- All > Medicine Information and Evidence for Policy > Medicines Policy
- All > Quality and Safety: Medicines > Regulatory Support
- Keywords > compulsory licences
- Keywords > generic drug policies
- Keywords > human rights
- Keywords > intellectual property laws
- Keywords > international legal framework
- Keywords > medicines regulation
- Keywords > patentability criteria - policy options
- Keywords > patents
- Keywords > right to medicines
- Keywords > TRIPS flexibilities
(2013; 120 pages)
This study focuses on policy options available to South Africa through reform of three interrelated areas of law affecting access to HIV treatment and other essential medicines: patent, competition and medicines law. The recommended reforms are aimed at safeguarding public health by optimizing the use of public health related TRIPS (the agreement on Trade Related Aspects of Intellectual Property Rights) flexibilities and therefore, the policy space available to countries within their international legal obligations at the World Trade Organisation (WTO). Potential drawbacks and challenges are highlighted, as are strategies for adoption that draw on the experiences of other low- and middle-income countries.
The recommendations of the report are aimed at achieving mutually reinforcing goals. First and foremost, it focuses on promoting access to essential medicines. But the recommendations are also made with a second objective in mind: to develop and support policies conducive to the growth and development of the domestic generic pharmaceutical industry. There is opportunity to better align and harmonize the three laws in question, both with each other and—particularly in the case of the Patents Act—with the Constitution. The process of reforming these laws could benefit from a policymaking approach that is consultative, coherent and developed with the input of all relevant actors, governmental and non-governmental alike.
With the specific commitments found in the National Strategic Plan (NSP), the Government of South Africa has recognized the role of human rights in achieving its objectives around HIV, TB and STIs. The pursuit of the law reform recommendations found in this paper can contribute to the Government’s achievement of its policy objectives and Constitutional commitments to respect, protect, promote and fulfill the right to medicines not only for these diseases, but also for other HIV co-infections and non-communicable diseases.