Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - Accord Australasia

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

Page last updated: 18 April 2013

Summary

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

Accord believes that the new scheduling arrangements have neither brought significant net benefits nor imposed new regulatory burdens on industry. While we are not unhappy with the current separate scheduling decision making process, we believe that there are a number of improvements that can be made. These include:

    • Improvements to information provision. This includes easier access to information and more detailed information. Also, stakeholders should be able to discuss scheduling decisions or clarify scheduling proposals with those that were involved in consideration of the scheduling proposal, whether it be the Scheduling Secretariat, the Delegate and/or the advisory committee members.
    • Tighten the definition/increase the specificity of ‘substance’ and/or issue being considered for both the consultation stage of the scheduling proposal and when including controls in the Poisons Standard.
    • Create a new simpler process for administrative decisions to exclude from scheduling, substances that were inadvertently captured in the initial scheduling process.
    • Ensure only the relevant advisory committee is involved for consideration of scheduling proposals.
    • Ensure that the same application process and information requirements are applied to all stakeholders.
    • Include consideration of costs and benefits in Section 52E, particularly for low risk products.
    • Consider the feasibility of an administrative review process.

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?
      Accord notes that the changes brought about with amendments to the scheduling arrangements appear not to have brought about significant net benefits in terms of flexibility, efficiency and effectiveness. However, we also note that the flexibility, efficiency and effectiveness of the overall system are no worse than before the amendments. In short, while the separation and expertise/focus on chemicals via an Advisory Committee on Chemical Scheduling (ACCS) is an improvement, we believe the new arrangements have achieved essentially status quo i.e. the opportunities for real efficiency gains have not yet been realised.

    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 timeframe for making decisions has become longer which can create inefficiencies for companies that are awaiting the final decision on the substance.

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

      We believe that there are a number of changes that can be implemented to improve the efficiency and flexibility of the scheduling arrangements while maintaining their effectiveness. These include the following:

      (a) Where a scheduling change is proposed for a substance to allow its use in the chemicals sector, only the Advisory Committee on Chemical Scheduling (ACCS) should meet to consider the proposal, not the joint committee of ACCS and the Advisory Committee on Medicine Scheduling (ACMS). We believe this would improve efficiency by ensuring that only the relevant advisory committee with specific expertise and focus considers the issue at hand.

      An example of this is the consideration of tranexamic acid by the ACMS/ACCS joint committee. The proposal to exclude tranexamic acid derivatives for cosmetic use did not impact on the medicinal use of the substance. However, the joint committee deliberated on the pros and cons of the cosmetic use of the substance which we believe is an inefficiency. Accord notes that industry was happy with the final decision – we simply note that it is an inefficient practice to involve the medicines advisory committee when the proposal had no bearing on medicinal use.

      Another example, although perhaps less clear cut, is the consideration of scheduling hydrogen peroxide/carbamide peroxide by the ACMS/ACCS joint committee. While the proposal by the applicant was rather confusing, it was clear that the proposal only related to the teeth whitening application. As teeth whitening is a cosmetic procedure, only the ACCS was needed to consider the application. While we concede that the applicant initially wanted medicine scheduling for this substance and the input from the ACMS that teeth whitening procedure which is purely cosmetic and should not be scheduled as a medicine is helpful, this could have occurred prior to the meetings. We also note that the applicant then amended the submission and did not seek a specific medicines scheduling, which should have put the consideration into the ACCS agenda, rather than to the joint committee.

      We also note that sodium lauryl sulphate was considered by the joint committee, although the consideration of its uses was clearly cosmetic/industrial and agvet chemical. We believe this may have led to a more conservative and unnecessarily restrictive decision, which has negatively impacted on our Members. More information is provided under responses to question 4.

      (b) Implement an administrative decision process for excluding scheduled chemicals where they are inadvertently captured. We propose an application using a simple application form and a decision by the Delegate of the Secretary of Department of Health and Ageing (the Delegate). We believe that this would improve the flexibility and efficiency of the scheduling process.

      Accord has noted a number of cases where chemicals that are freely available for use in industrial sector or in cosmetics have been caught up inadvertently in Schedule 4, prescription only medicines. Previously we had advocated separation of the committees and decision-making process, as well as the Poisons Standard itself to solve the problem. However, noting that the latter would require significant changes to State and Territory legislation, we believe that a simpler decision-making process to exclude substances inadvertently captured by scheduling decisions could also provide an acceptable and efficient outcome.

      Tranexamic acid is one such example. Derivatives of tranexamic acid are used as cosmetic ingredients globally, including in economies with equivalent consumer health and safety focus to Australia, such as the EU and the USA. It is our understanding that when tranexamic acid was scheduled as Schedule 4 without exemptions, the cosmetic use of the substance was never considered. We also note that the cosmetic use of the substance has no similarity to the use of the substance as a medicine. In this case, we believe that the inadvertent consequences could have been raised using a simple form noting the use of the substance in cosmetics, and the cosmetic use of the substance could have been excluded from scheduling by the Delegate, after considering similar uses globally. Instead, a full application including toxicity information had to be lodged for consideration by the advisory committees before the final decision could be reached. This is a costly exercise which put the onus on industry to prove that the substance shouldn’t be regulated, when the regulation of the substance for cosmetic use was purely an administrative error.

      Another more interesting example is the use of hydroquinone monomethyl ether (also known as MEHQ, mequinol, 4-methoxyphenol and p-hydroxyanisole) in gel nail polishes. This is a new, novel and minor use and we are seeing this technology in Australia being currently marketed by companies that are not Accord Members. MEHQ is being used in the nail polish as a polymerisation inhibitor. Currently the methyl ether of hydroquinones are capture in Schedule 4 monobenzone entry. The entry reads:

      MONOBENZONE and other alkyl ethers of hydroquinone for human therapeutic use or cosmetic use.

      Clearly nail polishes are cosmetics. However, it is our understanding that the cosmetic use that was considered was not as polymerisation inhibitors in nail polishes, but rather skin whitening applications. It can be easily established that the use of the MEHQ as a polymerisation inhibitor, which is used in ppm quantities in the formulation and binds to the polymer as they form on the nail, carries a much lower risk than as a skin lightening agent. However, in order for this to be considered, a full rescheduling application apparently must be made, which is onerous and again unnecessary.

      Further we note that while some of the State Health Departments are aware of this non-compliance by companies marketing these products, these products continue to be used in nail salons and sold to consumers through retail outlets. We understand that this is a low priority for compliance officers as these products do not pose a public health risk. However, we are concerned that this creates a situation where being compliant with existing legal requirements is seen as anticompetitive for compliant companies, and creates a view within the non-compliant companies that legal compliance is a “nicety” rather than a necessity.

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?

      While we believe that section 52E is appropriate and effective for higher risk medicines and chemicals, for lower risk chemicals, we would like to see the addition “costs and benefits” as a matter that should be taken into account.

      Two of the substances that were considered early on in the new scheduling arrangement were sodium lauryl sulphate (SLS) and laureth carboxylic acid (LCA). Both of these substances are used as surfactants. While SLS is used more widely including in food, we understand that LCA has lower skin and eye irritation potential than SLS.

      While the ACMS/ACCS joint committee considered that the current uses of these chemicals did not pose any concerns, rather than deciding not to include them in the schedule, new schedule entries were created which excluded all current uses of these substances. This has meant inefficiencies for both industry and the scheduling system, since we had to seek information from our Members than provide that information to the advisory committees to ensure that all current uses were excluded from the schedule entry. Further, as these substances are only excluded with safety statement, some Members had to change some of their product labels which were acceptable internationally before the change.

      We note that this has not changed the availability and accessibility of the products containing these substances.

      If costs and benefits of including SLS and LCA to the Poisons Standard were also considered including the addition of safety phrases, we do not believe this situation would have occurred.

      Costs and benefits routinely need to be established as part of Regulatory Impact Statement (RIS) considerations and therefore scheduling should not be exempt from this requirement.

      In the case of SLS, we understand that the consideration was initially raised because of a new proposal for a veterinary use of injectable solutions of SLS. We believe that a more efficient outcome would have been to limit the consideration to this use.


    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?

      From feedback received from Members, Accord believes that this is not very clear. Some of the questions raised include whether the Secretary (or Delegate) is merely a figurehead that takes the advice of the advisory committees, or whether he/she actively exercises their power to make decisions that are contrary to the advice of the advisory committees.

      One of our Members has indicated that they are unsure whether information could be provided directly to the Secretary (or the Delegate) or questions asked of them. For example a letter directed to the Delegate was responded to by the Scheduling Secretariat requesting that a full rescheduling application be submitted. The company was unsure whether the Delegate had even received the letter.

      The arrangements could be improved by clearly stating the roles and responsibilities of each of the players involved in scheduling e.g. Secretary, Delegate, advisory committee and Scheduling Secretariat. For example, clarifying whether information can be given directly to the Delegate, whether the Scheduling Secretariat (or the Delegate or the advisory committee members) can provide clarification on the final scheduling decisions and/or what the schedule entries mean or intend.


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

      The Scheduling Policy Framework is helpful for understanding the application and review process. However, we believe that the process itself needs to improve its flexibility and efficiency. For example, where a chemical is proposed for scheduling, there should be no need to explain why it should not be included in schedule 8, 4, 3 or 2. The only consideration should be schedules 7, 6 and 5, with some consideration of Appendix C if necessary.

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?

      While the definition of ‘substance’ may appropriately reflect the substances that may be considered for scheduling by the Secretary, because of the broad definition, it is not always possible for stakeholders to understand the full impact of the proposal.

      We have already provided examples of substances in Schedule 4 that are also used in cosmetics that were not properly considered in the initial scheduling process (please see our response to question 3).

      Another example is arbutin, which is a “derivative” of hydroquinone (glycosylated hydroquinone). Arbutin is naturally occurring and is found in wheat, pear skin and bearberry. We understand that commercial supplies of arbutin are extracted from bearberry plants. A company formulating a moisturiser using “bearberry extract” would not necessarily know that they are formulating using a scheduled substance. They may not even be aware that “arbutin” (recently scheduled) is present in bearberry extract.

      Another problem is that the definition can capture a group of substances that may be chemically related but have very different toxicological profiles.

      For example, ethylene glycol monoalkyl ether and their acetates are included in schedule 6. As this entry does not exclude derivatives, there was an interpretation a few years ago that meant that higher glycol ethers and any alkyl chain length were also Schedule 6. The toxicology of glycol ethers varies enormously depending on the level of ethoxylation and the length of the alkyl chain and yet, regardless of this consideration, all ethylene glycol monoalkyl ethers are controlled as though their risks are the same.

      Similarly, recently scheduled laureth carboxylic acid (LCA) captures all degrees of ethoxylation, even though the irritation potential for LCA varies significantly depending on the degree of ethoxylation.

      For the purposes of public consultation, more information on the ‘substance’ that is being considered would be useful i.e. include synonyms, if likely to be found in natural extracts what they may be, etc. For the purposes of including in the schedule, the definition should be narrower and should only be for the substances and derivatives considered.

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

We have no further comments for this section as we believe our responses to questions 1, 2 and 3 also address this section.

    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?


Section 52D Amendments to the Poisons Standard and associated Regulations

We have no further comments for this section as we believe our responses to questions 1, 2, 3, 4,5 and 6 also address this section.

    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.


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?

    We do not believe that this is very clear. Currently the information that is available for the application is as follows:

      1. General scheduling applications: General scheduling applications are those applications proposing to amend the Poisons Standard and must be supported by sufficient information and be in a form approved by the Secretary. (a footnote in TGA webpage for scheduling committees).

      It is not clear what is “a form approved by the Secretary”.

      In a separate webpage within the TGA website, the following information can be found under the heading “Application to amend the Poisons Standard” and subheading “About the application form”:

      Use of this form will ensure that applications are in an acceptable format and will help avoid possible.

      There is no indication that the form must be used to make an application, or that this form is approved by the Secretary. However, it is industry’s experience that this is expected of industry. We have provided an example where the Scheduling Secretariat has suggested that a full rescheduling application be made using an appropriate form.

      Unfortunately we find that the expectation is only on industry and not on other stakeholders.

      We note that the recent hydrogen peroxide/ carbamide peroxide rescheduling consideration occurred because the Australian Dental Association (ADA) wrote a letter to the Scheduling Secretariat asking for rescheduling. Even though it was not in the “right” format, the scheduling proposal was put forward and public consultation process began. We also understand that after the public consultation, the ADA withdrew its application, only to reapply, again by writing a letter. This was again put forward for rescheduling consideration including public consultation.

      Another example of the form not being used is the application to reschedule naphthalene. We understand that only a letter was received (we understand that the applicant was a physician) and yet this triggered a rescheduling consideration and amendments to the Poisons Standard, even though there was no new evidence put forward by the applicant.

      While we believe that some flexibility is necessary for rescheduling consideration, any proposal for rescheduling should be accompanied with enough science based and logical evidence to support the rescheduling proposal no matter whether the applicant is industry, professional body, government or the public.


    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 impact on Accord Members would be very small as this is already expected of the industry. However, we would prefer to see a more flexible arrangement where a judgement is made on the merits and relevant levels of the evidence put forward rather than in the format that it is provided. Also, we believe that the format that is required of industry should be that which is required for professional bodies and governments and potentially (but to perhaps a lesser degree) for the general public.

      As suggested in response to question 3, implementation of a separate administrative decision process where chemicals have been inadvertently captured in a scheduling process would improve the efficiency and flexibility of the scheduling system.

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?

      A number of our Members have indicated that the overall communication of the new scheduling system is rather confusing and information on TGA website difficult to access. This means that more time is spent by companies trying to find information that is relevant to them.

      Further, sometimes the information provided in the scheduling notices is too brief. For example, the recent notice for the scheduling proposal for thymol only stated “thymol: proposal for a new Schedule 6 entry for thymol.” Considering that thymol is widely used across cosmetic and therapeutic oral care products, it is understandable that some of our Members were concerned that the word “POISON” may be mandated on all of their oral care products containing thymol.

      Accord was able to deduce from the fact that the proposal was only for schedule 6 entry that this was likely to be a proposal from the Australian Pesticides and Veterinary Medicines Authority (APVMA). However we were unable to confirm this when we contacted the Scheduling Secretariat because apparently the Scheduling Secretariat is not supposed to provide any information other than what is already made publicly available (which we believe is not communicated very well – please see our comments under question 5).

      While Accord made the decision to make a simple submission on thymol to state that current uses of thymol should be excluded from the scheduling consideration based on an educated guess, our members were considering whether a full data package to demonstrate the safety of the use of thymol in oral care products should be submitted. Clearly this would have been a waste of time for our industry, the ACCS and the Delegate.

      We note that the safety of thymol in oral care products was never in question. In the end, the Delegate’s interim decision made it clear that the consideration of thymol schedule entry was for control of varroa mite. If the intial consultation had stated that the scheduling consideration of thymol is for the control of varroa mites, this would have made providing comments simpler for our industry.


    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?

      Please see our response to question 19.

    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?

      While Accord has not experienced any difficulty in accessing the decisions made by the Secretary, we note that the information provided is no longer as detailed as it was before the amendments to the scheduling arrangements.

      We understand that this is because the decision maker is no longer the scheduling committee but the Delegate, and the Record of Reasons which used to publish the evidence considered by the scheduling committee is no longer the direct deliberation of the Delegate’s decisions.

      However, it is difficult at times to understand the reasons for the Delegate’s decision from reading the summary of the decision alone. For example, in the notice of the Delegate’s decision on hydrogen peroxide, it appeared that the Delegate did not take the advice of the advisory committees. While Accord does not question that the Delegate has the right to make decisions that are contrary to the advice of the advisory committee, we believe that some reasons for that decision should be provided. This is particularly the case where the advisory committees and the Delegate do not agree, but also useful where they agree. Providing comments to the Delegate’s interim decision would be a lot easier if the stakeholders understood the reasons behind the decision.

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.

      While we find that the decisions from the scheduling process are well considered, there will be odd occasions where a second consideration or reconsideration of the evidence at hand may be useful.

      An example of this is the most recent rescheduling decision on naphthalene. We note that the applicant for the rescheduling process had not provided any new information to warrant a rescheduling consideration. The final decision of the Delegate was to impose child resistant packaging on naphthalene flakes. As this is currently impossible, this meant that these products had to be withdrawn from the market. This decision was rather odd as it did not address the applicant’s concerns, which was apparently to do with inhalation of naphthalene vapours i.e. as naphthalene works by releasing vapours, child-resistant packaging would not have addressed the applicant’s concerns.


    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?

      This is a difficult question. While we believe that there should be avenues for review of decisions, our members are currently unsure how this would work in practice. Also, we would not want to see the efficiency of the scheduling process being reduced because of large numbers of review requests.

      We believe that the current chemical scheduling process works relatively well because we have the right make-up of the advisory committee and the Delegate (in terms of expertise). However, we are also aware that this can change, and an external review process would ensure that the Secretary remains accountable for the decisions of the Delegate.

      However, as the expertise assembled in the ACCS and the Delegate are arguably the best there is, we are unsure who would undertake the review.

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?

      Accord has not identified any other benefits.

    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?

      We believe that some performance indicators are necessary. However, our members are currently unsure at this point what data would be relevant or how this would be meaningfully collected.

    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?

      Over the years Accord has provided comments to a number of different legislation amendment proposals and other work aimed at harmonising poisons control regulations across Australia. This includes:

      Proposal for implementation of the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), with preferred option of aligning classification with GHS and maintaining separate risk-based labelling system for consumer products.

      Review of the poisons control regulations across Australia, the work of the national Coordinating Committee on Therapeutic Goods (NCCTG) headed by the Queensland Department of Health.

      We note that no work appears to have progressed recently for the above mentioned projects. In terms of GHS implementation, while we support maintaining risk-based labelling for consumer products it is important that the scheduling system recognise the new classification system for industrial chemicals. Most of the data generated for chemicals now and into the future will be to the new GHS classification and the scheduling system must be able to work with this new system.

      As for the Harmonisation of Poisons Control work, we hope that this is still progressing, although we have not seen any progress on this and we understand that NCCTG no longer exists.

      We also note that there is continuing work on the Australia New Zealand Therapeutic Products Agency (ANZTPA). Given that New Zealand does not have a scheduling system, at least not for chemicals, we would like to understand how the scheduling system will be impacted by ANZTPA. It is important to note that some products that are considered cosmetic in New Zealand (e.g. sunscreens) are currently ‘medicines’ in Australia.

      While this may be outside the scope of this review, there should be greater recognition of the roles of other regulatory agencies. For example, workplace chemicals are regulated by workplace regulators with policy decisions sitting with Safe Work Australia. We note that Schedule 7 chemicals are only allowed for use in industrial setting and yet there are controls put on them by health regulators. As workplace regulators should recognise the role of health regulators in the consumer goods space, we believe that a reciprocal recognition of the role of workplace regulators is appropriate. This could be achieved by removing controls on Schedule 7 chemicals from the relevant poisons regulations.