Two competing approaches to promote access to medicines were born during the HIV/AIDS pandemic in the year 2000. Today, at the height of the COVID-19 pandemic, these same approaches are once more on a collision course. 

On the one side is the ‘international’ COVID response, led in name by WHO, but in fact by what is now the world’s largest and most powerful global health institution, the Gates Foundation – with the backing of the pharmaceutical industry and high-income countries.

On the other side is the access-to-medicines movement, led by civil society alongside low- and middle-income countries (LMICs) such as India and South Africa, with the backing of hundreds of grassroots, civil society groups and non-governmental organisations that are challenging monopolies on medicines and promoting generic competition to successfully expand supply and lower prices of COVID-19 drugs, tests and equipment, and future vaccines.

These groups argue that meeting the COVID-19 pandemic requires broad use of the same strategies that revolutionized access to antiretroviral medicines (ARVs) during the AIDS crisis. Can we learn from the successes and mistakes made the last time around?

The Gates Foundation has leaned into the COVID-19 pandemic

Two decades after its establishment, the foundation that boasts a total endowment of US$ 50 billion dollars, has rededicated its entire organizational focus to the pandemic.

Gates has spent or committed to spending hundreds of millions of dollars on the development and procurement of COVID-19 medical technologies, partnering with both global health agencies and pharmaceutical corporations to accelerate the development and deployment of technologies. The Foundation’s leaders have also used their ‘moral voice’ to respond to the predictable health technology nationalism that has taken hold.

Sounds amazing, right? 

But on a more careful examination, what still emerges is a set of narrow, inefficient, and inadequate solutions that are exclusively based on what charity or the market will allow. This means prioritizing pharma monopolies of technology and intellectual property (IP) and secretive, technocratic, and top-down approaches that mostly exclude LMICs from decision making as well as avoiding public scrutiny.

Moreover, the Foundation’s role and outsized voice threaten to undermine the role involvement of civil society groups in decision-making that was effective at the height of the HIV/AIDS epidemic – and which is urgently needed again today.

As evidence of that, just look at how the money flows.

The Gates Foundation is the second largest funder of the World Health Organization, the global health agency of UN member states, which sets standards and issues public recommendations working on an annual budget that is just a fraction of Gates’ own. The Gates Foundation also is a leading funder of, as well as a Board Member on, most of the world’s other leading global health agencies and public-private partnerships (such as Gavi The Vaccine Alliance, The Global Fund to fight HIV/AIDS Tuberculosis and Malaria, and Unitaid). This provides the Gates Foundation with decision-making power on the most salient issues with respect to research, development and delivery of health care systems in developing countries.

The Gates Foundation is, moreover, heavily invested in the development and finance of new technologies, including direct investments into many pharmaceutical corporations. This has included R&D of technologies to address infectious and neglected diseases, and financial and institutional support to expand immunization.

The COVID-19 solutions proposed by the Gates Foundation are thus anchored in this world view. And in terms of health products, they trap most countries into a system that primarily benefits pharmaceutical corporations and high-income country governments, which can subsidize these corporations with both billions of dollars in upfront subsidies and paying high prices for treatments and vaccines. These practices and trends will likely endure even after the pandemic recedes.

What are the key problems?

1. A lack of transparency

The Gates Foundation is neither discouraging nor overcoming an enduring problem within the pharmaceutical system – secrecy. For the last two decades, there have been concerted efforts by governments, international agencies, regulators, and investors, to improve the transparency of the pharmaceutical system in the areas of public contributions to funding R&D, research priorities, patent status, clinical trial data, price, and overall cost of R&D. There have also been efforts at improving transparency of terms and conditions of licensing agreements between multinational and generic companies, primarily due to the publication of licensing agreements by the Medicines Patent Pool.

Yet throughout this pandemic, and well before it, the Gates Foundation has not been transparent. It does not share the terms and conditions of the agreements it signs with companies (much less provide a clear picture of what it is funding) and does not demand transparency of the businesses that the foundation funds or for which it has made investments. It seems that the Foundation considers transparency should be limited to information about its grants, which are published on its website.

This insistence on secrecy encourages the worst tendencies of the pharmaceutical industry to hide information, and places decision-making power in the hands of only two parties – the Gates Foundation and a pharmaceutical corporation.

On September 28 2020, the Gates Foundation signed a new agreement with two diagnostic manufacturers to supply just 20% of their new diagnostic tests to 133 LMICs. This announcement raises many questions. Why only 20%? Which 133 countries are eligible? Who selected the countries and how? Were the governments of the countries involved in decision making and the planning of the delivery of the tests? What is the number of tests in relation to the population size of the countries? Will tests be equitably distributed? Is there an agreement to expand production through other sources? Who bears liability if the tests are faulty? Who knows the answers?

The Gates Foundation signed a similar, secretive agreement with Eli Lilly for the provision of its monoclonal antibody candidate (to treat COVID 19) on behalf of LMICs. Many of the same questions should be asked. There is a capacity reservation, but how did the parties agree on the number of doses? What is the expected price and is it based on a cost-of-goods analysis (and will that analysis be made public)? Who decides the countries? All these details are shrouded in mystery.

In fact, the Foundation is entering into many “partnerships” with industry where the public only gets the headlines of ‘commitments’ to innovation and access.

2. A dogmatic defender of intellectual property rights and monopolies

Those who own intellectual property (IP), hold power. There are three primary holders of IP over technologies to fight COVID-19 – government research institutions and agencies that are paying for or developing COVID-19 technologies, companies that are developing these technologies (admittedly often with IP accrued before the pandemic), and the Gates Foundation. The Gates Foundation has invested in many of these technologies – before and during the pandemic – and in doing so is able to negotiate certain rights in the technology. That gives it some authority as to how the technology is managed.

Why does IP matter?

In 2000, as the HIV/AIDS epidemic accelerated across Africa and parts of Asia and Latin America, pharmaceutical corporations, armed with IP monopolies and the backing of the United States and European Union, charged outrageous prices for HIV medicines, even in poor countries. Moreover, they filed lawsuits to deter developing countries from using legal measures to promote competition and reduce medicine prices.

High prices for HIV medicines were reduced only because of measures taken to overcome strict IP rules that forbid generic competition. Owing to generic competition, prices for HIV medicines are now more than 99 percent lower than they were two decades ago. Generic competition, or in the case of vaccines, the entry of multiple competitors onto the market, has been largely responsible for the availability of affordable medicines and vaccines around the world, including in the US and Europe. Flexible intellectual property rules have also been critical to enabling third parties to develop appropriate formulations of new medicines and vaccines, whether for children or those in resource poor settings.

During the COVID-19 pandemic, the use of flexible IP rules is a critical step to expanding supply of new tests, medicines and vaccines required by all countries to address COVID-19. No one company can supply a test, medicine or vaccine to the whole world, and therefore maximizing production is critical to control COVID-19. Not only would overcoming IP barriers allow expanded supply to speed up equitable distribution, it would introduce competition that could lower prices. One mechanism to overcome IP barriers is the COVID-19 Technology Access Pool (C-TAP), a government and WHO-led initiative for the sharing of data, know-how, biological material and IP in order to facilitate low-cost production and increased supply of medicines, vaccines and tests.

More recently, India and South Africa submitted a proposal to the TRIPS Council at the World Trade Organization (WTO) to suspend enforcement of COVID-19-related IP rights until an effective health response to the pandemic has been realized. Unfortunately, a consensus was not achieved amongst WTO Members during discussions held in mid-October at the WTO, but it will come forth for further discussion and decision by the end of the year.

Yet the Gates Foundation has not publicly supported the C-TAP and is instead undermining it by messaging in discussions with civil society organizations (and apparently in discussions with other global health agencies) that IP is not a barrier and simultaneously that overcoming IP is not sufficient to enable expanded and competitive supply.

It also argues that technology transfer is too difficult to do on a large scale and should instead be done with a small set of Big Pharma partners or pre-vetted contract manufacturers. In doing so, the Gates Foundation ignores the fact that C-TAP also calls for sharing of know-how and access to cell lines, technology transfer measures that are essential to entry by generic suppliers, issues addressed in a limited way among companies working with the Coalition for Epidemic Preparedness Innovations (CEPI). Gates has also said nothing in support of the India/South Africa WTO waiver proposal, even as several other global actors have come out in support.

This defence of the IP status quo, including both rights in inventions and data, as well as proprietary control over know-how and cell lines, means that power over COVID-19 health technologies rests almost entirely with a handful of large corporations – subsidized by public and philanthropic funding that develop these technologies. It has also enabled the Gates Foundation itself to act as a heavy weight broker to facilitate secret deals between pharmaceutical companies and vaccine producers in developing countries. These agreements, negotiated out of reach of governments and the wider public, mean that the Gates Foundation and pharmaceutical companies decide who gets limited rights to make vaccines and who ultimately gets access to medicines, tests or vaccines.

The most concrete example of the consequences of the Gates Foundation approach to IP has been the decision of the University of Oxford to sign an exclusive agreement with AstraZeneca to complete development of a leading COVID-19 vaccine candidate.

In April 2020, when the vaccine was under development by the University, the institution had posted guidelines for organizations seeking to license or otherwise access University of Oxford IP relevant to the COVID-19 pandemic. When the University initially announced it was moving ahead with a vaccine candidate, it had committed to working non-exclusively with multiple partners on a royalty-free basis to support a vaccine that would be “free of charge, at-cost or cost-plus limited margin as appropriate” for the duration of the pandemic. Then, only weeks later, an agreement was signed on an exclusive basis between pharma giant AstraZeneca and the University of Oxford; this was inconsistent with the university’s commitment to an open license, which could have allowed other companies to manufacture the vaccine and expand supply. This outcome is, in large part, because Bill Gates had pushed the University of Oxford to sign an exclusive agreement, thereby limiting worldwide production of the vaccine to reach more people.

The result? The accord has provided AstraZeneca excessive power in setting the price of the vaccine worldwide, including a unilateral power to declare the ‘end of the pandemic’ in July 2021, thereby freeing up the corporation to charge unaffordable prices even if the virus is not under control at that point.

3. A marriage with large pharmaceutical corporations 

Without transparency and without open access to IP, the only way forward is to leave decisions to pharmaceutical corporations and the Gates Foundation.

Thus, at the UN General Assembly on 30 September 30 2020, the Foundation and sixteen pharmaceutical corporations announced new ‘commitments’ to expand global access to COVID-19 diagnostics, vaccines and medicines. The declaration – described as a landmark by pharmaceutical corporations such as Johnson & Johnson – is anything but.

Consider the signal it sends. The responsibility for how pharmaceutical corporations should act is no longer the domain of governments, but the decision of a single philanthropy accountable only to itself. The irony of the Declaration is that while corporations and the Gates Foundation call for diversified representation from LMIC governments in decision-making, their framework for global access has been designed by a single foundation and pharmaceutical corporations without any such representation.

It also tries to institutionalize improper commercial practices of the pharmaceutical industry – in particular the unregulated use of price discrimination (tiered pricing). This is when corporations will charge different prices depending on inexact and often completely inappropriate measures of ability to pay (especially in a pandemic), without regard to the relationship between global sales and (risk and subsidy adjusted) development costs. A pledge to secure the lowest prices for low-income countries means that many countries that are at a slightly higher level of Gross National Income per capita (but are struggling under debt and devastation of their health system) will be forced to pay a higher price, decided unilaterally by corporations armed with monopolies. This will have a significant impact on the majority of poor people, because they live in middle-income countries.

The Foundation neglects to require drug corporations to make commitments to critical demands – notably transparency – as per a consensus resolution amongst governments at the World Health Assembly in 2019, as well as forging a commitment from corporations to share IP, data and know-how that has been promoted by many, including 41 governments that support the C-TAP.

Finally, the Gates plan does not address the need for and benefits of building out manufacturing capacity in more countries, so that the world is better prepared for what could be a long-term fight against COVID and other future epidemics and pandemics. This means vulnerable governments may have to continue relying on the supply/price charity of both the Gates Foundation and pharmaceutical corporations during subsequent pandemics.

In an interview in September 2020, Bill Gates noted: “[Pharmaceutical corporations’] response to the pandemic and this great work that pharma people are doing has reminded many of their capacities and how they can be helpful to the world – as opposed to the industry being viewed as kind of selfish and uncooperative.”

This faith and belief in the world’s largest drug corporations is hard to fathom. Even if we all believe that these corporations have a critical role to play in developing new technologies and ensuring access to such technologies, we are not so naïve to believe that they will take the necessary steps on their own to ensure that they are meeting global public health needs. Pfizer, one of the signatories to the Gates Foundation’s declaration, may earn up to $3.5 billion in just 2021 from the sale of its COVID-19 vaccine. In fact, just as the Gates Foundation was announcing its new partnership with pharmaceutical corporations in New York, the US House of Representatives Oversight Committee was holding its own hearings, in Washington D.C., just 200 miles away, to reveal a range of egregious practices by pharmaceutical corporations to overcharge patients, extend and abuse IP rights, pay executives excessive compensation and avoid taxes.

How the Gates Foundation funds Civil Society in the Pandemic Stifles Real Debate Over Hard Choices

It is normal today to look at any discussion in global health and see the Gates Foundation in the voice of almost every ‘independent’ actor. Even if there may eventually be concerns with the strategy of the Gates Foundation, there is no mechanism to hold the Foundation accountable to people and countries affected by its choices and influence.

The Gates Foundation, to its credit, is a major funder of civil society and advocacy. But this can also minimize or prevent non-governmental organizations from publicly criticizing the Foundation due to fear of losing funding or undermining access to funds in the future: critical in an environment of decreased government funding of advocacy-based NGOs. The Gates Foundation is also a major funder of journalism (including health and development journalism), raising concerns of the independence of the media to investigate and evaluate the Foundation’s activities.

The Foundation is funding new civil society organisations and networks that may simply mirror its own belief system or promote the views of non-governmental organisations that are both funded by the Gates Foundation and that do not challenge its worldview with respect to pharmaceutical corporations. Early in the pandemic, for example, a new network called the Pandemic Action Network – funded in part by the Gates Foundation and pharmaceutical companies, such as Johnson & Johnson – was created to represent civil society on the important question of pandemic preparedness and response. During the announcement of the Gates Foundation and sixteen pharmaceutical corporations at the UN General Assembly in September, the featured civil society speaker was the CEO of the ONE Campaign, whose organization has received at least $135 million from the Gates Foundation.

The Gates Foundation echo chamber is a concern because international health has become less about activism and human rights and more about power-point slides delivered from conference rooms in Geneva and Seattle. The response to the HIV/AIDS epidemic has always been just as much about what can be done through science, technology and money as about what can be accomplished through communities and civil society groups pressuring their governments and corporations to be accountable for their apathy or harmful decisions.

Activists Denied Seats at the Table 

Seasoned access to medicines activists from civil society organizations and affected communities have had a hard time gaining seats within the Access to COVID-19 Tools Accelerator, a collection of health agencies, public-private partnerships and foundations that is powered in large part by the Gates Foundation. The lack of civil society and community engagement and inclusion in decision making has been especially evident in the ‘Vaccines Pillar’ – which is primarily managed by Gavi and CEPI, two public-private partnerships that are closely tied to the Gates Foundation. Only after months of persistent advocacy did Gavi and CEPI agree to civil society representation, and yet still wanted to control the selection of representatives.

Even those civil society representatives that are integrated in the ACT-Accelerator are having a difficult time with involvement in the higher reaches of the Diagnostics and Therapeutics Pillars – where decisions are made and often brought pre-baked to work-stream meetings. Most commonly, the projects advanced in ACT-A are those that have been incubated and promoted by the Gates Foundation without any involvement by civil society and developing country governments. The capacity reservation for monoclonal antibodies previously described is one such Gates project.

Should governments cede management of a crisis to an unelected and unaccountable foundation? 

Even if we hypothetically agreed with some of the steps the Gates Foundation is taking, we question the self-appointed role that the Gates Foundation has assumed during the pandemic response. Many of the decisions the Gates Foundation, and the health agencies it works with, exclude the LMICs that are being left behind in the pandemic. These are the governments where people have received 4% of the diagnostic tests made available to people in rich countries. These are the governments that have not received allotments of Gilead’s remdesivir, a warning of what will happen when effective medicines and vaccines are eventually approved (recent clinical trial data indicates remdesivir may not provide a therapeutic benefit). These are the governments that have not been able to reserve vaccines, where instead over 50% of COVID-19 vaccine supplies have been hoarded by rich country governments with just 13% of the global population. Shouldn’t LMICs have a greater say in creating the architecture of the global response and in pounding out the policies needed to tackle this viral plague?

The Gates Foundation’s role, and the lack of leadership of governments, will have repercussions beyond the pandemic. We worry that donor governments, mostly unaffected by the practices of the Gates Foundation, are willing to let the Gates Foundation put its money into global health and other development priorities, thereby decreasing the moral and financial accountability of donor governments. It may also be that the sheer size of the Gates Foundation, its accumulation of information and ‘expertise’, as well as its investments in global health agencies, civil society, the media and companies, means that governments may no longer feel that they can challenge the Gates Foundation’s influence.

Developing countries see the Foundation as an integral part of the global health decision making architecture for these same reasons or may themselves not wish to challenge the overriding influence of the Gates Foundation. The result is a vicious circle of reduced government engagement and investment in global health, contributing and leading to even more Foundation intervention and influence, which leads to even less government influence and engagement.

Conclusion – Can We Avoid the Mistakes of the Past?

The COVID-19 pandemic is decimating health systems, economies, and communities around the world. Like the AIDS epidemic, COVID-19 is marked by injustice in the pharmaceutical system. Wealthy countries and philanthropies are paying for research and development and leveraging their investments to cut in line and hoard new vaccines, drugs and tests. In exchange, these same countries are allowing pharmaceutical corporations to control the supply and price through IP monopolies on technology. These policies are undermining any possibility of expanding manufacturing and supply of low-cost medicines, vaccines and tests that could save lives and livelihoods.

It is a moment made for a wider global movement to stop the pandemic in its tracks, to share medicines, tests, vaccines and other medical technologies fairly around the world. It is a moment to imagine and build a new pharmaceutical system that relies less on IP, monopolies and secrecy, and more on approaches to medical R&D that is driven by public health, openness, collaboration and sharing.

At the pinnacle of desperation in 2000, when medicines to treat HIV were unaffordable and pharmaceutical corporations were blocking access, a movement emerged – of people with HIV and AIDS, government officials and politicians in developing countries, treatment advocates, students, non-governmental organizations, health care workers, lawyers, and academics, to overcome the constraints of an IP-based pharmaceutical system that would leave millions of people without medicines.

Thanks to the efforts of this movement, public pressure encouraged developing countries to use legal measures to foster generic competition for antiretroviral medicines and forced pharmaceutical corporations to stop interfering with the efforts of developing countries to save lives. Today, over 90 percent of all medicines used in HIV treatment programs to treat an estimated 25 million people are low-cost generic medicines, including those supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria and the President’s Emergency Plan for AIDS Relief (PEPFAR). Without generic competition, low-cost medicines, and increased funding, the global AIDS response would not have been possible.

The Gates Foundation, and its founders, are the most powerful force in global health today. As a philanthropy, the Gates Foundation may believe that the most we can expect of those with wealth and power is to do things that make sense for them, and not what they must do to best advance global health justice. But to have so much influence and authority means that the Gates Foundation cannot be secretive, cannot prefer monopolies over competition, and cannot applaud pharmaceutical corporations instead of holding such corporations accountable. When the Gates Foundation behaves this way, it excuses all other parties, whether corporations or governments, to fall back on their worst impulses and practices, while trapping everyone within a pharmaceutical system that works best for pharmaceutical corporations and the world’s most powerful countries.

The world cannot rely uncritically on the voice and ideas of billionaires, who made their own fortunes through intellectual property rights, to pull us out of this pandemic. We learnt from the HIV/AIDS epidemic twenty years ago and until today, that only by people around the world holding their governments to account, demanding transparency, and ensuring that corporations are not allowed to put profits ahead of people, will we succeed during these extraordinary times.

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Rohit Malpani is a public health consultant and advocate, and also represents non-governmental organisations on the Board of Unitaid.

 

Brook K. Baker is a professor at Northeastern University School of Law, USA; an honorary research fellow at the University of KwaZulu Natal; and a senior policy analyst with Health GAP (Global Access Project).

Mohga Kamal-Yanni MPhil MBE is a consultant in global health and access to medicines.

 

 

 

 

The views expressed here are solely those of the authors and not of the institutions with which they may be affiliated. 

 

Image Credits: Mohga Kamal-Yanni, Médecins Sans Frontières.