Answer to questions 11, 12 and 13
Section 15c to be introduced into the Medicines and Related Substances Control Act 101 of 1965 by the Amendment Act No. 90 of 1997, grants the Minister of Health the power to determine that the rights granted in terms of the Patents Act to the patentee of a patented medicine will not apply in certain circumstances, namely to acts in respect of such medicine which has been put onto the market by the owner of the medicine or with his consent.
This is viewed (e.g. by pharmaceutical manufacturers) as being contrary to South Africa’s obligation in terms of Articles 27 and 28 of TRIPS.
However, TRIPS does allow the use of patented subject matter without the authorisation of the patentee, under certain circumstances (Articles 30 and 31). TRIPS also allows the adoption by member countries of measures necessary to protect inter alia public health, and measures to prevent the abuse of intellectual property rights by right holders (Article 8).
It should be noted that the Medicines Amendment Act has not yet been put into effect, partly because regulations to provide for its implementation have not yet been finalised. Accordingly, the parameters within which the power granted to the Minister of Health will be exercised, are still to be laid down. Until such time as the regulations have been finalised, a more complete response to this question is not possible.
