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Regulatory impact statement for a price information code of practice
4 August 2005
Following a review of the comments received on the most appropriate regulatory mechanism for providing price information on prescription and some non-prescription medicines to consumers, the National Co-ordinating Committee on Therapeutic Goods has agreed that a Price Information Code of Practice should be implemented.
The Price Information Code of Practice (the 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). Medicines that are un-scheduled or that are included in Schedule 2 or Appendix H of Schedule 3 of the SUSDP, are not generally regulated by the draft Code except where they are included in price lists with those medicines to which it applies.
The development of the Code was recommended by the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation ("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.
Some terminology in the draft Code reflects current regulatory legislation, and will be amended consistent with the Trans-Tasman legislation once that is implemented. The final Code is subject to endorsement by the National Co-ordinating Committee on Therapeutic Goods (NCCTG) as a sub-committee of the Australian Health Ministers' Advisory Council and the Australian Health Minister.
The final Regulation Impact Statement (the RIS) includes a description of the comments received and the draft Code. The RIS is designed to help determine the most appropriate regulatory mechanism, if any, for the provision to consumers of price information about certain categories of medicines specified above. The draft Code was one of three regulatory options considered in the RIS.
The Code will have legal underpinning through the new Australian only Regulations which will allow pharmacists or dispensing doctors to provide consumers with price information about these medicines, on condition that it is provided in a way that complies with the Code.
- Problem identification
- Regulatory options
- Assessment of impacts
- Conclusion and recommended option
- Implementation and review
- Price Information Code of Practice
- Recommendation 11 of the Galbally Review
- Submissions received to the consultation on the draft Code and RIS.29
- Key issues raised by stakeholders