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Biotech News AHMAC proposes new model for scheduling of drugs and poisons In brief: Lawyer Clare Cunliffe reviews the Australian Health Minister's Advisory Council's new draft model for the scheduling of drugs and poisons in Australia. |
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- The Current Scheme
- Background to Proposed Amendments
- What changes are proposed?
- Your chance to comment on the new scheduling model
- Conclusion
The Current Scheme
At present, the National Drugs and Poisons Schedule Committee (NDPSC) make scheduling decisions on medicines and poisons. Decisions are included in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and implemented in State / Territory legislation.
Background to Proposed Amendments
The Galbally Review
In 1999-2000, the COAG Review of Drugs, Poisons and Controlled Substances (the Galbally Review) reviewed State and Territory legislation on drugs, poisons and controlled substances in light of the obligations imposed by the Competition Principles Agreement and national competition policy.
A number of recommendations were made as a result of the Galbally Review including:
- that all States and Territories should adopt scheduling decisions by reference;
- that the NDPSC should be disbanded and replaced by two committees: a committee for medicines and a committee responsible for agricultural, veterinary and domestic chemicals;
- registration authorities should make scheduling recommendations to the relevant committees; and
- a regime to recover the costs of scheduling should be implemented.
A working party was formed from the Australian Health Minister's Advisory Council (AHMAC) to consider the Galbally Review recommendations. The relevant sub-committee of AHMAC, the National Co-ordinating Committee on Therapeutic Goods (NCCTG) has now responded to the recommendations of the Galbally Review.
The Trans-Tasman Treaty
After the Galbally Review made its recommendations, the Australian and New Zealand Governments signed a treaty (the Treaty) to establish a single trans-Tasman regulator (the Regulator) for therapeutic products. The Treaty provides that the Regulator will develop and maintain a medicines scheduling model which will apply in Australia and New Zealand. The AHMAC Working Party has taken account of the Treaty in its response to the recommendations of the Galbally Review.
What changes are proposed?
Changes to the scheduling model
Presently, Commonwealth legislation provides for a national scheduling standard for medicines (the Medicines Standard) to be developed. The Standard is then adopted by the States and Territories by legislation.
Under the new proposal, this model will be retained, except that:
- provision will be made for New Zealand to adopt the Medicines Standard by legislation. Australia and New Zealand will not harmonise their approach to agricultural, veterinary and domestic chemicals.
- the Regulator will maintain the Medicines Standard
The proposal also implements those recommendations of the Galbally Review which are relevant to scheduling and addresses some of the other weaknesses of the current model.
More information on the proposed model is available from the TGA website at www.tga.gov.au
A new scheduling standard
The NCCTG is developing a new draft scheduling standard. The standard will be structured in a similar manner to the existing SUSDP, but will incorporate some of the recommendations of the Galbally Review.
It is anticipated that the States and Territories will adopt the new standard into legislation by reference where possible.
The scheduling standard will also be redeveloped into an electronic format.
Fees and charges
Cost recovery for scheduling activities will be considered as part of a broader consultation process reviewing fees and charges for the Regulator.
Your chance to comment on the new scheduling model
The NCCTG has asked for comments from stakeholders on the new model and policy framework by 2 September 2005. Once the framework and model are agreed, the model will be implemented by rules and regulations.
The rules and regulations will be released for public comment in late 2005.
The NCCTG will also invite submissions on the new draft scheduling standard as soon as it is drafted.
Conclusion
The new proposals by the NCCTG deal with some, if not all, of the issues raised by the Galbally Review. Stakeholders will continue to watch with interest as the NCCTG finalises its model and standard.
For further information please contact Dr Trevor Davies on +61 2 9230 4007.
