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Important notice: Matters for consideration at the June 2010 NDPSC meeting

National Drugs and Poisons Schedule Committee

27 May 2010

Have you:

  • submitted an scheduling application for consideration at the June 2010 meeting of the National Drugs and Poisons Schedule Committee (the NDPSC); or
  • submitted, or intend to submit, a public comment in response to matters mentioned in the June 2010 pre-meeting notice

If either of the above applies to you, it is important you please consider the following regarding the June 2010 NDPSC meeting.

Please note that the following Checklist actions do not apply to those decisions from the February 2010 NDPSC meeting which will not have been implemented by 1 July 2010 (unless it was also a matter mentioned in the June 2010 pre-meeting notice). Details regarding this situation are provide below under the heading Transition Arrangements in relation to February 2010 decisions by the NDPSC.

Checklist

Please read the information below and, for each matter where you are the applicant or where you have submitted a public comment, please advise the NDPSC Secretariat (>before 11 June 2010) whether you are:

  • requesting consideration of an implementation date later than 1 September 2010, should a change of scheduling result from the June 2010 consideration; and/or
  • whether you:
    • are willing to accept a June 2010 decision as final even if the decision results in a scheduling change that does not align with your request (allowing the matter to be concluded); or
    • are requesting that any such decision not be considered final (noting that this would likely mean that consideration will need to start afresh under the new arrangements and may mean no final decision before the end of 2010).

Details

New scheduling arrangements from 1 July 2010

New scheduling arrangements will come into force on 1 July 2010 and the 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. The finer details of the revised scheduling process are currently being developed but are expected to be made available shortly. More information on these new scheduling arrangements can be found on the NDPSC website.

Consequences for matters before the June 2010 NDPSC meeting

Transition provisions are set out in Schedule 1, Item 13 of the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (the Amendment Act). These include that the Secretary, or her delegate, must have regard to any decisions made by the NDPSC after 1 January this year (ie at the February or June 2010 meetings) which have not been incorporated in a legislative instrument that either:

  • amends the current Poisons Standard (the legal title for the current SUSDP); or
  • is a document which is a new Poisons Standard substituting the current Poisons Standard, before 1 July 2010.

Transition arrangements in relation to February 2010 decisions by the NDPSC

Decisions made by the NDPSC at the February 2010 meeting which were to result in an amendment to the current Poisons Standard (including any changes from reconsideration of some of these decisions at the June 2010 NDPSC meeting) will be considered by the Secretary or her delegate for inclusion in the first Poisons Standard legislative instrument under the new arrangements (the 'first instrument').

It is currently intended that the first instrument will be registered in the Federal Register of Legislative Instruments (FRLI) prior to September 2010 so as to allow the February 2010 NDPSC decisions to be implemented on 1 September 2010 (the normal implementation date for NDPSC decisions from the February 2010 meeting had the existing scheduling arrangements continued past 1 July 2010).

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Transition arrangements for June 2010 decisions by the NDPSC

IMPORTANT - It is possible for the first instrument to encompass different commencement dates for a particular category or group of scheduling decisions. The proposed commencement date for the first instrument is likely to be 1 September 2010, significantly earlier than usually expected for June NDPSC decisions. As outlined above in the Checklist, it is important that any request to consider an implementation date later than 1 September 2010 be provided to the secretariat as soon as possible (deadline is 11 June 2010).

Decisions at a June meeting of the NDPSC would normally be implemented 1 January of the following year to allow time for consideration of further public submissions on the June decision at the subsequent October meeting. However, the transitional arrangements set out under the Amending Act include no provisions for further submissions on NDPSC decisions made at the June 2010 meeting, other than a subsequent request for scheduling/rescheduling under the new arrangements. As a consequence, matters to be considered at the June 2010 NDPSC meeting are expected to fall into one of the following categories:

No pre-meeting submissions - can be finalised

Under the current process, if an interested party has made a valid pre-meeting public submission in relation to a proposed scheduling decision and in response to a notice under subregulation 42ZCU(1) of the Therapeutic Goods Regulations 1990, they are invited to make further submissions on an amendment to the Poisons Standard following an NDPSC decision. This invitation is included in the Gazette notice under subsection 52D(4) of the Act. These arrangements are currently provided for under subregulation 42ZCY(1).

Therefore, decisions at the June 2010 NDPSC meeting for matters where no pre-meeting comments were received would not be required to undergo further reconsideration. The NDPSC would not require further submissions in relation to these matters had the current scheduling arrangements continued after 1 July 2010. These decisions will be considered by the Secretary, or her delegate, for inclusion in the first instrument. As discussed above, it is important that you provide to the Secretariat as soon as possible (deadline is 11 June 2010) any request to consider an implementation date later than 1 September 2010.

Pre-meeting submissions and application align with decision - can be finalised

Some June 2010 NDPSC decisions may result in scheduling changes consistent with both the application and any/all pre-meeting comments provided by interested parties. These decisions will be considered by Secretary or her delegate for inclusion in the first instrument (again noting the need to provide to the Secretariat as soon as possible (deadline is 11 June 2010) any request to consider an implementation date later than 1 September 2010).

Scheduling change appears to be in dispute

Other June 2010 NDPSC decisions may result in scheduling changes that are not consistent with either the application or some/all pre-meeting comments lodged in response to a notice under subregulation 42ZCU(1). As discussed above, had the NDPSC process proceeded past 1 July 2010 such decisions would have been reconsidered and an invitation to make a further public submission would have been made to those persons who provided valid public submissions for the June 2010 NDPSC meeting. However, as discussed above, there will be no avenue for making further submissions on June 2010 decisions by the NDPSC under the current regulatory framework.

Consequently, unless those parties whose position is not consistent with the scheduling change agree to accept a June 2010 decision by the NDPSC as final (allowing the matter to be concluded) then it is likely that such matters will not be concluded at the June 2010 meeting. If not concluded, these matters will be referred to the Secretary or her delegate for consideration under the new arrangements. This may mean no final decision is reached before the end of 2010.

IMPORTANT - As outlined in the Checklist above, could you please advise the NDPSC Secretariat (before 11 June 2010) whether you:

  • are requesting that, if a decision would result in a scheduling change that does not align with your preferred position, such a decision should not be considered final (noting that this would likely mean that consideration will need to start afresh under the new arrangements and may mean no final decision before the end of 2010); or
  • are willing to accept that any such decision be considered final even if the decision results in a scheduling change that does not align with your preferred position (allowing the matter to be concluded).
Amendments required to change SUSDP 24 into SUSMP 1

The current Poisons Standard consists of the Poisons Standard 2009 and the three amendments made to that Poisons Standard. The Poisons Standard 2009 consists of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) No. 24 and three subsequent amendments (referred to as Poisons Standard Amendment No. 2 of 2009, Poisons Standard Amendment No. 3 of 2009 and Poisons Standard Amendment No. 1 of 2010 in FRLI).

Under the revised scheduling arrangements, the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) will be replaced by the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). The proposed SUSMP has been developed by the National Co-ordinating Committee on Therapeutic Goods (NCCTG) (as the committee which oversees scheduling policy). This process included public consultation, with submissions on the proposed SUSMP being invited during May 2009.

The transitional amendments required to change the SUSDP 24 (and the three subsequent amendments to it as incorporated by the Poisons Standard amendments outlined above) into SUSMP 1 have now been referred to the June 2010 NDPSC meeting for consideration. It is a practical necessity for transitioning to the new arrangements that the NDPSC makes a decision on this matter at the June 2010 meeting and that the SUSDP 24 (and amendments to it) be considered by the Secretary or her delegate for inclusion in the first instrument. PLEASE NOTE - this will occur regardless of whether these changes are disputed in pre-meeting comments (pre-meeting comments will, as is always the case, be taken into consideration by the June 2010 meeting in reaching its decision).

It should be noted, however, that unlike many matters going before NDPSC, these proposed amendments, and a summary of reasons for these changes, have been made available on the NDPSC website at Transitional amendments: SUSDP 24 to SUSMP 1. This advice was included in the June 2010 pre-meeting notice. As such, interested parties should be in a position to provide detailed and considered pre-meeting submissions on this issue.

Finally, it is always open for interested parties to submit a rescheduling application under the new process, should they wish to request a change to any aspect of these transitional amendments (finalised at the June 2010 NDPSC meeting, and incorporated into the first instrument made by the Secretary or her delegate under the new scheduling arrangement).

Contacts for further information

Further information may be obtained from the NDPSC Secretariat on 02 6289 2584 during business hours or by emailing NDPSC@health.gov.au.

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