Changes to intellectual property policy in South Africa: putting a stop to evergreening?

Abstract

South Africa is a middle-income country with the world’s largest HIV patient cohort and a growing burden of communicable and non-communicable diseases – a prime location for pharmaceutical companies looking to expand their markets. Yet, 20 years after the country’s first democratic elections, poor health indicators and an over-burdened public health system belie persistently stark levels of socioeconomic inequality. As the South African government revises national intellectual property (IP) policies, the pharmaceutical industry and global access to medicines movement are watching, aware of ramifications South Africa’s actions will have on patent laws and the availability of generic medicines in other middle-income countries and across Africa. South Africa’s draft IP policy is meeting fierce resistance from industry, although proposed reforms are compliant with the Agreement on trade related aspects of intellectual property (TRIPS) and in line with on-going policies and actions of both developing and developed countries. Could the establishment of a patent examination system and new patentability criteria rein in evergreening and lead to lower medicine prices? What will be the potential impact of reform on medical innovation? And why is it both necessary and urgent that the South African government seek a fairer balance between private and public interests?

Keywords::

• evergreening
• innovation
• intellectual property reform
• patent examination
• patentability criteria
• pharmaceutical patents
• Pharmagate
• South Africa
• TRIPS flexibilities

Acknowledgements

Rohit Malpani and Hu Yuanqiong of the MSF Access Campaign reviewed drafts and participated in writing and technical editing of the manuscript.