2004-2005 The Parliament of the Commonwealth of Australia HOUSE OF REPRESENTATIVES Presented and read a first time National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 (Health and Ageing) A Bill for an Act to amend the National Health Act 1953, and for other purposes [Page Break] 1 Short title.......................................................................................1 2 Commencement .............................................................................1 3 Schedule(s)....................................................................................2 Schedule 1--Amendment of the National Health Act 1953 3 Part 1--Immunisation program 3 Part 2--Pharmaceutical Benefits Advisory Committee 6 i National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 [Page Break] 2 1953, and for other purposes 3 The Parliament of Australia enacts: 4 1 Short title 5 This Act may be cited as the National Health Amendment 6 (Immunisation Program) Act 2005. 7 2 Commencement 8 (1) Each provision of this Act specified in column 1 of the table 9 commences, or is taken to have commenced, in accordance with 10 column 2 of the table. Any other statement in column 2 has effect 11 according to its terms. 12 National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 1 [Page Break] Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 to 3 The day on which this Act receives the and anything in Royal Assent. this Act not elsewhere covered by this table 2. Schedule 1, A single day to be fixed by Proclamation. Part 1 However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period. 3. Schedule 1, A single day to be fixed by Proclamation. Part 2 However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period. 1 Note: This table relates only to the provisions of this Act as originally 2 passed by the Parliament and assented to. It will not be expanded to 3 deal with provisions inserted in this Act after assent. 4 (2) Column 3 of the table contains additional information that is not 5 part of this Act. Information in this column may be added to or 6 edited in any published version of this Act. 7 3 Schedule(s) 8 Each Act that is specified in a Schedule to this Act is amended or 9 repealed as set out in the applicable items in the Schedule 10 concerned, and any other item in a Schedule to this Act has effect 11 according to its terms. 2 National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 [Page Break] Immunisation program Part 1 1 2 Schedule 1--Amendment of the National 3 Health Act 1953 4 Part 1--Immunisation program 5 1 Subsection 4(1) 6 Insert: 7 designated vaccine has the meaning given by subsection 9B(2). 8 2 Subsection 4(1) 9 Insert: 10 vaccine means a vaccine for the purpose of immunising persons. 11 3 Section 9B 12 Repeal the section, substitute: 13 9B Provision of vaccines 14 (1) The Minister may provide, or arrange for the provision of, 15 designated vaccines. 16 Designated vaccines 17 (2) The Minister may, by legislative instrument, determine that a 18 specified vaccine is a designated vaccine for the purposes of this 19 Act. 20 Note: For variation and revocation, see subsection 33(3) of the Acts 21 Interpretation Act 1901. 22 (3) A vaccine may be specified by reference to any or all of the 23 following: 24 (a) brand; 25 (b) formulation; 26 (c) active ingredient; 27 (d) strength; 28 (e) number and timing of doses in a course of immunisation. National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 3 [Page Break] Part 1 Immunisation program 1 (4) Subsection (3) does not limit the ways in which a vaccine may be 2 specified. 3 (5) In addition to specifying a vaccine, a determination under 4 subsection (2) may specify the circumstances in which the vaccine 5 may be provided. 6 (6) If any such circumstances are specified, subsection (1) only 7 authorises the provision of the vaccine in those circumstances. 8 (7) A vaccine must not be specified in a determination under 9 subsection (2) unless: 10 (a) the Pharmaceutical Benefits Advisory Committee has 11 recommended to the Minister that the vaccine be a designated 12 vaccine; or 13 (b) at any time during the 60-day period ending immediately 14 before the commencement of this subsection, the vaccine was 15 provided under repealed section 9B of this Act. 16 (8) Before: 17 (a) revoking a determination under subsection (2); or 18 (b) varying a determination under subsection (2) in such a way 19 that a vaccine ceases to be a designated vaccine; 20 the Minister must obtain the written advice of the Pharmaceutical 21 Benefits Advisory Committee in relation to the proposed 22 revocation or variation. 23 (9) An advice under subsection (8) is to be tabled in each House of the 24 Parliament with the revocation or variation to which the advice 25 relates. 26 (10) This section does not limit the vaccine-related powers conferred on 27 the Minister by the Quarantine Act 1908. 28 4 After subsection 101(4A) 29 Insert: 30 Functions relating to vaccines 31 (4B) The Pharmaceutical Benefits Advisory Committee must: 32 (a) make recommendations to the Minister from time to time 33 about the vaccines it considers should be designated vaccines 34 (see section 9B); and 4 National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 [Page Break] Immunisation program Part 1 1 (b) advise the Minister about any other matter concerning the 2 operation of section 9B referred to it by the Minister. 3 (4C) For the purpose of deciding whether to recommend to the Minister 4 that a vaccine be a designated vaccine, the Committee must give 5 consideration to the effectiveness and cost of immunisation 6 involving the use of the vaccine, including by comparing the 7 effectiveness and cost of immunisation involving the use of the 8 vaccine with the effectiveness and cost of alternative options, 9 whether or not involving the use of other vaccines. 10 (4D) If immunisation involving the use of a particular vaccine (the first 11 vaccine) is substantially more costly than an alternative vaccine: 12 (a) the Committee must not recommend to the Minister that the 13 first vaccine be a designated vaccine unless the Committee is 14 satisfied that the first vaccine, for some individuals, provides 15 a significant improvement in efficacy or reduction of toxicity 16 over the alternative vaccine; and 17 (b) if the Committee recommends to the Minister that the first 18 vaccine be a designated vaccine--the Committee must 19 include in its recommendation a statement that the 20 Committee is satisfied as mentioned in paragraph (a). 21 (4E) Subsection (4D) does not limit subsection (4C). 22 (4F) If the Committee is of the opinion that a vaccine should be a 23 designated vaccine, but should only be provided under subsection 24 9B(1) in certain circumstances, the Committee must, in its 25 recommendation under subsection (4B), specify those 26 circumstances. 27 Note 1: The following heading to subsection 101(3) is inserted "Functions relating to drugs and 28 medicinal preparations". 29 Note 2: The following heading to subsection 101(5) is inserted "Procedure". 30 5 At the end of paragraph 101A(1)(b) 31 Add "or (4B)". National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 5 [Page Break] Part 2 Pharmaceutical Benefits Advisory Committee 1 2 Part 2--Pharmaceutical Benefits Advisory 3 Committee 4 6 Subsection 100A(2) 5 Omit "15", substitute "17". 6 7 After subsection 100A(5) 7 Insert: 8 (5A) The Chairperson holds office on a full-time basis. 9 8 Subsection 100A(6) 10 After "Committee", insert "(other than the Chairperson)". 11 9 Transition to full-time office--Chairperson of the 12 Pharmaceutical Benefits Advisory Committee 13 (1) This item applies to a person who was the Chairperson of the 14 Pharmaceutical Benefits Advisory Committee immediately before the 15 commencement of this item. 16 (2) After the commencement of this item, the person is taken to hold office 17 as Chairperson of the Pharmaceutical Benefits Advisory Committee on 18 a full-time basis. 19 (3) Subitem (2) does not prevent the person from ceasing to hold that 20 office. 6 National Health Amendment (Immunisation Program) Bill 2005 No. , 2005