Consultation: The Scheduling Policy Framework and Advertising of Pharmacist-only medicines (Schedule 3 substances)

31 March 2017

This consultation closes on 28 April 2017.

Invitation to comment

The TGA is seeking comments from interested parties on the review of the Scheduling Policy Framework and reforms to advertising of Pharmacist-only medicines (Schedule 3 substances).

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Friday, 31 March 2017.

Interested parties should respond by close of business Friday, 28 April 2017.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

In response to the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR), the Government agreed that "the Scheduling Policy Framework (SPF) is reviewed in consultation with State and Territory Governments to provide for:

  1. The development and adoption of a formal risk-benefit methodology to assess scheduling applications; and
  2. Opportunities to enhance input from interested parties into the scheduling process".

The Government also agreed with the MMDR recommendation that "the Schedule 3 (Pharmacist only) Advertising Guidelines be reviewed, in consultation with State and Territory Governments, and in concert with the review of the SPF".

Background

What is scheduling?

Whether a medicine is available on prescription only, may be purchased over-the-counter in pharmacies or is available on general sale in supermarkets is determined by the scheduling of its active ingredient(s) (referred to as the "substance") in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), more commonly known as the Poisons Standard.

The scheduling of a medicine involves consideration of a number of factors, such as the toxicity of the substance, potential for abuse, safety in use and the need for access to the substance. The scheduling of a substance further underpins the need for particular healthcare professionals to be involved in the supply of certain medicinal substances in order to promote safe and quality use. The scheduling of medicines is intended to promote the quality use of medicines, and balance consumer access with the need to manage risks associated with a medicine.

The scheduling of chemicals in schedules 5, 6 or 7 of the Poisons Standard involves consideration of a number of factors including the toxicity of the substance, purpose of use, potential for abuse, safety in use, the need for specialist training or personal protective equipment for safe or effective use, and the need for access to the substance. Similarly to medicines, the scheduling also supports safer use of agricultural, veterinary and domestic chemical products through labelling with specific "alert" phrases keyed to the major threat level or phrases emphasising the need for intervention by particular professionals (where warranted). Where necessary the scheduling of certain veterinary chemicals reinforces the need for intervention by a veterinary practitioner to promote safe use.

Advertising of Pharmacist-only medicines

Direct-to-consumer advertising of pharmacist only medicines (Schedule 3) is not permitted in Australia unless all Schedule 3 ingredients are substances listed in Appendix H of the Poisons Standard. As of December 2016, there were sixteen such substances in Appendix H, which means a significant number of schedule 3 substances are not permitted to be advertised.

Appendix H decisions are made by a delegate of the Secretary of the Department of Health who must take into account matters set out in the Schedule 3 advertising guidelines developed in 2000 by NCCTG. These guidelines require that the decision maker consider a number of matters, including:

  • The potential public health benefit, for example more appropriate use of scarce health resources or a better informed community.
  • The likelihood of advertising of the substance leading to inappropriate patterns of medication use.
  • Whether the application may result in the advertising of goods for an indication other than those approved by TGA during the registration process.
  • The desire of consumers to manage their own medication and the level of patient education necessary to ensure correct use.

Content of submissions

Submissions may address any, or all, of the proposed amendments to the Scheduling Policy Framework and provide options for the advertising of Pharmacist-only medicines (Schedule 3 substances).

In addition, submissions might include:

  • Suggested improvements
  • An assessment of how the proposed change will impact on you.

How to submit

Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.

Consultation submission form

Alternatively, hardcopy submissions with a printed coversheet may be mailed to:

Regulatory Reforms Team
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

How to access a Word document

Enquiries

Any questions relating to submissions should be directed to the Regulatory Reforms Team by email to .

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Following analysis of public responses, specific proposals for regulatory reforms will be developed and public consultation on these specific proposals is expected in late 2017.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.

More information

Further information on the Government's response to the MMDR recommendations is available at Medicines and Medical Devices Regulation review.