Dr Carolyn Johnston1, Prof. Dianne Nicol1, Professor Jane Nielsen1, Dr Lisa Eckstein1, Professor Cameron Stewart2
1Centre for Law and Genetics, University of Tasmania, Hobart , Australia, 2Law School, University of Sydney, Sydney, Australia
Biography:
Bios to come
Abstract:
This presentation will discuss a research project that mapped regulatory pathways of innovative health technologies, aiming to identify areas in need of reform and to recommend improvements.
Innovations in health technologies with a focus on personalised diagnosis, management and treatment of disease are increasing at a rapid pace. Yet throughout the process of research and development, regulatory encounters are prolific, complex and overlapping, with the potential to hinder the application of such technologies in practice.
The Reforming the Regulatory Environment for Innovative Health Technologies project (ARC grant) comprehensively mapped the regulatory encounters of innovative health technologies. One key outcome of the project is the development of an interactive map identifying the regulatory landscape, broadly correlating to phases of research, development, manufacture and clinical use. Topics include therapeutic product testing and registration, patents, licensing, consumer law and clinical ethics.
This interactive map highlights the regulatory landscape in the context of three case studies: Casgevy, a cell-based gene therapy for sickle cell disease; biologic therapies for arthritis; and kidney tissue engineering, illustrative of an innovative procedure, medicine and device, noting that in practice the boundaries are mutable.
Our presentation will demonstrate the interactive map, working through the Casgevy case study as illustration. We discuss our approach to the mapping exercise and our reflections on how the work done can have impact and utility for the intended audience. We comment on the range of regulatory frameworks identified and our conclusions on their appropriateness in context and suggestions for reform.
Presentation Slides PDF – Click here