Untitled document
National Health (Pharmaceutical Benefits) Regulations 2017
made under the
National Health Act 1953
Compilation No. 3
Compilation date: 5 December 2019
Includes amendments up to: F2019L01530
Registered: 19 December 2019
About this compilation
This compilation
This is a compilation of the National Health (Pharmaceutical Benefits) Regulations 2017 that shows the text of the law as amended and in force on 5 December 2019 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
Part 1—Preliminary 1
Division 1—General 1
1............ Name............................................................................................................................. 1
3............ Authority....................................................................................................................... 1
5............ Interpretation................................................................................................................. 1
Division 2—Application of this instrument to electronic prescriptions and electronic orders 7
7............ Preparing electronic prescriptions.................................................................................. 7
8............ Date when a prescription is written or a pharmaceutical benefit is prescribed............... 7
9............ Requirement to give information in writing................................................................... 7
10.......... Requirement to give a prescription................................................................................ 7
11.......... Approval of kinds of electronic communications.......................................................... 8
12.......... Approval of information technology requirements........................................................ 8
Part 2—Approvals under Part VII of the Act 10
13.......... Purpose of this Part..................................................................................................... 10
14.......... Application for certain approvals to be in approved form............................................ 10
15.......... Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner.................................................................................................................................... 10
16.......... Numbering of approvals.............................................................................................. 10
17.......... Certain requirements to be met after cancellation etc. of approval—approved pharmacists 11
Part 3—Safety net concession cards and pharmaceutical benefits entitlement cards 12
Division 1A—Value for safety net purposes 12
17A....... Value for safety net purposes...................................................................................... 12
Division 1—Pharmaceutical benefits prescription record forms etc. 13
18.......... Pharmaceutical benefits prescription record forms etc................................................. 13
Division 2—Issue of safety net concession cards 14
19.......... Application for safety net concession card.................................................................. 14
20.......... Prescribed offices........................................................................................................ 14
Division 3—Issue of pharmaceutical benefits entitlement card 15
21.......... Application for pharmaceutical benefits entitlement card............................................. 15
22.......... Prescribed offices........................................................................................................ 15
Division 4—Additional and replacement concession cards and entitlement cards 16
23.......... Purpose of this Division.............................................................................................. 16
24.......... Application for, and issue of, additional concession cards and entitlement cards........ 16
25.......... Application for, and issue of, replacement concession cards and entitlement cards..... 17
26.......... Refusal to issue additional or replacement cards by person other than the Secretary... 18
27.......... Refusal to issue additional or replacement cards by the Secretary............................... 18
28.......... Review of decisions.................................................................................................... 18
Part 4—Supply of pharmaceutical benefits 19
Division 1—General matters relating to supply 19
29.......... Meaning of practitioner.............................................................................................. 19
30.......... Variation of application of determination of maximum number of repeats or maximum number or quantity of units........................................................................................................... 19
Division 2—Supply by particular PBS prescribers 22
31.......... Meaning of practitioner.............................................................................................. 22
32.......... Prescriber bag supplies—practitioners on ships.......................................................... 22
33.......... Prescriber bag supplies—obtaining benefits by practitioners...................................... 22
34.......... Prescriber bag supplies—supply of pharmaceutical benefits by approved pharmacists 23
35.......... Prescriber bag supplies—payment for pharmaceutical benefits................................... 23
36.......... Pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act......................................................................................................................... 24
37.......... Payment for pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act.................................................................................................... 25
Part 5—Prescriptions and supply 27
38.......... Purpose of this Part..................................................................................................... 27
39.......... Writing prescriptions—general.................................................................................... 27
40.......... Writing prescriptions—prescriptions other than medication chart prescriptions.......... 27
41.......... Writing prescriptions—medication chart prescriptions................................................ 30
41A....... Writing prescriptions—additional requirements for all electronic prescriptions........... 33
41B....... Writing prescriptions—additional information that may be included in electronic prescriptions.................................................................................................................................... 33
42.......... Information about status of person.............................................................................. 33
43.......... Restriction on using PBS forms.................................................................................. 34
44.......... Supply of pharmaceutical benefit on first presentation of prescription........................ 35
45.......... Supply of pharmaceutical benefit on basis of medication chart prescription................ 36
46.......... Continued dispensing supply of pharmaceutical benefit.............................................. 37
47.......... Information about status of person—continued dispensing supplies and medication chart prescriptions.................................................................................................................................... 38
48.......... Supply of pharmaceutical benefits before surrender of written prescription................ 38
49.......... Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion.................................................................................................................................... 40
50.......... Continued dispensing supplies—repeated supply not to be supplied on one occasion 41
51.......... Repeated supplies of pharmaceutical benefits.............................................................. 41
52.......... Repeat authorisations................................................................................................... 43
53.......... Deferred supply authorisations.................................................................................... 45
54.......... Presentation of prescriptions in trading hours............................................................. 46
55.......... Presentation of urgent prescriptions............................................................................ 46
56.......... Special charge for delivery.......................................................................................... 47
57.......... Receipt of pharmaceutical benefit................................................................................ 47
Part 6—Other matters relating to prescriptions and supply etc. 50
58.......... Purpose of this Part..................................................................................................... 50
59.......... Keeping documents—other than for continued dispensing supplies or medication chart prescriptions.................................................................................................................................... 50
60.......... Keeping documents—continued dispensing supplies.................................................. 51
61.......... Keeping documents—medication chart prescriptions.................................................. 52
62.......... Proper stocks to be kept.............................................................................................. 52
63.......... Standards of composition and purity of pharmaceutical benefits and ingredients........ 52
64.......... Labelling of pharmaceutical benefits—full cost........................................................... 53
65.......... Surrender of forms...................................................................................................... 53
Part 7—Price reduction and price disclosure 55
Division 1—Price reduction 55
66.......... Reduction day.............................................................................................................. 55
Division 2—Price disclosure 56
Subdivision A—Interpretation 56
67.......... Meaning of data collection period............................................................................... 56
68.......... Meaning of price sampling day................................................................................... 57
69.......... Special rules for certain listed brands.......................................................................... 57
Subdivision B—Weighted average disclosed price 58
70.......... Method for determining weighted average disclosed price of listed brand of pharmaceutical item.................................................................................................................................... 58
71.......... Step 1—net revenue for brand..................................................................................... 58
72.......... Step 2—adjusted volume for brand............................................................................. 58
73.......... Step 3—average approved ex‑manufacturer price for brand........................................ 58
74.......... Step 4—disclosed price for brand............................................................................... 59
75.......... Step 5—price percentage difference of brand.............................................................. 60
76.......... Step 6—repeat steps for each brand of pharmaceutical item........................................ 60
77.......... Step 7—total adjusted volume of brands of pharmaceutical item................................. 60
78.......... Step 8—weighted average percentage difference of brands of pharmaceutical item.... 60
79.......... Step 9—repeat steps for each pharmaceutical item with related brands....................... 61
80.......... Step 10—weighted average percentage difference for listed brand and all related brands....... 61
81.......... Step 11—weighted average disclosed price for listed brand of pharmaceutical item... 62
82.......... When weighted average disclosed price is the same as the applicable approved ex‑manufacturer price.................................................................................................................................... 63
Subdivision C—Information that must not be taken into account 63
83.......... Information that must not be taken into account.......................................................... 63
84.......... Originator brands........................................................................................................ 63
Subdivision D—Price disclosure requirements 64
85.......... Price disclosure requirements...................................................................................... 64
Part 8—Arrangements for the Pharmaceutical Benefits Advisory Committee 66
Division 1—Matters relating to the appointment of members of the Committee 66
86.......... Nominating bodies...................................................................................................... 66
87.......... Number of nominations for appointment..................................................................... 67
88.......... Resignation.................................................................................................................. 67
Division 2—Matters relating to the procedure of the Committee 68
89.......... Purpose of this Division.............................................................................................. 68
90.......... Presiding member........................................................................................................ 68
91.......... Meetings of the Committee.......................................................................................... 68
92.......... Quorum....................................................................................................................... 68
93.......... Voting......................................................................................................................... 68
94.......... Disclosure of pecuniary interests by members............................................................ 69
95.......... Resolutions without a formal meeting......................................................................... 70
96.......... Reports and recommendations..................................................................................... 70
Division 3—Matters relating to sub‑committees 71
97.......... Remuneration for chair and members of sub‑committees............................................ 71
Part 9—Application, savings and transitional provisions 72
98.......... Definitions................................................................................................................... 72
99.......... Things done under old regulations.............................................................................. 72
102........ Transitional provision relating to the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019.................................................................. 72
Schedule 1—Prescribed offices 73
1............ Table of prescribed offices.......................................................................................... 73
Endnotes75
Endnote 1—About the endnotes 75
Endnote 2—Abbreviation key 76
Endnote 3—Legislation history 77
Endnote 4—Amendment history 78
Part 1—Preliminary
Division 1—General
1 Name
This instrument is the National Health (Pharmaceutical Benefits) Regulations 2017.
3 Authority
This instrument is made under the National Health Act 1953.
5 Interpretation
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) Chief Executive Medicare;
(b) public hospital;
(c) public hospital authority.
(1) In this instrument:
Act means the National Health Act 1953.
additional patient charge means the further additional patient charge referred to in clause 5.2.2(c) or 5.2.3(c) of the Sixth Community Pharmacy Agreement, as in force on 1 June 2018.
Note: The charge is based on a formula that takes into account whichever of the general patient charge, general patient reduced charge or concessional beneficiary charge is applicable to a supply under Part VII of the Act.
applicable amount has the same meaning as in Part VII of the Act.
approved hospital means a hospital in respect of which the hospital authority is approved under section 94 of the Act.
approved hospital authority has the same meaning as in Part VII of the Act.
approved information technology requirements means information technology requirements of a kind approved by the Secretary under section 12 for the purposes of the provision in which the expression is used.
approved medical practitioner has the same meaning as in Part VII of the Act.
approved pharmacist has the same meaning as in Part VII of the Act.
approved supplier has the same meaning as in Part VII of the Act.
authorised midwife has the same meaning as in Part VII of the Act.
authorised nurse practitioner has the same meaning as in Part VII of the Act.
authorised optometrist has the same meaning as in Part VII of the Act.
authority approval number, for an authority prescription, means the number allotted to the prescription when the prescription is authorised by the Minister or the Chief Executive Medicare.
authority prescription means a prescription that prescribes a pharmaceutical benefit and that has been authorised:
(a) in accordance with subsection 30(4); or
(b) in accordance with authority required procedures that:
(i) are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit; or
(ii) are part of the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit; or
(iii) are incorporated by reference into the circumstances determined for the pharmaceutical benefit under subsection 85B(4) of the Act.
brand, of a pharmaceutical item, has the same meaning as in Part VII of the Act.
Commonwealth price has the same meaning as in Part VII of the Act.
concessional beneficiary has the same meaning as in Part VII of the Act.
concession card has the same meaning as in Part VII of the Act.
CTS claim has the same meaning as in Part VII of the Act.
data collection period, for a brand of a pharmaceutical item, has the meaning given by section 67.
deferred supply authorisation means a deferred supply authorisation prepared under paragraph 53(3)(a).
delisted brand, of a pharmaceutical item: a listed brand of a pharmaceutical item becomes a delisted brand when a determination made under subsection 85(6) of the Act is no longer in force for that brand.
dependant, in relation to a concessional beneficiary, has the same meaning as in Part VII of the Act.
drug in a pharmaceutical item has the same meaning as in Part VII of the Act.
drug is on F2 has the same meaning as in Part VII of the Act.
electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.
electronic medication chart has the meaning given by subsection 41(6).
electronic order form means a form that is approved by the Secretary under subparagraph 33(1)(b)(ii) for the purposes of lodging an order under paragraph 33(1)(b).
electronic prescription means a prescription that is prepared and submitted:
(a) in accordance with approved information technology requirements (if any), by means of an eligible electronic communication; and
(b) in accordance with the form approved by the Secretary under:
(i) subparagraph 40(2)(c)(ii) (prescriptions other than medication chart prescriptions); or
(ii) subsection 41(5) (medication chart prescriptions).
eligible electronic communication means:
(a) an electronic communication of a kind approved by the Secretary under section 11 for the purposes of the provision in which the expression is used; or
(b) if no such approval is in force for the purposes of the provision in which the expression is used—any electronic communication.
entitlement card has the same meaning as in Part VII of the Act.
exempt item has the same meaning as in Part VII of the Act.
final day, of a data collection period, means the last day of the data collection period.
healthcare identifier has the same meaning as in the Healthcare Identifiers Act 2010.
healthcare provider organisation has the same meaning as in the Healthcare Identifiers Act 2010.
incentive, for a brand of a pharmaceutical item, includes anything given as an incentive to take supply of the brand (including a delisted brand before it was delisted) whether the incentive is given:
(a) before the supply of the brand, but on condition of taking supply; or
(b) at, or after, the time of the supply of the brand; or
(c) over a period of time; or
(d) directly for the brand; or
(e) indirectly for the brand (for example, for a group of brands of pharmaceutical items or other products).
information technology requirements has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.
initial month, for a brand of a pharmaceutical item that was not a listed brand immediately before the brand’s start day, means the first month of the brand’s first data collection period.
last listed brand, of a pharmaceutical item, means the brand of the pharmaceutical item that was the last to become a delisted brand before the final day of the data collection period for the brand of the pharmaceutical item.
listed brand has the same meaning as in Part VII of the Act.
maximum quantity, of a pharmaceutical item or a pharmaceutical benefit, means the maximum quantity or number of units of the pharmaceutical item or pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion, as determined by the Minister under subsection 85A(2) of the Act.
Medicare/DVA copy, for a paper‑based prescription, means the part of the prescription on which the words “Medicare /DVA copy” appear.
medicare number has the same meaning as in Part VII of the Act.
medication chart has the meaning given by subsection 41(4).
medication chart prescription has the meaning given by subsection 41(1).
optometrist has the same meaning as in Part VII of the Act.
originator brand has the same meaning as in Division 3B of Part VII of the Act.
out‑patient medication has the same meaning as in Part VII of the Act.
paper‑based prescription means a prescription that is prepared in duplicate in accordance with paragraph 40(2)(a), (b) or (d).
participating dental practitioner has the same meaning as in Part VII of the Act.
PBS prescriber has the same meaning as in Part VII of the Act.
pharmaceutical benefit has the same meaning as in Part VII of the Act.
pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.
pharmaceutical item has the same meaning as in Part VII of the Act.
pharmacist/patient copy, for a paper‑based prescription, means the part of the prescription on which the words “pharmacist/patient copy” appear.
practitioner:
(a) in Division 1 of Part 4—has the meaning given by section 29; and
(b) in Division 2 of Part 4—has the meaning given by section 31.
price adjustment means an adjustment under:
(a) a price agreement; or
(b) a price determination; or
(c) Division 3A of Part VII of the Act.
price agreement has the same meaning as in Part VII of the Act.
price determination has the same meaning as in Part VII of the Act.
price disclosure requirements has the same meaning as in Division 3B of Part VII of the Act.
price sampling day has the meaning given by section 68.
pricing quantity has the same meaning as in Part VII of the Act.
ready‑prepared pharmaceutical benefit means a pharmaceutical benefit in respect of which a determination made under subsection 85(6) of the Act is in force.
record form has the same meaning as in Part VII of the Act.
related brand, of a brand of a pharmaceutical item, means a brand of a pharmaceutical item that has the same drug and manner of administration as the first‑mentioned pharmaceutical item (including another brand of the same pharmaceutical item), but does not include a brand of an exempt item.
relevant day has the same meaning as in Division 3B of Part VII of the Act.
relevant entitlement period has the same meaning as in Part VII of the Act.
relevant streamlined authority code, for a pharmaceutical benefit that is prescribed, means the streamlined authority code that is part of:
(a) the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit; or
(b) the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit.
repatriation pharmaceutical benefit has the same meaning as in Part VII of the Act.
repeat authorisation means a repeat authorisation prepared under subparagraph 52(3)(a)(i).
repeat authorisation form means the form referred to in subparagraph 52(3)(a)(i).
residential care has the same meaning as in the Aged Care Act 1997.
residential care service has the same meaning as in the Aged Care Act 1997.
responsible person has the same meaning as in Part VII of the Act.
Schedule equivalent has the same meaning as in Part VII of the Act.
special patient contribution has the same meaning as in Part VII of the Act.
start day, for a brand of a pharmaceutical item, means the day on which the brand was first required to comply with the price disclosure requirements under section 99ADD of the Act.
value for safety net purposes has the same meaning as in Part VII of the Act.
WADP brand has the meaning given by subsection 83(2).
weighted average disclosed price has the same meaning as in Division 3B of Part VII of the Act.
(2) In this instrument, a reference to prescribing, or to the writing of a prescription, is a reference to the writing of a prescription for the supply of a pharmaceutical benefit under Part VII of the Act.
(3) In this instrument:
(a) a reference to the holder of a concession card or an entitlement card is a reference to a person who is, under section 84G of the Act, taken to be a holder of the card; and
(b) a reference to the original holder of a concession card is a reference to the person to whom a concession card has been issued under section 84DA of the Act; and
(c) a reference to the original holder of an entitlement card is a reference to the person to whom an entitlement card has been issued under section 84E of the Act; and
(d) a reference to a member of the family of a person is a reference to a person who is a member of that family within the meaning of section 84B of the Act.
Division 2—Application of this instrument to electronic prescriptions and electronic orders
7 Preparing electronic prescriptions
A reference in this instrument to writing or preparing a prescription, a repeat authorisation or a deferred supply authorisation, whether the expression writing, preparing or any other expression is used, is taken to include:
(a) for an electronic prescription—preparing the electronic prescription; and
(b) for a repeat authorisation that relates to an electronic prescription—writing or preparing the authorisation by means of an electronic form approved by the Secretary under subparagraph 52(3)(a)(i) for the supply of a pharmaceutical benefit under an electronic prescription; and
(c) for a deferred supply authorisation that relates to an electronic prescription—writing or preparing the authorisation by means of an electronic form approved by the Secretary under paragraph 53(3)(a) for deferring the supply of a pharmaceutical benefit under an electronic prescription.
8 Date when a prescription is written or a pharmaceutical benefit is prescribed
A reference in this instrument to the day or date on which a prescription is written by a PBS prescriber or the day or date on which a pharmaceutical benefit is prescribed is, in relation to an electronic prescription, a reference to the day or date on which the prescription is signed by the PBS prescriber.
9 Requirement to give information in writing
(1) If, under this instrument, a person is required to write information on a prescription, a repeat authorisation, a deferred supply authorisation or an order form, that requirement is taken to have been met in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form, if the person gives the information:
(a) in accordance with approved information technology requirements (if any); and
(b) by means of an eligible electronic communication.
(2) This section applies to a requirement to write information on a prescription, a repeat authorisation, a deferred supply authorisation or an order form, whether the expression write, certify, endorse, identify, indicate, mark, specify, state, or any other expression is used.
10 Requirement to give a prescription
If, under this instrument, a prescription is required to be given or presented to an approved supplier for the purpose of supplying a pharmaceutical benefit to the person for whom the prescription was written, that requirement is taken to have been met in relation to an electronic prescription if:
(a) the person who will receive the pharmaceutical benefit (whether or not for the person’s own use) requests the approved supplier to supply the pharmaceutical benefit; and
(b) the approved supplier consents, within the meaning of subsection 5(1) of the Electronic Transactions Act 1999, to the prescription being given or presented, in accordance with approved information technology requirements (if any), by means of an eligible electronic communication; and
(c) the prescription is accessible by the approved supplier.
11 Approval of kinds of electronic communications
The Secretary may, in writing, approve a kind of electronic communication for one or more of the following purposes:
(a) preparing or submitting an electronic prescription;
(b) giving information, for the purposes of this instrument, in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form;
(c) giving or presenting an electronic prescription to an approved supplier under this instrument;
(d) submitting a prescription to the Minister in accordance with paragraph 30(3)(b);
(e) lodging an order with an approved pharmacist under paragraph 33(1)(b);
(f) submitting a receipt for a pharmaceutical benefit under paragraph 33(4)(c);
(g) giving an acknowledgement under this instrument for the supply of a pharmaceutical benefit under an electronic prescription or an authorisation that relates to an electronic prescription;
(h) doing any other thing that is required or permitted to be done for the purposes of this instrument.
12 Approval of information technology requirements
The Secretary may, in writing, approve information technology requirements for one or more of the following purposes:
(a) preparing and submitting an electronic prescription;
(b) giving information, for the purposes of this instrument, in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form;
(c) giving or presenting an electronic prescription to an approved supplier under this instrument;
(d) lodging an order with an approved pharmacist under paragraph 33(1)(b);
(e) submitting a receipt for a pharmaceutical benefit under paragraph 33(4)(c);
(f) giving an acknowledgement under this instrument for the supply of a pharmaceutical benefit under an electronic prescription or an authorisation that relates to an electronic prescription;
(g) doing any other thing that is required or permitted to be done for the purposes of this instrument.
Part 2—Approvals under Part VII of the Act
13 Purpose of this Part
This Part is made for the purposes of section 140 of the Act.
14 Application for certain approvals to be in approved form
(1) The Secretary may refuse to consider:
(a) an application for approval of a pharmacist under section 90 of the Act; or
(b) an application for approval of a medical practitioner under section 92 of the Act;
if the application is not in a form approved, in writing, by the Secretary.
(2) The Minister may refuse to consider an application for approval of a hospital authority under section 94 of the Act if the application is not in a form approved, in writing, by the Secretary.
15 Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner
The following applications must be made in a form approved, in writing, by the Secretary:
(a) an application for approval as an authorised optometrist under subsection 84AAB(1) of the Act;
(b) an application for approval as an authorised midwife under subsection 84AAF(1) of the Act;
(c) an application for approval as an authorised nurse practitioner under subsection 84AAJ(1) of the Act.
16 Numbering of approvals
(1) If the Secretary approves:
(a) a dental practitioner under section 84A of the Act; or
(b) an optometrist under section 84AAB of the Act; or
(c) an eligible midwife under section 84AAF of the Act; or
(d) an eligible nurse practitioner under section 84AAJ of the Act; or
(e) a pharmacist under section 90 of the Act; or
(f) a medical practitioner under section 92 of the Act;
the Secretary may allot a number to that approval.
(2) If, under section 90A of the Act, the Minister substitutes for a decision of the Secretary a decision approving a pharmacist for the purpose of supplying pharmaceutical benefits at particular premises, the Minister may allot a number to that approval.
(3) If the Secretary grants permission to a person to supply pharmaceutical benefits under subsection 91(1) of the Act, the Secretary may allot a number to the approval that, under paragraph 91(7)(a) of the Act, is treated as having been granted to the person under section 90 of the Act.
(3A) If the Secretary grants permission to an applicant to supply pharmaceutical benefits under subsection 91B(1), (2) or (3) of the Act, the Secretary may allot a number to the approval that, under paragraph 91B(10)(a) of the Act, is treated as having been granted to the person under section 90 of the Act.
(4) If the Minister approves a hospital authority under section 94 of the Act, the Minister may allot a number to that approval.
17 Certain requirements to be met after cancellation etc. of approval—approved pharmacists
(1) A person commits an offence if:
(a) the person’s approval as an approved pharmacist is suspended, revoked or cancelled; and
(b) the person, in any way, indicates that he or she has been, or is, approved to supply pharmaceutical benefits.
Penalty: 1 penalty unit.
(2) An offence against subsection (1) is an offence of strict liability.
Part 3—Safety net concession cards and pharmaceutical benefits entitlement cards
Division 1A—Value for safety net purposes
17A Value for safety net purposes
(1) For the purposes of subsection 84C(1E) of the Act, this section prescribes the value for safety net purposes of the supply of a pharmaceutical benefit.
(2) If the supply is one to which subsection 99(2A), (2AB) or (2B) of the Act applies and the amount charged for the supply is in accordance with the Act, the value for safety purposes is the lesser of the following:
(a) the price of the pharmaceutical benefit worked out in accordance with a determination in force under subsection 84C(7) of the Act at the time of the supply, minus any additional patient charge (or part thereof) included in the amount charged for the supply;
(b) the amount charged for the supply.
(3) If subsection (2) does not apply and the amount charged for the supply is in accordance with the Act, the value for safety net purposes is the amount charged under whichever of paragraphs 87(2)(a), (b) and (e) of the Act applies (not including any amount charged under other subsections of section 87).
(4) If the amount charged for the supply is not in accordance with the Act, the value for safety net purposes is zero.
Division 1—Pharmaceutical benefits prescription record forms etc.
18 Pharmaceutical benefits prescription record forms etc.
(1) For the purposes of paragraph 84D(3)(b) of the Act, the following particulars of the person to whom a record form is issued are prescribed particulars:
(a) the given name and the surname of the person;
(b) the address of the person.
(2) For the purposes of subsection 84D(4) of the Act, the following particulars of a person (the family member) who is a member of the family of a person to whom a record form is issued are prescribed particulars:
(a) the given name and the surname of the family member;
(b) the relationship of the family member to the person to whom the record form is issued.
(3) For the purposes of paragraph 84D(7)(c) of the Act, the following particulars in relation to the supply of a pharmaceutical benefit or repatriation pharmaceutical benefit are prescribed:
(a) the item code number by which the pharmaceutical benefit or repatriation pharmaceutical benefit is identified as a pharmaceutical benefit or repatriation pharmaceutical benefit (as the case may be);
(b) the number allotted under section 16 to the approval of the approved pharmacist, approved medical practitioner or approved hospital authority supplying the pharmaceutical benefit or repatriation pharmaceutical benefit;
(c) the value for safety net purposes of the pharmaceutical benefit or repatriation pharmaceutical benefit.
(4) For the purposes of paragraph 84D(11)(c) of the Act, the following particulars in relation to the supply of an out‑patient medication are prescribed:
(a) particulars that identify the medication;
(b) particulars that identify the public hospital at which the medication was supplied;
(c) the value for safety net purposes of the medication.
Division 2—Issue of safety net concession cards
19 Application for safety net concession card
(1) For the purposes of paragraph 84DA(3)(b) of the Act, the following particulars are prescribed in relation to an application under subsection 84DA(1) or (2) of the Act:
(a) the given name and surname of the applicant;
(b) the residential address of the applicant;
(c) the given name and surname of each person who is a member of the applicant’s family;
(d) the relationship of each person referred to in paragraph (c) to the applicant;
(e) the date on which the application is made;
(f) the medicare number of the applicant.
(2) For the purposes of paragraph 84DA(3)(b) of the Act, the following documents are prescribed in relation to an application under subsection 84DA(1) or (2) of the Act:
(a) record forms issued to the applicant or to a member of the applicant’s family that:
(i) record the value for safety net purposes of the pharmaceutical benefits, repatriation pharmaceutical benefits and out‑patient medication supplied to the applicant, or to a member of the applicant’s family, during the relevant entitlement period to which the application relates; and
(ii) include a statement signed by the applicant declaring that the pharmaceutical benefits, repatriation pharmaceutical benefits and out‑patient medication recorded in the form were so supplied;
(b) in respect of any other pharmaceutical benefit, repatriation pharmaceutical benefit or out‑patient medication so supplied, any document that establishes the value for safety net purposes of the pharmaceutical benefit, repatriation pharmaceutical benefit or out‑patient medication.
20 Prescribed offices
For the purposes of subsection 84DA(5) of the Act, each office referred to in an item in the table in Schedule 1 is a prescribed office.
Division 3—Issue of pharmaceutical benefits entitlement card
21 Application for pharmaceutical benefits entitlement card
(1) For the purposes of paragraph 84E(3)(b) of the Act, the following particulars are prescribed in relation to an application under subsection 84E(1) or (2) of the Act:
(a) the given name and surname of the applicant;
(b) the residential address of the applicant;
(c) the given name and surname of each person who is a member of the applicant’s family;
(d) the relationship of each person referred to in paragraph (c) to the applicant;
(e) the date on which the application is made;
(f) the medicare number of the applicant.
(2) For the purposes of paragraph 84E(3)(b) of the Act, the following documents are prescribed in relation to an application under subsection 84E(1) or (2) of the Act:
(a) record forms issued to the applicant or to a member of the applicant’s family that:
(i) record the value for safety net purposes of the pharmaceutical benefits, repatriation pharmaceutical benefits and out‑patient medication supplied to the applicant, or to a member of the applicant’s family, during the relevant entitlement period to which the application relates; and
(ii) include a statement signed by the applicant declaring that the pharmaceutical benefits, repatriation pharmaceutical benefits and out‑patient medication recorded in the form were so supplied;
(b) in respect of any other pharmaceutical benefit, repatriation pharmaceutical benefit or out‑patient medication so supplied, any document that establishes the value for safety net purposes of that pharmaceutical benefit, repatriation pharmaceutical benefit or out‑patient medication.
22 Prescribed offices
For the purposes of subsection 84E(5) of the Act, each office referred to in an item in the table in Schedule 1 is a prescribed office.
Division 4—Additional and replacement concession cards and entitlement cards
23 Purpose of this Division
For the purposes of subsections 84H(1) and (3) of the Act, this Division sets out matters relating to the issue of additional and replacement concession cards and entitlements cards.
24 Application for, and issue of, additional concession cards and entitlement cards
(1) A person whose concession card, or entitlement card, has been lost, stolen, damaged or destroyed may apply to the Secretary for an additional card.
(2) A person who is a holder of a concession card, or an entitlement card, other than a person referred to in subsection (1), may apply for an additional card to:
(a) the Secretary; or
(b) if the original card was issued by an approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority—that approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority.
(3) An application under subsection (1) or (2) for an additional card must:
(a) be in accordance with the form approved, in writing, by the Secretary; and
(b) set out:
(i) the given name and surname of the applicant; and
(ii) the residential address of the applicant; and
(iii) the given name and surname of each person (other than the applicant) who is a member of the family of the original holder of the card and the relationship of that person to the original holder; and
(iv) for an additional concession card—the number (if known to the applicant) of any other concession card held by a member of the family of the original holder of the concession card; and
(v) for an additional entitlement card—the number (if known to the applicant) of any other entitlement card held by a member of the family of the original holder of the entitlement card; and
(vi) for an application that is made under subsection (1)—the number (if known to the applicant) of the concession card, or entitlement card, that the applicant holds; and
(vii) the medicare number of the applicant; and
(c) be signed and dated by the applicant; and
(d) be accompanied by the original card unless the application is made under subsection (1).
(4) Where, on an application to a person for the issue of an additional card, the person is satisfied, having regard to:
(a) the matters contained in the application; and
(b) any other relevant matters;
that an additional card should be issued to the applicant, the person must issue an additional card to the applicant.
25 Application for, and issue of, replacement concession cards and entitlement cards
(1) An original card holder (within the meaning of subsection 84H(3) of the Act) may apply for the issue of a replacement card.
(2) An application under subsection (1) must:
(a) be made, in accordance with the form approved in writing by the Secretary, to:
(i) the Secretary; or
(ii) where the original card was issued by an approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority—that approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority; and
(b) set out:
(i) the given name and surname of the applicant; and
(ii) the residential address of the applicant; and
(iii) the given name and surname of any new family member (within the meaning of subsection 84H(3) of the Act) and his or her relationship to the applicant; and
(iv) the medicare number of the applicant; and
(c) be signed and dated by the applicant; and
(d) be accompanied by the original card unless the application is made to the Secretary.
(3) Where, on an application to a person for the issue of a replacement card, the person is satisfied, having regard to:
(a) the matters contained in the application; and
(b) any other relevant matters;
that:
(c) the applicant is the original card holder (within the meaning of subsection 84H(3) of the Act); and
(d) each person identified in the application in accordance with subparagraph (2)(b)(iii) became, after the issue of that card and during the relevant entitlement period in respect of which that card was issued, a member of the original card holder’s family;
the person must issue a replacement card to the applicant.
26 Refusal to issue additional or replacement cards by person other than the Secretary
Where an approved pharmacist, an approved medical practitioner, a public hospital authority or an approved hospital authority makes:
(a) a decision under section 24 refusing to issue an additional card; or
(b) a decision under section 25 refusing to issue a replacement card;
the applicant may apply to the Secretary under subsection 24(2) or 25(1) for the issue of the additional card or replacement card, as the case requires.
27 Refusal to issue additional or replacement cards by the Secretary
(1) Where the Secretary makes:
(a) a decision under section 24 refusing to issue an additional card; or
(b) a decision under section 25 refusing to issue a replacement card;
the Secretary must, by notice in writing, inform the applicant of the making of, and reasons for, the decision.
(2) A notice under subsection (1) must include a statement to the effect that:
(a) applications may be made, subject to the Administrative Appeals Tribunal Act 1975, by or on behalf of a person whose interests are affected by the decision, to the Administrative Appeals Tribunal for review of the decision; and
(b) a person whose interests are affected by the decision may, except where subsection 28(4) of that Act applies, request a statement under section 28 of that Act.
(3) A failure to comply with subsection (2) in relation to a decision does not affect the validity of the decision.
28 Review of decisions
Applications may be made to the Administrative Appeals Tribunal for review of the following decisions of the Secretary:
(a) a decision under section 24 to refuse to issue an additional card;
(b) a decision under section 25 to refuse to issue a replacement card.
Part 4—Supply of pharmaceutical benefits
Division 1—General matters relating to supply
29 Meaning of practitioner
In this Division:
practitioner means any of the following:
(a) an authorised optometrist;
(b) a medical practitioner;
(c) an authorised midwife;
(d) an authorised nurse practitioner.
30 Variation of application of determination of maximum number of repeats or maximum number or quantity of units
(1) For the purposes of subsection 85A(3) of the Act, the Minister may vary the application of a determination under paragraph 85A(2)(a) or (b) of the Act in relation to a practitioner in the class covered by subsection (2) of this section.
(2) A practitioner is in the class covered by this subsection if:
(a) the practitioner has written a prescription, in accordance with section 40 or 41 (disregarding paragraphs 40(1)(c) and 41(3)(a) and (b)), that:
(i) is not in accordance with a determination referred to in subsection (1); and
(ii) in the case of a medication chart prescription—is written for a person who is receiving treatment in or at an approved hospital; and
(b) the prescription is submitted to the Minister in accordance with subsection (3).
(3) A prescription is submitted in accordance with this subsection if:
(a) the practitioner, or an agent of the practitioner, submits:
(i) the prescription itself; or
(ii) for a medication chart prescription that is not an electronic prescription—the medication chart by which the prescription was written, or a copy of so much of that chart as would indicate that subsection 41(2) has been complied with; or
(b) the practitioner submits details of the prescription:
(i) by telephone; or
(ii) by means of an eligible electronic communication.
(4) A variation under subsection (1) in relation to a practitioner may be made:
(a) for a paper‑based prescription submitted in accordance with subparagraph (3)(a)(i)—by the Minister signing his or her authorisation of the prescription on it and:
(i) if the Minister requires the practitioner to alter the prescription—by returning it to the practitioner for alteration before the practitioner gives it to the person in respect of whom it was prepared; or
(ii) by returning it to the practitioner; or
(iii) if requested by the practitioner—by sending it to the person in respect of whom it was written; or
(b) for a medication chart prescription submitted in accordance with subparagraph (3)(a)(ii)—by the Minister signing his or her authorisation of the prescription on the medication chart or the copy of the medication chart and:
(i) if the Minister requires the practitioner to alter the prescription—indicating this on the medication chart or copy; and
(ii) returning the medication chart or copy to the practitioner; or
(c) for an electronic prescription submitted in accordance with paragraph (3)(a)—by the Minister writing his or her authorisation of the prescription on the electronic prescription and:
(i) if the Minister requires the practitioner to alter the prescription—by returning it, including by means of an eligible electronic communication, to the practitioner for alteration; or
(ii) by returning it, including by means of an eligible electronic communication, to the practitioner; or
(iii) if requested by the practitioner—by making the prescription accessible by the person in respect of whom it was written, or by an approved supplier for the purpose of supplying a pharmaceutical benefit to the person in respect of whom the prescription was written; or
(d) if a prescription is submitted in accordance with subparagraph (3)(b)(i)—by the Minister authorising the prescription orally, at the time the Minister is given details of the prescription; or
(e) if a prescription is submitted in accordance with subparagraph (3)(b)(ii)—by the Minister sending his or her authorisation of the prescription, by means of an eligible electronic communication, to the practitioner.
(5) If the Minister makes a variation in accordance with paragraph (4)(d) or (e):
(a) the Minister must tell the practitioner, orally or by means of an eligible electronic communication, the number that has been allotted to the authorised prescription; and
(b) the practitioner must:
(i) mark that number on the prescription; and
(ii) retain the prescription, or a copy of the prescription, showing the number marked in accordance with subparagraph (i), for 1 year from the date on which the variation was made.
Note: The prescription, or copy of the prescription, may be retained in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).
(6) For the purposes of subparagraph (5)(b)(ii), the date on which the Minister makes a variation in relation to a person in respect of whom a practitioner submits an electronic prescription is:
(a) for a variation in accordance with paragraph (4)(d)—the date on which the Minister tells the practitioner the number that has been allotted to the authorised prescription; and
(b) for a variation in accordance with paragraph (4)(e)—the date on which the Minister sends, by means of an eligible electronic communication, his or her authorisation of the prescription to the practitioner.
Division 2—Supply by particular PBS prescribers
31 Meaning of practitioner
In this Division:
practitioner means any of the following:
(a) a medical practitioner;
(b) an authorised midwife;
(c) an authorised nurse practitioner.
32 Prescriber bag supplies—practitioners on ships
For the purposes of sections 93, 93AA and 93AB of the Act, a practitioner who is practising his or her profession on a ship is not authorised to supply pharmaceutical benefits.
33 Prescriber bag supplies—obtaining benefits by practitioners
(1) For the purposes of sections 93, 93AA and 93AB of the Act, a practitioner who is not an approved medical practitioner may obtain a pharmaceutical benefit only if he or she lodges with an approved pharmacist:
(a) an order, in duplicate, signed by the practitioner, in accordance with a form approved, in writing, by the Secretary; or
(b) an order, in accordance with subsection (2), that is:
(i) signed by the practitioner; and
(ii) in accordance with an electronic form approved, in writing, by the Secretary.
(2) For the purposes of paragraph (1)(b), an order is lodged with an approved pharmacist if:
(a) it is lodged in accordance with any approved information technology requirements and by an eligible electronic communication; and
(b) the practitioner, or an agent of the practitioner, who will receive the pharmaceutical benefit asks the approved pharmacist to supply the pharmaceutical benefit under the order; and
(c) the approved pharmacist consents, within the meaning of subsection 5(1) of the Electronic Transactions Act 1999, to the order being lodged in accordance with any approved information technology requirements and by an eligible electronic communication; and
(d) the order is accessible by the approved pharmacist.
(3) A practitioner who is not an approved medical practitioner may obtain a pharmaceutical benefit under subsection (1) only once in a calendar month.
(4) A practitioner, or an agent of a practitioner, who receives a pharmaceutical benefit under subsection (1), must:
(a) prepare a receipt for the benefit supplied, using the part of the order form identified for that purpose, that includes the following information:
(i) the date of supply of the benefit;
(ii) if the benefit is received by an agent of the practitioner—the agent’s address; and
(b) if the order is lodged in accordance with paragraph (1)(a)—give the receipt to the approved pharmacist supplying the benefit; and
(c) if the order is lodged in accordance with paragraph (1)(b):
(i) submit the receipt, in accordance with any approved information technology requirements and by an eligible electronic communication; and
(ii) ensure the receipt is accessible by the approved pharmacist supplying the benefit.
34 Prescriber bag supplies—supply of pharmaceutical benefits by approved pharmacists
(1) This section is made for the purposes of section 140 of the Act.
(2) An approved pharmacist commits an offence if:
(a) the pharmacist supplies a pharmaceutical benefit on an order lodged under section 33; and
(b) neither of the circumstances referred to in subsection (3) apply.
Penalty: 0.4 penalty units.
(3) For the purposes of paragraph (2)(b), the circumstances are as follows:
(a) the pharmacist knows the practitioner whose signature appears on the order;
(b) if the pharmacist does not know the practitioner, the pharmacist:
(i) is given the given name, surname and address of the practitioner by the person who lodged the order; and
(ii) if the practitioner is a medical practitioner—is given the medical registration number of the practitioner by the person who lodged the order; and
(iii) for any other practitioner—is given the number allotted to the approval for the practitioner by the Secretary under subsection 16(1) by the person who lodged the order; and
(iv) writes on the order form the details referred to in subparagraphs (i), (ii) and (iii).
(4) An offence against subsection (2) is an offence of strict liability.
35 Prescriber bag supplies—payment for pharmaceutical benefits
(1) This section is made for the purposes of subsections 93(3), 93AA(4) and 93AB(4) of the Act.
(2) An approved pharmacist who supplies a pharmaceutical benefit to a practitioner on an order under section 33 is entitled to be paid, by the Commonwealth for the supply, the sum of:
(a) the Commonwealth price of the pharmaceutical benefit; and
(b) the special patient contribution for a brand of the pharmaceutical item that is the pharmaceutical benefit (if any).
(3) Payment by the Commonwealth under subsection (2) is subject to the conditions set out in a determination under paragraph 98C(1)(b) of the Act that is in force at the time the benefit is supplied, as if the benefit had been supplied other than under section 93, 93AA, or 93AB of the Act.
Pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act
(1) This section is made for the purposes of section 140 of the Act.
Offence—obtaining pharmaceutical benefit for purposes of section 93 of the Act by lodging order under section 33 of this instrument
(2) An approved medical practitioner commits an offence if he or she obtains a pharmaceutical benefit for the purposes of section 93 of the Act by lodging with an approved pharmacist an order under section 33 of this instrument.
Penalty: 0.2 penalty units.
Offence—obtaining pharmaceutical benefit for purposes of section 93 of the Act more than once each month
(3) An approved medical practitioner commits an offence if he or she obtains a pharmaceutical benefit for the purposes of section 93 of the Act more than once in each month.
Penalty: 0.2 penalty units.
Offence—not giving notice of obtaining pharmaceutical benefit for purposes of section 93 of the Act (manual claim)
(4) An approved medical practitioner commits an offence if he or she:
(a) obtains a pharmaceutical benefit for the purpose of the supply of the benefit under section 93 of the Act; and
(b) makes a claim for a payment under section 99AAA of the Act, in relation to obtaining the benefit for such a supply, using the manual system referred to in that section; and
(c) does not, when making the claim, give notice to the Secretary that he or she has obtained the benefit.
Penalty: 0.2 penalty units.
(5) For the purposes of paragraph (4)(c), the notice must be:
(a) in a form approved, in writing, by the Secretary; and
(b) signed and dated by the practitioner.
(6) An approved medical practitioner commits an offence if he or she:
(a) gives a notice to the Secretary under subsection (4); and
(b) does not retain a copy of the notice for at least 2 years from the date on which he or she gives the notice to the Secretary.
Penalty: 0.2 penalty units.
Offence—not creating record of obtaining pharmaceutical benefit for purposes of section 93 of the Act (CTS claim)
(7) An approved medical practitioner commits an offence if he or she:
(a) obtains a pharmaceutical benefit for the purpose of the supply of the benefit under section 93 of the Act; and
(b) makes a CTS claim in relation to obtaining the benefit for such a supply; and
(c) does not create a written record of having obtained the benefit as soon as practicable after obtaining it.
Penalty: 0.2 penalty units.
(8) For the purposes of paragraph (7)(c), the record must be:
(a) in a form approved, in writing, by the Secretary; and
(b) signed and dated by the practitioner.
(9) An approved medical practitioner commits an offence if he or she:
(a) creates a record under subsection (7); and
(b) does not retain the record for at least 2 years from the date on which it was created.
Penalty: 0.2 penalty units.
Strict liability applies to offences
(10) An offence against subsection (2), (3), (4), (6), (7) or (9) is an offence of strict liability.
Payment for pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act
(1) This section is made for the purposes of subsection 93(3) of the Act.
(2) An approved medical practitioner is entitled to payment from the Commonwealth for obtaining a pharmaceutical benefit for the purpose of the supply of the benefit under section 93 of the Act if:
(a) the pharmaceutical benefit is obtained in accordance with this instrument; and
(b) the approved medical practitioner makes a claim for a payment under section 99AAA of the Act in relation to obtaining the benefit for such a supply; and
(c) if the claim is made using the manual system referred to in that section—the approved medical practitioner gives a notice to the Secretary in accordance with subsection 36(4) of this instrument.
(3) The approved medical practitioner is entitled to payment under subsection (2) at the rate applicable under section 35 for the supply of the same benefit on an order under section 33.
Part 5—Prescriptions and supply
38 Purpose of this Part
(1) Unless otherwise specified, this Part is made for the purposes of sections 105 and 140 of the Act.
(2) This Part:
(a) prescribes terms and conditions relating to the supply of pharmaceutical benefits; and
(b) provides rules about writing prescriptions.
39 Writing prescriptions—general
A prescription for the supply of a pharmaceutical benefit must be written in accordance with:
(a) either:
(i) section 40 (prescriptions other than medication chart prescriptions); or
(ii) section 41 (medication chart prescriptions); and
(b) if the prescription is an electronic prescription—section 41A (additional requirements for all electronic prescriptions).
Note: Other provisions of this instrument may also contain requirements for the writing of prescriptions.
40 Writing prescriptions—prescriptions other than medication chart prescriptions
Requirements for writing prescriptions
(1) A PBS prescriber writes a prescription in accordance with this section if the PBS prescriber:
(a) if the PBS prescriber is a participating dental practitioner, an authorised optometrist, an authorised midwife or an authorised nurse practitioner—states in the prescription the number allotted to his or her approval under section 16; and
(b) states in the prescription the name of the person for whom the pharmaceutical benefit is prescribed and the residential address of that person; and
(c) prepares the prescription in accordance with subsection (2); and
(d) identifies in the prescription the pharmaceutical benefit in accordance with subsection (2A); and
(e) states in the prescription:
(i) the quantity or number of units of the pharmaceutical benefit to be supplied; and
(ii) if the supply of the benefit is to be repeated—the number of times it is to be repeated; and
(f) if the pharmaceutical benefit to be supplied is not a ready‑prepared pharmaceutical benefit—indicates in the prescription the manner in which the pharmaceutical benefit is to be administered; and
(g) signs the prescription after it is prepared; and
(h) specifies on the prescription the date on which the prescription is written; and
(i) if the prescription is an authority prescription other than an authority prescription referred to in subsection (5)—writes on it:
(i) each authority approval number for the prescription, unless the prescription is to be posted or delivered to the Minister or Chief Executive Medicare for authorisation; or
(ii) the relevant streamlined authority code for the pharmaceutical benefit that is prescribed; and
(j) if, under section 49, the medical practitioner, authorised midwife or authorised nurse practitioner directs in the prescription the supply on the one occasion of a quantity or number of units of a pharmaceutical benefit exceeding the quantity or number of units that could otherwise be prescribed—writes on the prescription “Reg 24”, “Regulation 24”, “one supply” or “1 supply”.
Note: Section 49 of this instrument was previously regulation 24 of the National Health (Pharmaceutical Benefits) Regulations 1960.
(2) For the purposes of paragraph (1)(c), the prescription must be prepared:
(a) in duplicate, by handwriting the prescription in ink on a prescription form:
(i) that is as nearly as practicable 18 centimetres long by 12 centimetres wide; and
(ii) on which the name and address of the PBS prescriber, and the letters “PBS”, appear; and
(iii) on one part of which the words “pharmacist/patient copy” appear; and
(iv) on one part of which the words “Medicare/DVA copy” appear; or
(b) in duplicate, by means of a computer on a prescription form:
(i) that is as nearly as practicable 18 centimetres long by 12 centimetres wide; and
(ii) on which the name and address of the PBS prescriber, and the letters “PBS”, appear; and
(iii) on one part of which the words “pharmacist/patient copy” appear; and
(iv) on one part of which the words “Medicare/DVA copy” appear; and
(v) that is approved in writing for the purpose by the Secretary; or
(c) by means of a form:
(i) on which the name and address of the PBS prescriber and the letters “PBS” appear; and
(ii) that is approved, in writing, by the Secretary for the purpose of writing an electronic prescription; or
(d) by another method approved in writing by the Secretary.
(2A) For the purposes of paragraph (1)(d), the PBS prescriber must identify in the prescription:
(a) if:
(i) the prescription is prepared in accordance with paragraph (2)(a); or
(ii) the prescription is for the supply of a pharmaceutical benefit that has 4 or more drugs; or
(iii) the prescription is for the supply of a pharmaceutical benefit that is specified by the Secretary, in writing, for the purposes of this subparagraph;
the pharmaceutical benefit by such particulars as are necessary to identify the pharmaceutical benefit; or
(b) otherwise:
(i) each drug that the pharmaceutical benefit has; and
(ii) if the PBS prescriber considers that it is necessary for the medical treatment of the person for whom the pharmaceutical benefit is to be supplied to identify a brand of the pharmaceutical item that the pharmaceutical benefit has—the brand of the pharmaceutical item.
(2B) If subparagraph (2A)(b)(ii) applies, the brand of the pharmaceutical item must be listed after the drugs that the pharmaceutical benefit has.
(2C) Subsection (2A) does not apply to the extent that it would be contrary to a law of a State or Territory that would otherwise apply.
(3) A prescription written in accordance with this section must not provide for the supply of a pharmaceutical benefit (the prescribed benefit) to:
(a) a person if the PBS prescriber has written, on the same day, another prescription for the supply of a pharmaceutical benefit to the person that is:
(i) the same pharmaceutical benefit as the prescribed benefit; or
(ii) another brand of the same pharmaceutical benefit as the prescribed benefit; or
(iii) a pharmaceutical benefit that is a Schedule equivalent to the prescribed benefit; or
(b) more than one person.
(4) For the purposes of paragraphs (2)(b), (c) and (d), a prescription must not be prepared using a computer program that:
(a) operates, or may operate, to indicate on a prescription by default, for the purposes of subsection 103(2A) of the Act, that only the brand of pharmaceutical benefit specified in the prescription is to be supplied; or
(b) if paragraph (2A)(b) of this section applies to the prescription—operates, or may operate, to indicate on a prescription by default a brand of the pharmaceutical item that the pharmaceutical benefit has.
(5) Paragraph (1)(i) does not apply to authority prescriptions that have been authorised in accordance with authority required procedures that are incorporated by reference into the circumstances determined under subsection 85B(4) of the Act.
Note: If the authority required procedures referred to in subsection (5) require a streamlined authority code or an authority approval number to be written on an authority prescription, and the code or number is not written on the authority prescription, the special patient contribution is not payable by the Commonwealth: see subsection 85B(4) of the Act.
41 Writing prescriptions—medication chart prescriptions
Writing prescription by completing section of medication chart
(1) A PBS prescriber writes a prescription (a medication chart prescription) for a pharmaceutical benefit in accordance with this section if:
(a) the person for whom the pharmaceutical benefit is prescribed is receiving treatment in or at:
(i) a residential care service at which the person is receiving residential care; or
(ii) an approved hospital; and
(b) the PBS prescriber completes a section of a medication chart for the person in relation to the pharmaceutical benefit in accordance with:
(i) subsection (2); and
(ii) if the prescription would be an authority prescription other than an authority prescription referred to in subsection (3A)—subsection (3).
Completing section of medication chart—general
(2) A PBS prescriber completes a section of a medication chart in accordance with this subsection for a person (the patient) in relation to a pharmaceutical benefit if:
(a) the PBS prescriber writes in the section of the chart:
(i) particulars to identify the pharmaceutical benefit in accordance with subsection (2A); and
(ii) the date on which the pharmaceutical benefit is prescribed; and
(iii) the pharmaceutical benefit’s dose, frequency of administration and route of administration; and
(iv) the letters “PBS” or “RPBS”; and
(b) the chart contains the following information:
(i) the PBS prescriber’s given name, surname, address and PBS prescriber number;
(ii) the patient’s full name;
(iii) the name of the residential care service or approved hospital in or at which the patient is receiving treatment;
(iv) if the patient is receiving treatment in or at a residential care service—the Residential Aged Care Service ID for the residential care service;
(v) if the patient is receiving treatment in or at an approved hospital—the patient’s address; and
(c) the PBS prescriber writes his or her signature:
(i) in the section of the chart; and
(ii) except in the case of an electronic prescription—on the cover page of the chart; and
(d) the section of the chart does not provide for the supply of a pharmaceutical benefit to more than one person; and
(e) the section of the chart is not completed using a computer program that operates, or may operate, to indicate on a prescription by default, for the purpose of subsection 103(2A) of the Act, that only the brand of pharmaceutical benefit specified in the prescription is to be supplied; and
(ea) if paragraph (2A)(b) of this section applies to the prescription—the section of the chart is not completed using a computer program that operates, or may operate, to indicate on a prescription by default a brand of the pharmaceutical item that the pharmaceutical benefit has; and
(f) if the patient is receiving treatment in or at an approved hospital—the chart specifies the day on which the chart’s period of validity ends under subsection 45(4), which must be the day after the last day of one of the following periods starting on the day the first prescription for a pharmaceutical benefit is written in the chart:
(i) 1 month;
(ii) 4 months;
(iii) 12 months; and
(g) if the patient is receiving treatment in or at a residential care service and the chart is not an electronic medication chart—the pharmaceutical benefit is not referred to in Schedule 8 to the current Poisons Standard (within the meaning of the Therapeutic Goods Act 1989); and
(h) in any case—the section of the chart is completed before the end of the chart’s period of validity under subsection 45(3) or (4).
Note: A section in a medication chart may set out fields that only need to have information filled in if the information is relevant to the particular prescription concerned.
Example: For the purposes of paragraph (f), the first prescription is written in a medication chart on 11 June in a particular year. The day specified in the chart as the day on which the chart’s period of validity ends must be 11 July or 11 October in that year, or 11 June in the following year.
(2A) For the purposes of subparagraph (2)(a)(i), the PBS prescriber must write in the section of the chart:
(a) if:
(i) the prescription is prepared by handwriting the prescription on the section of the chart; or
(ii) the prescription is for the supply of a pharmaceutical benefit that has 4 or more drugs; or
(iii) the patient is receiving treatment in or at a residential care service and the medication chart is not an electronic medication chart; or
(iv) the prescription is for the supply of a pharmaceutical benefit that is specified by the Secretary, in writing, for the purposes of this subparagraph;
particulars sufficient to identify the pharmaceutical benefit; or
(b) otherwise:
(i) each drug that the pharmaceutical benefit has; and
(ii) if the PBS prescriber considers that it is necessary for the medical treatment of the patient to identify a brand of the pharmaceutical item that the pharmaceutical benefit has—the brand of the pharmaceutical item.
(2B) If subparagraph (2A)(b)(ii) applies, the brand of the pharmaceutical item must be listed after the drugs that the pharmaceutical benefit has.
(2C) Subsection (2A) does not apply to the extent that it would be contrary to a law of a State or Territory that would otherwise apply.
Completing section of medication chart—authority prescriptions
(3) A PBS prescriber completes a section of a medication chart in accordance with this subsection for a person for the purpose of writing an authority prescription if the section of the chart contains:
(a) each authority approval number for the prescription, unless the prescription is to be posted or delivered to the Minister or Chief Executive Medicare for authorisation; or
(b) the relevant streamlined authority code for the pharmaceutical benefit that is prescribed.
Authority prescriptions that have been authorised in accordance with certain authority required procedures
(3A) Subparagraph (1)(b)(ii) does not apply to authority prescriptions that have been authorised in accordance with authority required procedures that are incorporated by reference into the circumstances determined under subsection 85B(4) of the Act.
Note: If the authority required procedures referred to in subsection (3A) require a streamlined authority code or an authority approval number to be written on an authority prescription, and the code or number is not written on the authority prescription, the special patient contribution is not payable by the Commonwealth: see subsection 85B(4) of the Act.
Medication charts
(4) A medication chart is a chart in a form (if any) approved under subsection (5) that is used for prescribing, and recording the administration of, pharmaceutical benefits to persons receiving treatment in or at a residential care service or a hospital, whether or not the chart:
(a) is used for any other purpose; or
(b) contains any other information.
Note: For the purposes of paragraph (a), the chart may also be used (for example) to prescribe, and record the administration of, drugs, medicines and other substances that are not pharmaceutical benefits.
(5) The Secretary may, in writing, approve one or more forms for the purposes of subsection (4), including one or more forms for the purpose of writing an electronic prescription.
Electronic medication charts
(6) An electronic medication chart is a medication chart in a form approved under subsection (5) for the purpose of writing an electronic prescription.
41A Writing prescriptions—additional requirements for all electronic prescriptions
A PBS prescriber writes an electronic prescription in accordance with this section if the PBS prescriber:
(a) includes in the metadata of the prescription:
(i) the conformance identifier provided to the Australian Digital Health Agency in relation to the software used to prepare the prescription; and
(ii) a unique identifier for the prescription generated by that software; and
(b) states in the prescription:
(i) the healthcare identifier (if any) assigned to the PBS prescriber; and
(ii) the healthcare identifier assigned to a healthcare provider organisation to which the PBS prescriber is linked (within the meaning of the Healthcare Identifiers Act 2010).
41B Writing prescriptions—additional information that may be included in electronic prescriptions
An electronic prescription may include either or both of the following:
(a) the date of birth of the person for whom the pharmaceutical benefit is prescribed;
(b) the reason why the pharmaceutical benefit is prescribed to that person.
(ii) adding up each of those amounts; and
(iii) dividing that amount by the total adjusted volume of the brands of the pharmaceutical item.
79 Step 9—repeat steps for each pharmaceutical item with related brands
(1) For each brand (including delisted brands) of a pharmaceutical item with the same drug and manner of administration as the listed brand but a different form (the other pharmaceutical item), other than an exempt item, work out the price percentage difference of the brand for the data collection period ending on the same day as the data collection period of the listed brand.
(2) The price percentage difference of a brand of the other pharmaceutical item is worked out using steps 1 to 5, reading references to the listed brand as references to the brand of the other pharmaceutical item.
(3) If a brand of the other pharmaceutical item is a delisted brand on the final day, then the pricing quantity of the delisted brand on the final day is taken to be:
(a) if there is a listed brand of the other pharmaceutical item on the final day—the pricing quantity of the listed brand of the other pharmaceutical item; or
(b) if there is no listed brand of the other pharmaceutical item on the final day—the pricing quantity of the last listed brand of the other pharmaceutical item immediately before it was delisted.
Note: The pricing quantity of the brand on the final day is needed for working out the adjusted volume (step 2) and the average approved ex‑manufacture price (step 3).
(4) For each pharmaceutical item with the same drug and manner of administration as the listed brand but a different form, other than an exempt item, work out the weighted average percentage difference of the brands of the pharmaceutical item (using steps 7 and 8).
80 Step 10—weighted average percentage difference for listed brand and all related brands
(1) Work out the weighted average percentage difference for the listed brand and all related brands.
(2) The weighted average percentage difference is the amount (expressed as a percentage to 2 decimal places) worked out as follows:
(a) for each pharmaceutical item with the same drug and manner of administration as the listed brand (including the pharmaceutical item of the listed brand):
(i) multiply the total adjusted volume for the brands of the pharmaceutical item (see step 7) by the average approved ex‑manufacturer price for a brand of the pharmaceutical item (see step 3); and
(ii) multiply that amount by the weighted average percentage difference of the brands of the pharmaceutical item (see step 8);
(b) add up the amounts worked out under subparagraph (a)(ii);
(c) add up the amounts worked out under subparagraph (a)(i);
(d) divide the amount worked out under paragraph (b) by the amount worked out under paragraph (c).
(3) However:
(a) if the amount worked out under paragraph (2)(c) is zero or less, the weighted average percentage difference is zero; and
(b) if the amount worked out under paragraph (2)(d) is 99% or more, the weighted average percentage difference is 99%.
81 Step 11—weighted average disclosed price for listed brand of pharmaceutical item
(1) Work out the weighted average disclosed price of the listed brand of the pharmaceutical item for the data collection period.
(2) The weighted average disclosed price of the listed brand of the pharmaceutical item is the average approved ex‑manufacturer price for the listed brand reduced by the weighted average percentage difference for all related brands (see step 10).
(3) However, if the pricing quantity of the listed brand of the pharmaceutical item on the final day is different from the pricing quantity of the listed brand on the relevant day, the weighted average disclosed price is:
where:
PQ1 means the pricing quantity of the listed brand on the final day.
PQ2 means the pricing quantity of the listed brand on the relevant day.
WR means the average approved ex‑manufacturer price for the listed brand reduced by the weighted average percentage difference for all related brands (see step 10).
Note: See section 99ADHA of the Act for price reductions for brands listed after the end of the data collection period.
(4) This section has effect subject to section 82.
82 When weighted average disclosed price is the same as the applicable approved ex‑manufacturer price
Despite section 81, if all of the following apply, the weighted average disclosed price of the listed brand of the pharmaceutical item for the data collection period is taken to be the amount of the applicable approved ex‑manufacturer price of the listed brand of the pharmaceutical item:
(a) the total adjusted volume worked out for brands of the pharmaceutical item under section 77:
(i) is more than zero; and
(ii) is no more than 10% of the sum of the total adjusted volumes for the brands of each pharmaceutical item with the same drug and manner of administration as the listed brand (including the pharmaceutical item of the listed brand);
(b) the weighted average percentage difference worked out for brands of the pharmaceutical item under section 78 is not more than 3%;
(c) there is not a related brand of the listed brand of the pharmaceutical item:
(i) that is bioequivalent or biosimilar to the listed brand of the pharmaceutical item; and
(ii) to which paragraphs (a) and (b) do not apply;
(d) the Pharmaceutical Benefits Advisory Committee has not advised the Minister that the pharmaceutical item does not provide a significant improvement in efficacy or a reduction in toxicity over alternative therapies.
Subdivision C—Information that must not be taken into account
83 Information that must not be taken into account
(1) This Subdivision is made for the purposes of subsection 99ADB(6A) of the Act.
(2) Section 84 prescribes information that must not be taken into account in determining the weighted average disclosed price of a listed brand of a pharmaceutical item (the WADP brand) in respect of a data collection period.
(3) However, section 84 does not apply in relation to determining a weighted average disclosed price for the purposes of section 82.
(4) To avoid doubt, this Subdivision has effect:
(a) despite Subdivision B (weighted average disclosed price); and
(b) even if the information relates to the WADP brand.
84 Originator brands
(1) Information provided under section 85 about an originator brand must not be taken into account if:
(a) on the first day of each calendar month in the data collection period (from its beginning in relation to the originator brand) on which the originator brand is a listed brand, there is another listed brand of pharmaceutical item that:
(i) is not an originator brand; but
(ii) has the same pharmaceutical item as the originator brand; and
(b) at the end of the previous data collection period, the drug in the WADP brand had been on F2 for at least 30 months; and
(c) on a day at least 30 months before the end of the previous data collection period:
(i) there was a related brand of the WADP brand that had the same pharmaceutical item as, or was bioequivalent or biosimilar to, the WADP brand; or
(ii) there were 2 or more related brands of the WADP brand that had the same pharmaceutical item as, or were bioequivalent or biosimilar to, each other.
(2) Paragraph (1)(a) has effect even if the other listed brand is different from month to month.
(3) However, subsection (1) does not apply if taking the information into account would result in a higher weighted average percentage difference under section 80 (weighted average percentage difference for the WADP brand and all related brands).
Subdivision D—Price disclosure requirements
85 Price disclosure requirements
(1) This section is made for the purposes of subsection 99ADC(1) of the Act.
Prescribed information
(2) The responsible person must provide the following information in relation to the supply of a brand of a pharmaceutical item, other than the supply to a public hospital:
(a) the start and end dates of the period to which the information relates;
(b) the name of the brand;
(c) the name of the responsible person;
(d) the name of the drug in the pharmaceutical item;
(e) the form of the drug, including its strength;
(f) the manner of administration of the form of the drug;
(g) the number or quantity of units in a pack (the number of tablets in a pack, for example);
(h) the number of packs sold;
(i) the revenue from sales of the brand, excluding GST;
(j) if any incentive is given in relation to the brand:
(i) the kind of incentive; and
(ii) the value of the incentive, excluding GST.
(3) If information is provided under paragraph (2)(i), the information must not also be provided under paragraph (2)(j).
(4) The information referred to in each of paragraphs (2)(h), (i) and (j), to the extent that the information relates to the brand’s initial month, must be provided separately.
(5) An amount provided under paragraph (2)(i) or (j) must be:
(a) expressed in Australian dollars; and
(b) rounded to the nearest whole dollar, rounding 50 cents upwards.
Prescribed person
(6) The responsible person must provide the information to:
(a) Australian Healthcare Associates Pty Ltd (ABN 82 072 790 848); or
(b) if the responsible person receives written notice from the Department to provide the information to the Secretary—the Secretary.
Prescribed manner and form
(7) The responsible person must provide the information in a form approved, in writing, by the Secretary.
(8) The completed form must:
(a) include all the statements and information required by the form; and
(b) be signed (or authorised for electronic transmission) by a person who is authorised by the responsible person to provide the information.
Prescribed times
(9) Subject to subsection (10), the responsible person must provide the information:
(a) for each period between 1 April and 30 September in a year—before the end of 11 November in that year; and
(b) for each period between 1 October and the next 31 March—before the end of the next 12 May.
(10) However, for the period between a brand’s start day and the next 31 March or 30 September, whichever is the sooner, the responsible person must provide the information:
(a) if the start day happens between 1 April and 30 September in a year—before the end of 11 November in that year; or
(b) if the start day happens between 1 October and the next 31 March—before the end of the next 12 May.
Part 8—Arrangements for the Pharmaceutical Benefits Advisory Committee
Division 1—Matters relating to the appointment of members of the Committee
86 Nominating bodies
Industry organisations
(1) For the purposes of paragraph 100B(1AA)(a) of the Act, the following industry organisations are prescribed:
(a) Medicines Australia Limited;
(b) Generic Medicines Industry Association Pty Ltd trading as the Generic and Biosimilar Medicines Association;
(c) Ausbiotech Ltd.
Consumer organisations
(2) For the purposes of paragraph 100B(1AB)(a) of the Act, the following consumer organisations are prescribed:
(a) the Consumers Health Forum of Australia Ltd;
(b) the Australian Federation of AIDS Organisations Incorporated;
(c) the Australian Consumers’ Association.
Professional associations
(3) For the purposes of paragraph 100B(1A)(b) of the Act, the following professional associations of health economists are prescribed:
(a) the Australian Health Economics Society Inc;
(b) the Economic Society of Australia Inc.
(4) For the purposes of paragraph 100B(1A)(c) of the Act, the following professional associations of pharmacists are prescribed:
(a) the Pharmacy Guild of Australia;
(b) the Pharmaceutical Society of Australia;
(c) the Society of Hospital Pharmacists of Australia.
(5) For the purposes of paragraph 100B(1A)(d) of the Act, the following professional associations of medical practitioners are prescribed:
(a) the Australian Medical Association Limited;
(b) the Royal Australian College of General Practitioners;
(c) the Doctors Reform Society—Australia Inc;
(d) the Australian Federation of Medical Women Inc.
(6) For the purposes of paragraph 100B(1A)(e) of the Act, the following professional associations of clinical pharmacologists are prescribed:
(a) the Royal Australasian College of Physicians;
(b) the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists.
(7) For the purposes of paragraph 100B(1A)(f) of the Act, the following professional associations of specialists are prescribed:
(a) the Australian Medical Association Limited;
(b) the Royal Australasian College of Physicians;
(c) the Committee of Presidents of Medical Colleges.
87 Number of nominations for appointment
For the purposes of subsection 100B(1B) of the Act, each body prescribed for the purposes of subsection 100B(1AA), (1AB) or (1A) of the Act must be asked to nominate at least 3 persons for selection for appointment as members of the Pharmaceutical Benefits Advisory Committee.
88 Resignation
A member of the Pharmaceutical Benefits Advisory Committee may resign by notice in writing given to the Minister.
Division 2—Matters relating to the procedure of the Committee
89 Purpose of this Division
For the purposes of subsection 101(5) of the Act, this Division makes provision for and in relation to the procedure of the Pharmaceutical Benefits Advisory Committee.
90 Presiding member
(1) The Chairperson of the Pharmaceutical Benefits Advisory Committee must preside at a meeting of the Committee if the Chairperson is present.
(2) If the Chairperson is absent and there is a Deputy Chairperson of the Committee present, the Deputy Chairperson must preside at the meeting.
(3) If:
(a) the Chairperson is absent; and
(b) there is no Deputy Chairperson present;
the members of the Committee attending the meeting must elect a member to preside at the meeting.
91 Meetings of the Committee
(1) The Chairperson of the Pharmaceutical Benefits Advisory Committee may, at any time, by notice in writing to all members of the Committee, convene a meeting of the Committee.
(2) The Committee must keep minutes of its meetings.
92 Quorum
At a meeting of the Pharmaceutical Benefits Advisory Committee, a quorum is the number of members who constitute a majority of the membership of the Committee.
93 Voting
(1) At a meeting of the Pharmaceutical Benefits Advisory Committee, the members present each have a deliberative vote.
(2) A matter requiring a decision at a meeting must be determined by a majority of the votes of the members present and voting.
(3) If an equal number of votes is cast for and against a matter at a meeting:
(a) the member presiding at the meeting may exercise a casting vote; and
(b) if that member declines to exercise a casting vote—the matter is resolved in the negative.
(4) Decisions of the Committee must be recorded in the minutes of the meeting.
94 Disclosure of pecuniary interests by members
(1) Each member of the Pharmaceutical Benefits Advisory Committee must tell the Minister in writing, as soon as practicable after the beginning of each financial year, of all direct or indirect pecuniary interests that the member has, or proposes to acquire, in a business or in a body corporate carrying on a business that could conflict with the member’s duties.
(2) If a member does not have an interest of the kind referred to in subsection (1), the member must give a statement to that effect to the Minister.
(3) If the member presiding at a meeting of the Committee has a direct or indirect pecuniary interest in a matter that is to be considered at the meeting, the presiding member:
(a) must disclose the interest to the other members present at the meeting; and
(b) must not take part in the meeting during the consideration of that matter unless the other members present at the meeting agree that the presiding member may take part in the meeting.
(4) If the presiding member is precluded from taking part in a meeting or part of a meeting because of paragraph (3)(b):
(a) if the presiding member is the Chairperson of the Committee and a Deputy Chairperson of the Committee is present—the Deputy Chairperson must act in the place of the Chairperson for the duration of the Committee’s consideration of the matter; or
(b) if:
(i) the presiding member is the Chairperson of the Committee and no Deputy Chairperson of the Committee is present; or
(ii) the Deputy Chairperson is the presiding member;
the other members attending the meeting must elect a member who is present to act in the place of the presiding member for the duration of the Committee’s consideration of the matter.
(5) If a member (other than the presiding member) of the Committee has a direct or indirect pecuniary interest in a matter that is to be considered at a meeting of the Committee, the member:
(a) must disclose the interest to the presiding member at the commencement of the meeting; and
(b) must not take part in the meeting during the consideration of that matter unless the presiding member allows the member to take part in the meeting.
(6) The following matters must be recorded in the minutes of a meeting of the Committee:
(a) a disclosure made under subsection (3) or (5);
(b) an agreement under paragraph (3)(b);
(c) consent of the presiding member under paragraph (5)(b).
95 Resolutions without a formal meeting
If a majority of the members of the Pharmaceutical Benefits Advisory Committee sign a document that includes a statement that they are in favour of a resolution in the terms set out in the document, the resolution is taken to have been passed at a meeting of the Committee:
(a) on the day on which the document is signed; or
(b) if the members sign the document on different days—on the day on which the document is signed by the member who completes the majority.
96 Reports and recommendations
(1) A report or a recommendation made to the Minister by the Pharmaceutical Benefits Advisory Committee as part of its consideration of a matter must be in writing.
(2) If:
(a) the members of the Committee are not unanimous in agreeing to a report or a recommendation; and
(b) a member who is not part of the majority asks the Chairperson of the Committee to include, as part of the report or recommendation:
(i) a statement that the members are not unanimous; or
(ii) an explanation of the opinion of the member; or
(iii) a separate report or recommendation made by the member;
the report or recommendation must include the matter requested by the member.
Division 3—Matters relating to sub‑committees
97 Remuneration for chair and members of sub‑committees
Fees and allowances payable to chairs
(1) For the purposes of paragraph 140(a) of the Act, the fees and allowances payable to the Chair of the Drug Utilisation Sub‑Committee and the Chair of the Economics Sub‑Committee are the amounts payable to the Chairperson of the Pharmaceutical Services Federal Committee of Inquiry in accordance with a determination made by the Remuneration Tribunal.
Fees and allowances payable to other members
(2) For the purposes of paragraph 140(a) of the Act, the fees and allowances payable to a member (other than the Chair) of the Drug Utilisation Sub‑Committee or the Economics Sub‑Committee are the amounts payable to a member (other than the Chairperson) of the Pharmaceutical Services Federal Committee of Inquiry in accordance with a determination made by the Remuneration Tribunal.
Definitions
(3) In this section:
Drug Utilisation Sub‑Committee means the sub‑committee of that name established under section 101A of the Act.
Economics Sub‑Committee means the sub‑committee of that name established under section 101A of the Act.
Part 9—Application, savings and transitional provisions
98 Definitions
In this Part:
old regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
99 Things done under old regulations
(1) If:
(a) a thing was done for a particular purpose under the old regulations as in force immediately before those regulations were repealed; and
(b) the thing could be done for that purpose under this instrument;
the thing has effect for the purposes of this instrument as if it had been done under this instrument.
(2) Without limiting subsection (1), a reference in that subsection to a thing being done includes a reference to a notice, approval or other instrument being given or made.
102 Transitional provision relating to the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019
(1) This section applies in relation to a prescription for the supply of a pharmaceutical benefit that is written before 1 November 2020.
(2) Despite the amendments of section 40 made by Schedule 1 to the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019, a prescription that is not a medication chart prescription is taken to have been written in accordance with section 40 if the prescription is written in accordance with that section as in force immediately before 31 October 2019.
(3) Despite the amendments of section 41 made by Schedule 1 to the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019, a prescription that is a medication chart prescription is taken to have been written in accordance with section 41 if the prescription is written in accordance with that section as in force immediately before 31 October 2019.
Schedule 1—Prescribed offices
Note: See sections 20 and 22.
1 Table of prescribed offices
The following table sets out offices that are prescribed offices.
| Prescribed offices | |
| Item | Office |
| 1 | Pharmaceutical Benefits Scheme Claims Section Department of Human Services GPO Box 9826 SYDNEY NSW 2000 |
| 2 | Pharmaceutical Benefits Scheme Claims Section Department of Human Services GPO Box 9826 MELBOURNE VIC 3000 |
| 3 | Pharmaceutical Benefits Scheme Claims Section Department of Human Services GPO Box 9826 BRISBANE QLD 4000 |
| 4 | Pharmaceutical Benefits Scheme Claims Section Department of Human Services GPO Box 9826 PERTH WA 6000 |
| 5 | Pharmaceutical Benefits Scheme Claims Section Department of Human Services GPO Box 9826 ADELAIDE SA 5000 |
| 6 | Pharmaceutical Benefits Scheme Claims Section Department of Human Services GPO Box 9826 HOBART TAS 7000 |
| 7 | Pharmaceutical Benefits Scheme Claims Section Department of Human Services GPO Box 9826 CANBERRA ACT 2600 |
| 8 | Pharmaceutical Benefits Scheme Claims Section Department of Human Services GPO Box 9826 DARWIN NT 0800 |
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Editorial changes
The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.
If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
Endnote 2—Abbreviation key
| ad = added or inserted | o = order(s) |
| am = amended | Ord = Ordinance |
| amdt = amendment | orig = original |
| c = clause(s) | par = paragraph(s)/subparagraph(s) |
| C[x] = Compilation No. x | /sub‑subparagraph(s) |
| Ch = Chapter(s) | pres = present |
| def = definition(s) | prev = previous |
| Dict = Dictionary | (prev…) = previously |
| disallowed = disallowed by Parliament | Pt = Part(s) |
| Div = Division(s) | r = regulation(s)/rule(s) |
| ed = editorial change | reloc = relocated |
| exp = expires/expired or ceases/ceased to have | renum = renumbered |
| effect | rep = repealed |
| F = Federal Register of Legislation | rs = repealed and substituted |
| gaz = gazette | s = section(s)/subsection(s) |
| LA = Legislation Act 2003 | Sch = Schedule(s) |
| LIA = Legislative Instruments Act 2003 | Sdiv = Subdivision(s) |
| (md) = misdescribed amendment can be given | SLI = Select Legislative Instrument |
| effect | SR = Statutory Rules |
| (md not incorp) = misdescribed amendment | Sub‑Ch = Sub‑Chapter(s) |
| cannot be given effect | SubPt = Subpart(s) |
| mod = modified/modification | underlining = whole or part not |
| No. = Number(s) | commenced or to be commenced |
Endnote 3—Legislation history
| Name | Registration | Commencement | Application, saving and transitional provisions |
| National Health (Pharmaceutical Benefits) Regulations 2017 | 27 Mar 2017 (F2017L00313) | 1 Apr 2017 (s 2(1) item 1) | |
| National Health (Pharmaceutical Benefits) Amendment (Safety Net) Regulations 2018 | 16 May 2018 (F2018L00621) | 1 June 2018 (s 2(1) item 1) | — |
| National Health (Pharmaceutical Benefits) Amendment (Electronic Prescriptions) Regulations 2019 | 16 Aug 2019 (F2019L01072) | 31 Oct 2019 (s 2(1) item 1) | — |
| National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019 | 9 Oct 2019 (F2019L01312) | 31 Oct 2019 (s 2(1) item 1) | — |
| National Health (Pharmaceutical Benefits) Amendment (Supply of Pharmaceutical Benefits Following Bankruptcy or External Administration) Regulations 2019 | 29 Nov 2019 (F2019L01530) | 5 Dec 2019 (s 2(1) item 1 | — |
Endnote 4—Amendment history
| Provision affected | How affected |
| Part 1 | |
| Division 1 | |
| s 2............................................. | rep LA s 48D |
| s 4............................................. | rep LA s 48C |
| s 5............................................. | am F2018L00621; F2019L01072; F2019L01312 |
| s 6............................................. | rep F2018L00621 |
| Division 2 | |
| s 9............................................. | am F2019L01072 |
| s 10........................................... | am F2019L01072 |
| Part 2 | |
| s 16........................................... | am F2019L01530 |
| Part 3 | |
| Division 1A | |
| Division 1A.............................. | ad F2018L00621 |
| s 17A........................................ | ad F2018L00621 |
| Division 1 | |
| s 18........................................... | am F2018L00621 |
| Division 2 | |
| s 19........................................... | am F2018L00621 |
| Division 3 | |
| s 21........................................... | am F2018L00621 |
| Part 4 | |
| Division 1 | |
| s 30........................................... | am F2019L01072 |
| Division 2 | |
| s 33........................................... | am F2019L01072 |
| Part 5 | |
| s 39........................................... | am F2019L01072 |
| s 40........................................... | am F2019L01072; F2019L01312 |
| s 41........................................... | am F2019L01072; F2019L01312 |
| s 41A........................................ | ad F2019L01072 |
| s 41B........................................ | ad F2019L01072 |
| s 57........................................... | am F2019L01072 |
| Part 6 | |
| s 59........................................... | am F2019L01072 |
| Part 9 | |
| s 100......................................... | rep 1 Apr 2019 (s 100(3)) |
| s 101......................................... | rep 1 Apr 2019 (s 101(3)) |
| s 102......................................... | ad F2019L01312 |
| Schedule 2................................ | rep LA s 48C |
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