Doctors frequently use treatments that are outside the scope of standard practice and that have not (yet) been shown to be safe or effective according to the standards of evidence-based medicine. This practice, which may be thought of as clinical innovation, occurs across all areas of medicine and is extraordinarily diverse.
In most cases, clinicians innovate responsibly, and clearly have their patients’ best interests in mind. But unfortunately, this is not always the case, as evident in doctors’ use of autologous stem cell therapies for the treatment of dementia or motor neuron disease; IVF specialists’ use of endometrial scratching or embryo glue to enhance implantation; and surgeons use of avant-garde surgical approaches of questionable validity.
These and other issues have recently been recognised by the Medical Board of Australia, which has launched a public consultation into “complementary and unconventional medicine and emerging treatments”. The scope of the inquiry is broad—covering complementary medicines, innovative therapies and experimental practice, as well as the unconventional use of approved medical treatments and devices. The primary aim of the consultation is to gather feedback about whether additional regulation of doctors’ use of these treatments is necessary, and if so, what form this regulation could take.
In this presentation, we will discuss several key questions raised in the consultation paper, including those centered on definitional issues; outline and critique the strengths and weaknesses of existing regulatory mechanisms; and offer a series of ethically-informed recommendations to guide the governance of clinical innovation.