Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00511 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1)

 

Subsection 32A(2), Therapeutic Goods Act 1989

 

The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in or exported from Australia.  The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, administers the Act.

 

The purpose of the Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1) (the Specification) is to provide that a thing that comprises or contains live animal cells, tissues or organs is a ‘biological’ for the purposes of the Act.

 

This means, principally, that products meeting this description that also satisfy paragraph 32A(1)(b) of the Act, will now be regulated under the Part of the Act for biologicals (Part 3-2A of the Act), rather than under the Part of the Act for medicines (Part 3-2 of the Act).

 

The Specification commenced on the day after it was registered on the Federal Register of Legislation.

 

BACKGROUND

 

The clinical risks of live animal cell, tissue or organ transplantation are generally similar to those of human-to-human transplantation of organs or tissues, and relate primarily to the possible failure of the transplanted tissue and/or the transmission of infectious disease.  However, in relation to the latter, live animal cell, tissue or organ transplantation may pose an additional risk of transmission of a new or serious infectious disease from animals to transplant recipients.

 

Reflective of these concerns, in December 2004, the National Health and Medical Research Council (NHMRC) recommended that there be no clinical trials for animal to human transplantation (live animal cell, tissue or organ,  and human body fluids, cells, tissues or organs that have had contact with live animal cells or tissues outside the patient’s body) in Australia for five years.

 

On 9 December 2009, the Council of the NHMRC recommended that research into such products could proceed in Australia, subject to certain conditions, including that the TGA had in place a robust framework to regulate clinical trials involving the products.

 

A framework for the regulation of therapeutic goods based on human cells or tissues commenced on 31 May 2011. This new biological framework, set out in Part 3-2A of the Act, does not include materials of animal origin and hence these types of biological products remain regulated as medicines under Part 3-2 of the Act. Notably, at that time, there was an absence of live animal cell, tissue or organ products either under development or undergoing clinical trial in Australia.

 

No applications for marketing approval of any live animal cell, tissue or organ products have been made to the TGA to date.  However, it is now prudent to ensure that there is an appropriate regulatory framework in place for these products, particularly in anticipation of clinical trials involving such products, and in light of emerging technologies. This is consistent with the NHMRC’s recommendation outlined above.

 

The Specification would bring products that comprise or contain live animal cells, tissues or organs within the regulatory framework for biologicals in the Act that came into effect in 2011 (Part 3-2A of the Act).

 

Examples of the products that would be covered by the Specification include live animal cells that are transplanted or implanted into a human patient to compensate for the deficient functioning of the patient’s own cells, and whole animal organ transplants in which whole organs (e.g. heart, kidney) or tissues (e.g. skin) are used to replace a patient’s diseased organs or tissues.  The Specification does not cover such things as pig heart valves which are non-living animal products.

 

The Specification will create a regulatory approach that is consistent for both of the following types of goods under the Act:

  • live animal cells, tissues or organs; and  
  • human body fluids, cells, tissues or organs that have had contact with live animal cells or tissues outside the patient’s body.

Under section 32A of the Act, a biological is a thing that:

  • comprises, contains or is derived from human cells or human tissues, or is specified under subsection 32A(2) of the Act; and
  • meets the requirements in paragraph 32A(1)(b) of the Act – for example, is:
    • represented in any way to be for use in the treatment or prevention of a disease, ailment, defect or injury affecting persons
    • likely to be taken to be for use in the treatment or prevention of a disease, ailment, defect or injury affecting persons because of the way in which it is presented or for any other reason
    • represented in any way to be for use in influencing, inhibiting or modifying a physiological process in humans
    • likely to be taken to be for use in influencing, inhibiting or modifying a physiological process in humans because of the way in which it is presented or for any other reason
    • represented in any way to be for use in the replacement or modification of parts of the anatomy in persons
    • likely to be taken to be for use in the replacement or modification of parts of the anatomy in persons because of the way in which it is presented or for any other reason.

 

Subsection 32A(2) of the Act authorises the Secretary to make a legislative instrument specifying things for the purposes of subparagraph 32A(1)(a)(ii) of the Act, and the Specification is such an instrument.

 

CONSULTATION

 

At this stage, there is no established industry in Australia for the manufacture and supply of cells and tissues of animal origin with which to consult.  However, identified stakeholders (companies and consultants that have approached TGA on product development or clinical trials involving live animal cells and tissues) broadly endorsed the proposed changes.

 

A stakeholder raised concern that data protection provided for the sponsor of a medicine under section 25A of the Act do not apply to biologicals. Data protection was not considered relevant at the time the Biologicals Framework was developed (from 2004 to 2010). In addition, it has not been demonstrated that the concept of data protection is applicable to biologicals (and more specifically to xenotransplant products). The option remains open to government to add this type of data protection into the biologicals framework at a later stage if it becomes apparent that it is needed.

 

The Specification is a legislative instrument for the purposes of the Legislation Act 2003.

 

In relation to compatibility with human rights, it is considered that the Specification is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is below.


STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1)

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1) (the Specification) is made by the Secretary under subsection 32A(2) of the Therapeutic Goods Act 1989 and provides that a thing that comprises or contains live animal cells, tissues or organs is specified for the purposes of subparagraph 32A(1)(a) (ii) of that Act.

 

This means that, if the requirements in paragraph 32A(1)(b) are satisfied, ‘a thing that comprises or contains live animal cells, tissues or organs’ will now be regulated under the Act’s biologicals framework in Part 3-2A of the Act.

 

The effect is that a common regulatory approach will be taken to all cells and tissues, regardless of whether they are from humans or animals.

 

Human rights implications

This legislative instrument does not engage any of the applicable rights or freedoms.

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

 

LARRY KELLY

Delegate of the Secretary of the Department of Health

 

 

 

Overview

The Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1) was enacted to address the regulatory gap in the Therapeutic Goods Act 1989 concerning the regulation of products comprising or containing live animal cells, tissues, or organs. This specification was introduced by the Secretary under subsection 32A(2) of the Therapeutic Goods Act 1989, aiming to align the regulation of these biological products with the biologicals framework established in 2011. The primary policy objective is to ensure that such products, which include transplants of live animal cells, tissues, or organs into human patients, are appropriately regulated to manage the clinical risks associated with their use, such as the potential transmission of infectious diseases. This legislative measure ensures a consistent regulatory approach for both human and animal-derived biological products, facilitating the oversight of emerging technologies and anticipated clinical trials involving these products. The Specification commenced on the day after its registration on the Federal Register of Legislation.

Scope and Application

The Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1) pertains to the regulation of therapeutic goods in Australia under the Therapeutic Goods Act 1989. This legislation specifies that products comprising or containing live animal cells, tissues, or organs are categorised as 'biologicals' and thus fall under the biologicals framework of the Act, rather than the medicines framework. This specification applies to entities and individuals involved in the development, manufacture, and supply of such products, ensuring they comply with the regulatory requirements for biologicals, which focus on quality, safety, efficacy, and timely availability. The legislation applies nationally across Australia, administered by the Therapeutic Goods Administration, which is part of the Department of Health. Notably, the Specification does not apply to non-living animal products such as pig heart valves. The Specification was introduced in anticipation of potential clinical trials and technological advancements in the field of live animal cell, tissue, and organ transplantation, aiming to provide a consistent regulatory approach for both human and animal-derived cells and tissues. The Specification came into effect on the day after its registration on the Federal Register of Legislation, and it does not raise any human rights issues, as outlined in the Statement of Compatibility with Human Rights.

Key Provisions

The Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1) specifies that items containing live animal cells, tissues, or organs are considered biologicals under the Therapeutic Goods Act 1989 (sections 32A(2)). This means that products meeting these criteria, which also satisfy the requirements in paragraph 32A(1)(b) of the Act, will now be regulated under the biologicals framework (Part 3-2A of the Act), rather than under the medicines framework (Part 3-2 of the Act). This shift in regulation applies to products such as live animal cells used for transplantation into humans to compensate for deficient cell function, as well as whole organ and tissue transplants, like heart or skin transplants. The Act imposes several obligations on parties involved with these biologicals. These obligations include ensuring that the biologicals meet the specified criteria and comply with the requirements outlined in paragraph 32A(1)(b) of the Act. Additionally, entities must adhere to the regulatory standards and guidelines set forth in the biologicals framework to ensure the safety, quality, and efficacy of the biologicals. Compliance with these obligations is crucial to maintain the integrity of the therapeutic goods market and to protect public health. Breaching the provisions of the Therapeutic Goods Act 1989 can lead to significant legal consequences. Offences under the Act can result in both civil and criminal penalties. For instance, manufacturing, supplying, or advertising therapeutic goods that do not comply with the Act can attract fines and imprisonment. Specifically, under section 33DA of the Act, individuals can be fined up to $220,000, while corporations can face fines up to $1,100,000. These penalties underscore the importance of strict adherence to the regulatory requirements to avoid severe repercussions. Ensuring compliance not only protects public health but also safeguards the integrity of the therapeutic goods industry in Australia.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.