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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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Conclusion and recommended option

Option 3, the introduction of TGO 91 and 92 meets the objectives of the labelling reform, and Option 3C, introduction of TGO 91 and 92 over a 4 year transition period, is the preferred option.

Neither the status quo (option 1) nor the introduction of new best practice guidelines (option 2) would satisfy consumers who are already dissatisfied with the legibility of key medicine information.

Option 1 would continue to be out of alignment with international labelling requirements. Net benefits would be minimal and are the lowest of the three policy options put forward.

Implementation of Option 2 has the potential to create even greater inconsistency across medicine labels in the Australian marketplace. There is likely to be some benefit to consumers and healthcare practitioners when using the individual medicines whose labels have been updated in line with best practice principles - critical information should be easier to identify and read on these labels. However, education of, and improved awareness within, consumer populations will be adversely affected by uneven uptake and greater inconsistencies in medicine labels both within and across medicine classes.

Throughout the formal and informal consultations that have taken place over the last 5 years, there has been high level support for the objectives of the labelling reform from industry, healthcare groups, consumer groups and individuals. Option 3 is the only option likely to fully address the objectives of ensuring Australian medicine labels are easier to read and understand and that critical health information is easily identified. Improved medicine labels are a key component in improving quality use of medicines for both consumers of over-the-counter medicines and medical professionals administering to patients. Option 3 introduces a number of improvements to medicine labels.

Option 3 will result in increased prominence, and consistent placement, of the active ingredient. These requirements, along with consistent placement of critical health information, will assist in educating consumers about the medicines they are taking as they become familiar with where to find critical health information. By increasing consumer knowledge and awareness, Option 3 will help to minimise the chances of medication error.

Option 3 will also assist in communication of essential information in emergency situations. Due to prominence and consistency of information location, in an emergency phone call to poison information centres, a family member who has become familiar with a more standardised lay-out of medicine labels should be able to quickly identify the active ingredient consumed, or due to increased text size used for this information, be able to read this more easily. This increased knowledge will help ensure that the affected individual receives advice appropriate for that ingredient.

Option 3 draws upon medicine labelling best practice principles that have been adopted overseas. The benefits associated with improved labels in those jurisdictions are difficult to measure due to the interrelationships between confounding factors. However, the changes proposed under this option address recognised problems with readability and easy identification of critical health information using approaches that are consistent with those whose success in other countries is widely acknowledged.

Option 3C ensures that these changes can be made sustainably. A 4-year transition period will ensure that the burden placed on industry is minimised. This increases the opportunity to incorporate necessary label changes as part of business as usual activities as opposed to being triggered by the need to meet new regulatory requirements.

By reducing the burden on industry, Option 3C reduces the risk of medicine shortages that may arise as sponsors strive to meet the new requirements.

The 4-year transition period is also being aligned, as closely as possible, to the International Harmonisation of Ingredient Names (IHIN) labelling reform work.[110] The transition period for the IHIN reform commenced in April 2016. Executing both reforms in parallel will ensure that costs to industry are minimised. This aligns with feedback received from industry during recent consultation activities undertaken.

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