Recommendation 18C

Establish a regulatory sandbox that allows health services firms to offer low-risk health services and digital tools to controlled markets; providing an early market test for safety, efficacy, economics and enabling pre-market surveillance for regulators.

Goverment response
Not agreed

Australia already has one of the faster regulatory approvals for medicines and medical devices globally, and there are existing legislated schemes that provide priority review for products that address unmet medical need.

This proposal would require legislative change through Parliament to enable the sandbox to be established within the Therapeutic Goods Regulatory Framework and other applicable regulatory frameworks.

Further clarification is sought on the frameworks that have been reported to be barriers to export capability, as obtaining an AUST L entry to enable export often takes only matter of days or weeks.

This proposal also needs to be considered in the context of the role of clinical trials which enable collection of evidence prior to market release.

There are already provisions for “limited market release” of unapproved products such as Authorised Prescriber (and Special Access Schemes). An Authorised Prescriber and a company could work with a clinician to gain more experience with a product outside clinical trials.