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About the Medicines Repurposing Program
The Medicines Repurposing Program (MRP, the program) aims to improve patient access to medicines in Australia by identifying new indications for existing medicines. It does this by offering fee waivers for regulatory assessment by the Therapeutic Goods Administration (TGA) and fee waivers for consideration of subsidy by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS) where possible.
The program is open to nominations from clinicians, health organisations, patient groups, pharmaceutical companies, and researchers.
The program is managed by the TGA, with support from the Technology Assessment and Access Division (TAAD), who manage the PBS.
Under legislation, a medicine cannot be listed on the PBS unless the PBAC makes a recommendation in favour of listing. Information related to the role of PBAC can be found at Pharmaceutical Benefits Scheme (PBS) | Pharmaceutical Benefits Advisory Committee (PBAC) Membership.
Learn more about the program outcomes to date.
Establishment of the program
The program was announced as part of a broader community pharmacy reforms package in the Federal 2023-2024 Budget. The program currently has terminating funding for 4 years, until 30 June 2027.
The repurposing of medicines was included as an action item in the 2020 National Strategic Action Plan for Rare Diseases. Strong interest from patient and clinical groups in the repurposing of medicines was also expressed during the 2021 Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia. This initiative was also mentioned in the Strategic Agreement 2022-2027 with the medicines industry.
During 2021 and 2022, the Department of Health and Aged Care collected stakeholder inputs through workshops, roundtables, and public consultations to inform the Medicines Repurposing Program. Details of the public consultations along with feedback received from stakeholders are available on our website at: Consultation: Repurposing of medicines.
Intent of the program
Medicines are often used in clinical practice for conditions other than those approved by the TGA. This practice is known as ‘off-label’ use. Off-label use is a decision made at the discretion of individual prescribers, sometimes in an ad-hoc manner, and can lead to inequity of access for patients. Bringing ‘off-label’ use under regulatory oversight can expand treatment options and increase prescriber consistency, benefiting more patients.
The concept of repurposing has gained significant attention in recent years. A critical component of this program is the identification of the right candidate medicines, with the appropriate evidence to make new treatment options available. Overseas agencies are engaged in establishing similar programs to support clinicians, researchers, and non-commercial parties in identifying potential new uses for existing medicines. We discuss the approach taken by other regulators and consider applicability in the Australian setting.
For sponsors of generic prescription medicines, lack of commercial value and costs associated with applications often present barriers to applying for approval of a new use. Other parties, such as academic institutions, researchers, and health organisations, may be aware of a medicine’s potential new use and benefit to patients, but may not be adequately resourced to bring these medicines forward for consideration independently.
Identifying potential medicines for repurposing
A dedicated program team oversees the candidate nomination, assessment and selection process, incorporating advice from the Advisory Committee on Medicines (ACM). The ACM provides independent medical and scientific advice to the Minister for Health and the TGA on issues relating to the safety, quality and efficacy of medicines supplied in Australia.
The MRP works with stakeholders to identify potential candidate medicines and to better understand potential barriers to registration of new indications for existing medications in the Australian market. The MRP will continue to actively seek stakeholder inputs and feedback to improve and refine the program as the program continues.
Learn more about the program’s eligibility criteria and prioritisation considerations.
Contact
For all enquiries and to discuss program eligibility requirements please email mrp@health.gov.au.