Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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 the Department's 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.
(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.