Question no. 944
Mr M Waters (DA) to ask the Minister of Health:
(1) Whether (a) there are dates by which pharmaceutical companies must submit their application each year in order to establish the Single Exit Price (SEP) and (b) his department must approve or reject the submission; if not, why not in each case; if so, what are the relevant details in each case;
(2) when the new SEP comes into force;
(3) whether his department met the due date in (a) 2008 and (b) 2009 for approving all new SEP; if not, (i) why not, (ii) how many were (aa) approved and (bb) not approved by the deadline for each year and (iii) on which date was the new SEP approved for all medicines that failed to meet the deadline;
(4) how many people work in the Pharmaceutical Economic Unit that approves the SEP?
Reply:
(1)(a) Yes, pharmaceutical manufacturers must submit applications for price increases after the Minister has made a determination about the extent of the annual price increase. Pharmaceutical companies were requested to submit their applications for a maximum price increase by 1 September 2009.
(b) The department, through the Directorate: Pharmaceutical Economic Evaluations must approve these price increases within 30 days of receipt of an application by the manufacturer.
(2) The new SEP comes into force 30 days after an application is received.
(3)(a) Yes
(b) Yes
(ii) (aa) All products that qualified for a price increase were granted an increase.
(bb) No applications have fallen into this category; all applications received were processed for a price increase.
(iii) To date no applicant has failed to meet the deadline.
(4) Seven (7) officials are currently involved in approving the SEP– namely two Deputy Directors; three Chief Pharmacists; one SEP Pricing Administrator and one Database Administrator.
Issued by: Department of Health
10 September 2009
