National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 8) (PB 91 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01250 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2020 (No. 8)

PB 91 of 2020

 

Purpose

The purpose of this legislative instrument, made under subsection 89A(3) of the National Health Act 1953 (the Act), is to amend the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to make changes to the pharmaceutical benefits eligible to be provided as a Continued Dispensing supply.

The National Health (Continued Dispensing – Emergency Measures) Determination 2020 (the Principal Instrument) expands the list of pharmaceutical benefits that can 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 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.

This Instrument also provides for amendment of the definition of “PSA Guidelines”, in order to update the version of the PSA Guidelines that applies to that which is in force on the day this Instrument takes effect.  The PSA Guidelines, which are the Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, are prepared and issued by the Pharmaceutical Society of Australia.  In conducting a Continued Dispensing supply, the Determination requires pharmacists to consider the PSA guidelines.  The PSA Guidelines are incorporated by reference into this instrument (sections 2.01 and 2.10).  The PSA Guidelines are freely available from the Pharmaceutical Society of Australia website at www.psa.org.au/.

Authority

Subsection 89A(3) of the National Health Act 1953 (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 poisons laws. States and territories have been informed of the intended Commonwealth changes and asked to consider amendments that may be required to their law to allow access to the eligible medicines.

Amendments made by this Instrument

Schedule 1 to this instrument provides for the deletion of the listed drugs daclatasvir, danazol and dipyridamole and for the deletion of two forms of the listed drug dexamethasone from the list of pharmaceutical benefits that may be supplied as a Continued Dispensing supply.  It also provides for the addition of the listed drug apomorphine and for the addition of forms of the listed drugs aflibercept and amino acid formula with vitamins and minerals without phenylalanine to that list.  These changes are summarised, by subject matter, in the Attachment.

Schedule 1 to this Instrument also provides for the alteration of the definition of “PSA Guidelines”, to update the applicable version to that which is in force on the day this Instrument takes effect.


Consultation

This instrument affects approved pharmacists, at or from premises in respect of which the pharmacist is for the time being approved, supplying a pharmaceutical benefit. Consultation was undertaken prior to commencement of the Principal Instrument with relevant peak bodies including the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia. The Department has also undertaken direct consultation with Services Australia and has consulted with state and territory Departments of Health about implementation.

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 the Attachment.

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 (Continued Dispensing – Emergency Measures) AMENDMENT Determination 2020 (No. 8)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 8) and may also be cited as PB 91 of 2020.

 

2 Commencement

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

 

3 Authority

This section states that this instrument is made under subsection 89A(3) of the National Health Act 1953.

 

4  Amendments to the National Health (Continued Dispensing – Emergency Measures) Determination 2020

The amendments in Schedule 1 involve the addition and deletion of drugs and the addition and deletion of forms of listed drugs to/from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. These changes are summarised below.  The amendments in Schedule 1 also involve an alteration of the definition of PSA Guidelines, to update the applicable version to that which is in force on the day this Instrument takes effect. 

 

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) DETERMINATION 2020 MADE BY THIS INSTRUMENT

Listed Drugs Added

Listed Drug

Apomorphine

Listed Drugs Deleted

Listed Drug

Daclatasvir

Danazol

Dipyridamole

Forms Added

Listed Drug

Form

Aflibercept

Solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL)
pre-filled syringe

Amino acid formula with vitamins and minerals without phenylalanine

Sachets containing oral powder 28 g, 30 (PKU Lophlex)

Forms Deleted

Listed Drug

Form

Dexamethasone

Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL

 

Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

Documents Incorporated by Reference

Document incorporated

Document access

Pharmaceutical Society of Australia Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists (PSA Guidelines). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The PSA Guidelines provides advice to pharmacists on the appropriate and effective processes, desired behaviours of good practice, how to fulfil professional responsibilities, and the expected outcomes for dispensing eligible medicines under the Continued Dispensing supply provisions of the PBS

The PSA Guidelines are freely available from the Pharmaceutical Society of Australia website at www.psa.org.au/

 

 

 

 

 

 


Statement of Compatibility with Human Rights

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

National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 8)

(PB 91 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 (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 8) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 which specifies 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’).

The amendments in Schedule 1 involve the addition and deletion of drugs and the addition and deletion of forms of listed drugs to/from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply.  The amendments in Schedule 1 also involve an alteration of the definition of PSA Guidelines, to update the applicable version to that which is in force on the day this Instrument takes effect.

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 Pharmaceutical Benefits Scheme (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 (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 8) was enacted to address the need for flexibility in the supply of pharmaceutical benefits during emergency situations, particularly in the context of the COVID-19 pandemic. This legislative instrument, made under subsection 89A(3) of the National Health Act 1953, amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to expand the list of pharmaceutical benefits eligible for Continued Dispensing by pharmacists without a prescription. The policy objective is to ensure continued access to essential medications during public health emergencies, thereby supporting the right to health as outlined in the International Covenant on Economic, Social and Cultural Rights. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and update the Pharmaceutical Society of Australia (PSA) Guidelines, which pharmacists must consider when conducting a Continued Dispensing supply. The determination does not override state and territory poisons laws, and states and territories have been informed and encouraged to amend their laws to facilitate access to eligible medicines.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 8) is a legislative instrument made under subsection 89A(3) of the National Health Act 1953, and it amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to update the list of pharmaceutical benefits that can be supplied by approved pharmacists under the Part VII of the Act without a prescription, and the conditions for such a supply. The instrument applies to approved pharmacists who supply pharmaceutical benefits and it incorporates by reference the Pharmaceutical Society of Australia Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists. This instrument does not override state and territory poisons laws, and states and territories have been informed of the changes and asked to consider any necessary amendments to their laws. The instrument commenced on 1 October 2020 and is a legislative instrument for the purposes of the Legislation Act 2003. The instrument amends the list of pharmaceutical benefits eligible for Continued Dispensing by adding and deleting drugs and forms of listed drugs. Specifically, it adds apomorphine to the list, and removes daclatasvir, danazol, dipyridamole, and two forms of dexamethasone from the list. Additionally, it adds forms of aflibercept and amino acid formula with vitamins and minerals without phenylalanine to the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. The instrument also updates the definition of "PSA Guidelines" to reflect the version in force on the day the instrument takes effect. This 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.

Key Provisions

The main operative sections of the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 8) involve amendments to the list of pharmaceutical benefits eligible for Continued Dispensing by pharmacists without a prescription, as specified in the National Health (Continued Dispensing – Emergency Measures) Determination 2020. These amendments are detailed in Schedule 1, where certain drugs and forms of drugs are added or removed from the list. For example, the listed drug apomorphine is added, while daclatasvir, danazol, and dipyridamole are deleted. Additionally, Schedule 1 includes changes to the forms of listed drugs, such as the deletion of specific forms of dexamethasone and the addition of a form of aflibercept. The definition of "PSA Guidelines" is also updated to reflect the version in force on the day this instrument takes effect. The obligations and requirements imposed by this Act on the parties it governs include the need for approved pharmacists to adhere to the updated list of pharmaceutical benefits eligible for Continued Dispensing. Pharmacists must ensure they are supplying medications in accordance with the amended list and must consider the Pharmaceutical Society of Australia (PSA) Guidelines when conducting a Continued Dispensing supply. These guidelines provide advice on appropriate processes, good practice behaviours, professional responsibilities, and expected outcomes for dispensing eligible medicines under the Continued Dispensing supply provisions of the Pharmaceutical Benefits Scheme (PBS). The PSA Guidelines are incorporated by reference into this instrument, and pharmacists are required to be familiar with the guidelines, which are freely available on the PSA website. The instrument does not explicitly outline specific offences, penalties, or civil/criminal consequences for breach. However, any non-compliance with the amended list of pharmaceutical benefits eligible for Continued Dispensing or failure to adhere to the PSA Guidelines could potentially lead to regulatory action under the National Health Act 1953. Pharmacists found to be in breach of the Act may face disciplinary measures, which could include fines, suspension, or revocation of their approval to supply pharmaceutical benefits under the PBS. The exact penalties would depend on the nature and severity of the breach and would be determined in accordance with the provisions of the National Health Act 1953.

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