Biologicals regulatory framework changes from 1 July 2018

Including changes to regulation of autologous human cell and tissue products and classification of biologicals

2 July 2018

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Explanation of key terms

The specific terms used in the Therapeutic Goods Regulations 1990 associated with autologous HCT products are explained below.

Clinical care and treatment

For exclusion and exemptions to apply a registered medical or dental practitioner must have and assure the prime responsibility for the clinical care of their patient throughout the course of treatment in which the autologous HCT product is used. This provision does not apply to other health practitioners.

Registered medical and dental practitioners

Medical and dental practitioners are the health care providers that most frequently prescribe or administer therapeutic goods including medicines, medical devices and biologicals. The conduct of these practitioners (including advertising of services) is regulated by Australian Health Practitioner Regulation Agency (AHPRA) and the relevant state, territory and national boards and councils. To maintain registration in their respective specialities, medical and dental practitioners are required to participate in appropriate continuing professional development, to work within their scope of practice and to maintain recency of practice. Guidance for professional practice is contained in "Good medical practice: A code of conduct for doctors in Australia" and in the "Code of conduct for registered health practitioners".

We accept that clinical/dental practice is sufficiently regulated such that, if the conditions outlined in the exclusion or the exemptions are satisfied, additional regulation by the TGA of some autologous HCT products may impose unnecessary burden.

The exclusion or exemptions from regulation by the TGA of autologous HCT products used under the outlined conditions has no effect on the professional obligations of health practitioners to maintain satisfactory standards of practice that are appropriate to their profession. A registered medical or dental practitioner:

  • Must have prime responsibility for the clinical care of his/her patient throughout the course of treatment in which the autologous HCT products are used.
  • Should be 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.
  • Should ensure that prior to treatment of any patient with a product that has not been approved for use in Australia, that patient receives appropriate and adequate information about the material risks and benefits of that product to allow informed consent.

The Australian Health Practitioner Regulation Agency (AHPRA) also has the power to prosecute for particular advertising offences which may infringe the Health Practitioner Regulation National Law Act (in force in each state and territory). The Medical Board of Australia also publishes Guidelines for Advertising of Regulated Health Services.

Manufacture and use in a hospital

We believe that there is sufficient regulation of hospitals to mitigate possible risks that may arise as a result of manufacturing and using excluded autologous HCT products, and that credentialing processes applied by hospitals should be sufficient to ensure that medical/dental practitioners do not work outside of their scope of practice.

Public and private hospitals in Australia are subject to regulation under various state, territory and national provisions. Accreditation of hospitals is a requirement for funding by governments and other funding organisations. A national accreditation scheme for health service organisations and the National Safety and Quality Health Service (NSQHS) Standards were endorsed by the Australian Health Ministers in September 2011.

Commonwealth Hospital Declaration

The Australian Government Department of Health regularly updates a list of Commonwealth declared hospitals. Inclusion on this list of public hospitals requires State or Territory Department of Health confirmation of a public hospital and evidence of accreditation. Inclusion of private hospitals requires a copy of a state or territory hospital licence and evidence of accreditation.

NSQHS Standards considered applicable to biologicals and blood components

While the following National Safety and Quality Health Service (NSQHS) Standards do not specifically apply to biologicals, we believe that the principles applied to achieve the required standards are relevant and applicable to the safe use of biologicals, specifically autologous HCT products, in accredited hospitals:

  • NSQHS Standard 3: 'Preventing and controlling healthcare associated infections' includes criteria for governance and systems of infection prevention, control and surveillance, and for cleaning, disinfection and sterilisation.
  • NSQHS Standard 4: 'Medication safety' includes criteria for governance and systems for medication safety and medication management processes that outline mechanisms for "safe prescribing, dispensing, administering, storing, manufacturing, compounding and monitoring..." of medicines.
  • NSQHS Standard 7: 'Blood and blood products'. While blood and blood products are not currently regulated as biologicals by the TGA, the principles that underlie safe and appropriate prescribing and use of blood and blood products are also applicable to autologous HCT products. The criteria for Standard 7 apply to governance systems and systems to 'receive, store, transport and monitor wastage of blood and blood products safely and efficiently'.

Institutional credentialing of health practitioners

Health practitioners who work in hospitals are subject to mandatory institutional credentialing processes, to ensure the quality and safety of patient care. Credentialing includes review of qualifications, professional standing and professional registration and indemnity. Credentialing also requires the practitioner to undertake to work within his or her professional scope of practice. In 2015 the Australian Commission on Safety and Quality in Health Care released a guide to "Credentialing health practitioners and defining their scope of clinical practice – A guide for managers and practitioners". The "Standard for credentialing [sic] and defining the scope of clinical practice: a national standard for credentialing [sic] and defining the scope of clinical practice of medical practitioners, for use in public and private hospitals" was published in 2004.

Professional supervision over the manufacture of the product

For the exclusion or exemptions to apply, the autologous HCT product is to be 'manufactured by that medical/dental practitioner or by a person or persons under the professional supervision of that medical/dental practitioner'. The fact that the products being used for a patient are not directly manufactured by the treating medical/dental practitioner does not mean that the exemptions do not apply.

Professional supervision

Professional supervision in this context requires that the medical/dental practitioner with primary responsibility for the clinical care of a patient is party to all manufacturing steps that are performed in a formal governance arrangement with the person or persons undertaking the manufacturing. This would include input into the protocols and quality systems used in the manufacturing process. This enables use of goods that are not directly manufactured by the treating medical/dental practitioner.

For example, pancreatic tissue may be collected from a patient by a surgeon in collaboration with an endocrinologist, for processing of the islet cells in a laboratory. Subsequent to processing, the islet cells are infused into that same patient as an autologous transplant.

The collection, processing and infusion must however remain under the professional supervision, as described above, of the endocrinologist caring for the patient.

Specialised testing on a representative sample of the product by a third-party facility, for example sterility testing, would still be considered to fit within the professional supervision of the medical or dental practitioner.

Therapeutic application for a single indication in a single procedure

Where a HCT is removed from a patient and transplanted back into the patient during a single clinical procedure the risks to the patient are the same as those typically associated with surgical procedures. These operations will normally be exempt from regulation by the TGA. In contrast, any treatment that involves more than a single procedure, especially where storage of the HCT is required, can significantly increase the risks to safety associated with traceability, sterility and quality of the product. Treatments involving storage of the HCT do not fall within the scope of the exemption provisions.

The therapeutic application must also be limited to a single indication. Sometimes the therapeutic purpose of the cell or tissue therapy is clear from the context of the admission or the description of a surgical treatment.

For example:

  • Use of a saphenous vein to replace an occluded coronary artery during coronary artery bypass grafting
  • Use of an autologous skin graft to cover a burn
  • Use of small volumes of autologous bone to fill bony defects in dental practice.

However, clinical users of autologous HCT products, may conclude that some HCTs have therapeutic value in more than one indication. The primary indication for the autologous HCT product in any procedure or treatment should be clearly documented.

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