Register      Login
Australian Health Review Australian Health Review Society
Journal of the Australian Healthcare & Hospitals Association
RESEARCH ARTICLE

The Medicines Repurposing Program – a critical perspective

Narcyz Ghinea https://orcid.org/0000-0002-1457-7252 A *
+ Author Affiliations
- Author Affiliations

A Philosophy Department, Faculty of Arts, Ethics and Agency Research Centre, Macquarie University, North Ryde, NSW 2109, Australia.

* Correspondence to: narcyz.ghinea@mq.edu.au

Australian Health Review 48(3) 259-261 https://doi.org/10.1071/AH24077
Submitted: 9 March 2024  Accepted: 18 April 2024  Published: 7 May 2024

© 2024 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA.

Abstract

The Medicines Repurposing Program was launched on 1 March 2024. It provides a pathway for registering and subsidising off-label medicines of significant public health benefit but which sponsors have no financial incentive to pursue. This article provides a short overview and critical analysis of the program. One concern that emerges is that commercial sponsors still retain de facto veto power over which off-label uses are prioritised and so have the capacity to sway the process. Simple suggestions are proposed to help mitigate this risk.

Keywords: access to medicines, commercial determinants of health, health policy, health technology assessment, inequity, medicine repurposing, off-label medicines, orphan drugs, Pharmaceutical Benefits Scheme, pharmaceutical regulation, Therapeutic Goods Administration.

References

Therapeutic Goods Administration. Establishment of the Medicines Repurposing Program. Therapeutic Goods Administration (TGA); 2024. Available at https://www.tga.gov.au/resources/publication/publications/establishment-medicines-repurposing-program [cited 7 March 2024].

Ghinea N. The increasing costs of medicines and their implications for patients, physicians and the health system. Intern Med J 2024; 54: 545-50.
| Crossref | Google Scholar | PubMed |

Demonaco HJ, Ali A, von Hippel E. The major role of clinicians in the discovery of off-label drug therapies. Pharmacotherapy 2006; 26(3): 323-32.
| Crossref | Google Scholar | PubMed |

Day R, Lipworth W, Ghinea N. The ethics around drug labels and generic medicines. Ther Innov Regul Sci 2015; 49(3): 348-51.
| Crossref | Google Scholar | PubMed |

Mellor JD, Van Koeverden P, Yip SWK, Thakerar A, Kirsa SW, Michael M. Access to anticancer drugs: many evidence-based treatments are off-label and unfunded by the Pharmaceutical Benefits Scheme. Intern Med J 2012; 42(11): 1224-9.
| Crossref | Google Scholar | PubMed |

Therapeutic Goods Administration. Medicines Repurposing Program - Eligibility criteria and prioritisation considerations. Therapeutic Goods Administration (TGA); 2023. Available at https://www.tga.gov.au/products/medicines/medicines-repurposing-program-eligibility-criteria-and-prioritisation-considerations [cited 5 March 2024].

Therapeutic Goods Administration. Pharmacovigilance responsibilities of medicine sponsors. Therapeutic Goods Administration (TGA); 2022. Available at https://www.tga.gov.au/resources/resource/guidance/pharmacovigilance-responsibilities-medicine-sponsors [cited 5 March 2024].

Therapeutic Goods Administration. Summary of fees and charges. Therapeutic Goods Administration (TGA); 2022. Available at https://www.tga.gov.au/how-we-regulate/fees-and-payments/summary-fees-and-charges [cited 8 March 2024].

Therapeutic Goods Administration. Orphan drug designation eligibility criteria. Therapeutic Goods Administration (TGA); 2022. Available at https://www.tga.gov.au/resources/resource/guidance/orphan-drug-designation-eligibility-criteria [cited 8 March 2024].

10  IQVIA. White Paper: Access to Orphan Drugs in Australia. 2024. p. 8. Available at https://www.iqvia.com/-/media/iqvia/pdfs/australia-and-new-zealand/white-papers/access-to-orphan-drugs-in-australia.pdf