Ms Aminath Ali Mariya1
1PhD Candidate, University Of Adelaide
In Australia, patient harm arising from the DePuy hip implants, the Poly Implant Prothèse implants, and the transvaginal mesh implant devices, exposed the perils and limitations of the existing medical device regulatory framework. The Therapeutic Goods Administration (‘TGA’) describes its overall objective as protection of public health and safety by regulating therapeutic goods supplied in, or exported from, Australia. Under current law, TGA’s jurisdiction achieves this objective for medical devices available in the Australian market by engaging with a limited group of stakeholders, the sponsors and manufacturers of those devices. Effectively, these stakeholders have a responsibility to report ‘adverse events’ to the TGA. Sponsors and manufacturers have broad discretion in the type of medical device adverse events (MDAEs) reported by them to TGA. An efficient and responsive reporting system is the cornerstone to successful post-market surveillance of medical devices. Such a system will also help mitigate diffusion of avoidable device related harm to the public. This paper contends that the existing law and regulatory practices of the TGA are not designed to facilitate a system that protects public health from avoidable device related harm. In the post-market space, healthcare providers are the knowledge holders. They are also a less conflicted party than the sponsors and manufacturers of these medical devices. Whilst the TGA has initiated discussions on the potential expansion of MDAE reporting to include mandatory reporting by healthcare facilities; this paper concludes that to do so without extending TGA’s jurisdiction over healthcare providers would mean TGA remains a toothless tiger in the regulatory jungle.
Biography:
Mariya is a PhD candidate at Adelaide Law School, University of Adelaide. Mariya’s current research examines the Australian legal framework regulating medical devices and explores whether this framework adequately addresses diffusion of avoidable medical device related harm to the public. Mariya completed her Master of Laws from Monash University, Melbourne.