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TGA presentation given at ARCS webinar meeting, 26 November 2014

26 November 2014


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Presentation: Advertising Medical Devices to Consumers: Complying with the legislation

  • Presented by: Mick O'Connor, Director, Recalls & Advertising Section, Therapeutic Goods Administration
  • Presented at: ARCS webinar meeting, 26 November 2014
  • Presentation summary: This presentation provided an overview of the therapeutic goods consumer advertising requirements and TGA's approach to advertising compliance


Advertising Medical Devices to Consumers: Complying with the legislation

Mick O'Connor
Recalls & Advertising Section
Office of Product Review
Monitoring and Compliance Group

ARCS - Training - 26 November 2014

Slide 1 - Outline of presentation

  • Overview of the therapeutic goods consumer advertising requirements
  • TGA's approach to advertising compliance

Slide 2 - Three levels of controls

  • REGULATION - legislation administered by the TGA
    • Therapeutic Goods Act 1989
    • Therapeutic Goods Regulations 1990
    • Therapeutic Goods Advertising Code (TGAC)
  • CO-REGULATION - functions shared with Industry
    • Advertising directed to consumers
    • Therapeutic Goods Advertising Code Council (TGACC)
    • Complaints Resolution Panel (CRP)
  • SELF-REGULATION - not in legislation
    • Advertising directed to healthcare professionals
    • Voluntary industry codes of conduct/practice
    • Industry association complaints and monitoring panels

Slide 3 - The role of the TGA

  • Administers the legislation which underpins the advertising framework
  • Oversees the shared regulatory arrangements with industry associations
  • Initiates further regulatory action to obtain advertising compliance where required
  • Chair and member of TGACC
  • Observer on complaints panels

Slide 4 - Therapeutic goods advertising requirements

  • The advertising requirements are set out in the
    • Therapeutic Goods Act
    • Therapeutic Goods Regulations
    • Therapeutic Goods Advertising Code
    • Price Information Code of Practice
  • Advertising requirements are also set out in the Competition and Consumer Act

Slide 5 - Therapeutic Goods Act 1989 Chapter 1 - Preliminary

  • Important definitions listed in Section 3 - Interpretation:
    • Therapeutic Goods
    • Therapeutic Use
    • Medical Device (defined in Chapter 4)

Slide 6 - Therapeutic Goods Act 1989

Chapter 1- Preliminary
  • Advertisement is defined in Section 3 - Interpretation:
    • "...any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods"

Slide 7 - Therapeutic Goods Act 1989

Chapter 4 - Medical Devices
  • Subsection 41ML: Offence for Medical Devices
    • Advertising an intended purpose not accepted in relation to the inclusion of the device in ARTG
    • Applies to ads for HCPs and consumers
  • s41FN(5) - Conditions applying automatically - Advertising material
    • The inclusion of a kind of medical device in the Register is subject to a condition that advertising material relating to medical devices of that kind is consistent with the intended purpose as certified under section 41FD.

Slide 8 - Therapeutic Goods Act 1989

Chapter 5; Part 5-1 – Advertising
  • Provides for:
    • exemption for advertisements directed exclusively to health professionals
    • advertising definitions
    • establishes the Advertising Code
    • prohibited and restricted representations
    • offences

Slide 9 - Therapeutic Goods Regulations 1990

  • Part 2
    • establishes approval scheme for certain "specified media" advertisements
    • provides for the TGA to issue orders
  • Part 6, Divisions 2 & 3
    • establishes TGACC & CRP and their procedures
    • provides for the complaints register

Slide 10 - Therapeutic Goods Advertising Code

  • To ensure that the marketing and advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of therapeutic goods, is socially responsible and does not mislead or deceive the consumer
  • The conformity of an advertisement with the Code is assessed in terms of its probable impact upon the reasonable person to whom the advertisement is directed

Slide 11 - Therapeutic Goods Advertising Code

General principles
  • Section 4 sets out the key requirements including that therapeutic good advertisements "must not":
    • Mislead or be likely to mislead
    • Arouse unrealistic expectations of product effectiveness
    • Lead consumers to self-diagnosing, inappropriately treating or believing they have a serious disease
    • Abuse consumers' trust or exploit their lack of knowledge
    • Encourage inappropriate or excessive use
    • Claim that a good is guaranteed, certain, sure cure or that the goods are completely safe or harmless
    • Be directed to minors (subject to exceptions).

Slide 12 - Prohibited representations

Section 5(1) and Appendix 6, Part 1 of the Code
  • An advertisement must not contain, expressly or by implication, certain representations. Includes representations regarding abortifacient action or the treatment, cure or prevention of the following diseases:
    • Neoplastic disease
    • Sexually Transmitted Diseases (STD)
    • HIV AIDS and/or HCV
    • Mental illness
  • Note there are some exceptions which become restricted representations.

Slide 13 - Restricted representation

Section 5(2) and Appendix 6, Part 2 of the Code
  • A Restricted representation in an advertisement for therapeutic goods is a reference (whether expressly or by implication) to a serious form of disease, condition, ailment or defect specified in Table 1 of the Code
  • An advertisement that refers to a restricted representation requires approval for the reference before the advertisement is published or broadcast

Slide 14 - Applying for approval to make a restricted representation

  • Legislative requirements:
    • Set out in Chapter 5, Part 5-1, Division 3 of the Therapeutic Goods Act 1989
    • Specifically, section 42DD through to s.42DK

Slide 15 - Advertising complaints

  • Complaints about medical device advertisements directed to the public that do not comply with the advertising requirements can be made to the:
    • Complaints Resolution Panel – TV, radio, newspapers, magazines, cinemas, posters
    • Medical Technology Association of Australia – in-store material, brochures
    • Therapeutic Goods Administration

Slide 16 - Advertising compliance

  • Complaints considered by the Complaints Resolution Panel may result in the advertiser being requested to take certain actions
  • The Panel may make a recommendation to the Secretary of the Department of Health (TGA)
    • where the Advertiser fails to respond, or fails to indicate an intention to comply fully with Panel's requests

Slide 17 - Recommendations to Secretary

  • The Panel may recommend that Secretary orders the Advertiser to
    • withdraw an advertisement
    • withdraw claim or representation
    • publish a retraction or correction
  • May also recommend that the Secretary take other regulatory actions

Slide 18 - The Secretary's Order

  • Secretary's delegate in TGA reviews afresh the complaint and the Panel's findings
  • Based on this review the delegate may decide to order the Advertiser under regulation 9 to
    • withdraw an advertisement
    • withdraw claim or representation
    • publish a retraction or correction
  • Consequences of non-compliance with order and rights for 'review' advised

Slide 19 - Advertising tips

  1. Hold the appropriate level of evidence
  2. Claims must be consistent with intended purpose
  3. No references to prohibited or unapproved restricted representations, "TGA approved" or to the product being safe
  4. Endorsements and testimonials must comply fully with the Code
  5. Include mandatory warning statements

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