National Health (Supplies of out-patient medication) Amendment Determination 2020 (PB 132 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01694 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Supplies of out-patient medication) Amendment Determination 2020

 

PB 132 of 2020

 

Authority

 

Subsection 84BA(2) of the National Health Act 1953 (the Act) provides that the Minister must determine the amount that will be taken to have been paid to a public hospital for supplies of out-patient medication for the relevant entitlement period for the purposes of the Pharmaceutical Benefits Scheme (PBS) patient safety net threshold.

 

Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), 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.

 

Purpose

 

This instrument makes a minor amendment to the National Health (Supplies of out-patient medication) Determination 2019 (No. 2) (PB 110 of 2019) (the determination). In particular, this instrument updates the maximum value of the supply of out-patient medication to a person who is a general patient and who is not a holder of a concession card.

 

Background

 

Part VII of the Act regulates when benefits will be paid by the Commonwealth in respect of drugs and medicinal preparations that are listed on the PBS. As such, it is the legislative basis by which the Commonwealth provides reliable, timely and affordable access to a wide range of medicines to Australians.

 

Division 1A of Part VII of the Act provides for a safety net scheme in relation to pharmaceutical benefits. The safety net scheme is designed to provide financial protection for those patients and their families who require a large number of pharmaceutical benefits.

 

Subsection 84(1) of the Act defines out-patient medication as a drug or medicinal preparation supplied through the out-patient department of a public hospital. A drug or medicinal preparation that is supplied by a public hospital as out-patient medication may or may not be a pharmaceutical benefit under Part VII of the Act.

 

Subsection 84BA(1) of the Act provides that the purpose of section 84BA is to make provision so that account may be taken of payments made by a person to a public hospital authority for supplies of out-patient medication, when it is being ascertained, for the purpose of Part VII of the Act, whether the person is eligible to be issued with a concession card or an  entitlement card. 

 

Subsection 84BA(2) of the Act provides that prior to the commencement of the relevant entitlement period (a calendar year), the Minister must determine in writing the amounts that will be taken to have been paid to a public hospital for supplies of out-patient medication made by a hospital during the relevant entitlement period. 

 

Subsection 84BA(3) of the Act provides that, in making a determination, the Minister may determine:

a)      different amounts in respect of a supply of out-patient medication, having regard to the State or Territory in which the hospital supplying the medication is situated; and

b)     different amounts in respect of supplies made to:

  1. concessional beneficiaries and their dependants (within the meaning of subsection 84(4) or (7) of the Act),
  2. holders of a concession card; and
  3. general patients (other than holders of a concession card).

 

Generally, the parties to Pharmaceutical Reform Arrangements are the Commonwealth and a State or Territory. The National Health Reform Agreement at paragraph G5, page 56 provides that ‘States which have signed bilateral agreements for Pharmaceutical Reform Arrangements may charge the PBS for pharmaceuticals for specific categories of patients as provided for in the Arrangements’ (http://www.federalfinancialrelations.gov.au/content/npa/health/_archive/national-agreement.pdf).

 

This determination updates the maximum value of the supply of out-patient medication to a person who is a general patient and who is not a holder of a concession card from $32.80 to $33.00.

 

Consultation

 

Historically, the Department of Health has consulted with state and territory health departments through the Highly Specialised Drugs Working Party (HSDWP). The HSDWP was a working party of the Australian Health Ministers’ Advisory Council (AHMAC) and was made up of representatives from each state and territory health department and the Commonwealth. This Working Party has now been discontinued as a second tier committee of the Hospitals Principal Committee on recommendations endorsed by AHMAC.

 

Through the HSDWP, the state and territory health departments agreed to the value of out‑patient medication being 80% of the general co-payment each year, excluding hospitals which are in Queensland or participating in the Pharmaceutical Reform Arrangements.

 

State and territory health departments have been provided with the new maximum value of the supply of out-patient medication to a person who is a general patient and who is not a holder of a concession card and no additional comments have been received.

 

Further consultation was unnecessary given the nature of this minor change was to clarify a definition in the instrument.

 

Commencement

 

This instrument commences on 1 January 2021.

 

Details of the instrument are set out in the Attachment. This instrument is a legislative instrument for the purpose of the Legislation Act 2003.


ATTACHMENT

Details of the National Health (Supplies of out-patient medication) Amendment Determination 2020

 

1 Name

 

This section provides that the name of this instrument is the National Health (Supplies of out‑patient medication) Amendment Determination 2020. The instrument can also be cited as PB 132 of 2020.

 

2 Commencement

 

This section provides that this instrument commences on 1 January 2021.

 

3 Authority

 

This section provides that the instrument is made under section 84BA of the National Health Act 1953.

 

 4              Schedules

 

This section provides that each instrument that is specified in a Schedule to the 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 instrument has effect according to its terms.

 

Schedule 1—Amendments

 

National Health (Supplies of out-patient medication) Determination 2019 (No 2) (the determination)

 

1  Section 8(1)

 

This section repeals the maximum value of the supply of out-patient medication to a person who is a general patient and who is not the holder of a concession card, which is currently $32.80. This section replaces the amount of $32.80 with $33.00.

Statement of Compatibility with Human Rights

 

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

 

National Health (Supplies of out-patient medication) Amendment Determination 2020

(PB 132 of 2020)

 

This 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 the legislative instrument

 

This legislative instrument is made pursuant to subsection 84BA(2) of the National Health Act 1953, which determines the amounts that will be taken to have been paid to a public hospital for supplies of out-patient medication.

 

This instrument makes a minor amendment to the National Health (Supplies of out-patient medication) Determination 2019 (No. 2) (PB 110 of 2019) (the determination). In particular, this instrument updates the maximum value a general patient pays for out-patient medications.

 

Human rights implications

 

This legislative instrument engages Articles 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 to medicines.

 

This legislative instrument specifies what will be taken to have been paid to a public hospital for supplies of out-patient medication for the purposes of the PBS patient safety net threshold.

 

The safety net scheme is designed to provide financial protection for those patients and their families who require a large number of pharmaceutical benefits.

 

Conclusion

 

This legislative instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

Caroline Turnour

Acting Assistant Secretary
Pricing and PBS Policy Branch

Technology Assessment and Access Division
Department of Health

Overview

The National Health (Supplies of out-patient medication) Amendment Determination 2020, enacted in 2020, amends the National Health (Supplies of out-patient medication) Determination 2019 to update the maximum value of the supply of out-patient medication to a person who is a general patient and who is not a holder of a concession card. This instrument was enacted under subsection 84BA(2) of the National Health Act 1953, which mandates that the Minister must determine the amounts that will be taken to have been paid to a public hospital for supplies of out-patient medication for the purposes of the Pharmaceutical Benefits Scheme (PBS) patient safety net threshold. The objective of this amendment is to ensure the PBS patient safety net threshold remains current and effective in providing financial protection for patients and their families who require a large number of pharmaceutical benefits. This minor amendment is necessary to maintain the integrity and efficacy of the PBS, which is integral to providing reliable, timely, and affordable access to a wide range of medicines for Australians. The updated value ensures that the safety net scheme continues to offer the intended financial protection and aligns with the ongoing commitment to the highest attainable standard of physical and mental health as recognised under international human rights instruments.

Scope and Application

The National Health (Supplies of out-patient medication) Amendment Determination 2020 amends the National Health (Supplies of out-patient medication) Determination 2019, specifically updating the maximum value of the supply of out-patient medication to a person who is a general patient and who is not a holder of a concession card from $32.80 to $33.00. This amendment applies to the supply of out-patient medication by a public hospital, where such medication may or may not be a pharmaceutical benefit under Part VII of the National Health Act 1953. The determination is made under subsection 84BA(2) of the Act and applies to the supply of out-patient medication for the purposes of the Pharmaceutical Benefits Scheme (PBS) patient safety net threshold. The amendment is designed to ensure that the value of out-patient medication is accurately reflected, thereby providing a basis for determining eligibility for the PBS safety net scheme, which offers financial protection for patients requiring extensive pharmaceutical benefits. This instrument is a legislative instrument for the purpose of the Legislation Act 2003 and commenced on 1 January 2021. The amendment is a minor clarification of the definition within the instrument, and no additional consultation was deemed necessary beyond the prior agreement reached through the Highly Specialised Drugs Working Party.

Key Provisions

The main operative sections of the National Health (Supplies of out-patient medication) Amendment Determination 2020 (PB 132 of 2020) include sections that update the maximum value of the supply of out-patient medication for general patients who are not holders of a concession card. Specifically, Section 8(1) repeals the previous maximum value of $32.80 and replaces it with $33.00. This amendment aligns the value of out-patient medication with the general co-payment, ensuring consistency and fairness in the pricing of these medications. The instrument also specifies that this amendment will take effect from 1 January 2021. The obligations imposed by this Act on the parties involved are primarily administrative. The Minister, under Section 84BA(2) of the National Health Act 1953, is mandated to determine the amounts to be considered as payments made to public hospitals for out-patient medication. This determination must be made in writing prior to the commencement of the relevant entitlement period, which is a calendar year. The Act also allows for different amounts to be set based on the state or territory in which the hospital is situated and the type of patient, such as concessional beneficiaries, holders of a concession card, and general patients. Breach of the provisions within this Act could result in penalties, although the specific details regarding penalties are not explicitly stated in the text. Generally, under the National Health Act 1953, penalties for non-compliance with legislative instruments could include fines and other administrative sanctions. The precise penalties would depend on the nature of the breach and the discretion of the relevant authorities enforcing the Act. It is important for parties involved to adhere to these determinations to ensure compliance with the legislative framework governing pharmaceutical benefits in Australia.

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