Breakthroughs in genomic medicine are transforming the way health care is delivered. From treatments for rare genetic disorders to experimental cures for certain cancers, genomic therapies promise to change the lives of patients who previously had few, if any, options.

Yet many of these therapies come with staggering costs, sometimes exceeding a million dollars per treatment. For governments, this raises complex questions: who should receive access, how are these decisions justified, and what does fairness look like when the stakes are so high?

Professor Cameron Stewart, an expert in health law and ethics at Sydney Law School, is leading a major research project to investigate how these challenges are being navigated in Australia. Supported by grant funding, the project focuses on the legal and economic regulation of genomic therapies and the frameworks governments use when deciding whether and how to fund them.

“There are a number of government schemes to fund high-cost genomic therapies, but there is very little clarity about how those decisions are being reached,” Professor Stewart explained.

“My research is about mapping that process and asking whether it can be made more transparent, consistent and just.”

While the development of these therapies is often celebrated in medical and scientific circles, the pathways for patients to actually access them are far less clear.

Unlike standard treatments subsidised through the Pharmaceutical Benefits Scheme or Medicare, genomic therapies are often considered on a case-by-case basis, involving layers of ministerial discretion and bureaucratic assessment.

Professor Stewart’s work is unpacking how these decisions are made in practice, and where the law might allow them to be contested.

“At the heart of this research is the question of justice: how can we fairly distribute life-saving therapies when the costs are so high?”