The Ethical, Legal and Regulatory Issues Associated with Pharmacogenomics: Systematically Quantifying the Literature.

Since the human genome was successfully mapped much academic attention has been given to ethical, legal and regulatory issues associated with the integration and application of genomics in health care. In line with the recent political commitment to promoting precision medicine that relies heavily on omic knowledge, it is timely to review the issues that this body of literature has addressed. Focusing on pharmacogenomics, this review quantifies the issues identified in this body of academic work. It reveals that, after nearly two decades, interest in the regulatory and legal issues associated with pharmacogenomics continues to generate significant attention. The ethical issues, while not as predominant, also persist. The analyses highlights that there is a dearth of empirical research exploring the impact that these issues have had.

National Competition Policy and Australia's Health Care System: A Look at the Policy Landscape with New Eyes.

Australia spends nearly 10% of its gross domestic product on health services. With such a substantial financial commitment, even relatively minor improvements in efficiency, effectiveness and productivity can increase community welfare. Competition is a well-recognised policy lever implemented to achieve these goals in market economies. However, it has for many years struggled to gain traction in the health care sector. This article traces recent attempts to promote competition principles in Australia's health care sector. Highlighting where these attempts have stalled, it compares Australia's recent health reforms with those instituted in the United Kingdom's National Health Service where a sector-specific competition regulator has been in place for several years. It concludes that there is room in Australia's regulatory landscape to improve public reporting and increased choice in health care. A sector-specific regulator is envisaged to support these important competition-based initiatives.

Translating Knowledge from Research to Outcomes: Pharmacogenomics in the Treatment of HIV/AIDS.

Although therapeutic medicines are frequently prescribed to improve health, individual responses are often inconsistent, unpredictable and potentially harmful. Recognising that individual genetic variation can influence response, pharmacogenomics aims to identify clinically relevant medicine/genome relationships, and use this knowledge to improve the safe and effective use of medicines. To facilitate the translation of new pharmacogenomic knowledge from the scientific laboratories where it is generated, into the clinical health services where it can be applied, Khoury et al developed a framework outlining a continuum of translation research. This framework must be embedded within a social and political environment conducive to supporting translational research if the desired outcomes are to be achieved. Drawing on the example of one pharmacogenomic test that is now well integrated into clinical practice, this article traces the contemporaneous social and political factors that facilitated translational pharmacogenomic research, and enabled the safe use of a vital medicine.