Overcoming the Global Vaccine and Therapeutics Lag and ‘Vaccine Apartheid’: Abuse of Rights in the EU’s Continued Blocking of the TRIPS Waiver for COVID Vaccines and Related Medicines

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Entering the third year of this global pandemic, the United States posted a grim global record of 1 million COVID cases on 3 January 2022.  This record, of course, exists in a shadow of relative non-transparency about COVID incidences, fatalities, and hospitalizations in many parts of the world, arising either from authoritarian regimes refusing to provide open access to population and community health data (with a latest scientific study indicating outright data manipulation in authoritarian regimes to yield low numbers), or sheer resource challenges and health system incapacities on the part of many developing countries that make it nearly impossible to accurately track and report this data.  Official COVID death tolls are routinely undercounted in many developed and developing parts of the world.  The World Health Organization declared that the real COVID death toll is two or three times what the official statistics say.  While initial tracking of COVID vaccine supplies (see December 2021 data tracker by the International Monetary Fund and the World Health Organization) appeared promising, the rapid transmission of covid variants such as delta and omicron, and the rise of breakthrough infections around the world, make this an even tighter and more difficult race for States to effectively respond to this global health emergency. 

As of 4 January 2022, the global vaccine and therapeutics lag is still vast, with only 60% of the world population having received one dose of a COVID vaccine, and most of the developing world in Africa, Asia (South and Southeast Asia), Latin America, and Oceania being the least vaccinated.  And this lag has been estimated without even differentiating between COVID vaccines that have been more effective with or without a booster (either against the original COVID strain or its subsequent variants), as opposed to those that have been found outright ineffective.  Most of the developing world have had the least access to the most effective COVID vaccines.  We now know that the global vaccine lag comes at a steep cyclical price for everyone in the developed and developing world, by enabling the unchecked emergence of more COVID variants and endless cycles of continuing strains, pressures, and paralysis of health care systems all over the world with more COVID cases, hospitalizations, and (even in the case of Omicron) deaths.  The question relevant to all international lawyers is: what in our international legal arrangements prevents or delays overcoming the global vaccine and therapeutics lag that perpetuates this endless cycle for the whole world?

My own view is that entering the third year of this global public emergency – now knowing that there is no realistic terminus or “end in sight” due to the unrestrained emergence of variants all over the world – puts even greater urgency to achieve more rapid global vaccine and therapeutics access, and widen related testing and other needed health procedures.  Pharmaceutical companies have had two years to ‘vaccinate the world’, but for many market-driven, government-driven, and culturally-driven reasons, the global vaccine and therapeutics lag remains practically an unbridgeable gulf, especially with boosters now needed to protect against variants and yet so much of the developing world has barely received a first dose. Even the United States, home to the major effective COVID vaccines with arguably some of the best medical expertise, has still seen the worst effects of the global vaccine and therapeutics lag.  Elsewhere, Zero COVID strategies – including COVID camps, mass arrests, and extrajudicial killings – provide pretexts to normalize and make permanent the systemic suppression of individual and collective human rights. However, zero COVID strategies are also ultimately ineffective against the unexpected onslaught of COVID variants. 

While a TRIPS waiver is not the magic wand to solve this pandemic (especially since individual WTO Members would have to legislate domestically to implement the waiver), it should not be a closed option as more time is spent now confronting the global vaccine and therapeutics lag that keeps plunging us all in this repeating cycle of health and human rights emergencies.  If we have to live in a COVID-ridden world for the next few years, it should not be because we did not exhaust all our options to overcome this man-made global vaccine and therapeutics lag, or that some states, such as those in the EU, chose to keep blocking the proposed TRIPS waiver for vaccines and related medicines.  In this post, I provide reasons under international law why the EU should rethink its opposition to the TRIPS waiver.

The EU Counter-Proposal to a TRIPS Waiver

Knowing that we live in a climate of obvious inequalities in health capacities and responses, amid continued non-transparency of COVID data, makes it even more baffling to contemplate the European Union’s continuing position to block South Africa and India’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) waiver proposal (and its revised version here supported by many countries in Africa, Asia, Latin America, Oceania). The United States has itself strongly supported negotiations on a waiver since May 2021. The EU Parliament has itself declared support for temporary COVID vaccine patent waivers, but this has not yet swayed the EU’s foremost decision-makers.

The EU’s Counter-Proposal to the TRIPS Waiver relies on three items: 1) getting voluntary pledges from vaccine producers and developers; 2) using the TRIPS Agreement provisions on compulsory licensing; and 3) trade facilitation and removing export restrictions.  The EU calls its counter-proposal a “strong multilateral trade response.” The World Health Organization, as well as international civil society organizations, have called it vaccine apartheid

The EU Counter-Proposal, on its face, sidesteps the complex web of intellectual property (IP) rights that affect COVID-19 mrNA vaccines, which do not just involve patents but other forms of IP (e.g. copyrights, industrial designs, undisclosed information) that are not covered under the provided flexibilities for compulsory licensing in Article 31 of TRIPS. It does not provide any discussion or evidence as to the actual feasibility of pharmaceutical companies voluntarily agreeing, en masse, to make voluntary pledges not to enforce their intellectual property rights at this point in time, especially when they monopolistically dominate the global markets, and are not compelled to make public their own internal information and data on estimated vaccine stocks and supplies vis-a-vis global market demand. (None of the purchasing or licensing agreements with these companies have ever been made public, to begin with.) Thus, even if scholars have written strongly about the ethics and reasonableness of the Open COVID Pledge, we are entering the third year of this pandemic and no vaccine developer or producer has yet made any actual patent or other IP non-enforcement pledge. (Instead, 9 pharmaceutical companies simply made a voluntary pledge “to uphold the integrity of the scientific process as they work towards potential regulatory filings and approvals of the first COVID-19 vaccines.”). The United Nations-backed Medicines Patent Pool does not include any COVID vaccines patents and related intellectual property. 

The EU Counter-Proposal further relies on a fiction that the developing world is allegedly incapable of aiding in the mass production of vaccines and related COVID therapeutics, contrary to findings that over 100 pharmaceutical manufacturers in Asia, Africa, and Latin America already met technical requirements and quality standards to do so.  As former President of Ireland and UN High Commissioner for Human Rights Mary Robinson herself pointed out: “The European Union represents the biggest roadblock to this effective solution to ramp up the supply of lifesaving vaccines, treatments and tests, hasten the end of the pandemic and put solidarity at the heart of the world’s response. By temporarily removing legal barriers preventing developing countries from producing billions of vaccines and treatments through qualified manufacturers, the waiver would suspend the monopoly control of pharmaceutical corporations, which guarantees them eye-watering profits while sacrificing lives. It would unlock the strong manufacturing capability and capacity that exists worldwide to upscale vaccine production, which is still being underutilized.”

There remain strident voices opposed to any TRIPS waiver, pointing to the need for innovation rewards that led to vaccine development in the first place, and reiterating trust in the multilateral system to produce the desired multilateral cooperation to overcome the global vaccine lag.  While I well understand the concerns raised by those who defend innovation and its rewards as traditionally safeguarded by the intellectual property rights system and the international economic system as a whole, this is misplaced and myopic faith in the multilateral trading system to organically produce the desired global cooperation and coordination to overcome the global vaccine and therapeutics lag. The catastrophic failure of the Doha Development Round after 14 years of negotiations should be sufficient evidence enough that the multilateral system is mired in inertia and impasse.  Expecting altruistic behavior from the global trading system’s members, at this point of severe precarity and polarized interests, is plainly unrealistic, and keenly ignores the lived realities of millions today who bear the brunt of risks, hardships, and normalizing oppressive measures to their health, living conditions, jobs, education, freedom of expression, freedom against arbitrary detention, and all other human rights.  Moreover, as many have argued, the massive taxpayer funding that financed vaccine and therapeutic development creates a “global public goods” dimension to the access and distribution of vaccines and therapeutics.

While a State’s vote in any international organization, in and of itself, is a sovereign decision arguably well within matters essentially within its domestic jurisdiction under Article 2(7) of the Charter of the United Nations, I do not share the view that this sovereign decision is immune from any international legal consequences. There are specific legal grounds under international economic law, international human rights law, and general international law that are implicated in the EU’s continued blocking of the TRIPS waiver for COVID vaccines and medicines.  At the very least, there is plausible basis to observe that an abuse of rights is taking place with the EU’s continued blocking of the TRIPS waiver at the WTO, one that can be argued to cause serious transboundary and intergenerational health and welfare consequences, especially to the developing world suffering the burdens of the protracted global vaccine and therapeutics lag.

Abuse of Rights in Context: TRIPS, Human Rights Law, and Related International Legal Obligations

Ironically, it is the WTO Appellate Body itself that articulated the clearest definition of abuse of rights by Members at the WTO, in interpreting the chapeau of Article XX of the General Agreement on Tariffs and Trade (GATT):

“…[the principle of good faith], at once a general principle of law and a general principle of international law, controls the exercise of rights by states.  One application of this general principle, the application widely known as the doctrine of abus de droit, prohibits the abusive exercise of a state’s rights and enjoins that whenever the assertion of a right ‘impinges on the field covered by [a] treaty obligation, it must be exercised bona fide, that is to say, reasonably.’ An abusive exercise by a member of its own treaty right results in a breach of the treaty rights of the other members and, as well, a violation of the treaty obligation of the Member so acting.” (United States – Import Prohibition of Certain Shrimp and Shrimp Products, AB 1998-4, WT/DS58/AB/R, 12 October 1998, at para. 158)

Article 7 of the TRIPS Agreement notably provides for how WTO Members are expected to protect and enforce intellectual property rights, as the key objective of this treaty:

“The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.” (Emphasis added.)

This provision was specifically interpreted by the Panel in United States – Section 211 Appropriations Act, in relation to the doctrine of abuse of rights:

“Article 7 of the TRIPS Agreement states that one of the objectives is that ‘[t]he protection and enforcement of intellectual property rights should contribute … to a balance of rights and obligations.’ We consider this expression to be a form of the good faith principle. The Appellate Body in United States—Shrimp stated that this principle ‘controls the exercise of rights by states. One application of this principle, the application widely known as the doctrine of abus de droit, prohibits the abusive exercise of a state’s rights and enjoins that whenever the assertion of a right ‘impinges on the field covered by [a] treaty obligation, it must be exercised bona fide, that is to say reasonably.’ An abusive exercise by a Member of its own treaty right thus results in a breach of the treaty rights of the other members and, as well, a violation of the treaty obligation of the Member so acting.’ Members must therefore implement the provisions of the TRIPS Agreement in a manner consistent with the good faith principle enshrined in Article 7 of the TRIPS Agreement.” (Emphasis added.)

Thus, from the standpoint of TRIPS and WTO law, one can reasonably argue that the EU’s blocking of the TRIPS waiver, as an assertion of its voting and decision-making rights under Article IX:1 of the WTO Marrakesh Agreement in relation to the protection and enforcement of intellectual property rights in the TRIPS Agreement, should be done: 1) in good faith, consistent with the multiple objectives of the TRIPS Agreement to ensure that the promotion of technological innovation, technology transfer and dissemination; 2) is not only for the sole advantage of the vaccine developers or producers but also for its users; and 3) would be done in a manner that is indeed conducive to social and economic welfare.  

It is difficult to see how – especially at this point of the nonstop cyclical emergence of COVID variants amid (or because of) the protracted global vaccine and therapeutics lag – the EU’s continuing reliance on hard IP rights protection and enforcement in its Counter-Proposal, and its automatic blocking of proposals for the TRIPS waiver, would be in any way conducive to social and economic welfare, and the required mutuality of advantage for both the producers and users of vaccine and therapeutic technologies.  How is it asserting one’s rights in good faith to have us all enter into the third year of this global pandemic and force all populations in the world to just rely on the vagaries and vicissitudes of the market, the voluntary goodwill of pharmaceutical companies, and the narrow benefits of compulsory licensing (with its counterpart regulatory burdens on a product to product, market to market basis) to somehow get us to ‘equitable’ access to COVID vaccines and related therapeutics? The implementation of the TRIPS Agreement is supposed to be balanced with social and economic welfare objectives.  Persisting in blocking the proposed TRIPS waiver at this point in time, under the hardships borne by millions upon millions in the developing world, arguably amounts to the EU’s abuse of its rights at the WTO. Indeed, the Committee on Economic, Social and Cultural Rights emphasized in their April 2021 Statement that “States parties [to the ICESCR] have a duty to prevent intellectual property and patent legal regimes from undermining the enjoyment of economic, social and cultural rights.” (at para. 7)

Most importantly, the EU’s intransigence against proposed TRIPS waivers completely undermines its own proudly stated values in Article 2 of the Treaty of the European Union: 

“The Union is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities. These values are common to the Member States in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail.”

There is no respect for human dignity or human rights, let alone any sense of prevailing solidarity, justice, or equality, when the EU enables, condones, or contributes to the protracted infliction of health and human rights emergencies in most of the developing world as a result of the nonstop cycle of COVID and its variants, and the persistent global vaccine and therapeutics gap that burdens the developing world.  Many Member States of the EU are party to all, if not the majority of, international human rights treaties whose violations are being routinely normalized through pretext of health responses and law enforcement.  Member States of the EU bear the same obligations to respect, protect, facilitate/fulfil, economic, social, and cultural rights as well as civil and political rights, as well as the obligation to ensure remedy against violations of such rights.  Halting EU opposition to the TRIPS waiver is a key first step to protecting millions whose economic, social, cultural, civil, and political rights are violated daily in the name of alleged government responses to COVID. 

Avoiding the obstruction of the TRIPS waiver would be a strong example of the needed steps of international assistance and cooperation under Article 2(1) of the International Covenant on Economic, Social and Cultural Rights (ICESCR), as well as the required steps to achieve full realization of the right to the highest attainable standard of physical and mental health, including those necessary for the prevention, treatment and control of epidemic, endemic, occupational and other diseases under Article 12(2)(c) of the ICESCR.  Withdrawing the EU’s opposition to the proposed TRIPS waiver is also a remarkable demonstration of joint and separate action as contemplated in Articles 56 in relation to 55 of the Charter of the United Nations, intended to achieve the purposes of “higher standards of living, full employment, and conditions of economic and social progress and development; solutions of international economic, social, health, and related problems; and international cultural and educational cooperation; and universal respect for, and observance of, human rights and fundamental freedoms for all without distinction as to race, sex, language, or religion.”

Conclusion 

The EU reckons with its own predicament this 2022, facing down the assault of COVID and its variants, coupled with ongoing border security and migration emergencies. It is the start of the third year of this pandemic, and there is no end in sight in the cycle of COVID variants emerging, evolving, and spreading from and among the unvaccinated to rising breakthrough infections for the vaccinated. It is a pivotal time for the EU to stand by its commitments as well as its values, and avoid further abusing its rights under the TRIPS Agreement and the privileges it wields under the WTO consensus decision-making procedures.   Withdrawing EU opposition to the TRIPS waiver defends the EU’s integrity, and reinforces the legitimacy and legality of its own actions and policies that seek to vindicate human rights well beyond its own borders, such as in its business and human rights policies, climate ambitions and legal commitments, or the imposition of its global human rights sanctions regime on individuals, companies, or other States. In all these, including its own opposition to the proposed TRIPS waiver on COVID vaccines and therapeutics and toleration for ‘vaccine apartheid’, the EU is called upon to exert the same zeal and urgency in defending the human rights that the EU strenuously proclaims to the rest of the world. 

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Jakob Cornides says

January 15, 2022

Never let a crisis go waste. The Covid-Crisis is currently used by politicians to push their agendas, including by the Governments of India and South Africa in their perennial effort to undermine not only pharma patents, but intellectual property in general.

It is highly unlikely, and the present article makes no convincing argument to that effect, that the efforts of developing countries to overcome the COVID pandemic are significantly hampered by unaffordably high prices for vaccines. On the contrary, several critical observations impose themselves:

- if generally no patent rights existed, there would be considerably less motivation for pharma companies to invest huge sums in R&D of new drugs. That would not necessarily mean that there would be no more progress, but that progress would be slower, more incremental. Certainly it would not have been possible to develop, as was the case, new (and allegedly, highly efficient) vaccines within 1-2 years of the outbreak of the pandemic.

- second, if the prices for these new vaccines really were the problem, then the solution would not be the abolition of patents, but a tiered pricing policy, in which laboratories sell the vaccinations at a lower price, or even donate them for free, to poor countries. Many companies actually apply such policies, once the production can be scaled up. (In pharmaceutics, it is usually the development of a drug or vaccine that entails enormous costs, but once the product is there, producing - and selling - more of the same is not a big problem.) It is thus always the wealthy countries, not the poor ones, where the cost for R&D will be recouped.

- third, the real problem is not the cost of the vaccines, but the building of a reliable distribution network that brings them to every last person in every last village. This can already be a problem in developed countries (given that responsible use of vaccination would require a careful assessment of the specific needs and risks and needs of each single patient, rather than just injecting the stuff into every arm...), but it surely is an even bigger infrastructural problem in developing countries. One fails to see how a waiver of patent rights would address this.

- also, many developing countries lack the production facilities for drugs or vaccines. A TRIPS waiver is unlikely to change that, bot would only benefit some generic producers in India or Brazil. Why should the original inventors of the vaccines not be allowed to make that business themselves?

- finally, new variants of the virus will require new (or adapted) vaccines. If there are no patents, who will develop them?

Less moralizing overtones and a stronger connection to the real world would have done good to this blog post.