Advertising medical services that include schedule 4 substances
Points for medical practitioners and cosmetic/beauty therapists to consider when advertising services that involve therapeutic goods containing Schedule 4 substances
The issue
Some medical practitioners and cosmetic / beauty therapists are advertising, to the general public, therapeutic goods or substances by name that are available as "prescription-only" items. These products include injectable dermal fillers such as -
- Restylane, Perlane, Dermalive (hyaluronic acid)
- Hylaform (hyaluronan, sodium hyaluronate)
- Collagen, Zyderm, Zyplast (collagen)
- Botox, Dysport (botulinum toxin)
- Newfill, Nufill (polylactic acid)
- Aquamid (polyacrylamide)
which are generally administered for the purpose of temporarily removing / reducing wrinkles and lines on the face, around the eyes, forehead, lips and neck.
These substances are listed in Schedule 4 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) <http://www.tga.gov.au/ndpsc/susdp.htm> and the products are therefore regulated as "prescription-only" items. The advertising to consumers of Schedule 3, 4 or 8 products is unlawful as it constitutes an offence under s.42DL(1)(f) of the Therapeutic Goods Act 1989 ("the Act") (apart from the limited exceptions relating to some S3 products, which are not applicable to this situation).
As a result of amendments which were made to the therapeutic goods legislation during 2003, the advertising offences have now been transferred from the Therapeutic Goods Regulations to the Act, with a corresponding increase in penalties. For example, the maximum penalty for this offence is now $6,600 for an individual and $33,000 for a corporation, in respect of each offence.
Background
The SUSDP includes the following schedules -
Schedule 3: Pharmacist Only substances - includes substances that are obtainable only from a pharmacist, but without a doctor's prescription. (Appendix H of the SUSDP allows some Schedule 3 medicines to be advertised to the public).
Schedule 4: Prescription Only substances - includes substances, the use or supply of which should be by, or on the order of medical practitioners and should be available from a pharmacist on prescription.
Schedule 8: Controlled substances - includes substances which require restriction because they may be subject to abuse, misuse and physical or psychological dependence.
To reiterate, it is an offence under s.42DL(1)(f) of the Act for a person to publish or broadcast an "advertisement" about therapeutic goods that refers to goods, or substances or preparations containing goods, included in Schedule 3, 4 or 8 of the SUSDP.
Attention is also drawn to the broad definition of "advertisement", as defined in the Act ie. "advertisement" 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.
Suggested alternatives
To enable medical practitioners and cosmetic / beauty therapists to continue promoting their businesses and services, whilst also complying with the regulatory advertising requirements for therapeutic goods, the Therapeutic Goods Administration (TGA) recommends that the references in advertisements to individual, S4 items be deleted and substituted with phrases such as -
- cosmetic injections;
- anti-wrinkle injections / treatments;
- wrinkle injections / treatments;
- injections / treatments for lips;
- injections / treatments for fine lines / folds / age lines;
- wrinkle and lip enhancement / fulfilment / augmentation;
- injections to enhance pouting of the lips;
- injections which reduce the depth of fine lines / wrinkles around the face / lips; and
- etc
or other words and phrases with similar meaning, but without referring to specific products or ingredient names.
Further inquiries may be addressed to -
tga.advertising@tga.gov.au; or
The Head
Advertising and Export Section
Non-Prescription Medicines Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Tel: 02 6232 8757
Fax: 02 6232 8659
In concluding, the TGA would also take this opportunity to remind advertisers/businesses/service providers of their various obligations under the Trade Practices Act 1974 and State/Territory 'fair trading/consumer affairs' legislation.