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

Project Lead

• Prof Dianne Nicol

External Collaborators

• Professor Cameron Stewart

CLG Collaborators

• Prof Jane Nielsen
• Dr Lisa Eckstein

Funding Source: Australian Research Council Grant, Discovery Project  $628,576

Commencement: 2018-2023 (with extensions)

Project Status: Current

Project Summary

CLG members Nicol, Nielsen and Eckstein and Prof Cameron Stewart from Sydney University are CIs on this project, funded by the Australian Research Council (DP180101262). 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 are enhancing our capacity to identify and correct individual bodily defects. This project examines the Australian regulatory landscape within which these technologies are located.  To date the team has primarily focused on the role of intellectual property as a regulatory tool, the roles of transparency, accountability and public participation in the regulatory approval of new drugs and devices, research and professional ethics and tort law.  One of the outputs of this project is a website (https://healthinnovationmap.net.au) mapping the regulatory encounters faced by researchers into and developers of innovative health technologies. The aim of this regulatory map is to assist researchers, developers, clinicians, patients and others in understanding the regulatory landscape for innovative health technologies.