South African patent law : developing a balance between the rights of the patients and promoting innovation within the pharmaceutical industry

Abstract

Background: In South Africa many patented medicines are either unavailable or carry prices that most patients cannot afford. The effects of the patents systems on patient access could greatly depending on how the burden of a disease is distributed across least-developed, developing and developed countries. Method: The study based on a qualitative research method. The sample was based on a non-probability approach. The study used both primary and secondary data collection. The secondary data was critically evaluated and collected from scientific articles, company reports and internet sources, in order to obtain some better insight into the patent situation of pharmaceuticals. Interviews were conducted and analysed by selective ad open coding. Results: The South African patent system needs an examination process to evaluate patent applications. The Patent Act of 1978 meets the minimum TRIPS requirements. The South African market is unique and a small market for innovator companies therefore does not influence innovation by these companies. Conclusion: The study concluded that the key sections of the Patent Act that need further evaluation and aligning more with TRIPS flexibilities are: Compulsory License, “Evergreening”. Data Protection and Establishing an examination system. The study also concluded that the current South African Patent Act sufficiently promotes innovation within the pharmaceutical industry.