The Australian Cell Therapy Society are currently reviewing the Code of Practice in light of the new TGA regulations which began on the 1st July 2018.
ACTS is proud to have been a part of the submissions to the TGA and support the TGA outcomes. The TGA have determined that the level of regulation will be determined by the risk posed to patient safety. Autologous Cell-based Interventions are now excluded from TGA regulations provided that they meet all of the outlined conditions in the TGA regulations in a registered hospital.
CODE OF PRACTICE for Autologous Cell-Based Interventions
A copy of the Code of Practice may be downloaded here.
In 2012, a group of medical practitioners and research scientists from multiple disciplines, with a common interest in Autologous Cell-Based Interventions (ACBIs), formed the Australian Autologous Cell Therapy consortium. The aim of the consortium was to establish a professional organisation (the Australian Cell Therapy Society – ACTS) and fund the development of a Code of Practice (‘the Code’), to guide members in the safe, ethical, beneficial and timely clinical development and practice of ACBIs, within the existing regulatory framework.
SCOPE OF THE CODE
The Code will apply to the practice of ACBIs and use of HCT, which meet the requirements of item 4(q) of the Therapeutic (Excluded Goods) Order No.1 of 2011 (the EGO) and therefore are not regulated as therapeutic goods.
Item 4(q) of the EGO only relates to Human Cells and Tissue (HCT) that are:
- collected from a patient who is under the clinical care and treatment of a registered medical practitioner in Australia, and
- manufactured by that medical practitioner, or by a person or persons under the professional supervision of that medical practitioner, for therapeutic application in the treatment of a single indication and in a single course of treatment of that patient by the same medical practitioner, or by a person or persons under the professional supervision of the same medical practitioner
The Code does not apply to the use of haematopoietic stem and progenitor cells in accredited clinical settings for treatment of various haematological, immunological and metabolic disorders, which have been established as standard of care.
Any medical practitioner who is a non-member treating patients with innovative ACBIs under item 4(q) of the EGO is also invited to accept and observe this Code as it is considered that the standards to be followed apply to the industry as a whole if it is to maintain the confidence of all stakeholders and meet regulatory requirements and standards for professional conduct.
Whilst all medical practitioners can, and are encouraged to refer directly to laws, codes of conduct and guidelines applicable to their profession, the Code provides a convenient central reference document, which brings all these elements together, as they relate to the use of ACBIs by medical practitioner’s under the EGO) and guides members through the complex regulatory framework within which they practice.
PURPOSE of The Code
- guide translation of safe and effective therapies to improve patient’s lives
- highlight the principles of evidence-based medicine as applied to the practice of innovative ACBIs
- encourage meaningful and ethical clinical research to develop beneficial therapies
- outline regulatory requirements and professional standards applicable to the practice and advertising of ACBIs
- highlight the above requirements and provide additional guidance and ethical advice and make these ethical standards transparent
- outline informed consent processes designed to ensure patients are provided with comprehensive advice allowing them to make fully informed decisions before documenting their consent to undergo an innovative ACBI.
- Introduce recommendations for the development of an Accreditation Scheme to monitor high quality patient care and laboratory performance according to recognised standards.
- establish processes for monitoring compliance and independent complaints and adjudication procedures
We welcome your feedback. Please forward all correspondence on the CODE OF PRACTICE to firstname.lastname@example.org
Your response will be considered as part of the decision making process of the Code Committee, which shall be established by the Australian Cell Therapy Society’s Board of Directors. The Board shall be elected by and from Members in early 2015.
BECOME A SIGNATORY TO THE CODE
Please select the Membership tab for information on membership and becoming a signatory to the Code of Practice.