National Health (Highly Specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018 (PB 107 of 2018 (No. 11)) (Cth)

Case

PB 107 of 2018 (No. 11)

National Health (Highly specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018

National Health Act 1953

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I, JULIANNE QUAINE, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated         4 December 2018

JULIANNE QUAINE

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

Contents

  1. Name................................................................................................................................... 3

  1. Commencement.................................................................................................................. 3

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

  1. Schedules............................................................................................................................ 3

Schedule 1   Amendments.......................................................................................... 4

Schedule 2   Transitional provisions........................................................................... 6

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1       Name

(1)This Instrument is the National Health (Highly Specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018.

(2)This Instrument may also be cited as PB 107 of 2018 (No. 11).

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 instrument 21 December 2018

(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 section 100 of the National Health Act 1953.

4       Schedules

Each instrument that is specified in a Schedule to this instrument is amended or      repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1          Amendments

National Health (Highly specialised drugs program) Special Arrangement 2010

1        Section 4    (subparagraph (a)(ii) of the definition of approved hospital authority)

Omit 'Chief Executive Medicare', substitute 'Secretary'.

2        Section 4 (definition of Regulations)

Omit 'National Health (Pharmaceutical Benefits) Regulations 1960', substitute 'National Health (Pharmaceutical Benefit) Regulations 2017'.

3        Section 19 (including heading)

Repeal the section, substitute:

19    Application of section 51 of the Regulations

Section 51 of the Regulations does not apply to the supply of HSD pharmaceutical benefits.

4        Paragraph 21(a)

Omit 'regulation 19', substitute 'section 40'.

5        Paragraph 21(b)

Omit 'regulation 19AA', substitute 'section 41'.

6        Section 21 (note)

Omit 'Regulation 13', substitute 'section 30'.

7        Section 23

Omit 'regulation 19', substitute 'section 40'.

8        Section 26 (including heading)

Repeal the section, substitute:

26  Application of section 30 of the Regulations in relation to CAR drugs

Section 30 of the Regulations does not apply in relation to a prescription for an HSD pharmaceutical benefit that has a CAR drug supplied under this Special Arrangement.

9        Paragraph 51(b)

Omit 'regulation 8A', substitute 'section 16'.

10      Subsection 52(4)

Omit 'subregulation 8A(1)', substitute 'subsection 16(4)'.

11      Section 52

Omit 'Chief Executive Medicare' (wherever appearing), substitute 'Secretary'.

12      Subsection 54(4)

Omit 'the Regulations', substitute 'the National Health (Pharmaceutical Benefits) Regulations 1960 as in force immediately before the commencement of the Regulations'.

Schedule 2  Transitional provisions

1       Definitions

(1)       In this Schedule:

commencement day means the day on which the National Health (Highly specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018 commences.

new Special Arrangement means the National Health (Highly specialised drugs program) Special Arrangement 2010 as in force on the commencement day.

old Special Arrangement means the National Health (Highly specialised drugs program) Special Arrangement 2010 as in force immediately before the commencement day.

2       Applications for approval of public hospital authority

(1)     This item applies where an application under section 52 of the old Special Arrangement for approval of the hospital authority of a public hospital has been made but a decision whether to approve the hospital authority has not been made before the commencement day.

(2)     From the commencement day the decision may be made by:

(a)    the Secretary, as if the application had been made to the Secretary; or

(b)   the Chief Executive Medicare, as if the amendments made           by the National Health (Highly specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018 had not commenced;

3       Transition of approvals granted and things done by the Chief Executive       Medicare

(1)     This item applies in relation to an approval for a hospital authority for a public hospital, granted under section 52 of the old Special Arrangement, that was in force immediately before the commencement day.

(2)     From the commencement day:

(a)    the approval is taken to have been granted by the Secretary;

(b)   the conditions (if any) determined by the Chief Executive Medicare to which the   approval was subject are taken to have been determined by the Secretary; and

(c)    any number allotted to the approval by the Chief Executive Medicare is taken to     have been allotted by the Secretary.

4       Transition of suspensions issued by Chief Executive Medicare

(1)     This item applies where, immediately before the commencement day, the approval of the hospital authority for a public hospital is suspended following a notice issued by the Chief Executive Medicare under subsection 52(7) of the old Special Arrangement.

(2)     The notice of suspension is taken to have been issued by the Secretary.

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