EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (CONTINUED DISPENSING) AMENDMENT DETERMINATION 2024 (No. 3)
PB 114 of 2024
Purpose
The purpose of the National Health (Continued Dispensing) Amendment Determination 2024 (No. 3), made under subsection 89A(3) of the National Health Act 1953 (the Act), is to amend the National Health (Continued Dispensing) Determination 2022 to more accurately reflect the way that pharmaceutical benefits are defined for the purposes of the Act and provide that certain terms are to have the same meaning as they were given in the Act.
The National Health (Continued Dispensing) Determination 2022 (the Principal Instrument) lists the pharmaceutical benefits that may be supplied by an approved pharmacist under Part VII of the Act without a prescription, and provides the conditions for such a supply (a ‘Continued Dispensing’ supply).
The amendments made by this instrument also reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024) (Listing Instrument). The Listing Instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
Authority
Subsection 89A(3) of the Act provides that the Minister may determine the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the Act without a prescription, and the conditions for such a supply (‘Continued Dispensing’).
This instrument does not override state and territory legislation and does not apply in the external territories.
Amendments made by this Instrument
This instrument provides for clarification to the meaning of terms, technical amendments to the definition of pharmaceutical benefits covered by the Principal Instrument, updates to references and headings, and the repeal of a redundant section. It also provides for the addition of the drug dapagliflozin with sitagliptin to the table of listed drugs in Schedule 1 of the Principal Instrument. Pharmaceutical benefits having a drug listed in Section 1 of Schedule 1 may be supplied by an approved pharmacist under Continued Dispensing arrangements.
These changes are summarised, by subject matter, in Attachment A.
Consultation
This instrument affects approved pharmacists supplying a pharmaceutical benefit at or from premises in respect of which the pharmacist is for the time being approved. Prior to the commencement of the Principal Instrument, consultation was undertaken with relevant peak bodies including the Pharmaceutical Society of Australia, Australian Medical Association, Royal Australian College of General Practitioners, Consumers Health Forum, the Australian Federation of AIDS Organisations, and the Pharmacy Guild of Australia. The Department of Health and Aged Care (the Department) also undertook direct consultation with Services Australia, and consulted with state and territory Departments of Health about implementation for the Principal Instrument.
It was considered that further consultation for this instrument was unnecessary due to the nature of the consultation that had already taken place.
General
A provision-by-provision description of this instrument is contained in Attachment A.
This instrument commences on 1 November 2024.
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT A
Details of the National Health (Continued Dispensing) Amendment Determination 2024 (No. 3)
Part 1 – Preliminary
Section 1 – Name
This section provides the title of this instrument is the National Health (Continued Dispensing) Amendment Determination 2024 (No. 3).
This instrument can also be cited as PB 114 of 2024.
Section 2 – Commencement
This section provides that this instrument commences on 1 November 2024.
Section 3 – Authority
This section provides that this instrument is made under subsection 89A(3) of the National Health Act 1953 (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 has effect according to its terms. The Schedule amends the National Health (Continued Dispensing) Determination 2022 (Principal Determination).
Schedule 1 – Amendments
Item 1 – Subsection 1.05(1) (definition of purposes code)
Item 1 amends the definition of ‘purposes code’ in subsection 1.05(1) of the Principal Instrument to update the previous reference to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (2012 Listing Instrument) with reference to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (2024 Listing Instrument).
The 2012 Listing Instrument was replaced by the 2024 Listing Instrument on 1 April 2024.
Item 2 – Subsection 1.05(1) (definition of relevant purpose)
Item 2 substitutes reference to Schedule 4 of the 2012 Listing Instrument with reference to Part 1 of Schedule 4 of the 2024 Listing Instrument.
Part 4 of the 2012 Listing Instrument determined, among other things, purposes for which PBS prescribers could write a prescription for the maximum quantity of a pharmaceutical benefit or pharmaceutical item in a benefit that could be supplied to a patient on the one occasion. These purposes are now determined in Part 1 of Schedule 4 of the 2024 Listing Instrument.
Item 3 – At the end of section 1.05
Item 3 adds new subsection 1.05(2), which provides that certain terms in the Principal Instrument are to have the same meaning as they were given in Part VII of the Act. This subsection is added for drafting clarity and does not change the meaning of those terms.
Item 4 – Section 2.01
Item 4 substitutes a new section 2.01. Section 2.01 of the Principal Instrument determines the pharmaceutical benefits that may, subject to certain conditions, be supplied by an approved pharmacist without a prescription for the purposes of paragraph 89A(3)(a) of the Act.
Technical amendments have been made in new section 2.01 to more accurately reflect the way that pharmaceutical benefits covered by the Principal Instrument are defined for the purposes of the Act. The revised drafting is not intended to alter the operation of the provision.
Section 2.01 now provides that it determines each pharmaceutical benefit that has a drug mentioned in an item in Schedule 1 of the Principal Instrument. This means that where a drug is mentioned in an item in Schedule 1, any pharmaceutical benefit having that drug is determined for paragraph 89A(3)(a), irrespective of the form, manner of administration or brand.
Item 5 – Part 4
Item 5 repeals Part 4 of the Principal Instrument.
The Principal Instrument repealed the National Health (Continued Dispensing – Emergency Measures) Determination 2020 (Emergency Determination) on 1 July 2022. Section 4.01 was an application provision intended to ensure approved pharmacists could continue to submit claims under the National Health (Supply of Pharmaceutical Benefits – Under Co-payment Data and Claims for Payment) Rules 2022 for supplies made pursuant to the Emergency Determination on or before 30 June 2022.
Given the time that has elapsed since 1 July 2022, and applicable time limits on submitting claims for payment in relation to supplies of pharmaceutical benefits, Part 4 is redundant and can be repealed.
Item 6 – Schedule 1 (heading)
Item 8 – Section 1 of Schedule 1 (heading)
Items 6 and 8 amend the heading of Schedule 1 and the heading of Item 1 of Schedule 1, respectively. The amendments make clear that it is any pharmaceutical benefit having a drug listed in an item in the schedule that can be supplied without a prescription under Continued Dispensing arrangements.
Item 7 - Schedule 1 (note to Schedule heading)
Item 7 amends the section reference in the note to the heading to Schedule 1 to reflect that the schedule is made for the purposes of section 2.01 rather than section 3.01.
Item 9 - Section 1 of Schedule 1 (after table item 28)
Item 9 inserts a new listed drug to the table to section 1. A pharmaceutical benefit that has a drug included in the table can be supplied as a Continued Dispensing supply. This change is summarised below.
SUMMARY OF CHANGES TO THE CONTINUED DISPENSING MEASURE
MADE BY THIS INSTRUMENT
Drug Added
Listed Drug |
Dapagliflozin with sitagliptin |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Continued Dispensing) Amendment Determination 2024 (No. 3)
(PB 114 of 2024)
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
The National Health (Continued Dispensing) Amendment Determination 2024 (No. 3) (the Instrument) amends the National Health (Continued Dispensing) Determination 2022 (the Principal Instrument) which lists the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, and the conditions for such a supply (‘Continued Dispensing’).
Continued Dispensing arrangements enable approved pharmacists to supply pharmaceutical benefits without the presentation of a prescription. The Principal Instrument specifies the pharmaceutical benefits that can be supplied under Continued Dispensing arrangements and the conditions that must be met before an approved pharmacist can make a Continued Dispensing supply, which include that there is an immediate need for the supply and the Pharmaceutical Benefits Scheme (PBS) prescriber cannot be contacted or cannot provide a prescription for the patient electronically. Where an approved pharmacist makes a Continued Dispensing supply, they are required to dispense a maximum quantity of the pharmaceutical benefit.
This Instrument provides for amendments to the Principal Instrument to ensure that the Principal Instrument accurately reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (the Listing Instrument), made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act. The Instrument also provides for clarification to the meaning of terms, technical amendments to the definition of pharmaceutical benefits covered by the Principal Instrument, updates to references and headings, and the repeal of a redundant section.
Human rights implications
This Instrument engages Articles 9 and 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights to health and social security.
The Right to Social Security
The right to social security is contained in Article 9 of the International Covenant on Economic Social and Cultural Rights (ICESCR). It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.
The UN Committee on Economic Social and Cultural Rights (the Committee) reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.
The Right to Health
The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR. The Committee has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.
The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.
Analysis
This Instrument advances the right to health and the right to social security by ensuring that amendments to the Listing Instrument, that affect the pharmaceutical benefits that may be supplied as a Continued Dispensing supply, are also made in the Principal Instrument. The Listing Instrument determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based. The Instrument continues to provide the option for patients to have subsidised access to eligible PBS medicines through continued dispensing arrangements.
The other proposed amendments are technical in nature and are compatible with human rights as they do not alter any rights or entitlements under the Principal Instrument.
Conclusion
This legislative instrument is compatible with human rights because it advances the protection of human rights.
Nikolai Tsyganov
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health and Aged Care