Senator O'CHEE —On behalf of the Standing Committee on Regulations and Ordinances, I give notice, that 15 sitting days after today, I shall move:

That the Therapeutic Goods Regulations (Amendment), as contained in Statutory Rules 1997 No. 400 and made under the Therapeutic Goods Act 1989 be disallowed.

That the Therapeutic Goods Regulations (Amendment), as contained in Statutory Rules 1997 No. 401 and made under the Therapeutic Goods Act 1989, be disallowed.

I seek leave to make a short statement about the committee's concerns with these regulations.

Leave granted.

Senator O'CHEE —I thank the Senate. The committee's concerns with these regulations include an unclear definition, an unclear provision, an unfair provision and matters which may be more appropriate for parliamentary enactment. I seek leave to incorporate in Hansard a short summary of the matters raised by the committee.

Leave granted.

The summary read as follows—

Therapeutic Goods Regulations (Amendment) Statutory Rules 1997 No 400

These Regulations establish a pre-clearance scheme for advertisements to be published in mainstream print media about non-prescription drugs, herbal remedies and the like.

The definition of mainstream media in r.5B is unclear. For one thing, it refers to any magazine or newspaper for consumers but does not indicate what class of person is included within the notion of consumers. The definition might also be regarded as unnecessarily broad.

New rr.5K and 5L permit the Secretary to vary the conditions of an approval, or to withdraw an approval. The Committee notes that those decisions are subject to review by ministerial and AAT review. Subregulation 5M(6), however, provides that a request for a review of the Secretary's decision does not affect the operation of that decision. Neither rr.5K or 5L prevent the Secretary from issuing a notice of variation or withdrawal with immediate effect, which could have unfair financial implications for the intending advertiser of the relevant product.

Regulation 19 provides for the fees that are to be charged on an application for approval of an advertisement, but the Explanatory Statement does not indicate the basis on which those fees have been set. Furthermore, paragraph (c) of the regulation refers to an advertorial, which is presumably something other than an advertisement, and for which there is no warrant in the regulations for charging fees since advertorials do not need approval under r.5F.

Therapeutic Goods Regulations (Amendment) Statutory Rules 1997 No 401

These Regulations prohibit anyone from claiming that any therapeutic goods are drug free.

The two sets of regulations provide for important matters affecting the general administration of therapeutic goods. These appear to be of sufficient importance that it may be more appropriate to address them through amendment of the enabling Act, where the changes would be subject to full parliamentary debate.