National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 8) (PB 90 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01265 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2020 (No. 8)

PB 90 of 2020

 

Purpose

The purpose of this legislative instrument, made under subsection 84AAA(2) of the National Health Act 1953 (the Act) is to amend the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015) (the Principal Instrument).

PB 120 of 2015 specifies the pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies, and to specify the period following previous supply.

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

Authority

Subsection 84AAA(1) of the Act provides that a supply of a pharmaceutical benefit (whether or not the supply is of a kind described in paragraph 84C(4A)(a) of the Act) to a person is an early supply of a specified pharmaceutical benefit if:

(a)           The pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection 84AAA(2); and

(b)           the supply is made within 20 days after the day of a previous supply to the person of:

(i)       the same pharmaceutical benefit; or

(ii)     another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit; or

(iii)   another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit; and

(c)           the supply does not result from a prescription originating from a hospital.

Subsection 84AAA(2) of the Act provides that the Minister may specify, by legislative instrument, pharmaceutical items for the purposes of paragraph 84AAA(1)(b) of the Act.

Subsection 84AAA(3) provides that the instrument may specify a pharmaceutical item by reference to the circumstances in which a pharmaceutical benefit that has the pharmaceutical item is supplied or any other circumstances in relation to a pharmaceutical benefit that has the pharmaceutical item.

Paragraph 84C(4A) of the Act refers to repatriation pharmaceutical benefits supplied under the schemes established under section 91 of the Veterans’ Entitlements Act 1986 or section 18 of the Australian Participants in British Nuclear Tests (Treatment) Act 2006 or supplied in accordance with a determination made under paragraph 256(1)(c) of the Military Rehabilitation and Compensation Act 2004.

Subsection 101(3AA) of the Act requires the Pharmaceutical Benefits Advisory Committee (PBAC) to make recommendations to the Minister about what should be specified in the instrument under subsection 84AAA(2).

Changes to PB 120 of 2015 made by this instrument

Schedule 1 to this instrument provides for the deletion of the listed drugs daclatasvir and dipyridamole from the list of pharmaceutical items that are in pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies.  These changes are summarised, by subject matter, in the Attachment.

The ‘listed drug’, ‘form’, ‘manner of administration’, ‘maximum quantity or number of units’ and ‘maximum number of repeats’ for a pharmaceutical item are the same as declared and determined under the Act for pharmaceutical benefits that have a pharmaceutical item.  These declarations and determinations are made in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Therefore, a supply of a pharmaceutical benefit that has this pharmaceutical item will be an early supply of a specified pharmaceutical benefit providing the requirements of subsection 84AAA(1) are met.

Variation and revocation

Unless there is an express power to revoke or vary PB 120 of 2015 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 120 of 2015.

Consultation

The involvement of PBAC constitutes a formal and ongoing process of consultation.  The PBAC is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits.  PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  The Committee also includes a pharmaceutical industry nominee.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the Committee.  The PBAC has provided advice regarding what should be specified in this Instrument.

This amendment is minor and machinery in nature.

General

This Instrument commences on 1 October 2020.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2020 (No. 8)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 8) and may also be cited as PB 90 of 2020.

Section 2 Commencement

This section provides that the Instrument commences on 1 October 2020.

Section 3 Amendment of National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015)

This section provides that Schedule 1 amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015).

Schedule 1 Amendments

The amendments in Schedule 1 involve the deletion of listed drugs from the list of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme safety net entitlements will not apply for early supplies.  These changes are summarised below.

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS—EARLY SUPPLY) INSTRUMENT 2015 MADE BY THIS INSTRUMENT

Listed Drugs Deleted

Listed Drug

Daclatasvir

Dipyridamole


Statement of Compatibility with Human Rights

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

National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 8)

(PB 90 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

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 8) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 which specifies the pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies.

The amendments in Schedule 1 involve the deletion of listed drugs from the list of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme safety net entitlements will not apply for early supplies.  

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 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 Legislative Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

 

Thea Connolly

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2020 (No. 8) (PB 90 of 2020) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 to adjust the list of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This legislative instrument, enacted under the National Health Act 1953, aims to align the provisions of the principal instrument with recent amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes, which came into effect on 1 October 2020, involve the deletion of daclatasvir and dipyridamole from the list of pharmaceutical items exempt from PBS safety net entitlements for early supplies. The amendments are minor and machinery in nature, reflecting the ongoing consultation process with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that provides recommendations to the Minister regarding which drugs and medicinal preparations should be available as pharmaceutical benefits. This amendment assists in the progressive realisation of the human right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. The instrument was made under the authority of subsection 84AAA(2) of the National Health Act 1953, which empowers the Minister to specify pharmaceutical items by legislative instrument. The Pharmaceutical Benefits Advisory Committee played a pivotal role in the decision-making process, ensuring that the recommendations were evidence-based and aligned with the objectives of the PBS. The amendments are compatible with human rights, as they contribute to the advancement of the right to health by facilitating timely access to necessary medications, subject to the PBS regulations.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2020 (No. 8) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015, which specifies the pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This amendment applies to pharmaceutical benefits under the National Health Act 1953 and affects the circumstances in which certain pharmaceutical items are supplied. The changes, effective from 1 October 2020, involve the deletion of specific listed drugs, daclatasvir and dipyridamole, from the list of pharmaceutical items for which PBS safety net entitlements will not apply in cases of early supply. The Pharmaceutical Benefits Advisory Committee (PBAC) provided advice regarding these amendments, ensuring decisions are evidence-based. This amendment is a minor and machinery in nature, and it does not alter the fundamental structure or requirements of the PBS but modifies the specific list of pharmaceutical items affected by early supply provisions.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2020 (No. 8) (referred to as the Instrument) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2015 (PB 120 of 2015), specifying changes to the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This is detailed in Schedule 1 of the Instrument, which removes the listed drugs daclatasvir and dipyridamole from the list of pharmaceutical items affected by this exclusion (section 3, Schedule 1). This amendment came into effect on 1 October 2020 (section 2). Under the National Health Act 1953 (the Act), an early supply of a pharmaceutical benefit occurs if the pharmaceutical item is specified in the relevant instrument, and the supply is made within 20 days after the previous supply of the same or an equivalent pharmaceutical benefit (subsection 84AAA(1)). The Pharmaceutical Benefits Advisory Committee (PBAC) provides recommendations to the Minister about what should be specified in the relevant instrument (subsection 101(3AA)). These amendments, therefore, mean that supplies of daclatasvir and dipyridamole within 20 days of the previous supply will now be subject to PBS safety net entitlements, whereas previously they were not. Entities and parties governed by this legislation must comply with the updated list of pharmaceutical items specified in Schedule 1 of the Instrument. This involves ensuring that supplies of daclatasvir and dipyridamole within 20 days of the previous supply are processed in accordance with the PBS safety net entitlements. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in advising the Minister on these matters, ensuring that decisions are based on evidence and expert recommendations. The Act does not specify offences or penalties for non-compliance with the requirements of the Instrument. However, failure to adhere to the updated list of pharmaceutical items could lead to issues with the processing of PBS claims, potentially resulting in financial implications for both the suppliers and the patients involved. It is important for entities involved in the supply and administration of pharmaceutical benefits to stay updated with these changes to ensure compliance and avoid any potential disputes or financial penalties.

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