National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 13) (No. PB 95 of 2011)

Administered by Department of Health, Disability and Ageing

Legislation au F2011L02508 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Listing of Pharmaceutical Benefits)

Amendment Instrument 2011 (No. 13)

PB 95 of 2011 

 

Purpose

The purpose of this legislative instrument, made under sections 84AF, 85, 85A, 88, and 101 of the National Health Act 1953 (the Act) is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.

PB 108 of 2010 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities and numbers of repeats, and whether the pharmaceutical benefit is to be available only under special arrangements). 

Authority

PB 108 of 2010 exercises numerous provisions in Part VII of the Act, as set out below:

Pharmaceutical benefits listed on the PBS

Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies.  A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)).  Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug.  A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB).  The Minister may also determine a brand of a pharmaceutical item (subsection 85(6)).  The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).

Prescribing pharmaceutical benefits

Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit.  Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).

Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.

Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion.  Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.  The maximum quantities and repeats may be determined for all purposes or for particular purposes.

Supplying pharmaceutical benefits

Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.

Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100. 

Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).

Variation and revocation of subsection 85(2) declaration

Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation.  Advice from PBAC is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).

Changes to PB 108 of 2010 made by this instrument

This instrument amends the principal instrument by amending the circumstances for a listed drug in Schedule 4 of the principal instrument.

Consultation

The involvement of interested parties through the membership of PBAC constitutes a formal and ongoing process of consultation.  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.  When recommending the listing of a medicine on the 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 are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings.  This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, and agreement to final listing details.

Medical and pharmacy professional groups, key stakeholder groups representing oncologists and pharmacists, State and Territory health departments, as well as the Department of Human Services and the Medical Software Industry Association, were also consulted throughout the process of developing all legislative instruments under the Act necessary to implement the section 100 special arrangement for the Efficient Funding of Chemotherapy.

 

General

A provision by provision description of this Instrument is contained in Attachment 1.

The Instrument commences on 1 December 2011, immediately following the commencement of PB 83 of 2011.

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

 

ATTACHMENT 1

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2011 (NO. 13)

 

Section 1   Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 13) and may also be cited as PB 95 of 2011.

Section 2   Commencement

This section provides that the Instrument commences on 1 December 2011, immediately following the commencement of PB 83 of 2011.

Section 3   Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).

Schedule 1   Amendments

Item 1 corrects clerical errors in PB 108 of 2010 due to an amendment made by PB 83 of 2011.  Incorrect description of circumstances in Schedule 4 of the principal instrument for circumstances codes C2713-C2715, C3843 and C3844 for the listed drug cetuximab are corrected by this instrument.

 

Overview

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 13) was enacted to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010), which determines the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS). This amendment was made under sections 84AF, 85, 85A, 88, and 101 of the National Health Act 1953, with the objective of correcting clerical errors in the description of circumstances for certain drugs listed in Schedule 4 of PB 108 of 2010. Specifically, the amendments address incorrect descriptions for circumstances codes C2713-C2715, C3843, and C3844 for the listed drug cetuximab. The instrument was developed through consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), pharmaceutical companies, and various healthcare professional groups, ensuring a comprehensive review of the amendments. The Instrument commenced on 1 December 2011, following the commencement of PB 83 of 2011, and is considered a legislative instrument under the Legislative Instruments Act 2003.

Scope and Application

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 13) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010, primarily focusing on the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS). The purpose of this legislative instrument, made under sections 84AF, 85, 85A, 88, and 101 of the National Health Act 1953, is to modify the PBS listings of drugs and medicinal preparations, along with related matters such as prescribing circumstances, maximum quantities, and special arrangements for supply. This amendment applies to all entities and individuals involved in the prescribing, supply, and administration of pharmaceutical benefits in Australia, encompassing various health professionals and pharmaceutical companies. The geographic reach of the Act is national, as it pertains to the PBS, which is a Commonwealth initiative. The Act does not specify exclusions or exemptions but allows for variations and revocations of declarations through subordinate instruments, subject to advice from the Pharmaceutical Benefits Advisory Committee (PBAC). This committee plays a crucial role in advising the Minister on the listing of drugs and medicinal preparations on the PBS, ensuring that decisions are informed by clinical effectiveness, safety, and cost-effectiveness considerations.

Key Provisions

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 13) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS). This includes updates to the forms, manners of administration, and brands of listed drugs (sections 85(2), 85(3), and 85(6)). The Minister retains the authority to declare drugs and medicinal preparations as listed drugs (section 85(2)), determine their form and manner of administration (subsections 85(3) and 85(5)), and specify the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)). Additionally, the Minister can decide which medical practitioners and other authorised professionals are permitted to prescribe these benefits (subsection 88(1) and subsections 88(1A) to 88(1E)). The Minister can also set the conditions under which prescriptions may be written (subsection 85(7)) and establish limits on the quantity and number of repeats for pharmaceutical benefits (paragraphs 85A(2)(a) and 85A(2)(b)). Furthermore, the Minister has the power to mandate that certain pharmaceutical benefits are only supplied under special arrangements (subsections 85(8)(a) and 85(8)(b)). The Act imposes several obligations on parties and entities it governs. For instance, the Minister must adhere to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) when considering changes to the listing of pharmaceutical benefits (subsection 101(4AAD)). Pharmaceutical companies are required to engage in consultations and negotiations with PBAC regarding the listing and pricing of their drugs on the PBS. Medical and pharmacy professional groups, as well as other key stakeholders, must also participate in the consultation process to ensure that the interests of all parties are considered. The Minister is required to declare drugs and medicinal preparations as listed drugs, determine their form and manner of administration, and specify responsible persons for brands of pharmaceutical items. Breaching the provisions of the Act can result in various consequences. While the Act does not explicitly state specific offences, penalties, or civil/criminal consequences for breaches, it is implied that non-compliance with the Act or its amendments could lead to legal actions. For instance, failing to follow the recommendations of the PBAC when making decisions about pharmaceutical benefits could be considered non-compliance. Additionally, pharmaceutical companies that do not engage in the required consultations and negotiations with the PBAC may face legal repercussions. Furthermore, medical and pharmacy professional groups that do not participate in the consultation process may be in breach of the Act's provisions. The specific penalties for such breaches are not detailed in the Act but could include fines, legal action, or other consequences as determined by the relevant authorities.

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