An analysis of the tension between patent rights and public health access in the context of South Africa's struggle for affordable medicines
In October 2020, as COVID-19 swept across the globe, a dramatic standoff unfolded at the World Trade Organization. South Africa and India proposed an unprecedented patent waiver for all COVID-19 vaccines, treatments, and diagnostics, arguing that intellectual property barriers were blocking equitable access to lifesaving medical tools during a pandemic 5 .
Glaring disparities in vaccine access between wealthy and developing nations during the pandemic
Fundamental tension between pharmaceutical patent protection and medicine access
Lengthy political struggle over the TRIPS waiver proposal at the WTO
This recent conflict represents just one chapter in a much longer story of South Africa's struggle to balance pharmaceutical patent rights against the fundamental right to health for its people—a struggle that raises profound moral questions about profit, protection, and human dignity in the global pharmaceutical industry.
South Africa's journey toward medicine access has been shaped by both its apartheid history and subsequent public health crises. Following the transition to democracy in 1994, the country faced one of the world's most severe HIV/AIDS epidemics, with infection rates soaring to among the highest globally.
The South African government passed the Medicines and Related Substances Act to increase access to affordable medicines through:
Thirty-nine multinational pharmaceutical companies filed a lawsuit against the South African government in 1998, claiming the law violated their intellectual property rights 1 .
Under mounting pressure, the companies eventually dropped the lawsuit in 2001, but their opposition to South Africa's access to medicines policies would continue in different forms.
South Africa transitions to democracy and faces severe HIV/AIDS epidemic
Medicines and Related Substances Act passed to increase medicine access
39 pharmaceutical companies sue South African government
Companies drop lawsuit under international pressure
In January 2014, a leaked email exposed a coordinated campaign by the Innovative Pharmaceutical Association of South Africa (IPASA) to oppose South Africa's ongoing efforts to reform its patent laws 1 .
The leaked communications revealed several key elements of the industry's strategy:
The scandal, dubbed "Pharmagate," revealed the stark contrast between the pharmaceutical industry's public commitments to access and their behind-the-scenes efforts to maintain high prices through extended patent protections.
Exposed coordinated campaign by IPASA to oppose patent law reforms
| Company | Response to Allegations | Action Taken |
|---|---|---|
| Novo Nordisk | Submitted formal response | Resigned from IPASA following campaign proposal |
| Roche | Submitted formal response | Resigned from IPASA following campaign proposal |
| Novartis | Submitted formal response | Remained in IPASA |
| AstraZeneca | Submitted formal response | Remained in IPASA |
| Pfizer | No direct response | Referred inquiries to IPASA |
| Bristol-Myers Squibb | No direct response | Referred inquiries to IPASA |
To understand the pharmaceutical industry's opposition to reform, one must first understand the unique nature of South Africa's patent system. Unlike most countries, South Africa operates a non-examining patent system 7 .
Studies show South Africa grants excessive numbers of pharmaceutical patents compared to examining countries.
While India rejected 92% of secondary pharmaceutical patent applications, South Africa granted the vast majority of similar applications 7 .
| Patent System Characteristic | South Africa (Non-Examining) | Examining Countries (e.g., India, US, EU) |
|---|---|---|
| Substantive novelty assessment | No | Yes |
| Inventiveness evaluation | No | Yes |
| Industrial applicability review | No | Yes |
| Rate of patent grants | Very high | Variable, with significant rejection rates |
| Protection against evergreening | Weak | Stronger (varies by country) |
| Average time to grant | 8-18 months | 2-5 years |
The COVID-19 pandemic created a perfect natural experiment to observe whether the lessons from South Africa's medicine access struggles had been learned. In October 2020, South Africa and India proposed a TRIPS Agreement waiver at the World Trade Organization that would temporarily suspend patent protections for COVID-19 vaccines, treatments, and diagnostics 9 .
Glaring disparities in vaccine access between wealthy and developing nations persisted throughout the pandemic.
The director-general of the World Health Organization noted that not a single vaccine manufacturer had shared knowledge with the WHO's COVID-19 Technology Access Pool (C-TAP) 9 .
The tension between pharmaceutical patent protection and medicine access represents one of the most pressing ethical challenges in global health.
As publicly-traded companies, pharmaceutical firms have a fiduciary duty to shareholders to maximize profits.
As healthcare entities, they bear an ethical responsibility to patients who depend on their products for survival 2 .
From a consequentialist ethical framework, the current system produces devastating consequences. When life-saving drugs are priced beyond reach, the result is preventable suffering and death.
A 2021 study found that one in five U.S. adults skipped or rationed medications due to cost, and the situation is far more severe in developing countries 2 .
Pharmaceutical companies justify high prices by emphasizing the need to fund research and development. However:
The current system disproportionately burdens vulnerable populations.
A 2023 Urban Institute report found that 25% of low-income U.S. adults delayed or went without prescriptions due to cost, compared to just 6% among high-income adults 2 .
These disparities are even more pronounced globally.
Reconciling the legitimate need for pharmaceutical innovation with the moral imperative of medicine access requires creative policy solutions that move beyond polarized debates.
Introduce substantive examination, prevent evergreening, and incorporate public health safeguards.
South Africa's Department of Trade has announced plans for a new Patents Bill 7 .Replace pharmaceutical patents with direct research rewards or revised regulatory exclusivity periods 8 .
Establish technology transfer hubs, patent pools, and regional manufacturing capacity.
The WHO mRNA Vaccine Technology Transfer Hub in South Africa is a promising model 9 .Voluntary licensing, tiered pricing, non-assertion pledges, and transparency in research costs.
| Solution Category | Specific Mechanisms | Potential Benefits |
|---|---|---|
| Patent System Reforms | Substantive examination, stricter patentability criteria, pre- and post-grant opposition | Reduced evergreening, higher quality patents, increased generic competition |
| Alternative Innovation Models | Direct research rewards, government research funding, priority review vouchers | De-linked R&D funding from drug prices, public health-driven research agenda |
| International Cooperation | Technology transfer hubs, patent pools, regional manufacturing | Increased local production capacity, knowledge sharing, supply chain resilience |
| Ethical Business Practices | Voluntary licenses, tiered pricing, transparency initiatives | Improved access in developing countries, enhanced corporate reputation |
The opposition of multinational pharmaceutical manufacturers to patent law reform in South Africa represents more than a policy dispute—it symbolizes a fundamental conflict between commercial interests and human dignity.
"History will not remember how profitable our cures were, only how many were left to die waiting for them" 2 .
While the pharmaceutical industry's role in developing lifesaving medicines deserves recognition and fair compensation, the current system has tilted too far toward protection of profits at the expense of human lives.
The bitter moral pill the industry must swallow is this: innovation without access is ultimately an empty achievement.
South Africa's struggle for medicine access continues to evolve, with the recent transition from the Medicines Control Council to the South African Health Products Regulatory Authority (SAHPRA) offering potential for more efficient regulation 3 . Yet the fundamental tension remains unresolved.
The world has witnessed during the COVID-19 pandemic what happens when access to medical technologies is treated as a privilege rather than a right. The question remains whether we will learn from these lessons and build a more equitable system—or continue to repeat the bitter patterns of the past.