Managing scientific uncertainty in health legislation

Abstract

Legislation and regulation are one means of controlling biomedical research and its clinical applications. This is seldom a one-off process since biomedical science evolves rapidly, dynamically and often unpredictably, and legislative and regulatory reviews are often required in response to the emergence of apparently new ethical and legal issues. In recent years, there have been several reviews of Australian biomedical legislation including the Australian Law Reform Commission’s “Inquiry into the Protection of Genetic Information in Australia” (“the ALRC Inquiry”) released in 2003 1, and the Legislative Review of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, (“the Lockhart Review”) which was released in December 2005 2. The ALRC Inquiry was a response to developments in genetic research, particularly genetic epidemiological research involving powerful new techniques such as microarrays (gene chips). The Lockhart Review was concerned with developments in stem cell research, including the use of embryos produced in the course of assisted reproductive technology (ART) and through cloning. These two reviews, when juxtaposed, highlight the key elements—both recurring and review-specific—of biomedical legislative review.