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Tuesday, 31 March 1998
Page: 2056


Mr Andren asked the Minister for Health and Family Services, upon notice, on 10 March 1998:

(1) Is he able to say that recent changes to the Therapeutic Goods Regulations will not prevent access to therapeutic goods.

(2) Will the changed regulations increase restrictions on the ability of the therapeutic goods industry to advertise its products.

(3) Has the Therapeutic Goods Administration (a) confiscated and stopped supply of a natural progesterone cream without explanation and (b) restricted the use of promotional material connected with the product including use of the term `natural progesterone' in labelling.

(4) Has his Department assessed research into the efficacy of natural progesterone treatments and their claimed beneficial outcomes as an alternative to hormone replacement therapies.


Dr Wooldridge (Health and Family Services) —The answer to the honourable member's question is as follows:

(1) I can confirm that recent changes to the Therapeutic Goods Regulations will not prevent access to therapeutic goods.

The requirements for access to therapeutic goods are outlined in the principal legislation—the Therapeutic Goods Act 1989; and the amendments to the Regulations do not alter these requirements.

(2) The changed regulations will not increase restrictions on the ability of the therapeutic goods industry to advertise its products.

The basis of the restrictions upon advertisements for therapeutic goods is the Therapeutic Goods Advertising Code which has evolved from guidelines endorsed by the National Health and Medical Research Council in 1972. The main prohibitions of this Code have been adopted into the Therapeutic Goods Regulations since their commencement in February 1991.

The Therapeutic Goods Advertising Code seeks to prevent advertising of therapeutic goods to the general public for serious or life threatening conditions because such conditions are not amenable to self diagnosis or treatment.

(3) (a) The Therapeutic Goods Administration (TGA) has seized a quantity of illegally imported, unapproved medicine, containing the prescription only drug progesterone. This product did not contain any Dioscorea (the ingredient sometimes referred to as `natural progesterone').

This product was falsely presented as containing Dioscorea, not progesterone.

The importation and supply within Australia of unapproved medicines poses a significant public health risk and is a criminal offence under the Therapeutic Goods Act 1989. The product was lawfully seized under the provisions of a search warrant, issued by a Magistrate.

(b) The TGA has taken action to prevent the further importation, promotion and supply of the above seized product.

The term `natural progesterone' has been adopted as a marketing term by a number of United States based multi-level and direct marketing companies, to promote the sale of creams containing wild yam (Dioscorea). Dioscorea is not a controlled substance in Australia and does not contain progesterone. It is possible, by a series of complex chemical processes to produce progesterone from Dioscorea.

The TGA has taken action against the supplier of a product which was falsely labelled and promoted as a cosmetic containing wild yam (Dioscorea). The product did not contain any wild yam but did contain the prescription-only drug, progesterone. The product was neither a cosmetic, nor a natural therapy product, but was in fact a prescription drug.

(4) No. The Therapeutic Goods Act 1989 establishes a system for the regulation of therapeutic goods.

The Department will only undertake such an assessment if an application is made for inclusion of the product on the Australian Register of Therapeutic Goods. No application has been received to register any `natural progesterone' containing products as alternatives to hormone replacement therapy.