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AHMAC - Scheduling policy framework for medicines and chemicals, 2015
Chapter 1: The scheduling process
The Scheduling Policy Framework (SPF) sets out the national system for applying access restrictions on all poisons: medicines for human therapeutic use, veterinary, agricultural, domestic and industrial chemicals where there is a potential risk to public health and safety. Poisons are scheduled according to the degree of risk and the level of control required over availability 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 and associated Regulations. They have been developed to ensure operational effectiveness in the current regulatory environment while providing for the existing high level of scheduling uniformity across states and territories.
The key aspects of the agreed model for the scheduling of medicines and chemicals in Australia include:
- responsibility for scheduling policy under the Australian Health Ministers' Advisory Council;
- the Secretary of the Department of Health (or delegate/s) being the decision-maker on the scheduling of medicines and chemicals and other changes to the Poisons Standard;
- two separate Advisory Committees: the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) to advise the decision-maker/s; and
- a single Poisons Standard as the Commonwealth legislative instrument.
The National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the Galbally Review, 2001) recommended new separate arrangements for the scheduling of medicines and chemicals in Australia (Recommendation 7). This recommendation included replacing the National Drugs and Poisons Schedule Committee with two separate Advisory Committees that focus on the scheduling of medicines and chemicals respectively. The Council of Australian Governments (COAG) agreed to Recommendation 7 being progressed by the then Australian Health Ministers' Conference (AHMC).
This work was progressed with the intention of implementing the revised scheduling arrangements in the context of the joint Australia New Zealand Therapeutic Products Regulatory Scheme. However due to the postponement of a joint regulatory agency in July 2007, implementation of the revised scheduling arrangements continued in an Australia-only context.
In October 2008, COAG in responding to recommendations from the Productivity Commission Research Report on Chemicals and Plastics Regulations (2008) supported the implementation of reforms proposed under the Galbally Review to separate the medicines and chemicals scheduling processes and for decisions to be made by the Secretary of the Department.
The NCCTG, then a subcommittee of AHMAC, provided guidance to the Secretary for the purposes of applying access restrictions on all poisons: medicines for human therapeutic use, veterinary, agricultural, domestic and industrial chemicals in the form the Scheduling Policy Framework for Medicines and Chemicals, 1 July 2010.
3. Key aspects of the model
3.1 Scheduling policy
AHMAC has responsibility for policy principles, guidance and protocols on scheduling (including procedural guidelines) and other poisons regulatory controls. The SPF allows decision-makers, any expert Advisory Committees, reviewers or evaluators within the Therapeutic Goods Administration (TGA) or the Office of Chemical Safety (OCS) to judge the best fit for new substances and to facilitate the assessment process of scheduled substances when an application for rescheduling is received or new knowledge or practice emerges.
Recommendations on proposals to amend the SPF are to be referred to AHMAC for consideration. Minor editorial changes to the SPF can be undertaken by the Scheduling Secretariat without referral to AHMAC.
3.2 Secretary's delegate
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, by exercising powers under Sections 52D, 52E and 52EAA of the Act, in accordance with the Regulations as well as any guidelines notified by AHMAC including this document.
In practice, persons to whom the Secretary has delegated decision-making responsibility, being persons holding appropriate positions within the relevant areas of the Department (e.g. within the TGA and the OCS) will make the decisions.
When making a decision in relation to the scheduling of a substance the decision-maker may seek advice from the Advisory Committees, and/or any other expert committee, person or entity.
If it is considered for any reason that it is necessary to vary the policy framework, the matter can be referred to the AHMAC (or the relevant Principal Committee).
3.3 Implementation of decisions
The decision made by the Secretary will be incorporated in the Poisons Standard. The Poisons Standard includes a record of scheduling related decisions of the Department 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.
4. The scheduling process
4.1 Application to amend the Poisons Standard
An application proposing to amend the Poisons Standard may be made to the Secretary of the Department under s.52EAA of the Act.
In order to be accepted, an application must be supported by sufficient information and be in a form approved by the Secretary. The form of the application and the information requirements are set out in Chapter 4 of this document. The form of an application may also include such additional information notified by AHMAC (or the relevant Principal Committee) to the Secretary for this purpose.
The fee to accompany any application to amend the Poisons Standard is set out in a Schedule to the Regulations.
Applications related to agricultural and veterinary chemicals will be referred by the Australian Pesticides and Veterinary Medicines Authority (APVMA) via the OCS.
In certain circumstances the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) will refer an industrial or domestic chemical for scheduling based on the outcome of a risk assessment. AHMAC (or the relevant Principal Committee) may refer proposed amendments to the controls on medicines and poisons in the Poison Standard (Parts 1-3) to the Secretary for consideration.
4.2 Decision making process
Under Division 3D of Part 6 of the Regulations the Secretary may refer a scheduling proposal to an expert Advisory Committee. It is expected that all rescheduling proposals (i.e. where the substance has previously been scheduled) will be referred to the relevant Advisory Committee for advice. The referral of new substance applications to an Advisory Committee will not occur routinely for new human therapeutic substances evaluated by the TGA. New chemical scheduling proposals to include a new substance in Schedule 7 will be referred to the ACCS given the broad level of interest in such applications. Other new chemical scheduling proposals are also likely to be referred to the ACCS unless the proposal is straight forward and the chemical has been subject to the APVMA registration process.
Proposals to amend the controls (Parts 1-3) on medicines and poisons will not be routinely referred to an Advisory Committee when they are referred to the Secretary by AHMAC (or the relevant Principal Committee).
4.2.1 Applications referred to an Advisory Committee
Where the Secretary decides to refer an application received under s.52EAA of the Act or a proposed amendment initiated by the Secretary to either or both of the Advisory Committees, the Secretary is required to follow the process detailed in subdivision 3D.2 of Part 6 of the Regulations.
1st Phase of consultation
The Secretary must publish a notice setting out the matter to be considered by the Advisory Committee(s) along with a call for public submissionsin the manner detailed in reg 42ZCZK. Full details of public notifications are contained in Chapter 5.
The submissions received must be considered along with the proposal by the Advisory Committee which will then provide advice to the Secretary. Upon considering the advice of the Advisory Committee (and/or any other committee or person as required under section 52E of the Act) the Secretary will make an interim decision on the proposed amendment.
Where no submissions are received in the initial phase of consultation there is no interim decision. The Secretary may make a final decision having regard for the advice of the Advisory Committees as required by reg 42ZCZO and taking into account all the matters referred to in section 52E of the Act.
2nd Phase of Consultation (where relevant)
The Secretary must publish the interim decision in keeping with the requirements of reg 42ZCZP, which includes a call for further submissions from those who made a submission in the 1st phase and from the applicant. Full details of public notifications are contained in Chapter 5.
After considering any submissions received in the 2nd phase of consultation as required by reg 42ZCZQ, the Secretary must make a final decision as provided in reg 42ZCZR taking into account all of the matters referred to in section 52E of the Act. This process is referred to as a reconsideration of the interim decision in the Regulations.
Any public submissions must be relevant to the proposed amendment or interim decision (whichever is relevant) and must address the matters set out in section 52E of the Act (see Chapters 2 and 3 of this document).
4.2.2 Applications not referred to an Advisory Committee
Where an application to amend the Poisons Standard is received under section 52EAA and the Secretary chooses not to refer the proposed amendment to an Advisory Committee the Secretary must follow the process detailed in Subdivision 3D.3 of Part 6 of the Regulations.
Consistent with reg 42ZCZU, where the decision is to amend the Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision taking into account of the matters referred to in section 52E of the Act.
However where the decision is not to amend the Poisons Standard in the manner set out in the application, the Secretary must make an interim decision as required by reg 42ZCZV. The Secretary must provide the applicant with the reasons for the interim decision and provide an opportunity to make a written submission.
After considering any such submission from the applicant the Secretary must make a final decision as provided in reg 42ZCZW, taking into account all of the matters referred to in section 52E of the Act.
4.2.3 Submissions in response to notice of a proposal
Consistent with subdivision 3D.2 of Part 6 of the Regulations all submissions made in response to a notice inviting public submissions and setting out the details of a proposed amendments must be received within the period specified in the notice (which must be at least 20 business days after the publication of the notice).
4.2.4 Submissions after an interim decision
Consistent with subdivision 3D.2 of Part 6 of the Regulations all submissions made in response to an interim decision must be received within 10 business days of notification after publication of the notice [on the TGA internet site] or where the proposed amendment has not been referred to an Advisory Committee, within the period specified in the notice (which must be at least 10 business days after the date of the notice).
4.2.5 Interim and final decisions - process for the Secretary
The Secretary must take into account the following when making a final decision after an interim decision:
- the original application;
- submissions received in any consultation phase, either from the applicant or the public;
- any advice or recommendation of the Advisory Committees;
- any guidelines of the Australian Health Ministers' Advisory Council.
The Secretary may in making the final decision:
- confirm the interim decision;
- vary the interim decision; or
- set the interim decision aside and make a new decision.
4.3 Notification of decisions
As soon as practicable after making a final decision under regs 42ZCZO, 42ZCZR, 42ZCZU or 42ZCZW the Secretary must:
- publish the final decision and the reasons for the decision, along with the proposed date of effect on the TGA internet site; and
- amend the Poisons Standard where required, in accordance with the procedures required to amend a legislative instrument.
Each Advisory Committee will be notified of scheduling decisions made by the Secretary at its next meeting.
Decisions to amend the Poisons Standard come into effect at or before the time of registration (where relevant). All such decisions would come into effect no more than six months after the decision was made unless otherwise specified.
4.4 The Poisons Standard
The Poisons Standard is considered to be a Legislative Instrument for the purposes of the Legislation Act 2003 (LA). It must be registered and published on FRL in electronic form. In order to ensure certainty in the continuing application of state and territory laws, the Poisons Standard is not a disallowable instrument.
As scheduling decisions are legislative in character, the lawfulness of the Secretary's decision is not reviewable under the Act, in the AAT or in the Federal Court.
4.5 Amendments to the Poisons Standard initiated by the Secretary
Under section 52D(3) of the Act the Secretary has power to amend the Poisons Standard on their own initiative. A decision to exercise this power would be made on the basis of information that, in the Secretary's opinion, supports an amendment to the Poisons Standard. This information may be provided to the Secretary by a member of an Advisory Committee or the Department or by AHMAC (or the relevant Principal Committee). When the Secretary decides to amend the Poisons Standard on their own initiative this is a final decision. The Poisons Standard is amended in accordance with the procedures required to amend a legislative instrument.
However, the Secretary may decide to commence a new process by referring this amendment to an Advisory Committee for consideration and public consultation.
4.6 Adoption and implementation of decisions
It is envisaged that in all cases the states and territories will adopt (by reference) the scheduling recommendations in the Poisons Standard and give effect to them through their relevant drugs and poisons legislation. However, each jurisdiction reserves the right to implement a different scheduling decision to that included in the Poisons Standard to accommodate local circumstances.
As AHMAC is committed to the principle of national uniformity, any decision to depart from a scheduling entry in the SUSMP must be fully justified in an annual report to AHMAC (or the relevant Principal Committee). A consolidated report of these variances will be published annually by the Department.
5. The Advisory Committees
The Advisory Committees, 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 and procedures for the expert Advisory Committees are set out in the Regulations and this document.
Each Advisory Committee will:
- make recommendations to the Secretary regarding the classification and scheduling of substances;
- make recommendations to the Secretary in relation to other changes to the current Poisons Standard;
- reconsider a recommendation at the request of the Secretary;
- provide advice to the Secretary in relation to restrictions (including restrictions as to accessibility and availability) to be imposed in respect of particular substances;
- provide advice to the Secretary in relation to any other matter referred by the Secretary; and
- any other functions prescribed by the Regulations.
Recommendations of the expert Advisory Committees are available on the TGA website.
5.2 Responsibilities of the Advisory Committees
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 the following types of proposals to amend the Poisons Standard.
|Rescheduling of substance included in a therapeutic good (human medicine)||ACMS|
|Rescheduling of agricultural or veterinary chemical||ACCS|
|Rescheduling of industrial, domestic or personal use chemical||ACCS|
|Scheduling of a new substance (agricultural, veterinary or industrial) that may meet the criteria for inclusion in Schedule 7||ACCS|
|Scheduling of a substance that may meet the criteria for inclusion in Schedule 9||ACMS|
|Proposal to amend or include an entry in Appendices A, G or Schedule 10/Appendix C for:|
|Proposal to amend or include entry in Appendices D, H, K, & L||ACMS|
|Proposal to amend or include entry in Appendices E, F, J||ACCS|
|Proposal to amend a substance in Parts 1 to 3 that affects only therapeutic goods.||ACMS|
|Proposal to amend a substance in Parts 1 to 3 that affects only agricultural, domestic, industrial or veterinary chemicals||ACCS|
|Any other proposal to amend a substance in Parts 1 to 3||Joint meeting|
The Advisory Committees are staffed in accordance with Subdivisions 3A.2 and 3B.3 of Part 6 of the Regulations.
There are two kinds of members on the expert Advisory Committees:
5.3.1. Nominated members
To reflect the cooperative nature of the scheduling process and to encourage scheduling uniformity across Australia, the Commonwealth and each state and territory may nominate a member for each Advisory Committee. These nominations must be made in writing to the Commonwealth Minister for Health for the term nominated by the jurisdiction. Temporary nominees, to attend in the primary member's absence, can be nominated at the same time.
5.3.2 Appointed members
Appointed members are selected from applications received from a broad range of government bodies (including the APVMA and NICNAS), academic institutions, healthcare, consumer and industry groups, and the public.
The Minister appoints in writing whoever the Minister believes to be appropriately qualified, upon recommendations from the Department. Members are appointed on the basis of expertise rather than to represent a particular jurisdiction or interest group. Acting members can be appointed at the same time.
A member is appointed for a term stated in the member's appointment but must not be longer than three years. Such members can be appointed for a further term of up to three years but may not serve more than three consecutive terms.
5.3.3 Confidentiality and Conflict of Interest
All members are required to make an undertaking in relation to confidential information and conflicts of interest.
Advisory Committee on Medicines Scheduling
The Advisory Committee on Medicines Scheduling comprises up to 15 expert members with expertise in one or more of the following areas:
- the regulation of scheduled medicines in Australia;
- toxicology or pharmacology;
- clinical pharmacology;
- pharmacy practice;
- medical practice;
- consumer health issues relating to the regulation of therapeutic goods; and
- industry issues relating to the regulation of therapeutic goods.
Advisory Committee on Chemicals Scheduling
The Advisory Committee on Chemicals Scheduling comprises up to 15 expert members with requisite expertise in one or more of the following areas:
- the regulation of scheduled chemicals in Australia;
- clinical aspects of human poisoning;
- occupational health, with expertise preferably also as a medical practitioner.
- veterinary medicine or veterinary pathology;
- industrial or domestic chemicals;
- agricultural or veterinary chemicals;
- consumer health issues relating to the regulation of chemicals; and
- industry issues relating to the regulation of chemicals.
5.4 Advisory Committee procedures
The Advisory Committees are required to conduct and hold meetings in accordance with subdivision 3A.3 and 3B.3 of Part 6 of the Regulations.
The Advisory Committees may, with the agreement of the Secretary of the Department of Health, form subcommittees to undertake discrete bodies of work as provided for in Divisions 3A and 3B of Part 6 of the Regulations.
5.4.2 Appointment of Chair
The chair of each Advisory Committee is appointed by the Minister from within the existing Advisory Committee membership. The Chair holds that office for the term stated in the appointment and may be appointed for further terms. The Regulations also provide for an acting Chair to be appointed by the Minister, to assume the role and responsibilities of the Chair when he or she is unable to perform his or her duties.
Both appointed and nominated members may resign by signed notice to the Minister. The states and territories may nominate a replacement member at the same time.
The Chair may resign as either Chair and/or as an Advisory Committee member by signed notice to the Minister.
All members of the Advisory Committees will have equal voting rights. A recommendation arising from the reference of an application by the Secretary to the Advisory Committee is made at an Advisory Committee meeting by a majority of the votes of the members present and voting. The Chair or presiding member at an Advisory Committee meeting has the deliberative vote, and in the event of a tied vote, has the casting vote. The quorum is two thirds of the Advisory Committee members.
5.5 Joint meetings
Given the potential overlap of membership and interests, meetings of the ACMS and the ACCS may be run consecutively.
Where matters of interest to both Advisory Committees are identified, sufficient time is to be allowed for both Advisory Committees to jointly discuss these matters, including any matters relating to the Scheduling Policy Framework. Details outlining the procedures for joint meetings are included in Division 3C of Part 6 of the Regulations.
A recommendation arising from a joint meeting is a recommendation to the Secretary from each Advisory Committee.
The Medicines Scheduling Secretariat located within the TGA supports the ACMS. The Chemicals Scheduling Secretariat located with the OCS supports the ACCS.
Consultation has been undertaken on a Cost Recovery Impact Statement (CRIS). The Commonwealth Government is currently examining cost recovery arrangements in light of submissions received. Participation at Advisory Committee meetings by members employed by states and territories, as well as implementation of recommendations, will be borne by the respective jurisdictions.