NATIONAL ASSEMBLY
FOR WRITTEN REPLY
QUESTION NO. 944
DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 28 AUGUST 2009
(INTERNAL QUESTION PAPER NO. 12)
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?
NW1045E
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 SEPâ â
namely 2 Deputy Directors; 3 Chief Pharmacists; 1 SEP Pricing
Administrator; and 1 Database Administrator.
END.