Amendments to the Therapeutic Goods Act 1989

The Therapeutic Goods Amendment Act (No. 1) 2003 received royal assent on 27 May 2003. The purpose of these amendments to the Therapeutic Goods Act 1989 (the Act) is to tighten the existing requirements placed on manufacturers and sponsors of therapeutic goods to further ensure the quality, safety and efficacy of therapeutic goods that are supplied in Australia or exported from Australia.

The need for these amendments arises from the recent failure of the manufacturer, Pan Pharmaceuticals Limited, to meet the requirements of good manufacturing practice, and the difficulties encountered in quickly identifying affected therapeutic goods for the purposes of recall.

That case has highlighted the need to more clearly define the responsibilities and obligations of both sponsors and manufacturers of therapeutic goods, and the need for such persons to be held more accountable for their statutory responsibilities and obligations.

The offences and penalties require strengthening to provide a more adequate deterrent to breaches of standards and other statutory requirements designed to maintain the safety and quality of therapeutic goods. However, penalty levels are higher than for similar offences in the Criminal Code, such as falsifying documents, because of the potential to expose the general public to an unacceptable level of risk.

Please note that only the changes relating to the Pan Pharmaceuticals recall came into effect on Royal Assent. The advertising changes and change to the definition of 'therapeutic goods' will come into effect when proclaimed.

A copy of the changes to the Act and the explanatory memorandum can be found on the Parliament of Australia website <http://parlinfoweb.aph.gov.au/piweb/browse.aspx>.

These amendments will:

• Increase maximum penalties for a range of existing offences under the Act including where there has been a failure to comply with standards, false statements made in applications for entry of goods on the Australian Register of Therapeutic Goods (the Register), breach of a condition of a manufacturing licence (including failure to comply with the manufacturing principles), false statements made in a conformity assessment declaration and the counterfeiting of therapeutic goods;
• Create new offences for falsification of any document that has been created, retained or issued for the purposes of the Act and for supplying goods originating from a manufacturer or manufacturing site that has not been notified to the Secretary;
• Expand the compulsory public notification and recall provisions which may be used where there is a problem with a product or its manufacture;
• Insert a "fit and proper person" test into the provisions for granting a manufacturing licence or conformity assessment certificate and suspending or revoking a manufacturing licence or conformity assessment certificate;
• Insert new statutory conditions of licence to ensure compliance with the manufacturing principles and reporting of adverse effects known to a manufacturer;
• Require sponsors of therapeutic goods to maintain records of all manufacturers involved in the manufacture of each batch of therapeutic goods and have them available for inspection at any time or risk cancellation of the goods from the Register, as well as requiring them to notify the Secretary of any change of manufacturer;
• Provide for better identification of therapeutic goods in the event of a recall or where a sponsor applies for re-entry of previously cancelled goods on to the Register;
• Improve adverse event reporting for listed goods.