The ‘What’ and ‘Who’ of Advertising Malika Ladha malikal@paab.ca PAAB Reviewer

“20% of the regulated population will automatically comply with any regulation, 5% will attempt to evade it, and 75% will comply so long as they think the 5% will be caught and punished.” Usually at national workshops we do blind polling asking the audience in which group they belong in and traditionally, the results that we get come out to these % Even though this quote dates from 1941, we know from experience that it is still applicable today Chester Bowles Regulator and member in the 1941 U.S. Wartime Office of Price Administration

Government Regulation CANADA Self-regulation This has lead to a system of blended government regulation and self-regulation Government Regulation

For success Three critical elements: An effective mechanism (preclearance is best) Support from major industry players Support and trust from the government Self regulation is like a vaccine that prevents bad things from happening For this system to work, there are three critical elements required. An effective mechanism of self regulation Support for regulations by major industry players Support and trust from the government, that self-regulations will result in lawful and ethical practices

Policies, Guidelines & Regulations on Who reviews what? Food and Drugs Act PAAB Code Policies, Guidelines & Regulations on Drug Advertising Rx and non-Rx drug advertising to HCP Non-Rx drug advertising to General Public Rx drug advertising To General Public ASC/MIJO Controlled Advertising HC/PAAB/ASC Independent Preclearance Agencies Health Canada What does this system look like… Health Canada is the overarching regulatory body, with the Food and Drug Regulations. …. Etc. ASC: Advertising Standards Canada MIJO: not an acronym for something – it’s the name of the company Hc set up guidance and policies on drug advertising Non rx are not required to submit to paab but have to follow paab code - 3: can go through all three. If paab or asc reviews, we send to HC. All consumer advertising goes through hc

Important takeaways Drug advertising is regulated No person shall ... advertise a new drug unless…the Minister has issued a Notice of Compliance to the manufacturer of the new drug… (FDA c.08.002) No person shall ... 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 9.(1)) Self-regulation is a privilege, not a right Industry’s actions must be aligned with the regulations to promote credibility and trust through improvement of patient care Only health products that have been authorized for sale by Health Canada may be advertised in Canada Advertising cannot be false, misleading or deceptive Advertising must comply with the relevant legislation and regulations to promote credibility and trust through improvement of patient care

What is Drug Advertising? Definition in section 2 of the Food & Drugs Act: “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”

Food and Drugs Act Section 9(1) 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 composition, merit or safety

The Distinction Between Advertising and Other Activities What is the context in which the message is disseminated ? Who are the primary and secondary audiences ? Who delivers the message (the provider) ? Who sponsors the message and how ? What influence does the drug manufacturer have on the message content ? What is the content of the message ? With what frequency is the message delivered ? There are numerous provisions within the Food and Drugs Act and Regulations that apply to drug advertising. In order to determine the applicability of those provisions it is first necessary to determine whether or not a particular message can be considered to be advertising. The Distinction Between Advertising and Other Activities is a health Canada document that contains a list of 7 questions which, when answered objectively, help you distinguish between advertising and non-advertising.

The Distinction Between Advertising and Other Activities: “No one factor in itself will determine whether or not a particular message is advertising.” It is important to note that no single factor in itself can determine whether a message is advertising. Answer ALL 7 questions!! PAAB CAN provide opinion if unclear whether it’s advertising or not. Clients can refer to the fee schedule on our website for the fee for such service …If uncertain, don’t hesitate to ask PAAB. We’ll respond to requests for written opinions within 4 days.

PAAB

PAAB Brief History Incorporated 1976 Government threat to industry Multi-stakeholder approach Unique model Code applies to all companies Dynamic code Evolving organization Between Industry and Government Now we know why paab exists Lets’ look at the history Made up of multiple stakeholder Unique model to Canada We have input from industry and government 12

PAAB VISION MISSION VALUES Trusted healthcare product communication that promotes optimal health MISSION To provide a preclearance review that fosters trustworthy healthcare communications within the regulatory framework. VALUES Integrity, Competency, Credibility, Independence, Excellence, Transparency With this in mind, paab’s vision is… Our core values are….

MANDATE The PAAB is an independent review agency whose primary role is to ensure that healthcare product communication for prescription, non-prescription, biological and natural health products is accurate, balanced and evidence-based, and reflects current and best practice. The PAAB also monitors trends in health product advertising and promotion and adjusts its code and practices as required to fulfill its mandate. Summarize in 6 words

Scope The scope of the PAAB includes promotional healthcare product communication for prescription, non-prescription, biological and natural health products to health care professionals in all media. PAAB also provides advisory comments on direct-to-consumer materials for prescription drugs. PAAB’s Scope evolves with the regulatory framework. Does not currently include medical devices. Summarize in 6 words

New PAAB Code was implemented on July 1, 2013 This is what the paab code book looks like. If it doesn't look like this, you’re working off the old code book. If you don't have it, come find us. App available in the apple store (only for ipads – free download) : DOUBLE CHECK WITH PM 16

PAAB Code of Advertising Acceptance Dynamic, reflects current marketplace Works in best interest of patients Requires 2/3 majority vote of members to revise Standards including: regulatory scientific clinical ethical principles Paab code is…(first three bullets) Standards of what the code is based on are… When evaluating comments, remember we look at all 4 perspectives. e.g. Clinically relevant doesn’t mean it’s scientifically relevant.

PAAB’s Board of Directors pharmaceutical trade associations Rx&D, CGPA, CHPC, BioteCanada health professionals - CMA, CPhA, FMOQ, AFMC patients - Best Medicines Coalition (BMC) CARP, Consumers Council of Canada (CCC) Can Assoc of Medical Publishers (CAMP) advertising industry (AMAA) Chair, Vice-Chair, Treasurer Who are these members? The members are made up of trade associations, HCPs, patients, publishers and industry List of exactly who is in the board is on the website.

Annual Bilateral Consultation meetings Health Canada is an ex-officio observer and advisor “without relinquishing authority under the Food and Drugs Act” PAAB Commissioner liaison with Manager, Advertising and Risk Communications Section, Marketed Health Products Directorate Annual Bilateral Consultation meetings Policy - Roles and Consultation Related to Advertising Review, Health Canada and preclearance agencies Non voting member – sit in on the meeting and provide their guidance and feedbacks Not make sense to outvote health canada

PAAB preclearance services PAAB code covers HCP Advertising Patient Information provided through HCPs PAAB advisory service (using Health Canada policy documents): Consumer Information Consumer Advertising 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 So, the PAAB code covers HCP advertising whether product branded, editorial, or corporate with product mention. Also applies to patient info provided through HCPs. Having said this, PAAB also provides an advisory service relating to consumer info/advertising review. You can check the health Canada website to find out the roles of health Canada and the advertising preclearance agencies related to health product advertising.

PAAB Code section 6.6 Exemptions from PAAB review PAAB code 6.6(iv): Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed below, in any way. Examples: Company price lists containing no therapeutic claims, price comparisons or claims of company or product merit, status or issues Message comprised only of the words “now on provincial formulary” (or equivalent) in a manner which is not linked to a therapeutic message in any way Message of “Available at company X” A message of “Congratulations to company X on their 30th anniversary – sponsored by Company X makers of product Y” Packshots if no therapeutic claims are visible Items listed in this section are exempt from PAAB review. However, they may still fall under the definition of “advertising” in the Food & Drugs Act and Regulations. See the Health Canada Policy “The Distinction Between Advertising and Other Activities” on the Health Canada web-site.

Target your message to match your audience

Three regulatory audiences: HCP: Messaging directed to licensed members of the professions of medicine, dentistry, naturopathy, nursing, pharmacy and related health disciplines and institutions. Patient: Messaging directed to individuals prescribed that product OR messaging in a tool intended for use by HCPs only during counseling. Consumer: Messaging directed to the general public. Readily accessible by individuals who have not been prescribed the product. Mere act of targeting patients does not (in and of itself) render something “patient information”. The only real difference between a patient and the general public is that the patient has been prescribed the product and therefore likely knows it’s intended use. To determine whether DTCA can be targeted to patients therefore involves an assessment of whether linkage to the product’s therapeutic use affects the message in a manner contravening the regs. 23

APS directed towards PATIENTS

PAAB Code section 6.4.3 Information that is: Non-promotional Consistent with the consumer information section of the Product Monograph The information should focus on educating patients about particular diseases/conditions and optimal use of the product by the patient for whom it has been prescribed. Purpose of patient information materials: Educational (see PAAB Code s6.4) Instructions on how to take medication, what to expect Consistent with Part III of Product Monograph Non-promotional context

Thought Process Sequence Is the piece only about the specific product which was prescribed?  Is the drug content consistent with Part III of the Product Monograph? AND Is the disease content on label and supported by standard setting organizations or authoritative sources? Is the piece non-promotional? Is risk information from Part III of the Product Monograph required? 26

Standard Setting Organizations What they are: Group generally considered to be a credible source for patient information  Package complex medical information in a manner which is easy for patients to understand   What they aren't: A person A commercial website Controlled by pharma 27

Standard Setting Organizations Examples: Patient groups (e.g., the Asthma Society of Canada) Medical institutions (e.g., a hospital) Health care professional organizations (e.g., Canadian Nurses Association) Consensus groups (e.g., Canadian Diabetes Association) 28

Questions?