Abstract
In 2020, India and South Africa proposed a waiver (TRIPS Waiver) to temporarily suspend the protection of COVID-19 related intellectual property rights of countries belonging to the World Trade Organization (WTO). Disagreements between developing and developed countries over how to proceed stalled the adoption of the TRIPS Waiver until 2022. This was not the first time such a disagreement between the protection of intellectual property rights and the protection of public health arose within the WTO. To fully understand the underlying rationales for the TRIPS Waiver requires looking back twenty years ago at the passage of the Doha Declaration. The Doha Declaration, passed in 2001 by the WTO Ministerial Conference in an attempt to resolve the same disagreement, serves as a testament to developing countries’ long-time struggle to pursue equitable access to medicine. Sadly, as demonstrated in the disparity of vaccines between higher-income and lower-income countries, it is blatantly evident that the Doha Declaration has failed its original purpose. Reflecting on the Doha Declaration, this Essay explores arguments both in favor and against the adoption of the TRIPS Waiver. In light of the TRIPS Waiver’s formal adoption, this Essay also argues that the adoption of the TRIPS Waiver alone is not enough to solve the vaccine inequity, and that more progressive measures will be needed. Finally, this Essay calls for the fundamental reconsideration of the protection of intellectual property rights under the TRIPS Agreement and its implication for access to medicine.
Introduction
As of September 30, 2022, COVID-19 has infected more than 616 million people and has claimed over 6.5 million lives globally.[1] While the virus continues to spread, many countries have found themselves faced with a shortage of COVID-19 medications and vaccines. This shortage is in part due to intellectual property (IP) rights and protections over the vaccines and medications themselves. This is exemplified by the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)[2] which sets the minimum standards for all WTO members to protect IP rights within their jurisdictions.[3] To alleviate the shortage of vaccines in the face of the unrelenting spread and impact of COVID, in 2020 India and South Africa proposed that the WTO adopt a waiver (TRIPS Waiver)[4] to temporarily suspend the IP protections related to the COVID-19 virus to make production and distribution more accessible.[5] The proposal ignited global debate over whether doing so would help alleviate the shortages. While the TRIPS Waiver was officially adopted in June of 2022, the debate over its effectiveness and future continues.
The TRIPS Waiver debate is not the first time WTO members have disagreed over the merit of loosening the protection of IP rights amid a public health crisis. The Doha Declaration, passed in 2001 by the WTO Ministerial Conference, is an important precursor to understanding the evolution and continued conflict over this issue. It emerged during the HIV/AIDS crisis as an attempt to help developing countries pursue equitable access to medicine through compulsory licensing for exporting pharmaceutical products. More than twenty years after the Doha Declaration was passed, developing countries are once again facing with the same inequity in the face of a public health crisis—this time with COVID-19 medical technology and supplies. The background and making of the Doha Declaration shows the importance of adopting the TRIPS Waiver and teaches us that relying on IP waivers alone is unlikely to bring about equity and relief at the scale needed to address the COVID-19 global pandemic.
Reflecting on the lessons learned from Doha Declaration, this Essay explores the implications of passing the TRIPS Waiver.[6] It argues that the adoption of the TRIPS Waiver alone is not enough to solve the vaccine inequity and that more intensive measures are needed to achieve goals of equity and improved public health during a global health crisis like the COVID-19 pandemic. This Essay also calls for the fundamental reconsideration of the current system of IP protections created by the TRIPS Agreement and their effect on access to medicine.
Part I of this Essay provides a brief introduction to the Doha Declaration and its effectiveness. Part II discusses the TRIPS Waiver proposal to the WTO and examines the TRIPS Waiver Decision adopted at the MC12. Part III analyzes arguments in favor and against the adoption of the TRIPS Waiver. Part IV explains why the adoption of the TRIPS Waiver, without more, is not enough and calls for a reconsideration of the current system of IP rights protection created by the TRIPS agreement.
I. Compulsory Licensing and the Doha Declaration
Both the 2001 Doha Declaration and the 2022 TRIPS Waiver highlight the tension between protecting IP rights and protecting public health, each using different approaches to modifying IP rights. This Part begins with an overview of the WTO’s IP protections through the TRIPS Agreement. An explanation of the Doha Declaration follows along with a discussion of the first pathway taken to resolve the tension between protecting IP rights and public health and an assessment of its effectiveness.
A. Compulsory Licensing Under the TRIPS Agreement
The TRIPS Agreement went into force on January 1, 1995. It is the main international instrument overseeing IP protections and setting the minimum standards for all WTO members to protect IP rights.[7] The TRIPS Agreement recognizes “the rights of Members to adopt measures for public health and other public interest reasons and to prevent the abuse of intellectual property rights.”[8] It incorporates provisions to allow WTO members the flexibility to balance the protection of IP rights with the protection of public health.[9] One such provision is compulsory licensing, which authorizes members of the WTO to issue compulsory licenses for their government to use a patent or to authorize it to third parties without the right holder’s authorization.[10] This can only be done once efforts to obtain authorization on reasonable commercial terms have been made, except in cases of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.[11] The products produced under the compulsory licenses are required to be predominantly for the domestic market supply of the member authorizing such use and requires the member issuing the compulsory license to pay the patent holder adequate remuneration.[12]
Notwithstanding these provisions’ good intentions, the stringent criteria and procedural requirements for the issuance of compulsory licenses make the process complex and burdensome to comply with, particularly for countries that lack the necessary technical and legal expertise and administrative capacity. And even where these hurdles are cleared, countries also face external pressures. For example, developing country members such as Thailand, Brazil, India, and South Africa were pressured by developed countries and pharmaceutical companies not to utilize compulsory licenses, despite having the appropriate manufacturing capabilities to produce generic drugs.[13] Hurdles to using compulsory licenses are even worse for developing countries that lack proper manufacturing capabilities because the TRIPS Agreement requires that compulsory licenses to be issued predominantly for domestic use. Therefore, countries that lack manufacturing capability to produce their own pharmaceutical products must import them, often at a price that is unaffordable for much of their population.[14]
B. The Doha Declaration
The ineffectiveness and inefficiencies of the WTO’s compulsory licensing process during the HIV/AIDS crisis led to the 2001 Doha Declaration. Since the first cases of HIV infections were reported in 1981, the virus quickly became a public health crisis.[15] South Africa was especially hard-hit by the epidemic, with “approximately 4.5 million South Africans living with HIV” and an infection rate of over 1700 people per day, “200 of whom [were] babies.”[16] In 1997, South Africa took action to alleviate this public health crisis by focusing on allowing the “parallel importation of pharmaceutical products for reducing the cost of essential medicines.”[17] What followed was a legal battle in 2000, where thirty-nine pharmaceutical companies challenged the South African legislation. In response, the pharmaceutical companies were met with public outrage, causing them to back down three years later.[18] Outside of the South African courtrooms, an intensive international campaign supporting the South African government led to the WTO addressing the issue of the TRIPS Agreement and public health in 2001.[19] In November of 2001, a special Ministerial Declaration was adopted during the WTO Ministerial Conference in Doha, Qatar, which became known as the Doha Declaration.[20]
The Doha Declaration’s purpose was to address the public health crisis by confirming the rights of WTO members to use the IP flexibilities already laid out in the TRIPS Agreement. The Doha Declaration declared “that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health” and reaffirmed “the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”[21] Specifically, “[e]ach member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.”[22] Yet the WTO hit a roadblock: members failed to reach a consensus on which countries would be considered to have “insufficient or no manufacturing capacities in the pharmaceutical sector,”[23] which had implications for the ability to export compulsory license-sourced pharmaceuticals to countries without the capacity to produce them at home. It was not until 2003 that the WTO members finally broke the deadlock and agreed to allow member countries to export pharmaceutical products produced under compulsory licenses.[24] In 2005, WTO members approved amendments to the TRIPS agreement by incorporation the 2003 waiver making it permanent. Although the amendment did not enter into force until 2017, the 2003 waiver continued to apply prior to the amendment’s ratification.
C. The Doha Declaration
To gauge the effectiveness of the Doha Declaration, the number of compulsory licenses issued after its adoption serves as a useful indicator. A study analyzing the implementation of the compulsory licensing flexibilities from the Doha Declaration used data from 2001 to 2016 to identify 176 instances of possible use of flexibilities provided by the TRIPS Agreement in eighty-nine countries.[25] 56.8 percent of those instances involved “compulsory licenses or public noncommercial use licenses.” [26] However, the Doha Declaration’s approval of exportation of compulsory license-sourced products was only used once, by Canada in 2007, to export HIV/AIDS medication to Rwanda.[27] In addition to this being the only identified case of exportation utilizing the Doha Declaration mechanisms, the process was also cumbersome and plagued with delays.[28] This highlights the inefficiency of the TRIPS Agreement despite the Doha Declaration’s efforts to ameliorate the relationship between pharmaceutical IP protections and public health.
Additionally, developed countries have resisted and criticized the use of compulsory licensing by developing countries. From 2007 to 2008 Thailand issued compulsory licenses for medication for cardiovascular diseases and cancer, but this licensing for non-communicable diseases drew criticism from European countries and the United States.[29] Similarly, in 2012, India issued a compulsory license to a cancer drug and was also criticized by the United States.[30]
Because the TRIPS Agreement only sets the minimum standards of IP rights protection, member states are still free to set their own higher standards if they wish to do so.[31] Such discretion enables developed countries to use their economic strength to pressure developing countries into adopting similar higher standards of IP rights protection. The adoption of these additional standards, referred to as the “TRIPS-plus standards,”[32] often result from free trade agreements that implement higher thresholds and stricter criteria for compulsory licensing which favor developed countries as right holders.[33] Thus, adoption of the TRIPS-plus standards in conjunction with resistance from developed member states has curtailed the spirit of the Doha Declaration. All in all, this demonstrates that although some progress can be observed after the Doha Declaration, further reforms are still needed to ensure the equitable access to medicine.[34]
II. The TRIPS Waiver of Covid-19 Related Intellectual Property Rights
A. Proposal of the TRIPS Waiver
In October of 2020, India and South Africa jointly proposed to the WTO a temporary waiver of COVID-19 related IP rights, including patents, industrial designs, copyright, and protection of undisclosed information.[35] The proposal was welcomed by developing countries and garnered the support of fifty-eight governments and approximately one hundred countries.[36] However, it was met with resistance by developed countries where large pharmaceutical companies are based, including the United States, United Kingdom, European Union, Switzerland, and Japan.[37] The United States eventually softened its position under the Biden Administration, but on a narrow scope to support waiving only vaccine patents.[38] This gave the proposal some momentum but the European Union, the United Kingdom, and Switzerland continued to oppose the proposal, leading to a lack of progress at the negotiation tables.[39] The disagreement has led to critiques accusing wealthy countries of putting their greed in front of human lives.[40]
The TRIPS Waiver came to be because of language in the Marrakesh Agreement, the document establishing the World Trade Organization[41] which provides that “[i]n exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade Agreements”[42] and that “a waiver shall state the exceptional circumstances justifying the decision, the terms and conditions governing the application of the waiver, and the date on which the waiver shall terminate.”[43] From the texts, it can be understood that the Marrakesh Agreement allows the Ministerial Conference to adopt waivers in exceptional circumstances.
The TRIPS Waiver was initially scheduled to be reviewed on November 2021, but was postponed due to the newly emerged Omicron variant.[44] The delay caused a deadlock in passing the TRIPS Waiver due to the stiff opposition from some member states.[45] To break the deadlock, the WTO Director-General, Ngozi Okonjo-Iweala, took the issue to the informal small group negotiations among the “Quad,” consisting of the European Union, India, South Africa, and the United States.[46] What emerged after prolong negotiations by the WTO was a watered-down version of the initial TRIPS Waiver proposal, only implementing waivers related to COVID-19 vaccine patents.[47] Critics have warned against the adoption of the weakened TRIPS Waiver because of its lack of progress and because it may only be a “mere diplomatic compromise with little practical consequence.”[48]
B. TRIPS Waiver Decision Adopted at the MC12
After nearly two years since the TRIPS Waiver was first proposed, the TRIPS Waiver Decision was finally adopted at the Twelfth WTO Ministerial Conference (the MC12) in June 2022. However, the adopted TRIPS Waiver Decision is a diluted version of the original proposal after compromises were made to accommodate the developed countries’ concerns during the “Quad” negotiations.[49]
1. Eligibility for the Waiver
As adopted, the TRIPS Waiver defines “eligible members” as “all developing country Members.”[50] But this is followed by a caveat that encourages “[d]eveloping country Members with existing capacity to manufacture COVID-19 vaccines” to opt out of the TRIPS Waiver Decision by making a binding commitment not to take advantage of the waiver.[51] In the prior draft of the TRIPS Waiver, a second option was to exclude developing countries that exported more than 10 percent of the global vaccine doses in 2021 from waiver eligibility. This option was rejected by China and several other members, as China was the only developing country that surpassed the 10 percent threshold.[52] Later at a WTO General Council meeting, China announced its commitment to opt out of the waiver, which paved the way for the adoption of the current opt out model.[53] The adopted opt out model seems to be the direct result of a compromise between developed and developing members, just as commentators have pointed out “this ‘encouragement’ seems to contradict the general direction of the [TRIPS Waiver] Decision.”[54]
2. Scope of the Waiver
The TRIPS Waiver Decision will stand for five years from the date of the decision, and the WTO General Council will review it annually, with the option extend the life of the Waiver, “taking into consideration the exceptional circumstances of the COVID-19 pandemic.”[55]
The TRIPS Waiver as adopted is much narrower in scope compared to India and South Africa’s original proposal, which broadly covered patents, industrial designs, copyright, and undisclosed information “in relation to prevention, containment or treatment of COVID-19,” including “diagnostic kits, medical masks, other personal protective equipment and ventilators, as well as vaccines and medicines.”[56] Now, the Waiver only covers COVID-19 vaccine patents, excluding from coverage other forms of IP rights and COVID-19 related medication or therapeutics.[57] This exclusion will be revisited within six months for members to decide whether to extend the waiver to cover COVID-19 diagnostics and therapeutics.[58]
3. Loosened Requirements for Compulsory Licensing
The Waiver relaxes the TRIPS Agreement compulsory licensing requirements to allow developing countries to “authoriz[e] the use of the subject matter of a patent required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic,”[59] and specifies that the “‘subject matter of a patent’ includes ingredients and processes necessary for the manufacture of the COVID-19 vaccine.”[60]
The TRIPS Waiver as adopted further “clarifies and waives” some of the procedural requirements for compulsory licensing under the TRIPS Agreement.[61] The Waiver enables the issuance of compulsory licenses “through any instrument available in the law of the Member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not a Member has a compulsory license regime in place.”[62] This allows members who do not have a law that authorizes compulsory licensing in place, which is required by the TRIPS Agreement,[63] to issue compulsory licenses with more flexibility, and relieve the administrative and legal obstacles they may face. The Waiver also allows compulsory licenses to be issued without first making “efforts to obtain authorization from the right holder.”[64]
Other than the above changes that ease the requirements for compulsory licensing, little has changed from the TRIPS Agreement protections. The Waiver states that it “waive[s] the requirement of Article 31(f) that authorized use under Article 31 be predominantly to supply its domestic market” and allows the exportation of the products manufactured under the TRIPS Waiver Decision,[65] but this is merely a restatement of the status quo, the Doha Declaration already made that waiver permanent.[66] Additionally, adequate remuneration requirement from the TRIPS Agreement still stands, though the Waiver adds that members “may take account of the humanitarian and not-for-profit purpose of specific vaccine distribution programs aimed at providing equitable access to COVID-19 vaccines . . . .”[67]
Lastly, the language of the TRIPS Waiver only applies “to the extent necessary to address the COVID-19 pandemic.”[68] The requirement of necessity precludes countries where voluntary authorization of patents is sufficient enough to address the COVID-19 pandemic from invoking the TRIPS Waiver Decision to issue compulsory licenses.[69] This necessity requirement may become a point for future disputes, as conflicting views of necessity may potentially arise, and there will always be different perceptions of risks and urgency.
4. Clarifying Article 39.3 of the TRIPS Agreement
Article 39.3 of the TRIPS Agreement concerns the protection of undisclosed data submitted during regulatory approval.[70] Paragraph 4 of the TRIPS Agreement provides that: “Recognizing the importance of the timely availability of and access to COVID-19 vaccines, it is understood that Article 39.3 of the Agreement does not prevent an eligible Member from enabling the rapid approval for use of a COVID-19 vaccine produced under this Decision.”[71] Read together, some might suggest it “seems to allow eligible Members to suspend the protection of regulatory data filed by the manufacturer of a COVID-19 vaccine to allow generic manufacturers to supply the market with sufficient vaccines.”[72] However, given the vague wording of Paragraph 4, it is unclear whether this provision can be conceived as a waiver; since Paragraph 4 only clarifies the understanding of Article 39.3, but does not waive any obligation. The true intention and exact effect of this provision may remain unclear until future cases arise.
III. The Debate and Analysis of the TRIPS Waiver
A. Arguments For and Against the TRIPS Waiver
Leading up to the adoption of the TRIPS Waiver, strong arguments were made on both sides over what implications the Waiver will have on IP rights. Supporters of the TRIPS Waiver argue that despite efforts from within the pharmaceutical industry and government, the current IP voluntary sharing mechanisms simply do not work as intended. IP rights over COVID-19 vaccines and therapeutics “threaten [to restrict] scale-up of manufacturing, lock out diversified suppliers and undermine competition that would result in lower prices.” [73] This affordability problem creates inequality between developed and developing countries, and is most obvious when it comes to the distribution of vaccines. While wealthy countries represent only 13 percent of the global population, they had purchased at least half the potential available doses of the five main vaccines,[74] buying more than two billion doses before the vaccines were even ready.[75] As of June 30, 2022, just 17.4 percent of the people in low-income countries have been vaccinated with at least one dose, compared to the global percentage of 66.4 percent.[76] Moreover, despite warnings from the WHO that blanket boosters will exacerbate vaccine inequality, wealthy countries have rolled out blanket booster shots before poorer countries are able to sufficiently vaccinate their population.[77]
Opponents of the TRIPS Waiver argued that, because patents had not been filed in many developing countries, these countries were actually free to manufacture vaccines patented elsewhere.[78] Additionally, even without the threat of compulsory licensing, pharmaceutical companies have already engaged in voluntary sharing or licensing of COVID-19 treatments and vaccines.[9] For example, in May of 2020, the WHO initiated the COVID-19 Technology Access Pool (C-TAP) and invited pharmaceutical companies to voluntarily share COVID-19 technology-related patents and other kinds of intellectual properties such as data, know-how, and software.[80] Moreover, organizations such as the Access to Covid-19 Tools (ACT) Accelerator and COVAX have made vaccine supply agreements with countries and pharmaceutical companies. [81] However, as of May of 2021, vaccine manufacturers have refused to join the initiative.[82]
Another point that opponents make is about the harm the Waiver can do to the spirit of IP. Since IP rights stimulate innovation by enabling innovators to reap the benefits of their risky investments, opponents of the TRIPS Waiver argued that the adoption of a waiver will result in unintended negative impacts, stating that “in the long term, undermining [intellectual property rights] would eliminate the incentives that spark innovation” and “hinder the discovery and development of knowledge necessary for new products or technologies that the world needs.”[83] This was also one main reason cited by the pharmaceutical industry for its opposition to the TRIPS Waiver.[84] Vaccine manufacturing is extremely complex and requires high standards of quality. Waiving patents may lead to the risk of lower quality or even counterfeited vaccines flowing into the market.[85] Thus, in order to protect public health and prevent low-quality vaccines from jeopardizing public health, the protection of IP rights is essential to ensure the quality of vaccines and medicines.[86]
That being said, supporters of the Waiver point out that public funding is provided to pharmaceutical companies to develop COVID-19 treatments and vaccines worldwide.[87] The United States had provided eighteen billion dollars through “Operation Warp Speed” to fund the research and development of vaccines.[88] That money is, of course, taxpayer money. Researchers have also found that the development of the Oxford/AstraZeneca vaccine, one of the most widely used vaccine globally, 97% funded by public money.[89] The use of public funding is contrary to the premise of patents in which companies make risky investments to innovate to later be rewarded with a monopoly. Accordingly, the benefits of the patent should be shared with the public given the pharmaceutical companies’ use of public funds.[90]
B. Analysis of the TRIPS Waiver
Although various arguments have been made leading up to the adoption of the TRIPS Waiver, comparing the benefits to the harms shows that the benefits will outweigh the alleged harms.[91] First, pharmaceutical companies should not get to solely enjoy the economic benefits of producing vaccines when large amounts of public funding has been invested into their development. Patents are granted to provide incentives for those who are willing to undertake the risks accompanied by investments to innovate. However, in the development of COVID-19 vaccines, pharmaceutical companies did not face the usual investment risks because large sums of public funding was poured to neutralize those risks. Thus, concern over the drug industry’s profits when considering the TRIPS Waiver is misplaced.[92] On the contrary, since 1955 the drug industry has been the most profitable sector in the Fortune 500, exceeding even the energy and financial industries.[93] But record high profits have not necessarily produced solutions to all public health problems, including the SARS and MERS viruses or other neglected tropical diseases.[94] Alternatively, by allowing countries the freedom to produce vaccines the TRIPS Waiver may “spur new discoveries and better vaccines, such as single-dose vaccines,” to address both market and ethical failures.[95]
Second, the claim that pharmaceutical companies have already engaged in voluntary licensing and technology overlooks the impact of those that do not. During the peak of the pandemic, no major pharmaceutical company had agreed to share vaccine know-how with C-TAP.[96] Moreover, COVAX failed to reach its supply target, diminishing the hopes of lower-income countries to acquire affordable vaccines.[97] Vaccine manufacturers have only signed non-exclusive licenses with a handful of manufacturers. [98] Other manufacturers, such as pharmaceutical companies in Israel, Canada, Bangladesh, South Korea, and Pakistan, have failed to receive licenses when vaccines were critically in short supply despite having the capacity and willingness to produce vaccines due to the reluctance of vaccine manufacturers.[99] Thus, the TRIPS Waiver may also facilitate more voluntary sharing by “allow[ing] scientists worldwide to collaborate on innovations.”[100]
While some proponents claim waiving IP rights would reduce vaccine quality, such concerns can and should be addressed through other means. There are already many “global companies and government-run facilities with excellent records and strong oversight.”[101] On the global level, the WHO already has a COVID-19 prequalification program for pharmaceutical manufacturers to submit their products for assessment.[102] On the national level, state regulatory agencies, such as the United States’ Food and Drug Administration (FDA), review the safety, effectiveness, quality and appropriate use of the vaccines before their rollout.[103] Therefore, IP rights are not essential to ensure quality; what is essential is the regulatory bodies’ diligence to oversee and scrutinize vaccines and medicines. As there are other existing mechanisms in place to ensure quality, without further evidence that IP rights are irreplaceable when ensuring quality, the argument seems to be misplaced.[104]
Additionally, the distribution of COVID-19 vaccines has continued to fail, leaving developing countries faced with continued public health crises. The vaccine inequity has repeated itself in the distribution of the latest Novavax vaccine. Developed countries that already have a surplus of vaccines continued to receive the Novavax vaccine before developing countries. This is an especially disheartening reality considering Novavax’s suitability for developing countries because of its ease of storage and transportation.[105] The TRIPS Waiver is certainly not a perfect fix to end the pandemic, but it is clear the benefits of this implementation of the patent waiver outweighs its potential costs to IP rights overall. As explained by Dr. Tedros Adhanom Ghebreyesus, the WHO Director-General, and Ursula von der Leyen, the President of the European Commission, both of whom have been calling on world leaders for a global pandemic response, “none of us will be safe until everyone is safe.” [106] The TRIPS Waiver could be the first step in that direction.
IV. The TRIPS Waiver Alone is Not Enough
Having examined the TRIPS Waiver Decision in the previous part, this Part will argue that while the TRIPS Waiver Decision may mitigate the vaccine disparity to some extent, without more, the TRIPS Waiver alone is not enough to solve the entire problem of inequitable access to medicine.
A. Other Intellectual Property Rights Should be Waived
After the initial production bottleneck was resolved, the COVID-19 vaccine shortage has been relieved globally, if only temporarily.[107] Notably, some countries have even maintained a surplus of vaccines that end up being destroyed.[108] This illustrates that a shortage of vaccine availability cannot alone explain the disparity in supply and that the problem has increasingly become that vaccines are not distributed equally. Given a great disparity in access to vaccines and pharmaceuticals between developed and developing countries, the most effective way to ensure the equal distribution of vaccines is to allow and encourage the self-sufficiency of vaccine production for developing countries. Echoing the words of WHO Director-General, Dr. Tedros: “In the mid- to long-term, the best way to address health emergencies and reach universal health coverage is to significantly increase the capacity of all regions to manufacture the health products they need, with equitable access as their primary endpoint.”[109]
Yet, many developing countries do not have the capability to manufacture vaccines.[110] Even with the adoption of the TRIPS Waiver, it is unlikely that countries lacking the proper facilities and resources will be able to commercially manufacture vaccines locally at the necessary scale. This is because vaccine manufacturing involves not only patents, but also trade secrets and know-how—which are not covered by the adopted TRIPS Waiver Decision—and manufacturing needs require mass-producing vaccines at a commercial scale.
Suppose developing countries do gain this capability. What remains is that vaccine manufacturing is extremely complex and costly, takes multiple months if not years, and requires lengthy approval procedures.[111] Therefore, it is apparent that, without more, the TRIPS Waiver and its patent-waiving cannot serve as a final answer. Other forms of IP rights should be waived, such as trade secret or copyright, and the exact meaning of Paragraph 4 of the TRIPS Waiver Decision regarding the protection of data submitted for regulatory approval should also be clarified.[112]
These challenges are most evident in the bid to transform South Africa into a vaccine manufacturing hub for Africa.[113] After the leading mRNA vaccine manufacturers, Pfizer, BioNTech, and Moderna, did not respond to the WHO’s request to share their technology and expertise, the WHO collaborated with South Africa’s Afrigen Biologics in an attempt to reverse engineer Moderna’s mRNA vaccine [114]following Moderna’s pledge to not enforce its patent rights during the pandemic.[115] Despite some initial success after months of hard work, the approval process for Afrigen’s vaccines may take up to three years if the vaccine manufacturers continue to refuse to share their already approved technology and data.[116]
B. COVID-19 Diagnostics and Therapeutics Should be Covered
The current TRIPS Waiver Decision only covers COVID-19 vaccine patents, but vaccines are not the only tool to combat the virus; diagnostics and therapeutics are equally important in the fight against COVID-19.[117] As COVID-19 oral pills have been successfully developed and are being distributed globally, such as Pfizer’s Paxlovid or Merck & Co.’s Molnupiravir, a problem of inequitable distribution began to arise as was seen with the vaccines.[118] According to data compiled by Duke Global Health Innovation Center, most COVID-19 therapeutics are purchased by high income countries.[119] The more effective Paxlovid was purchased almost solely by high income countries, with 98 percent of the purchases going to high income countries.[120] At the same time, two-thirds of the less effective Molnupiravir was purchased by high income countries, with the remaining one-third of the supply going to global entities and lower middle income countries.[121]
In addition to the inequitable distribution of COVID-19 treatments, the pricing of the medications is also not without controversies. Despite being life-saving and a potential solution to the pandemic, the price tag of the COVID-19 medications is staggeringly high, notwithstanding the fact that public funding was used during their development.[122] Although Pfizer did pledge to sell generic versions of Paxlovid at a discounted price to low-income countries, the generic versions of the drug are still being developed and far from being approved.[123] Even though there have been voluntary licenses made with generic manufacturers to allow generic drugs to be produced at full capacity, there is still the need to waive the IP rights on COVID-19 medications, including patents and know-how.[124]
Even though the Waiver allows six months for deciding whether to extend its coverage to diagnostics and therapeutics, given the divisions among WTO members is unclear at this point whether that would happen.[125] Even if the WTO members eventually were able to overcome their differences and come together, wasting an extra six months to make the decision is simply unaffordable and unfortunate to the people in need.
C. Rebalancing Public Health and Intellectual Property Rights
Given that the TRIPS Waiver Decision is not enough, more progressive measures will be needed. For too long we have been fixated on patents, from the Doha Declaration to the TRIPS Waiver. But patents only tell one side of the story. Waiving patents or encouraging compulsory licensing has shown to only benefit developing countries in making use of the pharmaceutical patents. These benefits do not automatically confer developing countries the capability to produce medicine. A robust system of technology transfer and data sharing that does not rely on the “benevolence” of the pharmaceutical companies, unlike the WHO’s C-TAP, should be established to ensure all developing countries have equitable access to COVID-19 vaccines and medicines.
If the world genuinely desires to achieve an equitable standard of health and access to medicine for all humans, as enshrined in the Universal Declaration of Human Rights [126] and the International Covenant on Economic, Social and Cultural Rights (ICESCR),[127] the relationship between the protection of IP rights and the protection of public health will need to be fundamentally reconsidered.
Years ago, the Doha Development Round of trade negotiations promised to put the needs of developing countries at the center, however, WTO members have failed to deliver on that the promised.[128] The reality after the Doha Declaration has proved this to be true: “The poorest in developing countries are unable to access affordable medicine because members have failed to clarify ambiguities between the need for governments to protect public health on one hand and on the other to protect the intellectual property rights of pharmaceutical companies.” [129] It may be time to overhaul the current legal order created by the TRIPS Agreement and subsequent waivers and changes brought by the Doha Declaration and TRIPS Waiver in order to rebalance the incentive to reflect equitable access to innovation and medicine.[130]
Conclusion
Looking back twenty years ago, the HIV/AIDS crisis ignited the battle between developed and developing countries over equitable access to medicine, leading to the creation of the Doha Declaration. The Doha Declaration was hoped to be a solution to the health care disparity between the developed and developing countries, but twenty years later the disparity is still blatantly evident and exacerbated by the COVID-19 pandemic.
While the TRIPS Waiver was finally adopted nearly two years since it was first proposed, it helps but it does not entirely resolve this issue. At a time when countries continue to battle new waves of infections and newly emerging variants, there is more that can be done to save lives across the globe. The TRIPS Waiver is a positive first step in the right direction.
Whether it can deliver the results intended remains to be seen, and all eyes will remain on the WTO to see whether the Waiver will be extended.
[1]. See Ctr. for Sys. Sci. & Eng’g, COVID-19 Dashboard, JOHNS HOPKINS U. MED., https://coronavirus.jhu.edu/map.html [https://perma.cc/6BH8-CMZA] (last visited Dec. 7, 2022).
[2]. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 319 [hereinafter TRIPS Agreement].
[3]. See Press Release, Access Campaign, Médecins Sans Frontières, MSF Calls on All Governments to Support Landmark Move at WTO to Suspend Monopolies During COVID-19 (Nov. 18, 2020), https://msfaccess.org/msf-calls-all-governments-support-landmark-move-wto-suspend-monopolies-during-covid-19 [https://perma.cc/S737-F3RL] (“All COVID-19 health tools and technologies should be true global public goods, free from the barriers that patents and other intellectual property impose.”).
[4]. This Essay uses the term “TRIPS Waiver” to refer to the waiver on COVID-19 related intellectual property rights, since the waiver seeks to suspend the protections of intellectual property rights under the TRIPS Agreement. See TRIPS Agreement, supra note 2. Although the proposed TRIPS Waiver is usually discussed within the context of COVID-19 vaccines, the TRIPS Waiver broadly covers all COVID-19 related intellectual property rights on medicines, treatments, and personal protective equipment (PPE). Id. When referring to the TRIPS Waiver adopted at the WTO Twelfth WTO Ministerial Conference (MC12), which is narrower in scope and covers only COVID-19 patents, this Essay will use the term “TRIPS Waiver Decision” to indicate its adopted status. See World Trade Organization, Ministerial Decision on the TRIPS Agreement, WTO Doc. WT/MIN(22)/30, WT/L/1141 (2022) [hereinafter TRIPS Waiver Decision].
[5]. See Council for Trade-Related Aspects of Intellectual Prop. Rights, Waiver From Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19, WTO Doc. IP/C/W/669/Rev.1 (May 25, 2021) [hereinafter TRIPS Waiver Proposal].
[6]. See generally TRIPS Waiver Decision, supra note 4.
[7]. TRIPS—Trade-Related Aspects of Intellectual Property Rights, WTO, https://www.wto.org/english/tratop_e/trips_e/trips_e.htm [https://perma.cc/RM8Y-LNPM] (last visited Dec. 7, 2022).
[8]. Overview: The TRIPS Agreement, WTO, https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm [https://perma.cc/82EN-R8F7] (last visited Dec. 7, 2022).
[9]. See, e.g., TRIPS Agreement, supra note 2, art. 8.1 (“Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.”).
[10]. See id. art. 31 (“Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government . . . .”).
[11]. See id. art. 31(b) (“[S]uch use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use . . . .”).
[12]. See id. art. 31(f), (h).
[13]. See generally Brook Baker, Don’t Be Afraid of Compulsory Licenses Despite US Threats: Special 301 Reports 1998-2017—Listing Concerns but Taking Little Action, Health Gap (Feb. 20, 2018), https://healthgap.org/dont-be-afraid-of-compulsory-licenses-despite-us-threats-special-301-reports-1998-2017-listing-concerns-but-taking-little-action [https://perma.cc/5X82-7TJC].
[14]. See Max Klein & Jörg Schaaber, Unaffordable Treatment, Dev. & Coop. (June 30, 2021), https://www.dandc.eu/en/article/people-developing-countries-most-cancer-drugs-are-unaffordable [https://perma.cc/35DW-ZSH9] (“According to the World Health Organization (WHO), for example, medication for a woman with breast cancer costs $ 18,500 a year in India and $ 33,900 in South Africa. In both countries, that amounts toabout ten times the average annual income.”).
[15]. See A Timeline of HIV and AIDS, HIV.Gov (Apr. 29, 2022), https://www.hiv.gov/hiv-basics/overview/history/hiv-and-aids-timeline [https://perma.cc/3L3F-GMYW].
[16]. Ruth Mayne, Policy Dep’t Of Oxfam (Great Britain), South Africa Vs. The Drug Giants: A Challenge to Affordable Medicines ii (2001).
[17]. S. Ctr, Policy Brief 7, The Doha Declaration on TRIPS and Public Health Ten Years Later: The State Of Implementation n.3 (2011).
[18]. See generally Chris McGreal, Shamed and Humiliated—The Drugs Firms Back Down, GUARDIAN (Apr. 19, 2001, 1:00 PM), https://www.theguardian.com/uk/2001/apr/19/highereducation.world [https://perma.cc/24LT-ZZCP].
[19]. See South Centre, supra note 17, at 2.
[20]. See World Trade Organization, Ministerial Declaration of 14 November 2001, WTO Doc. WT/MIN(01)/DEC/2, 41 I.L.M. 746 (2002) [hereinafter Doha Declaration].
[21]. Id. para. 4.
[22]. Id. para. 5(b).
[23]. Id. para. 6 (“We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.”).
[24]. See Press Release, WTO, Decision Removes Final Patent Obstacle to Cheap Drug Imports (Aug. 30, 2003), https://www.wto.org/english/news_e/pres03_e/pr350_e.htm [https://perma.cc/8FXN-QE92].
[25]. See Ellen FM ‘t Hoen et al., Medicine Procurement and the Use of Flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016, 96 Bull. World Health Org. 185 (2018).
[26]. Id. at 187.
[27]. See Canada is First to Notify Compulsory Licence to Export Generic Drug, WTO (Oct. 4, 2007), https://www.wto.org/english/news_e/news07_e/trips_health_notif_oct07_e.htm [https://perma.cc/WVX7-BY7C].
[28]. See Jillian Clare Kohler et al., Canada’s Access to Medicines Regime: Promise or Failure of Humanitarian Effort?, 5(3) Healthcare Pol’y 40, 43–44 (2010).
[29]. See Baker, supra note 13 (discussing the United States’ response in adding Thailand to the Special 301 Report); see also Nattapong Suwan-in, Compulsory License, A Long Debate on TRIPS Agreement Interpretation: Discovering the Truth of Thailand’s Imposition on Pharmaceutical Patents, 7(1) Asian J. Wto & Int’l Health L. & Pol’y 225, 238–42 (2012).
[30]. See generally Prabhash Ranjan, Observer Rsch. Found., Issue Brief No. 456, The Case For Waiving Intellectual Property Protection For Covid-19 Vaccines 8 (2021).
[31]. See generally Overview, supra note 8.
[32]. Cynthia M. Ho, Access To Medicine In The Global Economy: International Agreements On Patents And Related Rights 226 (2011) (“[T]hese [TRIPS-plus] standards are more typically adopted as a result of external pressure. In particular, developing countries often accept TRIPS-plus standards as a result of political or economic pressure from other nations.”).
[33]. See id. at 237–38.
[34]. See, e.g., Carlos Correa & Duncan Matthews, UNDP, The Doha Declaration Ten Years on and its Impact on Access to Medicines and the Right to Health 31 ( 2011).
[35]. See TRIPS Waiver Proposal, supra note 5, para. 12.
[36]. See Press Release, Médecins Sans Frontières, Countries Obstructing COVID-19 Patent Waiver Must Allow Negotiations to Start (Mar. 9, 2021), https://www.msf.org/countries-obstructing-covid-19-patent-waiver-must-allow-negotiations [https://perma.cc/HJC4-PLKJ].
[37]. See id.
[38]. See U.S. Says It Will Push COVID Vaccine Waivers, But ‘May Take Time,’ REUTERS (June 10, 2021, 9:27 AM), https://www.reuters.com/business/healthcare-pharmaceuticals/us-raise-covid-19-vaccine-intellectual-property-issues-with-wto-may-take-time-2021-06-10/ [https://perma.cc/8FZV-DAJA].
[39]. See Emma Farge, Even After U.S. Shift, Opponents Resist COVID-19 Vaccine Patent Waiver, REUTERS (May 31, 2021, 1:48 PM), https://www.reuters.com/business/healthcare-pharmaceuticals/even-after-us-shift-opponents-resist-covid-19-vaccine-patent-waiver-2021-05-31/ [https://perma.cc/AY5Y-2GF9?type=standard].
[40]. See e.g., COVID-19: One Year Since Call For Vaccine Tech to be Shared, AMNESTY INT’L UK (Oct. 1, 2021, 10:53 AM), https://www.amnesty.org.uk/press-releases/covid-19-one-year-call-vaccine-tech-be-shared [https://perma.cc/3Q8L-9PXL] (“Greed is triumphing over human life and human rights. These companies and States are seeing the beginning of their economic recovery while letting millions of people risk their lives and health because they don’t have access to a life-saving vaccine.”).
[41]. TRIPS Agreement, supra note 2, at 154.
[42]. Id. art. IX(3).
[43]. Id. art. IX(4).
[44]. See Twelfth WTO Ministerial Conference, WTO, https://www.wto.org/english/thewto_e/minist_e/mc12_e/mc12_e.htm [https://perma.cc/MV6K-J5T7] (last visited Dec. 7, 2022).
[45]. See, e.g., WTO TRIPS Council March 2022: UK Statement, GOV.UK (Mar. 10, 2022), https://www.gov.uk/government/news/wto-trips-council-march-2022-uk-statement [https://perma.cc/AU88-G89K] (discussing the United Kingdom’s strong opposition to the TRIPS Waiver which “will not change” and “noting the role IP rights have played in the development and production of Covid-19 goods which are positively contributing to the global pandemic response”).
[46]. See Quad’s Outcome Document on IP COVID-19 Response Made Public, WTO (May 3, 2022), https://www.wto.org/english/news_e/news22_e/trip_03may22_e.htm [https://perma.cc/7M92-G5Q8].
[47]. See WTO Members Secure Unprecedented Package of Trade Outcomes at MC12, WTO (June 17, 2022), https://www.wto.org/english/news_e/news22_e/mc12_17jun22_e.htm [https://perma.cc/3MMB-6WBC].
[48]. Ellen‘t Hoen, A Plan to Fix Vaccine Inequity Offers False Comfort, BARRON’S (May 9, 2022, 1:51 PM), https://www.barrons.com/articles/trips-waiver-quad-compromise-wto-covid-vaccines-equity-51652118609 [https://perma.cc/G4YC-AWAP]; see also Fatima Hassan et al., The Leaked WTO COVID Patent Waiver Text Promises a Very Bad Deal, AL JAZEERA: OPINION (Apr. 8, 2022), https://www.aljazeera.com/opinions/2022/4/8/the-leaked-wto-covid-patent-waiver-text-promises-a-very-bad-deal [https://perma.cc/UC73-T48F].
[49]. See generally Nishant Sirohi, Compromised TRIPS Waiver: One Step Forward, Two Steps Back, OBSERVER RSCH. FOUND. (Apr. 16, 2022), https://www.orfonline.org/expert-speak/compromised-trips-waiver [https://perma.cc/LT69-FQZL].
[50]. TRIPS Waiver Decision, supra note 4, at n.1.
[51]. Id.
[52]. See Bryce Baschuk, China Rejects Its Exclusion from WTO Vaccine Waiver Proposal, BLOOMBERG (May 6, 2022, 10:36 AM), https://www.bloomberg.com/news/articles/2022-05-06/china-rejects-its-exclusion-from-wto-vaccine-waiver-proposal [https://perma.cc/N6FP-F5CH] (“U.S. policymakers want to prevent China from obtaining access to the mRNA technology that Pfizer Inc., BioNTech SE and Moderna Inc. used to produce Covid-19 vaccines, fearing that China will steal it to gain an unfair advantage.”).
[53].See Members Welcome Quad Document as Basis for Text-Based Negotiations on Pandemic
IP Response, WTO (May 10, 2022), https://www.wto.org/english/news_e/news22_e/gc_10may22_e.htm [https://perma.cc/G9C5-UAQF].
[54]. Thierry Calame et al., WTO Adopts Compromise on the Waiver of Patent Rights to Address COVID-19 Pandemic, LENZ & STAEHELIN (June 21, 2022), https://www.lenzstaehelin.com/fileadmin/user_upload/newsflash/220621_Update_Ne wsflash_WTO_adopts_compromise_on_the_waiver_of_patent_rights_to_address_COVID-19_pand_EN.pdf [https://perma.cc/CBB2-2XTD].
[55].TRIPS Waiver Decision, supra note 4, para. 6 (“An eligible Member may apply the provisions of this Decision until 5 years from the date of this Decision. The General Council may extend such a period taking into consideration the exceptional circumstances of the COVID-19 pandemic. The General Council will review annually the operation of this Decision.”).
[56]. TRIPS Waiver Proposal, supra note 5, paras. 5, 12.
[57]. See TRIPS Waiver Decision, supra note 4, para. 1.
[58]. The revision is set to occur by January of 2023. Id. para. 8.
[59]. Id. para. 1.
[60]. Id. at n.2.
[61]. Id. para. 1.
[62]. Id. para. 2.
[63]. TRIPS Agreement, supra note 2, art. 31.
[64]. TRIPS Waiver Decision, supra note 4, para. 3(a).
[65]. Id. para. 3(b).
[66]. 1 Article 31bis of the Agreement on Trade-Related Aspects of Intellectual Property Rights, WTO ANALYTICAL INDEX (Current as of July 2022) TRIPS Agreement art. 31bis: “The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) . . . .”
[67]. TRIPS Waiver Decision, supra note 4, para. 3(d).
[68]. Id. para. 1.
[69]. See Calame et al., supra note 54.
[70]. TRIPS Agreement, supra note 2, art. 39.3.
[71]. TRIPS Waiver Decision, supra note 4, para. 4.
[72]. Calame et al., supra note 54.
[73]. Bryan Mercurio, WTO Waiver from Intellectual Property Protection for COVID-19 Vaccines and Treatments: A Critical Review, 62 VA. J. INT’L L. ONLINE 9, 14 (2021).
[74]. Id. at 14–15.
[75]. See Ewen Callaway, The Unequal Scramble for Coronavirus Vaccines—By the Numbers, 584 NATURE 506, 506 (2020).
[76]. Hannah Ritchie et al., Coronavirus (COVID-19) Vaccinations, OUR WORLD IN DATA,
https://ourworldindata.org/covid-vaccinations [https://perma.cc/W3V6-6F2R](last visited Dec. 7, 2022).
[77]. See, e.g., WHO Warns Against Blanket Boosters, as Vaccine Inequity Persists, UN NEWS
(Dec. 22, 2021), https://news.un.org/en/story/2021/12/1108622 [https://perma.cc/XEQ2-29GS].
[78]. See Mercurio, supra note 73, at 20.
[79]. See id. at 20–21.
[80]. See WHO COVID-19 Technology Access Pool, WTO, https://www.who.int/initiatives/covid-19-technology-access-pool [https://perma.cc/QSQ7-BTXA] (last visited Dec. 7, 2022).
[81]. See, e.g., COVAX Announces New Agreement, Plans for First Deliveries, WHO (Jan. 22, 2021), https://www.who.int/news/item/22-01-2021-covax-announces-new-agreement-plans-for-first-deliveries [https://perma.cc/YKS6-UN38]; ACT-Accelerator Partnership Welcomes Leadership and Commitments at US COVID Summit to Ending COVID-19 Pandemic Through Equitable Access to Tests, Treatments, and Vaccines, WHO (Sept. 24, 2021), https://www.who.int/news/item/24-09-2021-act-accelerator-partnership-welcomes-leadership-and-commitments-at-us-covid-summit-to-ending-covid-19-pandemic-through-equitable-access-to-tests-treatments-and-vaccines [https://perma.cc/CVD2-SC2X].
[82]. See Ellen ‘t Hoen, The Arguments Against Sharing Covid-19 Intellectual Property Don’t Add Up, BARRON’S (May 3, 2021, 11:43 AM), https://www.barrons.com/articles/the-arguments-against-sharing-covid-19-intellectual-property-dont-add-up-51620056595 [https://perma.cc/H96K-G66W].
[83]. Mercurio, supra note 73, at 16–17.
[84]. See News Release, Int’l Fed. Pharm. Mfrs. & Assns., Pharmaceutical Industry Expresses Deep Disappointment with Decision on Waiving Intellectual Property Rights Adopted at the World Trade Organization Ministerial Conference (June 17, 2022), https://www.ifpma.org/resource-centre/pharmaceutical-industry-expresses-deep-disappointment-with-decision-on-waiving-intellectual-property-rights-adopted-at-the-
world-trade-organization-ministerial-conference [https://perma.cc/SW7F-4PVZ] (“Today’s decision sends a dangerous signal not only to the pharmaceutical industry but to all innovative sectors. Dismantling the very framework that has brought solutions to tackle COVID-19 and facilitated the unprecedented number of partnerships, voluntary licensing, and knowledge-sharing taking place during this pandemic can have ripple effects for the future.”).
[85]. See Press Release, Pharm. Rsrch. & Mfrs. Am., PhRMA Statement on WTO TRIPS Intellectual Property Waiver(May 5, 2021), https://phrma.org/Coronavirus/PhRMA-Statement-on-WTO-TRIPS-Intellectual-Property-Waiver [https://perma.cc/5PBR-GJG4] (“This decision [to support the patent waiver] will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.”).
[86]. See Mercurio, supra note 73, at 28–29.
[87]. See, e.g., Niall McCarthy, The Countries Funding Covid-19 Vaccine R&D, STATISTA (May 6, 2021), https://www.statista.com/chart/24808/top-sources-of-covid-19-vaccine-funding [https://perma.cc/WS8W-DF2H] (“The United States and Germany are the top sources for R&D investment, putting some $2 billion and $1.5 billion into development, respectively. The United Kingdom comes third on the funding list with just over $500 million while the EU has invested around $327 million.”).
[88]. Lancet Commission on COVID-19 Vaccines and Therapeutics Task Force Members, Operation Warp Speed: Implications for Global Vaccine Security, 9 LANCET GLOB. HEALTH e1017 (2021).
[89]. Michael Safi, Oxford/AstraZeneca Covid Vaccine Research ‘was 97% Publicly Funded,’ GUARDIAN (Apr. 15, 2021), https://www.theguardian.com/science/2021/apr/15/oxfordastrazeneca-covid-vaccine-research-was-97-publicly-funded [https://perma.cc/9NMH-H48S] (reporting that “[t]he overwhelming majority of the money . . . came from UK government departments, British and American scientific institutes, the European commission and charities”).
[90]. See generally ‘t Hoen, supra note 82.
[91]. Id.
[92]. Luke Hawksbee et al., Don’t Worry About the Drug Industry’s Profits When Considering a Waiver on Covid-19 Intellectual Property Rights, BMJ (Jan. 31, 2022), https://www.bmj.com/content/376/bmj-2021-067367 [https://perma.cc/7P8T-T8LT].
[93]. Id.
[94]. See id. (arguing that “it is far from clear” that the drug industry is focused on “the innovations most needed to improve and protect public health”).
[95]. Matthew M. Kavanagh et al., Sharing Technology and Vaccine Doses to Address Global Vaccine Inequity and End the COVID-19 Pandemic, JAMA (July 1, 2021), https://jamanetwork.com/journals/jama/fullarticle/2781756 [https://perma.cc/4WCL-L9ZX].
[96]. ‘t Hoen, supra note 82.
[97]. See Francesco Guarascio, Let Down by Rich and Failing the Poor, Global Vaccine Scheme to Be Shaken Up, REUTERS (June 23, 2021, 9:25 AM), https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-let-down-by-rich-failing-poor-global-vaccine-scheme-be-shaken-up-2021-06-23 [https://perma.cc/Q357-DG7L].
[98]. ‘t Hoen, supra note 82.
[99]. Id. (“Teva, a large Israeli pharmaceutical company, tried in vain to obtain the rights to produce Covid-19 vaccines and recently announced it will abandon its search for collaborators. Companies in Canada, Bangladesh, South Korea, and Pakistan have found themselves in the same situation.”).
[100]. Kavanagh et al., supra note 95, at 220.
[101]. Id.
[102]. ‘t Hoen, supra note 82.
[103]. See Vaccines and Related Biological Products Advisory Committee, U.S. FDA, https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee [https://perma.cc/5AL8-YHNH] (last visited Dec. 7, 2022).
[104]. See Kavanagh et al., supra note 95, at 220 (“Quality control is critical, but arguments that LMIC producers cannot produce quality vaccines are misplaced.”); ‘t Hoen, supra note 82.
[105]. See Maria Cheng & Aniruddha Ghosal, Rich Countries Getting New COVID Vaccine Before Poorer Ones, AP (Mar. 24, 2022), https://apnews.com/article/covid-science-business-health-europe-778444506a72e8f9c3be327640b1929d [https://perma.cc/EX7U-2N8C] (“[The Novavax] vaccine that was believed to be highly suitable for poor countries is now in large part going to rich countries . . . . It’s tragic that in year three of the pandemic, we still cannot get the resources, attention and political will to solve vaccine inequity.”).
[106]. Tedros Adhanom Ghebreyesus & Ursula von der Leyen, A Global Pandemic Requires a World Effort to End It–None of Us Will Be Safe Until Everyone Is Safe, WHO (Sept. 30, 2020), https://www.who.int/news-room/commentaries/detail/a-global-pandemic-requires-a-world-effort-to-end-it-none-of-us-will-be-safe-until-everyone-is-safe [https://perma.cc/2MZP-XGZN].
[107]. See Hanna Nohynek & Annelies Wilder-Smith, Does the World Still Need New Covid-19 Vaccines?, 386 NEW ENG. J. MED. 2140, 2140 (2022) (“Although there was a global shortage of Covid-19 vaccines in 2021, by mid 2022, the vaccine supply will no longer be a limiting factor in efforts to provide more equitable coverage.”).
[108]. See, e.g., Oyeronke Oyebanji, Too Many COVID-19 Vaccine Doses are Being Wasted, AL JAZEERA: OPINION (Dec. 30, 2021), https://www.aljazeera.com/opinions/2021/12/30/too-
many-covid-19-vaccine-doses-are-being-wasted [https://perma.cc/XBX7-4UF7] (explaining that much-needed vaccine donations are being rejected because wealthy countries are donating vaccines with “short shelf life and little notice”).
[109]. WHO Announces First Technology Recipients of mRNA Vaccine Hub with Strong Support from African and European Partners, WHO (Feb. 18, 2022), https://www.who.int/news/item/18–02–2022-who-announces-first-technology-recipients-of-mrna-vaccine-hub-with-strong-support-from-african-and-european-partners [https://perma.cc/W6E4-K3V5].
[110]. Mohammed Imran Khan et al., Vaccine Manufacturing Capacity in Low- and Middle-Income Countries, 99(7) BULL. WORLD HEALTH ORG. 479, 479 (2021) (“Many low-income countries have not been able to establish their own manufacturing units because of their human, financial and technical resource constraints in vaccine manufacturing.”).
[111]. See generally Stanley Plotkin et al., The Complexity and Cost of Vaccine Manufacturing– An Overview, 35(33) VACCINE 4064 (2017).
[112]. TRIPS Waiver Decision, supra note 4, para. 4.
[113]. See Emma Farge, Plans for African COVID Vaccine Production Hubs Could Be 'Revolutionary’, REUTERS (June 29, 2021), https://www.reuters.com/business/healthcare-pharmaceuticals/plans-african-covid-vaccine-production-hubs-could-be-revolutionary-2021-06-29 [https://perma.cc/BEY8-ZDQQ].
[114]. See Amy Maxmen, South African Scientists Copy Moderna’s COVID Vaccine, NATURE (Feb. 3, 2022), https://www.nature.com/articles/d41586-022-00293-2 [https://perma.cc/HG2H-3DTG].
[115]. See Statement By Moderna on Intellectual Property Matters During the COVID-19 Pandemic (Oct. 8, 2020), https://investors.modernatx.com/Statements-- Perspectives/Statements--Perspectives-Details/2020/Statement-by-Moderna-on-Intellectual-Property-Matters-during-the-COVID-19-Pandemic-10-08-2020/default.aspx [https://perma.cc/3FQ8-PW43].
[116]. Mrinalika Roy, Approval of COVID Vaccine Made in South Africa Could Take 3 Years,
WHO Says, REUTERS (Feb. 5, 2022, 12:35 AM), https://www.reuters.com/world/africa/approval-covid-vaccine-made-south-africa-could-take-3-years-who-says-2022-02-04 [https://perma.cc/37ZR-8NK2].
[117]. See 3 Reasons Why We Need a Waiver on Monopolies of ALL COVID-19 Medical Tools, MÉDECINS SANS FRONTIÈRES ACCESS CAMPAIGN (Oct. 1, 2021), https://msfaccess.org/3-reasons-why-we-need-waiver-monopolies-all-covid-19-medical-tools [https://perma.cc/2RQ3-DXRT].
[118]. See Duke Glob. Health Innovation Ctr., COVID-19 Therapeutics, LAUNCH & SCALE
SPEEDOMETER, https://launchandscalefaster.org/covid-19/therapeutics [https://perma.cc/5HHD-T8J4] (last visited Dec. 7, 2022).
[119]. Id.
[120]. Id.
[121]. Id.; see also Pien Huang, Doctors Find Limited Use for Less Effective COVID Pill, NPR (Feb. 22, 2022, 2:59 PM), https://www.npr.org/sections/health-shots/2022/02/22/1081898013/doctors-find-limited-use-for-less-effective-covid-pill [https://perma.cc/PZ66-M6XE] (“Data reviewed by the FDA showed molnupiravir was just 30% effective at cutting the risk of getting hospitalized with COVID-19. Paxlovid works much better, reducing the same risk by nearly 90%.”).
[122]. See David Sirota, Merck Wants Americans to Pay $712 for a Covid Drug That Taxpayers Helped Develop, GUARDIAN: OPINION (Oct. 14, 2021, 6:31 PM), https://www.theguardian.com/commentisfree/2021/oct/14/merck-drug-prices-us-healthcare-big-pharma [https://perma.cc/5Q2Z-8UJ3]; Deena Beasley, Price of COVID Treatments from Pfizer, Merck, GSK Align with Patient Benefits—Report, REUTERS (Feb. 3, 2022), https://www.reuters.com/business/healthcare-pharmaceuticals/price-covid-treatments-pfizer-merck-gsk-align-with-patient-benefits-report-2022-02-03 [https://perma.cc/END9-DJKD].
[123]. Michael Erman, Generic Drugmakers to Sell Pfizer’s Paxlovid for $25 or Less in Low-Income Countries, REUTERS (May 12, 2022, 1:08 PM), https://www.reuters.com/business/healthcare-pharmaceuticals/generic-drugmakers-sell-pfizers-paxlovid-25-or-less-low-income-countries-2022-05-12 [https://perma.cc/CGH6-HM6Q].
[124]. See e.g., 3 Reasons Why , supra note 117 (citing patents and intellectual property as a barrier to access COVID-19 treatments).
[125]. See generally Emma Farge, EXCLUSIVE WTO Faces New Battle Over COVID Tests, Drugs, REUTERS (July 7, 2022, 1:56 PM), https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-wto-faces-new-battle-over-covid-tests-drugs-2022-07-07 [https://perma.cc/GLL2-3MDR].
[126]. G.A. Res. 217 (III) A, Universal Declaration of Human Rights, art. 25.1 (Dec. 10, 1948), (establishing the right to “a standard of living adequate for the health and well-being” which includes “food, clothing, housing and medical care ”). /small>
[127]. G.A. Res. 2200A(XXI), International Covenant on Economic, Social and Cultural Rights, art. 12.1 (Dec. 16, 1966) (recognizing the right to “the enjoyment of the highest attainable standard of physical and mental health”).
[128]. Aurelie Walker, The WTO has Failed Developing Nations, GUARDIAN (Nov. 14, 2011,
10:49 AM), https://www.theguardian.com/global-development/poverty-matters/2011/nov/14/wto-fails-developing-countries [https://perma.cc/L2SS-X24P].
[129]. Id.
[130]. See generally Statement, Médecins Sans Frontières, Lack of A Real IP Waiver on COVID-19 Tools is a Disappointing Failure for People (June 17, 2022), https://www.msf.org/lack-real-ip-waiver-covid-19-tools-disappointing-failure-people [https://perma.cc/Y9WA-FSPA].
