15 July 2005
Key Points:
Under the proposed new model a single harmonised model will apply in both Australia and New Zealand for the scheduling of medicines for human use and in Australia for the regulation of poisons. However in New Zealand the scheduling of poisons will continue to be regulated by the Environmental Risk Management Authority.
The Therapeutic Goods Administration recently released a proposed model for the scheduling of medicines and poisons under the proposed trans-Tasman joint agency and is seeking public comment on the proposal. The deadline for receipt of submissions is 2 September 2005.
Current regime
The National Co-ordinating Committee on Therapeutic Goods ("NCCTG"), a sub-committee of the Australian Health Ministers' Advisory Council ("AHMAC"), is responsible for policy and protocol matters relating to scheduling of medicines and poisons in Australia.
Under the current regime in Australia, decisions in relation to the scheduling of medicines and poisons are made by the National Drugs and Poisons Schedule Committee ("NDPSC"). The NDPSC decisions are included in the Standard for the Uniform Scheduling of Drugs and Poisons ("the SUSDP") and implemented in State and Territory legislation.
Proposed model
The proposed model has been developed by NCCTG, in conjunction with the Australian Department of Agriculture, Fisheries and Forestry and the National Industrial Chemicals Notification and Assessment Scheme ("NICNAS"). The proposed new model attempts to incorporate the relevant recommendations of the Galbally Review (see below) in the context of the recent trans-Tasman developments.
Under the proposed new model, a single harmonised model for the scheduling of medicines for human use will apply in both Australia and New Zealand. However, while the procedure for the scheduling of poisons will be largely consistent across the two countries, the proposed new model for the scheduling of poisons will apply only in Australia. The Environmental Risk Management Authority will continue to regulate poisons in New Zealand.
The Galbally Review
In 1999-2000, the Galbally Review was undertaken to examine drugs, poisons and controlled substances legislation throughout Australia. This review highlighted the need for changes to the current approach, including the need for greater consistency across Australia in implementing scheduling decisions. The Review also highlighted the need for the scheduling system to be made more user-friendly and to separate the decision making process relating to medicines and poisons.
The Report following the Galbally Review recommended the dissolution of the NDPSC and the establishment of two distinct committees, one to deal with medicines and one to deal with poisons (agricultural veterinary and domestic).
Impact of trans-Tasman developments
The Galbally Review predated the decisions of the Australian and New Zealand governments to establish a joint regulatory agency for therapeutic products and to develop a scheduling system for medicines appropriate for both countries. Its recommendations, therefore, were focussed on changes to be made to the current scheduling regime in Australia and did not include a trans-Tasman context.
The proposed new model recognises the need for the Galbally Review recommendations to be implemented in the context of the trans-Tasman developments, and for any new scheduling model to be consistent across and appropriate for both Australia and New Zealand.
What are the objectives of the proposed new model?
The TGA suggests that the proposed new scheduling model has the following objectives:
How will the new system work?
The NCCTG will continue to operate as a sub-committee of the AHMAC, and will continue to be responsible for policy and protocol matters in relation to the scheduling of medicines and poisons.
The trans-Tasman agency will be responsible for all decisions on the scheduling and rescheduling of medicines (defined to mean the active ingredient in a therapeutic product) for Australia and New Zealand and for all decisions on the scheduling and rescheduling of poisons in Australia.
All scheduling decisions will be published in electronic form in a Standard for the Uniform Scheduling of Medicines and Poisons. This Standard will be in the form of a database to enable New Zealand to adopt the scheduling entries relevant only to medicines.
Two expert committees are to be established to provide the trans-Tasman agency with advice on scheduling.One is for medicines for human therapeutic use and prohibited substances, namely the Medicines Scheduling Committee ("MSC"); the other is for poisons, namely the Poisons Scheduling Committee("PSC"). The resources of NICNAS will be available to the trans-Tasman agency through the Office of Chemical Safety which will continue to provide advice on the potential risks of chemicals used in the Australian community.
These committees will review all applications for the scheduling of medicines and/or poisons, and any submissions received during the public consultation process. The committees, based on that review and a review of any Guidelines issued by AHMAC and New Zealand Ministry of Health, will make a recommendation on the classification most appropriate for the product being considered to the trans-Tasman agency.
When making scheduling decisions, the trans-Tasman agency will be obliged to take into consideration the recommendations of the relevant scheduling committee. Decisions of the trans-Tasman agency will be subject to internal review .
Where the trans-Tasman agency requires advice on particular scheduling issues which involve both medicines and poisons, the trans-Tasman agency may establish a joint working committee, consisting of members of both the MSC and the PSC. This joint committee will inquire into the appropriate classification of the product in question and report back to the trans-Tasman agency.
Written submissions
Stakeholders are invited to comment on the proposed model and suggest changes. Comments will be considered by the NCCTG, which will then make a decision on the new scheduling policy to be implemented.
Clayton Utz would be pleased to assist any stakeholders who may be interested in making submissions either on a named or unnamed basis.
