Federal Register of Legislation - Australian Government

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National Health (Paxlovid) Special Arrangement 2022

Authoritative Version
PB 39 of 2022 Arrangements as made
This instrument makes a special arrangement for the supply of Paxlovid, an anti-viral medicine that can be taken orally by patients with mild to moderate COVID-19 who are at high risk of developing severe disease.
Administered by: Health
Registered 28 Apr 2022
Table of contents.

Commonwealth Coat of Arms of Australia

 

PB 39 of 2022

 

National Health (Paxlovid) Special Arrangement 2022

I, Mariana Crank, as delegate for the Minister for Health and Aged Care, make the following special arrangement.

Dated 26 April 2022

Mariana Crank
Acting Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division

Department of Health

 

  

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Simplified outline of this instrument.............................................................................. 1

5............ Definitions..................................................................................................................... 1

6............ Meaning of Paxlovid..................................................................................................... 2

7............ Responsible person....................................................................................................... 2

8............ Approved ex‑manufacturer price................................................................................... 2

 


 

 

1  Name

             (1)  This instrument is the National Health (Paxlovid) Special Arrangement 2022.

             (2)  This instrument may also be cited as PB 39 of 2022.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 May 2022.

1 May 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under subsection 100(1) of the National Health Act 1953.

4  Simplified outline of this instrument

This instrument makes a special arrangement for the supply of Paxlovid, an anti‑viral medicine that can be taken orally by patients with mild to moderate COVID‑19 who are at high risk of developing severe disease.

The Commonwealth will be the responsible person for Paxlovid.

The approved ex‑manufacturer price of Paxlovid will be $1,000.

Note:          Part VII of the National Health Act 1953, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

5  Definitions

                   In this instrument:

Act means the National Health Act 1953.

brand has the same meaning as in Part VII of the Act.

Paxlovid has the meaning given by section 6.

pharmaceutical item has the same meaning as in Part VII of the Act.

6  Meaning of Paxlovid

                   Paxlovid is the brand of the pharmaceutical item specified in the following table:

                     (a)  in the form specified in the table; and

                     (b)  with the manner of administration specified in the table.

 

Paxlovid

Item

Drug

Form

Manner of administration

1

Nirmatrelvir and ritonavir

Pack containing 4 tablets nirmatrelvir 150 mg and 2 tablets ritonavir 100 mg

Oral

Note:          The drug specified in the table has been declared by the Minister under subsection 85(2) of the Act. The form and manner of administration of the drug specified in the table have been determined by the Minister under subsections 85(3) and (5) of the Act. The brand Paxlovid has been determined by the Minister under subsection 85(6) of the Act.

7  Responsible person

             (1)  The responsible person for Paxlovid is the Commonwealth.

             (2)  This section has effect despite the definition of responsible person in section 84 of the Act.

8  Approved ex‑manufacturer price

             (1)  The approved ex‑manufacturer price of Paxlovid is $1,000.

             (2)  This section has effect as if a price agreement under section 85AD of the Act were in force that provided that $1,000 is, for the purposes of Part VII of the Act, taken to be the appropriate maximum price of Paxlovid.