Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - Australian Self Medication Industry

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

Page last updated: 18 April 2013

Introduction

ASMI (Australian Self Medication Industry) is the peak body representing companies involved in the manufacture and distribution of consumer health care products (non-prescription medicines) in Australia. ASMI also represents related businesses providing support services to manufacturers, including advertising, public relations, legal, statistical and regulatory consultants.

ASMI appreciates the opportunity to comment on the Consultation “Review of Arrangements for Scheduling Substances – Part 6-3 of the Therapeutic Goods Act”.

ASMI supports reforms aimed at improving the transparency of processes and decision making relating to the scheduling of substances, and has provided responses to previous consultations held on this matter, in May 2009 and March 2010.

ASMI recognises that harmonisation with New Zealand for scheduling of medicines and poisons is outside the scope of this review. However, the outcomes of this review should be made within the context of initiatives currently underway for the formation of the Australia New Zealand Therapeutic Products Agency (ANZTPA).

ASMI provides the comments and responses to the consultation in relation to the types of applications submitted by member companies. These types of applications are mainly:
  • Rescheduling applications – for medicines in Schedule 4 to Schedule 3. These are usually in small pack sizes, for indications that are suitable for self-medication by patients/consumers.
  • Rescheduling applications – for medicines in Schedule 3 to Schedule 2, and from Schedule 2 to unscheduled.
  • Appendix H applications – to allow advertising of a medicine in Schedule 3.
  • Chemical substance scheduling applications, as some chemical substances are present as excipients in various types of formulations.
OTC and complementary medicines by definition have a long history of use, and a low potential for safety risks.

It should be noted that Section 52EC(3)(a) states that the review must report on “the system of access of controls for goods containing scheduled substances established by this Part”. This wording suggests that the terms of reference specified by the Act are much wider than those that are the subject of the review. The review appears to be confined to the wording of the Act and comparisons between the NDPSC model and the current model, and discussions on effectiveness and transparency of the process described in the Scheduling Policy Framework; however the review as specified in the Act would also encompass the Schedules, Appendices (including Appendix H), signal headers and labelling, i.e. all aspects of scheduling.

Given the importance of this review, ASMI is concerned at the short timeframe allowed for consultation. Taking into account statutory public holidays, less than 4 weeks was allowed. This is insufficient to prepare a comprehensive industry response with constructive alternate proposals. According to the COAG document “Best Practice Regulation"1 dated October 2007, stakeholders should be given sufficient time to provide considered responses, throughout the consultation period.

Matters Raised in Consultation Template

Responses are provided to matters as raised in subheadings of the document titled “Review of arrangements for scheduling substances Part 6-3 of the Therapeutic Goods Act 1989, Information for stakeholders Part A”. Some of the responses also provide comment on some broader aspects of medicines and poisons scheduling, although we have tried to work within the terms of reference of the review.

1. Key questions regarding the objectives of the amendments

The key questions raised relate mainly to whether the current scheduling arrangements provide a more flexible, efficient and effective operation for the scheduling of substances, compared to the former NDPSC model, and whether any suggestions can be provided on how the scheduling arrangements can be improved.

Industry is looking for efficient, effective and predictable scheduling arrangements, with respect to timeframes and procedures. Flexibility only appears to present in terms of the Delegate’s option on whether the advice of the ACMS is warranted or has some influence on the final decision.

ASMI members feel that the provisions under the current scheduling arrangements have provided some improvements in efficiency and effectiveness, compared to the former NDPSC model. In particular, the following aspects of the current scheduling arrangements have led to improvement in the operation of the system:
  • The Secretary being the decision-maker on the scheduling of medicines
  • Separate consideration of medicines and poisons, through the ACMS and ACCS
  • The single Poisons Standard as the Commonwealth Legislative Instrument

ASMI is of the view that these principles of the scheduling process have delivered improvements and should be retained, however there are a number of examples where members have experienced difficulties with the scheduling process and there are further changes that can be made to improve consistency of decision making, transparency and efficiency. These are discussed in more detail below, as they relate to some of the specific questions raised throughout the consultation document.

2. Key questions regarding the system of access controls:

Section 52E – Secretary to take certain matters into account in exercising powers (Questions 4, 5, 6)

In this section, questions have been raised by the review panel on the matters to which the Secretary must have regard when amending the Poisons Standard, and whether these are appropriately described and effective.

Information has also been requested on whether the Scheduling Policy Framework is helpful in understanding the review process, and whether the process described is clear and transparent. Suggestions for amendments are also requested.

According to Section 52E(1) of the Therapeutic Goods Act 1989, the matters that the Secretary must take into account in making a decision are:
(a) The risks and benefits of the use of a substance
(b) The purposes for which a substance is to be used and the extent of use of a substance
(c) The toxicity of a substance
(d) The dosage, formulation, labeling packaging and presentation of a substance
(e) The potential for abuse of a substance
(f) Any other matters that the secretary considers necessary to protect public health

These matters must also be addressed by sponsors in submissions for an application for rescheduling, as per the Scheduling Template “Guidelines for Applications and Information Requirements”.

In principle, ASMI does not object to the matters described above, however feedback from members as well as comparisons with other regulators indicates that more could be done to improve clarity and consistency around the way that risks and benefits are considered.

ASMI also has suggestions on other aspects of the Scheduling Policy Framework relating to Schedule 3 medicine advertising, scheduling principles, and other matters, addressed below.

Risk vs. Benefit of the use of a substance – further considerations

ASMI supports consideration of benefit vs. risk in decision making, however notes that there appears to be no consistent or transparent methodology being applied to the benefit vs. risk question, one of the main criteria used to make decisions on scheduling. It seems, to sponsors, that arbitrary risk vs. benefit assessments are made on the part of the ACMS, which then provides advice to the Delegate. This advice, in turn, can be taken into consideration by the Delegate as part of the decision-making process.

Presently, risk vs. benefit is assessed in a non-transparent way. The method or guidelines used by the ACMS and Secretary to consider benefit vs. risk have not been made available, and it appears to sponsors/applicants that risks that occur rarely or outside the context of the proposed OTC medication use can be given disproportionate emphasis.

Many overseas regulators, including those in New Zealand, the UK and Canada are examining frameworks for benefit-risk assessment and there is ongoing research into models that aim to develop assessment tools for application to non-prescription medicine scheduling and registration.

ASMI believes that the Scheduling Policy Framework should consider the introduction of a standardised way of assessing benefit and risk. This would improve and help achieve some consistency in the way that decisions are made. Benefit-risk models are useful tools for analysing potential benefits and risks associated with a product. Appropriate benefit- risk models have the potential to assist both sponsors and regulators during the review process.

The paper by Brass et al2 discusses the value-tree framework approach to assessing benefit-risk. This article discusses the benefit and risk domains associated with non-prescription medicines and proposes a value-tree tool for identifying relevant benefit and risk attributes for these types of medicines. The value tree tool has been adopted in a general way by the latest UK medicines reclassification guidelines3 and the latest minutes of the Medicines Classification Committee (MCC) in New Zealand4 indicate that it will be a topic of discussion at future meetings.

Australian sponsors of applications for rescheduling and Appendix H have found that regardless of the matters that are to be considered by the Secretary in forming a decision [(Section 52E(1)], the ACMS approach is very risk-averse and undue emphasis is placed on risk. It should be recognised that improved access to effective medicines, improved clinical outcomes, and improved involvement by consumers in their health represent benefits to the consumer, and should be considered in the assessment.

In rescheduling applications, much information will already be known about risks, either through use as a prescription medicine and in clinical settings, or through use as a Schedule 3 or Schedule 2 medicine. OTC medicine use is usually for minor and self limiting conditions. Using a standardised approach will enable a discussion on how to mitigate risks and the appropriate level of access. It may also facilitate a more mature reclassification model, encouraging non-industry stakeholders to apply for rescheduling of certain medicines (as has recently occurred in New Zealand), and enabling an objective examination of rescheduling proposals that are not limited to acute, self-limiting ailments but that may encompass maintenance therapy of certain chronic medical conditions.

ASMI therefore urges the review panel to consider the adoption of the value-tree framework benefit risk model, as described by Brass Brass5, in a similar way to the Medicines and Healthcare products Regulatory Agency (MHRA) in its reclassification guidelines. This approach would also provide sponsors with a suitable framework for addressing benefit as well as risk in rescheduling submissions.

Lack of clarity on scheduling principles

Unlike New Zealand, Australia has not been consistently applying the current policy in relation to the scheduling of combination products containing more than one substance, as set out in the Poisons Standard (page vi), which states that:
“Preparations containing poisons listed in two or more Schedules
If a preparation contains two or more poisons, the provisions relating to each of the Schedules in which those poisons are included apply.
Where it is not possible to comply with both a provision relating to one of those Schedules and with a provision relating to another of those schedules, the provision of the more restrictive Schedule applies, unless a contrary intention is indicated in the Schedules or relevant legislation.


The Schedules listed in order of greatest to least restriction on access and availability are 9, 8, 4, 7, 3, 2, 6, 5.

In Australia however this approach has not been followed consistently and the difficult situation can arise where a combination has a more restrictive schedule than either of its components. An example of this is the combination of ibuprofen and paracetamol, where the Scheduling is different in Australia and New Zealand.

ASMI believes that a consistent approach to scheduling of combination products should be adopted, consistent with the practice in New Zealand and the principles of Scheduling as specified in the Poisons Standard. This is an important aspect of scheduling harmonisation across both countries.

Helpfulness of the Scheduling Policy Framework in understanding the application and review process

In general terms, the Scheduling Policy Framework is a useful document in understanding the application and review process. However, there are some issues that should be noted, mainly relating to transitional issues and the problems that have been encountered when submitting new product applications to TGA that require a scheduling decision. The Scheduling Policy Framework also is more geared towards process matters rather than providing specific and meaningful advice on data requirements and content or considerations needed for applications.

ASMI members experienced various difficulties during the transition phase, with sponsors not being notified of the ACMS meeting to which their application was allocated, as well as some major delays (in some cases 6 month delays) between lodging an application and it being considered.

There is a lack of clear and transparent process with respect to applications for rescheduling that are tied with new product applications with the TGA, as permitted in Flowchart 3. Some sponsors have experienced unacceptable delays, with little or no information on which ACMS meeting would consider their scheduling application. ASMI is aware that in these cases, no evaluation reports were provided to sponsors, who were thus both ignorant of any information supplied by the TGA to the ACMS, and provided with no opportunity to respond prior to the ACMS meeting.

The previous practice where the TGA accepted Schedule 10 (S10) Route of Evaluation applications in relation to rescheduling applications appears to have changed, and the TGA OTC Medicines Section will not consider applications to register a new OTC medicine until a scheduling decision has been made, particularly under the new provisions of the new BPR process. The result of this is that some well known active ingredients, when presented in different dosage forms (e.g. transdermal vs. topical; oral spray vs. buccal preparations) are required to go through the scheduling process prior to an application for registration being submitted.

This can cause delays, as well as provide competitors with intelligence as to future launch plans for these products, given that calls for comment are published prior to the registration applications being considered by TGA. As a result of this, some innovator companies find that they have been commercially disadvantaged in comparison to their generic competitors.

ASMI believes that improvements should be made to the process for rescheduling applications involving new product applications, and that the scheduling process should be better aligned or integrated with the registration process. The Scheduling Policy Framework and Flowchart 3 both suggest that a concurrent process is available, however this is not the case.

ASMI encourages further discussion on establishing a workable model for concurrent scheduling and registration submissions, allowing transparency of timelines and provision of evaluations to sponsors. Under the current system, there is no period of market exclusivity and innovator companies that initiate rescheduling applications can be disadvantaged.

ASMI would be keen to assist with streamlining the process of new registration applications that require a scheduling decision.

Inconsistency of Decision-making

Consistency in decision making has also been an issue for some ASMI members. Of particular concerns are:
  • Disappointment that postitive evaluation reports are seemingly discounted by the ACMS in providing advice to the Delegate, resulting in a negative decision.
  • Evaluation reports provided to applicants suggesting that a “pharmacological class” approach should be taken to scheduling decisions, however this is not available under the Scheduling Policy Framework.

Some of these issues could be improved by including more information on scheduling principles, as well as content or data requirements in the Scheduling Policy Framework. The UK Reclassification Guidelines Appendix 36 provides comparatively more detail to applicants on what matters should be considered in assessing benefit, and what matters constitute different types of risks. It also provides guidance on self-diagnosis, risk of misuse, and which specific criteria apply to the various classifications. This detail assists sponsors with applications.

Improving the decision making criteria as expressed in the Scheduling Policy Framework may assist with making decisions more consistent. Poorly defined criteria for assessment often leads to inconsistent decision making and ASMI believes that efforts should be made to provide more background information to applicants, to improve the quality of applications and the consistency of decision making. The Scheduling Policy Framework should provide better, clearer guidance on data requirements as well as on procedural matters.

In summary:

ASMI believes that improvements can be made in the following areas:
  • More structured and transparent way of approaching benefit vs. risk, with the introduction of a value-tree framework as per the UK guidelines.
  • Increased recognition that improved access to more effective OTC medicines is a benefit for consumers and public health.
  • Consistent approach to scheduling of combination medicines, as per the New Zealand approach.
  • Clear and effective approach for new product applications that are contingent on scheduling decisions, working seamlessly with TGA new product applications.
  • Improvement to the background information and guidance contained in the Scheduling policy Framework.
  • Serious consideration should be given to harmonization of processes and decisions under the joint regulatory scheme for therapeutic products (ANZTPA).

Any changes to the Scheduling Policy Framework should go through the accepted consultation process and provide industry with the opportunity to comment, although it is not clear at this point how any revisions to Scheduling Policy might be made, give that the NCCTG has effectively been disbanded.

3. Key questions regarding the outcomes of administration

Section 52A – Definition (Question 7)

ASMI has no issue with the definition of “substance” and believes that the definition appropriately reflects the substances that may be considered for scheduling by the Secretary.

Section 52B and 52C and Section 52CA – Functions of ACMS and ACCS (Questions 8, 9, 10, 11)

ASMI believes that the establishment, functions and membership of both the ACMS and ACCS are appropriately described in the Act.

In relation to this section of the consultation, the panel will consider matters related to flexibility, efficiency, effectiveness, timeliness and quality of decision making, and these matters are of particular interest to ASMI members. ASMI questions the appropriateness of flexibility as an objective of the system, as predictability in relation to timeframes and decision making are more important attributes of the system from the point of view of industry stakeholders.

ASMI has no comment on the functions as described in Sections 52B and 52C, but would like to provide some suggestions for how the arrangements can be improved to be considered by the review panel.

It should be noted that the transitional phase during 2010, from the NDPSC to the ACMS/ACCS was quite problematic. A number of ASMI members experienced excessive delays and lack of timely allocation to meetings. However, in general terms and following the publication of the ACMS/ACCS meeting timelines and target dates, the arrangements for transparency and timeliness of the processes have been satisfactory for member companies.

The matters described below are suggestions for improvement in the operation of the Committee and effectiveness and quality of decision making.

Opportunity for Sponsors to be observers at the meetings of ACMS/ACCS as appropriate

The New Zealand Medicines Classification Committee (MCC) allows applicants/sponsors to be present during the committee discussion of applications, but not at the deliberations stage.

Feedback from members who have had the opportunity to be present at the meetings has been very positive, and the Review Panel should consider whether applicants might or could be allowed a similar opportunity during the Australian scheduling process.

Recent changes to the format of the “Reasons for Delegate’s Interim Decisions” and “Reasons for Delegate’s Final Decisions” documents have resulted in the publication of very brief, “dot point” records of the Delegate’s reasons for decisions made. Attendance as an observer at an ACMS meeting would allow greater understanding of areas of concern in an application, allowing the sponsor to address particular deficiencies should that be required at a later time.

A major focus of this review is transparency and effective functioning, and ASMI believes that applicants would feel that their application has been carefully and accurately considered, and that there is a level of transparency in the process should this change to allow observer status at meetings be made. It is also an important harmonisation issue.

Appendix H Recommendations by the ACMS

The arrangements for Appendix H decisions have not been considered or updated for the past 13 years. The most recent guidelines on advertising Schedule 3 medicines are the Schedule 3 Advertising Guidelines published by the NCCTG7.

The NCCTG has not met for a long period of time and recommendations have been made for it to be replaced by a series of ad-hoc working groups8. Section 52(E)(2)(b)(2) of the Act refers to the NCCTG, however this body has effectively been non-operational. For this reason, there is currently no effective mechanism in place for the review and amendment of the Schedule 3 Advertising Guidelines of November 2000. This guidance should therefore be considered as part of the Scheduling Framework Review by the review panel as it is currently a matter that is considered by the ACMS and the Delegate.

The draft NCCTG Scheduling Policy Framework for Medicines and Poisons April 2009 NCCTG9 stated that:

“Use of Appendix H is being phased out and replaced by legislation under the Therapeutic Goods Act 1989. Application to allow or vary the advertising of a Schedule 3 human medicine is to be made to the TGA. The decision will be made by the Secretary taking into account the NCCTG Guidelines for brand advertising of substances included in Schedule 3 of the Standard for Uniform Scheduling of Drugs and Poisons”

The NCCTG Guidelines for brand advertising of Schedule 3 medicines is dated, and the requirements are inconsistent with practices in the UK, EU, New Zealand and Canada, which allow branded advertising of Pharmacist-Only medicines. Consumers are seeking more information on medicines and medical treatments, yet there is a very low level of awareness on schedule 3 medicines and the role of pharmacists in provision of these medicines. A structured and tailored approach to brand advertising of Schedule 3 medicines should be adopted, allowing sponsors to provide an educational component on the medical condition or indication, the role of the pharmacist in the supply of the medicine, together with the brand name of the medicine.

Suitably tailored advertising can educate and increase awareness, and encourage consumers to interact with their pharmacist. It can help consumers understand that pharmacists are required to check that the particular Schedule 3 medicine is suitable for their condition.

ASMI has developed an alternative model for communications on Schedule 3 medicines, based on a structured framework that will ensure that information on Schedule 3 medicines is provided to consumers in a balanced way.

Please see Appendix 1 – “ASMI Proposal for an alternative regulatory model for creating consumer awareness of Pharmacist Only Medicines, April 2013”.
Harmonisation with New Zealand - ANZTPA

The governments of Australia and New Zealand have expressed a commitment to advancing a single economic market under which differences arising from policies and regulations of both countries will be minimised or removed10. Although the description of a possible joint regulatory scheme for therapeutic products under ANZTPA has so far excluded scheduling of medicines and advertising from the discussions, ASMI considers that scheduling and advertising have a significant impact on commercial activity across both countries and harmonisation of schedules and advertising arrangements should be key considerations in the development of future scheduling policy.

4. Section 52D Amendments to the Poisons Standard and associated Regulations

(Questions 12, 13, 14, 15, 16)

Section 52D of the Act refers to the process by which amendments to the Poisons Standard are made by the Secretary. Section 52(1) refers to the transition as a result of the new administrative arrangements.

ASMI has no issue with the new arrangements other than matters already raised above.

It must be noted however that the transition from the NDPSC model to the new model was problematic for a number of applicants, and specific issues experienced were:
  • Lack of visibility as to which meeting applications would be referred
  • Delays in allocation of applications to meetings
  • Some sponsors did not receive evaluation reports and had no opportunity to provide feedback to the ACMS

ASMI requests that any changes to the Scheduling Policy Framework as a result of this review should include effective and transparent transitional processes to avoid delays in consideration of applications.

5. Section 52EAA Application for amendment of Poisons Standard

(Questions 17, 18)

The review panel has sought feedback on the administrative arrangements for applications, including the template application form.

Application form template

ASMI members in general find the application template somewhat confusing and repetitive, and would appreciate a clearer and better structured application form template. In particular:
  • Part 1 – Summary of the application. There seems to be some repetition with Part 3 – Supporting data summary.
  • Part 2 – “Risks and benefits” encompasses the issues described in sections B, C, and E, namely the term “risks” covers toxicity, potential for misuse and abuse.
  • Part 3 Supporting Data – The “Body of the Application” Part 2, already contains supporting data, therefore it is unclear whether this section is really a repeat of Part 2.
  • No opportunity to present “benefits” as part of the benefit vs. risk consideration.

It is noted that Part 2.1 refers to the matters that the Secretary must consider in making a decision (Section 52E). ASMI believes that the application template should be designed such that the necessary data can be provided in a consistent, clear and logical manner which facilitates ease of application and evaluation.

It may be useful to consider aspects of the UK Reclassification Guidelines 2012, as well as consider harmonisation with New Zealand data requirements11 so that applicants can avoid the duplication involved in preparing two separate applications for the two Committees, as is presently required for the ACMS and the New Zealand Medicines Classification Committee (MCC).

ASMI would welcome the opportunity to participate in discussions on improvement of the template.

Material impact on organisations if the template was to be submitted electronically

ASMI supports electronic submissions on the condition that this can be done by use of existing commonly available software platforms and resources, for example use of bookmarked pdfs, and does not result in additional resource requirements for applicants. ASMI notes that applicants currently have issues with email submission size restrictions, and suggest that an online application portal would be useful.

6. Division 3D of the Regulations – Proposed amendments to the Poisons Standard

(Questions 19 & 20)

The review has requested information on access to public notices and decisions.

In general, ASMI members have not found difficulty in accessing the Scheduling notices and decisions electronically. The “opt-in” mailing list for scheduling update emails has been useful. There have been isolated examples of delays in publication of the interim decisions (as occurred in December 2012) and the agenda (as occurred April 2013); we trust that these will not become regular occurrences.

There are however some aspects of the public notices which should be reviewed further:

New abbreviated format of reasons for interim decisions/reasons for final decisions

A significant issue of concern to members has been the new abbreviated format of the interim decisions, as published on 7th January 2013. ASMI wrote to the Scheduling Secretariat on the 11th January 2013, voicing concerns over the abbreviated format, following up with a telephone conversation. No response has been received.

The provision of a very brief, three to four bullet point summary of “reasons” for the Delegate’s decisions does not fulfil the TGA’s stated commitment to provision of useful, transparent information. Applicants rely on the detailed minutes and records from previous ACMS deliberations and the Delegate’s reasons, to guide future applications and better understand the reasons for decisions.

The Scheduling Policy Framework and Application Template provide little guidance on data requirements and applicants have often relied on the detailed information from consideration of similar substances from previous ACMS meetings to guide their applications and data provision, and anticipate areas where the Committee had difficulties.

The new abbreviated interim decisions do not provide useful information to allow improvements or guidance for future applications. In addition, it provides less context for public stakeholders to use in framing their responses to public consultation on proposed scheduling changes.

ASMI encourages the review panel to ensure that the information contained within the public notices of reasons for decisions is detailed and transparent, as has been the practice until recently.

Redacting accuracy

At times, the redacting process has not been sufficiently accurate, and this has enabled identification of stakeholders who had requested anonymity. ASMI therefore requests that attention be given to the accuracy of the redacting process.

7. Effect of amendments on the therapeutic goods industry

The therapeutic goods industry is one of the key stakeholders in the scheduling process and provides a large proportion of the applications for rescheduling. The impact of lack of transparency, lack of robustness, and inconsistent and risk-averse decision making therefore affects the industry in a proportionately significant way.

According to Section 52EC(3) of the Act, the review must report on four matters, one of these being described in Section 52EC(3)(a) as “the system of controls for goods containing scheduled substances established by this part”.

ASMI welcomes this review, however it appears that the terms described in Section 52EC(3)(a) are wider than those covered in the review terms of reference, which focus mainly on the wording of the Section 52 of the Act and the policies and processes described in the Scheduling Policy Framework.

As stated previously in this submission, the main areas that have had an impact on the therapeutic goods industry are:
  • The transitional process from the NDPSC model to the current model was poorly handled, resulting in delays, lack of clarity and lack of transparency.
  • New product applications that require a related scheduling decision (for either new OTC medicines, rescheduling for different dosage forms or strengths) has been problematic. The guidance provided in the TGA document “Pathways to a scheduling decision12” is inaccurate, stating that product applications together with an application to amend the Poisons Standard may be submitted to the TGA. The TGA is now requiring finalized scheduling decisions prior to new product applications being made, and for those companies who have followed this guidance in the past, there was no visibility on meeting dates and evaluation reports; sponsors felt disadvantaged by what was intended to be a streamlined procedure. The associated flowchart in Part B of the Review papers13 (Flowchart 3) suggests that an application may be made to the TGA or the Medicines and Poisons Scheduling Secretariat. None of the flowcharts refer to timeframes involved. This is an area of process that should be clarified for sponsors/applicants.
  • Scheduling changes to existing products (already on the ARTG) typically require questions on labelling warning statements to be referred to the TGA OTC Medicines Section. These applications cannot be submitted until a final decision on labelling is made, and delays are typical due to the requirement for ACNM recommendations. More work needs to be done to integrate or align the “post scheduling” changes to labeling so that sponsors are able to meet the switch effective dates. Delays often mean that applications need to be made to the State Pharmaceutical Services Sections for labeling exemptions, and streamlining or aligning the two processes (TGA and labeling) would lead to efficiencies.
  • The risk-averse nature of decision making, compared to other agencies (e.g. the UK and New Zealand) means that many sponsors are deterred from allocating financial and staff resources into applying for rescheduling applications.
  • The conservative approach to advertising of Schedule 3 medicines is having a deleterious effect on the commercial viability of some S3 medicines. Consumers are unaware of the availability of these medicines and continue to visit GPs for self-limiting conditions that can be managed by pharmacists. This provides a poor incentive for further development in the Schedule 3 classification.

8. Avenues for review

(Questions 22, 23)

As a matter of principle, ASMI believes that sponsors or other persons who are affected by a scheduling decision ought to have access to a full range of review processes (including both merits review and judicial review).

We therefore suggest that section 60 of the Therapeutic Goods Act should be amended so that decisions under Part 6-3 can be reconsidered by the Minister and, if necessary, reviewed in the Administrative Appeals Tribunal. Judicial review in the Court ought also to be available.

In order to give full effect to such review, Part 6-3 of the Therapeutic Goods Act may also need to revised.

Importantly, the revision of the Act needs to allow review of decisions to amend the Poisons Standard (per s52D(2))as well as decisions not to amend the Poisons Standard.

9. Other Matters

(Questions 24, 25, 26)

ASMI has identified some additional matters not covered elsewhere in the submission and requests that the review panel consider the following issues.

Integration of Scheduling and Registration processes

The Scheduling Review appears to be confined to the specific processes involved in rescheduling applications – from the point of lodgement the “switch effective” date, or the date of the SUSMP amendment.

A major source of frustration to sponsors has been the way that TGA processes do not integrate well with the scheduling processes, and both ends of the process, namely for scheduling applications that require a new medicine registration application; as well as rescheduling decisions that apply to existing registered medicines for which changes to labelling may be required.

As already outlined in Section 2 of this consultation response, Flowchart 3 of the Scheduling Policy Framework suggests that a concurrent application and scheduling process exists. This is strictly no longer the case under the new TGA Business Processes (BPR). Sponsors who followed the theoretical process prior to the introduction of the BPR noted delays and no transparency as to information provided by TGA to the ACMS; nor did the sponsors receive evaluation reports. The “front end” of the process requires better integration with TGA processes. Sponsors should have the opportunity to submit concurrent applications and for the process to work effectively and in a transparent manner.

An additional source of delay occurs following scheduling decisions that affect existing OTC medicines, but for which advice or changes to labelling are required. The Delegate refers the matter to the TGA, which refers to the ACNM. This results in “post scheduling” delays and inability to meet the switch effective dates, as well as commercial disadvantage to innovator companies in many cases.

ASMI encourages the review panel to examine the way in which scheduling decisions interact with registration decisions and labelling variation applications, and work to develop a model that provides the stated review objectives of efficiency, transparency and effectiveness. ASMI would welcome the opportunity to provide input into any proposed models.

Exclusivity with rescheduling applications

Innovator companies are presently disadvantaged by the rescheduling process, due to the lack of data protection for “switch” applications.

When lodging a “switch” application to reschedule a medicine, all information is in the public domain. The final scheduling decision is made available to the applicant as well as to the public at the same time. Following rescheduling, labelling matters are then referred to the TGA, which refers the matter to the ACNM.

At this point, the TGA then provides labelling information to the innovator as well as to competitors, who will often register a copy of the rescheduled medicine at the same time as the innovator company, which invested its resources and data in obtaining the switch.

This has, in a number of cases, made the innovator’s switch commercially unviable.

Efforts should be made to address the issue of exclusivity so that a company which invests the data and resources to reschedule a product is not commercially disadvantaged. ASMI believes that a period of marketplace exclusivity, commensurate with the degree of innovation and investment, is required to recoup investment and costs associated with any rescheduling activity. This would act as an incentive to research new therapeutic claims and products.

In this setting, market exclusivity would mean a defined, enforced period during which a sponsor that is successful in obtaining some form of rescheduling approval for a medicine would be granted an exclusive market status that prevents subsequent sponsors from obtaining similar approval for equivalent goods during the period of market exclusivity.

ASMI believes that a period of marketplace exclusivity, commensurate with the degree of innovation and investment, is required to recoup investment and costs associated with any rescheduling activity. This would act as an incentive to research new therapeutic claims and products.

The Poisons Standard

ASMI requests that consideration should be given to providing a searchable Poisons Standard. New Zealand has a search facility for medicine classification, allowing sponsors to search a substance and quickly obtain information on the various levels of classification, as well as the history.

This would be of great assistance to sponsors who presently are required to look through the Poisons Standard in its entirety, and look through the records of every meeting in order to obtain information on the history of rescheduling decisions.

The Scheduling Secretariat

ASMI believes that the Scheduling Secretariat within the TGA should be sufficiently well resourced to enable it to function effectively and efficiently. There have been recent occurrences in delays to publication of the Agenda or to the Reasons for the Delegate’s Interim Decisions, as well as delay in responding to enquiries. It is in the interests of the ACMS as well as to applicants and other stakeholders for the secretariat to be adequately staffed and resourced.

SUMMARY

ASMI welcomes the review into the Arrangements for Scheduling of Substances as per Part 6-3 of the Act and appreciates the opportunity to comment.
Given the short timeframe provided, we have been unable to provide specific examples of member experiences, nor have we been able to provide detailed suggestions for changes that could be made to future Scheduling Policy.
The terms of reference of the consultation, as stated in Section 52EC(3)(a) of the Act, appear to be wider than those that are the subject of the review and appear to cover all aspects of the scheduling arrangements. In comparison, this review appears to be quite limiting.

ASMI supports reforms aimed at improving the transparency of processes and decision making relating to the scheduling of substances, and has provided responses to previous consultations held on this matter, in May 2009 and March 2010.

ASMI recognises that harmonisation with New Zealand for scheduling of medicines and poisons is outside the scope of this review. However, the outcomes of this review should be made within the context of initiatives currently underway for the formation of the Australia New Zealand Therapeutic Products Agency (ANZTPA).

ASMI is of the view that (compared to the previous NDPSC model) the current model which allows for the Secretary to be the decision-maker on scheduling; the separate consideration of medicines and poisons through the ACMS and ACCS; and the single Poisons Standard as the Commonwealth Legislative Instrument have led to improvement in the operation of the scheduling system overall.

ASMI also believes that further changes can be made to the current scheduling arrangements, to provide improvements in predictability, timeliness and transparency.

ASMI requests the review panel to consider the following key issues relating to scheduling under the current arrangements, with a view to making improvements in these areas:
  • Structured benefit vs. risk decision making – Consideration should be given to the adoption of the value-tree tool for assessment of benefit vs. risk, to help achieve consistency in decision making and focusing on improved clinical outcomes, benefits of improved consumer access to OTC medicines and factors involved in mitigation of risk, such as consumer education, labeling, and role of the pharmacist.
  • Clarity on scheduling principles - There is a need for consistency and clarity in decisions made of scheduling of combination products. The Poison Standard makes reference to scheduling principles in relation to combination medicines however the principles are not consistently followed.
  • Streamlining the process for new medicine registration applications that require a scheduling decision – The scheduling Policy Framework suggests that a concurrent process exists for new medicine registration and scheduling. This has not been the case, and the resultant delays, lack of transparency and lack of process has been a source of difficulty for members. Changes should be made to the process to provide an effective and efficient concurrent process.
  • Streamlining the “post-scheduling decision”stage – Improvements should be made to the process for referral of labeling questions to the TGA OTC Medicines Section and ACNM, as these processes are resulting in delays, lack of transparency and potential disadvantage to innovator companies.
  • Harmonisation – Serious consideration should be given to harmonizing scheduling processes and requirements, as well as decisions to enable sponsors to avoid duplication and allow trans-Tasman labeling. This is consistent with the objectives of the proposed joint regulatory scheme (ANZTPA). Although the description of a possible joint regulatory scheme for therapeutic products under ANZTPA has so far excluded scheduling of medicines and advertising from the discussions, ASMI considers that scheduling and advertising have a significant impact on commercial activity across both countries and harmonisation of schedules and advertising arrangements should be key considerations in the development of future scheduling policy.
  • ACMS processes – Consideration should be given to allowing sponsors to have “observer status” at the ACMS meetings, during the discussion of their application, but not the decision-making, as per the New Zealand MCC process.
  • Appendix H consideration - The arrangements for Appendix H decisions have not been considered or updated for the past 13 years. The most recent guidelines on advertising Schedule 3 medicines are the Schedule 3 Advertising Guidelines published by the NCCTG. The review panel should consider the issue of communication of Schedule 3 medicines to consumers using a structured model. ASMI has included a proposed alternate model for Schedule 3 communications with this consultation paper.
  • Application form template– Revisions should be made to the application form template to avoid confusion, repetition, and provide clearer guidance for data requirements to sponsors.
  • Market exclusivity - ASMI believes that a period of marketplace exclusivity, commensurate with the degree of innovation and investment, is required to recoup investment and costs associated with any rescheduling activity. This would act as an incentive to research new therapeutic claims and products.
  • As a matter of principle, ASMI believes that sponsors or other persons who are affected by a scheduling decision ought to have access to a full range of review processes (including both merits review and judicial review).

1. Council of Australian Governments (COAG). Best Practice Regulation – A Guide for Ministerial Councils and National Standard Setting Bodies, October 2007.
2. Brass EP, Lofstedt R, Renn O. Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit-Risk Assessment. Clin Pharmacol Ther 2011;90:791-803
3. MHRA. How to change the Legal Classification of a Medicine in the UK.
4. New Zealand Medicines Classification Committee, Minutes from the meeting held October 30th 2012.
5. Brass EP, Lofstedt R, Renn O. Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit-Risk Assessment. Clin Pharmacol Ther 2011;90:791-803
6. MHRA. How to change the Legal Classification of a Medicine in the UK.
7. NCCTG Schedule 3 Advertising Guidelines. Guidelines for brand advertising of substances included in Schedule 3 of the Poisons Standard.
8. Review of Arrangements for Scheduling Substances – Information for Stakeholders Part B – Background to the Scheduling Arrangements April 2013.
9. NCCTG Scheduling Policy Framework (Draft) April 2009; chapter 2 page 14.
10. ANZTPA. Description of a possible joint regulatory scheme for therapeutic products under ANZTPA. January 2013.
11. Medsafe. Classification of Medicines – Classification Process.
12. Pathways to a Scheduling Decision.
13. Review of Arrangements for Scheduling Substances – Information for Stakeholders Part B – Background to the Scheduling Arrangements April 2013.