ATTACHMENT

 

 

Details of the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021

 

Section 1 - Name

 

This section provides that the title of the Regulations is the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021.

 

Section 2 - Commencement

 

This section provides for the Regulations to commence on the day after registration on the Federal Register of Legislation, except Division 2 in Part 2 of Schedule 1, which commences on 1 January 2022.

 

Section 3 - Authority

 

The Regulations are made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 - Schedules

 

This section gives legal effect to the amendments in the Schedules.

 

 

Schedule 1 - Amendments

Part 1 - Medical Devices

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Item [1] - In the appropriate position in Part 11

This item introduces new Division 11.14 in Part 11 of the MD Regulations, to provide a Part for application provisions relating to these regulation amendments. New regulation 11.67 provides that the amendments made by Part 1 of Schedule 1, in relation to patient information materials, apply in relation to a medical device that is imported, supplied or exported on or after the commencement of that Part.

 

Item [2] - Clause 13A.1 of Schedule 1

This item makes a minor editorial amendment to clause 13A.1 of Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations), to accommodate the amendments made to clause 13A.1 in this Schedule.

 

Item [3] - At the end of clause 13A.1 of Schedule 1

This item introduces new paragraph (c) of subclause 13A.1(1) and new subclause 13A.1(2) in clause 13A.1 of Schedule 1 to the MD Regulations.

 

New paragraph 13A.1(1)(c) provides that cluses 13A.2 and 13A.4 do not apply to medical devices to which new subclause 13A.1(2) applies.

 

New subclause 13A.1(2) applies to a medical device that is intended to be wholly, or mostly, absorbed by a patient's body within 6 months of being implanted and that is for one of the purposes listed in subparagraphs 13A.1(2)(b)(i) to (iv), being for use as a filler, for haemostasis, tissue approximation, the fixation of other medical devices within tissue. Medical devices that are similar to such devices are also covered (subparagraph 13A.1(2)(b)(v) refers).

 

The effect of this item is to exempt such medical devices from the requirement to comply with the patient implant card and patient information leaflet requirements in subclauses 13A.2 to 13A.4 of Schedule 1 to the MD Regulations. 

 

This reflects that such implantable medical devices are lower risk and more minor, and that, as such, it is appropriate that regulatory burden be alleviated for such devices.

 

Item [4] - Part 2 of Schedule 4 (table item 2.16, column headed "Kinds of medical devices", subparagraph (c)(ii))

Item 2.16 of Part 2 of Schedule 4 to the MD Regulations exempts medical devices that are surgical loan kits from the requirement to be included in the Register. Surgical loan kits are kits comprising reusable surgical instruments, certain other kinds of medical devices and, in some instances, other therapeutic goods, that medical device sponsors and manufacturers loan to hospitals for use during surgery.

 

Item 2.16 currently requires that for such kits to be exempt they must contain two or more reusable surgical instruments and the only other therapeutic goods in the kit are either one or more implantable medical devices or one or more Class I medical devices, each of which is included in the Register.

 

Recent feedback from medical device sponsors and manufacturers has indicated that, in relation to medical devices other than implantable medical devices that are included in such kits, there is a need to reflect that higher risk such devices are also included in surgical loan kits (i.e. devices with a higher classification than the current Class I).

 

This item reflects this feedback, and has the effect that surgical loan kits that contain Class I, Class IIa, Class IIb or Class III medical devices are exempt from inclusion in the Register (provided that such kits also meet the other elements of the exemption).

 

 

Part 2 - Other amendments

 

Division 1 - Amendments commencing on day after registration

 

Therapeutic Goods Regulations 1990

 

Item [5] - Paragraph 7(g)
Under subsection 42DL(12) of the Act, it is an offence for a person to advertise, by any means, therapeutic goods, or to cause the advertising by any means of therapeutic goods, if the advertisement refers to therapeutic goods that are not entered in the Register and are prescribed for the purposes of the subsection. Subsection 42DLB(9) sets out a corresponding civil penalty provision for the same conduct. Paragraph 7(g) of the TG Regulations prescribes certain kinds of medical devices for the purposes of subsections 42DL(12) and 42DLB(9), with reference to the kinds of medical devices mentioned in column 2 of an item in Part 2 of Schedule 4 to the MD Regulations. Part 2 of Schedule 4 to the MD Regulations lists kinds of devices that are exempt from inclusion in the Register, subject to specified conditions.

 

Concerns have arisen that not all of the kinds of medical devices mentioned in Part 2 of Schedule 4 to the MD Regulations have a risk profile that would indicate that they should be prescribed for the purposes of subsections 42DL(12) and 42DLB(9) of the Act.

 

This item addresses these concerns by amending paragraph 7(g) of the TG Regulations with the effect of carving out a number of kinds of medical devices mentioned in column 2 of Part 2 of Schedule 4 to the MD Regulations - these relate to custom-made medical devices manufactured in Australia, custom-made medical devices manufactured outside Australia, certain patient-matched medical devices and medical devices that are certain kinds of clinical decision support software (items 2.12 to 2.15 of Part 2 of Schedule 4 to the MD Regulations refer). This reflects the lower risk profile of such devices and has the effect that it would not be an offence or contravention of a civil penalty provision under subsections 42DL(12) and 42DLB(9) of the Act to advertise such products.

 

Item [6] - Subregulation 12B(1B) (cell at table item 45A, column 4)

This item amends item 45A, for lifitegraft, in the table in subregulation 12B(1B) of the TG Regulations, to refer to the route of administration for medicines that contain lifitegraft as the only active ingredient as 'ophthalmic' rather than 'topical', to reflect that ophthalmic is a more accurate and appropriate description of the route of administration for this medicine.

 

Items [7] and [8] - Subregulation 12B(1B) (cells at table items 46B and 72A, column 2)

These items amend table items 46B and 72A of the table in subregulation 12B(1B) of the TG Regulations, to make very minor clarificatory amendments to two ingredient names referred to in that table.

 

Item [9] - In the appropriate position in Part 9

This item introduces new Division 17 in Part 9 of the TG Regulations, to provide application provisions for amendments relating paragraph 7(g) of the TG Regulations and amendments relating to item 1B of Schedule 5A to the TG Regulations.

 

New regulation 84 provides that the amendments to paragraph 7(g) apply in relation to an advertisement that is made on or after the commencement of those amendments and the amendments to item 1B of the table in Schedule 5A to the TG Regulations applies in relation to therapeutic goods imported in Australia on or after the commencement of those amendments.  

 

Item [10] - Schedule 5A (table item 1B, column 3, paragraph (a))
This item amends item 1B of Schedule 5A to the TG Regulations, to clarify that this exemption applies in relation to the importation, and supply by or on behalf of the sponsor to the hospital or healthcare facility, of the goods mentioned in column 2 of item 1B, but not to the step of supply to the patient.

 

This is principally in order to ensure that the supply of such goods to the patient is undertaken in accordance with the important safety criteria that apply in relation to the supply of unapproved therapeutic goods to patients who are seriously ill under subparagraphs 12A(2)(a)(ii) and (iii), and paragraph 12A(2)(b), of the TG Regulations, as part of the TGA's Special Access Scheme - Category A pathway.

 

Division 2 - Amendments commencing on 1 January 2022

 

Therapeutic Goods Regulations 1990

 

Items [11] and [12] - Subregulations 6B(1) and (2)

Subregulation 6B(1) of the Therapeutic Goods Regulations 1990 (the TG Regulations) prescribes prohibited representations for the purposes of subsections 42DJ(1) of the Act. Prohibited representations are representations relating to particular diseases (such as neoplastic diseases (i.e. cancer) and HIV/AIDS) or particular types of therapeutic goods (such as analgesics). 

 

Subregulation 6B(1) currently does this by reference to the representations in column 2 of an item in Part 1 of Schedule 2 to the TG Regulations about therapeutic goods in column 3 of that item, and the representations described in section 30 of the Therapeutic Goods Advertising Code (defined in subsection 3(1) of the Act as the code in force under section 42BAA of the Act) ("the Code"). Part 1 of Schedule 2 to the TG Regulations contains further references to the Code in items 4 and 8.

 

Item 11 replaces the current subregulation 6B(1) with a new subregulation 6B(1) that would (in conjunction with the effect of items 14-16 outlined below) ensure that all prohibited representations are prescribed in the TG Regulations (specifically, in Part 1 of Schedule 2 to the TG Regulations), without reference to the Code. This will improve readability and navigation, consistent with proposed reforms to the Code, and to otherwise align with subsection 42DJ(1).

 

Item 12 makes a very minor, editorial amendment to preface subregulation 6B(2) of the TG Regulations with a subheading that relates to required representations.

 

Items [13] and [14] - Regulation 8 and note
These items amend regulation 8 of the TG Regulations, and the following note, to update references to the Code. The effect of these amendments is to update the references to the Code in regulation 8, and the following note, to reflect updated provision numbers in the new Code which is to commence on 1 January 2022.

 

Item [15] - At the end of Division 17 of Part 9

This item introduces new section 85 in Division 17 of Part 9 of the TG Regulations, to provide application provisions for amendments relating to the Code.

 

New subregulation 85(1) provides that the amendments of regulation 6B and Part 1 of Schedule 2 to the TG Regulations apply in relation to an advertisement that is made on or after the commencement of those amendments.

 

New subregulation 85(2) provides that the amendment of regulation 8 of the TG Regulations apply in relation to the dissemination of generic information on or after the commencement of those amendments.

 

Items [16] to [17] - Part 1 of Schedule 2 (table items 4 and 8)

Item 4 of Part 1 of Schedule 2 to the TG Regulations refers, for the purposes of subregulation 6B(1) of the TG Regulations, to a representation referred to in subsection 24(2) of the Code. Subsection 24(2) of the Code refers to an implication in an advertisement for an analgesic that analgesic consumption is safe or that analgesics will relax, relive tension, sedate or stimulate.

 

Item 8 of Part 1 of Schedule 2 to the TG Regulations similarly refers to a representation referred to in section 25 of the Code. Section 25 of the Code refers to claims or implications in an advertisement for vitamin or mineral supplements that such supplements are a substitute for good nutrition or a balanced diet, or are in any way superior to or more beneficial than dietary nutrients.

 

These items repeal items 4 and 8 of Part 1 of Schedule 2 to the TG Regulations, with the effect that the items on their face refer to such representations, without the need to refer to the Code. The effect of these amendments (together with the amendments made by item 11 above) is therefore to consolidate prohibited representations in the TG Regulations by including these prohibited representations in Schedule 2.

 

Item [18] - Part 1 of Schedule 2 (at the end of the table)
This item introduces new item 10 to the table in Part 1 of Schedule 2 to the TG Regulations, to also consolidate prohibited representations in the TG Regulations.

 

New item 10 complements the repeal of paragraph 6B(1)(b) of the TG Regulations by item 11 above. Paragraph 6B(1)(b) provides that the representations in section 30 of the Code are prohibited representations for the purposes of subsection 42DJ(1) of the Act.

 

New item 10 sets out in Part 1 of Schedule 2 to the TG Regulations the same prohibited representation as those in section 30 of the Code.

 

 

 

 

Statement of Compatibility with Human Rights

 

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

 

Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021

 

The Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 (the Regulations) are 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 Regulations are made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act).

 

The purpose of the Regulations is to amend the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations), principally to reduce regulatory burden for sponsors and manufacturers of medical devices.

 

The Regulations reduce burden by:

*                    allowing surgical loan kits (which device manufacturers and sponsors loan to hospitals to assist with surgery) to contain higher risk (Class IIa, Class IIb or Class III) medical devices while remaining exempt from the requirement to be included in the Australian Register of Therapeutic Goods (the Register); and

*                     (in effect) exempting certain minor implantable medical devices from the requirement to comply with the patient implant card and patient information leaflet requirements in clause 13A of Schedule 1 to the MD Regulations - these are mainly certain absorbable implantable devices that are wholly or mostly absorbed by the body within 6 months of being implanted, e.g. glue used to connect tissue internally).

 

The Regulations also make a small number of more minor amendments, principally to:

*                     clarify the operation and scope of the exemption of prescription medicines that are imported and supplied for use in hospitals and other healthcare facilities for seriously ill patients, mainly to clarify that the exemption does not apply to the supply of such medicines to the patient as this step must be in accordance with the Special Access Scheme - Category A pathway and regulation 12A of the TG Regulations; and

*                     reflect the making of a new Therapeutic Goods Advertising Code by updating references to provisions of the Code in the TG Regulations;

*                     enable the advertising of certain personalised medical devices and software that is a medical device that are exempt from inclusion in the Register; and

updating a small number of ingredient names.

 

Human rights implications

The Regulations engage the right to health in Article 12 of the International Covenant on Economic, Social and Cultural Rights (the ICESCR). Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standards of physical and mental health. 

 

In General Comment No.14: The Right to the Highest Attainable Standard of Health (Art.12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a 'fundamental human right indispensable for the exercise of other human rights', and that the right to health is not be understood as the right to be healthy, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.

 

The Regulations take positive steps to support the right to health by:

*         reducing the regulatory burden for sponsors and manufacturers of a range of kinds of medical devices, principally minor absorbable medical devices that are wholly or mostly absorbed into the body within 6 months of being implanted, to encourage the continued supply of devices in Australia and remove potential impediments to their continued supply, with benefits for Australian patients in relation to the continued availability of these products; and

*         clarifying the regulatory requirements for the supply of life-saving medicines required urgently for the use of seriously ill patients in hospitals and other healthcare facilities in Australia, and ensuring that the final step of supply of such medicines, being supply to the patient, is in accordance with the important safety criteria that apply under the TGA's Special Access Scheme Category A pathway (including in particular that the patient or the patient's guardian has given informed consent to the medicine being given to the patient and that the medicine is dispensed on the prescription of a medical practitioner who has prescribed the medicine in accordance with good medical practice).

 

Conclusion

The Regulations are compatible with human rights because they maintain and support the right to health in Article 12 of the ICESCR as outlined above, and do not raise any other human rights issues.

 

Greg Hunt, Minister for Health and Aged Care