Amendment Determination under section 84AH of the National Health Act 1953 (2015) (No. 3) (PB 74 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01207 Not in force Legislative Instrument

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 EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 74 OF 2015

 

NATIONAL HEALTH ACT 1953

 

AMENDMENT DETERMINATION UNDER SECTION 84AH OF THE NATIONAL HEALTH ACT 1953 (2015) (No. 3)

 

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 = Levetiracetam, form = Oral solution, 100 mg per mL, 300 mL, manner of administration = Oral) 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 August 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. 3) (PB 74 of 2015)

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 levetiracetam 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 Amendment Determination under section 84AH of the National Health Act 1953 (2015) (No. 3) (PB 74 of 2015) was enacted to amend the Determination under section 84AH of the National Health Act 1953 (as amended) (PB 58 of 2007) regarding the pharmaceutical items that are determined to be exempt items under the Pharmaceutical Benefits Scheme (PBS). The PBS is a scheme under the National Health Act 1953 that ensures reliable, timely, and affordable access to medicines for all Australians. The Minister of Health, under section 84AH of the Act, determines whether a pharmaceutical item is an exempt item based on specific criteria, including the availability of suitable formulations for particular patient populations. This Amendment Determination removes one pharmaceutical item, specifically Levetiracetam in the form of an oral solution, 100 mg per mL, 300 mL, from the list of exempt items. This change aims to refine the allocation of exemptions to ensure they target the most appropriate therapeutic needs. The instrument was developed in consultation with pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the decision-making process is informed and evidence-based. The Amendment Determination 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 ensuring appropriate access to necessary medications.

Scope and Application

The National Health Act 1953 Amendment Determination under section 84AH (No. 3) 2015, issued as legislative instrument F2015L01207, modifies the list of pharmaceutical items exempt from certain provisions of the Act, specifically the Pharmaceutical Benefits Scheme (PBS). This Act applies to pharmaceutical items listed under the PBS, entities involved in the manufacture, distribution, and sale of these items, and the Pharmaceutical Benefits Advisory Committee (PBAC), which provides expert advice on the suitability of pharmaceutical items for particular patient populations. The amendment affects the Commonwealth of Australia and is applicable nationally, ensuring uniform standards across the country. The determination excludes certain pharmaceutical items from statutory price reductions and price disclosure requirements if they meet specific criteria, such as having a unique brand and form suitable for a particular patient subgroup. The changes made by this instrument are specific to one pharmaceutical item, an oral solution of Levetiracetam, which is removed from the exempt list. The instrument relies on subsection 33(3) of the Acts Interpretation Act 1901 for its authority to revoke or vary the principal instrument, PB 58 of 2007. This legislative 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 ensuring access to suitable pharmaceutical items through the PBS.

Key Provisions

The main operative sections of this legislation (F2015L01207) pertain to the determination of pharmaceutical items as 'exempt items' under the National Health Act 1953. Specifically, section 84AH of the Act allows the Minister for Health to designate certain pharmaceutical items as exempt, provided they meet specific criteria (subsections 84(1), 85(2), 85(3), and 85(5)). This determination excludes these items from statutory price reductions and price disclosure requirements. This amendment (PB 74 of 2015) modifies the previous determination (PB 58 of 2007) by removing the oral solution form of the drug levetiracetam from the exempt list. The determination process relies on advice from the Pharmaceutical Benefits Advisory Committee (PBAC), which evaluates the suitability of pharmaceutical items for particular patient subgroups. The Act imposes obligations on the Minister for Health to determine whether pharmaceutical items meet the criteria for being listed as exempt items. The Minister must consider advice from PBAC and ensure that the determination aligns with the criteria outlined in section 84AH. Additionally, pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS) must comply with the determinations made under the Act. The process also involves consultation with stakeholders, including the PBAC, to ensure that the decisions are evidence-based and consider the needs of specific patient populations. Failure to comply with the provisions of the Act can lead to civil and criminal consequences. While specific offences and penalties are not detailed in this instrument, breaches of the National Health Act 1953 can generally result in significant penalties. Under Australian law, penalties for breaches can include fines and imprisonment, depending on the severity of the offence. For example, under the Act, individuals or entities found guilty of contravening the provisions related to the PBS could face fines of up to $22,200 for individuals and $111,000 for bodies corporate, as well as potential imprisonment terms. These penalties underscore the importance of compliance with the Act and the determinations made under it.

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