An Analysis of Australia's Legal Framework for Access to More Affordable but Unapproved Medicines and Biologics.

Objective: Approved medicines are not always sufficient to address the needs of patients so several legal pathways exist to enable access to unapproved medicines for treatment purposes. This article is the first to provide an in-depth analysis of this regulatory framework that governs access to unapproved medicines in Australia with a specific focus on affordability-motivated access.

Methods: Legislation, regulations, and guidelines were critically analysed to identify the de jure basis for importation and supply of unapproved medicines in Australia.

Results: Most pathways for accessing unapproved medicines do not permit importation or supply for non-clinical justifications such as affordability. This is problematic as it fails to recognize that a medicine being unavailable is equivalent to a medicine being unaffordable for a patient. Better alignment can be achieved by permitting importation and supply of unapproved medicines if justified by good medical practice, which includes considerations of equity and access. It is also shown that the provisions of the Special Access Scheme Category A could be interpreted broadly to expand its use.

Conclusions: As medicines become more expensive and cost-barriers to treatment are more prevalent, ignoring affordability as a valid criterion for importing medicines is a significant oversight of current regulation.