Advertising prescription medicines to health professionals

8 April 2011

Whereas advertising prescription medicines to consumers is not permitted under the Therapeutic Goods Act 1989 (the Act), advertising to health professionals is permitted within the scope of the legislation (see below).

However, prescription medicines not included in the Australian Register of Therapeutic Goods (ARTG) are considered unregistered therapeutic goods and therefore may not be advertised in Australia to consumers or healthcare professionals.

International publications

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 that are unregistered in Australia. This includes prescription medicines currently under evaluation by the TGA's Medicines Authorisation 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.

Definition

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).

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 sections 41ML of the Act).

For prescription medicines, the 'registration approval' letters issued by the TGA's Medicines Authorisation Branch also contain a condition that promotional material must comply with the requirements of the Code of Conduct published by Medicines Australia.

Relevant legislation

Advertisements for therapeutic goods are subject to the requirements of: the Therapeutic Goods Act 1989 and Regulations 1990; the Competition and Consumer Act 2010 and other relevant legislation.

Those directed at consumers must also comply with the Therapeutic Goods Advertising Code. The relevant legislation and legislative instruments listed above are are available on the ComLaw Internet site.

Further information

The following information should also prove useful:

The Code of Conduct booklet published by Medicines Australia 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.