You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Review of drugs, poisons and controlled substances legislation (the Galbally Review)

15 September 2008

The Final Report of the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the 'Galbally Review') and the Australian Health Ministers' Advisory Council (AHMAC) Working Party response to the Review recommendations were unanimously approved by the Council of Australian Governments (COAG) on 28 June 2005.

Background

The Galbally Review examined Australian, States and Territories legislation regulating medicines and poisons against national competition principles. A number of proposals for national uniformity of regulations through legislative reforms were made by the Review.

The Final Report of the Galbally Review was presented to the Australian Health Ministers' Conference (AHMC) in January 2001. A response to the Galbally Review recommendations was prepared by a Working Party of the Australian Health Ministers' Advisory Council in April 2003.

In preparing its response, the AHMAC Working Party took account of the comments of the Primary Industries Ministerial Council (PIMC), as some of the Review recommendations had implications for the regulation of and ag/vet chemicals. The Working Party also took account of the proposal to establish the Australia New Zealand Therapeutic Products Authority (ANZTPA), and recommended that the Review recommendations be implemented in a trans-Tasman context.

The National Coordinating Committee on Therapeutic Goods (NCCTG) oversighted the implementation of the Galbally Review recommendations. A report detailing the implementation of the recommendations through the proposed joint regulatory scheme was prepared by the NCCTG and forwarded to COAG for consideration out-of-session in November 2006.

Most of the Galbally Review recommendations were implemented in 2006-07. With the suspension in negotiations in July 2007 regarding the establishment of the proposed ANZTPA, the NCCTG is now proceeding to implement the remaining Review recommendations on an Australia-only basis.

Implementation of recommendation 5 of the Galbally Review

At its meeting on 18 November 2005, AHMC endorsed a report prepared by the NCCTG on the results of research into A Cost-Benefit Analysis of Pharmacist Only (S3) and Pharmacy Medicines (S2) and Risk-Based Evaluation of the Standards commissioned by the Pharmacy Guild of Australia (PGA) to implement Recommendation 5 of the Galbally Review.

AHMC has agreed to continue separate S2 and S3 schedules for an interim period of 5 years, subject to evidence being supplied to the NCCTG to justify the need for retaining separate over-the-counter schedules. This information is likely to be obtained from a variety of sources, including research commissioned by the PGA.

Recommendation 7 - Administrative arrangements for scheduling

Implementation of Recommendation 7 is being reviewed in light of the scheduling-related recommendations of the Productivity Commission Research Report on Chemicals and Plastics Regulation.

Implementation of recommendation 11 - Price information code of practice

Recommendation 11(c) of the Galbally Review recommended (amongst other matters) that Commonwealth, State and Territory legislation prohibiting direct-to-consumer advertising of prescription medicines be amended to permit the price of Schedule 3, 4 and 8 medicines of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) to be published in a list.

The development of the Price Information Code of Practice (the Price Code) was recommended by the Galbally Review. It was considered that it would be in the public interest to allow the provision of this information to consumers. The intent is to provide consumers with price information only to enable comparison of prices between suppliers and not to promote the use of medicines.

A stakeholder Working Group was subsequently established to oversee the development of the Code setting out the requirements to be met regarding any publication of prices of medicines when directed to consumers. The Working Group comprised representatives of the Pharmacy Guild, the Pharmaceutical Society of Australia, the Council of Pharmacy Registering Authorities, the Therapeutic Goods Advertising Code Council, Medicines Australia, the Australian Self Medication Industry, the Generic Medicines Industry Association, the Consumers' Health Forum, New South Wales and Western Australia State Governments, and the Therapeutic Goods Administration.

The Price Information Code of Practice (the Code) came into effect in all States and Territories other than Queensland - on a voluntary basis - on 1 February 2007. The Price Code already legally applied in Queensland at that time. From 25 February 2008, the Price Code also legally applied in New South Wales.

The Price Code permits the publication of prices of medicines listed in Schedules 3, 4 and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The Price Code does not regulate the provision of price information for medicines that are permitted to be advertised, such as over-the-counter medicines in Schedule 2 of the SUSDP, medicines in Schedule 3 that are in Appendix H of the SUSDP, or medicines that are exempt from scheduling.

Review of drugs, poisons and controlled substances legislation final report

How to access a pdf document

*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

AHMAC working party response

AHMAC Working Party Response to Review of Drugs, Poisons and Controlled Substances Legislation (the Galbally Review) (pdf,180kb)