A conversation on Health Canada s Health Product Advertising Oversight Pharmaceutical Advertising Advisory Board (PAAB) Workshop Toronto November 17, 2016 Alain Musende, PhD Manager, Regulatory Advertising Section Health Canada
Purpose To carry out a conversation on Health Canada s oversight on health product advertising. To discuss the relationship between Health Canada and the Pharmaceutical Advertising Advisory Board (PAAB). To provide an update related to health product advertising initiatives. The Distinction Between Advertising and Other Activities Medical devices advertised to the general public Posting of Advertising Complaints 2
Why Health Canada Regulates Health Product Advertising To protect the health and safety of Canadians Mandated by law 3
Current Regulatory Requirements for Advertising 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. Note: Health Canada uses the policy The Distinction Between Advertising and Other Activities to distinguish promotional campaigns from information. 4
Key Regulatory Requirements for Advertising 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 C.08.002 Food and Drug Regulations: No person shall sell or advertise a drug unless it has received a notice of compliance. 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. 5
Regulatory Provisions for Advertising Clarified Enforced 6
How Do We Regulate Health Product Advertising L union fait la force! 7
Dynamic Interactions Applicable Federal Statutes: -Food & Drugs Act and Regulations -Controlled Drugs and Substances Act Health Canada Guidance Documents PAAB Code Health Product Advertising Industry Association Codes PAAB Healthcare Professionals / General Public Industry Associations 8
Health Canada s Role National regulatory authority for health product advertising. Sets the parameters under which health products are marketed in Canada (e.g. Product Monograph). Puts in place regulations to effectively regulate marketed health products. Provides guidelines for the interpretation of the regulations. 9
Health Products and Food Branch s Role Intervenes when advertising: Contravenes regulatory requirements and poses a significant risk to health. Preclearance agencies are unable to obtain willful compliance. Relates to incidents of illegal promotion (i.e., prescription drug advertising to the general public beyond name, price, and quantity, advertising of unauthorized products, off-label promotion, etc.). Contraventions of the legislation and regulations and violations of advertising guidelines are subject to compliance verification. Appropriate compliance & enforcement actions are taken when required (risk-based approach). 10
Marketed Health Products Directorate s Roles Responsible for overseeing the regulatory activities of health product advertising. Point of contact with the PAAB. Coordinates requests for clarifications from various stakeholders. Conducts regulatory assessments of certain types of advertising complaints. Ex-officio representative on PAAB Board. Chair of a Branch-wide Advertising Working Group. 11
Preclearance of Health Product Advertising The preclearance of advertising of marketed health products is: Governed by a self-regulatory and voluntary system Recommended by some industry associations to their members Strongly recommended by Health Canada The PAAB reviews and preclears health product advertisements to verify compliance with the legislative and regulatory advertising provisions and the PAAB Code of Advertising Acceptance. 12
Preclearance of Health Product Advertising (continued) The PAAB verifies that advertising is accurate, balanced and evidence-based The PAAB also offer an independent mechanism to resolve complaints and provides the first route of adjudication of complaints for authorized health products. 13
Health Canada and the PAAB You are in good hands with the PAAB! 14
Regulatory Provisions for Advertising Clarified Enforced 15
PAAB s impact! 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. 16
Health Canada and the PAAB Health Canada and the PAAB work in close collaboration: Health Canada provides policy clarifications to the PAAB when requested Health Canada resolves complaints referred by the PAAB Health Canada holds an annual bilateral meeting to share information on topics of mutual interest Health Canada is an ex-officio member on the administrative board of the PAAB and attends PAAB s Annual General Meeting Health Canada has the opportunity to comment and provide insight on PAAB s initiatives and code revisions Health Canada maintains ongoing collaboration on educational sessions (workshops) and on guidance document development 17
Health Canada and the PAAB (continued) Heath Canada and industry associations support & encourage PAAB s work: Innovative Medicines Canada s Code of Ethical Practices clarifies that members agree to comply with all applicable provisions of Health Canada regulations and the PAAB Code of Advertising Acceptance. A breach of the PAAB Code may be deemed to be a breach of IMC s Code. Complete information about the roles of HC and the PAAB is available in the Guidance Document entitled Health Canada and Advertising Preclearance Agencies Roles Related to Health Product Advertising (http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-pca-eng.php). 18
The Distinction Between Advertising and Other Activities The purpose is to distinguish material that is deemed promotional from activities that are not. The purpose, content and context must be taken into consideration. If Health Canada determines that the primary purpose of a message is advertising, an assessment is then made regarding compliance with applicable regulations. Dissemination of factual information in various media is not subject to the federal legislative & regulatory advertising provisions. 19
The Distinction Between Advertising and Other Activities Although no planned revision until 2017-2018, HC is considering updating the policy to potentially: Expand scope to: o All types of health products including vaccines, medical devices and veterinary drugs o All types of audiences (general public, healthcare professionals, etc.) 20
The Distinction Between Advertising and Other Activities Address activities such as: o o o o Social media platforms and other online interactive communications / activities: guidance provided at a 2009 social media PAAB sponsored workshop and which was included in the PAAB Code section 6.5: 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 vs Help-Seeking Announcements (Disease Awareness Campaigns) Sales representatives conduct / activities / materials 21
The Distinction Between Advertising and Other Activities Update current sections such as: o o o o Institutional Messages / Corporate Web sites Patient materials (eg. access to patient Web sites) Press Releases / Press Kits Continuing Medical Education / Conferences 22
Medical Device Advertising Guidelines Lack of Medical Device Advertising Guidance 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. Section 20(1) Food and Drugs Act: No person shall label, package, treat, process, sell or advertise any device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its design, construction, performance, intended use, quantity, character, value, composition, merit or safety.
Consumer Advertising of Medical Devices Current consultation: Inclusion of medical device advertising guidance in the Consumer Advertising Guidelines (CAG) for Marketed Health Products. Content will relate to lack of fair balance, exaggeration of merits, omission of safety information, promotion of off-label use, etc. Content will focus on medical devices advertised for sale to and purchased by the general public. The medical device content will not include the advertising of medical procedures involving the use of medical devices by healthcare professionals (e.g. laser eye surgery equipment, laser hair removal equipment, liposuction device, etc.). 24
Posting of Health Product Advertising Complaints In July 2015, HC started posting tables of health product advertising complaints that Health Canada has received and addressed, or is currently assessing for next steps. It is a quarterly posting which contributes to the Department s Openness and Transparency Initiative. It provides Canadians with relevant information on advertising complaints that were received by the Department. Complements current practices of Canadian Advertising Preclearance Agencies (APAs) and key international regulatory partners. 25
Advertising Prohibitions on Cannabis On November 25, 2014, Health Canada issued an Information Bulletin on advertising prohibitions on cannabis (http://www.hc-sc.gc.ca/dhp-mps/marihuana/info/bulletineng.php). The publishing of promotional materials and advertisements are of serious concern. Health Canada is especially concerned about advertisements of any kind which are false, misleading or deceptive, and those which advertise cannabis in relation to particular therapeutic claims. Licensed producers must refrain from giving the impression that they, their products, or their activities are endorsed by Health Canada. If a licensed producer is found to be in contravention of the advertising prohibitions in the F&DA, they could be subject to prosecution, and if convicted would be liable to fines ranging from $250,000 to $5,000,000, or to a term of imprisonment ranging from six months to two years, or to both (s.31.2 FDA). For individuals seeking information about the new Access to Cannabis for Medical Purposes Regulations, contact Health Canada. Call toll-free at 1-866-337-7705 or email omc-bcm@hc-sc.gc.ca. 26
Conclusion The PAAB is a key contributor to Health Canada s mandate of protecting the health and safety of Canadians Health Canada strives to maintain an efficient relationship with the PAAB, involving a close collaboration and a transparent & ongoing communication. Health Canada and the PAAB have implemented measures in place to stay informed on advertising trends and issues. Health Canada assists the PAAB in achieving their mandate. 27
Contact Alain Musende, PhD Manager, Regulatory Advertising Section 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 28
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