Contents
Part 1—Preliminary 2
1 Name 2
2 Commencement 2
3 Authority 2
4 Definitions 2
5 Pharmaceutical benefits covered by this Special Arrangement 3
6 Application of Part VII of the Act 3
7 Responsible person 3
8 No prescriber or prescription 4
Part 2—Supply for the paraplegic and quadriplegic program 4
9 Paraplegic and quadriplegic associations 4
10 Eligible persons 5
11 Maximum amount 5
12 Supply 5
13 Co‑payment etc. not to be made 6
14 Payment from Commonwealth 6
15 Charge for delivery 7
16 Claims for payment 7
17 Stock of pharmaceutical benefits etc. 7
18 Internal review of decisions 8
19 Application of this Special Arrangement 8
Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information 9
Schedule 2—Responsible Person Codes 10
Schedule 3—Repeals 11
National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 11
1 Name
(1) This Special Arrangement is the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021.
(2) This Special Arrangement may also be cited as PB 31 of 2021.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information |
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | The day after this instrument is registered. | |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This Special Arrangement is made under section 100 of the National Health Act 1953.
In this Special Arrangement:
ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.
Act means the National Health Act 1953.
authorised association means a paraplegic and quadriplegic association authorised to supply pharmaceutical benefits under this Special Arrangement by section 9.
eligible person means a person that is eligible to receive pharmaceutical benefits under section 10.
Note: Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislation Act 2003. These terms include:
· approved ex‑manufacturer price
· brand
· claimed price
· listed drug
· pack quantity
· pharmaceutical benefit
· pharmaceutical item
· proportional ex‑manufacturer price
· responsible person.
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
(2) Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note: Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.
(1) Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
(2) A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.
Note: See subsection 100(3) of the Act.
(1) If a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2)(a) is the responsible person for the brand of the pharmaceutical item.
(2) For subsection (1):
(a) the person is the person mentioned in Schedule 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and
(b) the pharmaceutical item is the listed drug mentioned in Schedule 1:
(i) in the form mentioned in Schedule 1 for the listed drug; and
(ii) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note: A person identified by a code in the column headed ‘Responsible Person’ in Schedule 1 has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.
(1) If a pharmaceutical benefit is supplied in accordance with this Special Arrangement, the following determinations do not apply to the supply:
(a) a determination made under section 88 of the Act about PBS prescribers for the pharmaceutical benefit;
(b) a determination made under paragraph 85(7)(b) of the Act about the circumstances in which a prescription for the pharmaceutical benefit may be written;
(c) a determination made under paragraph 85A(2)(a) of the Act about the maximum quantities or number of units of the pharmaceutical item in the pharmaceutical benefit that may, in 1 prescription, be directed to be supplied on any 1 occasion;
(d) a determination made under paragraph 85A(2)(b) of the Act about the maximum number of occasions on which the pharmaceutical benefit may be directed to be supplied in a prescription.
The following paraplegic and quadriplegic associations are authorised to supply pharmaceutical benefits under this Special Arrangement:
(a) The Paraplegic & Quadriplegic Association of NSW (ABN 42 000 355 948); and
(b) Independence Australia Group (ABN 80 973 805 243).
A person is eligible to receive a pharmaceutical benefit from an authorised association if the person:
(a) is an eligible person within the meaning of the Health Insurance Act 1973; and
(b) has paraplegia or quadriplegia; and
(c) is a member of the association.
(1) The maximum amount of the pharmaceutical item in a pharmaceutical benefit that may, during a month, be supplied by an authorised association to an eligible person is the amount mentioned in the column in Schedule 1 headed ‘Maximum Amount’ for the pharmaceutical benefit.
(2) For subsection (1):
(a) the pharmaceutical item is the listed drug mentioned in Schedule 1:
(i) in the form mentioned in Schedule 1 for the listed drug; and
(ii) with the manner of administration mentioned in Schedule 1 for the form of the listed drug; and
(b) the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(i) in the form mentioned in Schedule 1 for the listed drug; and
(ii) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
(1) An authorised association may supply a pharmaceutical benefit to an eligible person:
(a) on the person’s request; and
(b) despite section 89 of the Act, without a prescription written for the supply to the person.
Note: Section 89 of the Act provides for pharmaceutical benefits to be supplied only on prescription.
(2) The association may supply the pharmaceutical benefit to the person by:
(a) making the pharmaceutical benefit available to be picked up by the person at the association’s premises; or
(b) sending the pharmaceutical benefit to the person.
An authorised association must not demand or receive a payment or other valuable consideration for the supply of a pharmaceutical benefit under this Special Arrangement, other than:
(a) a payment from the Commonwealth under section 14.
(b) a charge mentioned in section 15.
(1) An authorised association that supplies a pack quantity of a pharmaceutical benefit is entitled to be paid by the Commonwealth for the supply the amount worked out under subsection (2).
(2) For subsection (1), the amount is:
(a) if there is no claimed price for the pack quantity of the pharmaceutical benefit:
(i) the price to pharmacists for the pack quantity worked out under the determination under paragraph 98B(1)(a) of the Act; and
(ii) a handling fee of 2.75% of that amount; or
(b) if there is a claimed price for the pack quantity of the pharmaceutical benefit:
(i) the claimed price for the pack quantity plus a wholesale mark‑up calculated in accordance with subsection (3); and
(ii) a handling fee of 2.75% of that amount.
(3) For paragraph (2)(b), the wholesale mark‑up for the pack quantity of the pharmaceutical benefit is to be worked out using the methodology for calculating the wholesale mark‑up for ready‑prepared pharmaceutical benefits in the determination under paragraph 98B(1)(a) of the Act, subject to the following:
(a) for the purposes of identifying the appropriate wholesale mark‑up formula in Step 2 of the methodology, the ex‑manufacturer price for the relevant quantity is to be worked out proportionately from the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity of the pharmaceutical benefit; and
(b) otherwise, the methodology is to be applied as if the claimed price for the pack quantity of the pharmaceutical benefit were the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity.
If an authorised association supplies a pharmaceutical benefit by sending it to a person the association may charge the person an amount that is equal to the cost of sending the pharmaceutical benefit to the person.
(1) An authorised association that wants to receive payment for the supply of a pharmaceutical benefit under this Special Arrangement must make a claim for payment to the Chief Executive Medicare.
(2) The Chief Executive Medicare must determine the amount payable for a claim made under this Part and make any payment relating to the claim.
(3) Despite section 99AAA of the Act, the association must submit its claims for the supplies it makes during a month on a form approved in writing by the Chief Executive Medicare for this section.
Note: Section 99AAA of the Act provides for rules to be made by the Minister about procedures for claims for payment.
An authorised association may:
(a) order a pharmaceutical benefit from:
(i) the responsible person for the brand of the pharmaceutical item in the pharmaceutical benefit; or
(ii) a wholesaler for the pharmaceutical benefit; and
(b) keep in stock at its premises an adequate supply of pharmaceutical benefits for supply to its members under this Special Arrangement.
Application for review
(1) A person who is affected by a decision of the Chief Executive Medicare under this instrument may apply to the Secretary for review of the decision.
(2) An application for review must:
(a) be in writing; and
(b) be made within:
(i) 28 days after the day the decision first came to the notice of the applicant; or
(ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.
Review of decision
(3) On receiving an application, the Secretary must:
(a) review the decision; and
(b) affirm, vary or set aside the decision; and
(c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.
(4) The decision (the decision on review) of the Secretary takes effect:
(a) on the day specified in the decision on review; or
(b) if a day is not specified—on the day the decision on review was made.
Notice of decision
(5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:
(a) the terms of the decision;
(b) the reasons for the decision.
This Special Arrangement applies to a supply of a pharmaceutical benefit that is made the day after registration.
(sections 5, 7 and 11)
| Listed Drug | Form | Manner of Administration | Brand | Responsible Person | Maximum Amount |
| Bisacodyl | Tablet, 5mg | oral | Lax‑Tab | AE | 400 |
| | Suppositories 10mg, 10 | rectal | Dulcolax | VZ | 9 |
| | | | Petrus Bisacodyl Suppositories | PP | 9 |
| | Suppositories 10mg, 12 | rectal | Petrus Bisacodyl Suppositories | PP | 8 |
| | Enemas 10mg in 5mL, 25 | rectal | Bisalax | AS | 2 |
| Macrogol 3350 | Sachets containing powder for oral solution 13.125g with electrolytes, 30 | oral | APOHEALTH Macrogol with Electrolytes | GX | 2 |
| | | | APO-MACROGOL plus ELECTROLYTES | TX | 2 |
| | | | Chemists’ Own Macrogol with Electrolytes | RW | 2 |
| | | | LaxaCon | EA | 2 |
| | | | lax-sachets | AE | 2 |
| | | | Macrovic | RF | 2 |
| | | | Molaxole | GO | 2 |
| | | | Movicol | NE | 2 |
| | Powder for oral solution 510g | oral | OsmoLax | KY | 1 |
| Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | Enemas 3.125g‑450mg‑45mg in 5mL, 12 | rectal | Micolette | AE | 4 |
| Sterculia with Frangula Bark | Granules 620mg‑80mg, per g, 500g | oral | Normacol Plus | NE | 2 |
(section 7)
| Code | Responsible Person | Australian Business Number |
| AE | AFT Pharmaceuticals (AU) Pty Ltd | 29 105 636 413 |
| AS | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
| EA | Amneal Pharmaceuticals Pty Ltd | 11 163 167 851 |
| GO | Mylan Health Pty Ltd | 29 601 608 771 |
| GX | Apotex Pty Ltd | 52 096 916 148 |
| KY | Key Pharmaceuticals Pty Ltd | 21 001 215 130 |
| NE | Norgine Pty Ltd | 78 005 022 882 |
| PP | Petrus Pharmaceuticals Pty Ltd | 21 108 884 126 |
| RF | Arrow Pharma Pty Ltd | 35 605 909 920 |
| RW | Arrow Pharma Pty Ltd | 35 605 909 920 |
| TX | Apotex Pty Ltd | 52 096 916 148 |
| VZ | Sanofi-aventis Healthcare Pty Ltd | 43 076 651 959 |
National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010
1 The whole of the instrument
Repeal the instrument