AHMAC - Scheduling policy framework for medicines and chemicals
Endorsed by AHMAC December 2017
Version 1.0, January 2018
This policy document is to be read in conjunction with the Scheduling Handbook.
The Scheduling Policy Framework (Scheduling Policy) sets out the national policy for applying access restrictions on all "poisons". As defined in the Poisons Standard, poisons include medicines for human therapeutic use, veterinary medicines, agricultural, domestic and industrial chemicals where there is a potential risk to public health and safety.
Poisons are scheduled according to the risk of harm and the level of access control required to protect consumers. State and territory governments are responsible for imposing legislative controls on the supply of poisons. Generally, these controls flow from the schedule in which the poison has been included.
Provisions for the scheduling of medicines and chemicals are set out in the Therapeutic Goods Act, 1989 (the Act) and associated Regulations. They have been developed to ensure operational effectiveness while supporting the existing high level of scheduling uniformity across states and territories.
Responsibilities & obligations
The key aspects of the scheduling of medicines and chemicals in Australia include:
- the Australian Health Ministers' Advisory Council (AHMAC) is responsible for scheduling policy (including this document)
- the Secretary of the Department of Health (in practice his or her delegate/s) is the decision-maker on the scheduling of medicines and chemicals, and other changes to the Poisons Standard
- two Advisory Committees: the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) advise the decision-maker/s
- a single Poisons Standard is produced, typically updated three times annually, and is a Commonwealth legislative instrument
- the States and Territories give effect to the Poisons Standard, usually by reference, through the relevant medicines and poisons legislation.
AHMAC has responsibility for the policy principles on scheduling and other poisons regulatory controls, as set out in this document. The Scheduling Handbook provides further guidance for stakeholders and provides details of the processes that underpin the scheduling policy.
The Scheduling Policy allows decision-makers, expert Advisory Committee(s), evaluators and the delegate to judge the best fit for new substances and to facilitate the rescheduling assessment process when an application for rescheduling is received or new knowledge or practice emerges.
An ad hoc group will be convened as required to review and provide oversight of the guidance and process for scheduling. The Scheduling Policy and Scheduling Handbook documents are maintained by the Scheduling Secretariat. Any policy considerations arising will be referred to AHMAC for consideration.
The Secretary may make decisions on the scheduling of medicines or chemicals, as well as changes to other parts and appendices of the Poisons Standard. This authority is provided under sections 52D, 52E and 52EAA of the Act.
In practice, persons to whom the Secretary has delegated decision-making responsibility will make the decision. These persons have the appropriate expertise and hold appropriate positions within the Department of Health, or other Government Agencies if required.
When making a decision in relation to the scheduling of a substance the decision-maker may seek advice from the Advisory Committees, relevant State and Territory regulators, and/or any other expert committee, person or entity. The decision-making process will be undertaken in accordance with the relevant sections of the Act, the Therapeutic Goods Regulations 1990 (the Regulations) and the Scheduling Policy and Scheduling Handbook.
The Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling are established under sections 52B and 52C of the Act. The membership, functions and procedures for the expert Advisory Committees are set out in the Regulations and the Scheduling Handbook.
As provided for by Subdivision 3D.2 of Part 6 of the Regulations the Secretary may refer an application or proposal to amend the Poisons Standard to either or both of the Advisory Committee(s). They will provide advice to the Secretary on rescheduling and certain new proposals to amend the Poisons Standard.
Implementation of decisions
The decision made by the Secretary will be incorporated in the Poisons Standard. The Poisons Standard is the cumulative result of scheduling related decisions of the Secretary and is maintained by the Scheduling Secretariat on behalf of the Secretary of the Department.
Decisions to amend the Poisons Standard are recommendations to the states and territories.
States and territories will give effect to these decisions by adoption of the Poisons Standard through their relevant legislation.
To be legally enforceable in any or all jurisdictions, decisions must be incorporated in the Poisons Standard.
Part 6-3 of the Act, sections 52AA through 52EC inclusive, sets out the legislative basis for scheduling.
In particular, section 52E sets out the matters to be taken into account when making scheduling decisions.
The legislation is further supported by regulations 42ZCA through 42ZCZX inclusive of the Regulations.