Examining how the WTO's ambitious framework has failed to establish the infrastructure needed for pharmaceutical access in developing countries
Imagine two patients diagnosed with the same lethal illness. One receives a life-saving medication, readily available at a local pharmacy. The other is told the treatment exists but is unattainable—too expensive, not imported, or simply unavailable in their country. This is not a hypothetical scenario but a daily reality dividing the global population along geographic and economic lines.
COVID-19 Impact: The pandemic offered a stark illustration of this failure, where vaccine inequity cost an estimated 1.3 million lives in poor countries by the end of 2021, even as wealthy nations achieved vaccination rates of 75-80% 6 .
For decades, the World Trade Organization (WTO) has been tasked with creating a trading system that would bridge this chasm, yet millions continue to die from treatable diseases because the medicines they need remain out of reach. This article explores how the WTO's ambitious framework, designed to harmonize global intellectual property and trade, has ultimately failed to establish the infrastructure needed to deliver pharmaceutical drugs to developing countries—and examines the emerging solutions that could finally make health equity a global reality.
The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, established in 1995, represented a landmark effort to bring intellectual property rules into the global trading system. Negotiated during the Uruguay Round, TRIPS established minimum standards of protection for intellectual property—including patents for pharmaceuticals—across all WTO member states 2 .
By protecting patent rights, TRIPS would incentivize pharmaceutical innovation while allowing flexibilities for governments to protect public health.
The system created fundamental tensions between commercial interests of patent holders and public health needs of developing countries.
The TRIPS Agreement does contain safeguards designed to protect public health. It permits governments to issue compulsory licenses—allowing a competitor to produce a patented product without the consent of the patent owner—under specific conditions 2 . A 2003 amendment further clarified that countries with insufficient pharmaceutical manufacturing capacity could import generic versions of patented medicines from other countries 7 .
However, these flexibilities have proven difficult to implement in practice. The process requires multiple compulsory licenses—one from the exporting country and one from the importing country—creating what Médecins Sans Frontières has criticized as a "burdensome system" that "imposes new legal, economic and political obstacles" 7 . Many developing countries lack the legal expertise or political leverage to navigate this complex system, leaving life-saving treatments languishing in regulatory limbo.
While intellectual property disputes capture headlines, a less visible but equally formidable barrier to medicine access lies in the fragmented regulatory landscape governing pharmaceutical products. Even when patent barriers are overcome, medicines must still navigate a labyrinth of national regulatory systems that vary dramatically in their standards, requirements, and capacity.
A groundbreaking 2016 study published in Globalization and Health mapped the state of pharmaceutical regulation across 78 developing countries, creating three original indicators of market oversight 1 . The findings revealed a landscape of remarkable diversity and inconsistency.
Existence of laws, regulations, and institutions for pharmaceutical oversight
Finding: Remarkable resistance to implementing global pharmaceutical norms
Capacity to supervise private drug distributors and pharmacies
Finding: Human capacity remains limited across many developing countries
Government ability to ensure medicine quality in public sector
Finding: Variation among states is stark with no clear regional patterns
Estimated regulatory capacity scores based on composite indicators 1
The research found "remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states" 1 . Contrary to theories of international norms diffusion, established regulatory powers like the United States and European Union appeared to have "surprisingly little influence on standard setting" across the surveyed countries 1 .
Regional Disparity: The consequences of this regulatory patchwork are particularly evident in sub-Saharan Africa, where according to the Access to Medicine Foundation, efforts to transfer technology and establish local production are "lagging in sub-Saharan Africa (except for South Africa)" 5 . Only six of twenty major pharmaceutical companies report having established technology transfer initiatives in this region 5 .
The inequities in pharmaceutical access begin long before medicines reach the market—they are embedded in the very research and development process. The geographic distribution of clinical trials significantly influences where companies prioritize market access once products are approved. Unfortunately, the populations most burdened by disease are dramatically underrepresented in pharmaceutical research.
Source: 2024 Access to Medicine Index 5
This research gap has profound implications. It means that genetically diverse populations may be excluded from research, potentially affecting how medicines work across different ethnic groups 5 . Perhaps more importantly, it creates a commercial disincentive for companies to ensure broad availability of their products in regions where they haven't conducted trials. As the Access to Medicine Foundation notes, "pharmaceutical companies typically prioritise access planning in countries where they conduct trials" 5 , leaving much of the world behind from the earliest stages of drug development.
Even when effective medicines are developed and approved, the mechanisms designed to facilitate their distribution to developing countries are faltering. Voluntary licensing agreements, particularly when supported by technology transfers to local manufacturers, represent one of the most powerful tools for improving long-term, sustainable access to essential medicines in regions where pharmaceutical companies have limited operations 5 . Yet recent data indicates a troubling slowdown in these activities.
New non-exclusive voluntary licensing agreements in 2024 analysis
Agreements in the previous 2022 analysis period
The 2024 Access to Medicine Index identified only two new non-exclusive voluntary licensing agreements during its period of analysis, compared with six in the 2022 Index 5 . This decline represents a significant missed opportunity to improve local availability of innovative medicines, particularly in underserved regions.
Pre-Pandemic Dependency: The limitations of this approach were evident during the COVID-19 pandemic, when excessive concentration in vaccine production capacity left the world vulnerable. Prior to the pandemic, 80% of global vaccine exports came from only ten countries, with Africa importing 99% of its vaccines 6 . This dependency left the continent "particularly exposed and vulnerable to export restrictions" when the crisis hit 6 .
Only 6 of 20 major pharmaceutical companies report initiatives in sub-Saharan Africa 5
The persistent failure to create an effective global infrastructure for medicine delivery has spurred innovative approaches that bypass traditional barriers. One promising model is the parallel technology and regulatory transfer, which pairs manufacturing technology transfers with regulatory control mechanisms from developed to developing regions 3 .
This approach was successfully implemented through the Vaccine Equity for Africa initiative, which transferred BioNTech's SARS-CoV-2 mRNA vaccine technology to Rwanda based on the European Marketing Authorization of the product 3 .
The BioNTech facility in Kigali, opened in December 2023, represents an important step in making the African continent more independent from global vaccine manufacturers in the global north 3 .
The Rwanda FDA provides an encouraging example of quick progression in regulatory maturity through an extensive network of collaborators and twinning partners, including several leading agencies from the Global North and within Africa 3 .
Less experienced national regulatory agencies can use reliance schemes to recognize marketing authorizations or Good Manufacturing Practice licensure issued by mature regulatory agencies 3 .
Local regulators learn through practical training and participation in inspection activities performed by mature regulatory agencies 3 .
Starting with simple regulatory reliance schemes, countries can gradually develop skills and expertise to eventually establish independent regulatory capabilities 3 .
The success of this approach depends on establishing foundational elements in recipient countries: a basic but robust regulatory framework in accordance with WHO principles, an independent national regulatory agency mandated by law to oversee all regulatory functions, and a contemporary drug law in accordance with international standards 3 .
Moral Imperative: As Okonjo-Iweala has starkly framed the moral imperative: "We cannot accept a world in which you are denied access just because you are poor, or because you happen to live in a poor country" 6 .
The WTO's failure to create an effective infrastructure for delivering medicines to developing countries represents one of the most significant systemic failures in global health. The intricate web of intellectual property barriers, regulatory fragmentation, research inequities, and supply chain vulnerabilities has created a world where your life expectancy remains heavily determined by your country of birth.
Yet emerging models offer a path forward. The parallel technology and regulatory transfer approach demonstrates how strategic collaborations can bypass historical barriers. The persistent efforts of some pharmaceutical companies to include low-income countries in clinical trials and licensing agreements shows that more equitable practices are possible. The ongoing work to strengthen regulatory systems in developing countries proves that capacity can be built with intentional support.
The future of global health depends on our ability to transform this principle into practice, creating a pharmaceutical infrastructure that truly serves all of humanity, regardless of nationality or economic status.