Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017 (collectively, the Bills) propose to bring significant changes to the Therapeutic Goods Act 1989 (the TG Act) and the Therapeutic Goods (Charges) Act 1989. One significant change may allow companies to ‘advertise’ their unapproved therapeutic goods.

Proposed changes to advertising

Offences relating to the promotion of unapproved therapeutic goods

Currently, under subsection 22(6) of the TG Act, a person must not make a claim, by any means, that the person or another person can arrange the supply of therapeutic goods (not being exempt goods or goods exempt under section 18A) that are not registered goods or listed goods.

This section is to be repealed and substituted by the following:

A person commits an offence if:

  1. the person claims, by any means, that the person or another person can arrange the supply of therapeutic goods; and
  2. none of the following subparagraphs applies in relation to the goods:
    1. the goods are registered goods or listed goods;
    2. the goods are exempt goods;
    3. the goods are exempt under section 18A;
    4. the goods are the subject of an approval or authority under section 19 that covers the supply of the goods by the person or other person;
    5. the goods are the subject of an approval under section 19A that covers the supply of the goods by the person or other person (emphasis added).

Impact of changes

The Explanatory Memorandum states the amendments “clarify that a person does not commit an offence by claiming to be able to arrange the supply of goods, that the person can supply, or by claiming that another person can arrange the supply of goods that the other person can supply, if the goods are subject to any relevant exemption, approval or authority under the Act” (emphasis added).

This suggests that unapproved therapeutic goods supplied under the Special Access Scheme (SAS) by an Authorised Prescriber (AP) may, in the future, be ‘advertised’. Currently:

  • Subsection 19(1) of the TG Act states the Secretary may grant an approval to a person for the supply in Australia of specified therapeutic goods that are not registered goods, listed goods, or exempt goods for use in the treatment of another person or for use solely for experimental purposes in humans. That is, via SAS (Cat B).
  • Subsection 19(7A) of the TG Act states that the Minister may, by legislative instrument, make rules authorising a health practitioner, who is included in a specified class of health practitioners, to supply specified therapeutic goods. That is, via SAS (Cat C).
  • Subsection 19(5) of the TG Act enables a medical practitioner to be granted authority to become an AP of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition.

What else is changing?

Notably, the definition of ‘advertising’ is also changing.

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 repeals the current definition of ‘advertisement’, and replaces it with the definition of ‘advertise’.

Advertise’, in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

  1. is on the label of the goods; or
  2. is on the package in which the goods are contained; or
  3. is on any material included with the package in which the goods are contained.

The proposed definitional change is reflected in all provisions that currently refer to ‘advertisements’ or ‘advertising’ and previous references to ‘publish’ or ‘broadcast’ are to be removed.

The inclusive list of what constitutes ‘advertising’ leaves open the possibility of other examples of what it means to ‘advertise’. It is clear that the definition of ‘advertise’ is intended to maintain a wide compass.

We anticipate the Bills will be passed next year. The proposed reforms to advertising will no doubt change how companies choose to advertise therapeutic goods, particularly unapproved therapeutic goods.