Key Points:

Critical legislative reform in relation to the regulation of therapeutic goods are now a reality with recent measures passed by the Federal Government.

The Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 was recently passed by both houses of parliament and will affect the operation of the Therapeutic Goods Act (Cth) 1989 (the TG Act) in a variety of ways. The changes include:

  • the introduction of provisions exempting certain medical devices from the operation of the TG Act so that such devices can be made available for use in an emergency;
  • amendments to the test of whether a person will be a “fit and proper person” to hold a manufacturing licence or a medical device conformity assessment certificate;
  • adoption of the European Pharmacopoeia and United States Pharmacopeia standards under the TG Act;
  • amending provisions relating to the release of information to the public from the Therapeutic Goods Administration (the TGA);
  • clarifying the operation of advertising provisions to ensure that restrictions apply to advertisements in all media; and
  • amending the penalty provisions in the TG Act to bring them in line with current policy.

In addition, a further Act was recently assented to by the Governor-General. The Therapeutic Goods Amendment (2009 Measures No1) Act2009 (Measures Act) is intended to clarify the current regulation of therapeutic goods in Australia. In particular, the Measures Act introduces the following changes:

  • allowing medicines to be temporarily suspended from the Australian Register of Therapeutic Goods (ARTG) to allow for the resolution of safety concerns during the suspension period;
  • requiring, except in limited circumstances, separate manufacturing licences for each site which manufactures therapeutic goods;
  • improving the powers of authorised officers under the TG Act to attend and inspect sites;
  • introducing a new regulatory framework incorporating homoeopathic and anthroposophic medicines from July 2011; and
  • converting lists currently containing permitted and prohibited ingredients into legislative instruments that must be complied with.

Finally, the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 (Measures 2 Bill) was introduced into Parliament in June 2009. The Measures 2 Bill has now been passed by the House of Representatives and is currently under consideration by the Senate. If passed, the Measures 2 Bill will:

  • enable the Secretary of the Department of Health and Ageing to declare purposes for which particular medical devices cannot be included on the ARTG;
  • amend the advertising provisions in the TG Act to create an offence for a person who inappropriately advertises a therapeutic good;
  • introduce separate scheduling arrangements for medicines and chemicals; and
  • implement provisions enabling the Minister to specify advisory statements which must be included on the labels of particular medicines by legislative instrument

These changes reflect the Australian Government's regulatory reform agenda, aimed at improving therapeutic good regulation in Australia.