Advertising prescription medicines to healthcare professionals
An 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 (Section 3 of the Therapeutic Goods Act 1989).
Advertisements for therapeutic goods are subject to the requirements of the Therapeutic Goods Act 1989* and Regulations 1990*, the Trade Practices Act* and other relevant legislation. Those directed to consumers must also comply with the Therapeutic Goods Advertising Code*.
*All available from the ComLaw Internet site <http://www.comlaw.gov.au>
Advertising of a therapeutic good can only refer to the indications (for medicines) or intended purpose (for medical devices) which are included in the Australian Register of Therapeutic Goods (ARTG) for that specific good (section 22(5) and section 41FN(5) of the Act refer). For prescription medicines, the 'registration approval' letters issued by the Drug Safety & Evaluation Branch also contain a condition that promotional material must comply with the requirements of the Code of Conduct of Medicines Australia.
Advertising registered prescription medicines to consumers is not permitted, but advertising is permitted to healthcare professionals, within the scope of the legislation. However, prescription medicines not included in the ARTG are considered unregistered therapeutic goods and are therefore not to be advertised in Australia to consumers or healthcare professionals.
An unusual situation arises when an advertisement is placed in an international journal or publication by an overseas parent company or head office and is directed at healthcare professionals, but the prescription medicine is unregistered in Australia. In this case, if the publication can have specific Australian customised advertising, then sponsors must not place advertisements for goods which are unregistered in Australia. This includes prescription medicines currently under evaluation by the Drug Safety & Evaluation Branch, even though approval for registration may be pending.
Please ensure your head office or overseas parent company is informed of these local requirements for customisable international publications. The TGA views this issue seriously and sponsors should be aware there are provisions in the legislation for penalties, fines or referral of the advertisement to the Medicines Australia Code of Conduct Committee.
The TGA website contains information on advertising of therapeutic goods <http://www.tga.gov.au/advert/index.htm> which sponsors may find helpful.
The Code of Conduct booklet published by Medicines Australia <http://www.medicinesaustralia.com.au> also contains information on advertising of therapeutic goods, in particular section 1.3.1, in which products not approved for registration must not be promoted.