National Health Act 1953 (Cth)

National Health Act 1953

No. 95, 1953

Compilation No. 149

Compilation date: 15 February 2025

Includes amendments: Act No. 8, 2025

About this compilation

This compilation

This is a compilation of the National Health Act 1953 that shows the text of the law as amended and in force on 15 February 2025 (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 Register (www.legislation.gov.au). 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 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 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 I—Preliminary 1 Short title 2 Commencement 4 Interpretation 6 Delegation 6A External Territories 7A Application of the Criminal Code Part II—National health services 8 Interpretation 9 Provision of certain medical and dental services 9A Provision of medical and surgical aids and appliances etc. by the Commonwealth 9B Provision of vaccines 9C Arrangements with States for provision of surgical aids and appliances etc. 10 Arrangements with other Ministers 11 Arrangements with States Part III—Continence Aids Payment Scheme 12 Continence Aids Payment Scheme 13 Secretary or Chief Executive Medicare may request information 14 Reviewing decision whether applicant is eligible for the scheme 15 Reviewing decision whether participant is eligible for the scheme Part VII—Pharmaceutical benefits Division 1—Preliminary 83Z Repeal and saving 84 Interpretation 84AAA Early supply of a specified pharmaceutical benefit 84AA Concessional benefit prescriptions, concession card prescriptions and entitlement card prescriptions 84A Participating dental practitioners 84AAB Authorised optometrists 84AAC Secretary may suspend or revoke approval of authorised optometrist 84AAD Review of decisions relating to authorised optometrists 84AAE Meaning of eligible midwife 84AAF Authorised midwives 84AAG Secretary may suspend or revoke approval of authorised midwife 84AAH Review of decisions relating to authorised midwives 84AAI Meaning of eligible nurse practitioner 84AAJ Authorised nurse practitioners 84AAK Secretary may suspend or revoke approval of authorised nurse practitioner 84AAL Review of decisions relating to authorised nurse practitioners 84AB Pharmaceutical items 84ABA References to pharmaceutical items, combination items or pharmaceutical benefits having a drug 84AC When listed drug is on F1 or F2 84AE Co‑marketed brands 84AF Responsible person for a brand of a pharmaceutical item 84AG Therapeutic groups 84AH Exempt items 84AI Rounding amounts 84AJ When pharmaceutical benefits are Schedule equivalent 84AK Quantities of pharmaceutical items Division 1A—Safety net concession cards and pharmaceutical benefits entitlement cards 84B Family relationships 84BA Supplies of out‑patient medication 84C Eligibility for concession and entitlement cards 84CA Transferred value 84D Pharmaceutical benefits prescription record forms etc. 84DA Issue of safety net concession card 84E Issue of pharmaceutical benefits entitlement card 84F Form of cards 84G Persons covered by card 84H Additional and replacement cards 84HA Fee to approved pharmacist etc. for issuing card 84J Period of effect of card 84K Return of card 84L Offences Division 2—Supply of pharmaceutical benefits 85 Pharmaceutical benefits 85AAA Pharmaceutical benefits that can only be supplied under the prescriber bag provisions 85AA Pharmaceutical benefits that can only be supplied under special arrangements 85A Determinations of forms of pharmaceutical benefits or pharmaceutical items with respect to classes of persons 85AB Minister may determine that a listed drug is on F1 or F2 85AD Price agreements 85B Price determinations and special patient contributions 85BA Effect of deemed reductions of, or increases to, approved ex‑manufacturer price 85C Each brand of a pharmaceutical item is to have the same approved ex‑manufacturer price 85D Proportional ex‑manufacturer price 85E Minister may enter into deeds with responsible persons 86 Entitlement to receive pharmaceutical benefits 86A Pharmaceutical benefits not to be supplied in respect of persons reasonably believed not to be in Australia 86B Approved supplier may request provision of medicare number 86C On and after 1 January 2001 approved supplier must request provision of medicare number in certain circumstances 86D Power of approved suppliers to record and retain medicare numbers and expiry dates 86E Minister may determine certain persons to be special evidentiary categories 87 Limited charges for pharmaceutical benefits 87AA Meaning of eligible for increased discounting 87A Entitlement to refund in certain circumstances 88 Prescribing of pharmaceutical benefits 88AA Power of PBS prescribers to record and retain medicare numbers and expiry dates 88A Prescription of certain pharmaceutical benefits authorised only in certain circumstances 89 Pharmaceutical benefits to be supplied only on prescription etc. 89A When pharmaceutical benefits may be supplied by approved pharmacists without prescription 90 Approved pharmacists 90A Minister may substitute decision approving pharmacist 90B Request to Minister to approve pharmacist 90C Circumstances in which request may not be made 90D Provision of further information 90E Effect of decision by Minister to approve pharmacist 91 Application to supply pharmaceutical benefits following the death of approved pharmacist 91A Application to supply pharmaceutical benefits at alternative premises because of disaster or exceptional circumstances 91B Application to supply pharmaceutical benefits if approved pharmacist is bankrupt or external administrator in relation to pharmacy 92 Approved medical practitioners 92A Approvals to be subject to conditions 92B Persons not to enter into certain refund agreements 93 Prescriber bag supplies—medical practitioners 93AA Prescriber bag supplies—authorised midwives 93AB Prescriber bag supplies—authorised nurse practitioners 93A Supply of certain pharmaceutical benefits to patients in private hospitals or aged care facilities 94 Approved hospital authorities 95 Suspension or revocation of approval 98 Cancellation by Secretary of approval of pharmacists etc. 98AA Cancellation by Minister of approval of hospital 98AB Notification by Department of alterations to pharmaceutical benefits scheme 98AC Information about supplies Division 3—Payment for supply of pharmaceutical benefits Subdivision A—Preliminary 98AD What this Division is about Subdivision B—Determination of Commonwealth price and Commonwealth payments 98A Establishment of Pharmaceutical Benefits Remuneration Tribunal 98B Functions of Tribunal 98BA Inquiries by Tribunal 98BAA Tribunal must give effect to certain agreements 98BB Constitution of Tribunal 98BC Procedure of Tribunal 98BD Findings etc. of Tribunal to be made public 98BE Date of operation of determination of the Tribunal 98C Determinations by Minister 98E Secrecy Subdivision C—Payments for the supply of pharmaceutical benefits 99 Payment for supply of benefits—general 99AAAA Additional payment for ACSS eligible supplies 99AAAB Conditions on payments 99AAA Claim for payment relating to supply of benefits 99AAB Certain suppliers exempted from requirement to use the Claims Transmission System 99AAC Declaration by Secretary exempting approved supplier from using Claims Transmission System Division 3AA—Recovery of payments for the supply of pharmaceutical benefits 99AA Unauthorised payments etc. 99AB Advances 99ABA Recovery of amounts for false or misleading information 99ABB Notice to produce documents 99ABC Notice of decision to claim amounts as debts 99ABD Review of decisions to claim amounts as debts 99ABE Liability for administrative penalty 99ABF Amount of administrative penalty 99ABG Notice of administrative penalty and review of assessments 99ABH Power to obtain information relating to a debt 99ABI Amounts recoverable once only 99ABJ Garnishee notices 99ABK Failure to comply with garnishee notice 99ABL Recoverable amounts may be set off Division 3A—Price reductions Subdivision A—Preliminary 99AC What this Division is about 99ACA Definitions etc. Subdivision B—First new brand price reductions for brands of pharmaceutical items that are not combination items 99ACB First new brand price reductions for brands of pharmaceutical items that are not combination items 99ACBA Ministerial determination—brand of pharmaceutical item that is not a combination item is not a new brand Subdivision C—Price reductions for combination items 99ACC Price reductions for single brands of combination items 99ACD First new brand price reductions for brands of combination items 99ACEA Ministerial determination—brand of pharmaceutical item that is a combination item is not a new brand Subdivision D—Other statutory price reductions 99ACF Statutory price reductions 99ACG Other price reductions do not apply if a price disclosure reduction has applied 99ACHA 5% statutory price reduction for drugs on F1—fifth anniversary 99ACHB 5% statutory price reduction for drugs on F1—fifth anniversary 99ACJ 10% statutory price reduction for drugs on F1—tenth anniversary 99ACJA 5% statutory price reduction for drugs on F1—tenth anniversary 99ACK 5% statutory price reduction for drugs on F1—15th anniversary 99ACKA 26.1% statutory price reduction for certain drugs—15th anniversary 99ACKB 30% statutory price reduction for certain drugs—15th anniversary 99ACL Special rule—statutory price reduction for drugs on F1 99ACM 5% statutory price reduction for drugs on F1—tenth anniversary 99ACN Catch‑up price reduction for certain drugs—15th anniversary 99ACNA Catch‑up price reduction for certain drugs—meaning of previous price reduction under this Division 99ACP 1.48% statutory price reduction for certain drugs—15th anniversary Subdivision E—Flow‑on of first new brand price reductions to existing brands and related brands 99ACQ Flow‑on of price reductions to existing brands of the same pharmaceutical item 99ACR Flow‑on of first new brand price reductions to related brands Division 3B—Price disclosure Subdivision A—Preliminary 99AD What this Division is about 99ADA Division does not apply to exempt items 99ADB Definitions etc. 99ADBA Meaning of data collection period Subdivision B—Price disclosure requirements 99ADC The price disclosure requirements 99ADD When the price disclosure requirements apply Subdivision D—Consequences for failing to comply with the price disclosure requirements 99ADF Offence for failing to comply with the price disclosure requirements 99ADG Other consequences for failing to comply with the price disclosure requirements Subdivision E—Price reduction 99ADH Price reduction based on information provided under the price disclosure requirements 99ADHA Price reduction for brands listing after end of data collection period 99ADHB Flow on price reductions for brands of combination items Division 3BA—Floor price of a brand of a pharmaceutical item 99ADHC Floor price of a brand of a pharmaceutical item 99ADHD Meaning of previous data collection period Division 3C—Guarantee of supply Subdivision A—Preliminary 99AE What this Division is about 99AEA Definitions Subdivision B—Guarantee of supply 99AEB Guarantee of supply Subdivision C—Brands that are guaranteed brands 99AEC Guaranteed brand: new brand 99AED Guaranteed brand: first brand to offer a lower price Subdivision D—Meaning of fails to supply and unable to supply 99AEE Meaning of fails to supply 99AEF Meaning of unable to supply Subdivision E—Requirement to notify Minister of failure or inability to supply etc. 99AEG Requirement to notify Minister of failure to supply etc. Subdivision F—Consequences for guaranteed brands of failure or inability to supply 99AEH Minister's powers if responsible person fails to supply, or is unable to supply, guaranteed brand Subdivision G—Consequences for other brands 99AEI Minister may increase approved ex‑manufacturer price if guaranteed brand delisted 99AEJ Minister may determine drug is on F1 if guaranteed brand delisted 99AEK Minister may revoke or vary formulary determination if guaranteed brand delisted Division 3CAA—Minimum stockholding requirement 99AEKA Brands subject to the minimum stockholding requirement 99AEKB Minimum stockholding requirement 99AEKC Applicable quantity of a brand of a pharmaceutical item 99AEKD Minister to be notified of breach of minimum stockholding requirements 99AEKE Minister's power if responsible person breaches minimum stockholding requirement 99AEKF Stockholding disclosure requirements Division 3CA—Discounts and incentives 99AEL Minister's powers if responsible person offers discounts or incentives for certain brands of pharmaceutical items Division 4—Provisions relating to members of the Pharmaceutical Benefits Remuneration Tribunal 99A Terms and conditions of appointment 99B Remuneration and allowances 99C Resignation and removal from office 99D Acting Chairperson 99E Acting additional member Division 4A—Indexation etc. Subdivision A—Preliminary 99F Definitions Subdivision B—Indexation 99G Indexation Subdivision C—Reduction of allowable discounts 99GA Definitions 99GB Supplies to which this Subdivision applies 99GC Reduction of allowable discount relating to the general patient charge 99GD Reduction of allowable discounts relating to the general patient reduced charge and concessional beneficiary charge 99GE Effect of reduction in allowable discount Division 4B—Australian Community Pharmacy Authority 99H Interpretation 99J Establishment of Authority 99K Functions 99L Determination of rules by Minister 99M Powers 99N Membership 99P Terms and conditions not provided for by this Act 99Q Defective appointment not invalid 99R Remuneration and allowances 99S Leave of absence 99T Disclosure of interests 99U Resignation 99V Termination of appointment 99W Meetings 99X Committees Division 4C—Cost recovery Subdivision A—Preliminary 99YB What this Division is about Subdivision B—Payment of fees etc. for certain services 99YBA Payment of fees etc. for certain services Subdivision C—Consequences if fees not paid 99YBB Minister may refuse to exercise certain powers if prescribed fees not paid Subdivision D—Review of cost‑recovery measures 99YBC Review of impact of cost‑recovery measures Division 4D—Export restriction 99ZH Definitions 99ZI Restrictions on carriage or consignment of drug like substances 99ZJ Detention of certain drug like substances being carried out of Australia and retention of related documents 99ZK Detention of certain drug like substances consigned for export and retention of related documents 99ZL Examination and inspection powers 99ZM Detention of some drug like substances and not others 99ZN Treatment of detained substances and retained documents 99ZO Treatment by the Chief Executive Medicare of detained substances and retained documents 99ZP Right of compensation in certain circumstances for substances destroyed 99ZQ Disposal of forfeited substances 99ZR Liability for acts done in good faith 99ZS Guidelines for detention of, dealing with, and disposal of, substances 99ZT Forfeiture of substances detained under section 99ZJ or 99ZK Division 5—General 100 Special arrangements 100A Establishment and membership of the Pharmaceutical Benefits Advisory Committee 100B Appointment etc. of members of the Pharmaceutical Benefits Advisory Committee 100C Termination of appointment 100D Remuneration 101 Functions of Pharmaceutical Benefits Advisory Committee 101A Sub‑committees of the Pharmaceutical Benefits Advisory Committee 101B Use of computer programs to take administrative action 102 Testing of drugs 103 Offences 104A Pharmacists to furnish statement of stocks 104B Transitional—price increases on 1 October 2022 105 Regulations Part VIIA—Reviews by Administrative Review Tribunal 105AA Interpretation 105AB Application for review by Tribunal 105AC Statements to accompany notification of decisions 105AD Application for review by Tribunal of decisions of the Australian Community Pharmacy Authority 105AE Time limits Part VIII—Committees of Inquiry Division 1—Preliminary 107 Interpretation Division 3—Pharmaceutical Services Committees of Inquiry 113 Pharmaceutical Services Federal Committee of Inquiry 114 Functions of Federal Committee 115 Pharmaceutical Services State Committees of Inquiry 116 Functions of State Committee 117 Reports not to relate to conduct of PBS prescribers Division 4—Provisions applicable to Committees generally 118 Interpretation 119 Membership of Committees 119A Acting Member 120 Chairperson 120A Vacancies in Committees 121 Procedure of Committees 122 Evidence 123 Proceedings in private 124 Determination of questions at meetings 125 PBS prescriber or pharmacist affected by inquiry to be given notice 126 Summoning of witnesses 127 Committee may examine upon oath or affirmation 128 Failure to attend or produce documents 129 Refusal to be sworn or give evidence 130 Protection of witnesses 131 Allowances to witnesses 132 Protection of members Part VIIIA—Data‑matching 132A Definitions 132AB Meaning of permitted purpose 132B Data‑matching by the Chief Executive Medicare 132C Secretary may disclose therapeutic goods information to the Chief Executive Medicare 132D Private health insurer may disclose information about hospital or general treatment to the Chief Executive Medicare 132E Breach of provision of this Part is an interference with privacy 132F Data‑matching principles Part VIIIB—COVID‑19 vaccines and treatments 132G Provision of COVID‑19 vaccines and treatments Part IX—Miscellaneous 133 Effect of prosecution for offence 133A Territories 134 Effect of suspension or cancellation of approval or authority 134A Publication of particulars of certain action taken under this Act 134B Time for commencing prosecutions 134C Defence in certain prosecutions 134D Civil penalty provisions 134E Obligations not affected by State or Territory laws 134F Conduct by directors, employees or agents 135 Right of Commonwealth officers to practise 135A Officers to observe secrecy 135AAA Prescribers and approved suppliers must observe secrecy in relation to medicare numbers and expiry dates provided for pharmaceutical benefit scheme purposes 135AA Privacy rules 135AB Breaches of the privacy rules 135AC Authorisation of collection of particular health information 135B Prosecution of offences 136 Committees 136A Filling of vacancies on committees 137 Moneys from which payments under this Act are to be made 138 Exercise of Secretary's powers subject to directions of Minister 138A Telephone access to offices 139 Judicial notice of signature of Secretary 139A Evidence 139C Information with respect to concessional beneficiaries 140 Regulations Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history