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Regulation impact statement: Codeine re-scheduling

Version 1.1, December 2016

20 December 2016

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Due to significant health risks associated with over the counter (OTC) codeine-containing medicines, the medicine's scheduling delegate of the Department of Health is considering re scheduling codeine in the Poisons Standard to change the way codeine-containing medicines are made available to the consumer.

In October 2015, the delegate made an interim decision that all medicines containing codeine currently available OTC (Schedules 2 and 3) would be up-scheduled to prescription only medicines (Schedule 4). In November 2015, the delegate announced that a decision on the re scheduling of codeine would be delayed to allow a more thorough consideration of the numerous submissions and the broader implications to current products in the market. In addition to the re-scheduling of codeine, further public submissions were requested on other options, such as reducing in pack size and including a warning statement on the packaging.

To better inform the regulatory, social and health impacts of any change to the scheduling of codeine, a Regulation Impact Statement (RIS) has been completed. An external consultantancy team has modelled the regulatory costing and economic and social impacts of the codeine re scheduling options. During several public consultations by the Therapeutic Goods Administration (TGA) regarding the proposed codeine re-scheduling, feedback was received from individual consumers, healthcare professionals and the pharmaceutical industry, as well as state and territory jurisdictions. During the preparation of the RIS, further consultations were held with key stakeholders to document the potential business process impacts, to inform the development of the modelling, and to determine any implementation timeframes that might be required by industry to comply with any change in codeine scheduling. These consultations aimed to minimise the regulatory impact and to address identified issues, including the risk to consumer safety if no action is taken.

The international restrictions of codeine medicines applied by overseas jurisdictions, including the USA, Canada and Europe were reviewed. Due to harm from abuse and misuse of codeine, including dependency and death, medicines containing codeine are specifically regulated in many countries. Regulatory controls include limits on pack sizes, label warnings on packaging, warnings in consumer information leaflets, and limiting the availability of codeine-containing medicines to prescription only.

Stakeholders participating in these consultations were industry peak bodies and key healthcare professional and consumer groups including:

  • Generic Medicines Industry Association (now the Generic and Biosimilar Medicines Association)
  • Medicines Australia
  • Australian Self Medication Industry (ASMI)
  • The Pharmacy Guild of Australia (PGA)
  • Pharmaceutical Society of Australia (PSA)
  • Society of Hospital Pharmacists of Australia (SHPA)
  • Council of Australian Therapeutic Advisory Groups (CATAG)
  • Australian Medical Association (AMA)

The RIS summarises the consultation process that has been undertaken with stakeholders including consumers, healthcare professionals and industry to explore the available options to minimize regulatory impacts of up-scheduling codeine.

The regulatory burden and potential social and financial impacts on public, industry, and government have been considered. The RIS concludes with a recommended scenario that affords the best protection of public health and safety, balanced against any regulatory burden placed on stakeholders. Not all aspects of the modelling, such as social and economic burdens are able to be considered by the Secretary of the Department of Health or their delegate in making their decision. Scheduling decisions are made according to subsection 52D(2) of the Therapeutic Goods Act 1989 (TG Act) which takes into account relevant matters of public health as set out under section 52E of the Act. These matters include the risks and benefits of the use of a substance, the purposes for which a substance is to be used, the substance's toxicity, dosage, formulation, labelling, packaging, presentation, and any potential for abuse. Guidance of the matters to be considered by the delegate are outlined in the Scheduling Policy Framework (SPF).

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