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Focus: Changes continue for therapeutic goods regulation

9 April 2010

In brief: Some amendments under the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (Cth), the third in a series of legislative measures affecting therapeutic goods legislation, have recently commenced, with others coming into effect on 1 July 2010. The amendments affect scheduling procedures, the inclusion of medical devices in the Australian Register of Therapeutic Goods, advice on genetically modified organisms, and advertising and labelling. Partner Sarah Matheson (view CV) and Lawyer Nikki Macor report.

How does it affect you?

  • From 1 July 2010, the Secretary to the Department of Health and Ageing will have responsibility for amending the Poisons Standard to alter the scheduling of medicines and chemicals. In this regard, the Secretary may be advised by one or both of two new advisory committees for medicines and for chemicals respectively, or 'any person'.
  • As of 29 March 2010, labels on (typically over the counter or off the shelf medicines must contain any relevant advisory statement the Minister specifies.

Background

The Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (Cth) (the amending Act) received Royal Assent on 29 September 2009. The amendments to the Therapeutic Goods Act 1989 (Cth) (the TG Act) come into effect between 30 September 2009 and 1 July 2010. Draft regulations setting out further procedures for the scheduling-related amendments have also been released (the draft Regulations).

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Scheduling

Currently, decisions regarding the scheduling of therapeutic goods are made by the National Drugs and Poisons Schedule Committee (the NDPSC) and incorporated into the Poisons Standard for adoption by the states and territories. The NDPSC considers the scheduling both of medicines and other chemicals.

The Amending Act provides for the Secretary to take responsibility for making decisions to amend the Poisons Standard, which will continue in a similar form. These amendments will commence on 1 July 2010 and a compulsory six-month review of the operation of the relevant part of the TG Act must commence by mid-2013.

The definition of 'substance' is amended to specify comprehensively the substances that the Secretary may consider for scheduling, and that the new committees may consider in order to advise the Secretary. The change in definition from the broad 'any medicine or poison' may result in a narrowing of the substances that will be eligible for scheduling consideration.

The advisory committees will be named the Advisory Committee on Medicines Scheduling (the Medicines Committee) and the Advisory Committee on Chemicals Scheduling (the Chemicals Committee) (together, the Committees). The functions are exclusively in relation to substances, or classes of substances (eg antibiotics) to the extent that they are, or in relation to some functions are included in, therapeutic goods (the Medicines Committee), or goods other than therapeutic goods (the Chemicals Committee).

Generally speaking, those functions relate to making recommendations to the Secretary regarding scheduling, the Poisons Standard, restrictions on particular substances and any other matter the Secretary refers to them. The Draft Regulations set out the requirements for membership of each of the Committees, requiring expertise in at least one of a number of specified fields relevant to the speciality of the particular Committee. For example, expertise in toxicology or pharmacology, or clinical pharmacology, is recognised for inclusion on the Medicines Committee, while veterinary medicine, veterinary pathology or toxicology experts are acceptable members of the Chemicals Committee.

The Secretary's power to amend the Poisons Standard, either on the Secretary's own initiative or following an application by a person for amendment, must be exercised only on taking into account specific matters, including:

  • the risks and benefits of using a substance;
  • the purpose for which it is to be used;
  • its toxicity;
  • the dosage, formulation, labelling, packaging and presentation;
  • the potential for abuse; and
  • any other matters the Secretary considers necessary.

The Secretary must also comply with any guidelines of the Australian Health Ministers' Advisory Council and its subcommittee, the National Coordinating Committee on Therapeutic Goods (the NCCTG). The NCCTG's Scheduling Policy Framework (the SPF), currently published in draft form, is one such set of guidelines.

The Secretary may seek advice from the Committees, and must consider any recommendations or advice of the Committees, but such recommendations or advice are not binding. The Secretary may also seek the advice of another committee or 'any person'; for example, an international expert.

The Draft Regulations set out procedures by which public consultation is to take place. The SPF sets out further detail regarding factors to be considered, when advice is to be sought from the Committees and public consultation. In particular, the SPF provides that for the scheduling of new substances, the Secretary may seek the Committees' advice, whereas for rescheduling of a substance, the Secretary must do so. The SPF also acknowledges that the Secretary's decision-making powers are likely to be exercised in practice by the Therapeutic Goods Administration (the TGA) (for medicines) and the Office of Health Protection (for chemicals), although the TGA will serve as secretariat for both Committees.

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Labelling

As of 29 March 2010, the Minister may, by legislative instrument, specify advisory statements in relation to medicines. Labels on medicines will be unacceptable if they do not contain any relevant specified advisory statement. The medicines to which such labels would need to be applied generally include over the counter or off the shelf medicines. The Explanatory Memorandum notes that advisory statements include, for example, 'If symptoms persist beyond 5 days consult a doctor'.

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Purpose declarations for medical devices

Prior to the Amending Act, a medical device that satisfied all of the application and certification requirements under the TG Act was required to be included in the Australian Register of Therapeutic Goods (the ARTG). As of 30 September 2009, the Secretary may declare purposes for which kinds of medical devices cannot be included in the ARTG. A medical device will not be able to be included in the ARTG if the Secretary is satisfied it is to be used exclusively for one or more of the specified purposes. Applicants for the inclusion of medical devices in the ARTG will be required to certify that devices of that kind are not to be used exclusively for a specified purpose. Devices that are intended for two purposes, only one of which is a specified purpose, may be included in the ARTG only for the purpose that is not specified.

The Secretary's power is likely to be exercised to prevent use of otherwise effective medical devices in unsafe or harmful ways; in particular, home testing kits for serious conditions where expert support is required.1

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Genetically modified organisms and consultation

As of 30 September 2009, there has been a definition of 'genetically modified organism' in the TG Act, that term having the same meaning as in the Gene Technology Act 2000 (Cth).

The Secretary may now request advice from the Gene Technology Regulator in regard to applications for listing or registration of therapeutic goods (other than medical devices) that are, or contain, a genetically modified organism, as well as a genetically modified product.

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Advertising

Since 30 September 2009, it has been an offence for any person, not just the sponsor, to advertise a therapeutic good (other than a medical device) inappropriately.

Inappropriate advertising refers to advertising for an indication that is not an indication accepted in relation to the inclusion of that therapeutic good on the ARTG. There is now also an offence for false advertising in relation to medical devices; that is, advertising for a purpose that is not an accepted purpose for the inclusion of that device on the ARTG.

Footnotes
  1. Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 (Cth) Explanatory Memorandum, p.2.

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