Your views are sought The TGA description takes into account the response of stakeholders to the previous consultation. Does the description of the problems adequately reflect the actual or potential problems associated with the existing regulation of autologous cells and tissue? Are you able to provide specific evidence particularly in the Australian context, in relation to the practices outlined above, that demonstrates risk to patient health? Part C Objectives of any government action – The objectives of any government action in relation to autologous human cells and tissues would be as follows: to minimise public health and safety risks; to maintain consumer confidence in the regulation of therapeutic goods, specifically the national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods; to duplication of regulatory effort, particularly where the regulation of therapeutic goods intersects with the regulation of medical practice (by AHPRA and State/Territory regulators) and the regulation of consumer goods more generally (via the ACCC); to align, as far as possible, with international best practice; and to minimise unnecessary regulatory burden. Part D Options – Revised options Four options are proposed for the future regulation of autologous human cell and tissue products. Each of the options represents progressively increased regulation based on the two key risks: the risk that direct-to-consumer advertising may result in patients failing to get more suitable or efficacious treatment in a timely way and/or expose them to unnecessary risk; and the risk associated with increased manipulation of the cells or tissue. Each option describes the regulatory exclusions and inclusions that would apply: Option 1 Human cell and tissue products: – for autologous use, under the supervision of a medical/dental practitioner, as part of a single course of treatment, would be excluded from TGA regulation;
Your views are sought The TGA description takes into account the response of stakeholders to the previous consultation. Does the description of the problems adequately reflect the actual or potential problems associated with the existing regulation of autologous cells and tissue? Are you able to provide specific evidence particularly in the Australian context, in relation to the practices outlined above, that demonstrates risk to patient health? Part C – Objectives of any government action The objectives of any government action in relation to autologous human cells and tissues would be as follows: to minimise public health and safety risks; to maintain consumer confidence in the regulation of therapeutic goods, specifically the national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods; to duplication of regulatory effort, particularly where the regulation of therapeutic goods intersects with the regulation of medical practice (by AHPRA and State/Territory regulators) and the regulation of consumer goods more generally (via the ACCC); to align, as far as possible, with international best practice; and to minimise unnecessary regulatory burden. Part D – Options Revised options Four options are proposed for the future regulation of autologous human cell and tissue products. Each of the options represents progressively increased regulation based on the two key risks: the risk that direct-to-consumer advertising may result in patients failing to get more suitable or efficacious treatment in a timely way and/or expose them to unnecessary risk; and the risk associated with increased manipulation of the cells or tissue. Each option describes the regulatory exclusions and inclusions that would apply: Option 1 – Human cell and tissue products: for autologous use, under the supervision of a medical/dental practitioner, as part of a single course of treatment, would be excluded from TGA regulation;
consultation-regulation-autologous-cell-and-tissue-products.docx