TGA consultation on the repurposing of medicines

The TGA is conducting a follow-up consultation on the repurposing of medcines.

What is repurposing?

TGA defines repurposing of medicines as the process of identifying potential new therapeutic uses (or ‘indications’) for older medicines through new research and evidence. This includes indications where a public health benefit has been identified, including indications that are:

  • already approved overseas
  • for a less common disease
  • already accepted clinical practice albeit ‘off-label’ and
  • likely to be less commercially profitable.
Consultations held thus far on repurposing
Date(s)What was the consultation about?Outcome
 A six-week public consultation from 4 February 2021 to 30 March 2021TGA asked asked for feedback to understand potential obstacles and/or incentives to repurposing of medicines that may influence a sponsor’s decision to extend an indication for an existing medicine and to identify regulatory and reimbursement policy options.

The three key areas are:
i) reducing regulatory burden i.e fee reduction, simplified submissions, and exclusivity.
ii) supporting the development of repurposed drugs through improving access to information i.e. standard of care off-label use and consolidated international regulatory information; and
iii) actively pursuing new indications i.e. using non-commercial entities as sponsors.
The public consultation proposed options and ideas that may encourage and reduce barriers for sponsors to seek registration of new indications to medicines already registered in Australia.
A follow-up stakeholder workshop with representatives from peak industry groups, pharmaceutical companies, patient groups and medical professional bodies was held in May 2021.This consultation found broad support for the repurposing of medicines. However, a number of potential issues and obstacles were raised. A summary of these can be found on the Department of Health Consultation Hub.
Several roundtable discussions in July 2021As above
What is this consultation about?

The Department has released a follow up consultation on 10 March 2022 that seeks input on how the TGA might:

  • Address commercial and intellectual property issues
  • Identify the best candidates for repurposing
  • Shortlist candidates; and
  • Approach and incentivise the market for repurposing a medicine.

For this consultation the focus is the process of marketing authorisation for novel clinical uses of existing medicines registered on the ARTG, rather than the commonly used practice with certain on-patent medicines of extension of indications to related populations. The intent of consultation is to establish options to reduce barriers and identify incentives for medicines to be repurposed for novel clinical uses. There is a particular focus on off-patent medicines, although opportunities for repurposing on-patented medicines also exist.

What is the intention of this consultation?

The intention of this consultation is to inform the development of options for Government consideration, noting that that some options may have legislative, regulatory change or financial implications. It is likely that further consultation will be required to determine the final approach.

What are the start and end dates of the consultation?

Start date: 10 March 2022

End Date: 1 April 2022

Where can you respond to the consultation?

You can respond to the consultation here

Source: TGA Australia