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Regulation impact statement: General requirements for labels for medicines

Version 3.0, July 2016

10 August 2016

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What policy options are being considered?

Three policy options are put forward in this RIS.

Removing some or all of the current regulatory requirements would not be a viable option. Doing so would result in considerable problems and risks to public health and safety, including an additional burden on the healthcare system.

The three proposed options are status quo (option 1), best practice guidelines (option 2) and introduction of a new therapeutic goods order (option 3).

Option 1: No change

Under the status quo, TGO 69 would be maintained. It represents current policy and would not change regulatory arrangements.

Existing guidelines will remain available including:

  • Best practice guidelines on prescription medicine labelling
  • Australian regulatory guidelines for over-the-counter medicines (ARGOM)
  • Australian regulatory guidelines for complementary medicines (ARGCM)
  • Australian regulatory guidelines for sunscreens (ARGS)

Importantly, the majority of stakeholders support the objectives of the labelling reform including the need to update TGO 69, providing justification as to why option 1 is not appropriate.[83] In recent years, Australian legislative intervention measures have also been implemented for both food[84] and tobacco[85] to assist with clearer labelling for consumers. As medicines are generally higher risk than these two types of products, it is imperative that some degree of consistent legislative intervention be applied to medicines to ensure appropriate minimum standards for their labelling.

Limitations to option 1 include:

  • Usability and currency issues with TGO 69, which was drafted over 16 years ago
  • Objectives to improve labelling on medicines, as described in the problem section above, would not be realised under option 1. The current Australian requirements fall short of best practice. International literature supporting the need for consistency of information and active ingredient prominence to improve patient safety would be largely ignored by choosing to continue with current practices. Accordingly, there would be a lack of recognition of the identified public health and safety issues, including the importance of patients and health professionals being able to easily locate information on labels and the argument for improved minimum standards to be applied to all medicines.
  • As described in the 'implementation and review' section, TGO 69 is due to 'sunset' on 1 October, 2017. A case must be made as to why this piece of legislation is still needed, and should therefore be re-made, and this gives extra incentive to review the current requirements.

Option 2: Best practice guidelines in line with most current evidence

Option 2 proposes that TGO 69 be retained but the current guidance for industry is updated in-line with internationally agreed best practice.

It is proposed that the updated guidelines would include labelling elements described in option 3 (see below), including prominence of active ingredients, space for a dispensing label, consistent location of medicine information and specific formatting of critical health information.

As described in the 'implementation and review' section, TGO 69 is due to 'sunset' on 1 October, 2017. At this time, under this option, consideration would have to be given as to the need for a nationally applied minimum standard for medicine labels.

Option 2 has other limitations, including:

  • To be successful, this option would rely on universal, voluntary application of the best practice guidelines. From TGA's experience voluntary uptake is difficult to regulate and adoption would be uneven. There is a commercial advantage for companies not to re-label to adopt best practice principles, as costs are not incurred.
  • Without any nationally-applied legislation, there is potential for wide diversity in labelling of medicines containing the same active ingredients or those intended for the same therapeutic use. This would increase confusion due to poorer recognition of critical health information by both consumers and health practitioners, resulting in risks to patient safety.
  • This option does not provide clear direction to industry on which standards should apply to all sponsors in the Australian market. There is industry perception that the best practice principles adversely affect brand recognition (due to greater prominence being given to information on active ingredients) and this would result in resistance to their adoption.
  • Limitations already described under option 1.

This option is not considered 'up-regulation' or 'additional regulation' as there would be no mandatory requirement for compliance.

Option 3: Introduction of new Therapeutic Goods Orders (TGOs 91 and 92)

This option involves the making of new standards for medicine labels that would replace the existing TGO 69 after a transition period. New requirements to be included were identified in the initial consultation undertaken by the TGA in 2012. Acting in response to further stakeholder feedback during the 2014 consultation, it is proposed that two new TGOs be created: one for prescription medicines and the other for non-prescription medicines, TGO 91 and TGO 92, respectively. It is proposed that the new Orders are supported by revised best practice guidance documentation.

The division into these two classes recognises the different risks and information requirements associated with medicines prescribed by a medical practitioner, or used in a clinical setting, to those self-selected by consumers.

Key proposed changes to existing requirements that are included in TGO 91 and 92 are as follows:

Both TGO 91 and TGO 92 (prescription and non-prescription medicines)

  • Increased prominence and consistent location of information on active ingredients (noting the minimum text height for all other information is 1.5 millimetres):
    • introduction of a new requirement that the name(s) and quantities of active ingredient(s) be a minimum text size of 3.0 millimetres on the front panel for registered medicines, placed either directly under or adjacent to the trade name; or
    • for a registered medicine containing four or more active ingredients, in a minimum text size of 2.5 millimetres on a side or rear panel; or
    • for a registered medicine supplied in a small container (i.e. containers with a capacity up to or equal to 25 millilitres but greater than 2.5 millilitres) in a minimum text size of 2.0 millimetres.
  • New requirements for declarations of certain substances (e.g. crustacea, fish, eggs, soya, milk, tree nuts) on all medicine labels, not just those on non-prescription medicines. These requirements have been modified to address consumer needs. The cut off for declaring gluten has also been modified and aligns with Food Standards Australia and New Zealand.

TGO 91 (prescription medicines)

  • Introduction of a new requirement for a defined space to be made available for a dispensing label. This is to ensure that important health information (e.g. dosage and active ingredient information) is not covered up by the dispensing label.
  • Introduction of a new requirement such that Schedule 1 substances must be declared on the label or identified by a statement that directs consumers to the Consumer Medicine Information. (Note: Schedule 1 is a list of substances that, if present in a medicine, must be declared on the label as they have the potential to cause allergic reactions or other serious adverse health consequences in sensitive individuals. The current TGO 69 requirements for declaration of Schedule 1 substances do not apply to prescription medicines).
  • Introduction of a new requirement for inclusion of a machine-readable code, this would not preclude future international convergence with the international requirements for serialisation of prescription medicines.

TGO 92 (non-prescription medicines)

  • Introduction of a new requirement for higher risk non-prescription medicines to provide critical health information in a consistent order within a tabulated format. This is consistent with international requirements.
  • Introduction of a new requirement to mandate the inclusion of warnings related to the use of medicines by those who are, or may be, pregnant.
  • Introduction of a new requirement to permit the use of an active moiety only (not full approved name of the active ingredient) on the main label. This requirement only applies when the full approved name is included in the mandated tabulated 'critical health information' format. This requirement aligns with the UK Medicines and Healthcare Products Regulatory Agency.

Footnote

  1. Out of 80 submissions received in the 2014 public consultation, half a dozen stakeholders indicated they were satisfied with current TGO legislative requirements.
  2. Department of Industry, New country of origin food labels are coming.
  3. The Department of Health, Introduction of Tobacco Plain Packaging in Australia (27 May 2016).

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