Intellectual property and trade: Rights affecting medicines access and innovation
Intellectual property and trade: Balancing access and innovation
Dr. Thandiwe Nkosi (Johannesburg, South Africa) watched helplessly as her patient died. It was March 2001. The patient, a 34-year-old teacher named Sipho, had advanced AIDS. His CD4 count was dangerously low—just 48 cells per cubic millimeter. He desperately needed antiretroviral therapy to survive.
“The antiretroviral drugs existed. They were keeping people alive in wealthy countries. But they cost $10,000 per patient per year—far beyond what Sipho or almost anyone in South Africa could afford. He earned about $3,000 per year as a teacher. Even if he spent every cent he earned, he couldn’t afford three months of treatment,” Dr. Nkosi recalled, her voice breaking even decades later.
“What made it worse—what made it unbearable—was knowing that generic versions of these same drugs existed. Manufacturers in India and Brazil were producing identical antiretrovirals for about $350 per patient per year. But patent protections prevented these affordable generics from being sold in South Africa. The pharmaceutical companies that held the patents were protecting their intellectual property rights. Those rights—those legal monopolies—were worth more than Sipho’s life,” Dr. Nkosi continued.
Sipho died six weeks later, leaving behind a wife and two young children. He was one of hundreds of thousands of South Africans dying from AIDS because lifesaving medicines were priced beyond reach by patent monopolies. Dr. Nkosi attended his funeral, then returned to her clinic to watch more patients die from the same preventable cause.
“Sipho didn’t die from AIDS. He died from intellectual property law. He died because the balance between innovation incentives and access to medicines was catastrophically broken. His death was legal, justified by international trade agreements, and completely unnecessary. That’s what makes it unforgivable,” Dr. Nkosi stated.
According to WHO, Intellectual property and trade refers to intellectual activity in the industrial, scientific, literary and artistic fields. In the context of health care, the concept relates to topics such as the use of generic medicines, specifically how companies can market and sell these products within specific geographic regions. Intellectual property rights and the laws that govern them are important both to the control of standards and access to medicines, but also as an incentive for the development of new pharmaceuticals and health care products.
For more on medicine access, see our articles on global health equity and pharmaceutical policy at ObserverVoice.com.
Debates and WHO Framework
There has been great debate in recent years about the issue of intellectual property protection relating to access to generic medicines. This is particularly the case in areas where drug development is needed to treat a disease endemic to the region, but where the market is not large enough to support the costs of research. The balance needed between access and profit are at the heart of these debates and continue through discussions of free trade and regulation.
Much of WHO’s work with intellectual property and trade relates to the World Trade Organization framework from 2001, known as the Doha Declaration and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In 2006, the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) submitted its report containing 60 recommendations aimed at fostering innovation and improving access to medicines.
WHO closely collaborates with World Trade Organization and World Intellectual Property Organization through Trilateral cooperation on intellectual property and public health to support Member States on matters of intellectual property and trade policies, conduct training on the health impact of trade agreements, research innovation and intellectual property, and facilitate access to patent information.
WHO provides WIPO intellectual property handbook, Guidelines on patentability and access to medicines, Guide for application and granting of compulsory licences, and Patentscope database.
Related topics include Health Laws, Medical devices, Medicines, Health systems governance, Substandard and falsified medical products, and Universal health coverage. For more on health policy, see our article on global medicine regulation at ObserverVoice.com.
Impact on Access and Innovation
Intellectual property rights to medicines and other medical products can be an incentive for the private sector to pursue innovation. However, this system is made more complicated for products intended for populations where the potential paying market is small or uncertain. Low- and middle-income countries, which account for more than 80% of the world’s population, are responsible for just 10% of global sales of many drugs due to the difficulty in affording or accessing necessary products. Poverty affects purchasing power, and the inability of poor people to pay reduces effective demand, which in turn affects the degree of interest of for-profit companies.
Member States, the pharmaceutical industry, charitable foundations and nongovernmental organizations have taken initiatives in recent years to develop new products against diseases affecting poor and middle-income countries and to increase access to existing health products and medical devices. International intellectual property agreements also contain flexibilities that could facilitate increased access to necessary pharmaceutical products. However, these initiatives are not sufficient to surmount the challenges of ensuring access and innovation for needed health products and medical devices. Much work is required to reverse the skewing of world drug markets towards the wealthiest nations.
WHO provides Commercial determinants of health fact sheet and Q&A on Ethics in public health surveillance. WHO’s Health product and policy standards team leads technical work.
Recent Activities and Publications
May 2020 WHO and partners launched COVID-19 Technology Access Pool (C-TAP) to facilitate timely, equitable and affordable access of COVID-19 health products by boosting their supply. WHO coordinates Overall programme review of GSPA. WHO works on Strengthening access to essential medicines, Facilitating access to patent information, and Ensuring fair prices for medicines.
July 2025 WHO reported Public procurement as key tool to tackle health issues discussed at WHO-WIPO-WTO webinar. February 2025 WHO announced WHO, WIPO, and WTO hold first joint briefing for Geneva-based officials. April 2020 WHO and WTO issued Joint statement by Directors-General.
December 2025 WHO published Technology Transfer and Intellectual Property Management for Public Health in Regional Office for South-East Asia as framework. November 2025 WHO published Regional workshop Capacity Building in Technology Transfer on Public-Health Oriented Intellectual Property Management to encourage South-South collaboration. July 2025 WHO published Quality Local Production Training Workshop. June 2025 WHO published Access to safe, effective and quality-assured health products and technologies roadmap 2025-2030 outlining WHO’s role. January 2018 WHO published commentary Facilitating access to patent information.
World Health Assembly Resolutions
World Health Assembly passed multiple resolutions: WHA73.11 on Global strategy and plan of action on public health, innovation and intellectual property, WHA73.1 on COVID-19 response, WHA72.8 on Improving transparency of markets for medicines, vaccines, and other health products, WHA71.9 on Global strategy and plan of action overall programme review, WHA68.18 on Global strategy and plan of action, WHA62.16 on Global strategy and plan of action, WHA61.21 on Global strategy and plan of action, WHA60.30 on Public health, innovation and intellectual property, WHA59.24 on Public health, innovation, essential health research and intellectual property rights.
Change Through TRIPS Flexibilities
Dr. Nkosi’s experience—and the deaths of hundreds of thousands like Sipho—catalyzed massive change in South Africa and globally. In 2001, the South African government invoked TRIPS flexibilities—legal provisions in international trade law that allow countries to override patents in public health emergencies. South Africa authorized importation of affordable generic antiretrovirals from India and Brazil.
“Almost overnight, the price of antiretroviral therapy dropped from $10,000 per patient per year to $350. Suddenly, treatment became affordable. Government clinics could stock the medicines. Patients who were dying could access treatment. People who thought they had death sentences began recovering. I watched patients I’d given up for dead return to work, to their families, to normal lives. It was miraculous—except it wasn’t a miracle. It was simply making existing lifesaving medicines accessible through generic competition,” Dr. Nkosi explained.
“Today, South Africa has one of the world’s largest HIV treatment programs. Over 5 million South Africans are receiving antiretroviral therapy. Most are on generic medicines that cost a fraction of the original patented versions. The generic competition drove prices down further—today’s antiretroviral regimens cost as little as $75 per patient per year. That’s 99% cheaper than 2001 prices. That price drop saved millions of lives across Africa and globally,” Dr. Nkosi continued.
“WHO’s work on intellectual property and trade provided crucial technical support, policy frameworks, and international advocacy during this transformation. WHO helped Member States understand TRIPS flexibilities—compulsory licensing, parallel importation, research exemptions—that allow countries to prioritize public health over patent monopolies. WHO documented the health impacts of patent monopolies and the benefits of generic competition. WHO facilitated collaboration between the World Trade Organization, World Intellectual Property Organization, and health ministries to balance innovation incentives with medicine access,” Dr. Nkosi emphasized.
“The debate continues: How do we incentivize pharmaceutical innovation while ensuring everyone can access the medicines they need to survive? The answer isn’t simple. Companies need revenue to fund research. But when patent monopolies price medicines beyond reach, innovation becomes irrelevant to those who die waiting. WHO’s ongoing work—through C-TAP for COVID-19 technologies, through technology transfer initiatives, through transparency in medicine pricing, through support for local production—seeks to create systems where innovation and access coexist rather than conflict. My work now focuses on teaching the next generation of doctors and policymakers that medicine access isn’t optional—it’s a fundamental human right. Sipho’s death taught me that lesson in the cruelest possible way. WHO’s leadership ensures his death—and millions like his—drive policy changes that prevent future tragedies.”
For more information, visit WHO’s intellectual property and trade topic page or explore related content at ObserverVoice.com.
Frequently Asked Questions (FAQs)
Intellectual property and trade refers to intellectual activity in industrial, scientific, literary and artistic fields. In context of health care, concept relates to topics such as use of generic medicines, specifically how companies can market and sell these products within specific geographic regions. Intellectual property rights and laws that govern them are important both to control of standards and access to medicines, but also as incentive for development of new pharmaceuticals and health care products. There has been great debate about issue of intellectual property protection relating to access to generic medicines, particularly in areas where drug development needed to treat disease endemic to region, but where market not large enough to support costs of research. Balance needed between access and profit are at heart of debates. WHO provides Commercial determinants of health fact sheet. WHO’s Health product and policy standards team leads work. Related: Health Laws, Medicines, Universal health coverage.
Much of WHO’s work with intellectual property and trade relates to World Trade Organization framework from 2001, known as Doha Declaration and Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In 2006, WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) submitted report containing 60 recommendations aimed at fostering innovation and improving access to medicines. WHO closely collaborates with World Trade Organization and World Intellectual Property Organization through Trilateral cooperation to support Member States on matters of intellectual property and trade policies. WHO provides WIPO intellectual property handbook, Guidelines on patentability and access to medicines, and Patentscope database. Related: Medical devices, Health systems governance.
Intellectual property rights to medicines and other medical products can be incentive for private sector to pursue innovation. However, this system made more complicated for products intended for populations where potential paying market is small or uncertain. Low- and middle-income countries, which account for more than 80% of world’s population, are responsible for just 10% of global sales of many drugs due to difficulty in affording or accessing necessary products. Poverty affects purchasing power, and inability of poor people to pay reduces effective demand, which affects degree of interest of for-profit companies. Member States, pharmaceutical industry, charitable foundations and nongovernmental organizations have taken initiatives to develop new products and increase access. International intellectual property agreements contain flexibilities that could facilitate increased access. However, initiatives not sufficient to surmount challenges. Much work required to reverse skewing of world drug markets towards wealthiest nations. WHO provides Q&A on Ethics in public health surveillance. WHO works on Strengthening access to essential medicines. Related: Substandard and falsified medical products.
May 2020 WHO and partners launched COVID-19 Technology Access Pool (C-TAP) to facilitate timely, equitable and affordable access of COVID-19 health products. WHO coordinates Overall programme review of GSPA. WHO works on Facilitating access to patent information and Ensuring fair prices for medicines. July 2025 WHO reported Public procurement as key tool discussed at WHO-WIPO-WTO webinar. February 2025 WHO announced WHO, WIPO, and WTO hold first joint briefing. December 2025 WHO published Technology Transfer and Intellectual Property Management framework. November 2025 WHO published Regional workshop on Technology Transfer. June 2025 WHO published Access to health products roadmap 2025-2030. Related: Health Laws.
World Health Assembly passed multiple resolutions on intellectual property and trade: WHA73.11 on Global strategy and plan of action on public health, innovation and intellectual property, WHA73.1 on COVID-19 response, WHA72.8 on Improving transparency of markets, WHA71.9 on overall programme review, WHA68.18 on Global strategy, WHA62.16 on Global strategy, WHA61.21 on Global strategy, WHA60.30 on Public health, innovation and intellectual property, WHA59.24 on intellectual property rights. April 2020 WHO and WTO issued Joint statement. WHO provides Guide for compulsory licences. Related: Medicines, Universal health coverage.
- WHO Intellectual Property and Trade Topic Page
- WTO TRIPS and Public Health
- WIPO Global Challenges and Intellectual Property
- WHO COVID-19 Technology Access Pool
- WHO Trilateral Cooperation
Disclaimer: This article is an adaptation of publicly available information from WHO’s Intellectual property and trade health topic page (WHO, Geneva. Licence: CC BYNC-SA 3.0 IGO). WHO is not responsible for the content or accuracy of this adaptation. This content is for informational and educational purposes
only and does not constitute medical advice. ObserverVoice.com is a news and information platform
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