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Consultation: Repurposing of medicines
Submission of feedback on the repurposing of medicines closed on 1 April 2022
Repurposing 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 overseas
- for a less common disease
- already accepted clinical practice albeit 'off-label' and
- likely to be less commercially profitable.
Recently, repurposing older medicines has been a prominent area of research for potential COVID-19 treatments. It has also been considered by the House of Representatives Standing Committee on Health, Aged Care and Sport, with a recommendation that the Department continue to develop options that establishes a more flexible way forward for the repurposing of drugs in Australia.
Public consultation on repurposing of medicines
The Department of Health undertook a six-week public consultation from 4 February 2021 to 30 March 2021 where we 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 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.
The three key areas are
- 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 Consultation Hub.
Our current consultation
The Department released a follow up consultation on 10 March 2022 to seek input on how we 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.
We have included more information on the Department of Health Consultation Hub.
This consultation was for three weeks, opening on 10 March 2022 and closed on 1 April 2022.
Changes we are making
Feedback received from this consultation will be used to shape options for Government consideration. It is likely that further consultation will be required to determine the final approach.