1. The ‘What’ and ‘Who’ of Advertising
Malika Ladha
PAAB Reviewer

2. “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

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

4. 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

5. 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

6. 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 )
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

7. 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”

8. 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

9. 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.

10. 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.

11. PAAB

12. 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

13. 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….

14. 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

15. 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

16. 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

17. 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.

18. 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.

19. 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

20. 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:
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.

21. 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.

22. Target your message to match your audience

23. 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

24. APS directed towards PATIENTS

25. 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

26. 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

27. 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

28. 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

29. Questions?