Advertising to health professionals so that consumer rules do not apply

Advertisements directed exclusively to health professionals are exempt from the requirements in Parts 5-1 of the Therapeutic Goods Act 1989 (the Act). 

This includes the restrictions on: 

• advertising prescription and some pharmacist-only medicines 
• advertising unapproved therapeutic goods 
• using references to restricted and prohibited representations. 

Note that promotion of the goods for an “off-label” use, that is, for an indication or intended purpose that is not entered in the Australian Register of Therapeutic Goods (ARTG) for the goods is prohibited, including to health professionals.

Section 42AA of the Act provides a definition for 'health professional', which includes: 

• a range of mainstream and natural health practitioners
• purchasing officers for hospitals, government and registered charities
• purchasing officers or practice managers for a health professionals captured within these lists (other than a person in retail pharmacy)
• wholesalers. 

For notified vaping goods, the exemption for advertising to health professionals only applies to those mentioned specifically within the Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024, not the broader definition within section 42AA of the Act.

If your advertising is accessible to health professionals not captured within these lists, then your advertising must be compliant with the requirements for advertising therapeutic goods to the public.

The exemption for advertising exclusively to health professionals does not apply to advertisements that are in the public domain, including where:

• products are not available for purchase by the public and/or 
• the advertising content clearly targets health professionals.

Physical advertisements

For physical advertising directed to health professionals, such as posters, leaflets and samples you must ensure that these cannot be accessed or seen by the public.

This would include leaflets distributed at a health professional conference if the event was open to the public.

Online advertisements

For online advertisements to be considered as directed exclusively to health professionals, the content needs to be secured so that it can only be accessed by confirmed health professionals.

How this is achieved is up to advertisers. 

The following examples demonstrate the degree of separation needed from the public domain for us to consider it to be 'directed exclusively' to health professionals.

• The material is secured with a username and password, issued by the advertiser following confirmation of health professional status through:
  • The provision of a current Australian Health Practitioner Regulation Agency (AHPRA) registration number and associated confirmatory details (such as provider number) for matching against the Ahpra Practitioner information exchange - external site.
  • A statutory declaration from the worker or their employer that the user is a health professional, in combination with other identity confirmation protections, including an email address with a domain for a hospital, clinic or other business established as providing relevant health services.
  • Confirmation of health professional status by visiting sales representatives.
• Mechanisms to limit the access of the material to specific health professional locations. For example, ensuring material is only accessible from a range of IP addresses used by the hospital concerned or from an application or program configured to run on approved hospital platforms only.

Information provided via email should only be provided once the professional credentials of the individual have been established.

Factual information, including scientific or medical information, intended for health professionals does not need to be secured, provided that it would not be seen as promotional. See Activities that represent advertising for more details.

Providing factual information to the public in a promotional context is likely result in that information being considered advertising to the public.