EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2)
The Therapeutic Goods Act 1989 (“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.
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. Manufacturing principles are legislative instruments under subsection 36(4) of the Act.
Manufacturing principles provide minimum requirements to be observed in carrying out any steps in the manufacture of therapeutic goods. 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 manufacturing therapeutic goods.
The Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2) (“Amendment Determination”) amends the Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2013 (“Manufacturing Principles Determination”).
The Amendment Determination is consequential on account of the repeal of the Therapeutic Goods Order No. 75 – Standard for Haematopoietic Progenitor Cells derived from Cord Blood (“the former standard”) and the making of the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017 (“the new standard”). The effect of the Amendment Determination is to address the repeal of the former standard and the making of the new standard by:
- substituting the definition for the term “haematopoietic progenitor cells” in section 4 of the Manufacturing Principles Determination with a new definition, which reproduces the definition of the same term in the new standard; and
- substituting a paragraph in the definition for the term “Technical Master File” in section 4 of the Manufacturing Principles Determination with a new paragraph, which replaces the reference to the former standard with a reference to the new standard in relation to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.
The purpose of the Amendment Determination is to ensure that the Manufacturing Principles Determination adequately reflects the new standard.
Background
It is a statutory condition under subparagraph 40(4)(a)(ii) of the Act that each holder of a manufacturing licence observes the manufacturing principles in carrying out any steps in the manufacture of goods under the licence. Manufacturing principles are defined in section 3 of the Act to mean the principles for the time being, having effect under section 36.
The Manufacturing Principles Determination is made under section 36(1) and incorporates definitions for the terms “haematopoietic progenitor cells” and “Technical Master File”. These definitions require amendment as a result of the repeal of the former standard and the making of the new standard, as outlined above. By way of background, the new standard specifies the requirements in the document titled NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Sixth Edition, published by NetCord and the Foundation for the Accreditation of Cellular Therapy in July 2016 (“NetCord-FACT International Standards”) as minimum requirements for the manufacture of therapeutic goods that are haematopoietic progenitor cells derived from cord blood.
Consultation
The Office of Best Practice Regulation advised that a regulation impact statement was not required in relation to the making of this Amendment Determination, as the amendments do not have more than minor regulatory impacts on business, community organisations or individuals (OBPR ID 22634).
However, the Therapeutic Goods Administration (“TGA”) conducted public consultation in May 2017 prior to the making of this Amendment Determination on the proposed options for developing a new standard for therapeutic goods that are haematopoietic progenitor cells derived from cord blood. As part of that process, the consultation included discussion regarding the consequential amendments required to the Manufacturing Principles Determination that would be required if a new standard was made.
Written submissions were received from numerous interested parties, including both public and private cord blood banks, specialist colleges and societies. These submissions all favoured the latter option to repeal and replace the former standard, noting that this option would also involve consequential amendments to the Manufacturing Principles Determination.
Details of the Order are set out in Attachment A.
The Order is compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
The Amendment Determination is a disallowable legislative instrument and commences on 30 September 2017 to correspond with the making of the new standard.
Attachment A
Details of the Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2)
Section 1 – Name
This section provides that the name of the determination is the Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2) (“Amendment Determination”).
Section 2 – Commencement
This section provides that the Amendment Determination commences on 30 September 2017.
Section 3 – Authority
This section provides that the legislative authority for making the Amendment Determination is subsection 36(1) of the Therapeutic Goods Act 1989 (“Act”).
Section 4 – Schedule
This section provides that the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 is amended as set out in Schedule 1.
Schedule 1 – Amendments
Item 1 substitutes the definition for the term “haematopoietic progenitor cells” in section 4 of the Manufacturing Principles Determination. The new definition reproduces the definition for the same term in the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017 (“the new standard”).
Item 2 substitutes a new paragraph (b)(ii) in the definition for the term “Technical Master File” in section 4 of the Manufacturing Principles Determination. The new paragraph replaces the reference to the Therapeutic Goods Order No. 75 – Standard for Haematopoietic Progenitor Cells derived from Cord Blood with a reference to the new standard in relation to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.
Attachment B
Statement of compatibility with human rights
This statement is prepared in accordance with subsection 9(1) of the Human Rights (Parliamentary Scrutiny) Act 2011.
Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2)
The Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2) 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 legislative instrument
This instrument is made under subsection 36(1) of the Therapeutic Goods Act 1989 (“Act”) by a delegate of the Minister for Health. This instrument amends the Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2013 (“Manufacturing Principles Determination”).
The instrument is consequential on account of the repeal of the Therapeutic Goods Order No. 75 – Standard for Haematopoietic Progenitor Cells derived from Cord Blood (“the former standard”) and the making of the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017 (“the new standard”). The effect of the instrument is to address the repeal of the former standard and the making of the new standard by:
- substituting the definition for the term “haematopoietic progenitor cells” in section 4 of the Manufacturing Principles Determination with a new definition, which reproduces the definition of the same term in the new standard; and
- substituting a paragraph in the definition for the term “Technical Master File” in section 4 of the Manufacturing Principles Determination with a new paragraph, which replaces the reference to the former standard with a reference to the new standard in relation to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.
This instrument is intended to ensure that the Manufacturing Principles Determination adequately reflects the new standard.
Human rights implications
This instrument does not engage any of the applicable rights or freedoms.
Conclusion
This instrument is compatible with human rights as it does not raise any human rights issues.
Larry Kelly, delegate of the Minister for Health