A Way Forward for Equitable Pharmaceutical Access After COVID-19

By Brook Baker and Rachel Thrasher

COVID-19 exploded on a global stage dominated by an international legal and policy regime that instantiates closed science, intellectual property (IP) monopolies and privatized control over the testing, supply, price and distribution of life-saving health technologies. As a result, there were avoidable delays in biopharmaceutical preparedness, ill-adapted technologies that were not optimized for use in resource-poor settings, inconclusive and non-comparative clinical trials, artificially restricted supplies, needlessly high prices and grotesquely inequitable distribution. IP right holders have preferentially and disproportionately supplied richer countries paying high prices all while those countries stockpiled excessive quantities of COVID-19 health technologies. What resulted is now recognized as vaccine, therapeutic and diagnostic apartheid.

Despite the remarkable effectiveness of the currently available vaccines, almost one-third of the world remains totally unvaccinated, allowing the virus to run rampant in many low- and middle-income countries (LMICs), and increasing the likelihood that newer, post-Omicron variants will emerge. The same is true of therapeutics. While many are being developed for in-patient and more recently out-patient use, access remains elusive for people in LMICs. Moreover, both polymerase chain reaction (PCR) lab tests and antigen rapid diagnostic tests have been vastly more available in high-income countries than low-income countries—where almost half of the global population has received only 20 percent of the tests to date. In light of these realities, it is increasingly important that countries work together to overcome health inequality in the short- and long-term.

A new journal article published in the Boston University International Law Journal seeks to explain the legal, political and commercial obstacles that have barred LMICs from accessing the pharmaceutical products needed to protect their populations during the pandemic. Although access to medicines is fraught even in ordinary times, these dynamics were exacerbated by the realities of a worldwide pandemic, despite a myriad of public and private efforts to combat COVID-19. The article concludes by offering ways forward that would enable national policymakers and the global community to face the next pandemic more effectively and equitably.

Barriers to equitable pharmaceutical access

The World Trade Organization (WTO)’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) introduced a global minimum standard for IP protection including a minimum 20-year patent term and protection for test data and other confidential information. The TRIPS Agreement also established some key flexibilities, intended to allow countries to implement IP laws consistent with their own innovation and access priorities. In 2001, WTO countries adopted the Doha Declaration on TRIPS and Public Health that affirmed the rights of the parties to balance the interests of IP rights holder and the public’s need to gain access to essential medicines by confirming countries’ discretion to define grounds for compulsory licenses and allowing those licenses to be issued for export, as well as domestic consumption.

Despite the affirmation of these flexibilities, several legal and practical realities interfere with their exercise. First, a parallel and growing regime of bilateral, regional and mega-regional free trade agreements has further ratcheted up the IP protection. Second, historical and on-going political pressure on developing countries to not use existing flexibilities has kept countries from adopting IP curtailment measures that would otherwise be allowed. Finally, the patent and trade secret complexity specific to COVID-19 products makes country-by-country and product-by-produce solutions, like compulsory licensing, exceedingly difficult. 

Policy responses and challenges

All told, despite acknowledged TRIPS flexibilities, patent complexity and other global IP standards defended by most developed countries have blocked countries attempting to respond to the COVID-19 pandemic in real time. Considering these seemingly insurmountable challenges, public and private actors worldwide mobilized to secure adequate affordable and equitably distributed COVID-19 health technologies. Each response had successes and shortcomings; however, the lessons learned from these efforts set the stage for new proposals to create new rules of engagement in preparation for and response to future pandemics.

The boldest and most impactful response to the COVID-19 pandemic was the decision by governments to significantly expand public funding for product development, clinical trials, expanded manufacturing capacity and at-risk production of the vaccine, diagnostic and therapeutic countermeasures needed to prevent, contain and treat the virus. The downside of reliance on public funding, however, is that it depends on the fiscal space of individual countries and has pitted the political pressures of governments to care for their domestic population versus ensuring broader global access.

Collective purchasing and donations through COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, initially provided hope that 2 billion vaccines could be delivered to LMICs in a relatively short period of time. Unfortunately, this process was fraught from the beginning, suffering from under-funding, export restrictions and low engagement from the key donor countries. Another collective effort to pool patent and technological knowledge through the COVID-19 Technology Access Pool and the Medicines Patent Pool experienced even lower engagement from countries and firms, struggling to get any diagnostic, therapeutic or vaccine technology from major pharmaceutical companies until late in 2021. Successes from voluntary licensing (by firms) and compulsory licensing (by countries) are incidental, at best, though some promising research by firms in South Africa, India and a handful of other countries did moderately increase access to certain vaccines and treatments.

The effort that received the most public attention, but perhaps with the least practical impact, was the Indian and South African proposal for a waiver of key TRIPS provisions to ease the pressure on countries to protect IP for COVID-19 products during the crisis. The result of such negotiations was an extremely limited waiver of a rule governing export of vaccines to developing countries only via compulsory licensing – not enough to get around the patent complexity making product-by-product and country-by-country solutions impractical and accomplishing nothing with respect to access to know-how and technology transfer.

Health for the future

Given the failure of the international legal regime to appropriately reform its IP and commercial distribution mechanisms in the face of the COVID-19 pandemic, many access-to-medicines advocates and pandemic preparedness proponents are simultaneously turning their attention to establishing a new legal framework. Some proposals involve fundamental IP reform by turning pandemic countermeasures into global public goods. Others have taken the form of new domestic and regional efforts to address vaccine and medicines shortages through industrial policy, building up new regional pharmaceutical manufacturing capacity, securing and strengthening supply chains and providing for pooled procurement. The World Health Organization’s mRNA vaccine technology transfer program has shown the potential to create a new share-and-share-alike, open-science research model and a new commitment to sustainable research and equitable access in developing country regions, but only when fully financed and provided institutional support by an inter-governmental organization.

The way forward could take many forms. Prospects for multilateral agreement at the World Health Organization on how to improve pandemic preparedness and a truly equitable pandemic response and how to reform international health regulations are uncertain – though some progress has been made. What is clear, however, is that future pandemic responses must include major IP reform, adequate financing and the assurance of equitable distribution of diagnostics, therapeutics and vaccines for the next threat to global public health.

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