ISCT Webinar: A New Dawn of Stem Cell Medicine or Unfettered Patient Exploitation? Lessons from Unregulated Clinics in Australia and Japan
Presented by the ISCT Australia & New Zealand Legal & Regulatory Affairs Committee
Date: October 18/19, 2016
Time: 18:00 PT/21:00 EST on October 18, 09:00 SGT/12:00 AEDT on October 19
- Dominic Wall, PhD, FFSc, (RCPA), Chief Scientific Officer - Cell Therapies Pty Ltd & Chair ISCT ANZ LRA Committee
- Megan Munsie, PhD, Head - Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, Department of Anatomy and Neuroscience, The University of Melbourne, Australia
- Tamra Lysaght, PhD, Director of Phase III Health Ethics, Law and Professionalism Programme, Centre for Biomedical Ethics, National University of Singapore, Singapore
The availability of unproven stem cell treatments is often assumed to be a feature of low-to-middle income economies that lack the resources to control medical claims and entrepreneurs offering questionable treatments to patients with intractable and devastating diseases. However both Japan and Australia are running experiments in deregulation which is creating new business models based upon unproven treatments.
Dr. Megan Munsie from the University of Melbourne will present her perspective on the explosion in stem cell clinic activity based upon Australia’s unique regulatory experiment of having a medical practitioner exemption framework for supply of unproven autologous cell-based treatments that is unrestricted by either homologous use or by the extent of manipulation of the cells.
Dr. Tamra Lysaght from the National University of Singapore will share her perspective on the new legislative framework for regenerative medicine in Japan and the impacts it has had on clinics offering unproven treatments with autologous stem cells.
The speakers will share their insights on the risk posed by these clinics to all stakeholders - the patients and their families, the practitioners and their professional indemnifiers, the academic, clinical and commercial sponsors developing legitimate products and the broader commercial milieu – particularly in the absence of demonstrable benefit. The presenters will also discuss how patient and clinician autonomy in the current environment is out of step with the basic science and the potential risks with these practices.
· To understand the current legislative framework permitting unproven cell-based therapies provided under medical exemption in Australia with a comparative analysis of frameworks in the US, EU, and Japan.
· To understand specific concerns with the Australian and Japanese situation and the current commercial activity in both markets in unproven treatments provided by “stem cell clinics” and in promoted “trials”.
· To consider the medico-ethical issues with the marketing of these treatments by medical practitioners and their scope of professional practice.