New Rules for Marketing Health Products to Consumers in 2017 – Get Ready to Preclear Canadian Advertising for Medical Devices and Vaccines
December 21, 2016
By Jennifer McKenzie, Catherine Lovrics, and Tony Orsi
Since 1997, Advertising Standards Canada (ASC) has been responsible for preclearing consumer directed advertising of non-prescription drugs. Since then, ASC’s jurisdiction has expanded to include consumer directed advertising of natural health products and communications regarding prescription drugs (i.e. both “information” pieces and limited name brand “advertising”).
Consumer directed advertising of medical devices and vaccines has previously been outside ASC’s jurisdiction, leaving an anomalous gap in advertising oversight. This is about to change. On November 22, 2016, ASC closed its consultation on an update to the 2006 Consumer Advertising Guidelines for Marketed Health Products (the “New Guidelines”). The decade of living with the old guidelines informed the improvements that needed to be made. The New Guidelines are more streamlined and user friendly, and substantively, they fill some voids that have existed over the last 10 years and beyond.
Formal preclearance for consumer directed advertising of medical devices and vaccines is expected to begin in early 2017, and an advisory opinion (which has always been available) can be sought now.
(a) Medical Device Advertising Review
As of 2014, medical devices were an estimated $6.7 billion industry in Canada. Medical devices are pervasive in our lives. From toothbrushes, condoms and tampons to pregnancy tests and blood glucose monitors, we interact with them every day. They are regulated by Health Canada. There are four classes of medical devices with Class I being the least invasive (e.g. manual toothbrush, thermometers, bandages) to Class IV being the most invasive (e.g. breast implants). Classes II to IV medical devices require licenses to be sold in Canada, whereas Class 1 medical devices do not.
Advertising of medical devices is regulated, but to date, there has been no preclearance required for such advertising. For example, the Food and Drugs Act (“FDA”) prohibits anyone from advertising a medical device in a way that is false, misleading, deceptive or likely to create an erroneous impression concerning its merit or safety, among other things. Furthermore, manufacturers are only permitted to make those claims found in the license or market authorization granted by Health Canada.
ASC currently reviews the advertising of non-prescription drugs and natural health products directed to consumers. However, medical devices were not part of ASC’s jurisdiction, nor was any other agency tasked with regular review of consumer directed advertising of medical devices. This gap was strange since medical devices are very much like non-prescription drugs and natural health products in that we use them for similar purposes, such as the diagnosis and treatment of diseases, and correcting or modifying certain functions of the body. The New Guidelines close this gap. (As an aside, the Pharmaceutical Advertising Advisory Board preclears advertising directed to healthcare professionals and medical devices and vaccines have long been within their jurisdiction, making this previous gap in consumer directed advertising for these categories even stranger.)
The focus of ASC’s preclearance will be on communicating benefits and risks, in accordance with the market authorization granted by Health Canada. ASC will preclear advertising for Class II to IV medical devices. It is anticipated that ASC preclearance will have its largest effect on Class II medical devices. Class I medical devices will not require preclearance since Class I medical devices do not require a license to be sold, and generally do not carry a commensurate level of risk to warrant heavy regulatory oversight.
For context, direct-to-consumer-advertising (“DTCA”) of prescription drugs is a controversial subject. In most countries it is permitted to some extent. However, in Canada, there is a general prohibition on DTCA of prescription drugs (i.e. those listed on Schedule F of the FDA). There is a limited exception: you can advertise the name (brand and chemical), price and quantity of a Schedule F drug directly to consumers. Any express or implied claims regarding the named drug’s therapeutic indication are strictly prohibited. In the late 1990s, Canadians started to see the proliferation of ads such as “VIAGRA. TALK TO YOUR DOCTOR”. These “brand name” or “reminder” ads are “legal” provided they contain no express or implied representations (including innuendo and visual cues) regarding the therapeutic indication of the named drug.
Vaccines are not listed on Schedule F; rather they are listed on Schedule D and because the section of the Food and Drug Regulations prohibiting DTCA refers specifically to Schedule F drugs, vaccines were seemingly not subject to the same prohibition as drugs. Consequently, Canadians started to see brand name advertising for vaccines that identified the therapeutic indication such as immunity from hepatitis A and B. More recently, ads for vaccines for HPV were controversial since they targeted sexually active teenagers. Vaccine ads seemed strange in the Canadian landscape, due to the general prohibition of DTCA and the limited exception for name brand advertising that was permitted.
To try to address the anomaly, at least on an interim basis, Health Canada issued a document called “Interim Guidance: Fair Balance in Direct-to-Consumer Advertising” (“Interim Guidance”). The Interim Guidance recommended fair balance in vaccine advertising. For example, the document stated that advertising should not only discuss the positive benefits of vaccines but also include information about the most common and serious side effects, allergic reactions, precautions and warnings, contraindications in certain populations, as well as information related to the protection offered by the vaccine (duration, need for boosters, etc.). While Health Canada also encouraged vaccine manufacturers to submit advertising to ASC prior to dissemination, this was not a requirement. However, with the New Guidelines, review of vaccine advertising by ASC becomes more than a recommendation. The New Guidelines also supplement the Interim Guidance by providing examples of how to communicate risk in advertising for flu, HPV and travel vaccines. For example, regarding the HPV vaccine, example language reads: “Product X helps protect girls/women against cervical cancer caused by HPV (type #). It does not protect against all HPV strains and may not protect everyone who is vaccinated. Regular Pap tests should continue after vaccination. Side effects and allergic reactions can occur. Visit URL for more information”.
(c) Some highlights from the New Guidelines
The New Guidelines are concise and follow ASC’s other guidelines by providing numerous examples in each category of acceptable and unacceptable advertising claims. Some highlights of the New Guidelines now follow:
- To assess compliance with the New Guidelines, advertising will be considered as a whole, including visuals.
- Ads must present fair, balanced and accurate information about both the benefits and risks of the product.
- Paraphrasing consistent with the market authorization is permitted, unless the authorization prescribes language.
- There are specific technical requirements for the duration, contrast, placement, volume and/or font of supers used in video, audio and print, out of home and online advertising.
- Advertising must clearly communicate the product’s indication and recommended use according to the market authorization issued by Health Canada (namely, indications for use for Class II medical devices, authorized labelling for Class III and IV medical devices, and the product monograph for vaccines).
- Directions for use, duration of use and storage need not be described in the advertising, but if described, must be consistent with the market authorization.
NEW CLAIM ABOUT AUTHORIZED SALE
- The claim “Product X is authorized for sale by Health Canada” is permitted for all drugs, NHPs and medical devices (except Class I) since they must all be reviewed and approved by Health Canada prior to sale. However, the advertisement must not otherwise imply endorsement, approval or recommendation by Health Canada or another government agency
CLAIMS OF HEALTH BENEFITS AND COMPOSITION
- Advertising can promote health benefits in accordance with the market authorization for the advertised product.
- Claims exceeding the market authorization, including health promotion claims, may be permitted if they are true and substantiated, and the advertiser should expect to provide evidence that the claim was authorized by Health Canada.
Non-therapeutic claims may also be made, provided they do not imply a therapeutic benefit or obscure the therapeutic indication.
- “Organic” claims are permitted for ingredients and products if certified according to recognized standards, with evidence of certification being required upon request. “Natural” claims are permitted for products and ingredients, provided Health Canada definitions are met.
DESCRIPTION OF RISKS
- Known risks must be communicated, but it may not be necessary to detail risks in the advertising. The New Guidelines permit directing the consumer to the label (e.g. “This product may not be right for you. Always read and follow the label”), and a website for additional risk information if the label is not up-to-date (e.g. “For more information visit ...”).
- The New Guidelines are prescriptive about risk disclosures in advertising for different product categories, including medical devices. For example, for medical devices where injuries/infections can happen or improper use may worsen a condition, the consumer must also be advised that the product may not be suitable for everyone, may not be used under certain circumstances, and it must be explained that the product has to be used/handled with caution. Specific examples of acceptable language are provided in the New Guidelines.
CLAIMS REGARDING PERFORMANCE
- The basis for comparative claims against prior models, competitive products, and non-medical devices must be clearly communicated.
- There will remain a one year clock on “new”, “improved”, and similar claims.
- Ads must not to exaggerate product performance, imply a product is risk free, natural, or convey it is essential to use the product. For example, words such as “amazing”, “powerful”, “fantastic” and “unique” are likely to present hurdles to clearance, and “guarantee” claims will not be permitted, nor will “safe”, “side effect free”, “no known side effects”, and most “natural” claims.
- Testimonials, endorsements, seals of approval, and user generated content may be permitted, provided they are consistent with the market authorization for the product
- Advertising must be overtly directed to adults, and not suggest that a child is capable of making a rational decision regarding use of advertised health product.
While ASC has stated that the New Guidelines are consistent with international norms, there will no doubt be Canadian nuances. Generally, ASC works with advertisers to get advertising cleared. However, until there is a better understanding of how the New Guidelines will play out in practice, submitting advertising for pre-clearance sooner than later will leave more time for changes to be accommodated.
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