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1 Digital marketing masterclass for branded materials Speaker: Dannie Newman, Reviewer, PAAB

2 Agenda Understand how target audience and product schedules intersect to determine the regulations relevant to advertising (consumers) Creating digital tools: What do you need to know and how to link assets in a compliant manner Work on cases to cement your understanding of regulations relating to SEO and SEM

3 Consumers: Messaging directed to the general public. Readily accessible by individuals who have not been prescribed the product. Identify your audience Patients: Messaging directed to individuals prescribed that product OR messaging in a tool intended for use by HCPs only during counseling. Healthcare professional: Messaging directed to licensed members of the professions of medicine, dentistry, naturopathy, nursing, pharmacy and related health disciplines and institutions.

4 Communicating with Consumers Consumer Advertising or Consumer Information?

5 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

6 Still unsure? See the Health Canada policy document: Distinction Between Advertising and Other Activities Can be found on the Health Canada and PAAB website.

7 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?

8 Breaking down the 7 questions. 1. Content /creation factors: 2. Distribution/availability factors What is the content? Who sponsors the message and how? Extent of drug manufacturer influence over message content? Audience? Context of dissemination? Who delivers? Frequency of delivery?

9 No one factor in itself will determine whether or not a particular message is advertising. If uncertain, don t hesitate to ask PAAB. We ll respond to requests for written opinions within 4 days.

10 Communicating with Consumers For Consumer Information (nonadvertising): Need to consider the relevant provisions from the Distinction Document. Examples: Help-seeking Messages Consumer Brochures

11 Help-seeking Messages

12 Consumer Brochure

13 Consumer Brochure

14 For Consumer Advertising: Communicating with Consumers Need to consider: product s federal schedule & whether disease/condition treated is on schedule A.

15 Prescription drugs Prescription Consumer Advertising Regulations Choose HerpRex for the prevention of HPV Some products may have a dual Federal drug schedule

16 Disease Consideration - Schedule A Acute alcoholism Acute anxiety state Acute infectious respiratory syndromes Acute psychotic conditions Acute, inflammatory and debilitating arthritis Addiction, except nicotine addiction Appendicitis Arteriosclerosis Asthma Cancer Congestive heart failure Convulsions Dementia Depression Diabetes Gangrene Glaucoma Haematologic bleeding disorders Hepatitis Hypertension Nausea and vomiting of pregnancy Obesity Rheumatic fever Septicaemia Sexually transmitted diseases Strangulated hernia Thrombotic and embolic disorders Thyroid disease Ulcer of the gastro-intestinal tract See Health Canada website for list of Schedule A Diseases

17 DIGITAL ACTIVITIES edetail Aids, Apps, Websites, s, social media

18 Critical Considerations for any e-media type i) The intent of the message: Is the intent of the message to promote a drug, disease awareness or a company? ii) The target audience solicited: Is the information targeted towards healthcare professionals, patients or the consumer? iii) The type of drug product: Does the information pertain to a prescription, nonprescription, vaccine or natural health product? iv) The nature of the online content: Does the site allow for dynamic content or is it static (i.e. entirely controlled by the sponsor)?

19 Key considerations when building a product website CONTROL OF ACCESS CONTENT LINKAGES PROMOTION OF WEBSITE

20 Access Control If the content exceeds that which is allowable in a consumer context, there must be a barrier to keep consumers out It is the sponsors responsibility to ensure sufficient mechanisms to determine the regulatory category of the person requesting the information online

21 Creating an acceptable barrier Registration and/or attestation alone are NOT sufficient barriers Password required for entry (controlled distribution) Professional License # Arbitrary set of characters selected by manufacturer URL of a website which is not indexed keys which bypass the barrier (controlled distribution) CD, webkey, Access through moderator approval (with verification on the front end) Remember: Landing page is accessible by the consumer

22 Let s look at our product website for Jensulin

23 About PAABPharm.ca HCP website landing page

24 Revisions required?

25 About PAABPharm.ca

26 Welcome to JENSULIN.ca, your JENSULIN Resource Center This site contains: - Information on the efficacy of JENSULIN - Guideline Recommendations - Lifestyle tips and programs for your patients - And so much more Lets get started learning about JESNULIN Enter your professional licence number here: *This site is intended for Healthcare Professionals Links to page on PAABPharma - approved for DTC use.

27 Content Websites tend to house large amounts of content Websites are not typically read in their entirety within a single sitting Difficult to predict the path users will take through the site. Challenge: Effective placement of fair balance (for HCPs) Solution: Indication & fair balance on the home page (or beginning of each section containing product claims) A prominent Safety Information menu item visible from any screen on the site

28 Disclosure of Company Name The name of the pharmaceutical company sponsor should be stated clearly on: i) Every page of the web-site controlled by the sponsor ii) On every sponsored web-page of a site with no access control

29 Homepage

30 About PAABPharm Homepage

31 Safety Information

32 Linkages Making Compliant Connections

33 Linkages Principles: If you join advertising and non-advertising, everything becomes advertising Branded and unbranded disease info Internet links Product Package shot

34 Linkages Consider: Proximity Appearance Sequence Context The sponsor may link to corporate global sites only by linking to the global site home page. The sponsor should not link to the global site product pages/sections.

35 Unbranded disease info Brand website landing page Linkage

36 Unbranded disease info Colour gradient Linkage Brand visuals

37 Linkages: Branded Patient Website Corporate website Branded Patient App Branded HCP website Social Media campaign Wellness/adherence reward program HCP direct branded mailer

38 Branded HCP website Branded patient website Branded HCP website to a patient branded website Both branded, different audiences It is acceptable for the HCP to be exposed to patient material Branded patient website to branded HCP website Both are branded, but HCP content should not be promoted to patients

39 Branded App Patient support program Branded patient website Branded patient app to a patient branded website and vise versa This is deemed acceptable and does not change the regulatory status of either platform

40 Corporate website Branded patient website Patient branded website to corporate website Link from branded pre-gate landing page Not acceptable Link from any page post-gate can link to the homepage

41 Branded HCP App or HCP website Corporate website HCP branded website to corporate website Link from branded pre-gate landing page Not acceptable Link from any page post-gate can link to the homepage Corporate website to branded HCP app/website Must link to the landing page haven t verified regulatory audience yet

42 Wellness/adherence reward program Branded HCP App Branded Patient App Branded patient or HCP app linking to an unbranded wellness/adherence reward program Unbranded now has to be reviewed in the context of the brand Copy which may have been acceptable in the unbranded context may now be challenged

43 Social Media campaign Branded HCP App Branded Patient App Branded HCP app or patient app linking to social media campaign Branded (previously reviewed and approved by PAAB) - OK Unbranded disease support group/chat room/blogger Sponsors responsibility to ensure that the content meets branded patient regulations Violation could affect the acceptability of one or both channels

44 Promotion of a website Search Engine Optimization Search Engine Marketing

45 Search Engine Optimization (SEO) Regulations apply to any meta data text provided by the manufacturer (or it s agent) to a search engine Descriptors under control of the sponsor should be submitted for preclearance Must not exceed consumer advertising regulations. Must not refer to competitor products.

46 Search Engine Marketing Meta data requirements are the same as SEO with the addition of sponsor purchased keywords (s ) (SEM)

47 URL Meta description H1 tag Keywords Jensulin.ca Jensulin.ca, an online resource designed to provide valuable information about Jensulin for healthcare professionals, diabetes patients and the general public. Taking Jensulin? Diabetes Insulin Glycemic control Hypoglycemia SEO Keywords Jensulin.ca/ patientlogin Jensulin.ca/ hcplogin Jensulin.ca/ talktodoctor Jensulin patient information Taking Jensulin? Diabetes Patient Jensulin information for healthcare professionals See icebreakers to help you talk to your doctor about hypoglycemia, low blood sugar and more. Jensulin for healthcare professionals Help talking to doctors Healthcare professional Diabetes treatment Talk to your doctor about low blood sugar Jensulin.ca/ realdeal Learn the dangers of counterfeit products Dangers of counterfeit drugs Counterfeit Real Jensulin Jensulin.ca/ seenontv See the latest Jensulin commercials online As Seen on TV

48 URL Meta description H1 tag Keywords Jensulin.ca Jensulin.ca, an online resource designed to provide valuable information about Jensulin for healthcare professionals, diabetes patients and the general public. Taking Jensulin? Diabetes Insulin Glycemic control Hypoglycemia Jensulin.ca/ patientlogin Jensulin patient information Taking Jensulin? Diabetes Patient SEO Keywords Jensulin.ca/ hcplogin Jensulin.ca/ talktodoctor Jensulin information for healthcare professionals See icebreakers to help you talk to your doctor about hypoglycemia, low blood sugar and more. Jensulin for healthcare professionals Help talking to doctors Healthcare professional Diabetes treatment Talk to your doctor about low blood sugar Jensulin.ca/ realdeal Learn the dangers of counterfeit products Dangers of counterfeit drugs Counterfeit Real Jensulin Jensulin.ca/ seenontv See the latest Jensulin commercials online As Seen on TV Subject to consumer regulations; should not identify the therapeutic area

49 Ad related to Jensulin Jensulin Jensulin.ca Learn about diabetes treatment Keywords: Jensulin Gensulin Jennsulin Jensalin Insulin passad Diabetes Injection HbA1c Hyperglycemia Hypoglycemia Foot care Blood sugar Safety profile Prescribe

50 Examples If Schedule D and not for the treatment of a schedule A disease: Vaccinator For prevention of [something bad] Ages For risk/benefit info : If schedule F: Arbace Learn more about Arbace. (11 characters) (31 characters) (34 characters)

51 Summary: Composite of the user generated keyword, the metadescriptor, the landing page, and the Uniform Resource Locator (URL) must not exceed consumer advertising regulations.

52 Questions?

53 Questions?

54 Questions?

55 Virtual Community CUSTOMER ENGAGEMENT SHARE INFORMATION LARGER AUDIENCE INCREASED RISK

56 Scope of Online Activities Apply to all online advertising activities which are: within the sponsor s control or influence and where the intended audience is Canadians.

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