Repurposing of medicines program development and consultations
Repurposing of older medicines is 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 in other jurisdictions
- for a less common disease
- already accepted clinical practice albeit 'off-label' and
- likely to be less commercially profitable.
Medicines repurposing has also been considered by the House of Representatives Standing Committee on Health, Aged Care and Sport, with a recommendation that the Department of Health and Aged Care continue to develop options that establishes a more flexible way forward for the repurposing of medicines in Australia.
First public consultation 2021
The Department undertook a six-week public consultation from 4 February 2021 to 30 March 2021 where it asked for feedback to understand potential obstacles and/or incentives to repurposing of medicines that may influence a pharmaceutical companies decision to extend an indication for an existing medicine and to identify regulatory and reimbursement policy options.
The public consultation proposed options and ideas that may encourage and reduce barriers for companies to seek registration of new indications to medicines already registered in Australia.
The options included three key areas:
- reducing regulatory burden
- fee reduction, simplified submissions, and exclusivity.
- supporting the development of repurposed drugs through improving access to information
- standard of care off-label use and consolidated international regulatory information; and
- actively pursuing new indications
- using non-commercial entities as sponsors.
A follow-up stakeholder workshop with representatives from peak industry groups, pharmaceutical companies, patient groups and medical professional bodies was held in May 2021 in Sydney, followed by several roundtable discussions in early July 2021.
These consultations 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 & Aged Care Consultation Hub.
Second public consultation 2022
The Department released a follow up consultation on 10 March 2022 to seek input on how it 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.
The intention of this consultation was to inform the development of options for Government consideration, noting that that some options may have legislative, regulatory change or financial implications.
The consultation found continued support for the repurposing of medicines and several potential solutions to obstacles raised in the earlier consultation. More information on the consultation and a summary of the responses is available on the Department of Health & Aged Care Consultation Hub.
All recent TGA consultations can be found at the TGA consultation hub.