Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - Cosmetic Physicians Society of Australasia

The submission period for this review commenced on 2 April 2013.

Page last updated: 20 May 2013

Summary

Please provide a short summary, up to half a page, outlining the key points of your submission.

Specific areas you may wish to address

Respondents should refer to the document REVIEW OF ARRANGEMENTS FOR SCHEDULING SUBSTANCES - PRT 6.3 OF THE THERAPEUTIC GOODS ACT 1989, Information for stakeholders, Part A - What this review is about for more detailed information about these questions.

You are not required to respond to every question.

Objectives of the amendments:


    1 - Have the new arrangements met the objectives of providing a more flexible, efficient and effective operation of the scheduling of substances?

    2 - Have the objectives of the amendments been met?

    3 - Have any areas of operation become less flexible, efficient and effective compared with the former NDPSC decision making model? Please provide examples to illustrate your points.In terms of the operation of Part 6-3 do you have any suggestions how the scheduling arrangements can be improved?


The CPSA's primary endeavour is to safeguard the public by ensuring regulations are adhered to and standards are upheld in this evolving area of cosmetic medicine.

Cosmetic injections are minimally invasive procedures, classified as Schedule 4 medicines.

The CPSA believes the amendments provide a more flexible and efficient operation of scheduling of substances.   

System of access controls for goods containing scheduled substances

Section 52E Secretary to take certain matters into account in exercising powers


    4 - Are the matters to which the Secretary must have regard when amending the Poisons Standard appropriately described and effective? If not, what amendments would you suggest?

    5 - Is the process whereby the Secretary has regard to the Scheduling Policy Framework, the recommendations or advice by the ACMS and/or ACCS or another relevant committee or expert clear and transparent?  If not, how could the arrangements be improved?

    6 - Is the Scheduling Policy Framework helpful in understanding the application and review process? If not, what amendments would you suggest?


The CPSA believes the current matters which the Secretary must take into account when exercising a power under subsection 52D(2) of the TGA Act are appropriate and not exhaustive. The list of matters provide the Secretary with the flexibility to also consider matters that are in the public interest.

Outcomes of administration

52A Definition


    7 - Does the definition of 'substance' appropriately reflect the substances that may be considered for scheduling by the Secretary and which the committees may consider and advise the Secretary on? If not, how should the definition be amended? What would be the material impact on your organisation if it were to be amended in this way?

The CPSA is of the view that the definition of 'substance' is appropriate for the purposes of the TGA Act.

Section 52B and Section 52C and Section 52CA Functions of the ACMS and ACCS and associated Regulations


    8 - Are the establishment, functions and membership of the ACMS and/or ACCS appropriately described in the Act? If not, how could they be better described? What would be the material impact on your organisation if the Act were amended in this way?

    9 - Have the new arrangements for the ACMS and/or ACCS met the objective to provide for more flexible, efficient and effective operation of the scheduling of substances? Have the objectives of the amendments been met?

    10 - Have any areas of operation become less flexible, efficient and effective compared with the former NDPSC decision making model? Please provide examples to illustrate your points.

    11 - In terms of the operation of the committees do you have any suggestions how the arrangements can be improved?


The CPSA is of the view that if the membership of the ACMS and/or ACCS are to be expanded, then consideration should be given for a registered health practitioner to be included.

Section 52D Amendments to the Poisons Standard and associated Regulations


    12 - Is the process by which the Secretary makes amendments to the Poisons Standard appropriately described and effective? If not, what amendments would you suggest?

    13 - Is the process whereby the Secretary makes amendments to the Poisons Standard clear and transparent?  If not, how could the arrangements be improved?

    14 - How have the new administrative arrangements benefited your organisation or sector in relation to a proposal to amend the Poisons Standard? Where possible, please provide comparative data for the following two periods: June 2008-June 2010 and October 2010-October 2012.

    15 - Have the new administrative arrangements had any negative impact on your organisation or sector in relation to a proposal to amend the Poisons Standard? Where possible, please provide comparative costs for the following two periods: June 2008-June 2010 and October 2010-October 2012.

    16 - Have the new administrative arrangements had an impact on the time taken between your proposal to amend the Poisons Standard and the final decision to amend (or not) the Poisons Standard? Where possible, please provide comparisons in timeframe relevant to decisions made during the following two periods: June 2008-June 2010 and October 2010-October 2012 and how they have impacted on your organisation or sector.


The CPSA does not have a view on these amendments at this stage.

Section 52EAA Application for amendment of the Poisons Standard


    17 - Are the administrative arrangements for applications (including the template application form) to be made to the Secretary sufficiently clear and transparent?

    18 - What would be the material impact on your organisation if the Secretary mandated that all applications for amendment of the Poisons Standard be submitted electronically (and on the template application form)?


The CPSA believes that a template application adds efficiency to the process and that applications for amendments should be accepted by the Secretary either electronically or by post.

Division 3D of the Regulations Proposed amendments to the Poisons Standard


    19 - Have you had any difficulty accessing notices regarding the intention of the Secretary to amend the Poisons Standard? If so, what was that difficulty and how did it affect your organisation or sector?

    20 - Have you had any difficulty accessing public submissions received in response to a proposed amendment of the Poisons Standard? If so, what was that difficulty and how did it affect your organisation or sector?

    21 - Have you had difficulty accessing decisions made by the Secretary to amend the Poisons Standard and/or the reasons for the decision and/or the date of effect of the decision? If so, what was that difficulty and how did it affect your organisation or sector?


The CPSA has not experienced any difficulty at this stage.

Avenues for review


    22 - What has been the impact on your organisation or sector of the lack of an administrative review process, if any? Please provide a specific example.

    23 - Should there be avenues for review of decisions made by the Secretary and by the committees? If so, what avenues for review of decisions should be included and why?


The CPSA has not requested any reviews at this stage and is unable to provide a response to these questions.

Other matters


    24 - In addition to the above, have you realised any other benefits or adverse impacts as a result of the amendments? If so, what were they and how did they affect your organisation or sector?

    25 - What key measurable performance indicators do you think are important for monitoring the efficiency and effectiveness of the system for the scheduling of substances? How should the relevant data be collected? How often?

    26 - Are there any other matters relevant to the terms of reference for this review which you would like to make the panel aware of?


No.