Codeine re-scheduling Regulation Impact Statement (RIS)

Scheduling medicines and poisons

20 December 2016

The codeine Regulation Impact Statement (RIS) and the associated economic modelling report prepared by KPMG are now publicly available, in addition to the delegate's final decision on the rescheduling of codeine.

The RIS reviews the significant public health concerns regarding the use of codeine, the scheduling options available (Table 1) and the regulatory impacts associated with these scheduling options.

Table 1: The codeine scheduling options considered in the RIS

Scenario 1

(Option 1)

No change to the status quo.

Scenario 2

(Options 2 & 5)

Schedule 2 (Option 2) and Schedule 3 (Option 5) entries for codeine (including, but not limited to, cough and cold medicine preparations and codeine containing analgesics) be amended to reduce the pack size to not more than three days' supply and include a label warning that codeine can cause addiction.

Summary: Reduce pack size and include warning label for S2 and S3

Scenario 3

(Options 3 & 5)

The current Schedule 2 entries for codeine in cough and cold medicine preparations be up-scheduled to Schedule 3 (Option 3), and then all Schedule 3 entries (Option 5) (i.e. those currently Schedule 3 and those previously Schedule 2) for codeine (including, but not limited to, cough and cold medicine preparations and codeine containing analgesics), be amended to reduce the pack size to not more than three days' supply, and include a label warning that codeine can cause addiction.

Summary: S2 up-scheduled to S3 and reduce pack size and include warning label for S3

Scenario 4*

(Options 4 & 6)

Schedule 2 (Option 4) and Schedule 3 (Option 6) entries for codeine (including, but not limited to, cough and cold medicine preparations and codeine containing analgesics) be up-scheduled to Schedule 4.

Summary: S2 and S3 up-scheduled to S4

* Current interim decision (as of 1 October 2015).

The Office of Best Practice Regulation (OBPR) found the RIS to be compliant. OBPR acknowledged the extensive nature of the RIS, but in order to make the RIS best practice, required further information on the expected consumer behaviours for each option. To include this information would have been speculative and unlikely to provide additional benefits to our stakeholders. The RIS included information that was supported by appropriate citations, but this did not cover every possible behavioural change that may have resulted from the options being considered.

Noting the substantial benefits in the protection of public health and safety when codeine is up-scheduled to Schedule 4, and noting the RIS process requires a preferred scheduling scenario to be nominated (on the basis of the information considered), the preferred scenario was to up-schedule codeine to Schedule 4.

The RIS is supported by an independent modelling report completed by KPMG that models the economic, social and regulatory impacts, and net benefit to society associated with each scheduling option. The key finding of the modelling was that a net benefit to society could only be achieved when codeine is up-scheduled to Schedule 4. This will result in a net economic benefit to society (estimated at $5.2 billion over 10 years) and is a consequence of:

  • prevention of deaths from accidental or deliberate codeine overdose
  • improved quality of life years (QALY), resulting from the adoption of more effective treatment options for moderate pain
  • net financial savings to consumers through lower cost alternative over the counter (OTC) medicines
  • prevention of adverse events related to the unintentional overdose of paracetamol or ibuprofen (which may be combined with codeine in many products)
  • reduced codeine dependence and reduced risk of dependency.

Importantly, even when the assumptions for costs are maximised and those for benefits are minimised, the estimated net economic benefit to society still remains positive.

The RIS was not a consultation RIS, as extensive public consultation has already occurred during the scheduling process and the development of the RIS.

Moreover, in line with the delegate's requirements under the Therapeutic Goods Act 1989, it should also be noted that not all aspects of the RIS, such as impacts on industry, may be considered by the delegate in making a scheduling decision. For example, economic and regulatory costs or savings are not necessarily considered by the delegate under the Scheduling Policy Framework (SPF) and the scheduling regulatory framework as specified in Therapeutic Goods legislation. Scheduling decisions are made according to subsection 52D(2) of the Therapeutic Goods Act 1989 (TG Act) taking into account the following matters of public health (where relevant) as set out under subsection 52E(1) of the TG Act:

  1. the risks and benefits of the use of a substance;
  2. the purposes for which a substance is to be used and the extent of use of a substance;
  3. the toxicity of a substance;
  4. the dosage, formulation, labelling, packaging and presentation of a substance;
  5. the potential for abuse of a substance; and
  6. any other matters that the Secretary considers necessary to protect public health.

In addition to considering the matters prescribed above under subsection 52E(1) of the TG Act, the scheduling delegate must also consider the factors in the SPF.

After considering advice from the ACMS, as well as all relevant matters required under the Therapeutic Goods Act 1989, input from the public submissions, TGA safety reviews, the RIS and the KPMG modelling report, the delegate has made their final scheduling decision.

Certification

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