Autologous human cell and tissue products

20 April 2018

Autologous human cell and tissue (HCT) products are those that are removed from, and applied to, the same person, i.e. the donor and the recipient are the same. These include some products commonly referred to as 'stem cell treatments'.

Certain autologous human cell and tissue products have not been captured by TGA regulatory oversight, because historically they have been seen as part of medical practice. However, there is growing global concern for patient safety due to the increasing complexity of treatments offered.

  • Medical practitioners could undertake high levels of manipulation on cells and tissues (more akin to manufacturing) while still being excluded from TGA regulation
  • Consumers may be misled about unproven treatments by direct to consumer advertising

Following public consultation on the regulation of autologous human cell and tissue products in 2015 and 2016, the Government has decided to change the regulation of human cells and tissues for autologous use under the supervision of a medical or dental practitioner. As a result of the changes, a larger proportion of these products will become subject to regulation by the TGA, with the level of regulation being determined by the risk posed to patient safety.

Updates

20 April 2018

Guidance on the new regulatory approach has been published

Publication of Biologicals Regulatory Framework proposed changes to start on 1 July 2018: including changes to autologous human cell and tissue product regulation and biological classification

Current regulation

Most autologous human cells and tissue (HCT) products are to be approved by us prior to being supplied in Australia.

However, if certain conditions are met, autologous HCT products are not considered therapeutic goods and can be supplied without approval by the TGA. Specifically, if they are:

  • collected from a patient who is under the clinical care and treatment of a medical practitioner registered under a law of a State or an internal Territory;
  • manufactured by that medical practitioner, or by a person or persons under the professional supervision of that medical practitioner; and
  • 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.

This is achieved by the provisions outlined in Item 4(q) of the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011. Further information on the interpretation and scope of this exemption is available in Excluded Goods Order No. 1 of 2011: Guideline for Items 4(o), 4(p), 4(q) and 4(r).

Upcoming changes

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Guidance on the new regulatory approach has been published to assist in understanding the new requirements.

The proposed changes to the regulation of autologous human cell and tissue (HCT) products are to:

  1. Prohibit advertising to consumers of autologous HCT products, similar to the prohibition in Australia of the advertising of prescription medicines, but noting that services (that do not mention specific products) will still be permitted to be advertised.
  2. Exclude from regulation by the TGA only those autologous HCT products that are manufactured and used in an accredited hospital by a medical or dental practitioner, for a patient in the care of the same practitioner.
  3. Introduce regulation by the TGA, with exemptions from some requirements, for autologous HCT products that are:
    • minimally manipulated
    • for homologous use only
    • manufactured and used outside an accredited hospital by a medical or dental practitioner, and
    • for a patient in the same practitioner's care.
  4. Regulate under the Biologicals Regulatory Framework autologous human cell and tissue products that are:
    • manufactured and used outside an accredited hospital, and
    • more than minimally manipulated, or
    • for non-homologous use.

For autologous HCT products that will become regulated, the provisions to access unapproved therapeutic goods, such as through Clinical trials and the Special Access Schemes, will still be available to patients and their treating doctors.

Autologous human cell and tissue products have previously sat outside TGA's regulatory oversight because historically they have been seen as an extension of medical practice. However, there is growing global concern with direct to consumer advertising of unproven autologous stem cell interventions. There are also concerns with risks to patient safety due to the increasing complexity of treatments offered, often for very serious illnesses.

The new approach by government is designed to provide graduated regulatory oversight of these products commensurate with the safety risks to patients. The approach will bring Australia into closer alignment with international regulation such as in the United States and the European Union.

Following two cycles of public consultation on the regulation of autologous human cell and tissue products in 2015 and 2016, the Government has decided that changes to regulation should be implemented.

The new regulations are currently being drafted and will soon be submitted to Government for approval.

The timeframe for implementation is:

  • Changes to the regulation of autologous human cell and tissue products will commence on 1 July 2018
  • The advertising restriction will come into effect on 1 July 2018
  • Transition provisions have been included to allow affected providers time to align with the new regulatory requirements, such as the need to obtain a manufacturing license and/or approval of a clinical trial. The transition period will finish on 30 June 2019.