Medicine shortages and discontinuations: Proposed changes to reporting requirements

The Therapeutic Goods Administration (TGA) continually seeks out ways to improve the way we monitor and manage the impact of shortages and discontinuations in Australia. In late 2024, we asked for feedback on proposed changes to the medicine shortages and discontinuations regulatory framework to:

1. Improve TGA’s monitoring of medicine shortages by:
   1. Adding more critical non-prescription medicines to the list of reportable medicines - this would require pharmaceutical companies (‘sponsors’) of those medicines to report shortages and discontinuations to the TGA; and
   2. Updating the Therapeutic Goods Act 1989 to enable the TGA to request detailed supply information from sponsors when needed about any approved medicine, not just reportable medicines.
2. Require sponsors to provide 12 months’ notice to the TGA of a decision to permanently discontinue supply of any reportable medicine in Australia.

We received 39 submissions from a range of stakeholders, including the pharmaceutical industry, health professional and consumer organisations and government agencies.

Monitoring medicine shortages

There was extensive support for the TGA’s proposal to add the 23 non-prescription medicines identified in the consultation to the Reportable Medicines Determination, and to update the Therapeutic Goods Act 1989 to enable the TGA to request detailed supply information from sponsors about any approved medicine.

Respondents provided a range of views and suggestions, including:

• a majority view that the TGA’s proposals presented a balanced approach to improving medicine shortages monitoring without significant increase in regulatory burden
• acknowledgement from multiple industry respondents that the alternative option of making all registered non-prescription medicines reportable would result in significant regulatory burden
• requests for additional individual non-prescription medicines to be added to the list of reportable medicines
• recognition and support from respondents on the importance of regularly reviewing and updating the list of reportable medicines to ensure currency
• support for continued stakeholder engagement with the TGA about emerging medicine shortage issues and policy considerations.

Medicine discontinuations

Overall, the majority of respondents preferred the TGA’s proposal to mandate a uniform 12 months’ notice of a decision to permanently discontinue a reportable medicine (or as soon as practicable after the decision is made). 

The following range of views were received:

• the most support for introducing a uniform 12-month notice period for medicine discontinuations came from government, health professional and consumer organisations
• it was strongly recognised that the TGA proposal would make reporting obligations clearer for sponsors, but concerns were raised about sponsors’ ability to meet the TGA’s proposed 12-month notice requirement
• it was noted that the TGA’s proposed 12-month notice requirement was greater than discontinuation reporting requirements in other countries
• industry stakeholders noted the importance of maintaining the existing clause ‘or as soon as practicable after the decision is made’ for situations when sponsors are unable to provide 12 months’ notice of an upcoming discontinuation (e.g. due to unforeseen commercial factors)
• requests for flexibility in the timing of TGA publication of discontinuations, due to concerns about risks of stockpiling and wastage when patients change to alternative treatments
• concerns about situations where one product is replaced with another (e.g. resulting from product reformulations), and how they are currently reported and published as ‘discontinuations’, despite supply being maintained.

Thank you to everyone who provided feedback on the above proposals.

We are reviewing all submissions and seeking further input from affected parties relating to the suggested additional non-prescription medicines to be included in the list of reportable medicines. This feedback will inform recommendations to the Minister (or their delegate) on next steps, including amendments to the TGA’s regulatory framework for medicine shortages and discontinuations.