EXPLANATORY STATEMENT
National Health Act 1953
National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2012 (No.2)
PB 91 of 2012
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
The purpose of this legislative instrument, made under subsections 100(1) and (2) of the Act, is to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (PB 118 of 2010) (the Special Arrangement) to make a change to the special arrangement relating to the Paraplegic and Quadriplegic Program and to amend the Special Arrangement to reflect amendments to the Act made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 which commence on 1 October 2012.
Background
This Special Arrangement permits three specified paraplegic and quadriplegic associations (‘authorised associations’) to supply certain pharmaceutical benefits which relate to bowel management to persons with paraplegia or quadriplegia.
To be eligible to receive a supply of pharmaceutical benefits from a specified paraplegic and quadriplegic association under this Arrangement (an ‘eligible person’ under this Arrangement), a person with paraplegia or quadriplegia must be a member of the authorised association. The person must also be an ‘eligible person’ within the meaning of the Health Insurance Act 1973, that is, eligible to receive Medicare benefits.
The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the main PBS listing instrument) commencing 1 October 2012, has been amended to reflect one item for the Bisalax and Lax-Tab brands of bisacodyl tablet 5mg with the maximum amount referring to the number of tablets rather than the number of packs.
This instrument amends the Special Arrangement so that:
- the pharmaceutical item for the Bisalax brand and Lax-tab brand of bisacodyl 5mg specifies the number of tablets (ie, in the same manner as the main listing instrument);
- the maximum amount for bisacodyl 5mg for this Special Arrangement is 400, which refers to the number of tablets (rather than 2 packs);
- reference to ‘section 100 only’ is removed for bisacodyl 5mg as a result of changes to the main listing instrument.
Details of the amendments in this Instrument are set out in the Attachment.
Amendments to the Act
The principal amendments to the Act which are reflected in this legislative instrument are:
- the removal of the concept of an approved price to pharmacists and its replacement with the approved ex-manufacturer price as the base PBS price. The approved ex-manufacturer price of a brand of a pharmaceutical item is the price agreed or determined under the Act as the appropriate maximum price for the purposes of Part VII of the Act. The price for each brand of a pharmaceutical item must be agreed or determined by reference to the lowest pack quantity of any brand of the pharmaceutical item; this quantity is called the pricing quantity. The Act provides for proportional ex-manufacturer prices for other pack quantities;
- claimed prices may be determined under subsection 85B(3) of the Act for any pack quantity of a brand of a pharmaceutical item. These claimed prices are now prices at the ‘ex-manufacturer’ level, whereas prior to 1 October 2012, they were prices at the ‘price to pharmacists’ level.
Consultation
The amendments made by this instrument are machinery in nature and no consultation was undertaken.
This instrument commences on 1 October 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
Details of the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2012 (No.2)
1 Name of Instrument
This section provides that the name of the instrument is the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2012, and that it may also be cited as PB 91 of 2012.
2 Commencement
This section provides that the instrument commences on 1 October 2012.
3 Amendment of the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010
This section provides that Schedules 1 amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (PB 118 of 2010).
SCHEDULE 1 – AMENDMENTS
Item [1] – Section 3, Note
This item amends the list of terms in the Note which are not defined because they have the same meaning as in the Act. One term which is no longer used in the Special Arrangement is omitted from the list and four new terms inserted.
Item [2] – Omit section 8
This item omits section 8 of the Special Arrangement reflecting that from 1 October 2012 there will be no pharmaceutical benefits covered by this Special Arrangement that are section 100 only.
Item [3] – Subsection 14(1)
This item inserts the words ‘a pack quantity of’ in the subsection to make it clear that pack quantities of pharmaceutical benefits are supplied under the Special Arrangement.
Item [4] – Subsection 14(2)
This item substitutes new subsections (2) and (3) for existing subsection (2). The changes reflect changes to the Act commencing on 1 October 2012 and do not affect the level of payment under the Special Arrangement.
Previously, payments were based on the agreed price or the claimed price, which were prices at the price to pharmacists level. From 1 October 2012 prices must be agreed or claimed at the ex-manufacturer level.
New paragraph (2)(a) provides for payments to be based on the price to pharmacists worked out under the paragraph 98B(1)(a) determination; the price to pharmacists is the approved ex-manufacturer price or the proportional ex-manufacturer price, plus a wholesale mark-up.
However, where there is a claimed price for the pack quantity, paragraph (2)(b) applies and payments are based on the claimed price (which is an ex-manufacturer price) plus a wholesale mark-up worked out under subsection (3).
Item [5] – Schedule 1
This item replaces Schedule 1 of the Special Arrangement to remove the column headed ‘Section 100 only’. In addition, 2 pharmaceutical benefits of bisacodyl in the form Tablet, 5mg, 200 are replaced with 2 pharmaceutical benefits of bisacodyl in the form Tablet 5mg. This reflects that the 2 pharmaceutical benefits with bisacodyl in the form Tablet, 5mg, 200 are being removed by the new main listing instrument (the National Health (Listing of Pharmaceutical Benefits) Instrument 2012), which commences 1 October 2012, and that the 2 pharmaceutical benefits of bisacodyl in the form Tablet 5mg will instead be available under this Special Arrangement. Due to the change in form the maximum quantity for the replacement pharmaceutical benefits is being changed from 2 packs to 400 tablets.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2012 (No.2)
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 purpose of this legislative instrument, made under subsections 100(1) and (2) of the Act, is to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (PB 118 of 2010) (the Special Arrangement) to make a change to the special arrangement relating to the Paraplegic and Quadriplegic Program, and to amend the Special Arrangement to reflect amendments to the Act made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 which commence on 1 October 2012.
This Special Arrangement permits three specified paraplegic and quadriplegic associations (‘authorised associations’) to supply certain pharmaceutical benefits which relate to bowel management to persons with paraplegia or quadriplegia.
This instrument amends the Special Arrangement by replacing two pharmaceutical benefits with the listed drug bisacodyl in the form Tablet, 5mg, 200 with two pharmaceutical benefits with the listed drug bisacodyl in the form Tablet 5mg.
Human rights implications
This legislative 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 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.
Kim Bessell
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health and Ageing