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TGA presentation: ACCORD, 15 March 2019

Presentation: Therapeutic Goods Advertising Code (No. 2) 2018

16 May 2019

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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Leanne McCauley and Alexandra Dance
  • Presented at: ACCORD
  • Presentation date: 15 March 2019
  • Presentation summary: An overview of the Therapeutic Goods Advertising Code (No.2) 2018, with examples to illustrate the application of key sections.

Transcript

Therapeutic Goods Advertising Code (No. 2) 2018

Leanne McCauley, Director and Alexandra Dance, Assistant Director,
Advertising Education and Assurance Section, Regulatory Education and Compliance Branch

Webinar: Advertising therapeutic goods in 2019: The Code basics - 20 November

Slide 1 - Background information

Slide 2 - Therapeutic goods advertising legislation

  • The advertising requirements are set out in the
    • Therapeutic Goods Act
    • Therapeutic Goods Regulations
    • Therapeutic Goods Advertising Code
  • Advertising is also subject to the Competition and Consumer Act (Australian Consumer Law)

Slide 3 - Compliance with Advertising Code

  • Advertising to the public for therapeutic goods MUST comply with the Advertising Code
  • Requirement to comply with the Code is specified through a criminal offence and civil penalty provision in the Act:
    • Section 42DM - criminal offence
    • Section 42DMA - civil penalty
  • For an ad to be approved under the Regulations (5G), the delegate must be satisfied that it complies with the Code

Slide 4 - Role of the Advertising Code

  • The Code is the cornerstone of the advertising framework
    • Requires that advertising supports appropriate use of therapeutic goods and does not mislead or deceive
  • Advertising Code (No.2) 2018 took effect on 1 January 2019
  • The Code was revised to provide clarity and more objective tests to support sanctions and penalties

Slide 5 - The cosmetic - Therapeutic goods interface

Slide 6 - Interface issues - Cosmetic products

  • "Cosmetic" products are not intended to be "therapeutic goods"
  • Cosmetics are regulated under legislation administered by the National Industrial Chemicals Notification & Assessment Scheme (NICNAS):
  • the Industrial Chemical Notification Act 1990 (ICNA Act)
  • Further information see www.nicnas.gov.au

Slide 7 - Interface issues - Cosmetic products

screenshot

https://www.nicnas.gov.au/cosmetics-and-soaps/is-my-product-a-cosmetic

Slide 8 - Interface issues - Cosmetic products

  • A cosmetic:
    • must meet the definition of "cosmetic" in the ICNA Act
    • cannot be a 'therapeutic good' within the meaning of the Therapeutic Goods Act 1989
      • i.e. must not be for therapeutic use
      • therapeutic use includes preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons, influencing physiological processes

Slide 9 - Interface issues - Cosmetic products

Regular cosmetic advertisement?

sample-ad

Slide 10 - Interface issues - Cosmetic products

sample-ad

Slide 11 - Interface issues - Cosmetic products

  • Making therapeutic claims about regular consumer goods may bring them into TGA's jurisdiction
  • This includes claims such as:
    • stating a product can modify a biological function
    • implying the product can cure, treat or diagnose a disease
  • We work closely with other regulators including ACCC and NICNAS

Slide 12 - ACCC warning notice

sample-notice

Slide 13 - Miracle mineral solution

exp-safety

Slide 14 - The Therapeutic Goods Advertising Code (No.2) 2018 in detail

Slide 15 - Structure of the 2018 code

  • Part 1 - Preliminary - definitions, object, application
  • Part 2 - General requirements for advertising therapeutic goods
  • Part 3 - Specific rules relating to particular therapeutic goods
  • Part 4 - Prohibited & restricted representations
  • Schedule 1 - Medicines with specific health warnings
  • Schedule 2 - Advertising to children
  • Schedule 3 - Samples
  • Schedule 4 - Price information
  • Schedule 5 - Repeals

Slide 16 - Part 1 - Preliminary

Slide 17 - Section 4 - Definitions

  • It is important to read the Code in conjunction with the Act and the Therapeutic Goods Regulations 1990
    • Terms that are not defined in the Code may be defined in the Act and Regulations (e.g. 'advertise')
  • Most Code definitions straightforward but there are some that we will explore in detail:
    • Health warning
    • Prominently displayed or communicated

Slide 18 - Definition of 'advertise'

"…in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the goods are contained.”

Slide 19 - What are health warnings?

  • In some cases, health warnings need to be included in ads
  • Concept of 'health warning' is defined in s.4 of the Code
  • The purpose of health warnings is to alert consumers to information that will be critical to the consumer's assessment of whether the advertised product is right for them before purchase

Slide 20 - Health warning definition - Medicines

  • Health warnings for medicines are prescribed in Schedule 1 of the Code
  • Schedule 1 health warnings are:
    • an exhaustive list but may be updated from time to time
    • based on RASML, permitted ingredients determination, TGO69 and TGO92
    • divided into different parts for warnings for registered medicines, listed medicines and both types of medicines

Slide 21 - Example of medicine health warnings

1. Ingredients 2. Circumstances 3. Health warning

Hydroxyanthracene derivatives such as those from:

  • Aloe
  • Buckthorn
  • Cascara
  • Frangula
  • Rhubarb
  • Senna
In preparations for oral use where the MRDD contains MORE than 10mg Do not use if you have abdominal pain, nausea, vomiting or diarrhoea
Ibuprofen/Paracetamol combinations In preparations for oral use Do not use if you have a stomach ulcer, impaired kidney function, heart failure, allergic to anti inflammatory medicines, pregnant or trying to become pregnant

Slide 22 - Health warning definition - Devices/OTGs

…a statement that is required under the Act or Regulations or Medical Devices Regulations to be included on the label or in instructions for use that warns that a person who takes or uses the device or goods as intended may:

(i) die; or
(ii) require hospitalisation or a longer period of hospitalisation than would be required if the person had not taken or used the device or goods; or
(iii) require a medical practitioner to treat or prevent injury, disability, incapacity or impairment of any bodily function, organ or structure as a consequence of taking or using the device or goods

Slide 23 - Prominently displayed or communicated

'prominently displayed or communicated' is defined as:

(a) either:

(i) for a visual statement—standing out so as to be easily read from a reasonable viewing distance for the particular media type in the context in which the advertisement is intended to be viewed; or
(ii) for a spoken statement—able to be clearly heard and understood; and

(b) repeated as often as is necessary to ensure that it is likely to be noticeable for a viewer or listener.

Slide 24 - Section 5 - Object of the code

"...to ensure that the advertising of therapeutic goods to consumers is conducted in a manner that:

promotes the safe and proper use of therapeutic goods by minimising their misuse, overuse or underuse; and
is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance; and
supports informed health care choices; and
is not inconsistent with current public health campaigns.
"

Slide 25 - Section 6 - Application

  • Applies to:
    • The advertising of therapeutic goods (ss.6(1))
    • By any person advertising or causing advertising (ss.6(5))
  • Does not apply to:
    • Genuine news (ss.6(6)) by certain bodies (ss.6(7)) - including broadcasters, datacasters and publishers
    • Advertising directed exclusively to health professionals (ss.6(2))

Slide 26 - Application of specific sections of the code

  • Certain sections and parts of the Code do not apply to:
    • Labels (as defined in s.3 of the Act)
    • Consumer medicine information leaflets (CMIs) - (defined in Regulations as 'patient information documents')
    • Patient information leaflets (PILs) - for implantable medical devices (see Code - s.4 - Definitions)
  • These exemptions are set out in the relevant sections of the Code
  • These documents can still be considered promotional - if so, they have to comply with all other relevant Code provisions

Slide 27 - Section 6 - Application

  • How to apply the Code to a particular advertisement:
    • consider its likely impact on a reasonable person to whom the advertisement is directed (ss.6(3))
    • the total presentation and context of the advertisement is to be taken into account (ss.6(4))

Slide 28 - Audience advertisement directed to

  • Advertising may be directed to the public in general or a sub-population
  • A direction may be made in many forms, including:
    • An overt statement e.g. "Do you suffer from mild eczema?", "For the relief of very dry skin"
    • An implied call to capture the attention of a sub-population e.g. for the measurement of blood pressure
    • The location of the ad e.g. in a magazine for diabetics

Slide 29 - Total presentation and context

  • Total presentation: the advertisement as a whole
  • Context includes:
    • What other information is provided around the advertisement that could change the take-out message? e.g. an editorial on a page opposite the advertisement
    • Does the environment in which it is displayed have the potential to alter the take-out message? E.g. a billboard ad that is viewed when passing in a car at speed

Slide 30 - Example - Bean's tonic

sample-ad

Slide 31 - Section 6A and 6B - Repeals and transition

  • Section 6A, by reference to Schedule 5, repeals the 2015 Code and the original 2018 Code
  • Section 6B allows for a transition period for ads pre-approved under the 2015 Code - i.e.
    • Complaints about such ads will be assessed against the 2015 Code for the life of the approval

Slide 32 - Part 2 - Requirements for advertising all therapeutic goods to the public

Slide 33 - Section 8 - Approved ads

  • Ads for medicines for ‘specified media’ (e.g. free-to-air television, newspaper, billboard) require prior approval under Regulation 5G
    • Arises from offence under section 42C of Act
  • S.8 requires ads appearing in print media and billboards to display the approval number in the advertisement as set out in ss.8(3) – must be legible

Slide 34 - S.9 - Accuracy

Validity and substantiation

Advertising for therapeutic goods must satisfy the following:

  • (a) any claims made in the advertising are valid and accurate, and all information presented has been substantiated before the advertising occurs

Truthful and not misleading

Advertising for therapeutic goods must satisfy the following:

  • (b) it is truthful, balanced and not misleading or likely to mislead, including in its claims, presentations, representations and comparisons

Slide 35 - S.9 - Accuracy

Comparisons

Advertising for therapeutic goods must satisfy the following:

  • (c) any comparisons made in the advertising between therapeutic goods or classes of therapeutic goods do not directly or indirectly claim that the goods or class of goods being used as the comparator are harmful or ineffectual;

Consistency with the ARTG

Advertising for therapeutic goods must satisfy the following:

  • (d)if the goods are included in the Register— it is consistent with the entry for the therapeutic goods in relation to that inclusion.

Slide 36 - S.10 - Effect

Support proper use

(a) Advertising for therapeutic goods must support the safe and proper use of therapeutic goods by:

  • (i) presenting the goods in accordance with directions or instructions for use; and
  • (ii) not exaggerating product efficacy or performance;

Delaying proper treatment

(b) Advertising for therapeutic goods must…not be likely to lead to people delaying necessary medical attention or delaying the use of, or failing to use, treatment prescribed by a medical practitioner;

Slide 37 - S.10 - Effect

Encourage inappropriate use

(c) Advertising for therapeutic goods must not encourage inappropriate or excessive use of the therapeutic goods

Safe or cannot harm

(d) Advertising for therapeutic goods must not contain any claim, statement, implication or representation that:

  • (i)the therapeutic goods are safe or that their use cannot cause harm, or that they have no side-effects

Slide 38 - S.10 - Effect

Sure cure

(d) Advertising for therapeutic goods must not contain any claim, statement, implication or representation that…

(ii) the therapeutic goods are effective in all cases of a condition or that the outcome from their use is a guaranteed or sure cure;

Miraculous

(d) Advertising for therapeutic goods must not contain any claim, statement, implication or representation that…

(iii) the therapeutic goods are infallible, unfailing, magical or miraculous;

Example: A testimonial on a website for a sunscreen claiming that it completely blocks harmful UV rays.

Slide 39 - S.10 - Effect: harmful consequences

(d) Advertising for therapeutic goods must not contain any claim, statement, implication or representation that…

(iv) harmful consequences may result from the therapeutic goods not being used - unless the claim, statement, implication or representation is permitted under section 42DK of the Act or approved under section 42DF of the Act.

Example: Spending time in the sun without an SPF 30 can result in increased incidence of skin cancer.

Slide 40 - Sections 11 - 13 Mandatory information and statements

Slide 41 - Overview: application of sections

Section 11 Section 12 Section 13
Ad for S3 (App H) medicine tick icon
Ad for non-S3 therapeutic good that allows purchase without seeing the good tick icon

(selected items only)

tick icon

Any other ad for non-S3 therapeutic good tick icon

Slide 42 - S.11: Required statement – S3s

  • An advertisement for a medicine containing a substance included in Schedule 3 of the Poisons Standard and Appendix H must prominently display or communicate:
    • ASK YOUR PHARMACIST - THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU
  • This is the only mandatory statement required by Part 2 for S3 ads
    • Part 3 still applies – e.g. analgesics warning
  • Does not apply to labels, CMIs or PILs

Slide 43 - Section 12 and 13 requirements

Advertising must contain…

  • Basic info about the goods
  • Information that needs to be prominently displayed or communicated:
  • Important health information (or a prompt to consumers to read it)
  • Advice to follow directions
  • If there are symptoms claims in the ad - an appropriate symptom statement

Slide 44 - S.12: What must ads contain (goods not available for inspection

  • This section is only for ads for goods that are not available for physical examination by the consumer before or at the time of purchase (e.g. internet, mail order marketing)
  • Does not apply to:
    • advertisements subject to section 11
    • a label, consumer medicine information or a patient information leaflet

Slide 45 - Section 12 mandatories: medicines

Type of information Provision and the information required in ad
Basic information about the goods
  • ss.12(3)(a) - (c) - the name of the medicine, dosage form, the quantity of the medicine
  • ss.12(3)(d) - one or more of the indications for the medicine, as they appear on the medicine's label
  • ss.12(3)(e) - a list of certain ingredients - see definition in s.4
Important health information* ss.12(3)(f) - an alert to the consumer to read the label or warnings (as appropriate for the nature of the medicine)
Follow the directions statement* ss.12(3)(g) - 'Follow the directions for use' or 'Follow the instructions for use' from ss.13(6)
Symptom statement* ss.12(3)(h) - If there are symptoms claims in ad, include appropriate statement/s from ss.13(7)

* Needs to be prominently displayed or communicated (as defined in s.4)

Slide 46 - ss.12(3)(f): Important health info for medicines

  • Are there health warnings in Schedule 1 of the Code for the medicine?
    • No - USE: 'Always read the label'
    • Yes - Do you want to include the health warnings in the ad?
      • No - USE: 'This medicine may not be right for you. Read the warnings before purchase' followed immediately by information about where the health warnings can be found
      • Yes - USE: 'Always read the label' and the health warnings

Slide 47 - Section 12 mandatories: devices

Type of information Provision and the information required in ad
Basic information about the goods
  • ss.12(4)(a) – (b) – an accurate description and a reference to EITHER the trade name or another name for the device
  • ss.12(4)(c) – the intended purpose or indications for the device as they appear on label or primary packaging
  • ss.12(4)(d) - a list of the ingredients if applicable
Important health information* ss.12(4)(e) – an alert to the consumer to read the label, instructions or warnings (as appropriate for the device)
Follow the directions statement* ss.12(4)(f) – 'Follow the directions for use' or 'Follow the instructions for use' from ss.13(6) as appropriate for the device
Symptom statement* ss.12(4)(g) - If there are symptoms claims in ad, include appropriate statement/s from ss.13(7)

*Needs to be prominently displayed or communicated (as defined in s.4)

Slide 48 - ss.12(4)(e): Important info for devices

  • Are there statements on the label or instructions for use for the device that meet the definition of 'health warning' in section 4 of the Code?
    • No - USE: 'Always read the label/instructions for use'
    • Yes - Do you want to include the health warnings in the ad?
      • No - USE: 'This product may not be right for you. Read the warnings before purchase' followed immediately by information about where the health warnings can be found
      • Yes - USE: 'Always read the label/instructions for use' and the health warnings

Slide 49 - Section 12 mandatories: OTGs

Type of information Provision and the information required in ad
Basic information about the goods
  • ss.12(5)(a) – (b) – an accurate description and a reference to EITHER the trade name or another name for the goods
  • ss.12(5)(c) – the intended purpose or indications for the goods as they appear on label or primary packaging
  • ss.12(5)(d) - a list of the ingredients where relevant
Important health information ss.12(5)(e) - an alert to the consumer to read the label, instructions or warnings (as appropriate for the goods)
Follow the directions statement ss.12(5)(f) - 'Follow the directions for use' or 'Follow the instructions for use' from ss.13(6) as appropriate for the goods
Symptom statement ss.12(5)(g) - If there are symptoms claims in ad, include appropriate statement/s from ss.13(7)

Slide 50 - ss.12(5)(e): Important info for OTGs

  • Are there statements on the label or instructions for use for the goods that meet the definition of 'health warning' in section 4 of the Code?
    • No - USE: 'Always read the label/instructions for use'
    • Yes - Do you want to include the health warnings in the ad?
      • No - USE: 'This product may not be right for you. Read the warnings before purchase' followed immediately by information about where the health warnings can be found
      • Yes - USE: 'Always read the label/instructions for use' and the health warnings

Slide 51 - Examples: Bean's tonic internet marketing

Slide 52 - Example 1 - Bean's tonic

Slide 53 - Example 2 - Bean's tonic

Slide 54 - Example 3 - Bean's tonic

Slide 55 - Example 4 - Bean's SUPERclean

Slide 56 - Example 4 - Bean's clean

Slide 57 - S.13: What must ads contain (general)

  • This section is only for ads that:
    • are for goods other than Schedule 3 medicines (see s.13(1)(d) - section 11 applies to these)
    • do not facilitate purchase of the goods without the consumer being able to inspect them (see s.13(1)(e) - section 12 applies to these)
  • It does not apply to labels, consumer medicine information or a patient information leaflet (s.13(1)(a) and (b))

Slide 58 - S.13: What must ads contain (general)

  • This section also does not apply to picture/price/point of sale ads (see s.13(1)(c)) – i.e.:
    • an advertisement displaying only the name or picture of therapeutic goods or their price or point of sale, or any combination of these, provided the advertisement does not contain or imply a claim relating to therapeutic use, or any other representation

Slide 59 - Section 13 mandatories: medicines

Type of information Provision and the information required in ad
Basic information about the goods ss.13(2)(a) - (b) - a reference to the trade name of the medicine and one or more of the indications as they appear on label
Important health information* ss.13(2)(c) - an alert to the consumer to read the label, instructions or warnings (as appropriate for the goods)
Follow the directions statement* ss.13(6) - 'Follow the directions for use' or 'Follow the instructions for use' as appropriate for the goods
Symptom statement* ss.13(7) - If there are symptoms claims in ad, include appropriate statement/s

*Needs to be prominently displayed or communicated (as defined in s.4)

Slide 60 - ss.13(2)(c): Important info for medicines

  • Are there health warnings in Schedule 1 of the Code for the medicine?
    • No - USE: 'Always read the label'
    • Yes - Do you want to include the health warnings in the ad?
      • No - USE: 'This medicine may not be right for you. Read the warnings before purchase'
      • Yes - USE: 'Always read the label' and the health warnings

Slide 61 - Section 13 mandatories: devices

Type of information Provision and the information required in ad
Basic information about the goods
  • ss.13(3)(a) – (b) – an accurate description and a reference to EITHER the trade name or another name for the device
  • ss.13(3)(c) – the intended purpose or indications for the device
Important health information* ss.13(3)(d) – an alert to the consumer to read the label, instructions or warnings (as appropriate for the device)
Follow the directions statement* ss.13(6) – 'Follow the directions for use' or 'Follow the instructions for use' as appropriate for the device
Symptom statement* ss.13(7) - If there are symptoms claims in ad, include appropriate statement/s

*Needs to be prominently displayed or communicated (as defined in s.4)

Slide 62 - ss.13(3)(d): Important info for devices

  • Are there statements on the label or instructions for use for the goods that meet the definition of 'health warning' in section 4
    • No - USE: 'Always read the label/instructions for use'
    • Yes - Do you want to include the health warnings in the ad?
      • No - USE: ''This product may not be right for you. Read the label/instructions for use before purchase' depending on whether there is a label visible on primary pack
      • Yes - USE: 'Always read the label/instructions for use' and the health warnings

Slide 63 - Section 13 mandatories: OTGs

Type of information Provision and the information required in ad
Basic information about the goods
  • ss.13(4)(a) - (b) - an accurate description and a reference to EITHER the trade name or another name for the goods
  • ss.13(4)(c) - the intended purpose or indications for the goods
Important health information* ss.13(4)(d) - an alert to the consumer to read the label or instructions (as appropriate for the goods)
Follow the directions statement* ss.13(6) - 'Follow the directions for use' or 'Follow the instructions for use' as appropriate for the goods
Symptom statement* ss.13(7) - If there are symptoms claims in ad, include appropriate statement/s

*Needs to be prominently displayed or communicated (as defined in s.4)

Slide 64 - ss.13(4)(d): Important info for OTGs

  • Are there statements on the label or instructions for use for the goods that meet the definition of 'health warning' in section 4
    • No - USE: 'Always read the label/instructions for use'
    • Yes - Do you want to include the health warnings in the ad?
      • No - USE: ''This product may not be right for you. Read the label/instructions for use before purchase' depending on whether there is a label visible on primary pack
      • Yes - USE: 'Always read the label/instructions for use' and the health warnings

Slide 65 - Exemptions from parts of section 13: short form ads

  • "Short form ads" are:
    • Radio commercials 15 seconds or less duration
    • Text-only ads of 300 characters or less with no ability to include pictures, logos or other imagery
  • Short form ads are exempt from:
    • The calls to action - 'Always read the label' etc
    • Symptoms statement (ss.13(6))

Slide 66 - Examples: Bean's tonic magazine ads

Slide 67 - Example 1 - Bean's tonic

An example of prominently displayed mandatories for a medicine without health warnings

example-ad

Slide 68 - Example 2 - Bean's tonic

An example of prominently displayed mandatories for a medicine with health warnings - using mandatories option 1 in s.13(2)(c) of the Code

example-ad

Slide 69 - Example 3 - Bean's tonic

An example of prominently displayed mandatories for a medicine with health warnings – using mandatories option 2 in s.13(2)(c) of the Code

example-ad

Slide 70 - Example 4 - Bean's tonic

Will not be compliant under the Code

example-ad

Slide 71 - Applying prominently displayed and communicated to catalogues

Slide 72 - Example 1 - catalogue

example-ad

Slide 73 - BREAK

back in 5 minutes

Slide 74 - S.15: Scientific or clinical representations

  • Ss.15(1) - this section does not apply to labels, CMIs or PILs
  • This section is in two parts:
    • Requirements for use of scientific or clinical claims (ss.15(2))
    • Requirements for use of citations (ss.15(3))

Slide 75 - S.15(2): Scientific or clinical claims

Where an advertisement makes a scientific or clinical claim:

  • (a) any scientific or clinical terminology must be appropriate, clearly communicated and able to be readily understood by the audience to whom it is directed; and
  • (b) any scientific or clinical representation must be consistent with the body of scientific or clinical evidence applicable to the advertised therapeutic goods.

Slide 76 - S.15(3): Scientific citations

Where an advertisement contains a citation to scientific or clinical literature, either explicitly or impliedly:

  • (a) any research results must identify the researcher and financial sponsor of the research, where the advertiser knows, or ought reasonably to have known that information; and
  • (b) the study must be sufficiently identified to enable consumers to access it.

Slide 77 - Example - Not compliant

  • Stellar is clinically proven to relieve gastro upsets in 10 minutes.
    • Implied scientific citation - reference needs to be provided
    • This would need to reflect the body of evidence available
  • The active ingredient in Stellar, hydroxyexpialedocious, works on the gastrointestinal system to suppress x2 receptor activity.
    • Scientific information is inappropriate and won't be readily understood
    • This would need to reflect the body of evidence available

Slide 78 - Example

  • Stellar is clinically proven to relieve gastro upsets in 10 minutes.
  • Stellar contains in ingredient to slow the spasms in your gastrointestinal tract to help you feel better.
    • Provided these claims reflect the body of evidence available about the product or ingredient, this would likely comply with s.15

Slide 79 - S.16(1): Endorsements

  • The endorsement provisions in section 16 do not apply to:
    • Testimonials captured by section 17 (s.16(1)(a))
    • Claimer for efficacy assessed non-prescription medicines – as described in Regulations (s.16(1)(b))

Slide 80 - S.16(2) and (2A): Endorsements

  • Endorsements (express or implied) from the following are prohibited:
    1. a government authority, hospital or healthcare facility; or
    2. an employee or contractor of a government agency, hospital or healthcare facility; or
    3. a health practitioner, health professional, medical researcher or a group of such persons.
  • Health care facilities do not include community pharmacies

Slide 81 - S.16(3): Endorsements

Subject to conditions, endorsements from the following are permitted:

  1. an organisation that:
    1. represents the interests of healthcare consumers; or
    2. represents the interests of health practitioners, health professionals or medical researchers; or
    3. conducts or funds research into any disease, condition, ailment or defect; or
  2. an employee or contractor of an organisation mentioned above, other than an individual mentioned in paragraph (2)(b) or (c)

Slide 82 - S.16: Endorsement conditions

  • Endorsements made under s.16(3) are subject to the conditions that the advertisement:
    • names the organisation concerned; and
    • discloses:
      • the nature of the endorsement; and
      • whether the organisation or employee, has received, or will receive, any valuable consideration for the endorsement
  • 'Organisation' defined in s.16(4) - any group, association etc.

Slide 83 - S.17: Testimonials

  • Testimonial = a statement about a therapeutic good made by a person that claims to have used that good (s.17(1))
  • This section specifies three types of requirements:
    • Characteristics of the person making testimonial (s.17(2)(a))
    • Obligations of the advertiser before using testimonial in advertising (s.17(2)(b) and (c))
    • Information that must be disclosed in the ad about the testimonial (s.17(3))

Slide 84 - Example acceptable use policy

  • We welcome your comments on our page but we ask that you help us comply with the Therapeutic Goods Advertising Code (the Code).Please consider these guidelines before commenting. We will remove any comments that may result in us breaching the Code.
  • We love when you comment and tag your friends and family on our posts but we ask that you do not:
  • endorse our product if you are:
    • an employee or contractor of a government authority, a hospital or a healthcare facility
    • a health practitioner, health professional or medical researcher
    • involved with the production, sale, supply or marketing of our product
    • not using your own name on this social media platform.
  • imply that a government authority, a hospital or a healthcare facility endorse our product
  • make comments about how a product works for you outside of its intended purpose, as these comments can be dangerous or misleading.- our products are developed for particular purposes, as stated on the label and/or in our advertising, and these comments can be dangerous and misleading
    • make comments about serious conditions, diseases, ailments or defects, such as comments about how a product helped with your cancer treatment or how it will relieve a tagged person's rheumatoid arthritis pain
  • We also have an obligation to make sure any advertisements we make, including endorsements and testimonials, are not misleading, therefore we promise to disclose:
    • where a person has been, or will be, compensated for making a testimonial
    • where we have actors making the testimonial, such as in cases where the original person who made the testimonial does not want to appear in our advertisement
    • where the person making the testimonial is an immediate family member of anyone employed by our business

Slide 85 - Who can make a testimonial for use in ads?

s.17(2)(a) - a person:

  • (i) whose details are verified prior to the advertising occurring; and
  • (ii) who has used the goods for their intended purpose; and
  • (iii) who is not:
    1. involved with the production, sale, supply or marketing of the goods; or
    2. an employee or officer of a corporation that is involved with the production, sale, supply or marketing of the goods; or
    3. a corporation; or
    4. mentioned in subsection 16(2) (e.g. health professionals, staff from government agency, hospital or healthcare facility)

Slide 86 - Advertiser obligations when using testimonials

s.17(2)(b) and (c) - the advertiser needs to ensure that they have:

  • verified as to the use of the goods and the claims made by the person prior to the advertising occurring; and
  • checked that the testimonial is typical of the results to be expected from the use of the goods in accordance with the directions for use, or purpose, of the goods.

Slide 87 - Information re testimonials to be included in ads

s.17(3) - An ad containing a testimonial must:

  1. disclose whether the person providing the testimonial has received, or will receive, any valuable consideration for the testimonial;
  2. disclose where another person is taking the place in the advertisement of the person providing the testimonial; and
  3. disclose where the person providing the testimonial is an immediate family member of an individual who is involved with the production, sale, supply or marketing of the goods.

Slide 88 - S.18: Incentives

  • Ads must not offer any personal incentive to a pharmacy assistant, or any retail sales person who is not a health professional, to recommend or supply therapeutic goods.
  • Pharmacy assistants and other retail staff do not meet the criteria for 'health professionals' for the purposes of the advertising (s.42AA)
  • Ads for these audiences must comply with the Code - including this provision

Slide 89 - S.19: Advertising to children

  • Advertising must not be primarily directed to children under the age of 12 years at all
  • Advertising must not be primarily directed to children aged 12 years or over, EXCEPT for those products listed in Schedule 2 of the Code, which include tampons and condoms
  • Labels are excluded from this provision
  • 'primarily directed' does not include incidental exposure

Slide 90 - S.20: Samples

  • An ad must not contain an offer of a sample EXCEPT for those products listed in Schedule 3:
    • condoms
    • Sunscreens
    • Stoma devices for self-management
    • Continence catheter devices for self-management
  • Samples can in themselves be an ad - consider Act definition of 'advertise'
  • Some samples may also be subject to state and territory laws - e.g. scheduled substances

Slide 91 - S.20: Samples example

NOT COMPLIANT

Have you been diagnosed with IBS recently?

Wondering if you will ever find anything to help your symptoms?

You can feel better in just two weeks - take the Bean's challenge!

Sign up at www.beanstonic.com.au and we will email you a voucher for a free one month supply of Bean's Tonic from your local pharmacy.

Slide 92 - S.21: Consistency with public health campaigns

  • If a relevant public health campaign of which the advertiser knows, or ought reasonably to have known is or will be current at the time of advertising therapeutic goods, the advertising must not be inconsistent with the public health campaign
  • Campaigns can be current but not necessarily active - e.g. respiratory hygiene campaigns only run in cold & flu season
  • Guidance contains more information on establishing current public health campaigns

Slide 93 - S.21: Consistency with public health campaigns

Example: There are a range of current initiatives in Australia to encourage responsible alcohol consumption

NOT COMPLIANT - Drinkers Delight liver tonic

  • improves liver function
  • protects the liver from damage from alcohol consumption - especially on a big night out!

Slide 94 - Part 3 - Requirements when advertising sunscreens

Slide 95 - S.27 - Sunscreens

For an ad for a therapeutic good that is or contains a sunscreen that is claimed to prevent sunburn or skin cancer, the ad must:

  • depict sunscreens as being only one part of sun protection; and
  • include statements or visual representations, prominently displayed or communicated, to the effect that:
    • prolonged high-risk sun exposure should be avoided; and
    • frequent re-application or use in accordance with directions is required for effective sun protection.

Slide 96 - Example 1 – Bean's TOTAL screen

sample-ad

Slide 97 - Example 2 – Bean's TOTAL screen

sample-ad

Slide 98 - Part 4 – Restricted and prohibited representations

Slide 99 - Prohibited and Restricted Representations

  • The Act makes it a criminal offence, and provides civil penalties, where an advertiser makes reference certain conditions (explicitly, or by implication) in advertising of therapeutic goods without prior approval:
    • S. 42DL(7) and 42DLB(4) - restricted representations
    • S. 42DL(5) and 42DLB(2) - prohibited representations
  • The Act also provides that the Secretary may approve the use of these representations under certain circumstances (s.42DF and s.42DK)

Slide 100

s.29(1)(a) - medically accepted to be a form requiring diagnosis, treatment or supervision by a suitably qualified health professional? - if yes see point 1. if no see point 2.

  1. s.29(1)(a) - Once medically diagnosed, is it medically accepted to be suitable for self-treatment and management? - if yes see point 3. if no see point 4.
  2. s.29(1)(b) - Is there a diagnostic/screening, or other kind of test for the form which requires medical interpretation or follow-up? if yes see point 3. if no see point 4.
  3. NOT a serious form
  4. The form IS a serious form

Slide 101 - Restricted representations

  • A range of examples of what are and are not considered serious conditions are provided in the Guidance.
  • The conditions included in the Guidance make for a fairly easy assessment of whether or not they need to be medically diagnosed.
  • Where the serious condition is implied by the representation, this may be more difficult to assess.

Slide 102 - Permitted restricted representations

  • TGA has permitted the use of certain restricted representations by all advertisers of therapeutic goods, where the ad and product meets the characteristics and requirements specified.
  • Permitted restricted representations include:
    • Neural tube defect risk reduction in pregnancy when advertising medicines with at least 400µg folic acid/day
    • representations about sleep apnoea, Obstructive Sleep Apnoea (OSA) and Central Sleep Apnea/Apnoea (CSA) in relation to Continuous Positive Airway Pressure (CPAP) equipment

Slide 103 - S.30 - Prohibited representations

  • Representations (express or implied) about the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to:
    • Neoplastic diseases (i.e. all types of cancer)
    • Sexually transmitted disease
    • HIV/AIDS
    • Hepatitis C virus
    • Mental illness
  • Abortifacient action

Slide 104 - Using prohibited representations

  • The use of a prohibited representation may be authorised where it is necessary for either:
    • Public health interest; or
    • The appropriate use of the goods (packaging & labelling only)
  • There is no process for applying to use prohibited representations - TGA will identify where it is needed
  • Representations about preventing transmission of STDs/HIV/AIDS and prevention of skin cancer through sunscreen use are prohibited representations but will be permitted.

Slide 105 - Restricted and prohibited representation approvals / permissions are published on the TGA website

Slide 106 - Compliance overview

Slide 107 - What's in our compliance toolkit?

Voluntary compliance

  • Education program (further information about this later in the afternoon)
  • Enquiry services
  • Advertising pre-approvals remain until June 2020

Assisted compliance

  • Obligations Notice - informs advertisers that their advertising may not be compliant and advises them of their obligations
  • Warning - informs advertisers that their advertising is non-compliant and advises them of regulatory action that may be taken if they fail to respond/comply - requires a written response

Slide 108 - What's in our compliance toolkit? (2)

Regulatory Compliance

  • Substantiation Notice
  • Directions Notice
  • Cancellation or suspension of the therapeutic good from the ARTG
  • Public Warning Notice
  • Injunction from the Federal Court or Federal Circuit Court
  • Infringement Notice
  • Enforceable Undertaking
  • Prosecution of a civil penalty provision
  • Referral to the Commonwealth Director of Public Prosecutions for criminal prosecution

Slide 109 - Risk based regulatory action

sample-ad

Slide 110 - Code version applied in compliance

  • For ads with current approval: version of Code approved under
  • For ads (other than pre-approved ads) that occurred:
Advertising occurred Assessed against
On or after 1 January 2019 2018 code
Before 1 January 2019 and is no longer occuring 2015 code
Before 1 January 2019 and is still occurring 2018 code

Slide 111 - Compliance approach

Slide 112 - Top tips for compliant advertising

  • Ensure ads contain the correct mandatory statements and information with appropriate prominence
  • Check advertising for complementary medicines, analgesics, vitamins, weight loss products and sunscreens carefully to ensure full compliance with the express provisions
  • Don’t use advertising with references to diseases, conditions, ailments or defects before checking if you need restricted representation approval

Slide 113 - Top tips for compliant advertising

  • Ensure testimonials, endorsements and scientific representations fully comply with clarified requirements
  • Don't use advertising that is inconsistent with the product’s ARTG entry, directions, or instructions for use
  • Don't use advertising that encourages people to delay seeking medical advice or cease prescribed therapies
  • Don't use advertising that conflicts with public health campaigns

Slide 114 - Summary and finding more information

Slide 115 - Find out more about advertising

Slide 116 - Find out more about the TGA

Slide 117 - Questions for the Panel

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