Question NW656 to the Minister of Health
14 October 2019 - NW656
Singh, Mr N to ask the Minister of Health
Whether, in light of the exorbitantly high cost of cancer medication in the Republic and in comparison to other countries such as India, he will consider removing the patent laws on cancer medication and treatment in order for low-cost generics to be produced to enable the majority of South Africans to have access to affordable treatment; if not, why not; if so, what are the relevant details?
Reply:
A patent allows the pharmaceutical manufacturer an exclusivity over the sale of a medicine. During this time the manufacturer price is very high and unaffordable to low and middle income countries. Companies argue that the high prices are intended to recoup their costs of research and development, however these companies have been reluctant to be transparent about such costs. There is much evidence to suggest that the cost of research and development is actually much lower than claims made by the pharmaceutical industry.
South Africa has been at the forefront of challenging the high prices of medicines globally including where patents are the barrier to access. There currently are legislative provisions which would allow us to access a medicine that is protected by a patent. These provisions are included in Section 15C of the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965). It is important to bear in mind that in order for one to access medicines using Section 15C, such a medicine must first be registered by the South African Health Products Regulatory Authority (SAHPRA) in terms of efficacy, safety and quality. SAHPRA will consider an application of a generic even while a patent remains in effect. So the provisions to address patent barriers already exist in South Africa however a product must be registered by SAHPRA before we can implement such a provision.
South Africa has never had to use the patent legislation to access a lower priced generic medicine. The patent holders have in many cases negotiated either through bilateral agreements or have participated in the Medicines Patent Pool which provides manufacturers in developing countries like South Africa access lower cost generic antiretroviral (ARV) drugs at an affordable price. This has allowed us to afford the world’s largest ARV programme.
END.