Amendment Determination under section 84AH of the National Health Act 1953 (2015) (No. 2) (PB 45 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00603 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

 

Amendment Determination under section 84AH of the National Health Act 1953 (2015)

(No. 2)

 

PB 45 OF 2015

 

Purpose

 

The purpose of this legislative instrument, made under section 84AH of the National Health Act 1953 (the Act), is to amend the legislative instrument titled Determination under section 84AH of the National Health Act 1953 (as amended) (PB 58 of 2007) to make changes to the pharmaceutical items that are determined to be exempt items.

 

Background

 

Part VII of the Act is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely and affordable access to a wide range of medicines for all Australians.

 

Drugs and medicinal preparations to which Part VII applies are declared as such by the Minister, by legislative instrument under subsection 85(2) of the Act. These are listed drugs (as defined in subsection 84(1)). The Minister may also determine by legislative instrument the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)) and the manner of administration of the form of the listed drug so determined (subsection 85(5)). If a drug has a declaration under subsection 85(2) in force in respect of it and determinations under subsections 85(3) and 85(5) in force in respect of it, then that declared drug in that determined form with that determined manner of administration is a pharmaceutical item. The Minister may also determine, by legislative instrument, brands of pharmaceutical items (subsection 85(6)).

 

Section 84AH empowers the Minister to determine, by legislative instrument, that a pharmaceutical item is an ‘exempt item’ if the pharmaceutical item satisfies the criteria in section 84AH. The criteria in section 84AH are as follows:

(a)   that there is only one listed brand of the relevant pharmaceutical item; and

(b)   there are no listed brands of other pharmaceutical items that are bioequivalent or biosimilar to the one listed brand of the relevant pharmaceutical item; and

(c)   there is at least one other pharmaceutical item that has the same listed drug as the relevant pharmaceutical item; and

(d)   the Minister is satisfied (having regard to advice, if any, from the Pharmaceutical Benefits Advisory Committee (PBAC)) that:

  1. the listed drug in the relevant pharmaceutical item represents suitable therapy for a particular patient population; and
  2. the relevant pharmaceutical item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration; and
  3. no other pharmaceutical item that has that drug is suitable for use by that subgroup because of either or both of the form and manner of administration of the drug in that other item.

 

The effect of a pharmaceutical item being determined to be an exempt item is that the listed brand of that pharmaceutical item is excluded from statutory price reductions and price disclosure requirements under Division 3A and 3B of Part VII of the Act. The intention is to encourage the availability of certain pharmaceutical items with particular formulations of drugs that are used by a demographic subgroup (eg. children or geriatric patients) for whom other formulations of the drug are not suitable.

 

Changes to PB 58 of 2007 made by this instrument

 

This instrument makes the following change to PB 58 of 2007:

 

One pharmaceutical item (listed drug = Oestradiol, form = Vaginal tablets 25 micrograms, 15, manner of administration = Vaginal) is no longer determined to be an exempt item.

 

Variation and revocation

 

Unless there is an express power to revoke or vary PB 58 of 2007 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 58 of 2007.

Consultation

This instrument affects pharmaceutical companies with medicines listed on the PBS.  In relation to the introduction of the exempt items measure, which commenced on                      1 August 2007, pharmaceutical companies have been consulted during both the policy development and implementation phases.

The Pharmaceutical Benefits Advisory Committee (PBAC) was also consulted in relation to issues relevant to this determination.  The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health about which drugs and medicinal preparations should be available as pharmaceutical benefits and about other matters as required under the Act.  Under subsection 101(4AB) of the Act PBAC provides advice to the Minister if it is satisfied of certain matters concerning suitability of pharmaceutical items for use by particular sub-groups.  Consideration given by PBAC, under section 101(4AB), to the pharmaceutical items affected by the instrument, was considered by the delegate of the Minister who made the instrument.

General

The instrument commences on 1 May 2015. 

This instrument constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003.

 

 

 

 

Statement of Compatibility with Human Rights

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

Amendment Determination under section 84AH of the National Health Act 1953 (2015) (No. 2)

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 section 84AH of the National Health Act 1953 (the Act), which determines when a pharmaceutical is exempt.  This instrument amends the principal instrument which provides for the allocation of drugs to the exempt list if the pharmaceutical item satisfies the criteria in section 84AH of the Act. 

This Instrument (the Amending Determination) amends the Principal Determination by removing the specified form of the drug oestradiol from the exempt list.

 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 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.

Conclusion

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

 

 

Adriana Platona

Assistant Secretary, Pharmaceutical Evaluation Branch,

Pharmaceutical Benefits Division, Department of Health

 

 

 

Overview

The National Health Act 1953, enacted by the Australian Parliament, established the Pharmaceutical Benefits Scheme (PBS) to ensure Australians have reliable, timely, and affordable access to a wide range of medicines. The Act provides the legislative basis for the PBS, with the Minister for Health authorised to determine various aspects of the scheme, including which drugs are listed and their forms and administration methods. One significant aspect of the PBS is the exemption of certain pharmaceutical items from statutory price reductions and price disclosure requirements, a measure intended to encourage the availability of specific drug formulations suitable for particular patient populations. In 2015, an amendment to the PBS was introduced via the Amendment Determination under section 84AH of the National Health Act 1953 (2015) (No. 2), which adjusted the list of exempt pharmaceutical items. This amendment specifically removed a particular form of oestradiol from the exempt list, reflecting changes in the availability or suitability of certain drug formulations. This legislative instrument aligns with the human rights framework by promoting the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. The involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about which medicines are subsidised under the PBS are evidence-based, thereby supporting the progressive realisation of these human rights through the provision of accessible and affordable healthcare.

Scope and Application

The National Health Act 1953 Amendment Determination under section 84AH of the National Health Act 1953 (2015) (No. 2) amends the pharmaceutical items deemed exempt under the Pharmaceutical Benefits Scheme (PBS). The Act applies to pharmaceutical companies with medicines listed on the PBS, particularly those concerned with the exempt items measure. The legislation is designed to ensure that certain pharmaceutical items, which are suitable for specific patient populations due to their form and manner of administration, are exempt from statutory price reductions and disclosure requirements. This is to ensure that patients who require particular formulations of drugs have access to suitable medications. The amendments made by this instrument specifically remove a particular form of oestradiol from the exempt list. The Act applies across the Commonwealth of Australia and is enforced through subordinate instruments, which may include further regulations or determinations as necessary. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on the suitability of pharmaceutical items for particular subgroups, ensuring that decisions are evidence-based. The instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by providing subsidised access to necessary medicines.

Key Provisions

The National Health Act 1953 (the Act) Amendment Determination under section 84AH (2015) (No. 2) primarily involves the removal of a specific pharmaceutical item from the list of exempt items, which was previously determined by the Determination under section 84AH of the National Health Act 1953 (as amended) (PB 58 of 2007). This determination, effective from 1 May 2015, specifically removes oestradiol in the form of vaginal tablets 25 micrograms, 15, administered vaginally, from the list of exempt items (section 84AH). This change is made under the authority granted by section 84AH of the Act, which allows the Minister to determine that a pharmaceutical item is an 'exempt item' if it meets certain criteria. The Act imposes obligations on the Minister to ensure that the pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) are appropriately categorised. These obligations include consulting with the Pharmaceutical Benefits Advisory Committee (PBAC) and considering advice from this committee when determining the suitability of pharmaceutical items for the PBS (subsection 101(4AB) of the Act). The Minister must also ensure that pharmaceutical items that are determined to be exempt items meet the criteria outlined in section 84AH of the Act, such as being a unique listed brand with no bioequivalent or biosimilar listed brands available, and being suitable for a specific patient population due to its form and manner of administration. There are no specific offences, penalties, or civil/criminal consequences outlined in the Act for breaches related to the determination of exempt items. However, the Act provides a framework under which the Minister can make determinations, and these determinations can have significant implications for the availability and pricing of pharmaceutical items on the PBS. The Act relies on the Acts Interpretation Act 1901 for the revocation or variation of determinations unless expressly stated otherwise, ensuring that any changes are made in a controlled and transparent manner.

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