E-drug: South African CL and PI clause
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[copied from PHARM-POLICY with thanks]
I've had a few requests for the text of Section 15C of
the South African Medicines Act. This is the text as it
passed in 1997. The Act was re-enacted last year, but I
don't think it was changed.
Paragraph (b) is to explicitly permit parallel imports.
Paragraph (a) was first put in to make it clear that there
would be no basis for saying patents rights could be used
to stop parallel imports. However, once the provision
was included, it has become even more controversial as
a strong statutory authority for compulsory licensing.
The South Africa government says it will adopt procedures
for compulsory licensing under 15C(a) that are TRIPS
compliant, including the TRIPS requirement for compensation.
If and when SA ever issues a compulsory license, the
US government could challenge the action before the
WTO, if the US believed that SA was not giving
patent owners their rights under TRIPS. The main
reason for US government pressure on this issue is to
get the South African government to repeal the law
before it is ever used. USTR's fear is that SA
will issue TRIPS complaint compulsory licenses, and
that other countries will follow suit. All SA really
has to do is to give the patent owner adequate compensation,
and to provide a legal review of the amount of compensation,
in a South African court. The WTO will not itself
determine the adequacy of compensation, but could review
the procedures followed by the SA government in making
the SA government's determination.
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, Director, Consumer Project on Technology
I can be reached at love@cptech.org, by telephone 202.387.8030,
by fax at 202.234.5176. CPT web page is http://www.cptech.org
--
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