Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - Australian Pesticides and Veterinary Medicines Authority

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

Page last updated: 14 May 2013

Summary


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

The APVMA welcomes the opportunity to provide input into the Review of Arrangements for Scheduling Substances Part 6-3 of the Therapeutic Goods Act 1989.

The APVMA is the Australian Government regulator for agricultural and veterinary medicine (agvet) chemicals. Its mission is to protect the health and safety of people, animals and crops, the environment, and trade and to support Australian primary industries through evidence-based regulation of agvet chemicals. It does this through the approval of active constituents and the registration of agvet chemical products; its permit scheme; and the review of older chemicals or chemicals for which concerns have been raised to ensure they meet contemporary standards.

The requirements for scheduling active constituents that are in specific agvet chemical products are detailed in the Manual for Requirements and Guidelines (MORAG) and are part of the registration evaluation process. The APVMA generally seeks human health advice from the Office of Chemical Safety (OCS). When appropriate this advice is sent to the Secretary of the Department of Health and Ageing (‘the Secretary’) for their consideration and decision and potential inclusion in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

There are a number of beneficial features in the Scheduling Policy Framework (SPF), for example improved processes to achieve quicker decision making. However, the APVMA notes that a number of improvements could be made to enhance its operation, including:
  • Consideration of substances already scheduled and Secretary only decisions;
  • Enhanced scope for the APVMA to provide direct recommendations to the Secretary;
  • Increased flexibility for committee meetings and forward planning of committee meetings;
  • Enhanced flow of information between agricultural and veterinary medicine applicants and the scheduling secretariat;
  • Parallel consultation process between the APVMA and scheduling secretariat; and
  • Greater recognition of the independent roles of the scheduling committee and APVMA reconsideration process.
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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? Have the objectives of the amendments been met?

The objectives of the new arrangements were to provide a more flexible, efficient and effective process for the scheduling of substances. In broad terms, the APVMA believes the new arrangements have to a large extent met the objectives. Nevertheless, in its three years of operation, the APVMA has observed some areas of the SPF which would benefit from enhancement in order to make it more streamlined and effective. These improvements are discussed in subsequent sections of this submission.
    2. 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.
      The APVMA does not believe there has been any detrimental effect on flexibility, efficiency and effectiveness of the scheduling process.
        Having said this, the APVMA believes there is unrealised potential to further increase the efficiency and effectiveness of the process by amending the SPF. This would include increasing the percentage of applications that are determined by the Secretary (without going to committee) and decreasing the number of S4 medicines with an unqualified listing that go to the Secretary. These issues are discussed further in subsequent sections.

        3. In terms of the operation of Part 6-3 do you have any suggestions how the scheduling arrangements can be improved?

        The APVMA accepts the new scheduling arrangements appear to have made the process of scheduling substances quicker, but believe further efficiencies can be delivered (as outlined in further detail under questions 5, 11 and 26).

        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?
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        The APVMA notes that for the matters referred to in section 52E of the TGA Act there are characteristics (including toxicity, usage patterns, dosage, formulation, labelling) and subjective judgments (including the risks and benefits of the use and the potential for abuse of a substance that form matters relevant to each decision). Further guidance on the more subjective judgments and what weight they are given or ought to be given would improve the operation of the legislation. For example many companies and regulators that manage hazard or risk employ the As Low As Reasonably Practicable (ALARP) principle. This principle helps decision makers contemplate the extent of restrictions that are reasonable when competing interests exist, providing protection via restrictions to access in the context of appropriate chemical product availability and usage. ALARP decision making amounts to taking a balanced view and reaching a defensible compromise – resulting in the appropriate management of risk rather than attempting to achieve absolute zero risk. The SPF outlines the process used to amend the Poisons Standard but not the methodology used by the Secretary when making subjective judgments. The APVMA also notes this type of guidance is not available in any other publicly available documentation.
          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?

          The APVMA suggests that the process arrangements are relatively clear. However, there are opportunities for improvement.
            a) Rescheduling proposals

            Currently the SPF is operationalised by having all rescheduling proposals referred to the ACCS. While the SPF states ‘it is expected that all rescheduling proposals (i.e. where the substance has previously been scheduled) will be referred to the relevant Committee for advice’ it also provides that the Secretary is able to determine whether advice from the committee is required for other proposals to amend the Poisons Standard ‘where an application to amend the Poisons Standard is received under section 52EAA and the delegate chooses not to refer the proposed amendment to a Committee the delegate must follow the process detailed in Subdivision 3D.3 of Part 6 of the Regulations.’

            The APVMA understands current practice is for these rescheduling decisions to automatically be referred to the ACCS. An alternate process, which enables the contemplation of the level of complexity of the decisions or the hazards and risks associated with the substance, with a greater number of ‘lower-risk’ proposals going directly to the Secretary for decision could significantly shorten timeframes for relatively straight-forward decisions.

            The process of considering and providing advice in relation to potentially routine matters may be diverting the committees attention from other scheduling recommendations on which their advice is specifically and actively sought by the Secretary to supplement or enhance decision making (for example complex new chemicals or complex rescheduling on a chemical reconsideration report).
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            The APVMA suggests removing the apparent inconsistencies in the SPF so the practice becomes the Secretary determining which rescheduling decisions need to be sent to the committee for advice. This would be consistent with the explanatory memorandum of the amending Bill which stated “…will be assessed and scheduled by the Secretary on the advice of separate expert committees, where required”, and enable the committee to focus on areas of higher regulatory complexity.

            b) Current S4 medicines with an unqualified listing

            The Poisons Standard currently contains a number of S4 substances that are unqualified (for example does not contain the wording ‘for human medicine only’) by any other SUSMP requirement. The S4 classification restricts these types of medicines to generally being made available under prescription by registered veterinarians only. Currently the SPF is operationalised by requiring all veterinary medicine substances, even those with active constituents that are within the current S4 unqualified listing, to be sent to the Secretary for consideration. The APVMA would suggest these medicines do not need to be routinely referred to the Secretary for consideration.

            Under the proposed changes, the APVMA would be able to determine there is no requirement to refer it to the Secretary to confirm the scheduling, where the APVMA is satisfied that the existing scheduling is appropriate. Where the APVMA considers that the product may raise issues that merit further consideration of the scheduling classification of an active constituent, then the APVMA would refer these and request that the Secretary consider re-scheduling the substance.

            Such a change could significantly reduce the timeframes for some registrants in getting their product to market.

            c) Capacity for APVMA to make formal recommendations to the Secretary

            Currently the APVMA assessment process seeks to gather relevant information about a proposed chemical product. That information includes the physical chemical characteristics of the proposed product, the proposed use patterns, relevant risk mitigation strategies and safety directions. The APVMA is also statutorily obliged to have regard to the relevant Poisons Schedule (if known) when approving relevant particulars for labels.

            Under the Agvet Code the APVMA must have regard to whether an active constituent or chemical product would not:
              • be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
              • would not be likely to have an effect that is harmful to human beings; and
              • would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

            In making these determinations the APVMA has broad powers to consult and receive expert advice from various sources including:
              • the OCS within the Department of Health and Ageing (DoHA)
              • the Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC), and
              • independent scientific experts as required.
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            At the point of deciding to approve an active constituent and register a product the APVMA has considerable information regarding toxicological risk from these sources and is able to form a view as to which schedule would be appropriate. This schedule classification will also provide the access restrictions which are reflected in the overall risk mitigation considerations of the APVMA. Consequently the APVMA believes that it is well placed to formally provide an evidence based recommendation to the Secretary for consideration.

            This proposal is consistent with Recommendation 5 of the Galbally Review 2001 that the Therapeutic Goods Act 1989 and the Agricultural and Veterinary Chemicals Code Act 1994 and related subordinate legislation be amended to enable the then National Registration Authority to:
              • recommend the schedule in which a new substance should be included; and
              • recommend changes to the schedule of a substance where, in evaluating new formulations, new presentations and new uses of substances currently scheduled, a significant change in the risk profile of the substance is identified.

            This is particularly pertinent where OCS does not have the specific scientific expertise that is required for a particular assessment. The APVMA uses its broad powers to consult independent scientific experts. An example of this is antibiotic resistance management. In such cases the APVMA could recommend the schedule classification to the Secretary. This would increase the efficiency, effectiveness and timeliness of the APVMA assessment process for agricultural and veterinary chemicals, and it would be welcomed by industry and other stakeholders.

            It should be noted at the implementation phase of the new scheduling arrangements the APVMA identified that it did not have any power under its legislation to be the ‘applicant’ for scheduling, nor could it foresee any circumstances where there would be regulatory benefit in the APVMA being contemplated as being an applicant. The APVMA suggests an amendment to the SPF stating the APVMA is able to provide a recommendation directly to the Secretary, but not be the applicant.
              6. Is the Scheduling Policy Framework helpful in understanding the application and review process? If not, what amendments would you suggest?
                The APVMA currently has no specific interaction with this element of the scheduling process. As mentioned above, the APVMA identified at the implementation phase that it did not have any power under its legislation to be the ‘applicant’ for scheduling, nor could it foresee any circumstances where there would be regulatory benefit in the APVMA being contemplated as being an applicant. This was raised with the Scheduling Secretariat and an alternative process developed, agreed and implemented (May 2010). The SPF needs to be amended to reflect the current agreed process which has overcome this initial impediment and is working satisfactorily. The specific amendments should be reflected under chapter 4. - The Scheduling Process, specifically 4.1 Application to Amend the Poisons Schedule.

                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 previous definition of ‘substance’ was ‘any medicine or poison’. The current definition is much more substantial, with the operative parts being ‘an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury to persons or animals’ , or a substance already listed in the Poisons Standard or specified by legislative instrument.

                  The explanatory memorandum identifies the definition of substance was replaced with the new definition to reflect comprehensively the substances that may be considered for scheduling by the Secretary, and which the new Committees may consider and advise on. However, the new definition is very broad, and depending on how strictly or broadly the “may cause death, illness or injury to persons or animals” is interpreted could lead to confusion for industry as to the requirement to be scheduled. If interpreted too broadly it could mean the scheduling system has an undue number of unnecessary applications that only result in further additions to Appendix B (Substances considered not to require control by scheduling).
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                  In terms of exact APVMA application categories, applicants and the APVMA need to form a view as to the necessity for scheduling when:
                    • Conducting a full assessment (Categories 1 and 2);
                    • Registering a chemical product containing an approved active constituent and approval of the product label (Category 4); and
                    • Conducting certain modular assessments (Category 10 when Module 4 is specifically required).
                  For these applications, both the APVMA and the applicant are required to address the necessity of poison scheduling. Further guidance on how to interpret this definition in the SPF would be useful for industry and the APVMA. We note that the Department of Health and Ageing has previously published Guides to its website which provide general guidance on the legislative requirements.
                    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?
                      The APVMA wants to have a continued presence as an ‘observer’ on the ACCS and the joint meeting of the ACCS/ACMS. In the SPF there is limited guidance relating to committee appointments as stated under 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 APVMA is able to provide specific technical expertise (for example intended use of the product and label particulars). This technical expertise contributes greatly to the overall discussion during the committee meetings. However it should be noted that both the TGA Act and the TGA Regulations do not provide ‘observer’ status. While such status may be available under meeting the procedure provisions at Regulation 42ZCL (4), it might be prudent to provide for such status under the SPF.
                        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?
                          The objectives of the new arrangements have gone a considerable way to providing a more flexible, efficient and effective operation for the scheduling of agricultural and veterinary medicines chemicals. However, as noted previously, the APVMA proposes a number of enhancements to further improve the current scheduling process and the SPF. They are outlined in further detail under questions 5, 11 and 26.
                            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.
                              The APVMA considers the new arrangements have not had a detrimental effect on the flexibility, efficiency and effectiveness of the scheduling process.

                              11. In terms of the operation of the committees do you have any suggestions how the arrangements can be improved?
                                a) Increased flexibility for committee meetings:
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                                The APVMA notes the provision outlined in Regulation 42ZCL (1) ‘If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session’ to conduct ‘out of session’ meetings. The APVMA considers this provision is not being used to its full potential and suggests a process enhancement to provide greater flexibility on ‘how and when’ these committees meet. The amendment could be achieved if the Secretary engaged the committee members electronically and provided them with the proposed decision electronically. How often the committee members meet ‘out of session’ would depend on the scheduling proposals received by the secretariat. For example the ‘out of session’ meetings could be conducted in between the current schedule of face-to-face meetings.
                                  The benefits to the scheduling process would be:
                                    • decrease the length of time that scheduling proposals are with the Secretary , using the above example the length of time could be reduced by approximately 60 days;
                                    • continue to provide a level of comfort for the Secretary and the committee members while decreasing the length of time scheduling proposals are with the Secretary; and
                                    • potentially reduce the costs of scheduling decisions

                                  The benefits to industry would be:
                                    • quicker decision making in relation to scheduling proposals that need to go to the committees;
                                    • greater certainty for when they may be able to obtain market access; and
                                    • potential for reduced scheduling costs.

                                  b) Expanded committee meeting timetable:

                                  The APVMA has statutory timeframes to meet, for example 15 months for a new active/new product. The APVMA project manages its portfolio of registration applications and the current 12 month planning period for committee meetings adds to the uncertainty of timing for those products that require a longer timeframe for assessment. It would, therefore, assist the APVMA and industry stakeholders provide more predictability for planning purposes to have future committee meetings and cut off dates for a rolling 24 month period rather than the current 12 month period.
                                    c) Increased access by Individual companies:

                                    To encourage transparency and improve timeliness in the scheduling process, the APVMA proposes that when a scheduling proposal is with the Secretary for their decision that individual companies liaise directly with the scheduling secretariat rather than through the APVMA. This will enhance the flow of information to the scheduling secretariat and ensure there are fewer steps in the scheduling process.

                                    d) Parallel Consultation Processes:

                                    The APVMA has its own statutory consultation processes when approving active constitutes and registering products. Part of this is the Product Release Summary (PRS), a publication of the summary of the data reviewed and an outline of the regulatory considerations for the proposed registration of a particular product containing a specified active. At the point when the APVMA is proposing to register a product, it will have considered the physical chemical characteristics of the proposed product and use patterns, relevant risk mitigation strategies and safety directions, and any advice received from OCS or other experts. The APVMA is also statutorily obliged to have regard to the relevant Poisons Schedule (if known) when approving relevant particulars for labels.
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                                    In working to improve predictability and reduce the overall time taken to make regulatory decisions, the APVMA has been working with the Scheduling Secretariat to streamline the APVMA public consultation processes. Specific elements of both APVMA and Scheduling consultation could be conducted concurrently, rather than the traditionally sequential model where the APVMA PRS consultation is only triggered when an appropriate signal heading has been decided through the scheduling process and incorporated into the Poisons Standard. Adopting a parallel consultation process triggered by the Secretary’s Interim Decision would remove a number of months from the assessment timeframe. The APVMA is looking at this option because legislation is before the parliament that will introduce ‘elapsed timeframe’. The introduction of elapsed timeframes without enhancements to associated processes would place further pressure on the APVMA assessment process.

                                    The APVMA suggests that both agencies adopt parallel consultation, which will still ensure transparency and predictability in each process, while also increasing the efficiency, effectiveness and timeliness of the APVMA assessment process. A parallel consultation process should also be welcomed by industry and other stakeholders.

                                    Further information on possible timeframes and more detailed operational considerations can be supplied separately if requested. Consideration of any legislative implications would also be needed.

                                    e) Scheduling and APVMA Chemical Reconsideration:

                                    The APVMA proposes that the ACCS consider a more flexible approach in reaching recommendations for the scheduling of antibiotics. There has been a case where a scheduling decision about an antibiotic has not been made as the antibiotic was under chemical review. This has led to considerable delays in scheduling some products due to the lengthy nature of the chemical review.

                                    It is recommended that scheduling of substances be determined irrespective of whether or not that substance has been prioritised for chemical review. The two processes, scheduling and chemical review, are independent of each other due to separate legal and process obligations. Should the outcomes of a chemical review impact on the scheduling of an antibiotic; submissions can be made at that time for rescheduling. At this part of the process Registrants have an opportunity to provide up to date information to the Secretary, who in turn can seek independent advice on this information.
                                      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?
                                        The current APVMA practice when approving an active constituent or registering a product is to rely on the Secretary’s final decision when it is published on the TGA website not when the SUSMP is updated. The SPF could be strengthened in this area to provide further clarity.
                                          13. Is the process whereby the Secretary makes amendments to the Poisons Standard clear and transparent? If not, how could the arrangements be improved?
                                            The APVMA is not aware of any specific examples where amendments to the Poisons Standard are not clear and transparent.
                                              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.
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                                              As previously mentioned in question 2, the APVMA does not believe there has been any detrimental effect on flexibility, efficiency and effectiveness of the scheduling process.

                                              The throughput performance of the Advisory Committee on Chemicals Scheduling (ACCS) and the Advisory Committee on Medicines Scheduling (ACMS) is comparable with the former National Drugs and Poisons Scheduling Committee (NDPSC).
                                                Section 52EAA Application for amendment of the Poisons Standard
                                                  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 APVMA would welcome electronic submission of scheduling process applications.

                                                    Other matters


                                                    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?
                                                      The APVMA has suggested a number of process and SPF improvements in questions 5 and 11, the benefit of these proposals would be enhanced if an analysis of scheduling decisions made under the new arrangements was conducted. They are:
                                                        a) The APVMA has suggested a number of process and SPF improvements in questions 5 and 11, the benefit of these proposals would be enhanced if an analysis of scheduling decisions made under the new arrangements was conducted. They are:

                                                        a) Rescheduling proposals:
                                                            • Number of Delegate only decisions vs. Delegate decisions requiring input from the committee using the current practice;
                                                            • Number of Delegate only decisions vs. Delegate decisions requiring input from the committee using the APVMA proposal under question 5

                                                        b) Current S4 ‘unqualified’ medicine (for example does not contain the wording ‘for human medicine only’):
                                                            • Number of Delegate only decisions vs. Delegate decisions requiring input from the committee using the current practice;
                                                            • Number of Delegate only decisions vs. Delegate decisions requiring input from the committee using the APVMA proposal under question 5
                                                          c) Increased flexibility for committee meetings:
                                                              • Number of occasions that out of session meetings yielded advice to the Secretary; and
                                                              • Total number of decisions completed per year
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                                                          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?
                                                            There is currently the potential for the committee’s recommendations, and the Secretary’s decisions, to have unintended consequences for widely used substances. For example, a rescheduling decision relating to an agvet active constituent may have implications for industrial chemicals that use the same active. A recent example of where such a decision for a substance was seemingly made in isolation on an agvet chemical and then had significant implications for other sectors is provided below.

                                                            The example highlights the APVMA’s responsibilities only being the regulation of agvet chemicals. Potential scheduling consequences for the same substances used in other sectors need to be considered and what consultation may be appropriate needs to be determined and managed. Chemical regulation is sectoral, with the scheduling secretariat being the common entry point to the scheduling process. The APVMA suggests the scheduling secretariat should have the responsibility to prepare a ‘substance profile’ for each scheduling proposal. The profile would map the use of the substance across the sectors and ensure that cross linkages between sectors are identified prior to scheduling decisions being made. This would reduce the prospect of unintended consequences in sectoral use not specifically considered during the scheduling process.

                                                            By way of example, carbendazim is a systemic benzimidazole fungicide used in agriculture; which is also included in paints and sealants and potentially used as a mould inhibitor during manufacturing. The agricultural uses of carbendazim were reviewed by the APVMA because of concerns over its potential to cause birth defects and impair human fertility at exposures above a threshold dose.

                                                            The October 2009 meeting of the NDPSC recommended rescheduling of carbendazim from Schedule 6 to Schedule 7. The meeting also concluded that an exemption for paints, jointing compounds or sealants containing 0.5 per cent or less of carbendazim was no longer appropriate.

                                                            There is confusion in this area as the APVMA regulates only anti-fouling paints but does not regulate other paint, sealant and jointing compound products. There was no direct consultation with the manufacturers of other types of paint products. Although the APVMA does not regulate these other paints, it became aware of concerns being raised by the broader paint industry. The APVMA understands that following representations from these stakeholders, the NDPSC noted the potentially large negative impact of the removal of this exemption and agreed to delay the implementation of the October 2009 decision to 1 January 2011. This allowed time to consider a proposed new exemption cut-off of 0.1 per cent carbendazim in paints, sealants and jointing compounds. This also meant a delay in the implementation of the decision to move agricultural products from Schedule 6 to Schedule 7.
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