Introduction

19 submissions were received from stakeholders on the proposed scheduling model for medicines and poisons and a draft scheduling policy framework <http://www.tga.gov.au/consult/2005/scheduling.htm>.

All comments received have been considered by the NCCTG, which will now proceed to finalise its recommendations to the Australian Health Ministers' Conference on the scheduling models to be implemented through the new therapeutic product legislation and State/Territory legislation. There will also be further opportunity for stakeholders to comment on the exposure draft of the therapeutic products legislation.

The consultation process for the scheduling of medicines is to be dealt with separately in New Zealand, with the formal consultation period commencing with the introduction of the legislation into the New Zealand Parliament (in accordance with the usual processes for consultation).

As a number of common issues were identified in the submissions for further discussion, the Committee considered that a summary of the most significant comments received should be made available to all stakeholders in the interests of greater transparency in the development of the scheduling regulatory models.

Potential for a different scheduling decision to be implemented

One of the key issues for the medicines industry sector is the continuing potential for jurisdictions to implement a different scheduling decision.

NCCTG Comments

• While each jurisdiction and New Zealand will be able to implement a different scheduling decision to that included in the scheduling standard, a decision to depart from the entry in the scheduling standard would not be taken lightly. NCCTG members are committed to the principle of national uniformity and under the current arrangements there are only a minor number of entries in the SUSDP which have not been adopted on a nation-wide basis.
  
  As particular access issues may arise in certain States/Territories as a result of particular scheduling recommendations it is appropriate that these jurisdictions are able to take a different decision where this is warranted. Additionally, any proposal to implement a different scheduling decision would require stakeholder consultation at the jurisdictional level. It is also expected that NCCTG will play an active role in monitoring any increase in the number of different scheduling decisions implemented by the States/Territories.

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Legislative underpinning for the poisons scheduling model

The chemicals industry sector expressed a preference for the legislative underpinning for the scheduling of poisons to be in the Industrial Chemicals Notification and Assessment Scheme legislation rather than in the Australian only Regulations under the Therapeutic Products Implementing Act.

NCCTG Comments

• It is the responsibility of the Australian Government to decide on the most effective governance arrangements for the poisons scheduling model. While the preference of industry on this issue is understood, it is important to recognise that Commonwealth legislation regulates only the national expert advisory committee and the process to arrive at scheduling recommendations. The regulation of drugs and poisons is actually implemented at State/Territory level and in each case it occurs in the one piece of legislation. Regulation of the two committees and creating processes in separate legislation requires duplication of provisions and increases the possibility of divergence in processes for the scheduling of medicines and poisons. Thus, there is a clear argument for retaining the scheduling committee and process in the same legislation. Once the decision is made by the Australian Government, the NCCTG will reconsider any implications for the scheduling model. However, it is important that there is a single secretariat to support both the Medicines and Poisons Scheduling Committees in the interests of efficiency and consistency.

Membership of expert scheduling committees and nomination process

Most submissions included comment on the membership of the Medicines Schedule Committee and the Poisons Schedule Committee and the nomination process. Some stakeholders suggested that there should be additional member expertise in one or more of the areas listed below:

Many submissions proposed that nominations for particular areas of member expertise should be requested from a particular association or interest group while others expressed concern that the expert members in consumer or industry issues should not be nominated by the Agency, the States/Territories or the New Zealand Ministry of Health.

NCCTG Comments

• The nomination process for membership to these committees should be consistent with the process for nomination for any other expert committee which may provide advice to the Agency. NCCTG understands that further Agency-wide Business Rules are to be developed on the process for appointing members to expert committees. Consistent with other expert committee processes it is also expected that the MSC or the PSC will be able to seek advice from any other persons as necessary to perform the functions of the respective committees.
  
  Agency officials, members of the Australian or New Zealand Governments, industry stakeholders, healthcare practitioner groups and consumer groups may be requested to assist in the identification of suitable candidates for membership. Appointment of members by the Ministerial Council is to be based on the need to satisfy the legislative requirements for particular expertise to be represented on the Committee and the potential member's background and qualifications.
  
  If necessary, the legislation could make it clear that the expert members nominated by the Commonwealth, the States/Territories or New Zealand are not to be experts in consumer issues or therapeutic product industry issues.

Submissions in the public interest

Many submissions queried how the Agency would deal with applications for rescheduling which were not lodged by product licence holders for commercial reasons but were submitted in the public interest. It was noted that these types of applications should not be discouraged due to any application fee requirements.

NCCTG Comments

• NCCTG recognises the need to provide an avenue for a scheduling review to be initiated based on a submission for scheduling or rescheduling which is considered to be in the interest of public health and safety.

External merits review

A number of submissions from the therapeutic product and chemical industry associations called on the model to be changed to provide for Agency decisions (as reflected in the scheduling standard) to be subject to an external merits review process.

NCCTG Comments

• The proposed scheduling model has been developed co-operatively between the States/Territories, the TGA and Medsafe to ensure that the decision-making process is robust and that the risk of a jurisdiction implementing a different scheduling decision is minimised. This decision-making process includes access to internal review where the applicant (or an interested party in the case of rescheduling) considers that the scheduling policy framework has not been correctly applied. This is considered to be a significant improvement to the current arrangements, whereby there is no further recourse if the applicant is dissatisfied with the outcome of a scheduling decision.
  
  Additional access to external merits review (particularly without State/Territory participation) has the potential to mean little in terms of scheduling as a jurisdiction is not obliged to implement the decision of the external merits review panel and would be likely to lead to a greater risk of a lack of national uniformity.
  
  Where an applicant or interested party believes that an error in law has been made in deciding on a scheduling matter, the Administrative Decisions (Judicial Review) Act 1977 (ADJR Act) provides a right to written reasons for decisions reviewable under that Act. The Act also provides the grounds upon which administrative decisions may be challenged in the Federal Court.

Cost recovery

Some submissions noted that the model does not propose a fee for rescheduling applications.

NCCTG Comments

• A separate stakeholder consultation paper is currently being developed by TGA and Medsafe on proposed fees and charges.