Commonwealth: National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009 (Cth)

National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009 No. 71, 2009 An Act to amend the National Health Act 1953, and for related purposes Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—Cost recovery National Health Act 1953 National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009 No. 71, 2009 An Act to amend the National Health Act 1953, and for related purposes [Assented to 22 July 2009] The Parliament of Australia enacts: 1 Short title This Act may be cited as the National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009. 2 Commencement (1) Each provision of this Act 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 Provision(s) Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day on which this Act receives the Royal Assent. 22 July 2009 2. Schedule 1 1 July 2008. 1 July 2008 Note: This table relates only to the provisions of this Act as originally passed by both Houses of the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent. (2) Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—Cost recovery National Health Act 1953 1 After Division 4B of Part VII Insert: Division 4C—Cost recovery Subdivision A—Preliminary 99YB What this Division is about This Division enables fees to be charged for certain services provided by the Commonwealth in order to recover the cost to the Commonwealth of providing those services. Those services relate to the exercise of certain powers of the Minister under this Act. 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. for certain services 99YBA Payment of fees etc. for certain services (1) The regulations may make provision in relation to services provided by the Commonwealth in relation to the exercise of a power by the Minister under any of the following: (a) section 9B; (b) a provision in Part VII (other than a provision in that Part prescribed by the regulations). (2) Without limiting subsection (1), the regulations may make provision in relation to the following: (a) the making of applications for those services; (b) prescribing fees for those services; (c) the time that prescribed fees are due and payable (including extending the time for payment of the fees); (d) the manner of payment of prescribed fees (including payment by instalments); (e) the payment of penalties in respect of late payment of prescribed fees; (f) exemptions from prescribed fees; (g) the waiver, remission or refund of prescribed fees; (h) the refusal to provide those services until a prescribed fee is paid; (i) the review of decisions made under the regulations. (3) A prescribed fee must not be such as to amount to taxation. (4) A prescribed fee is payable to the Commonwealth. (5) A prescribed fee that is due and payable may be recovered by the Commonwealth as a debt due to the Commonwealth. Subdivision C—Consequences if fees not paid 99YBB Minister may refuse to exercise certain powers if prescribed fees not paid (1) If: (a) a person applies for a service referred to in subsection 99YBA(1) in relation to the exercise of a power by the Minister; and (b) either: (i) a fee prescribed under paragraph 99YBA(2)(b) is payable by the person for the service; or (ii) a fee prescribed under paragraph 99YBA(2)(b) is payable by the person for another service referred to in subsection 99YBA(1) that the person has applied for; then, without limiting any power the Minister may otherwise have under section 9B or this Part, the Minister may refuse to exercise the power until the prescribed fee is paid. (2) A refusal referred to in subsection (1) is not a legislative instrument. Subdivision D—Review of cost‑recovery measures 99YBC Review of impact of cost‑recovery measures Review (1) The Minister must cause an independent review of the impact of cost‑recovery measures provided for under this Division and any regulations made under this Division to be undertaken as soon as possible after the second anniversary of the commencement of this Division and completed within 4 months of that anniversary. (2) The review must report on: (a) the average number of times a submission is presented before gaining approval and the reasons provided for requiring applicants to resubmit; (b) the average fee for submissions by type of submission (major/minor/generic according to Department of Health and Ageing classifications); (c) the number of applications where the population is likely to be small and utilisation of the drug, medicinal preparation or vaccine is likely to be highly targeted; (d) the number of reviews requested by applicants; (e) the number of fee waivers given to applicants and the reasons why waivers were given; (f) the length of time taken for submissions to be approved; (g) the number of applications that fail to gain a listing, the reasons why and the types of drugs concerned; (h) any increase in operating costs of the Pharmaceutical Benefits Advisory Committee; (i) any increase in the cost of pharmaceutical benefits scheme medications to patients; (j) any other matters considered relevant. (3) The review must be conducted by a panel which must comprise not less than five persons, including: (a) a medical professional nominated by the Minister; (b) a nominee of the Consumers Health Forum of Australia; (c) three other persons nominated by the Minister, each of whom must have relevant professional qualifications and must not be employed within the pharmaceuticals industry. (4) The panel must give the Minister a written report of the review, and the Minister must cause a copy of the report to be tabled in each House of the Parliament within 15 sitting days of receiving the report. Annual report on processes (5) The Secretary must, as soon as practicable after 30 June in each year, prepare and give to the Minister a report on processes leading up to the Pharmaceutical Benefits Advisory Committee consideration, including: (a) the extent and timeliness with which responsible persons are provided copies of documents relevant to their submission to the Pharmaceutical Benefits Advisory Committee; (b) the extent to which responsible persons exercise their right to comment on these documents, including appearing at hearings before the Pharmaceutical Benefits Advisory Committee; (c) the number of responsible persons seeking a review of a Pharmaceutical Benefits Advisory Committee recommendation. (6) The Minister must cause a copy of each report prepared under subsection (5) to be tabled in each House of the Parliament within 15 sitting days of receiving the report. [Minister's second reading speech made in— House of Representatives on 12 May 2009 Senate on 14 May 2009] (71/09)