Veterans' Affairs Pharmaceutical Benefits Schemes Amendment Instrument 2017 (Cth)

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Australian Government

Veterans’ Entitlements Act 1986

Military Rehabilitation and Compensation Act 2004

Veterans’ Affairs Pharmaceutical Benefits Schemes Amendment Instrument 2017

Instrument 2017 No. R7/MRCC7

I, Dan Tehan, Minister for Veterans’ Affairs, approve:

(a) under section 91 of the Veterans’ Entitlements Act 1986, the variations by the Repatriation Commission of the Repatriation Pharmaceutical Benefits Scheme in the following instrument; and

(b) under section 286 of the Military Rehabilitation and Compensation Act 2004,  the variations by the Military Rehabilitation and Compensation Commission of the MRCA Pharmaceutical Benefits Scheme in the following instrument.

Dated this  8th  day of  December 2017

Dan Tehan

DAN TEHAN

The Repatriation Commission, under section 91 of the Veterans’ Entitlements Act 1986, makes the variations to the Repatriation Pharmaceutical Benefits Scheme in the following instrument.

Dated this  4th  day of  December  2017

The Seal of the      )

Repatriation Commission                 )  SEAL

was affixed hereto in the                 )

presence of:   ) 

Simon Lewis   C Orme   MA Kelly

………………………………………………………………………………………………..

 SIMON LEWIS    CRAIG ORME   MAJOR GENERAL MARK KELLY

            DSC AM CSC    AO DSC

    PRESIDENT                      DEPUTY PRESIDENT   COMMISSIONER

The Military Rehabilitation and Compensation Commission, under section 286 of the Military Rehabilitation and Compensation Act 2004, makes the variations to the MRCA Pharmaceutical Benefits Scheme in the following instrument.

Dated this  4th  day of  December  2017

The Seal of the   )
Military Rehabilitation and Compensation Commission    ) SEAL

was affixed hereto in the   )

presence of:                 )

  Simon Lewis   C Orme   MA Kelly

   …………………………………………………………………………………………………………..

 SIMON LEWIS                    CRAIG ORME   MAJOR GENERAL MARK KELLY
     DSC AM CSC     AO DSC

         CHAIR                   MEMBER   MEMBER

          BS Wolski   Jennifer Taylor   T Smart

……………………………………………………………………………………………………..…
REAR ADMIRAL BRETT WOLSKI        JENNIFER TAYLOR                AIR VICE-MARSHAL TRACY SMART
         AM   AM

                       MEMBER   MEMBER     MEMBER

EMBER

1Name

This instrument is the Veterans’ Affairs Pharmaceutical Benefits Schemes Amendment Instrument 2017.

2Commencement

This instrument commences on 1 January 2018.

3Authority

This instrument is made under:

(a)section 91 of the Veterans’ Entitlements Act 1986 in respect of the variations to the Repatriation Pharmaceutical Benefits Scheme in Schedule 1; and

(b)section 286 of the Military Rehabilitation and Compensation Act 2004 in respect of the variations to the MRCA Pharmaceutical Benefits Scheme in Schedule 2.

4Schedules

Each instrument that is specified in a Schedule to this instrument is varied 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-Variations to the Repatriation Pharmaceutical Benefits Scheme (Instrument 2013 No. R43)

Part 1 – Updating of incorporated documents and other amendments

[1] Schedule 1 – Incorporated Documents

substitute:

SCHEDULE 1 – INCORPORATED DOCUMENTS

The following documents are incorporated-by-reference into the Scheme in the version in which they exist on 1 January 2018:

·    Explanatory Notes

·    RPBS Explanatory Notes

·    PBS or Pharmaceutical Benefits Scheme

·    RPBS Schedule

Note: “RPBS Schedule” is defined to mean the Repatriation Schedule of

Pharmaceutical Benefits which is further defined.

·    Sixth Community Pharmacy Agreement

[2] Subparagraph 7(d) – conformity with standards

substitute:

(d)                conformity with standards: no drug or therapeutic substance shall be prescribed unless it conforms with the specific or general standards as determined by the relevant Minister under the Therapeutic Goods Act 1989.

[3] Section 41 - Standards

substitute:

41  Standards

The minimum acceptable standard for a Pharmaceutical benefit is that described in the regulations under the Therapeutic Goods Act 1989 which relate to specific standards for drugs.

[4] Section 42 – Editions of monographs and  standards

omit the section

[5] Section 43 – Order of precedence

omit the section

Part 2 – Consequential amendments

[6] Section 3 (Interpretation) Definition of approval number

omit the definition, substitute:

approval number means a number allotted by the Secretary or the Minister for Health under section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017 to an approval under the National Health Act 1953 of a person described in the section who, under the Scheme, is a Community Pharmacist;

[7] Section 3 (Interpretation) Definition of approved electronic communication

omit:

regulation 5E of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

section 11 of the National Health (Pharmaceutical Benefits) Regulations 2017

[8] Section 3 (Interpretation) Definition of approved information technology requirements

omit:

regulation 5F of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

section 12 of the National Health (Pharmaceutical Benefits) Regulations 2017

[9] Section 3 (Interpretation) Definition of Authority Prescription Form

omit:

National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

National Health (Pharmaceutical Benefits) Regulations 2017;

[10] Section 3 (Interpretation) Definition of deferred supply authorisation

omit:

regulation 26A of the National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

section 53 of the National Health (Pharmaceutical Benefits) Regulations 2017;

[11] Section 3 (Interpretation) Definition of electronic prescription (paragraph(b))

omit paragraph (b)

substitute:

(b) in accordance with the appropriate form approved by the Secretary under:

(i) subparagraph 40(2)(c)(ii) (prescriptions other than medication chart prescriptions) of the National Health (Pharmaceutical Benefits) Regulations 2017; or

(ii) subsection 41(5) (medication chart prescriptions) of the National Health (Pharmaceutical Benefits) Regulations 2017.

[12] Section 3 (Interpretation)

insert the following definition:

Minister for Health means the Minister administering the National Health Act 1953;

[13] Section 3 (Interpretation) Definition of paper-based prescription

omit:

subparagraph 19(1)(a)(i), (ii) or (iii) of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

subsection 40(2) of the National Health (Pharmaceutical Benefits) Regulations 2017

[14] Section 3 (Interpretation) Definition of repeat authorisation form

omit:

subparagraph 26(1A)(a)(i) of the National Health (Pharmaceutical Benefits) Regulations 1960.

substitute:

subparagraph 52(3)(a)(i) of the National Health (Pharmaceutical Benefits) Regulations 2017.

[15] Section 3 (Interpretation) Definition of Standard Prescription Form

omit:

subparagraph 19(1)(a)(i), (ii) or (iii) of the National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

subsection 40(2) of the National Health (Pharmaceutical Benefits) Regulations 2017;

[16] Section 11 - Form of prescriptions (paragraph 11(1)(a))

omit:

National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

National Health (Pharmaceutical Benefits) Regulations 2017;

[17] Section 11A - Writing of prescriptions – prescriptions other than medication chart prescriptions (paragraph 11A(1)(e))

omit:

regulation 8A of the National Health Act 1953;

substitute:

section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017;

[18] Section 11A -Writing of prescriptions – prescriptions other than medication chart prescriptions (paragraph 11A(1)(i))

omit:

(as defined in the National Health (Pharmaceutical Benefits) Regulations 1960)

substitute:

(as defined in the National Health (Pharmaceutical Benefits) Regulations 2017)

[19] Section 16 - Supply of Pharmaceutical Benefits – Procedure by Community Pharmacists (the Note to the section)

omit:

National Health (Pharmaceutical Benefits) Regulations 1960.

substitute:

National Health (Pharmaceutical Benefits) Regulations 2017.

[20] Section 16AA - Supply of pharmaceutical benefit on basis of medication chart prescription (subparagraph 16AA(2)(c)(i))

omit:

regulation 8A of the National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017;

[21] Section 16A - When Pharmaceutical benefits may be supplied by Community Pharmacists without prescription (paragraph 16A(4)(a))

omit:

regulation 8A of the National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017;

[22] Section 16A - When Pharmaceutical benefits may be supplied by Community Pharmacists without prescription (subsection 16A(8))

omit:

subregulation 25(2) of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

subsection 51(2) of the National Health (Pharmaceutical Benefits) Regulations 2017

[23] Section 45 – Keeping documents – other than for continued dispensing or medication chart prescriptions (after subsection 45(2))

insert, at the end of the section:

Note: The document may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

[24] Section 45A – Keeping documents – continued dispensing

insert, at the end of the section:

Note: The information may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

[25] Section 45B – Keeping documents – medication chart prescriptions

insert, at the end of the section:

Note: The document may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

Schedule 2-Variations to the MRCA Pharmaceutical Benefits Scheme (Instrument 2013 No. MRCC 44)

Part 1 – Updating of incorporated documents and other amendments

[1] Schedule 1 – Incorporated Documents

substitute:

SCHEDULE 1 – INCORPORATED DOCUMENTS

The following documents are incorporated-by-reference into the Scheme in the version in which they exist on 1 January 2018:

·    Explanatory Notes

·    RPBS Explanatory Notes

·    PBS or Pharmaceutical Benefits Scheme

·    RPBS Schedule

Note: “RPBS Schedule” is defined to mean the Repatriation Schedule of

Pharmaceutical Benefits which is further defined.

·    Sixth Community Pharmacy Agreement

[2] Subparagraph 7(d) – conformity with standards

substitute:

(d)                conformity with standards: no drug or therapeutic substance shall be prescribed unless it conforms with the specific or general standards as determined by the relevant Minister under the Therapeutic Goods Act 1989.

[3] Section 41 - Standards

substitute:

41  Standards

The minimum acceptable standard for a Pharmaceutical benefit is that described in the regulations under the Therapeutic Goods Act 1989 which relate to specific standards for drugs.

[4] Section 42 – Editions of monographs and  standards

omit the section

[5] Section 43 – Order of precedence

omit the section

Part 2 – Consequential amendments

[6] Section 3 (Interpretation) Definition of approval number

omit the definition, substitute:

approval number means a number allotted by the Secretary or the Minister for Health under section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017 to an approval under the National Health Act 1953 of a person described in the section who, under the Scheme, is a Community Pharmacist;

[7] Section 3 (Interpretation) Definition of approved electronic communication

omit:

regulation 5E of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

section 11 of the National Health (Pharmaceutical Benefits) Regulations 2017

[8] Section 3 (Interpretation) Definition of approved information technology requirements

omit:

regulation 5F of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

section 12 of the National Health (Pharmaceutical Benefits) Regulations 2017

[9] Section 3 (Interpretation) Definition of authority prescription (paragraph(b))

omit:

National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

National Health (Pharmaceutical Benefits) Regulations 2017;

[10] Section 3 (Interpretation) Definition of Authority Prescription Form

omit:

National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

National Health (Pharmaceutical Benefits) Regulations 2017

[11] Section 3 (Interpretation) Definition of deferred supply authorisation

omit:

regulation 26A of the National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

section 53 of the National Health (Pharmaceutical Benefits) Regulations 2017;

[12] Section 3 (Interpretation) Definition of electronic prescription (paragraph(b))

omit:paragraph (b)

substitute:

(b) in accordance with the appropriate form approved by the Secretary under:

(i) subparagraph 40(2)(c)(ii) (prescriptions other than medication chart prescriptions) of the National Health (Pharmaceutical Benefits) Regulations 2017; or

(ii) subsection 41(5) (medication chart prescriptions) of the National Health (Pharmaceutical Benefits) Regulations 2017.

[13] Section 3 (Interpretation)

insert the following definition:

Minister for Health means the Minister administering the National Health Act 1953;

[14] Section 3 (Interpretation) Definition of paper-based prescription

omit:

subparagraph 19(1)(a)(i), (ii) or (iii) of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

subsection 40(2) of the National Health (Pharmaceutical Benefits) Regulations 2017

[15]   Section 3 (Interpretation) Definition of repeat authorisation form

omit:

subparagraph 26(1A)(a)(i) of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

subparagraph 52(3)(a)(i) of the National Health (Pharmaceutical Benefits) Regulations 2017

[16] Section 3 (Interpretation) Definition of Standard Prescription Form

omit:

subparagraph 19(1)(a)(i), (ii) or (iii) of the National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

subsection 40(2) of the National Health (Pharmaceutical Benefits) Regulations 2017;

[17] Section 11 - Form of prescriptions (paragraph 11(1)(a))

omit:

National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

National Health (Pharmaceutical Benefits) Regulations 2017;

[18] Section 11A - Writing of prescriptions – prescriptions other than medication chart prescriptions (paragraph 11A(1)(e))

omit:

regulation 8A of the National Health Act 1953;

substitute:

section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017;

[19] Section 11A -Writing of prescriptions – prescriptions other than medication chart prescriptions (paragraph 11A(1)(i))

omit:

(as defined in the National Health (Pharmaceutical Benefits) Regulations 1960)

substitute:

(as defined in the National Health (Pharmaceutical Benefits) Regulations 2017)

[20] Section 16 - Supply of Pharmaceutical Benefits – Procedure by Community Pharmacists (the Note to the section)

omit:

National Health (Pharmaceutical Benefits) Regulations 1960.

substitute:

National Health (Pharmaceutical Benefits) Regulations 2017.

[21] Section 16AA - Supply of pharmaceutical benefit on basis of medication chart prescription (subparagraph 16AA(2)(c)(i))

omit:

regulation 8A of the National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017;

[22] Section 16A - When Pharmaceutical benefits may be supplied by Community Pharmacists without prescription (paragraph 16A(4)(a))

omit:

regulation 8A of the National Health (Pharmaceutical Benefits) Regulations 1960;

substitute:

section 16 of the National Health (Pharmaceutical Benefits) Regulations 2017;

[23] Section 16A - When Pharmaceutical benefits may be supplied by Community Pharmacists without prescription (subsection 16A(8))

omit:

subregulation 25(2) of the National Health (Pharmaceutical Benefits) Regulations 1960

substitute:

subsection 51(2) of the National Health (Pharmaceutical Benefits) Regulations 2017

[24] Section 45 – Keeping documents – other than for continued dispensing or medication chart prescriptions (after subsection 45(2))

insert, at the end of the section:

Note: The document may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

[25] Section 45A – Keeping documents – continued dispensing

insert, at the end of the section:

Note: The information may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

[26] Section 45B – Keeping documents – medication chart prescriptions

insert, at the end of the section:

Note: The document may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

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