Commonwealth Consolidated Acts

NATIONAL HEALTH ACT 1953

TABLE OF PROVISIONS

           Long Title

   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  
   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