On this page: Disclaimer | Presentation | Transcript

Disclaimer

Presentation

• Presented by: Virginia Deigan, Office of Product Review, Therapeutic Goods Administration
• Presented at: TGA Sydney International Spa & Beauty Expo 23-24 August 2014
• Presentation summary: This presentation provided information on complying with the therapeutic goods legislation when advertising cosmetic injectables

Transcript

Show transcript for this slideshow

Advertising cosmetic injectables - Complying with the therapeutic goods legislation

Virginia Deigan
Assistant Director, Advertising & Recalls Section, Office of Product Review

TGA Sydney International Spa & Beauty Expo 23-24 August 2014

Slide 1 - Therapeutic Goods Administration

The TGA was established in 1990 to 'safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods'.

Slide 2 - TGA's role

• Regulates the manufacture, import, export, supply and advertising of therapeutic goods such as prescription, over-the-counter and complementary medicines, medical devices (including in-vitro diagnostic devices (IVDs), biologicals, blood and blood products.
• This is done through
  • pre-market assessment and labelling
  • post-market monitoring and enforcement of standards, including advertising requirements
  • licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts

Slide 3 - What the TGA doesn't do

• Recommendations/decisions about which devices/medicines receive Government subsidy;
• Give clinical advice regarding treatment of patients;
• Regulate practices or services of healthcare professionals;
• Fund research on the development of therapeutic goods

Slide 4 - National medicines policy

• One of the central objectives of Australia's National Medicines Policy is:
  • quality use of medicines (QUM);

Slide 5 - Quality Use of Medicines (QUM)

• QUM means:
  • selecting management options wisely;
  • choosing suitable medicines, if a medicine is considered necessary; and
  • using those medicines safely and effectively.

Slide 6 - Scheduling

• Medicines and chemicals are classified into Schedules according to the level of regulatory control over their availability, required to protect public health and safety. The schedules are published in the Poisons Standard:
  • There are 9 Schedules, but the schedule most relevant to cosmetic injectables is:
    • Schedule 4 - Prescription Only Medicine

Slide 7 - Scheduling of cosmetic injectables

• The most common scheduled substances used in non-surgical cosmetic procedures are:
  • Botulinum Toxin = Schedule 4
  • Hylauronic Acid = Schedule 4
  • Hylauronic Acid = Schedule 4

Slide 8 - What is an advertisement?

• The definition of "advertisement" under the Act is very broad:
  • '...in relation to therapeutic goods, includes 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 9 - Can Schedule 4 substances be advertised to the public?

• Section 42DL(1)(f) of the Therapeutic Goods Act 1989 is an offence provision:
  • A person must not publish or broadcast an advertisement about therapeutic goods that contains a statement referring to goods, or substances or preparations containing goods, included in Schedule 3, 4 or 8 to the current Poisons Standard, other than a statement authorised or required by a government or government authority (including a foreign government or foreign government authority);

Slide 10 - What is the effect of s42DL(1)(f)?

• Schedule 4 substances used in cosmetic medical procedures such as anti-wrinkle treatments, are captured under this section of the Act, if advertised to the general public.

Slide 11 - Is my website an advertisement for a therapeutic good?

• Generally, any website that is promotional in some way and also refers to a therapeutic good, is likely to be taken to be an advertisement for a therapeutic good.
• Whether or not the advertisement is intended to promote the use or supply of a therapeutic good, comes down to whatever the customer believes the intention of the information is, or put it another way, what the impact on the customer is.

Slide 12 - How to comply with s42DL(1)(f)

• Advertisements to consumers for cosmetic services must not specify:
  
  • trade names of products containing Schedule 4 substances (e.g. Botox, Dysport, Restylane, Perlane, Dermalive, Juvéderm, Aquamid, Sculptra)
  • ingredients that are Schedule 4 substances (e.g. botulinum toxin, hyaluronic acid, polylactic acid)
  • acronyms, abbreviations or other references to such trade names and ingredient names (e.g. BTX, HA, colloquial terms for specific products/substances).

Slide 13 - Social media

A common area of non-compliance is third-party posts on Facebook, websites etc.

• The owner of the website/Facebook page is responsible for the content, this includes any third-part posts, for example, testimonials or messages left by your clients.
• Any posts that may cause the material to be non-compliant with the therapeutic goods advertising legislation should be removed as soon as you become aware of it.
• It is recommended for businesses to have a process in place for regular monitoring.

Slide 14 - Consequences of non-compliance

• In the first instance, the TGA seeks to inform, educate and assist advertisers to comply with the rules relating to advertising.
• If this approach fails, the TGA may take regulatory action. The Act provides for financial penalties for a breach of 42DL(1)(f). Penalties can be:
  • Up to $10,200 for individuals; and
  • Up to $51,000 for corporations

Slide 15 - Educational material

• There are a number of resources available to assist advertisers to comply with the therapeutic goods advertising legislation:
  • Brochure
  • Website information
  • www.tga.gov.au