[Pharm-policy] Section 15c of the South Africa Medicines Act
James Love
love@cptech.org
Tue Jan 23 22:23:07 2001
I had actually a few requests for the actual text of
Section 15c of the South Africa Medicines Act. The
lawsuit against this act (which covers more than 15c),
is scheduled to begin March 5. Jamie
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Amendments to the South African Medicines and Related
Substances Control Act No. 101 of 1965
Section 15C
The minister may prescribe conditions for the supply of
more affordable medicines in certain circumstances so as to
protect the health of the public, and in particular may-
(a) notwithstanding anything to the contrary contained in the
Patents Act, 1978 (Act No. 57 of 1978), determine that
the rights with regard to any medicine under a patent
granted in the Republic shall not extend to acts in
respect of such medicine which has been put onto the
market by the owner of the medicine, or with his or her
consent;
(b) prescribe the conditions on which any medicine which is
identical in composition, meets the same quality standard
and is intended to have the same proprietary name as that
of another medicine already registered in the Republic,
but which is imported by a person other than the person
who is the holder of the registration certificate of the
medicine already registered and which originates from any
site of manufacture of the original manufacturer as
approved by the council in the prescribed manner, may be
imported:
(c) prescribe the registration procedure for, as well as the
use of, the medicine referred to in paragraph (b).
--
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org
love@cptech.org
1.202.387.8030 fax 1.202.234.5176