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E-DRUG: South African CL and PI clause
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Jamie Love wrote:
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.
Just to clear up one point - the entire medicines regulatory system
was overhauled in 1998, with the passing of the South African
Medicines and Medical Devices Regulatory Authority Act (Act 132 of
1998). This Act was promulgated (brought into effect) on 30 April
1999. However, the controversial aspects of the Medicines and Related
Substances Control Amendment Act (Act 90 of 1997), such as the clause
which introduced section 15C, were not repeated in the new Act. To do
so would have constituted contempt of court, as the matter was
already the subject of a legal challenge by a group of mostly
multinational manufacturers. Instead, the new Act repealed almost all
of the old Medicines and Related Substances Control Act (Act 101 of
1965), bar those sections which would be amended by the contested
clauses in Act 90. Once they clear the legal hurdles (in some way or
another), they will come into effect, and be read together with the
new Act. In time, another amendment Act can be brought before
Parliament to combine the two pieces of legislation.
Apart from the parallel importation/ compulsory licensing issue,
there are other sections which were not repeated. These include
measures to introduce generic substitution by pharmacists, a pricing
committee, and a code of practice for pharmaceutical marketing. In
particular, the section on generic substitution is urgently needed if
the tender system of procurement used in the public sector is to
remain operative.
regards
Andy Gray
Pharmaceutical Policy Practice Group
University of Durban-Westville
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