The valley of death – trying to get repurposed drugs registered for new indications: the Australian Experience

The issue of taking drugs from laboratory into clinical trials or clinical practice can be long, expensive and arduous. As seen during the pandemic where there was additional urgency, together with often a lack of funding, little clinical pharmacology input into choice of drug and dose, and potted engagement with multidisciplinary skillsets, Australia spent a lot of funds and human resources on repurposed medicines research and drug and vaccine trials that never provided any therapeutics available for clinical use.

In addition, both the Australia and New Zealand medicines market are disproportionally affected by supply chains, as their pharmaceutical markets are small on a global scale; and for both countries almost all of their medicines are imported; these facts are a major risk to Australasian health and access to much needed medicines. Recently the Australian government announced a program to support registration of repurposed drugs, the Medicines Repurposing Program. Registration by our regulatory body enables access for doctors to be able to prescribe these therapies. This talk will discuss the new program, the implications of such change in policy, and what it means for clinicians, clinical and non-clinical researchers.