ATTACHMENT

 

Details of the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018

 

Section 1 - Name

This section provides for the Regulations to be referred to as the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018.

 

Section 2 - Commencement

This section provides for the commencement of the Regulations on the day after registration, except for Part 8 of Schedule 1 to the Regulations (which sets out minor amendments to the Therapeutic Goods Regulations 1990 (the TG Regulations)) which commences contemporaneously with the commencement of the Therapeutic Goods Advertising Code 2018 on 1 January 2019.

 

Section 3 - Authority

This section provides that the Regulations are made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 - Schedules

This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Regulations has effect according to its terms.

 

 

Schedule 1 - Amendments

 

Part 1 - Fees for Class I medical devices for export only   

 

Division 1 - Main amendments

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Item 1- Part 1 of Schedule 5 (table item 1.5)

This item repeals and substitute item 1.5 of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations), with the effect of introducing a lower application fee for a Class I medical device that is intended by its manufacturer to be for export only, from the current fee of $530 to a new fee of $90. Medical devices that are intended by the device manufacturer to be for export only are classified as Class I medical devices under clause 5.8 of Schedule 2 to the MD Regulations

 

The current application fee of $530 for applications to include Class I medical devices (not intended to be supplied in sterile state and not having a measuring function) in the Australian Register of Therapeutic Goods (the Register) was introduced under the recent Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2018, and commenced on 1 July 2018 (before then, the only Class I medical devices for which there was an application fee were those supplied in a sterile state or which have a measuring function). 

 

Since then, however, an opportunity to reduce this fee for export only devices has arisen, particularly as the processing of such applications only requires verification that applicants use the correct application form, and pay the required application fee, resulting in a reduced effort than required to process applications for devices other than export only devices.

 

The reduced fee of $90 - as compared with the current fee of $530 - reflects savings that will be achieved mainly through lower staffing costs associated with processing export only applications.  The fee of $90 also incorporates amortisation costs associated with modification of the e-BS software in respect of export only entries.

 

This item also amends paragraphs (e) and (g) of item 1.5 of Schedule 5, to make it clear that these paragraphs do not apply to export only medical devices.

 

Division 2 - Application of amendments made by Division 1

 

Item 2 - In the appropriate position in Part 11

This item introduces a new Division 11.9 to the MD Regulations, containing new regulation 11.37. The new provision is an application provision, which has the effect that the amendments to item 1.5 of Schedule 5 to the TG Regulations apply retrospectively from 1 July 2018. This is in order to ensure that medical device sponsors who applied to include export only devices in the Register between 1 July 2018 and the commencement of the amendments to item 1.5, and who paid the current application fee of $530 in relation to those applications, will not be disadvantaged in comparison to sponsors who apply after that time to include export only devices in the Register.

 

New regulation 11.37 also introduces a refund mechanism for such sponsors, which requires the Secretary to refund them the difference (i.e. $440) between the fee paid (i.e. $530) and the new reduced fee (i.e. $90), for that period.

 

Part 2 - Disinfectants   

 

Division 1 - Main Amendments

 

Therapeutic Goods Regulations 1990

 

Item 3 - Part 1 of Schedule 3 (table item 3, column headed "Therapeutic goods")

This item makes a minor amendment to item 3 of Part 1 of Schedule 3 to the TG Regulations, to reflect the effect of item 4 below, in relation to the repeal of Part of Schedule 3 to the TG Regulations.

 

Item 4 - Part 2 of Schedule 3

This item repeals Part 2 of Schedule 3 to the TG Regulations. Schedule 3 identifies therapeutic goods that are required to be included in the Parts of the Register for goods known as registered goods and goods known as provisionally registered goods, for the purposes of regulation 10 of the TG Regulations and paragraph 9A(4)(a) of the Act. Part 2 of Schedule 3 only contains one item, item 6, which refers to hospital grade or household grade disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides.

 

As part of the reduction of regulatory burden for hard surface disinfectants, these products are now to be required to be included in the Part of the Register for listed goods, rather than the Part of the Register for registered goods (item 6 below refers) and, accordingly, this item repeals both item 6 and Part 2 from Schedule 3.

 

Items 5, 8, 9, 10, 11, 12, 13, 14 and 15 - Schedule 4 (table item 2, paragraph (aa)) and Schedule 9 (table item 2, paragraphs (b) and (h), table item 2A, paragraphs (d) and (e) and table item 5B)

These items make minor, consequential amendments to paragraph (aa) of table item 2 of Schedule 4 to the TG Regulations, paragraphs (b) and (h) of table item 2, paragraphs (d) and (e) of table item 2A, and table item 5B, of Schedule 9 to the TG Regulations, principally to repeal references to Part 2 of Schedule 3 to the TG Regulations (repealed by item 4 above) or to the kinds of hard surface disinfectants mentioned in that Part.

 

Item 6 - Schedule 4 (table item 16)

This item repeals and substitutes the current item 16 of Schedule 4 to the TG Regulations, with the effect that hospital grade or household grade disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides will be required to be included in the part of the Register for listed goods.

 

Taken together with item 4 above, this has the effect that rather than (as currently) these goods being required to be included in the Part of the Register for registered goods, they will be listable - reducing the regulatory burden on sponsors of these products.

 

Item 7 - Schedule 5 (table item 8, column 2, paragraph (f))

This item repeals and substitutes sub-item 8(f) of Schedule 5 to the TG Regulations, removing the reference to disinfectants included in item 6 of Part 2 of Schedule 3 to the TG Regulations.  Sub-item 8(f) of Schedule 5 currently provides that disinfectants other than those mentioned in item 6 of Part 2, or item 16 of Schedule 4, to the TG Regulations are exempt from the requirement to be entered in the Register.

 

The effect of this amendment is that those hard surface disinfectants that are currently required to be included in the Part of the Register for listed goods under the current item 16 of Schedule 4 (noting the effect of item 6 above) will be exempt from the requirement to be entered in the Register.

 

In other words, the combined effect of items 4, 6 and 7 is that those hard surface disinfectants that are currently registrable would instead be listable, and those that are currently listable will be exempt, to implement an overall reduction in regulatory burden for these disinfectants. All hard surface disinfectants will still be required to comply with the applicable standard for such products, Therapeutic Goods Order 54 - Standard for Disinfectants and Sterilants.

 

Division 2 - Application of amendments made by Division 1

 

Therapeutic Goods Regulations 1990

 

Item 16 - In the appropriate position in Part 9

This item introduces new Division 10 to Part 9 of the TG Regulations, containing a new regulation 67. The new provision is an application provision, which has the effect that the amendments to Schedules 3, 4 and 5 to the TG Regulations set out in Division 1 of this Schedule (i.e. those outlined above) apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.

 

Part 3 - Human Cells and Tissues

 

Therapeutic Goods Regulations 1990

 

Item 17 - Regulation 16AB

This item makes a minor amendment to regulation 16AB of the TG Regulations to correct an inadvertent error in that provision introduced by the recent Therapeutic Goods Legislation Amendment (2018 Measures No.2) Regulations 2018. The correction replaces the reference in regulation 16AB to item 14 of Schedule 5A to the TG Regulations, with the correct reference to item 13 of that Schedule.

 

Item 18 - Regulation 64 (paragraph (c) of the definition of transitional goods)

This item makes a minor amendment to regulation 64 of the TG Regulations, to correct the same inadvertent error as that mentioned above in item 17, by replacing the reference in paragraph (c) of the definition of 'transitional goods' in regulation 64 to item 14 of Schedule 5A to the TG Regulations, with the correct reference to item 13 of that Schedule.

 

Part 4 - Instalments of fees for biologicals

 

Therapeutic Goods Regulations 1990

 

Items 19, 20 and 21 - Subparagraph 45AA(4)(c)(ii) and (iii)

Regulation 45AA of the TG Regulations allows for the Secretary to approve the payment of certain fees set out in Schedules 9 and 9A to the TG Regulations (including a number of fees for the evaluation of biologicals for suitability for inclusion in the Register) by instalments, in certain circumstances.

 

These items make minor amendments to subparagraphs 45AA(4)(c)(ii) and (iii) of the TG Regulations, to clarify that paragraph 45AA(4)(c), which sets out when the remaining 25 per cent of such a fee is payable, applies to biologicals and the biologicals fees covered by regulations 45AA.

 

Part 5 - Sunscreen preparations with certain indications

 

Therapeutic Goods Regulations 1990

 

Division 1 - Main amendments

 

Item 22 - Schedule 4, table item 7

Item 7 of Schedule 4 to the TG Regulations has the effect that certain sunscreen preparations for dermal application that only contain ingredients permitted under the permitted ingredients legislative instrument made by the Minister under section 26BB of the Act and that comply with Australian Standard AS/NZS 2604:2012 (the Sunscreen Standard) including in relation to testing of the claimed sun protection factor, are required to be included in the Part of the Register for listed goods.

This item amends item 7 to also require that in order for such sunscreen preparations to be eligible for listing, they must also comply with the permitted indications legislative instrument made by the Minister under section 26BF of the Act.

 

The principal effect of this amendment is to preclude such sunscreen preparations from utilising the new efficacy pathway for marketing approval for listed medicines for which the sponsor has evidence of claims relating to the efficacy of their product - under section 26AE of the Act.

 

This is designed to provide consumers with one consistent message about the efficacy of the sun protection factor of all sunscreen preparations; that efficacy is appropriately referenced by compliance with the Sunscreen Standard. Allowing some sunscreens to access the new assessed listed medicines pathway might be misinterpreted by consumers as implying that other sunscreens with the same sun protection factor that are listed in the Register but not under the new listed efficacy pathway were less effective, when this would not be the case provided those other sunscreens were complying with the Sunscreen Standard.

 

Division 2 - Related amendments

 

Therapeutic Goods Regulations 1990

 

Items 23-26 - Subparagraph 3AA(d)(i) and Schedule 4 (table items 3(d), 4A(f) and 5(e))

These items make minor amendments to subparagraph 3AA(d)(i) of, and items 3(d), 4A(f) and 5(e) of Schedule 4 to, the TG Regulations, to replace references to medicines or preparations that "contain indications" with references to medicines or preparations that "have indications". The intended effect of these amendments is to improve the clarity of these references, and to better reflect that medicines do not "contain" indications, but rather that indications (statements of therapeutic use) are made in relation to them.

 

Part 6 - Applications to list medicines under section 26AE of the Act

 

Therapeutic Goods Regulations 1990

 

Items 27-29 and 31-34 - Regulations 2, 16GH and 16GJ, and Part 4 and Clause 5 of Schedule 9

Items 27 - 29 amend the definitions of L(A)1 application, L(A)2 application and L(A)3 application in regulation 2 of the TG Regulations, to remove "complementary" from each of those definitions, in order to clarify that the medicines that may be listed under section 26AE of the Act are not limited to complementary medicines.

 

Items 31-34 remove "complementary" from regulations 16GH and 16GJ of, the heading of Part 4 of Schedule 9 and clause 5 of Schedule 9 to, the TG Regulations, in order to similarly reflect that regulation 16GJ and Part 4 and clause 5 of Schedule 9 are also not limited to complementary medicines and may also apply to some other medicines (principally, listable over the counter medicines).

 

Item 30 - Division 4 of Part 3A (at the end of the heading)

This item makes a minor amendment to the heading of Division 4 of Part 3A of the TG Regulations, to reflect that the provisions in Division 4 of Part 3A may also relate to other listed medicines as well as listed complementary medicines.

Part 7 - Correction, and repeal of spent provision

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Item 35 - Subregulation 5.3(3)

This item makes a minor amendment to regulation 5.3 of the MD Regulations to remove subregulation 5.3(3), as it is spent and redundant (subregulation 5.3(3) ceased to have any practical operation following the expiry of 60 working days after 1 July 2014).

 

Item 36 - Subregulation 5.13(2)

This item makes a minor amendment to subregulation 5.13(2) of the MD Regulations to correct an unintended omission, and to clarify that the condition of inclusion of a kind of medical device mentioned in subregulation 5.13(1) of the MD Regulations (being, a kind of device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard) set out in subregulation 5.13(3) does not apply to such a kind of device if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of device.

 

Part 8 - Advertising  

 

Therapeutic Goods Regulations 1990

 

Item 37 - Regulation 2 (definition of Therapeutic Goods Advertising Code)

This item repeals the definition of 'Therapeutic Goods Advertising Code' in regulation 2 of the TG Regulations, as this term is already defined in the Act (subsection 3(1) of the Act refers).

 

Item 38 - Paragraph 6B(1)(b)

Subregulation 6B(1) of the TG Regulations prescribes representations about therapeutic goods that are prohibited representations, for the purposes of subsection 42DJ(1) of the Act.

This item replaces the reference in paragraph 6B(1)(b) of the TG Regulations to Part 1 of Appendix 6 of the Therapeutic Goods Advertising Code (the Code) (which reflects the current Therapeutic Goods Advertising Code 2015 (the 2015 Code)), with an updated reference to section 30 of the Code (which would reflect the new Therapeutic Goods Advertising Code 2018 (the 2018 Code)), from 1 January 2019.  

 

As with all references to the Code in the TG Regulations, the intention with regard to the reference to the Code in regulation 6B (and also in the regulations and Schedules mentioned below) is to adopt the Code as in force from time to time, as authorised by subparagraph 14(1)(a)(ii) of the Legislation Act 2003 (the Code being a disallowable legislative instrument, made under section 42BAA of the Act).

 

Item 39 - Regulation 8

This item replaces the reference to subsections 4(1) to (6) of the Code in regulation 8 of the TG Regulations (which reflect the 2015 Code), with corresponding new references to sections 9, 10, 15, 16, 18, 19 and 21 of the Code (which would reflect the 2018 Code), from 1 January 2019.

 

 

 

Item 40 - At the end of regulation 8

This item adds a note at the end of regulation 8, to highlight that the application of the sections of the Code mentioned in regulation 8 (i.e. sections 9, 10, 15, 16, 18, 19 and 21) are affected by section 6 of the Code (section 6 is the application provision of the 2018 Code).

 

Item 41 - Part 1 of Schedule 2 (table item 1)

This item repeals item 1 in Part 1 of Schedule 2 to the TG Regulations, as it is unnecessary as it duplicates paragraph 6B(1)(b) of the TG Regulations.

 

Item 42 - Part 1 of Schedule 2 (table item 4, column 2)

Part 1 of Schedule 2 to the TG Regulations lists prohibited representations about therapeutic goods for the purposes of paragraph 6B(1)(a) of the TG Regulations and subsection 42DJ(1) of the Act. Item 4 of Part 1 of Schedule 2 currently refers to a representation referred to in subparagraph 7(1)(e)(i) or (ii) of the Code, as being a prohibited representation in relation to therapeutic goods that are analgesics.

 

This item amends item 4 to replace the reference to subparagraph 7(1)(e)(i) or (ii) of the Code (which reflect the 2015 Code), with a corresponding new reference to subsection 24(2) of the Code (which would reflect the 2018 Code), from 1 January 2019.

 

Item 43 - Part 1 of Schedule 2 (table item 8, column 2)

Table item 8 of Part 1 of Schedule 2 to the TG Regulations refers to a representation referred to in paragraph 7(2)(a) or (b) of the Code as being a prohibited representation about therapeutic goods that are vitamins. This item amends item 8 to replace the reference to paragraph 7(2)(a) or (b) of the Code (which reflects the 2015 Code) with a corresponding new reference to section 25 of the Code (which would reflect the 2018 Code), from 1 January 2019.

 

Item 44 - Part 1 of Schedule 3 (table item 2A, column headed "Therapeutic goods", paragraph (a))

This item makes a minor, consequential amendment to item 2A of Part 1 of Schedule 3 to the TG Regulations, to reflect the amendment that would be made by item 49 below, to add a new item 8A to Schedule 5 to the TG Regulations.

 

Item 45 - Schedule 4 (table item 7, column headed "Therapeutic goods")

Schedule 4 to the TG Regulations lists therapeutic goods that are required to be included in the Part of the Register for listed goods, for the purposes of paragraph 10(b) of the TG Regulations and paragraph 9A(4)(a) of the Act.

 

Item 7 of Schedule 4 refers in this regard to sunscreen preparations for dermal application that meet certain requirements, other than such products that are for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Code.  Item 45 repeals this reference to Part 1 or 2 of Appendix 6 of the Code (which reflects the 2015 Code) from item 7. This reference is no longer needed, in light of the amendments that would separately be made to item 7 of Schedule 4 by item 22 above to require sunscreen preparations mentioned in item 7 to comply with the permitted indications legislative instrument made by the Minister under section 26BF of the Act in order to be eligible for listing in the Register.

 

Item 46 - Schedule 4 (table item 8, column headed "Therapeutic goods", subparagraph (d)(ii))

This item amends subparagraph (d)(ii) of item 8 of Schedule 4 to the TG Regulations, to replace the current reference in that item to (briefly) a form of a disease, condition, ailment defect or injury identified in a part of the Code as a serious form of a disease etc. (this reference reflecting the current 2015 Code), with a corresponding new reference to a serious form of a disease, condition, ailment or defect in subsection 28(1) of the Code (which would reflect the 2018 Code), from 1 January 2019.

 

Item 47 - Schedule 5 (table item 8, column 2)

Schedule 5 to the TG Regulations lists therapeutic goods that are exempt from the requirement to be registered or listed in the Register. Item 8 of Schedule 5 refers in this regard to a number of different kinds of goods, such as certain homoeopathic preparations, antiperspirant preparations, and lotions or shampoos for the treatment or prevention of dandruff.

 

This item amends the chapeau of item 8 to repeal the reference to Part 1 or 2 of Appendix 6 of the Code (which reflects the 2015 Code). The 2018 Code, commencing on 1 January 2019, will not set out a list of diseases or conditions as provide for by Appendix 6 of the 2015 Code.

 

The amendment of item 8 makes it clear that in order to qualify for the exemption, the indications (statements of therapeutic use) for the goods mentioned in item 8 must not relate to the treatment of any disease, condition, ailment or defect. This is appropriate, and consistent with current practice, as it would reflect the intention that for such goods to be exempt from entry in the Register, their claims for therapeutic use should be less serious, lower level claims - e.g. focussing on the provision of symptomatic relief.  

 

Item 48 - Schedule 5 (table item 8, column 2, paragraph (e)

This item removes paragraph (e) of item 8 of Schedule 5 to the TG Regulations. Because paragraph (e) refers to lotions, shampoos and hairdressings for the prevention or treatment of dandruff (except those that are included in a Schedule to the Poisons Standard), and as the chapeau would be amended by item 47 above to remove references to 'prevention' and 'treatment', it would be inconsistent to maintain paragraph (e) in item 8.  

 

The products covered by paragraph (e) are separately provided for as a new item 8A of Schedule 5, by item 49 below.

 

Item 49 - Schedule 5 (after table item 8)

This item amends Schedule 5 to the TG Regulations to introduce a new item 8A to Schedule 5, which would refer to the same products as currently covered by paragraph (e) of item 8 - i.e. principally, lotions, shampoos or hairdressings for the prevention or treatment of dandruff (except those that are included in a Schedule to the Poisons Standard).

 

New item 8A however, also make it clear that such products are only exempt from the requirement to be registered or listed in the Register by virtue of being included in Schedule 5 if they are not for the treatment, cure, prevention, diagnosis or monitoring of, or testing of the susceptibility of persons to, any other condition, disease, ailment or defence.

 

Statement of Compatibility with Human Rights

 

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

 

Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018

 

The Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 (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), and amend the Therapeutic Goods Regulations 1990 (TG Regulations) and Therapeutic Goods (Medical Devices) Regulations 2002 (MD Regulations), principally to reduce the regulatory burden for hard surface disinfectants and to introduce a new, lower fee for marketing approval applications for Class I medical devices that are intended by their manufacturer to be for export only.

 

Hard surface disinfectants are regulated under the Act and TG Regulations and are required to be either registered or listed in the Australian Register of Therapeutic Goods (the Register) or, in some cases, are exempt from having to be in the Register:

*      hospital grade or household grade disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides must be registered in the Register (meaning in particular a greater level of pre-market assessment, as opposed to those products that are only required to be listed in the Register);

*      hospital grade disinfectants when used as recommended on non-critical surfaces and not claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides must be listed in the Register; and

*      other disinfectants, e.g. antibacterial cleaning wipes, are exempt from entry in the Register.

 

In each case, these hard surface disinfectants are for the general purpose disinfection of building and fitting surfaces, and are to be distinguished from disinfectants used for disinfecting other medical devices or to be used on human skin.

 

The Expert Panel Review of Medicines and Medical Devices Regulation recommended the review of goods that are listed in the Register to ensure that the regulatory requirements for such goods are commensurate with the risks that they pose (recommendation 14). Consistent with that recommendation, options that would reduce the regulatory burden for hard surface disinfectants, while maintaining important safety protections, were identified.

 

The Regulations amend the TG Regulations to reduce regulatory burden for hard surface disinfectants by allowing those hard surface disinfectants that are claimed to be biocidal to be listed rather than registered in the Register, and exempting hard surface disinfectants with no such claims from entry in the Register. In other words, the effect of these amendments is that that those hard surface disinfectants that are currently registrable would instead be listable, and those that are currently listable will be exempt, to implement an overall reduction in regulatory burden for these disinfectants. The safety and performance of hard surface disinfectants will continue to be addressed through the requirement to comply with Therapeutic Goods Order 54 - Standard for Disinfectants and Sterilants, a standard for these products made by the Minister under section 10 of the Act and which applies to all such products including those that are exempt from entry in the Register.

 

The Regulations amend the MD Regulations to introduce a new lower application fee for marketing approval applications for medical devices (other than in vitro diagnostic medical devices) that are intended by their manufacturer to be for export only, in the amount of $90, rather than the current fee of $530. The new fee reflects that less information is needed to be verified as part of the processing of such applications than for other Class I devices, and better automation of the processing of these applications through modifying the TGA's existing e-BS software.

 

The new fee would apply retrospectively from 1 July 2018, in order to ensure that medical device sponsors who applied to include export only devices in the Register between 1 July 2018 and when the amendments to introduce the new fee commenced, and who paid the fee of $530 to do so, will not be disadvantaged in comparison to sponsors who apply after that time to include such devices in the Register. The Regulations include a refund mechanism requiring the Secretary to refund such sponsors the difference between the two fees for applications submitted during that period.

 

The Regulations also make a small number of other, more minor amendments to the TG Regulations and MD Regulations, to:

*      preclude sunscreens from accessing the new pathway for listed medicines that are assessed for their efficacy claims, in order to avoid confusion for consumers (particularly the risk that this might be misinterpreted as implying that other sunscreens not listed under this pathway, but with the same sun protection factor, were less effective when this would not be the case if those other products comply with Australian Standard AS/NZS 2604:2012);

*      make consequential amendments to reflect the commencement of the Therapeutic Goods Advertising Code 2018 from 1 January 2019; and

*      make a small number of corrections to minor errors and omissions.

 

Human rights implications

As the Regulations do not introduce any changes to the TG Regulations or MD Regulations other than to implement the measures outlined above, they do 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.

 

Greg Hunt, Minister for Health