Regulation of autologous cell and tissue products

Including so called ‘autologous stem cell’ therapies

24 October 2017

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.

As a result of the changes, some of these products will be subject to regulation as biologicals by the TGA, with the level of regulation being determined by the risk posed to patient safety.

Autologous human cell and tissue products are those that are removed from and applied to the same person, so the donor and the recipient are the same. These include some products referred to commonly as ’stem cell treatments’. The products may be subject to a range of levels of chemical, physical and biological processing steps prior to being transplanted back into the patient. Sometimes the processing is minimal, but in other cases it is significant.

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.

Over the coming months, new regulations will be drafted by the Office of Parliamentary Counsel and submitted to Government for approval.

The proposed changes to the regulation of autologous cell and tissue products are to:

  1. Not permit direct advertising to consumers of autologous cell and tissue products, similar to the prohibition in Australia in 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 cell and tissue products that are manufactured and used in a 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 cell and tissue products that are:
    • minimally manipulated, and
    • for homologous use only, and
    • manufactured and used outside a hospital by a medical or dental practitioner,
    • for a patient in the same practitioner’s care.
  4. Regulate under the Biologicals Regulatory Framework those 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.

    Products would fall into the relevant class, based on risk. Inclusion in the Australian Register for Therapeutic Goods and Compliance with TGA standards is required, including manufacturing standards. Adverse event reporting to TGA is required and advertising of the products to the public would not be permitted.

It is anticipated that changes to the regulation of autologous cell and tissue products will commence in early 2018, and a transition period will allow affected providers time to align with the new regulatory requirements.

Detailed guidance on the new regulatory approach is currently being drafted. This will assist in the interpretation and enforcement of the new requirements. The TGA will consult with stakeholders on the development of these documents in the coming months.

For those autologous human cell and tissue products that will become regulated, the current provisions to access unapproved therapeutic goods (such as through Clinical Trials and the Special Access Schemes) will remain available to patients and their treating doctors.