Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1995 NO. 253

STATUTORY RULES 1995 No. 253

Issued by Authority of the Minister for Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Section 63 of the Act enables the Governor-General to make regulations prescribing matters necessary or convenient to be prescribed for carrying out or giving effect to the Act. In particular Paragraph 63(2)(c) prescribes requirements for the advertising of therapeutic goods.

Regulation 6 of the Therapeutic Goods Regulations (the Regulations) prohibits certain forms of advertisement for therapeutic goods. In particular, paragraph 6(1)(a) prohibits the publication of any advertisements that contain prohibited representations about therapeutic goods, as outlined in Schedule 2 of the Regulations. Paragraph 6(1)(e) prohibits the publication of advertisements about therapeutic goods included in Schedule 3, 4 or 8 to the Poisons Standard (the Standard for the Uniform Scheduling of Drugs and Poisons). These are mainly drugs available from pharmacists, prescription drugs or drugs of dependence. Regulation 6(1A) provides for an exception to these prohibitions where the advertisement is made by, or on behalf of, the Commonwealth.

The need for this amendment has arisen as a result of the need for the Commonwealth to undertake public interest advertising of pharmaceuticals in support of Government policy initiatives and in particular to inform consumers of their rights in brand substitution. To undertake effective public information in this area advertisements need to refer to pharmaceutical products by brand name and to set out the indications for which those products can be used. A public information campaign on brand substitution and cost savings which consumers can achieve, will be launched shortly and the amendment was required to ensure that there is no conflict between this and any subsequent public interest advertising and the provisions of the Therapeutic Goods Regulations.

The proposed Regulations commenced on Gazettal.