Access and Benefit, Quid Pro Quo

In the talks, there are many lines of disagreement between developed and developing nations, but the main point of contention lies with the quid pro quo at the heart of the negotiating text — the proposed access-and-benefit mechanism, formally titled the WHO Pathogen Access and Benefit-Sharing System (WHO PABS System).

Better monitoring of spillover from animal reservoirs of novel pathogens is essential to pandemic prevention. This requires increased laboratory and surveillance capacity, including innovative tools for data collection and predictive analytics in all countries, but especially in developing nations where such capacity is severely limited — and where there is the highest risk of zoonotic spillovers.

For monitoring to work at a global level, it has to be adequately funded and, crucially, coupled with sharing of data that is produced via the monitoring, as well as collaboration among research centers worldwide. Knowledge sharing is essential for rapid genetic sequencing of pathogens and then, for pharmaceutical firms, production of vaccines and therapeutics.

Such knowledge sharing does come with risks, however: potential closure of travel to and from countries that have identified and shared information about domestic outbreaks, along with constraints on or even the collapse of trade. Such economic threats are most grave for those least able to suffer such interruptions: the least developed countries.

And so, in return for Global South knowledge sharing, the Global North is supposed to commit to help finance monitoring in these poorer regions, and to provide universal access to the medical fruits of such monitoring: vaccines and therapeutics.

During the COVID-19 pandemic, global supply chains, including of precursors to vaccine and therapeutics production, were stretched to breaking. Until governments in key countries, particularly the United States with the liberal application of the Korean War–era Defense Production Act, took many distribution decisions out of the hands of the private sector, essential materials were sent to the highest bidder, not the location most in need. Even within wealthier nations, locations less able to outbid competitors regularly experienced inadequate delivery of personal protective equipment (PPE), ventilators, medical refrigerators, and other key supplies. It was a deadly example of the “alignment problem” of markets: what is profitable is not always what is beneficial.

Next time, ample stockpiling, global coordination of distribution, and the ability to rapidly deploy skilled medical teams where appropriate should all be core to the treaty. But for it to work in service of everyone’s interest, all this activity has to be carried out based on need rather than profit, and also given substantial, ongoing, guaranteed funding.

The WHO cannot be going cap in hand every year to its funders. This is not just a problem of capacity. Underfunding also undermines monitoring: a cash-strapped WHO is less able to critique a funder such as China, the United States, or the European Union when they are not pulling their weight, failing to share data or issue alerts, or engaging in risky, bioinsecure activities. The same conflict of interest undermines distribution and other response activities. The WHO can’t bite the hand that feeds it.

Alongside the treaty process, and in recognition of lack of pandemic capacity particularly in the Global South, the G20 in 2022 launched the Pandemic Fund under the aegis of the World Bank, with technical staff seconded from the WHO. Last year, the fund awarded its first round of grants, totaling $338 million, a piddling sum. The fund itself says that “substantially more” is required. Billionaire Bill Gates, who has made pandemic prevention one of his key areas of focus of his philanthropy, last year said what he terms a “Global Epidemic Response Mobilization” team, managed by the WHO, would cost the world $1 billion per year — although he is also opposed to raising taxes on the wealthy and corporations, which is necessary for governments to source such funds.

If developed nations are willing to sign off on the access-and-benefit concept, the system would be modeled on the WHO’s preparedness framework for influenza but would apply to all viruses and bacteria with pandemic potential. Under the influenza preparedness framework, all countries share samples of flu viruses. The samples are then used by pharmaceutical firms to manufacture vaccines. In return for the data sharing, the firms pay into a central fund that is used for the monitoring and other prevention, preparedness, and response activities, including the development of medical countermeasures such as vaccines.

Concretely, in the negotiating text, in the event of another pandemic, the PABS System would see 20 percent of the production of medical countermeasures donated to the WHO to be distributed on the basis of need. Civil society development and public health organizations have, understandably, criticized this as woefully insufficient. A fifth of resources distributed on the basis of need is four-fifths too few.

Moreover, when COVID-19 hit, developing countries freely shared sampling data on the expectation of receiving the benefits of such sharing under existing frameworks, but never did.

But for pharmaceutical companies, even 20 percent is too much. In response to the release of the negotiating text last October, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) denounced it. In addition to the proposed PABS system, IFPMA opposes the inclusion of temporary intellectual property waivers, which would allow developing nations to manufacture vaccines and therapeutics in order to overcome the hoarding and “vaccine apartheid” experienced during COVID-19.

In response to the initial negotiating text, the IFPMA argued that if it were adopted as is, it would have a “chilling effect on the innovation pipeline for medical countermeasures,” thus leaving us worse off than we are currently, and so “the world would be better served with no agreement.”

The United States, the UK, the EU, Canada, and Switzerland — home to many of the largest pharmaceutical firms — have backed the IFPMA position and oppose the access-and-benefit mechanism. Germany’s Social Democratic Party (SPD)–led coalition government, in particular, is in Big Pharma’s corner.

“For countries like Germany and most European countries, it is clear that such an agreement will not fly if there is a major limitation on intellectual property rights,” Germany’s SPD health minister, Karl Lauterbach — himself a physician and epidemiologist — told the World Health Summit last October.

But most of the medical countermeasures, particularly the vaccines, were primarily the product of research performed in publicly funded university laboratories, and the story of their rapid rollout is for the most part one of the governments derisking private-sector manufacturing via billions in direct subsidies and advance-purchase agreements. It was socialism of a sort — certainly economic planning rather than markets — that delivered the vaccine.

This was necessary because until the pandemic, for about four decades, Big Pharma had largely gotten out of the business of vaccine research, development, and production for the same reasons they got out of developing new classes of antibiotics (and still are out of the game): it’s insufficiently profitable. You might think that delivering billions of shots during a pandemic is mighty profitable, and you wouldn’t be wrong. But in the early days of the COVID-19 pandemic, it was not clear whether this was indeed the big one, or whether it would just fizzle out like SARS or MERS had. If the firms invested in production only for SARS-CoV2 to turn out like these earlier scares, they would lose billions. The state had to step in to derisk vaccine production via subsidies and advance-purchase agreements.

Another of the thorniest issues within the treaty negotiating text is a proposed requirement that any firms that received public financing for their work would have to waive or reduce their royalties.

Pushing back against the stance of the IFPMA and these Global North governments, the People’s Vaccine Alliance, a coalition of over one hundred development and health NGOs, trade unions, and human rights campaign groups, notes that during the COVID-19 pandemic, the twenty biggest pharmaceutical giants spent almost as much on payouts to shareholders and executives as they did on research and development. Between 2020 and 2022, these firms spent $377.6 billion on such largesse and $414.6 billion on R&D. The People’s Vaccine Alliance argues that this is proof that IP waivers and the access-and-benefit mechanism would not dent these businesses or harm innovation.

A clear case of corporate greed and Big Pharma’s capture of the diplomatic force of Western governments, it would appear.

Threatening Pharma’s Business Model

In fact, the question of intellectual property shows how a critique of corporate greed is insufficient. We need to consider the limitations of market incentives more broadly, and the challenges of global enforcement and the democratic governance of that enforcement. When we do, we can explain how the Biden administration and Trudeau government, for example, can simultaneously be fighting pharmaceutical companies over lower drug prices domestically and taking these same firms’ side overseas.

The People’s Vaccine Alliance is not wrong that pharmaceutical firms would indeed be able to easily swallow the loss of profits from temporary IP waivers and the fees paid into an access-and-benefits fund without any threat to the viability of their businesses or even to sufficient funds for innovation. It’s not the hit of slightly lower profits that motivates either the firms or the governments backing their position.

The crux is instead the threat to pharmaceutical intellectual property, and indeed to IP across all sectors.

Lower domestic drug prices only mean slightly lower profits, while IP waivers, even temporary ones, threaten the very business model of pharmaceutical firms. If the precedent is set that human lives trump intellectual property rights in an emergency, why do human lives not trump IP rights at other times?

And yet, while a great deal of medical innovation does occur at publicly funded universities, in government labs, or via nonprofit medical charities, the private sector does engage in innovative work as well. These firms and their diplomatic avatars are not lying when they say that they need to be compensated for this work.

So the problem posed is not merely one of corporate greed but that the market incentives are not aligned with what is in the best interest of society. It’s identical to the famous “artificial intelligence alignment problem.”

This alignment problem also exists across the private provision of healthcare more broadly: liberalism’s recognition of a right to life and its recognition of a right to private property are in conflict. The Gordian Knot is cut in most developed countries by variations on the theme of public health insurance or, as in the UK, direct public ownership of healthcare provision. Although Britain’s National Health Service has been eroded over the decades by wave after wave of “internal market” wheezes, corporate outsourcing, and partial privatization, it remains the case that the principle of a nationalized healthcare system resolves the conflict between need and profit incentive: the provider is compensated for their work not by profits but instead via taxation, or other forms of cooperative pooling of resources.

The resolution of the irreconcilable conflict between the right to protection from pandemics and pharmaceutical intellectual property rights is for there to be similar public provision of pharmaceutical research, development, production, and distribution. Allocation of resources would be based on medical need rather than on profit. Nationalization of the pharmaceutical sector, or, at a minimum, a significant public option: publicly owned pharmaceutical firms alongside the continued existence of private ones.

But here we run into the wall of global governance, financing, enforcement, and, in turn, democratic accountability. Which country is to perform the nationalization, or set up of public-option pharma firms? Are America and Switzerland to nationalize their pharmaceutical sectors on behalf of the world?

This also goes for other aspects of pandemic countermeasures beyond therapeutics, from production of medical refrigerators to ventilators and oxygen tanks. And how do those in other nations on the receiving end of these public pharma firms hold their governors to account? There is only a domestic, not international, mechanism of democratic accountability.

Another Toothless Treaty

This challenge of global governance, enforcement, and accountability is the second major sticking point of the pandemic treaty negotiations, even in the absence of any grand vision of a global publicly owned pharmaceutical service. Lack of enforcement capability also affects coordination of pandemic countermeasure stockpiles, the deployment of international medical response teams, monitoring, and data sharing.

Even if the Global North were to agree on all points regarding intellectual property and all the rest, without robust enforcement, this becomes just deckchair rearrangement on an infectious Titanic.

The existing International Health Regulations — which date back to 1969 and were last revised in 2005 — are already legally binding. Yet this did nothing to prevent hoarding of vaccines and other pandemic countermeasures during COVID-19. The regulations also stipulate that in return for sharing genetic information, countries are not to be slapped with travel or trade restrictions, yet this legal requirement was one of the first of many to be ignored in 2020.

At a time when Israel continues to ignore the orders of the International Court of Justice — killing 1864 Palestinians since its ruling against Benjamin Netanyahu’s war machine, according to Euro-Med Human Rights Monitor — it should be clear more than ever how the text of a document is meaningless in the absence of a sovereign entity capable of its enforcement.

Proposals for a decision-making body comprising a conference of the parties (“COP”) to the treaty, with a secretariat (a team of civil servants tasked with carrying out the decisions of the conference) under the aegis of the World Health Organization have been included in the negotiating text, although it is far from clear that negotiators will agree to this. The structure is modeled on the UN Framework Convention on Climate Change (UNFCCC) summits, also formally termed COPs, in which all nations receive an equal vote.

After decades of slow-moving UN climate summits dependent on consensus among almost two hundred countries, the challenge such a model poses to rapid pandemic response should immediately be obvious.

Even more importantly, the UNFCCC/COP process is not democratic. Luxembourg, with its population of 650,000, and India, with 1.4 billion, both have the same voice. There is no majority rule. No parties with different ideas about how to respond to climate change compete for voters at any stage. So if a majority in the world disagrees with a policy or action of the pandemic treaty secretariat or COP or WHO, there is no mechanism for that majority to depose them and install others who would carry out their will.

And is there any expectation that the requests of a pandemic treaty secretariat made to a particular government would be respected any more than the much more freighted orders of an International Court of Justice?

Lack of democracy is the flip side of the enforcement coin. Enforcement, of course, is illegitimate without democratic accountability. As farmer protests break out against climate policies in country after country in the European Union, the rallying cry is that no one ever voted for this. Regardless of where one falls on the correctness of EU climate and agriculture rules, the farmers are not wrong about the EU’s democratic deficit.

Over and over again, in recognition of the need for policy to cross borders in a number of areas, from climate to trade to war crimes, elites have opted for undemocratic intergovernmentalism — treaty making — that they see as more politically feasible than proposing the construction of a higher level of democratic assembly. And this is being repeated now for the most urgent policy area there can be, pandemics — already far more deadly than climate change.

The head of the WHO, Tedros Adhanom Ghebreyesus, has complained that movement in the pandemic treaty talks has been further slowed down by what he called “a torrent of fake news, lies, and conspiracy theories.” He was almost certainly referring to the right-wing Heritage Foundation’s declaration that the pandemic treaty threatens US sovereignty, or one of the few news articles on the negotiations to make headlines in a major newspaper, a May 2023 report by Britain’s Daily Telegraph quoting Conservative UK ministers worried that the proposed treaty would allow the WHO to impose lockdowns and vaccine passports, or force the country to spend 5 percent of its health budget on pandemic preparedness.

Tory MP Danny Kruger told the paper: “Coordination and cooperation in a public health emergency is sensible but ceding control over health budgets and critical decision-making in a pandemic to an unelected international organisation seems profoundly at odds with national autonomy and democratic accountability.”

As with the EU farmer protests, the Tory’s critique here — and even that of the Heritage Foundation — is not entirely wrong. The WHO or a pandemic treaty secretariat would indeed be unelected. It is not right that such a body could impose its will over elected national parliaments.

This is a sovereignty paradox that the organs of intergovernmental treaties across so many policy areas face — from the WHO and the World Trade Organization, through the European Commission and the International Monetary Fund, to the International Court of Justice and the UNFCCC. As a result of the manifest democratic deficits of the organs of intergovernmental treaties, there is a reluctance to cede too many powers to them. At the same time, with some modest amount of power, these organs can be quite useful to those same politicians who might want to impose a policy but know that it does not enjoy domestic majority support. If there is consensus for the politician’s preferred policy at the international forum, they can then return to their electorate and say that there was nothing they could do; their hands were tied.

This intergovernmentalist halfway house leaves such bodies both with too much sovereignty and not enough: any decision-making power they have, no matter how limited, is democratically illegitimate, but they also need much greater power to make policy effective.

So let us make global decision-making democratic. Let us establish a global popular sovereign.

To be sure, this is a mammoth ask and extremely unlikely any time in the near future. For now, the priority has to be pushing Western governments to back a treaty text that rejects inegalitarian and irrational market imperatives, even if there is no global democratic sovereign yet capable of enforcing it.

But all around us, we are confronted with so many cross-border phenomena that have to be tackled at the global level — from pandemics and climate change, through trade and migration, to human rights and war crimes. And the number of such issues is only growing. Governance of near-Earth asteroids, orbital debris, seabed mining, geoengineering, and artificial intelligence are just the latest to have emerged. There will be many more.

We are living in the decades where the conversation about planetary governance, about global democracy, must at least begin.