Article by TGA
What is proposed?
It is proposed that the Standard for the Uniform Scheduling of Medicines and Poisons (the SUSMP or the Poisons Standard) be amended to place some cannabis-derived substances, when used in particular ways, in Schedule 8 of the Standard.Potential down-scheduling to S8 still allows very strict controls on access to the substances. A number of other therapeutically used-substances which have risk of addiction or criminal diversion such as cocaine or morphine are also included in schedule 8.
Cannabis and THC (a psycho-active component of cannabis) currently sit in Schedule 9, which means access for their use is extremely restricted.
Why is this being proposed?
On 17 October 2015, the Commonwealth Government announced that it will seek parliamentary approval of amendments to the Narcotic Drugs Act 1967 to establish a national scheme to allow the cultivation of cannabis for medicinal purposes. However, the access to these products – including handling, transportation and storage – is controlled by their scheduling status under the Poisons Standard. Most cannabis products are currently listed in Schedule 9 of the Poisons Standard which makes supply of product grown and manufactured in Australia very difficult and, in some states, potentially impossible. This scheduling proposal complements the planned amendments to the Narcotic Drugs Act and aims to simplify access for those qualified for such access, while keeping appropriate controls in place to prevent these products from being diverted to illicit uses.
What is the scheduling process?
Scheduling is the national system for applying access restrictions on human and veterinary medicines as well as a range of chemicals where there is a potential risk to public health and safety. Substances are scheduled according to the degree of risk and the level of control required over availability to protect consumers.While decisions on medicines scheduling are made by a delegate, who is a senior medical officer, in the Commonwealth Department of Health, the implementation of scheduling decisions is the responsibility of state and territory governments. The state and territory government are responsible for imposing legislative controls on the supply of substances and the controls these governments impose usually flow from the schedule in which the poison is located.
The policy is outlined in the Australian Health Ministers’ Advisory Council Scheduling Policy Framework.
The proposal will be referred to the Advisory Committee on Medicines Scheduling (ACMS) for advice, and after publication on the TGA website today (21 January 2016), public comment is invited prior to committee consideration by close of business 18 February.
After the Committee considers the re-scheduling proposal, public comment and background papers, they will provide a recommendation to the senior medical officer.
Does this public notice mean that substances derived from cannabis will definitely be down-scheduled?
No. The scheduling decision will be made by a senior medical officer (in the capacity as a delegate of the Secretary of the Commonwealth Department of Health). Comments are being sought prior to a meeting of the Advisory Committee on Medicines Scheduling in March 2016. The Committee is made up of independent experts as well as state and territories representatives that provide advice to the scheduling delegate. The scheduling delegate will make an interim decision based on the comments made and the advice from the Committee.
What is the role of states and territories in this?
An entry in the Poisons Standard has no legal effect unless it is adopted through state and territory drugs and poison legislation. If approved, the proposal aims to support a consistent approach that all states and territories can apply to allow the supply of medicinal cannabis in their jurisdiction. It will be up to the individual states and territories how they might wish to implement any final decision.
Why can’t the Therapeutic Goods Act 1989 be used to guarantee a consistent approach to supply of medicinal cannabis products?
The role of the Therapeutic Goods Act relates to the regulation of the supply of therapeutic goods and works in tandem with state and territory legislation on the access to scheduled particular substances. This proposal is designed to facilitate the access pathways already available under the Therapeutic Goods Act for unregistered products.The Therapeutic Goods Act makes provision for the use of unregistered medicines in certain cases where there is medical opinion that it is justified, such as through the Authorised Prescriber Scheme, where a medical practitioner can be authorised by the TGA to prescribe a specific medicine to a specific patient group.
It also allows for the conduct of clinical trials, which are necessary to test new medicines to enable them to be registered by the TGA for general use.
When will a decision be made?
Following the meeting of the ACMS in March, an interim decision will be published seeking further comment. A final decision would then be made before the end of May 2016 and published with an implementation date, if appropriate.However, implementation of the decision in individual states and territories will depend on when and how the decision is adopted into state and territory legislation.
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