Questions and Answers about the proposed medicines scheduling provisions of the draft Administration and Interpretation Rule
February 2007
What are the key points covered by the proposed medicines scheduling provisions?
The proposed medicines scheduling provisions of the draft Administration and Interpretation Rule cover:
- the membership and role of the Medicines Scheduling Committee (this committee would provide advice on the scheduling of medicines to the new Australia New Zealand Therapeutic Products Authority);
- the establishment of a scheduling standard as an electronic register;
- procedures for scheduling new substances and rescheduling existing substances, including consultation and notification processes.
What will the Medicines Scheduling Committee look like and what qualifications will the members be required to have?
It’s proposed that the Medicines Scheduling Committee be made up of experts including:
- a nominee from each of Australia’s States and Territories, New Zealand and a nominee from ANZTPA and additional experts to ensure an adequate range of expertise;
- a member with expertise in consumer issues;
- a member with expertise in therapeutic product industry issues.
It is proposed that the committee members’ qualifications and experience would include:
- expertise in the regulation of medicines in Australia or New Zealand;
- expertise in toxicology;
- pharmacy practice expertise;
- medical practice expertise;
- clinical pharmacology expertise.
How would members of the Medicines Scheduling Committee be appointed?
Members are to be appointed by the Ministerial Council on the recommendation of the Authority.
What happens if members of the Medicines Scheduling Committee are absent or there is termination of appointment?
The Ministerial Council is able to grant leave of absence to the Chair and the Chair is able to grant leave of absence to another Committee member. The Ministerial Council may appoint an alternate to act as a member to cover a member of the Committee who needs to take a leave of absence. As with other members of the Committee, any member appointed to cover a leave of absence would be expected to have relevant expertise.
The Ministerial Council can terminate a Committee member’s appointment on certain grounds including: physical or mental incapacity; misbehaviour; incompetence; inefficiency; bankruptcy; failing to disclose an interest in a matter; if a member is convicted of an offence punishable by imprisonment for 1 year or longer; or is absent without leave of absence from 3 consecutive meetings of the Committee.
Will there be scheduling uniformity between New Zealand and the Australian States and Territories?
Australia and New Zealand have been working to harmonise their scheduling of medicines for several years now in preparation for the establishment of the Authority.
New Zealand legislation prevents harmonisation of some medicines which come under the Misuse of Drugs Act 1975. Country specific issues have led the two countries to place some medicines in different schedules. For example, asthma medicines which are prescription only in New Zealand are available over the counter at pharmacies in Australia.
What will the electronic scheduling 'register' look like?
One of the roles of the Authority is for it to maintain a register known as the Standard for the Uniform Scheduling of Medicines and Poisons. The Scheduling Standard would be required to contain a record of scheduling decisions and is required to be maintained electronically.
The electronic Scheduling Standard will list the medicines and their scheduling classifications. It will be a searchable electronic document posted on the Authority’s website that will allow individuals to identify the schedule of a substance.
What information would be considered when an application to schedule a substance is made?
When considering the scheduling of a medicine, the Authority must take into account:
- the toxicity and safety of the substance;
- the risks and benefits associated with the use of the substance;
- the potential hazards associated with the use of substance;
- the extent and patterns of use of the substance;
- the dosage and formulation of the substance;
- the need for access to the substance, taking into account its toxicity compared with other substances available for a similar purpose;
- the potential for abuse of the substance;
- the purposes for which the substance is to be used;
- any other matters that the Authority considers necessary to protect public health and safety, including the risks (whether imminent or long-term) of death, illness or injury resulting from its use;
- advice or recommendations from the Medicines Scheduling Committee, or another expert advisory committees;
- public submissions relating to the proposed scheduling.
The Authority may also take into account the labelling, packaging and presentation of the substance and must comply with the relevant policy guidelines.
What is the timeframe for public gazetting of medicines scheduling applications?
Before making a decision on an application to schedule a new substance, the Authority may decide to publicly consult on the application by publishing a Gazette notice. All medicines rescheduling applications will be subject to public consultation.
A Gazette notice invites public submissions on the application to schedule a substance. It is proposed that Gazette notices will be published 6-8 weeks prior to the next meeting of the Medicines Scheduling Committee to allow enough time for the public to make submissions and for the Committee to consider the submissions.
What material will be considered commercial-in-confidence for purposes of scheduling submissions?
Information contained in scheduling submissions that is considered by the Authority to be Commercial-in-confidence information is to be identified in the proposed scheduling policy framework which is expected to be released for public consultation in the next few months.
What will happen to the appendices contained in the SUSDP under ANZTPA?
The draft Scheduling Standard is expected to be released for public consultation in the next few months. The document will continue to contain appendices but a number will be redrafted / removed. These changes are in line with the recommendations of the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the 'Galbally Review').
What rights of appeal are there for scheduling decisions?
The proposed Administration and Interpretation Rule sets out a process for the Authority to reconsider a scheduling decision. It is expected that judicial review will also be available so that courts in Australia and New Zealand can review the legality of scheduling decisions on grounds that include, a breach of the rules of natural justice, or a failure to take into account a relevant consideration.
URL: http://www.anztpa.org/meds/qascheduling.htm