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