From psychedelic-assisted therapy to embryo models and cellular therapies at the nanoscale, science is rapidly expanding the boundaries of what is possible in healthcare. Australia has often been at the forefront of these developments.

Yet while the science moves forward, the laws and regulations designed to protect patients and ensure safe access remain increasingly out of step with emerging technologies.

Dr Christopher Rudge, Deputy Director of Sydney Health Law, is examining how well Australia's current frameworks are equipped to handle the medical technologies of tomorrow.

His research reveals a system marked by rigidity, inconsistency and gaps that can stifle innovation while raising patient safety concerns.

His work identifies critical pressure points across the medical frontier. For psychedelic-assisted therapy, he and his colleague Reeve McClelland (pictured, above) have revealed how inconsistent state laws create unequal access while exposing patients to risks from unlawful advertising and exploitation.

For personalised nanomedicines, Dr Rudge critiques a narrow regulatory focus on risk-based clinical trials. He argues that regulation needs to become more adaptive, especially where clinical evidence cannot be generated in cases of rare diseases or bespoke treatments.

Current models of regulatory approval can create blind spots by shifting responsibility from the regulator to the patient, leaving space where foreseeable harm can occur.

"Our current regulatory system was designed for a different era of medicine," Dr Rudge said.