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Regulations of Biological Treatments

Biological Treatments Regulated

Macquarie Stem Cells are governed by 4 major bodies as listed below;

Code of Conduct for Biological Treatments

Dr. Ralph Bright and the team at Macquarie Stem Cells are registered medical and scientific professionals. We strictly follow the Australian guidelines as indicated by the Therapeutic Goods Association (TGA).

History Of Code

In 2012, we were called in along with a group of other 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.

 

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

You can download this 66 page copy of the code here.

TGA Regulations

The TGA has made the decision to increase the regulation of biological treatments effective as of 1st of July 2018.

In a nutshell, the TGA wants biological treatments to be safer for the public.  Our laboratory systems and processes are accredited to the international standards. The TGA wants everyone to move to the GMP manufacturing standard with clean rooms. They also want the cell separation process to be included in the ARTG register.

What are we doing?

  • We are currently in the process of building a new GMP level laboratory that will be used specifically for patient treatments.
  • We will build a separate laboratory with the strict purpose of research.
  • We will further improve our systems and protocols beyond the current certification of ISO 9001.
  • We will upgrade our systems and processes to be included through the ARGB (Australian Regulatory Guidelines for Biologicals) and on the ARTG (Australian Register of Therapeutic Goods).
  • We will expand our collaboration into Private Hospitals.
  • We have already placed the application through HREC (Human Rights Ethics Committee) to start our blinded, placebo controlled clinical trial for Osteoarthritis. We aim to finalise this trial by the end of 2019.
    (more information here.)
  • WE WILL CONTINUE TREATING PATIENTS FOR OSTEOARTHRITIS AND JOINT INJURIES.

We pride ourselves on practising well above the required standards.

The complete regulation can be found here on the TGA website.

AMA & AHPRA Registration

About AMA

Directly stated by the AMA website ” The Australian Medical Association (AMA) is the most influential membership organisation representing registered medical practitioners and medical students of Australia.

The AMA exists to promote and protect the professional interests of doctors and the health care needs of patients and communities.” (AMA, 2017)

The AMA improves patient care by supporting the medical profession through a range of essential services including:

  • protecting the academic, professional, and economic independence of medical practitioners
  • protecting the wellbeing of medical practitioners
  • promoting and advancing ethical behaviour of the medical profession
  • protecting the integrity and independence of the doctor/patient relationship
  • preserving and protecting the political, legal and industrial interests of medical practitioners

(AMA, 2017)

All medical professionals in Australia have obligations to follow. Dr. Bright has to maintain satisfactory standards of practice that are appropriate to health sector. Dr. Bright is mindful of adherence to professional standards when using products that have not been evaluated for safety and efficacy by the TGA. This would include consideration of whether the treatment being undertaken is necessary and safe and whether its efficacy is supported by credible clinical evidence.

What does AHPRA do?

Taken directly from the AHPRA website “AHPRA’s operations are governed by the Health Practitioner Regulation National Law, as in force in each state and territory (the National Law), which came into effect on 1 July 2010. This law means that for the first time in Australia, 16 health professions are regulated by nationally consistent legislation under the National Registration and Accreditation Scheme.

AHPRA supports the 15 National Boards that are responsible for regulating the health professions. The primary role of the National Boards is to protect the public and they set standards and policies that all registered health practitioners must meet. Each Board has entered into a health profession agreement with AHPRA which sets out the fees payable by health practitioners, the annual budget of the Board and the services provided by AHPRA. ” (AHPRA 2017)

Please click on the picture below to follow through to the AHPRA website.

Furthermore, Macquarie Stem Cells professional standards include professional performance and conduct, which are governed by the Medical Board of Australia. Guidance is contained in Good Medical Practice: A Code of Conduct for Doctors in Australia.

TO OBTAIN FURTHER INFORMATION

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