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Focus: Changes to regulation of therapeutic goods

23 June 2009

In brief: Federal Parliament is changing the regulation of therapeutic goods. The first of three Bills before Parliament, the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008, received Royal Assent on 17 June 2009, and the others are likely to be passed during the next sitting. Partner Sarah Matheson (view CV) and Senior Associate Ric Morgan report.

How does it affect you?

  • Exemptions allowing emergency stockpiling by government now extend beyond medicines to medical devices, and may be kept secret.
  • The 'fit and proper persons' criteria will be more objective and, in some circumstances, more onerous.
  • The applicable standard for medicines may be drawn from the European and United States Pharmacopeia, as well as from the British Pharmacopeia.
  • The requirement for advertising approval applies to a broader range of media.
  • Wider public access is permitted to information held by the Therapeutic Goods Administration (the TGA).

Background

The Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 was passed on 27 May 2009, and received Royal Assent on 17 June 2009. This is the first of three Bills that will change the Therapeutic Goods Act 1989 (Cth) (the Act) in a wide range of areas.

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Emergency stockpiling of medicines

Exemptions to allow emergency stockpiling of medicines no longer have to be made by legislative instrument, thereby removing such exemptions from parliamentary scrutiny. Exemptions may be kept secret for the purposes of national security, the argument being that knowledge of stockpiles of particular medicine could assist with the planning of bioterrorism.

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Emergency stockpiling of medical devices

The Minister may exempt particular medical devices from the requirements of the Act, where they need to be stockpiled to:

  • prepare for a potential threat to public health caused by a possible future emergency; or
  • deal with an actual threat to public health caused by an emergency.

These provisions mirror existing stockpiling provisions for medicines and allow the Minister to impose conditions on the exemption. While the exemptions are to be published in the Gazette, there is no requirement that they be tabled and, hence, no parliamentary scrutiny.

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'Fit and proper person' test

The current requirement for manufacturing licences for medicines and conformity certificates for medical devices is that the applicant (or its managers and major interest holders) is a 'fit and proper person'. From no later than 17 December 2009, the requirement will be that the applicant has not:

  • been convicted of an offence against, or ordered to pay a pecuniary penalty in relation to, the Act or a breach of a law involving fraud or dishonesty;
  • breached a condition of a manufacturing licence; or
  • had a manufacturing licence suspended or revoked.

Further criteria may be included in the regulations.

While clearer than the 'fit and proper person' test, the new test may be more onerous in some circumstances. For example, the breach of a condition, or the suspension or revocation of a manufacturing licence, would not ordinarily mean a person is not a 'fit and proper person'.

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European, United States or British Pharmacopeia

From 1 July 2009, any of the European, United States or British Pharmacopeia may be used as the standard for a medicine, giving manufacturers and importers of therapeutic goods a wider choice of standards. The Minister retains the ability to determine the standard for a particular substance and, hence, overrule the standard set out in any Pharmacopeia or determine that only one such Pharmacopeia may be used as the standard.

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Release of information

Public access to information relating to therapeutic goods held by the TGA has increased, as follows.

  • A specific public access right to information will be included in the Act, removing any doubt about the public's right to access the Australian Register of Therapeutic Goods (the ARTG).
  • Language that can be construed as restricting the ability to transfer information relating to therapeutic goods between government authorities and departments will be removed.
  • The TGA may release information provided to it by a sponsor (eg the manufacturer or supplier) and any information generated within the TGA.
  • The Minister may specify particular releases of information. While such decisions will be in the form of legislative instruments and, hence, subject to parliamentary scrutiny, it opens up the possibility of disclosure of confidential information provided to the TGA.

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Regulation of advertising

Previously, the Act only required pre-approval of advertisements of therapeutic goods for 'mainstream' media. Now the pre-approval requirement also includes broadcast media, cinematograph films and displays about goods, including posters.

The TGA has an additional power to prohibit any publication or broadcasting of an advertisement that contains a false or misleading representation about a therapeutic good, even where it would otherwise be allowed.

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Further amendments likely

The two further Bills before Parliament, the Therapeutic Goods Amendment (2009 Measures No 1) Bill 2009 and the Therapeutic Goods Amendment (2009 Measures No 2) Bill 2009, will provide for:

  • the suspension of medicines from the ARTG due to temporary safety issues;
  • more onerous manufacturing licences;
  • greater inspection powers;
  • regulation of homeopathic and anthroposophic medicines;
  • changes to the process of listing permitted ingredients;
  • separation of the classification of medicines and poisons; and
  • a new regulatory framework for biologicals, including human cellular and tissue therapy products.

We will provide further updates as these changes pass through Parliament.

Published 23 June 2009

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