EXPLANATORY STATEMENT
Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No.1)
Subsection 36(1), 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 purpose of the Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No.1) (the Determination) is to amend the Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2013 (the Manufacturing Principles) to provide that the applicable manufacturing principles for biologicals that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1 of the Manufacturing Principles.
The Determination commenced on the day after it was registered on the Federal Register of Legislation.
BACKGROUND
Subsection 36(1) of the Act provides that the Minister may, from time to time, determine written principles to be observed in the manufacture of therapeutic goods for use in humans. Subsection 36(4) of the Act provides that manufacturing principles are legislative instruments. The Determination is such a legislative instrument.
The manufacturing principles are designed to set out the minimum requirements to be observed for the manufacture of certain types of therapeutic goods, including therapeutic goods regulated under Part 3-2A of the Act - biologicals.
It is a condition of each manufacturing licence that manufacturers of therapeutic goods comply with the manufacturing principles (see subparagraph 40(4)(a)(ii) of the Act). If the holder of a manufacturing licence breaches this (or any other) condition the Secretary can suspend or revoke the licence (see subparagraph 41(1)(a)(viii) of the Act). The Secretary can also refuse to grant a manufacturing licence if satisfied that the applicant for the licence will be unable to comply with the manufacturing principles (see paragraph 38(1)(e) of the Act).
The manufacturing principles may relate to any of the matters specified in paragraphs 36(2)(a) –(e) of the Act, including the standards to be maintained, and the equipment to be used, at manufacturing premises, procedures for quality assurance and quality control, and the manufacturing practices to be employed in producing therapeutic goods.
The effect of the Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1) (the Specification) is that a thing that comprises or contains live animal cells, tissues or organs is a ‘biological’ under the Act if the requirements in paragraph 32A(1)(b) of the Act are met. This means that such things are now to be regulated under the Act’s biologicals framework, in Part 3-2A of the Act, rather than (as was the situation before the making of the Specification) being products to which the regulatory framework for medicines in Part 3-2 of the Act would have applied.
The effect of the Specification is therefore to align the regulatory approach taken to both:
- 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 a single framework, being the biologicals framework set out in Part 3-2A of the Act.
It is considered, however, that the appropriate manufacturing principles that should apply to things containing or comprising live animal cells, tissues or organs should be those set out in Division 1 of the Manufacturing Principles, which previously applied to them as medicines, rather than those principles applicable to the manufacture of other biologicals under that Determination.
This is because the Division 1 manufacturing principles cover aspects of control for animal houses and control around animal material used in the manufacturing process. Further, Division 1 applies to biological medicines and covers the production of biological medicinal products, such as cultivation of cells or extraction of material from living organisms. They also cover setup of ancillary areas such as animal houses.
The Determination makes the necessary amendments to the Manufacturing Principles to give effect to this.
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, proposed changes were communicated to ten identified stakeholders (companies and consultants that have approached TGA on product development or clinical trials involving live animal cells and tissues) in December 2015 seeking their input on the proposal. Responses were only received from two stakeholders, with both supporting the change to the Manufacturing Principles.
The Determination is a legislative instrument for the purposes of the Legislation Act 2003.
In relation to compatibility with human rights, it is considered that the Determination 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.
SUPPLEMENTARY MATERIAL - 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 (Manufacturing Principles) Amendment Determination 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 (Manufacturing Principles) Amendment Determination 2017 (No.1) is made by the Minister under subsection 36(1) of the Therapeutic Goods Act 1989 (the Act) and amends the Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2013 (the Manufacturing Principles) to provide that the applicable manufacturing principles for therapeutic goods that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1 of the Manufacturing Principles, and not those set out in Division 2, which would otherwise apply to them, as biologicals.
This means that the manufacturing principles which previously would have applied to those things when they were regulated under the medicines framework will continue to apply to them, even though they are now regulated under the Act’s biologicals framework.
This is because the Division 1 manufacturing principles cover aspects of control for animal houses and control around animal material used in the manufacturing process. Further, Division 1 of the Manufacturing Principles apply to biological medicines and cover the production of biological medicinal products, such as cultivation of cells or extraction of material from living organisms. They also cover setup of ancillary areas such as animal houses.
The Determination makes the necessary amendments to the Manufacturing Principles to give effect to this.
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 Minister for Health