Revised medicines and chemicals scheduling arrangements
28 June 2010
Revised scheduling arrangements for medicines and chemicals take effect on 1 July 2010.
The changes include:
- the National Drugs and Poisons Schedule Committee (NDPSC) will be replaced by the Secretary of the Department of Health and Ageing (DoHA) - or her delegate - as the decision maker for the scheduling of medicines and chemicals;
- two new expert advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, will be established to provide advice and make recommendations to the Secretary (or delegate) on medicines and chemicals scheduling decisions;
- a single Secretariat, supporting both Advisory Committees, will ensure ongoing consistency and cohesiveness of processes and decisions; and
- closer integration of the revised scheduling arrangements with existing Commonwealth evaluation and product registration schemes.
Other planned changes include:
- the Poisons Standard, at present named the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) will be renamed the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), and
- cost recovery arrangements are being examined.
The changes aim to improve the efficiency and timeliness of scheduling decisions, while maintaining the existing high level of scheduling uniformity across Australian states and territories.
The Therapeutic Goods Administration, the Office of Health Protection, the Australian Pesticides and Veterinary Medicines Authority and the National Industrial Chemicals Notification and Assessment Scheme are working together to develop and implement these revised arrangements for medicines and chemicals scheduling.
The revised scheduling arrangements have been endorsed by the Australian Health Ministers' Conference (AHMC) and the Council of Australian Governments.
Background to the revised medicines and chemicals scheduling arrangements
In October 2008 the Council of Australian Governments (COAG) endorsed the scheduling-related recommendations from the Productivity Commission Research Report: Chemicals and Plastics Regulation <http://www.pc.gov.au/projects/study/chemicalsandplastics/docs/finalreport>.
This report supported scheduling reforms that had previously been recommended by the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the 'Galbally Review') <http://www.tga.gov.au/docs/html/rdpdfr.pdf.
Since 2008 the Department of Health and Ageing, in collaboration with the National Coordinating Committee on Therapeutic Goods (NCCTG), has been consulting <http://www.tga.gov.au/consult/archive-scheduling.htm> on changes to the framework to give effect to the revised scheduling arrangements. The NCCTG is a subcommittee of the Australian Health Ministers' Advisory Council (AHMAC) and is the body responsible for scheduling policy in Australia. It comprises representatives from the Australian, state and territory governments and the New Zealand government. The Therapeutic Goods Administration (TGA) provides the Secretariat for the NCCTG.
The NCCTG is the author of the Scheduling Policy Framework <http://www.tga.gov.au/regulation/scheduling-policy-framework.htm> which is a guidance document that decision-makers within the Department must have regard to when making scheduling decisions. This document also provides guidance for applicants about the scheduling process including public consultation, classification systems and information requirements.
Legislation to amend the Therapeutic Goods Act 1989 (the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009) received Royal Assent on 29 September 2009 <http://www.comlaw.gov.au/ComLaw/Legislation/Act1.nsf/0/9B549F56FB50EF36CA257648007535E8?OpenDocument>. Changes to the Therapeutic Goods Regulations 1990 to underpin these legislative changes, are expected to be in place by 1 July 2010.
Major changes
The major changes are summarised below. They include:
- Two new advisory committees
From 1 July 2010, the National Drugs and Poisons Schedule Committee (NDPSC) will be disbanded and two new expert advisory committees: the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), will be established. - The Secretary as the decision-maker
Under the revised arrangements the Secretary, or her delegates, will have the power to make scheduling related decisions and amend the Poisons Standard. This is compared with the current arrangements where the NDPSC makes these decisions.
Appropriate officers within the TGA and Office of Health Protection (OHP) will be delegated this responsibility. Under the new arrangements, delegates may seek and have regard to advice provided by the two Advisory Committees before amending the Poisons Standard. - New streamlined decision making processes
The new scheduling arrangements aim to improve timeframes by reducing duplication of effort. Under the new arrangements only applications for rescheduling, or contentious new applications, need be referred to the Advisory Committees.
New scheduling processes for medicines are currently being developed by the TGA, while processes for the scheduling of agricultural, veterinary, industrial and domestic chemicals are being developed by the OHP, the Australian Pesticides and Veterinary Medicines Authority and the National Industrial Chemicals Notification and Assessment Scheme.
Reviewing these processes also involves identifying the appropriate decision makers for medicines and chemicals scheduling decisions.
Transition arrangements
While the finer details of the revised scheduling arrangements are being developed, scheduling applications will continue to be accepted by the NDPSC Secretariat.
Transition provisions are set out in Schedule 1, Item 13 of the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009. In summary, these provisions include:
- Any valid amendment to the Poisons Standard made by the NDPSC prior to 1 July 2010 remains valid after this time.
- The Secretary, or her delegate, must consider any decisions made by the NDPSC between 1 January and 30 June this year, which have not yet been finalised and incorporated into an amendment to the current Poisons Standard.
- Any application for scheduling of a new substance lodged on or after 1 January 2010, where the application has not been actioned by the NDPSC, will be treated as if it is an application under the revised scheduling arrangements and the decision will be made by the Secretary or her delegate. If it is a rescheduling application, it will be referred to the relevant scheduling advisory committee by the Secretary prior to the decision being made by the Secretary, or her delegate.
- Applicants will be advised of any Advisory Committee meeting dates which will consider their application, and the decision maker for their application.
The Poisons Standard
The Poisons Standard, currently named the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), will be renamed the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
The SUSMP will replace the SUSDP as a record of decisions regarding the classification of medicines and chemicals into Schedules for inclusion in the relevant legislation of the states and territories.
The SUSMP will also continue to include model provisions about containers and labels, and recommendations about other controls on medicines and chemicals.
The SUSMP will continue to be registered on the Federal Register of Legislative Instruments <http://www.frli.gov.au> as the Poisons Standard.
Cost recovery arrangements
The AHMC agreed that 100% cost recovery should be implemented as part of the arrangements for scheduling of medicines and chemicals.
A draft Cost Recovery Impact Statement (CRIS) <http://www.tga.gov.au/regreform/drcris.htm> was released for public consultation between January and March 2010. This document was developed to identify:
- all relevant costs involved with the new scheduling arrangements,
- calculation of the expected recoveries from each industry sector, and
- calculation of proposed application fees for each sector based on estimated work input to applications for scheduling.
Cost recovery arrangements are currently being examined in light of comments received on the draft CRIS. More details on the draft CRIS <http://www.tga.gov.au/regreform/drcris.htm> are available on this website.