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National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Bill 2008

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The Parliament of the

Commonwealth of Australia








National Health Amendment (Pharmaceutical and other Benefits—Cost Recovery) Bill 2008



(1)     Schedule 1, item 1, page 3 (after line 20), at the end of section 99YB, add:

Subdivision D provides that the Minister must cause a review to be undertaken of the impact of cost-recovery measures.

[review of cost-recovery measures]

(2)     Schedule 1, item 1, page 5 (after line 5), at the end of Division 4C, add:

Subdivision D—Review of cost-recovery measures

99YBC  Review of impact of cost-recovery measures

             (1)  The Minister must cause an independent review of the impact of cost-recovery measures to be undertaken as soon as possible after the second anniversary of the commencement of this Division.

             (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 cost of submissions by type of submission (major/minor/generic according to Department of Health and Ageing classifications);

                     (c)  the number of applications received for non-orphan drugs that are highly specialised, low volume and target a small population, including applications for specific formula requirements, unplanned activity discovery and the addition of an indication for a medicine;

                     (d)  the number of complaints received from sponsors/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 5 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.

[review of cost-recovery measures]