Saving Lives with IP Law?
Proposed changes to intellectual property laws in South Africa may have significant impact in facilitating research into life-saving treatment and increasing access to life-saving medication. In addition to publicly advocating for these reforms, public health organizations, international NGOs, and academics in South Africa have submitted comments to the government’s Department of Trade and Industry in regarding the national policy and amendments to patent legislation. The South African Draft National Policy on Intellectual Property was released on September 4th with the public comment period ending last week.
South Africa has the highest number of people living with HIV in the world and significant prevalence of tuberculosis (TB), according to a newly published UNDP study. However, high prevalence in developing countries does not correlate to a profitable market for pharmaceutical companies, which hold patents to existing treatments and have little incentive to invest in further treatment research. The UNDP Study, “Using Law to Accelerate Treatment Access in South Africa,” outlines several strategies to reform the country’s legal and regulatory systems regarding patent, competition, and medicine laws with the aim of improving the country’s access to pharmaceutical products and ability to conduct related research.
Médecins Sans Frontières (MSF) recently piloted a project in South Africa that saved the life of Phumeza Tisile from drug-resistant TB using the patented antibiotic Linezolid. According to MSF, the current laws prevent the public sector from accessing such treatments. In South Africa, Linezolid costs about ten times as much as a generic version available in India.
In addition to access, current South African laws impose limitations on research by requiring testing of drug combinations to be negotiated with the rights holder first. Activists also complained that the current system allowed companies to obtain multiple patents for the same medicine, thereby blocking competition. Critics of the changes caution that altering the intellectual property laws will have impact beyond pharmaceuticals and will stifle investment in products.
The UNDP report recommends that the South African government take international trade law into account when developing reforms, particularly the World Trade Organization’s (WTO) Agreement on Trade Related Aspects of Intellectual Property Protection (TRIPS), which South Africa is a party to. TRIPS requires minimum intellectual property protections but also provides flexibilities when it comes to public health-related issues, including access to treatment. Indian patent law exemplifies how a country can take advantage of the flexibilities within the international trade law framework.
Whether South Africa follows the UNDP recommendations or takes civil society recommendations into account, the result could set an example for the rest of sub-Saharan Africa in developing policies for sustainable access to life-saving treatment while respecting international intellectual property protections.