EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020
PB 29 of 2020
Authority
This legislative instrument is made pursuant to subsection 84AG(1) of the National Health Act 1953 (the Act), which gives the Minister the power to determine a therapeutic group and that two or more listed drugs are in the same therapeutic group.
Purpose
The purpose of the National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020 is to determine the number of therapeutic groups and the listed drugs that are in those therapeutic groups, specifically that eprosartan and losartan are the listed drugs in the angiotensin II receptor antagonist (ATRA) therapeutic group.
This legislative instrument repeals and replaces National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2010, which sunsets on 1 April 2020.
The Drugs listed within a therapeutic group are therapeutically interchangeable with other drugs in the same group. That is, they are of similar safety, efficacy and provide similar health outcomes.
The Government subsidises all drugs within a group up to the level of the lowest price drug. Any difference between the subsidised price and the price of the drug used by the patient is due to a claimed price determined under section 85B of the Act. The additional amount is paid by the patient as a Special Patient Contribution (SPC).
When the Minister determines a SPC for a pharmaceutical item under section 85B of the Act, the Minister does so having regard to whether the drug has been determined to be within a therapeutic group under section 84AG of the Act.
The Minister has determined a SPC for eprosartan, as it was in the ATRA therapeutic group along with losartan, under section 85B of the Act. This instrument determines that eprosartan and losartan are the listed drugs that are in the ATRA therapeutic group. This allows the SPC under section 85B of the Act to continue.
Consultation
This legislative instrument affects the pharmaceutical company that supplies eprosartan and losartan medicines listed on the PBS.
The pharmaceutical company with a listed brand of eprosartan and losartan was consulted about whether it considered these drugs should continue to be determined in the ATRA therapeutic group. The pharmaceutical company requested that the instrument be remade to enable the SPC that currently applies to eprosartan to continue.
Further, the Pharmaceutical Benefits Advisory Committee (PBAC) provided advice to the Minister under section 101(4AA) of the Act that eprosartan should be treated as interchangeable on an individual patient basis with losartan and that the Minister should determine that eprosartan and losartan should be included in an ATRA therapeutic group.
This instrument commences on the date after this instrument is registered.
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
A provision-by-provision description of this instrument is contained in the Attachment.
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – THERAPEUTIC GROUPS) DETERMINATION 2020
Section 1 Name of Determination
This section provides that the name of this instrument is the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2020 and that it may also be cited as PB 29 of 2020.
Section 2 Commencement
This section provides that this instrument commences on the date after this instrument is registered.
Section 3 Authority
This section provides that this instrument is made under subsection 84AG(1) of the National Health Act 1953.
Section 4 Repeal of previous instrument
This section provides that the National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2010 is repealed.
Section 5 Definitions
This section provides definitions of the ‘Act’ meaning the National Health Act 1953 and ‘ATRA group’ meaning the Angiotensin II receptor antagonist group.
Section 6 Therapeutic groups
This section provides that for paragraph 84AG(1)(a) of the Act, a therapeutic group is a group mentioned in a Part of Schedule 1.
Section 7 Drugs in therapeutic groups
This section provides that for paragraph 84AG(1)(b) of the Act, each listed drug mentioned in a Part of Schedule 1 is in the therapeutic group mentioned in the Part.
Schedule 1 Therapeutic groups and listed drugs
This schedule lists the therapeutic groups and listed drugs within those groups. Part 1 is the ATRA group and lists Item 1 as eprosartan and Item 2 as losartan.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Pharmaceutical Benefits—Therapeutic Groups) Determination 2020
(PB 29 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 84AG(1) of the National Health Act 1953 (the Act), which relates to therapeutic groups. This legislative instrument determines the angiotensin II receptor antagonist (ATRA) therapeutic group and determines that eprosartan and losartan are the listed drugs that are in the ATRA therapeutic group.
Drugs listed within a therapeutic group are therapeutically interchangeable with other drugs in the same group. That is, they are of similar safety, efficacy and provide similar health outcomes. The independent Pharmaceutical Benefits Advisory Committee (PBAC) provides this advice.
Human rights implications
This legislative 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 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 PBAC ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Thea Daniel
Assistant Secretary
Pricing and PBS Branch
Technology Assessment and Access Division
Department of Health