South Africa Endorses Groundbreaking IP Policy to Enhance Access to Affordable Medicines

South Africa’s highest decision-making body formally approved the initial phase of a new intellectual property (IP) policy on 23 May, marking a significant step toward improving access to affordable, high-quality medicines in a country grappling with high rates of HIV/AIDS and tuberculosis infections.

As Africa’s second-largest economy, South Africa faces the world’s largest HIV epidemic, according to UNAIDS. The country is home to one in five people globally living with HIV, with 15% of new infections occurring within its borders. Additionally, the World Health Organization ranked South Africa seventh worldwide in 2016 for new tuberculosis cases.

Christoph Spennemann, head of UNCTAD’s intellectual property unit, congratulated South Africa on adopting the national IP policy. He emphasized that the policy not only advances access to medicines but also strengthens the domestic pharmaceutical sector.

"The policy is in line with international practices and strikes a fair balance between incentives for innovation and the need to promote generic competition and access to medicines," Mr. Spennemann stated.

He noted that for effective implementation, the South African government must amend domestic laws to align with the new IP framework. Furthermore, he highlighted the importance of initiating the policy’s second phase, which will address broader development goals such as intellectual property use in the informal sector, commercialization through licensing agreements, and the intersection of IP with environmental and climate change concerns.

The overarching purpose of the IP policy is to guide policymakers on leveraging intellectual property to promote domestic development objectives, including innovation, technology transfer, and industrial growth.

South Africa prioritized public health in Phase 1 of the policy because the government identified the local pharmaceutical industry as a key sector for industrial development.

The Department of Trade and Industry enlisted UNCTAD’s expertise to assist in developing the policy, drawing on UNCTAD’s extensive experience in technical cooperation related to IP, access to medicines, and local pharmaceutical production.

"UNCTAD’s main role in this process was to assess whether the proposed policy complied with multilateral IP law and how it compared to IP policy practices in other jurisdictions," Mr. Spennemann explained.

In 2016 and 2017, UNCTAD organized two stakeholder consultations in collaboration with South Africa’s Department of Trade and Industry and the United Nations Development Programme (UNDP). The World Health Organization, World Intellectual Property Organization, and World Trade Organization also participated in these consultations.

These consultations helped ease tensions surrounding certain policy elements. Mr. Spennemann acknowledged that some domestic stakeholders found parts of the policy controversial. Some feared the measures might discourage innovation incentives and foreign investment, while others insisted on preserving the public policy goal of ensuring access to affordable medicines.

"UNCTAD sought to address these tensions by demonstrating that the proposed measures follow practices long exercised in other jurisdictions and are consistent with multilateral IP and trade law," he said.

For instance, the policy calls for substantive examination of patent applications, meaning patents would only be granted if applications meet specific legal requirements. This approach provides enhanced legal certainty for both applicants and competitors.

Beyond its advisory role on the IP policy, UNCTAD, in cooperation with UNDP, analyzed how the proposed framework could help South Africa fulfill international and domestic human rights obligations related to the right to health. In this context, UNCTAD sought technical input from the Office of the High Commissioner for Human Rights.