Towards a National Medicines Traceability Framework (NMTF)

Between November 2021 and March 2022, the Department of Health and Aged Care conducted initial targeted consultations with the medicines sector about the potential to introduce a National Medicines Traceability Framework in Australia.

This initial round of consultation sought to:

• help shape the framework policy
• determine feasible framework designs and implementation approaches
• gauge industry’s appetite and readiness to operation within a framework
• identify the expected impacts and benefits a framework may have on businesses.

We received 42 submissions from a cross section of stakeholders, including medicines sponsors, wholesalers, peak bodies (including consumer and clinical representatives), pharmacies, and state and territory organisations.

We have reviewed all submissions and the results are now available in the NMTF - Analysis of Consultation Survey Responses. Note, the questions that relate to each section of analysis are summarised in the report at the end of each page.

The results show:

• the type of NMTF will determine the benefits that can be realised, for example, while 79 per cent of respondents proposed that an NMTF could provide faster and more accurate product recalls, this is likely to refer to a full track and trace model, rather than ‘point of dispense’ model
• organisations expect additional investment in data systems and services, with some planning and implementation assistance likely to be needed
• organisations expect a high regulatory burden, noting this is dependent on the type of NMTF to be implemented i.e. full track and trace, point of dispense verification, or a dispersed data model
• organisations are confident they could participate in an NMTF, however, there is a clear need for further detailed stakeholder engagement on the function and scope of an NMTF.

In addition to these results, there are a range of other issues that require further detailed consultation, for example, impacts on patient privacy, data security, and the appropriate role of governments.

We will continue to consult with stakeholders as the NMTF policy recommendations are further developed. More opportunities for wider consultation on key elements of the framework will be available at a later date.