National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2) (PB 13 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00216 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2019 (No. 2)

PB 13 of 2019

 

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.

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

Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

Purpose

This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2) (this Instrument).  The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs program.

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.

The amendments made by this Instrument include additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).

A provision by provision description of this Instrument is contained in the Attachment.

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.

PBAC is an 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 as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations 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.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  In addition, an industry nominee has been appointed to the PBAC membership.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS.  This includes consultation through the PBAC process.

Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.

Details of this Instrument are set out in the Attachment.

This Instrument commences on 1 March 2019.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2019 (No. 2)

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2). It can also be cited as PB 13 of 2019.

Section 2 Commencement

This section provides that this Instrument commences on 1 March 2019.

Section 3 Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule Amendments

The amendments in Schedule 1 provide for additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).  These changes are summarised below.

 

SUMMARY OF CHANGES

Listed drugs added

Bictegravir with emtricitabine with tenofovir alafenamide

Brands added

Valaciclovir

Tablet 500 mg (as hydrochloride) (Valaciclovir APOTEX)

Brands deleted

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL (DEZTRON)

 


Statement of Compatibility with Human Rights

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

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2)

(PB 13 of 2019)

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.

Overview of the Instrument

The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs program.

The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.

Human rights implications

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

 

 

 

Ben Sladic

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2019 (No. 2) was enacted to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This Instrument, made under the authority of the National Health Act 1953, aims to update the Highly Specialised Drugs program by reflecting amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The policy objective of the Instrument is to ensure that the Highly Specialised Drugs program remains current and effective in providing subsidised access to medicines for chronic conditions requiring specialised treatment, through the evidence-based recommendations of the Pharmaceutical Benefits Advisory Committee. The Instrument is compatible with human rights, particularly advancing the right to the highest attainable standard of physical and mental health by ensuring access to necessary medications. The amendments made by this Instrument include additions, deletions, and changes to drugs, forms, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits, including authority requirements. These changes are in response to recommendations from the Pharmaceutical Benefits Advisory Committee and align with the Pharmaceutical Benefits Scheme’s objectives to provide equitable access to cost-effective medications. The Instrument commenced on 1 March 2019, ensuring that the Highly Specialised Drugs program continues to meet the evolving healthcare needs of patients in Australia.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2) is an amendment to the National Health (Highly specialised drugs program) Special Arrangement 2010. The Instrument is made under the authority of the National Health Act 1953, specifically under subsection 100(2) which allows the Minister to vary or revoke a special arrangement made under subsection 100(1). This Instrument applies to the Highly Specialised Drugs program, which is part of the Pharmaceutical Benefits Scheme (PBS), and it affects the supply of pharmaceutical benefits for the treatment of chronic conditions requiring specialised treatment. The amendments include changes to drugs, forms, responsible person codes, and prescribing circumstances for various pharmaceutical benefits, reflecting updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes are aimed at ensuring that the Special Arrangement remains current and effective in providing access to necessary treatments. The Instrument came into effect on 1 March 2019 and is considered a legislative instrument under the Legislation Act 2003.

Key Provisions

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2) (F2019L00216) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to make changes to the Highly Specialised Drugs program. This Instrument, made under subsection 100(2) of the National Health Act 1953, reflects amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The amendments include additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits, including authority requirements. These changes are outlined in the Attachment to the Instrument. The Act imposes certain obligations and requirements on parties involved in the Highly Specialised Drugs program. The Minister for Health, under subsection 100(1), has the authority to make special arrangements for the supply of pharmaceutical benefits, which includes the ability to vary or revoke these arrangements as per subsection 100(2). The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, provides recommendations to the Minister about which drugs should be available as pharmaceutical benefits. These recommendations are based on the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety, and cost-effectiveness compared with other treatments. Pharmaceutical companies are also required to consult throughout the process of changes to the listings on the Pharmaceutical Benefits Scheme (PBS). Failure to comply with the provisions of this Instrument may result in legal consequences. Although the specific offences, penalties, or civil/criminal consequences for breach are not explicitly stated in the Instrument, non-compliance with the Act or the special arrangements could potentially lead to legal actions. The penalties for breaches of the National Health Act 1953 may include fines or imprisonment, depending on the severity of the breach. Additionally, any changes to the Special Arrangement and the PBS listings may have implications for the availability and access to pharmaceutical benefits for patients, which could result in civil consequences for parties that fail to adhere to the requirements set forth in the Act. In conclusion, the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2) amends the Special Arrangement to reflect changes in the Highly Specialised Drugs program. It imposes obligations on the Minister for Health and the Pharmaceutical Benefits Advisory Committee, as well as requirements for pharmaceutical companies. While the specific penalties for non-compliance are not explicitly stated, breaches of the Act or special arrangements may result in legal consequences, including fines or imprisonment.

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