Review of drugs, poisons and controlled substances legislation

The Galbally Review

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. The AHMC was required by the terms of reference of the Review to forward the report to COAG with its comments. An AHMAC Working Party was established in February 2001 to assist with the preparation of the comments on the Report for COAG.

As a number of the Galbally Review recommendations potentially impacted on the management of agricultural and veterinary chemicals, the AHMAC Working Party also consulted the Primary Industries Ministerial Council (PIMC) in preparation of the response. The response was endorsed by the AHMC out-of-session in November 2003 and was considered by COAG, along with the final report of the Review, also out-of-session.

Agreement by the Council of Australian Governments to move closer towards a national uniform system of regulation of medicines and poisons was recognised as bringing significant administrative efficiencies and cost-savings. While the target timeframe for implementation of the Galbally Review recommendations (as accepted in the response) is within twelve months from the time of COAG endorsement, many of the recommendations which involve legislative change are to be implemented for the commencement of the Australia New Zealand Therapeutic Products Authority.

A Report on the implementation of the Galbally Review Recommendations is currently under consideration by COAG out-of-session.

Implementation of recommendation 5 of the Galbally Review

At its meeting on 18 November 2005, AHMC endorsed a report prepared by the National Coordinating Committee on Therapeutic Goods (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 <http://www.tga.gov.au/meds/s2s3report.htm>, commissioned by the Pharmacy Guild of Australia 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, in consultation with key stakeholders.

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 (other than those medicines listed in Appendix H), 4 and 8 medicines of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) to be published.

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 <http://www.tga.gov.au/meds/vipicop.htm> (the Code) will come into effect on a voluntary basis from 1 February 2007. The Price Code will permit 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.