EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) AMENDMENT (APPROVAL OF CERTAIN HOSPITAL AUTHORITIES) SPECIAL ARRANGEMENT 2018
PB 107 of 2018 (No. 11)
Authority
Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Purpose
The National Health (Highly specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018 (the Instrument) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement) to:
- reflect changed administrative arrangements for the approval of certain hospital authorities to supply pharmaceutical benefits under the Special Arrangement; and
- make a number of technical changes to update outdated references to regulations made under the Act.
The transfer of responsibility for a number of functions under the Act from the Chief Executive Medicare (through the Department of Human Services) to the Department of Health was announced in the 2018-19 Federal Budget as part of a Budget Measure relating to improving access to medicines and sustainability of approvals processes.
The Instrument gives effect to the transfer of functions, from the Chief Executive Medicare to the Secretary, for approval of certain public hospital authorities to supply Highly Specialised Drugs under the Special Arrangement. These are public hospital authorities that cannot otherwise be approved under section 94 of the Act.
The amendments also substitute references to the National Health (Pharmaceutical Benefits) Regulations 1960, which is no longer in force, with references to the National Health (Pharmaceutical Benefits) Regulations 2017.
Schedule 2 of the Instrument provides transitional provisions in relation to applications and decisions about approval of hospital authorities made prior to the commencement day, to ensure that applications that have been made but not approved on the commencement date can continue to be processed, and that any approvals given by the Chief Executive Medicare remain in force.
A provision by provision description of this Instrument is contained in the Attachment.
Consultation
The Department of Health has consulted with the Department of Human Services on the transfer of functions, including the requirement to update delegations to allow for the Secretary to consider applications for approval under the Special Arrangements. Details of this Instrument are set out in the Attachments.
The Instrument commences on 21 December 2018.
The Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) AMENDMENT (APPROVAL OF CERTAIN HOSPITAL AUTHORITIES) SPECIAL ARRANGEMENT 2018
Section 1 Name of Instrument
This section provides the name of the Instrument is the National Health (Highly specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018. It can also be cited as PB 107 of 2018 (No. 11).
Section 2 Commencement
This section provides that the Instrument commences on 21 December 2018.
Section 3 Authority
This section provides that this Instrument is made under section 100 of the National Health Act 1953.
Section 4 Schedules
Section 4 provides that any instrument specified in a Schedule to the Instrument is amended or repealed as set out in the relevant item and any other item in a Schedule has effect according to its terms. Schedule 1 provides for the amendment of the National Health (Highly specialised drugs program) Special Arrangement 2010 (the Special Arrangement) and Schedule 2 provides for transitional arrangements.
Schedule 1 - Amendments relating to the transfer of function for approval of hospital authorities
Item 1 replaces ‘Chief Executive Medicare’ with ‘Secretary’ in the definition of approved hospital authority in section 4 of the Special Arrangement. This is a consequence of amendments to section 52 of the Special Arrangement to transfer of function for approving certain public hospital authorities for the purposes of the supply of pharmaceutical benefits under the Special Arrangement from the Chief Executive Medicare in the Department of Human Services, to the Secretary of the Department of Health (see item 11).
Item 11 replaces the reference to ‘Chief Executive Medicare’ wherever it appears in section 52, with a reference to ‘Secretary’. This will enable the Secretary of the Department of Health to undertake functions previously undertaken by the Chief Executive Medicare, including approving certain public hospital authorities to supply pharmaceutical benefits under the Special Arrangement, allot an approval number to a hospital authority to which approval has been granted and determine conditions on an approval.
Schedule 1 - Amendments relating to the remaking of the National Health (Pharmaceutical Benefits) Regulations 1960
Items 2 - 10 and item 12 of Schedule 1 of the Instrument are consequential amendments reflecting the remaking of the National Health (Pharmaceutical Benefits) Regulations 1960 (the 1960 Regulations) as the National Health (Pharmaceutical Benefits) Regulations 2017 (the 2017 Regulations).
None of these amendments make any change to the current operation of the Pharmaceutical Benefits Scheme or the rules to which PBS prescribers and suppliers are subject. The specific amendments are:
- Item 2 amends the definition of Regulations in section 4 of the Instrument to refer to the 2017 Regulations;
- Item 3 updates section 19 of the Special Arrangement to refer to section 51 of the 2017 Regulations (repeat supplies);
- Items 4, 5 and 7 update sections 21 and 23 of the Special Arrangement to refer to section 40 or 41 of the 2017 Regulations, as appropriate (requirements for prescribing);
- Items 6 and 8 update the note to section 21 of the Special Arrangement and section 26 of the Special Arrangement to refer to section 30 of the 2017 Regulations (variation of maximum quantity or number of repeats);
- Items 9 and 10 update sections 51 and 52 to refer to section 16 of the 2017 Regulations (numbering of approvals)
Item 12 amends existing transitional arrangements in part 9 of the Special Arrangement, put in place as a result of amendments to the Special Arrangement made in 2015. Section 54 of the Special Arrangement establishes transitional arrangements for existing medication chart prescribing and paperless claiming for certain hospitals. However, these transitional arrangements do not apply to a hospital that was a 'listed approved hospital' under regulation 59 of the 1960 Regulations.
Regulation 59 of the 1960 Regulations was not maintained under the 2017 Regulations. While there should not be any more listed approved hospitals, for the avoidance of doubt section 54 has been amended to maintain the reference to listed approved hospitals under the 1960 Regulations as in force immediately before the commencement of the 2017 Regulations.
Schedule 2 - transitional provisions
Schedule 2 specifies the transitional provisions relating to the amendments to the Special Arrangement resulting from the transfer of responsibility for approving public hospital authorities under section 52 of the Special Arrangement from the Chief Executive Medicare to the Secretary of the Department of Health.
Item 1 contains definitions relevant for the Schedule:
- commencement day means the date of effect of the provisions under this Instrument (21 December 2018);
- new Special Arrangement means the Special Arrangement as in force from the date of the amendments made by the Instrument;
- old Special Arrangement means the Special Arrangement as in force immediately before the amendments made by the Instrument.
Item 2 provides for transitional arrangements which apply from the commencement day, for applications made to the Chief Executive Medicare under section 52 of the old Special Arrangement where a decision on approval has not yet been made. The decision will be able to be made by the Secretary, as if the application had been made by the Secretary. The decision will also be able to be made by the Chief Executive Medicare. This provides flexibility for either the Chief Executive Medicare or the Secretary to process an application open at the transition time. Decisions on any applications made after the commencement day will be made by the Secretary.
Item 3 provides for transitional arrangements for decisions made by the Chief Executive Medicare in relation to approvals granted under section 52 of the Special Arrangements in place before the commencement day.
It ensures that any approvals granted by the Chief Executive prior to commencement day, including any conditions to which the approval may be subject, and the number allotted to the approval, remain in force from the commencement day as if the Secretary had: (a) granted the approval; (b) determined if the approval was subject to any conditions; and (c) allotted the number to the approval.
Item 4 provides for transitional arrangements where a public hospital authority's approval is suspended immediately before the commencement day. From the commencement day, the suspension will be taken to have been made by the Secretary.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Highly specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018
(PB 107 of 2018 (No. 11))
This 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 Instrument
The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs program.
The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.
The Instrument:
- amends the Special Arrangement to reflect the change in responsibility for granting approval for certain public hospital authorities to supply highly specialised drugs under the Special Arrangement from the Chief Executive Medicare to the Secretary of the Department of Health; and
- includes transitional provisions to ensure that applications for approval made to the Chief Executive Medicare but that have not been finalised at the time the amendments commence can continue to be processed by the Chief Executive Medicare, and also to ensure that approvals granted and approval numbers issued by the Chief Executive Medicare will continue to be recognised following the amendments; and
- makes a number of consequential amendments to the Special Arrangement to remove references to the National Health (Pharmaceutical Benefits) Regulations 1960, which have been remade, with references to the National Health (Pharmaceutical Benefits) Regulations 2017.
Human rights implications
This Instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.
The amendments relating to the granting of approvals to certain hospital authorities are necessary to ensure the effective implementation of the transfer of responsibilities between the Department of Human Services and the Department of Health.
The consequential amendments to update outdated references to the redundant National Health (Pharmaceutical Benefits) Regulations 1960 do not affect human rights. They do not affect the rules applying to PBS prescribers or suppliers, or eligibility to receive a pharmaceutical benefit.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Julianne Quaine
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health