National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2015 (No. 12)

PB 117 of 2015

Purpose

The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.

PB 71 of 2012 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 (equivalent brands, responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).

Authority

This Instrument exercises various powers 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 4(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).  Subsection 85(6) provides that the the Minister may determine a brand of a pharmaceutical item.

The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).  Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.

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 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).

Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.

Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions. 

Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.

Variation and revocation

Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.

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 the Pharmaceutical Benefits Advisory Committee (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 71 of 2012 made by this instrument

Schedule 1 to this instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), equivalent brands, determined quantities, pack quantities, section 100 only status and prescriber bag only status.  These changes are summarised, by subject matter, in the Attachment.

This instrument amends PB 71 of 2012 to implement a measure included in the PBS Access and Sustainability Package announced by the Australian Government in May 2015 for the removal of PBS subsidy for certain low-cost Over-The Counter (OTC) medicines.  The PBAC has recommended delisting or amendment to the prescribing of these OTC medicines.  A small number of OTC products are being delisted from the PBS from 1 January 2016 for most consumers.  The only OTC medicines affected are those where the manufacturer’s price is lower than the concessional co-payment.  The PBAC recommended retaining these listings for patients receiving palliative care; those relying on access to these medicines through the Section 100 Paraplegic and Quadriplegic Program; and for patients identifying as being of Aboriginal or Torres Strait Islander origin.

In some cases, following consultation, the sponsors of some OTC products have elected to delist their brand(s) from the PBS as a result of this measure.  PBAC considered each of the affected brands at its November 2015 meeting.  Delisting of these drugs and pharmaceutical items takes effect on 1 January 2016. 

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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the PBS, the 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, guarantee of supply and agreement to final listing details.

In  July 2015 the PBAC considered a list of OTC products identified for delisting from the PBS.  The PBAC considered stakeholder input from sponsors and patient organisations that had responded to the call for comments.  In particular, the PBAC noted the issues raised regarding maintenance of access for Aboriginal and Torres Strait Island peoples, and for paraplegic and quadriplegic patients who rely on current access arrangements. 

The PBAC recommended that rather than delisting these OTC drugs from the PBS, it would be appropriate for the PBS listings to restrict access to patients receiving palliative care; for those patients relying on access to these medicines through the Section 100 paraplegic and quadriplegic program; and for patients identifying as being of Aboriginal and Torres Strait Island origin.  The PBAC considered that these recommendations would address the needs of the most vulnerable Australian patients. 

A list of OTC items recommended for delisting or amendment from 1 January 2016 was published on 3 November 2015.

General

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

This Instrument commences on 1 January 2016.

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

ATTACHMENT

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2015 (No. 12)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) and may also be cited as PB 117 of 2015.

Section 2 Commencement

This section provides that this Instrument commences on 1 January 2016.

Section 3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1   Amendments

The amendments in Schedule 1 involve additions, deletions and changes to forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status.  These changes are summarised below.

SUMMARY OF CHANGES

Listed Drugs Deleted

Forms Deleted

Brands Added

Brands Deleted

Alteration of Responsible Person

Addition of Responsible Person Code

Deletion of Responsible Person Code

Alteration of Responsible Person Name

Alteration of Circumstances

Alteration of Circumstances Code

The circumstances codes for the following drugs in Schedule 1 and the corresponding circumstance codes in Schedule 4 to the principal instrument have changed, no other change has been made to the circumstances.  Any other changes to these listings are detailed under the relevant headings in this summary.

Alteration of terminology

The term “non-narcotic analgesics” in the circumstances for the following drugs has been replaced by the term “non-opioid analgesics”.  The term “narcotic” is outdated in opioid clinical practice and the PBAC recommended that the change to “opioid” would ensure that the opioid restrictions reflect current clinical practice.  There is no functional difference between “narcotic” and “opioid” in the restriction and as a result the circumstances codes for these drugs are unchanged.