National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 (PB 109 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01366 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020

PB 109 of 2020

 

Authority

This legislative instrument is made pursuant to section 88 and subsection 100(2) of the National Health Act 1953 (the Act).

Section 88 of the Act provides that the Minister may authorise by legislative instrument, the classes of authorised prescriber who may prescribe a pharmaceutical benefit. It also provides that the Minister can list pharmaceutical benefits without determining any authorised prescribers for the benefit.

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Purpose

The National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 (the instrument) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to allow for pharmaceutical benefits to be listed without an authorised prescriber from 1 November 2020 and therefore be listed for supply only.

Pharmaceutical benefits will be listed for supply only for a period of up to 12 months, after which time they will be fully de-listed from the PBS (available for neither prescribing nor supply).

The changes provide administrative clarity for the Department, Services Australia, Approved Pharmacists and software vendors who have been relying on manual workarounds prior to 1 November, to ensure that patients receive critical medicines regardless of the administrative circumstances of a pharmaceutical benefit.

These supply only arrangements ensure that patients will not be disadvantaged as existing valid prescriptions will remain valid after the pharmaceutical benefit is removed for prescribing purposes. This removes the need for a patient to consult with their prescriber about an existing prescription which has become invalid due to the delisting of the pharmaceutical benefit.

The arrangements will also allow manufacturers time to deplete remaining stock of the pharmaceutical benefit which reduces medicine wastage.

Background

Changes made to the Act in February 2018 provided for pharmaceutical benefits to be listed on the Pharmaceutical Benefits Scheme (PBS) for supply only, but not for prescribing.

This was achieved by extending the Minister’s power already in place to determine authorised prescribers for a pharmaceutical benefit (such as optometrists, dental practitioners, and medical practitioners) to also be able to determine that a pharmaceutical benefit has no authorised prescribers applying to it (subsection 88(1EB)).

This change allows for a pharmaceutical benefit to be listed on the PBS, but with no authorised prescriber. In this way, the Minister could revoke any determination made under any of subsections 88(1) to 88(1E) in the event that the listing needs to be retained only for supply purposes. This has the effect of preventing any new prescriptions being written in relation to the specified listing, while still allowing the pharmaceutical benefit to remain listed on the PBS for supply of the benefit on the basis of a valid prescription written prior to the date the determination of authorised prescribers was revoked.

The powers conferred by the changes made to the Act in February 2018 have not been exercised to date but are scheduled to begin being exercised with effect from 1 November 2020.   The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and the National Health (Highly specialised drugs program) Special Arrangement 2010 consequently require amendment to support the implementation of this policy by describing the pharmaceutical benefits that are available on the PBS for supply purposes only.

Consultation

The amendments made by this Instrument accord with changes made to the Act in February 2018. These changes were minor and mechanical in nature and were made to allow valid prescriptions written for a subsequently deleted pharmaceutical benefit to be dispensed after the deletion.

This change has been made in response to prior consultation with, and ongoing feedback from, PBS prescribing and dispensing Software Vendors, and Services Australia, who frequently undergo complicated and time consuming manual efforts to allow valid scripts to continue being supplied, and related claims to be paid, for pharmaceutical benefits that may no longer be prescribed under the Act.

It was considered that further consultation for this instrument was unnecessary due to the minor and mechanical nature of the change.

This instrument commences immediately after the commencement of the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 10) and the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 9).

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

 

 

 

 

 

 

 

 

 


ATTACHMENT

Details of the National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020

1 Name

This section provides that the name of this instrument is the National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 and may also be cited as
PB 109 of 2020.

2 Commencement

This section provides that the instrument commences immediately after the commencement of the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 10) and the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 9).

3 Authority

This section states that this instrument is made under subsections 88 and 100(2) of the National Health Act 1953.

4  Schedules

Section 4 provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule has effect according to its terms.

 

Schedule 1–Amendments

 

Part 1 - Listing of pharmaceutical benefits

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

1 Section 9 (heading)

This section repeals the name of the section, being ‘9 Authorised prescriber’. The name is replaced with the new name ‘9 Authorised prescribers—Part 1 of Schedule 1’.

2 Subsection 9(1A)

This section makes changes to restrict authorised medical practitioners to write a prescription for pharmaceutical benefits listed only in Part 1 of Schedule 1.

3 Subsections 9(1), (2), (3), (4) and (5)

This section makes changes to restrict authorised dental practitioners, authorised optometrists, authorised midwives and authorised nurse practitioners, to write a prescription for pharmaceutical benefits listed only in Part 1 of Schedule 1.

4 Schedule 1 (heading)

This section repeals the name of schedule 1, being Schedule 1—Ready‑prepared pharmaceutical benefits (sections 5 to 10, 16 to 18, 20, 21, 23 to 26). The name is replaced with the new name Schedule 1—Ready prepared pharmaceutical benefits Note: See sections 5 to 10, 16 to 18, 20, 21 and 23 to 26. Part 1—Ready prepared pharmaceutical benefits for prescription and supply.

5 At the end of the Schedule 1

This section inserts a new part to Schedule 1 in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). This part, Part 2—Ready prepared pharmaceutical benefits for supply only, lists pharmaceutical benefits which are not able to be prescribed and are therefore listed for supply only.

Part 2 - Highly specialised drugs

National Health (Highly specialised drugs program) Special Arrangement (PB 116 of 2010)

6 At the end of Section 8

This section inserts a new subsection which limits the power of Subsection 8(1) so that it does not apply to HSD pharmaceutical benefits mentioned in Part 2 of Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (ready prepared pharmaceutical benefits for supply only).


Statement of Compatibility with Human Rights

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

National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020

(PB 109 of 2020)

This Disallowable 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 Disallowable Legislative Instrument

The National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 (the amendment instrument) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010). The amendment instrument introduces for the first time pharmaceutical benefits which are available on the Pharmaceutical Benefits Scheme for the purposes of supply only.

The National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 (109 of 2020) modifies  Schedule 1 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to include Part 2, which lists pharmaceutical benefits which are available for the purposes of supply only. This allows for pharmaceutical benefits which have been removed from the PBS for prescribing purposes to be supplied to patients who still possess valid prescriptions.

PB 109 of 2020 also amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to align it with the changes being made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) so that any pharmaceutical benefits listed in Schedule 1 Part 1 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 can also no longer be prescribed under the National Health (Highly specialised drugs program) Special Arrangement 2010.

Human rights implications

This Disallowable 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 ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

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

 

Paul Hansen

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 was introduced to address a gap in the National Health Act 1953, particularly concerning the listing of pharmaceutical benefits on the Pharmaceutical Benefits Scheme (PBS) for supply only, without an authorised prescriber. This legislative amendment was enacted by the Minister for Health under sections 88 and 100(2) of the National Health Act 1953. The primary objective of this amendment is to provide administrative clarity for the Department of Health, Services Australia, Approved Pharmacists, and software vendors, ensuring that patients can continue to receive critical medicines even when pharmaceutical benefits are removed from the PBS for prescribing purposes. This amendment allows for pharmaceutical benefits to be listed for supply purposes only for up to 12 months, thereby ensuring that existing valid prescriptions remain valid and reducing medicine wastage. In summary, the National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 was made to facilitate the transition of certain pharmaceutical benefits from prescribing to supply-only status, thereby providing continuity of supply to patients and allowing manufacturers to manage remaining stock effectively. This legislative instrument aims to streamline the administration of the PBS and ensure that patients' access to necessary medications is not disrupted.

Scope and Application

The National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 applies to the regulation of pharmaceutical benefits within the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This instrument specifically governs the listing and supply of pharmaceutical benefits for supply only, which means these medications can be supplied to patients based on valid prescriptions written before the pharmaceutical benefit was delisted from prescribing purposes, without the need for a new prescription. The instrument affects pharmaceutical entities, healthcare professionals, patients, and software vendors who deal with PBS prescriptions and dispensing. Geographically, the application of this legislation is national, as it pertains to the PBS, which is administered across Australia. The instrument excludes certain highly specialised drugs, as these are subject to separate arrangements detailed in the National Health (Highly specialised drugs program) Special Arrangement 2010. The application of the Act can be further extended or restricted through subordinate instruments made under the authority of the National Health Act 1953. This legislative instrument is designed to provide clarity and continuity in the supply of essential medications by allowing certain pharmaceutical benefits to be listed for supply purposes only, following their removal from the list of items available for prescribing. This ensures that patients who have valid prescriptions for these medications can still receive them, while preventing new prescriptions from being written. The instrument aims to reduce administrative burdens on healthcare providers and software vendors, and to minimise medicine wastage by allowing time for existing stock to be depleted. By amending the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and the National Health (Highly specialised drugs program) Special Arrangement 2010, the instrument ensures that the legislative framework is aligned with the new policy of listing pharmaceutical benefits for supply only.

Key Provisions

The National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 (section 2) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to allow for pharmaceutical benefits to be listed on the Pharmaceutical Benefits Scheme (PBS) for supply only, from 1 November 2020. This means that a pharmaceutical benefit can be listed on the PBS and available for supply, but no longer available for prescribing. This change was made to ensure that patients who have valid prescriptions for a pharmaceutical benefit that has been removed from the PBS for prescribing purposes can still obtain the medicine. The changes also aim to reduce medicine wastage by giving manufacturers time to deplete remaining stock of the pharmaceutical benefit before it is fully de-listed from the PBS. The amendments made by this Instrument accord with changes made to the Act in February 2018, which provided for pharmaceutical benefits to be listed on the PBS for supply only, but not for prescribing. The National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 imposes obligations on the Minister to list pharmaceutical benefits for supply only, without an authorised prescriber, for a period of up to 12 months. The Minister is also required to ensure that pharmaceutical benefits listed for supply only are available for supply to patients who have valid prescriptions for the benefit. The Instrument also imposes obligations on Approved Pharmacists to supply pharmaceutical benefits listed for supply only to patients who have valid prescriptions for the benefit. The Instrument imposes obligations on software vendors to update their software to ensure that valid prescriptions for pharmaceutical benefits listed for supply only can continue to be supplied, and related claims to be paid. Breaching the obligations imposed by the National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 may result in civil or criminal consequences. The maximum penalty for a civil penalty offence under the National Health Act 1953 is $22,200 for an individual and $111,000 for a body corporate. The maximum penalty for a criminal offence under the National Health Act 1953 is $55,500 for an individual and $277,500 for a body corporate. The penalties for breaching the obligations imposed by the Instrument are in addition to any other penalties that may apply under the National Health Act 1953 or other legislation. The National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 is a legislative instrument for the purposes of the Legislation Act 2003. It is made under subsections 88 and 100(2) of the National Health Act 1953, and commences immediately after the commencement of the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 10) and the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 9). The 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, as it assists 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.

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