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A proposed new model for the scheduling of medicines and poisons within the Joint Agency
This document was released in July 2005 for comment and comments closed on 9 September 2005. It remains on this website as a historical reference.
The information on this page relates to the following consultation papers:
- A proposed model for the scheduling of medicines (pdf,92kb)
- A proposed model for the scheduling of poisons in Australia (pdf,81kb)
- Draft scheduling policy framework for medicines and poisons (pdf,133kb)
Current scheme in Australia
Presently, scheduling decisions on medicines and poisons are made by the National Drugs and Poisons Schedule Committee (NDPSC), which is a statutory committee under the therapeutic goods legislation. These decisions are included in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and implemented in State/ Territory legislation by reference or other means.
Considerations for the development of a new model
The Galbally Review
In Australia, the COAG1 Review of Drugs, Poisons and Controlled Substances Legislation (the Galbally Review) was undertaken in 1999-2000 to examine State and Territory drugs, poisons and controlled substances legislation in relation to obligations under National Competition Policy and the Competition Principles Agreement.
One of the terms of reference of the Galbally Review was to consider the processes and arrangements for decisions on scheduling. The Review process included extensive consultation with stakeholders, including submissions and face-to-face meetings. In reviewing the submissions to the Galbally Review which are relevant to scheduling there were a number of common calls for changes to certain aspects of the current scheduling arrangements, including the need for:
- national uniformity in implementing scheduling decisions and dates of effect;
- the timely finalising of NDPSC decisions;
- better coordination of decisions on registration of medicines and scheduling;
- separate committees to be established to consider scheduling of poisons and the scheduling of medicines;
- equal voting rights for all members of these committees; and
- support for the scheduling standard to be more readily accessible to users.
In considering these stakeholder comments, the report of the Galbally Review recommended that:
- all States and Territories adopt all scheduling decisions by reference (Recommendation 4);
- the National Drugs and Poisons Scheduling Committee (NDPSC) be disbanded and replaced with two separate committees, one responsible for medicines and the other responsible for poisons (ie agricultural, veterinary and domestic chemicals), (Recommendation 7);
- relevant registration authorities to make scheduling recommendations to these Committees; and
- cost recovery of activities associated with scheduling be introduced.
1. COAG is the Council of Australian Governments
At the time of the release of the Galbally Review, the various options for addressing the exemption for therapeutic goods under the Trans Tasman Mutual Recognition Act were still being discussed. Hence, the Review did not consider these recommendations in the context of the Treaty which has been since been signed between the Australian and New Zealand Governments to establish a single regulatory agency for therapeutic products (the Agency). The AHMAC Working Party response to the recommendations of the Galbally Review therefore propose that these recommendations be progressed in a trans-Tasman environment.
The Treaty provides for the Agency to develop and maintain a scheduling framework for medicines which will apply in Australia and New Zealand. It is therefore necessary for Australia and New Zealand to agree on a scheduling model for medicines which is suitable for both countries.
The need for a consistent approach to the scheduling of medicines and poisons
The National Co-ordinating Committee on Therapeutic Goods (NCCTG) is the inter-jurisdictional sub-committee of the Australian Health Ministers' Advisory Council which currently has responsibility for overarching policy guidance and protocols for scheduling in Australia. In considering a new model for scheduling, the Australian States and Territories (as represented on the NCCTG) have agreed that the scheduling model for medicines and the scheduling model for poisons should be as closely aligned as possible in the interests of consistency and supporting a national outcome.
Objectives of the new scheduling model
The proposed new scheduling model is not part of a national reform agenda for the scheduling of medicines and poisons but rather is intended to be a model which builds upon the current arrangements in implementing the recommendations of the Galbally Review in a trans-Tasman context.
The present scheduling model in Australia is based on the fundamental principle that Commonwealth legislation provides for a scheduling standard to be developed to facilitate national uniformity and relevant Australian State/Territory legislation implements the scheduling decisions as reflected in the scheduling standard. There is no mandate to change this arrangement under the new therapeutic products legislation, other than to provide for New Zealand legislation to also adopt the scheduling standard for medicines, in as much as possible.
Against this background, the Australian Health Ministers' Conference (including New Zealand) has agreed to implement a model for the scheduling of medicines and poisons in Australia which is consistent with the recommendations of the Galbally Review and the trans-Tasman medicines scheduling scheme. This model has been developed by the NCCTG in consultation with the Australian Department of Agriculture, Fisheries and Forestry and the Director of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).
The proposed scheduling model has four key objectives:
- support for harmonised trans-Tasman scheduling arrangements for medicines;
- to provide for the maintenance of the scheduling standard within the Joint Agency;
- implementation of the Galbally Review recommendations relevant to scheduling;
- to address the other key weaknesses of the current model identified by stakeholders during the Galbally Review consultation process, in so far as possible.
Call for comment
Comments from stakeholders were invited on the proposed new scheduling model and the scheduling policy framework.
Comments received will be considered by the National Co-ordinating Committee on Therapeutic Goods, which will then finalise the scheduling policy framework and agree on any recommendations which should be made to Health Ministers to change the proposed scheduling model.
The final scheduling model will need to be given legal underpinning in the draft Rules and Australian-only Regulations for the new legislation, specifically in regard to the role and powers of the Agency, the role and membership of the scheduling committees, scheduling processes, public consultation arrangements and rights to review. The scheduling of poisons relates only to Australia and would therefore be dealt with in Australian-only Regulations.
These draft Rules and Regulations to implement the approved scheduling model will be released for public comment, together with the other Rules and Regulations which will give legal effect to the broader joint scheme, later in 2005.
Draft scheduling standard
Please note that a new draft scheduling standard is also being developed by NCCTG and stakeholders in Australia will be invited to submit comments as soon as the draft for consultation is finalised. This document will mirror the current SUSDP in that it will include Chapters on interpretation, labelling and containers and miscellaneous regulations plus a number of appendices and will be drafted so as to implement a number of the Galbally Review recommendations. It is expected that the Australian States and Territories will adopt these Chapters and appendices by reference into their drugs and poisons legislation, in as much as possible.
In response to calls from stakeholders, the scheduling standard is also to be redeveloped into an electronic format which will be included on the Agency website. Users will be able to readily search and print the scheduling entries.
In moving from the hard-copy SUSDP to a new web-based scheduling standard, it is intended that the previous scheduling decisions of the NDPSC will be retained. However, where a current single entry in the SUSDP is qualified dependent on the use of the substance, the single entry will be split into two or more entries which will be specific to the purpose of use (ie as a medicine, ag/vet chemical, industrial/domestic chemical).
Fees and charges
Consultation on the fees and charges associated with scheduling activities is a separate process which will be conducted as part of the broader consultation arrangements for fees and charges for the Agency.