuing Medical Education (CME) materials - Data obtained through surveys of healthcare professionals - Cases received through a US Bad Ad Program type Step 1: Detection Detect ads involving all heath products including devices Step 2: Pre-screening Apply preliminary compliance assessment on all detected ads Step 3: Prioritization Apply a risk-based prioritization approach to screened-in ads Step 4: Compliance Assessment Apply full compliance assessment according to priority levels Step 5: Compliance Enforcement Take compliance enforcement actions according to priority levels Detection of emerging trends & issues Targeted strategies to prevent or mitigate the trends and issues Outreach and education as needed Ongoing monitoring of media/venues involved in noncompliance Targeted monitoring Outreach and education as needed Page 17 17
PROACTIVE MONITORING OF ADVERTISING Key advantage: Ability to investigate, detect and take actions on: Advertising trends and issues, especially those that may become or contribute to serious public health crises Issues identified internationally e.g. in the US Example: 18
PROACTIVE MONITORING OF ADVERTISING Overall process & timelines: Consultation with APAs Target Date: Fall 2018 Stakeholders Communication Target Date: Fall 2018 Launch Target Date: Late Fall 2018 19
OPIOID ADVERTISING ACTIONS Mandatory preclearance: Under the new Terms and Conditions All opioid-related materials that would be provided to healthcare professionals must be precleared by an external advertising preclearance agency recognized by Health Canada This preclearance would verify that advertising of opioids: Presents balanced information on benefits and risks Aligns with the product monograph Is not false or misleading 20
OPIOID ADVERTISING ACTIONS Minister s call for voluntary cessation of opioid marketing: A voluntary call on opioid manufacturers and distributors to immediately cease opioid marketing activities to healthcare professionals in Canada. All respondents did not object to the call and committed to collaborate with Health Canada. 21
OPIOID ADVERTISING ACTIONS Request for PAAB-approved materials: Industry to provide Health Canada with PAAB-approved materials: From 2010 to 2018 Materials provided will contribute to: Health Canada s understanding of the retrospective context of the dissemination of opioids Information on mandatory preclearance volume 22
An Example of Advertising Complaint Addressed by Health Canada In this workshop, Health Canada will discuss an example of advertising complaint it has addressed: In the spirit of providing the audience with a meaningful educational content As requested by some members of industry, to prevent others from making similar mistakes 23
Advertising Complaint: Controlled Substances on InnoviCares Web site Overview Health Canada received a trade complaint in relation to companies retaining the services of STI Technologies Limited to advertising Free Prescription Savings cards involving controlled substances on InnoviCares Web site. 24
What is InnoviCares Web site? The Web site allows individuals to sign up for a free prescription savings card that is available to all Canadian residents The card is funded by participating pharmaceutical manufacturers Individuals may present the card to any pharmacy in order to access brand name medications The card automatically covers a portion of the cost of the brand name medication by coordinating with the individual s existing insurance plan or The card may be used on its own in the event that the individual does not have a primary drug plan The Web site lists each province s formulary of products available through their program Brand name logos are listed in tile format 25
Screenshots from the InnoviCares Web site www.innovicares.ca August 13, 2018 26
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List of All Controlled Substances on InnoviCares Web site * * Controlled Drugs and Substances Act 28
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Example of a Controlled Substance on the InnoviCares Web site 30
Section 2(1) of the Narcotic Control Regulations (NCR) Note: These regulations are enabled under the Controlled Drugs and Substances Act advertisement means any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of a narcotic Section 2 of the Food and Drugs Act (F&DA) advertisement includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device 31
Applying the Distinction Policy to the InnoviCares Web site 1) Who are the primary and secondary audiences? According to the Distinction Policy, when the primary and secondary audiences are different but the disseminated message is reaching the secondary audience, the activity is most likely to be advertising InnoviCares Web site is not restricted to patients who have already been prescribed controlled substances that is, the primary audience It is also accessible to the public that is, non-users of controlled substances who constitutes the secondary audience 32
Applying the Distinction Policy to the InnoviCares Web site 2) Who sponsors the message and how? The Distinction Policy states that where any fee is paid by the manufacturer to have the message disseminated, it is more likely to be advertising InnoviCares Website states that the medication payment card program is funded and sponsored by participating pharmaceutical companies Therefore, market authorization holders of controlled substances are paying fees to indirectly promote their brand to the general public 33
Applying the Distinction Policy to the InnoviCares Web site 3) With what frequency is the message delivered? The Distinction Policy suggests that where the same message is delivered repeatedly, the message is more likely to be considered as advertising InnoviCares is a medication payment card program focusing on disseminating product-related messages to healthcare professionals and to the public Although the program may benefit patients financially, Health Canada s position is that such a tool is part of a marketing plan placing an emphasis on particular products and repeated frequently to healthcare professionals, patients and the public 34
Health Canada s Assessment Outcome InnoviCares Web site constitutes advertising and controlled subtances advertised on this site are subject to the provisions of the: Narcotic Control Regulations Food and Drug Regulations Benzodiazepines and Other Targeted Substances Regulations 35
Health Minister s Call to Action June 19, 2018 The Minister of Health sent a letter to all opioid manufacturers and distributors to voluntarily cease opioid marketing activities in Canada: I call on industry to show leadership by immediately suspending marketing and advertising of opioids 36
Section 70 of the Narcotic Control Regulations No person shall publish or cause to be published or furnish any advertisement to the general public respecting a narcotic 37
Section G.01.007(a) of the Food & Drug Regulations (F&DR) No person shall advertise a controlled drug to the general public 38
Section 3(a) of the Benzodiazepenes and Other Targeted Substances Regulations A person must not advertise a targeted substance to the general public 39
Summary of Applicable Contraventions to the Controlled Substances on the InnoviCares Web site F&DR F&DR F&DR 40
Health Canada s Actions 1.Requested that STI Technologies stops the advertising practice immediately 2.Informed involved manufacturers 3.Held teleconferences with STI Technologies Note: Some manufacturers claimed that they were unaware of the listing of their products on the InnoviCares Web site. 41
Outcomes STI Technologies collaborated with Health Canada to achieve compliance with health product advertising law. The formulary listing on InnoviCares Web site was revised for controlled substances: All information regarding controlled substances is provided under a gated environment only accessible with a username and password (only for patients). 42
Emerging Issue: Single Ingredient Iron NHPs Single Ingredient Iron Natural Health Products (NHPs): Health Canada Authorized Indications: General: A factor in the maintenance of good health Specific: Helps to form red blood cells and helps in their proper function Dose-specific: For products providing daily doses of iron at or above the Recommended Dietary Allowance or Adequate Intake (adjusted for the life stage groups), either of the following use or purpose statements are acceptable provided that they are used verbatim: Helps to prevent iron deficiency Helps to prevent iron deficiency anaemia 43
Single Ingredient Iron Natural Health Products (NHPs) (continued) Dose-specific (continued): For products providing daily doses of iron between 16-20 mg: Helps pregnant women meet the recommended intake for iron, when taken in conjunction with a healthy diet Notes: For products providing a daily dose of iron above 35 mg per day, the Specific use or purpose and/or the Dose-specific use or purpose indicated above are required Licence Holders: Over 150 companies 44
History of Iron-Containing Products in Canada In 2009, Health Canada issued an important Safety Information Update to the general public about important labelling information for iron-containing products: Products on the market were found to display the dose in different ways on their labels Consumers could take an incorrect dose: The potential for harm from consuming too much iron includes adverse effects, such as constipation, nausea, vomiting and diarrhea At very high doses, iron may cause serious harm, and children may be particularly at risk for overdose 45
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2009/13391a-eng.php 46
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2009/13391a-eng.php 47
Overview of Advertising Issues An influx of advertising complaints involving: Web sites open to the general public Catalogues directed to healthcare professionals Sell sheets to healthcare professionals Advertising making claims: Beyond the Terms of Market Authorization Lacking fair balance Involving misleading comparisons 48
Section 9(1) of the Food & Drugs Act No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. 49
1) Claims beyond the Terms of Market Authorization Defined as advertising claims that extend beyond the Iron Monograph (in cases where companies received authorization of a product by means of attestation) or that are not supported by scientific data (in cases where companies received authorization of a product following pre-market review by Health Canada) Examples Resolves iron deficiency anemia Treatment of iron deficiency anemia [Specific product] contributes to better immune function, increased energy levels, and improved cognitive function 50
2) Lack of Fair Balance Occurs when fair and balanced information about the benefits and the risks of the advertised product are not presented in promotional media Examples Side Effects NONE No known side effects associated with taking [product] Incidence of side effects will be virtually none 51
3) Misleading Comparisons Involves the use of hanging comparisons (e.g., lower, faster, less) that do not specify a comparator and/or are not substantiated with scientific evidence Examples More effective and affordable than ever Better tolerated Much easier to use then [other iron products] 52
Next Steps Health Canada will remind all licence holders of singleingredient iron NHPs of: The relevant legislative and regulatory advertising provisions Health Canada s health product advertising policies The advertising preclearance system HC will proactively monitor advertising of these products. 53
CONCLUSION Health Canada has recently initiated a series of initiatives: Goals: Protect the health and safety of Canadians and allow them to make informed decisions about their health, especially in the context of the opioids crisis Provide industry and other stakeholders with clarity in terms of what constitutes advertising Initiatives include: Updating the Distinction policy Proactive monitoring of health products advertising 54
For more information Alain Musende, PhD Manager, Section for Transparency and Advertising Regulatory Surveillance Marketed Health Products Directorate Health Products and Food Branch Tel.: (613) 954-6780 Facsimile: (613) 948-7996 E-mail: alain.musende@hc-sc.gc.ca Regulatory Advertising Section Tel.: (613) 960-2868 Facsimile: (613) 948-7996 E-mail: mhpd_dpsc-advertising_reg_publicite@hc-sc.gc.ca Web site Health Canada s Regulatory Requirements for Advertising: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index-eng.php 55
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