The Regulatory Environment for Innovative Health Technologies: Identifying Overreach and Filling Gaps

Researchers

• Prof Dianne Nicol (Chief Investigator)
• Dr Jane Nielson (Chief Investigator)
• Dr Lisa Eckstein (Chief Investigator)
• Prof Dr Cam Stewart (Chief Investigator)
• Jenny Kaldor (Postdoctoral Research Fellow)

Funding Source: ARC Grant

Commencement: 2018

Project Status: Current

Project Background

Innovative, personalised health technologies are being heralded as solutions to intractable health conditions. Procedures such as genome editing, medicines such as biologics targeted to individual patients, and devices such as 3D printed biological structures, to name a few, are enhancing our capacity to identify and correct individual bodily defects. Given the pace of scientific discovery, however, clinical transition is not occurring as rapidly as might be expected. The law should play a key role in ensuring that the clinical transition of these technologies is regulated in ways that are responsive to societal values and needs, ensuring safety, effectiveness, access, affordability, allocative efficiency and fairness.

Project Aims

While insufficient oversight can impede patient safety, resulting in unnecessary morbidity and mortality, an undue regulatory burden can impede innovation and associated heath and economic benefits. This project aims to provide recommendations on how best to balance these concerns by mapping the landscape of regulatory requirements governing the clinical transition of innovative medical technologies in Australia. It will identify, analyse, compare and evaluate regulatory provisions across Australia and other jurisdictions in order to identify areas of over and under regulation with regard to its three case studies of genome editing, biologic medicines and 3D printed biological structures.

Project Outcomes

The project will produce an interactive online map of Australia’s regulatory environment for each of its case studies, providing a convenient and readily interpreted resource to guide policy-makers toward clear benchmarks for responsible innovation and current congestion and gaps. While they will emanate from the selected technologies, the principles forming the backbone of the map will be adaptable for application to other innovative technologies. To this end, the project’s findings will be widely disseminated, and presented to international experts to highlight the transferability of its principles to other technology areas.

While this study focuses on a limited number of case studies, it uses a methodology that allows comparison across technology areas and across regulatory pressure points to account for multiple and diverse perspectives. The study results will encourage discourse at an international level on optimal regulatory strategies in the innovative personalised healthcare space. They will also identify priority areas for law reform.

Postdoctoral Opportunities

The Project has funding for two postdoctoral scholarships and is accepting expressions of interest for PhD positions.