Commonwealth Consolidated Acts

NATIONAL HEALTH ACT 1953

TABLE OF PROVISIONS

   PART I--PRELIMINARY

   1.      Short title [see Note 1]  
   2.      Commencement [see Note 1]  
   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  
   9BA.    The National HPV Vaccination Program Register  
   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 [see Note 2]  
   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  
   84AD.   When listed drug is in Part A or Part T of 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  

           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.   Modification of amounts paid  
   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  
   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  
   85AC.   Minister may determine that a listed drug is in Part A or Part T of F2  
   85AD.   Price agreements  
   85B.    Price determinations and special patient contributions  
   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  
   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.  
   90.     Approved pharmacists [see Note 1]  
   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  
   92.     Approved medical practitioners  
   92A.    Approvals to be subject to conditions  
   92B.    Persons not to enter into certain refund agreements  
   93.     Supply of certain pharmaceutical benefits by medical practitioners  
   93AA.   Supply of certain pharmaceutical benefits by authorised midwives and 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  
   98AC.   Information about supplies  

           Division 3--Payment for supply of pharmaceutical benefits

   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  
   98D.    Form, and date of operation, of determinations under section 98C  
   98E.    Secrecy  
   99.     Payment for supply of benefits  
   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  
   99AA.   Unauthorised payments etc.  
   99AB.   Advances  

           Division 3A--Price reductions

              Subdivision A--Preliminary

   99AC.   What this Division is about  

              Subdivision B--requires there to be at least a 16% price reduction in the price of a new brand of a pharmaceutical item (other than a combination item) when it lists. The listing of the new brand of the pharmaceutical item also provides a trigger for price reductions to occur under Subdivision D (see section 99ACH) for:

              Subdivision C--sets out the circumstances in which price reductions are required for combination items.

              Subdivision CA--sets out the circumstances in which price reductions are required for new brands of pharmaceutical items that have the same drug as an existing brand of a pharmaceutical item that is subject to an outstanding staged reduction under section 99ACK. The listing of the new brand or brands also provides a trigger for price reductions to occur under Subdivision D (see sections 99ACM and 99ACN) for existing brands of pharmaceutical items that have that drug.

              Subdivision D--provides for other price reductions for pharmaceutical items (including for combination items in some cases). These price reductions:

   99ACA.  Definitions etc.  

              Subdivision B--16

   99ACB.  16% price reduction for new brands of pharmaceutical items that are not combination items  

              Subdivision C--Price reductions for combination items

   99ACC.  Price reductions for single brands of combination items  
   99ACD.  16% price reduction for new brands of combination items  
   99ACE.  Flow-on of 16% price reduction to related brands of combination items  

              Subdivision CA--New brands of pharmaceutical items having drugs with outstanding staged reductions

   99ACEA. Price reduction for new brand of pharmaceutical item having drug with outstanding staged reductions--new brand bioequivalent or biosimilar to existing listed brand  
   99ACEB. New brands of pharmaceutical items having drug with outstanding staged reductions----new brands not bioequivalent or biosimilar to existing listed brand  

              Subdivision D--Other statutory price reductions

   99ACF.  Statutory price reductions  
   99ACG.  Other price reductions do not apply if 12.5% or 16% statutory price reduction or price disclosure reduction applies  
   99ACH.  16% statutory price reduction flow-on to related brands  
   99ACI.  2% statutory price reduction on 1 August 2008, 2009 and 2010  
   99ACIA. 2% statutory price reduction on 1 February 2011  
   99ACJ.  25% statutory price reduction on single day  
   99ACK.  25% statutory price reduction staged over 2 or more days  
   99ACL.  Staged price reduction: staged reductions under section 99ACK causing statutory price reductions for other brands of pharmaceutical items having the drug  
   99ACM.  Staged price reduction: new brand listing bringing forward outstanding staged reductions  
   99ACN.  Staged price reduction: bringing forward outstanding staged reductions causing statutory price reduction for other brands of pharmaceutical items having the drug  
   99ACO.  5% statutory price reduction for brands of pharmaceutical items having a drug that is not subject to outstanding staged reductions  
   99ACP.  5% statutory price reduction for brands of pharmaceutical items subject to outstanding staged reductions  
   99ACQ.  5% statutory price reduction for brands of pharmaceutical items having a drug that is subject to outstanding staged reductions  

           Division 3B--Price disclosure

              Subdivision A--Preliminary

   99AD.   What this Division is about  
   99ADA.  Division does not apply to exempt items  
   99ADB.  Definitions etc.  

              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  
   99ADJ.  Minimum average 23% price reduction for some brands of pharmaceutical items  

           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 price to pharmacists etc. 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 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

   99F.    Definitions  
   99G.    Indexation  

           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  
   99Y.    Cessation of operation [see Note 1]  

           Division 4C--Cost recovery

              Subdivision A--Preliminary

   99YB.   What this Division is about  

              Subdivision B--provides for regulations to set out the fees that are payable for those services, as well as other matters relating to the payment of those fees and the provision of those services (including some consequences of failing to pay a fee).

              Subdivision C--sets out another possible consequence of failing to pay a fee by providing for the Minister to refuse to exercise certain powers until the fee is paid.

              Subdivision D--provides that the Minister must cause a review to be undertaken of the impact of cost-recovery measures provided for under this Division and any regulations made under this Division, and must table an annual report on related processes.

              Subdivision B--Payment of fees etc

   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.   Customs may detain some drug like substances and not others  
   99ZN.   Customs 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  
   102.    Testing of drugs  
   103.    Offences  
   104A.   Pharmacists to furnish statement of stocks  
   104B.   Report on impact of National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007  
   105.    Regulations  

   PART VIIA--REVIEWS BY ADMINISTRATIVE APPEALS 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 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  
   134E.   Conduct by directors, servants 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 guidelines  
   135AB.  Breaches of the privacy guidelines  
   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  
   139B.   Certain instruments subject to disallowance  
   139C.   Information with respect to concessional beneficiaries  
   140.    Regulations