EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Amendment (Excluded Goods) Determination 2019
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 Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Department of Health.
Section 7AA of the Act provides that the Minister may, by legislative instrument, determine that specified goods (other than goods declared to be therapeutic goods under an order in force under section 7 of the Act) are excluded goods for the purposes of the Act, or are excluded goods for the purposes of the Act when used, advertised or presented for supply in a specified manner.
The Therapeutic Goods (Excluded Goods) Determination 2018 (“the Principal Determination”) is made under section 7AA, and sets out a range of products that are excluded goods. The Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 (“the Former Determination”) is also made under section 7AA of the Act, and identifies specific goods for use in humans that are excluded goods.
The Therapeutic Goods Amendment (Excluded Goods) Determination 2019 (“the Amendment Determination”) is made under section 7AA of the Act. The purpose of the Amendment Determination is to amend the Principal Determination to include the products specified as excluded goods by the Former Determination. It also makes a small number of minor amendments, principally to the circumstances in which human cells and tissues that are excluded by the Former Determination may be manufactured in order to qualify for the exclusion.
The Amendment Determination also repeals the Former Determination, meaning that the Principal Determination will provide a single snapshot of all the products that are excluded goods for the purposes of the Act.
Background
Section 7AA of the Act confers a power on the Minister for Health to determine specified goods to be excluded goods for the purposes of the Act. The effect of this provision is to exclude specified goods from the operation of the Act.
Specifically, subsection 7AA(1) provides that the Minister may determine that specified goods are excluded goods for the purposes of the Act. Further, subsection 7AA(2) provides that the Minister may determine that specified goods are excluded goods for the purposes of the Act when used, advertised or presented for supply in a specified way.
A determination made under subsections 7AA(1) or 7AA(2) must be made by legislative instrument; and, in accordance with subsection 13(3) of the Legislation Act 2003, may be made with reference to a class or classes of goods.
Before making a determination under section 7AA, the Minister is required to have regard to certain matters specified in subsection 7AA(3). In addition, the Minister may have regard to any other matter that the Minister considers relevant (subsection 7AA(4) refers).
The matters that the Minister must have regard to before making a determination are:
(a) whether it is likely that the specified goods might harm the health of members of the public if not regulated under the Act;
(b) whether it is appropriate in all the circumstances to apply the national system of controls established by the Act (as mentioned above) to regulate the specified goods; and
(c) whether the kinds of risks that members of the public might be exposed to from the specified goods could be more appropriately dealt with under another regulatory scheme.
The Principal Determination was made in 2018, as part of implementing recommendations 14, 23 and 48 of the Expert Panel Review of Medicines and Medical Devices Regulation (“the Review”), in relation to the regulation of low risk products under the Act.
Relevantly, the Australian Government’s response to these recommendations required the TGA to examine whether the regulatory oversight applied to a range of lower risk products, which represent a negligible safety risk to consumers, was consistent with the principles of best practice regulation. The response to these recommendations also required the TGA to identify opportunities for streamlining or simplifying regulatory requirements in relation to those products.
The Principal Determination reflects the outcome of that process, by identifying a number of lower risk products for which regulation under the Act is not appropriate or commensurate with the risk those products may pose to consumers, for example, ear candles, mattress overlays and mattress protectors.
Separately, the Former Determination was also made in 2018, as part of measures to introduce an appropriate level of regulatory oversight for autologous human cell and tissue (“HCT”) products, commensurate with the safety risk to patients.
The principal purpose of the Former Determination was to exclude from the scope of the regulatory scheme HCT products, which are collected from a patient under the clinical care of a registered medical or dental practitioner in a hospital and manufactured by that practitioner in the hospital for use in the same patient from whom they were collected, provided those products are not advertised directly to consumers.
The Former Determination also excluded fresh viable human organs or parts of organs for direct donor-to-host transplantation, fresh viable human haematopoietic progenitor cells for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution, and reproductive tissue for use in assisted reproductive therapy.
The Amendment Determination amends the Principal Determination to include the goods covered by the Former Determination, providing a single instrument under section 7AA for determining specified goods to be excluded goods for the purposes of the Act. The Amendment Determination repeals the Former Determination, as a consequential measure.
The Amendment Determination also makes a small number of minor amendments, principally to reflect that in some instances, HCT products, which are collected from donors in hospitals by registered medical or dental practitioners and manufactured by that practitioner in the hospital for use in the same patient from whom those products were collected, may be stored or tested at other premises by a person under contract with the hospital. This is consistent with current practice whereby a hospital may need to contract out storage or testing to a third party if it is not able to store such products on its own premises, or if specialised testing is not performed by the hospital’s in-house pathology provider.
Consultation
The amendment to allow storage or testing of excluded autologous HCT products to be undertaken by a person under contract with a hospital, where these steps are not carried out in the hospital itself, was introduced in response to issues raised by stakeholders in relation to the Former Determination, since its commencement in July 2018. In particular, issues were raised by medical practitioners and representatives of hospitals (including large tertiary teaching hospitals) involved in the use of these products. Informal feedback from these stakeholders supported the clarifications that are set out in the Amendment Determination.
The Office of Best Practice Regulation (OBPR) advised that a regulation impact statement was not required in relation to the Former Determination, and would not be required unless the measures reflected in that instrument changed significantly (OBPR reference: 19128).
Details of the Amendment Determination are set out in Attachment A.
The Amendment Determination 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 for the purposes of the Legislation Act 2003 and commences on the day after it is registered on the Federal Register of Legislation.
Attachment A
Details of the Therapeutic Goods Amendment (Excluded Goods) Determination 2019
Section 1 – Name
This section provides that the name of the instrument is the Therapeutic Goods Amendment (Excluded Goods) Determination 2019 (“the Amendment Determination”).
Section 2 – Commencement
This section provides that the Amendment Determination commences on the day after it is registered on the Federal Register of Legislation.
Section 3 – Authority
This section provides that the legislative authority for making the Amendment Determination is section 7AA of the Therapeutic Goods Act 1989 (“the Act”).
Subsection 33(3) of the Acts Interpretation Act 1901 relevantly provides that, where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character, the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument. This instrument is made in accordance with that provision.
Section 4 – Schedules
This section provides that each instrument that is specified in a Schedule to the Amendment Determination is amended or repealed as set out in the applicable items in the Schedule concerned, and that any other item in a Schedule to the instrument has effect according to its terms.
Schedule 1Amendments
This Schedule amends the Therapeutic Goods (Excluded Goods) Determination 2018 (“the Principal Determination”).
Item 1 of Schedule 1 clarifies that the reference to “Act” in section 3 of the Principal Determination is a reference to the Therapeutic Goods Act 1989.
Item 2 of Schedule 1 amends section 4 of the Principal Determination to insert two new definitions, to make it clear that ‘haematopoietic progenitor cells’ has the meaning given by clause 1 of Part 1 of Schedule 9 to the Regulations, and that ‘Regulations’ means the Therapeutic Goods Regulations 1990.
Item 3 of Schedule 1 inserts a new item 4A into the table in Schedule 2 to the Principal Determination, with the effect that goods in relation to which all of paragraphs (a) to (d) of that item apply are excluded goods for the purposes of the Act.
Principally, these are goods that comprise, contain or are derived from human cells or human tissues that are collected from a patient under the clinical care of a registered medical or dental practitioner and manufactured in a hospital in a State or internal Territory of Australia. These products were excluded under paragraph 4(a) of the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 (“the Former Determination”).
However, item 3 of Schedule 1 also provides an exception to the requirement that the goods are manufactured in the relevant hospital, in that the goods will still be excluded goods if a step in their manufacture relating to storage or testing is not carried out in the relevant hospital, but is carried out elsewhere by a person under a contract with the hospital.
Item 3 of Schedule 1 also inserts a new item 4B into the table in Schedule 2 to the Principal Determination, with the effect of making it clear that goods that are fresh, viable human haematopoietic progenitor cells are excluded goods, when they are used for direct donor-to-host transplantation for the purposes of haematopoietic reconstitution. These products were specified as excluded goods under paragraph 4(c) of the Former Determination.
Item 3 of Schedule 1 also inserts a new item 4C into the table in Schedule 2 to the Principal Determination, with the effect of making it clear that goods that are fresh viable human organs or parts of human organs are excluded goods when used for direct donor-to-host transplantation. These products were specified as excluded goods under paragraph 4(b) of the Former Determination.
Item 3 of Schedule 1 also inserts a new item 4D into the table in Schedule 2 to the Principal Determination, with the effect of making it clear that goods that are human reproductive tissue are excluded goods, when used in assisted reproductive therapy. These products were specified as excluded goods under paragraph 4(d) of the Former Determination.
Item 4 of Schedule 1 amends the Principal Determination to remove the note at the end of the Schedule 2, as this note is no longer necessary.
Schedule 2 – Repeals
This Schedule repeals the Former Determination.
Attachment B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Therapeutic Goods Amendment (Excluded Goods) Determination 2019
This disallowable 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 legislative instrument
The Therapeutic Goods Amendment (Excluded Goods) Determination 2019 (“the instrument”) is made under section 7AA of the Therapeutic Goods Act 1989 (“the Act”). The purpose of the instrument is to make a small number of amendments to the Therapeutic Goods (Excluded Goods) Determination 2018 (“the principal instrument”), and to repeal the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 (“the former instrument”).
The principal instrument was made in 2018, as part of implementing recommendations 14, 23 and 48 of the Expert Panel Review of Medicines and Medical Devices Regulation (the Review), in relation to the regulation of low risk products under the Act.
Relevantly, the Australian Government’s response to these recommendations required the TGA to examine whether the regulatory oversight applied to a range of lower risk products, which represent a negligible safety risk to consumers, was consistent with the principles of best practice regulation. The response to these recommendations also required the TGA to identify opportunities for streamlining or simplifying regulatory requirements in relation to those products.
The principal instrument reflects the outcome of that process, by identifying a number of lower risk products for which regulation under the Act is not appropriate or commensurate with the risk those products may pose to consumers, for example, ear candles, mattress overlays and mattress protectors.
Separately, the former instrument was also made in 2018, as part of measures to introduce an appropriate level of regulatory oversight for autologous human cell and tissue (“HCT”) products, commensurate with the safety risk to patients.
The principal purpose of the former instrument was to exclude from the scope of the regulatory scheme HCT products, which are collected from a patient under the clinical care of a registered medical or dental practitioner in a hospital and manufactured by that practitioner in the hospital for use in the same patient from whom they were collected, provided those products are not advertised directly to consumers.
The former instrument also excluded fresh viable human organs or parts of organs for direct donor-to-host transplantation, fresh viable human haematopoietic progenitor cells for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution and reproductive tissue for use in assisted reproductive therapy.
The instrument amends the principal instrument to include the goods covered by the former instrument, providing a single instrument under section 7AA for determining specified goods to be excluded goods for the purposes of the Act. The instrument repeals the former instrument as a consequential measure.
The instrument incorporates a small number of amendments, principally to reflect that in some instances, HCT products, which are collected from donors in hospitals by registered medical or dental practitioners and manufactured by that practitioner in the hospital for use in the same patient from whom those products were collected, may be stored or tested at other premises by a person under contract with the hospital. This is consistent with current practice whereby a hospital may need to contract out storage or testing to a third party if it is not able to store such products on its own premises, or if specialised testing is not performed by the hospital’s in-house pathology provider.
Human rights implications
As the instrument does not introduce any changes to the principal instrument other than to implement the measures outlined above, it would not appear to engage any of the applicable rights or freedoms.
Conclusion
The instrument is compatible with human rights because it does not raise any human rights issues.
Jane Cook, delegate of the Minister for Health