From proposal to compromise: the TRIPS waiver debate and the crisis of WTO decision-making

Abstract

The Marrakesh Agreement, which established the World Trade Organization (WTO), permits WTO member countries to jointly decide to temporarily suspend certain obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The TRIPS Decision adopted at the 12th WTO Ministerial Conference in June 2022, following 20 months of extended negotiations during the COVID-19 pandemic, approved only a limited portion of the waiver proposal originally submitted by India and South Africa. Since the Decision was adopted, WTO members have faced a deadlock over whether to extend its scope to include COVID-19 diagnostics and therapeutics, despite being required by the Decision to reach a conclusion on this issue within six months. This paper re-examines the discussions surrounding the potential expansion of the Decision and argues that including COVID-19 diagnostics and therapeutics within its scope was both appropriate and necessary. In addition, the paper proposes ways to make effective use of TRIPS flexibilities during a pandemic, so that developing countries are not left dependent on unpredictable waiver negotiations. The paper also outlines possible approaches for reforming the waiver decision-making process, aiming to ensure that such decisions are made promptly and efficiently, without prolonged negotiations during times of emergency.

Clinical trial number Not applicable.

Introduction

There has been a challenging relationship between patent law and global public health, as the exclusive rights granted through patents often hinder the widespread production and fair distribution of innovative health technologies [1]. By allowing patent-holding companies to control production and limit competition from generic manufacturers, patents on medicines and vaccines can negatively affect their availability, affordability, and accessibility for patients [2]. Given the significant impact of patent protection on access to healthcare, particularly during public health emergencies, the TRIPS Agreement includes specific flexibilities designed to safeguard public health. Additionally, Article IX(3) of the Marrakesh Agreement Establishing the WTO outlines a temporary waiver from TRIPS obligations as a form of flexibility, intended to address urgent needs during exceptional circumstances [3].

The COVID-19 pandemic clearly constituted an exceptional circumstance. In response, India and South Africa invoked the flexibility provided under Article IX(3) of the Marrakesh Agreement and submitted a proposal to waive certain TRIPS obligations. However, following 20 months of prolonged negotiations, the WTO Ministerial Conference adopted a decision that granted only a limited waiver compared to what had originally been proposed [4]. This limited waiver applied only to COVID-19 vaccines. However, the TRIPS Decision also required WTO Members to determine, within six months, whether the waiver should be extended to cover COVID-19 therapeutics and diagnostics. Despite this mandate, developed country Members of the WTO opposed such an extension [5]. As a result, more than three years after the Decision was adopted, the issue of expanding its scope to include therapeutics and diagnostics remains unresolved.

This paper revisits the ongoing debate surrounding the TRIPS waiver proposal and the proposed extension of the Decision to COVID-19 diagnostics and therapeutics. It further explores how the WTOs decision-making process on waiver proposals can be improved and how existing TRIPS flexibilities can be effectively used to address public health emergencies such as a global pandemic. While the waiver debates have been examined in prior literature, this paper offers a combined legal, institutional, and equity-focused perspective that links past experiences of public health emergencies warranting use of TRIPS flexibilities (e.g., during HIV/AIDS) with COVID-19 and proposes a dual-track reform agenda that strengthens both global mechanisms and domestic implementation frameworks.

As of October 2025, the global death toll from COVID-19 has surpassed 7.1 million, according to the latest data reported by the World Health Organization (WHO) [6]. The absence of universal access to COVID-19 vaccines, diagnostics, and therapeutics has significantly contributed to the high global death toll. In the first and second years of vaccine distribution, low-income countries received only 0.89% and 4.71% of the total available doses, respectively [7].

These figures highlight the stark disparities in vaccine coverage, with high-income and upper-middle-income countries achieving over 80% coverage, compared to 66% in lower-middle-income countries and just 33% in low-income countries [8].

From the outset of the pandemic, discussions around the concept of ‘people’s vaccines’ emerged, even before any vaccines had been developed. The United Nations (UN) Secretary-General emphasized that ‘we must ensure that vaccines are seen as a global public good - people’s vaccines - accessible and affordable to all’ [9]. The President of the European Union, along with the heads of state from Canada, Norway, Italy, Germany, and France, affirmed that COVID-19 vaccines should be treated as a global public good [10]. In April 2020, the UN General Assembly adopted two resolutions that underscored the urgent need to rapidly expand the production of health technologies related to the pandemic [11]. At the Group of Twenty (G20) Leaders’ Summit held in March 2020, the following statement was issued:

We commit to take all necessary measures and seek to ensure adequate financing to contain the pandemic and protect people, especially the most vulnerable. We will share timely and transparent information; exchange epidemiological and clinical data; share materials necessary for research and development; and strengthen health systems globally [12].

Achieving broader and more diverse manufacturing capacity depended on ‘the unhindered global sharing of technology and know-how’ [13]. There was a noticeable absence of genuine solidarity in sharing technology and expertise. Despite public declarations by political leaders [14], these statements were not followed by meaningful actions to promote the widespread sharing of intellectual property rights, which is essential for enabling diverse manufacturing and ensuring fair access to COVID-19 vaccines, therapeutics, and diagnostics.

In April 2020, the WHO launched the COVID-19 Vaccines Global Access (COVAX) initiative as a public-private partnership aimed at promoting fair and equitable access by consolidating global demand for COVID-19 vaccines. However, COVAX was unable to fulfill its commitment due to vaccine supply shortages, largely driven by ‘vaccine nationalism’ in high-income countries [7]. While vaccines were still under development, wealthier countries leveraged their financial resources to secure advance purchase agreements [15].

In May 2020, the WHO introduced the COVID-19 Technology Access Pool (C-TAP) initiative, designed to establish a shared repository of knowledge by offering a platform for the voluntary sharing of intellectual property, technical expertise, and data related to COVID-19 vaccines and treatments [16]. C-TAP was designed with the purpose of supporting efforts to ‘accelerate the development of products needed to fight COVID-19 as well as to accelerate the products available globally’ [17]. The proposal to establish a global, non-exclusive licensing platform was firmly opposed by the biopharmaceutical sector, as vaccine technology holders declined to voluntarily license their patents or disclose technical knowledge. In its official statement, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) expressed clear criticism of the C-TAP initiative [18]. Entities holding vaccine-related rights, including Moderna, consistently declined requests for voluntary technology transfer made by the People’s Vaccine Alliance, C-TAP, and other organisations [19]. Voluntary licensing has significant limitations, as discussed in Section ‘The TRIPS waiver proposal in the context of the COVID-19 pandemic’.

Even before COVID-19 vaccines were created, lower-income countries anticipated that the typical practices of patent-holding companies during a pandemic could endanger global health, as only a few manufacturers would have control over the production and distribution of vaccines and other critical goods. Previous experiences with H1N1 and H5N1 vaccines in developing countries indicate that these concerns were well-founded [15]. The perceived shortcomings in the global response to COVID-19 created a backdrop for India and South Africa to present the TRIPS waiver proposal. As highlighted by the South African delegation in their opening remarks to the TRIPS Council:

[G]lobal cooperation and collaboration is key to addressing the COVID-19 pandemic; initiatives such as the COVAX facility are helpful but insufficient. Our waiver proposal is designed to work synergistically with such initiatives by enabling the rapid scaling of production by multiple producers across many countries, enabling sharing of knowledge and transfer of technology with the aim of addressing the pandemic [20].

The TRIPS waiver proposal in the context of the COVID-19 pandemic

On October 2, 2020, India and South Africa jointly presented a proposal to the TRIPS Council seeking a waiver of certain obligations outlined in specific provisions of the TRIPS Agreement. This proposal focused on COVID-19-related health technologies and included provisions concerning copyright and related rights, industrial designs, patents, and the safeguarding of undisclosed information, as specified in Sections ‘Introduction’, ‘The TRIPS Decision: Dilution of the Original Waiver Proposal’, ‘Deviation from WTO Rules Relating to TRIPS Waiver’, and ‘Inadequate use of TRIPS flexibilities in the global response to COVID-19’ of Part II of the Agreement [21]. India and South Africa recommended that the waiver remain in effect ‘until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity’ [21].

Waiver requests are expected to undergo a swift approval process. In accordance with Article IX(3)(b) of the WTO Agreement, such requests must be reviewed within a 90-day timeframe, after which the responsible Council must present a report to the Ministerial Conference [3]. Despite the urgency, advancement on the waiver request proceeded slowly. Critics of the proposal at the TRIPS Council argued that its original scope was excessively broad. As a result, the procedural requirements could not be fulfilled within the designated timeframe. In December 2020, the WTO General Council directed the Council for TRIPS to continue deliberations on the proposal [22].

During the General Council meeting on May 5, 2021, the WTO Director-General emphasised that ‘vaccine policy is an economic policy because the global economic recovery cannot be sustained unless we find a way to get equitable access to vaccines, pharmaceuticals and diagnostics’ [23]. On the same day, United States Trade Representative (USTR) Katherine Tai declared that the U.S. would endorse the waiver, while noting that its scope should be limited exclusively to vaccine patents [24]. The Biden-Harris administration cited ‘extraordinary times call for extraordinary measures’ [25]. Several other high-income countries, including Canada, demonstrated a greater willingness to engage with the waiver proposal.

To help bridge differing views, India and South Africa, together with their co-sponsors, submitted a revised proposal on May 21, 2021. This version proposed that the waiver remain in effect for a minimum of three years from the date of adoption, with provisions for annual review [26]. The updated proposal refined the definition of COVID-19 health technologies to include ‘health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19’ [21]. The scope of technologies and products included in the proposed waiver, along with its duration, was clearly defined in an effort to enhance its acceptability among high-income countries and other relevant stakeholders.

On June 18, 2021, the European Union put forward an alternative proposal that recommended modifying the existing compulsory licensing provisions outlined in Articles 31 and 31bis of the TRIPS Agreement, rather than endorsing a waiver [27]. The alternative proposal suggested that ‘the exporting Member may provide in one single notification a list of all countries to which vaccines and medicines are to be supplied by the exporting Member’ [27]. The proposal was narrowly framed, primarily aiming to simplify export-oriented compulsory licensing by allowing a single notification to cover multiple recipient countries. This patent-focused counterproposal served as the foundation for ‘compromise’ negotiations among India, South Africa, the European Union, and the United States - the Quad members [19].

Assessing the principal counterarguments to the TRIPS waiver proposal

The revised proposal garnered support from over 100 countries, alongside more than 300 civil society organisations, the WHO, Unitaid, South Centre, and other international entities. It was also endorsed by legislators across various jurisdictions, numerous scholars, and a range of political figures [28]. Despite the clear challenges arising from the exclusive rights held by patent-owning corporations, numerous developed countries - such as the United Kingdom, the European Union, Switzerland, Norway, Japan, Canada, and Australia - firmly resisted the waiver proposal, advocating instead for maintaining the existing framework or implementing only limited changes to the compulsory licensing system [29]. This section examines the credibility of the arguments presented in opposition to the waiver proposal.

Intellectual property rights are not a barrier to access

Critics of the waiver maintained that intellectual property was not the primary barrier to accessing COVID-19 health technologies, asserting that there was no reliable evidence indicating that intellectual property rights had restricted access [30]. During discussions at the TRIPS Council, the European Union asserted that there was ‘no indication that IPRs issues have been a genuine barrier in relation to COVID-19-related medicines and technologies’ [20]. Likewise, the IFPMA stated:

While we share a number of the objectives of access and cooperation of the “Solidarity Call to Action,” we disagree with some of its premises, as they imply that intellectual property (IP) rights that are not waived or licensed globally are potential barriers to R&D, public-private collaborations or access to COVID-19 products. This does not correspond to our experience and may be counterproductive to achieving the objectives of the Solidarity Call to Action [18].

In November 2020, Australia, Canada, Chile, and Mexico expressed doubts about the need for the waiver, aligning with the view held by its opponents that intellectual property rights were not obstructing access to COVID-19 health technologies [31]. Also in November 2020, the G20 summit convened in Riyadh, where the Leaders’ Declaration affirmed: ‘We recognize the role of extensive immunization against COVID-19 as a global public good’ [32]. Nevertheless, the G20 stated that intellectual property ‘has not been an impediment to the common goal of ending this pandemic’ [32].

On the other hand, supporters of the waiver contended that it was essential for enabling timely and equitable access to COVID-19-related health technologies by eliminating intellectual property barriers that hindered the decentralised production of these goods [31]. In a letter addressed to the USTR, several distinguished scholars - including Graham Dutfield, Srividhya Ragavan, and Ana Santos Rutschman - argued that ‘patents protecting pharmaceuticals remain an important barrier although a vast spectrum of medical products required to deal with the pandemic such as diagnostics, therapeutics, vaccines are protected as private property using other forms of intellectual property as well’ [33].

In an effort to minimize the perceived influence of intellectual property protections on access, critics of the waiver maintained that the primary obstacles to supply and accessibility include insufficient public healthcare infrastructure, trade limitations, regulatory challenges, and constraints related to logistics, transportation, and storage [34, 35]. In the past, companies holding patents have tended to overstate the difficulties related to logistics and infrastructure in low-income countries. For instance, in 2000, when global attention turned to the issue of access to HIV/AIDS treatment, these companies argued that the primary barrier was the lack of sufficient public healthcare infrastructure. This claim was ultimately unsuccessful in shifting attention away from the core issue—the unaffordability of patented treatments, which cost over USD 10,000 per patient annually. Once generic alternatives became available, the cost dropped significantly to USD 61 per patient per year [36].

If intellectual property truly plays no significant role, it is worth questioning why patent-holding corporations so strongly oppose even a temporary waiver of TRIPS obligations. The pharmaceutical industry’s firm resistance to the waiver indicates that they perceive it as a threat to their control over the production and distribution of COVID-19 vaccines, treatments, and diagnostic tools. Supporting this perspective, a patent landscape report by the World Intellectual Property Organization (WIPO) found that a total of 7758 patent applications were filed between January 2020 and September 2022 in relation to COVID-19 technologies more broadly, of which 4787 pertained to COVID-19 therapeutics and 1298 concerned COVID-19 vaccine development [37]. On the one hand, pharmaceutical companies actively pursued intellectual property protections to strengthen their monopoly power; on the other hand, they simultaneously claimed that intellectual property was not a barrier.

Another argument put forward against the waiver was that it could place pressure on the limited supply of highly specialised raw materials and components required for the production of COVID-19 vaccines. Pfizer CEO Albert Bourla expressed concern that the implementation of the waiver could potentially trigger a global competition for raw materials, thereby posing risks to the safe and efficient production of COVID-19 vaccines [38]. A report published by the Center for Strategic and International Studies in November 2021 stated that ‘waiving IP protections would not lead to the manufacture of a single additional dose of a vaccine. One key reason is that there is currently no capacity to make more; production facilities are running at full tilt, and the supply of key ingredients in the manufacturing process has already been fully tapped’ [39].

On the one hand, patent-holding corporations cautioned that the waiver would hinder vaccine production due to increased competition for raw materials. On the other hand, they asserted that, with exclusive control over manufacturing, they could produce enough vaccines to meet global demand. This contradiction implies that sufficient raw materials and ingredients were available. The underlying concern for these corporations was not resource scarcity, but rather the need to maintain monopoly control over production to maximise profits. Regrettably, preserving this absolute control appears to have become an end in itself.

Voluntary licensing mechanisms and existing TRIPS flexibilities are sufficient

One of the central claims made by opponents of the waiver was that it was entirely unnecessary, as the objectives of global cooperation and large-scale manufacturing could be achieved through voluntary licensing agreements. Opponents of the waiver contended that innovators in the life sciences sector had already engaged in extensive voluntary licensing of intellectual property rights to facilitate the production of COVID-19 vaccines and therapeutics, suggesting that voluntary licensing was sufficient to support global production and access [34]. The Biotechnology Innovation Organization (BIO) contended that the most effective strategy for broadening access to COVID-19 vaccines and treatments was the voluntary collaborative approach, whereby innovators shared their expertise with manufacturing partners [40]. A limited number of examples have been cited to support these claims. Oxford/AstraZeneca entered into a voluntary licensing agreement with the Serum Institute of India. Similarly, Johnson & Johnson negotiated a voluntary contract with Aspen Pharmacare in South Africa [19].

Despite the claims of effectiveness, voluntary licensing has proven to be an insufficient mechanism for ensuring equitable access to COVID-19-related technologies. These agreements are often geographically restricted, lack transparency, and impose regulatory hurdles that exclude large segments of the global population [41]. For instance, licenses for Paxlovid and molnupiravir through the Medicines Patent Pool (MPP) excluded significant regions in Latin America and the Middle East [41]. Medecins Sans Frontiers (MSF) reports that Latin American countries are likely to encounter difficulties in obtaining access to Paxlovid until at least 2041, due to Pfizer’s decision to file patents across all of these countries [42]. Another example is the MPP’s licensing agreement for molnupiravir, which restricts supply to nearly half of the world’s population [36]. Many licensees are also subject to stringent regulatory prequalification processes that delay access [43]. Further, technology holders have routinely denied licensing requests from qualified manufacturers in developing countries [41], or often include restrictive provisions in these agreements to maintain control over both the production process and the distribution of the product [44] These structural limitations illustrate that voluntary licensing, while helpful in limited contexts, cannot substitute for more robust and enforceable access mechanisms such as a comprehensive waiver.

These limitations associated with voluntary licensing have also been clearly acknowledged in the United States International Trade Commission (USITC) report titled ‘COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities’. The report states that:

… the substantial control maintained by the licensor can give rise to disadvantages in terms of access to medicine in LICs, LMICs, and UMICs. First, the licensor determines what IP rights and products are made available to licensees. There is no assurance that the most successful or most needed treatments will be made available for licensing. Second, licensors control the countries to which licensees may export their products and the countries that may obtain access through imports from licensees. … Third, BLAs (voluntary licenses) generally are not published; this means complete information about the terms and conditions of the agreements is not available. This lack of transparency makes it difficult for the public to assess competing claims about the advantages and limitations of the agreements’ terms and conditions [43].

Even when licenses are granted or waivers implemented, many developing countries lack the requisite biomanufacturing capacity, including specialized technology, equipment, and skilled labour. This underscores the need for accompanying technology transfer and infrastructure investment [45].

A central argument raised against the proposed waiver was that the TRIPS Agreement already contains sufficient flexibilities to respond to a public health emergency. However, given the scale and urgency of the COVID-19 crisis, it is difficult to maintain that these flexibilities are adequate. Despite this, opponents of the waiver contended that it was unnecessary, as the TRIPS Agreement permits the use of compulsory licensing.

Although the term ‘compulsory licensing’ is not explicitly used, Article 31 of the TRIPS Agreement outlines a series of conditions under which a non-voluntary license, or ‘other use without authorization of the right holder’, may be granted. The effectiveness of this mechanism is weakened by the requirement to address each product and each country individually. Coordinating non-voluntary licenses across multiple jurisdictions for COVID-19 vaccines, which rely on complex global supply chains, is not a practical policy solution when rapid action is essential. The consequences of relying on this flexibility are outlined as follows:

The negotiation is complex, costly, and often inefficient because a) it needs a previous negotiation with the patent holder as a pre-condition and for the establishment of adequate remuneration; b) they are case-by-case and product-by-product; c) a compulsory license applies only to technologies already patented and not those in the pipeline; d) the technical and institutional inability of many countries to deal with compulsory license, especially when it comes to forms of protection other than patents; e) they mainly serve to supply the domestic market and the case of issuing licenses to supply countries without productive capacity is even more complex and costly [46].

Under Article 31 of the TRIPS Agreement, a non-voluntary license may be granted for a patent, but this provision does not extend to other categories of intellectual property rights (IPRs). This limitation becomes particularly significant when a product or technology is protected by multiple forms of IPRs. Even in cases where patent protection alone applies, challenges remain due to the presence of numerous patents held by different right holders across various countries. As noted by MSF:

[W]hen it comes to products like vaccines, patents may exist at many stages of the development, production and delivery process. The COVID-19 vaccine portfolio involves numerous novel platforms and technologies, such as mRNA. Patents may cover specific strains, adjuvants, antigen production and other such elements. These background patents are frequently owned by different entities in different countries, adding great complexity, as well as potential legal risks, even where compulsory licensing tools are available [47].

Navigating a complex patent landscape is often burdensome and time-intensive, requiring prior art searches and other forms of due diligence. The effective utilisation of non-voluntary licensing mechanisms for COVID-19 vaccines is constrained by multiple factors. These include the absence of comprehensive information regarding the complex network of potentially applicable patents, insufficient transparency around manufacturing and regulatory procedures, and the undisclosed terms of cross-licensing arrangements. Moreover, limited access to the contents of relevant patent applications - many of which remain unpublished by the respective patent offices - further complicates the preparation of compulsory licensing applications [48].

The mechanism of non-voluntary licensing is burdened with numerous restrictions and practical challenges. It does not offer a streamlined pathway to enhance access. It is too slow to be effective in emergency situations and fails to provide a global solution, as patents are territorial and such licenses must be issued under the national laws of individual countries.

Less affluent countries are often hesitant to issue non-voluntary licenses due to concerns about potential trade retaliation from developed countries and patent-holding corporations [49]. There are concerns that invoking the process for issuing a non-voluntary license may expose lower-income countries to the risk of trade sanctions and a reduction in foreign direct investment (FDI) [49]. The USTR Special 301 Reports have routinely criticized countries attempting to exercise these flexibilities. Even during the COVID-19 pandemic, the 2020 Special 301 Report criticised countries for issuing, threatening to issue, or encouraging the use of non-voluntary licensing mechanisms [50]. Pfizer strongly opposed the application for a non-voluntary license for Paxlovid in the Dominican Republic, invoking a human rights-based defence [51].

Export-oriented non-voluntary licensing under Article 31bis of the TRIPS Agreement presents even greater challenges [52]. Canada’s Access to Medicines Regime (CAMR), which operationalises Article 31bis of the TRIPS Agreement, is highly complex and difficult to navigate without legal expertise. The legislation comprises 19 sections and over 100 clauses and sub-clauses. Reflecting on the challenges of using export-oriented non-voluntary licensing under this framework, Tanzania’s High Commissioner to Canada remarked: ‘It’s not that we don’t want to do it. It’s just that we haven’t because … all the bureaucratic, administrative, and legal requirements take a lot of time … The system is too complicated’ [53].

The Bolivia-Biolyse case illustrates the practical difficulties associated with export-oriented non-voluntary licensing. In February 2021, Bolivia formally notified the WTO of its intention to procure COVID-19 vaccines from the Canadian generic manufacturer Biolyse Pharma, using the export-oriented licensing mechanism outlined in Article 31bis of the TRIPS Agreement [54]. Since March 2021, Biolyse Pharma has made repeated efforts to initiate the process, but has yet to make any progress. The reliance on existing flexibilities, which have proven to be impractical, has not offered a viable or effective means of expanding access to essential health products during times of crisis.

Compounding these structural and legal barriers is the limited regulatory and institutional capacity in many developing countries [4]. Effective use of TRIPS flexibilities, such as compulsory licenses, requires significant technical expertise in patent law, regulatory approvals, and international procurement procedures [55]. The absence of coordinated support structures—either from the WTO or WHO—means that these mechanisms remain legally available but practically inaccessible to many countries [56]. This gap must be recognized and addressed to ensure equitable global access to essential medical technologies.

Concerns about the potential adverse impact of TRIPS waiver on innovation

Critics of the waiver argued that bypassing intellectual property protections could weaken incentives for future research and development, thereby undermining innovation [57]. Certain stakeholders described the waiver as an act of ‘international disrespect for IP’ and ‘IP theft’, expressing concerns that it could severely harm the future of medical science by weakening incentives for innovation in the biopharmaceutical sector [58]. On one hand, critics of the waiver maintained that it would have no impact, arguing that intellectual property is not a barrier. On the other hand, they contended that the waiver could seriously undermine their future operations.

There is no reliable evidence to substantiate the claim that enhancing patent protection leads to increased innovation [59]. The relationship between patent protection and innovation remains complex and contested. While some argue that stronger intellectual property rights incentivize innovation, others point to empirical studies showing that such protections may hinder access or stifle follow-on innovation in certain contexts [60, 61]. There is evidence indicating that patents may, in some cases, hinder innovation [1, 62]. When patents are controlled by a single entity, they can obstruct innovative efforts due to expensive and prolonged legal disputes, which may delay or prevent significant medical breakthroughs. This issue was exemplified by recent conflicts over mRNA technology patents [63].

The argument that innovation was under threat appears unconvincing in the exceptional context of COVID-19 vaccines, due to two main reasons. First, the development of vaccines and treatments was heavily supported by public funding and subsidies. In 2020, for example, the United States government provided over USD 19 billion in financial support to seven potential manufacturers through the Biomedical Advanced Research and Development Authority (BARDA), along with tax incentives [64]. A number of COVID-19 vaccines were based on technologies developed by universities, such as the University of Pennsylvania and Oxford University, as well as public institutions, including the United States National Institutes of Health [48]. The advancement of mRNA technology was made possible through decades of research and development, supported by billions of dollars in government funding [65].

The second key factor was the use of advance market commitments to reduce financial risks. In addition to receiving direct public funding for research and development, patent-holding companies were able to limit their investment exposure by entering into advance purchase agreements with national governments across various countries, as well as with international organizations such as the Global Alliance for Vaccines and Immunizations (GAVI) and the Coalition for Epidemic Preparedness Innovations (CEPI) [66]. Even before their vaccines and treatments were proven to meet safety and efficacy standards, manufacturers were assured of a substantial and urgently awaiting market - essentially, the global population. Given the ongoing worldwide demand for COVID-19 vaccines, profitability has not been a concern. Vaccine producers have already made unprecedented profits. Therefore, the claim that investments in research and development will not be recovered lacks foundation.

The TRIPS decision: dilution of the original waiver proposal

On June 17, 2022, the 12^th WTO Ministerial Conference adopted a Ministerial Decision concerning the TRIPS Agreement [67]. Negotiations to reach this limited five-year waiver took nearly 20 months. During this period, COVID-19 continued to claim millions of lives and caused widespread economic disruption, despite the availability of vaccines and treatments. The unequal distribution of these medical resources allowed the pandemic to disproportionately affect the health and livelihoods of many, while discussions on the waiver remained stalled at the WTO. Supporters of the waiver sought to emphasise a sense of ‘shared urgency’, whereas opponents focused on framing the issue as one of ‘technical complexity’ and argued for the need for further deliberation [10]. Opponents of the waiver repeatedly raised obstructive questions that had already been addressed in detail through various formal written submissions.

The scope of the Decision is narrowly limited to COVID-19 vaccines. The final outcome of the prolonged negotiations largely reflects the positions of high-income countries. In alignment with the European Union’s stance, the Decision identifies compulsory licensing as the preferred solution. Beyond reaffirming and clarifying provisions already permitted under the TRIPS Agreement, its most notable feature is the waiver of export restrictions under Article 31(f), thereby enabling the export of COVID-19 vaccines to eligible countries.

The outcome of the prolonged debate represents only a small portion of the original proposal. The final Decision bears little resemblance to the initial waiver request in terms of both scope and potential impact. James Love highlighted that the original proposal submitted by India and South Africa in 2020 sought to waive 40 provisions of the TRIPS Agreement. In contrast, the eventual compromise resulted in the waiver of only a single, 20-word paragraph within one article - specifically, the provision concerning exports under a non-voluntary authorisation [68].

Footnote 1 further restricts the scope of the Decision. While it initially states that ‘all developing country Members’ qualify as ‘eligible Members’, it subsequently adds that ‘Developing country Members with existing capacity to manufacture COVID-19 vaccines are encouraged to make a binding commitment not to avail themselves of this Decision’ [67].

Due to its highly restricted scope, the Decision has faced criticism from over 300 civil society organizations [19]. Health advocates in South Africa have described the Decision as ‘a massive step back’ and ‘a slap in the face’ [69]. The following statement by Indian Commerce Minister Piyush Goyal clearly reflects India’s view that the outcome favours maintaining the status quo.

My own sense right now with the number of meetings that are being held and with the number of green room engagements, is that the effort they are putting in, is more to showcase to the world that ‘Oh! We found a wonderful solution, we agreed with 80 countries or more to give a TRIPS waiver’. Now the common man does not understand that this is nothing near a TRIPS waiver, they do not understand that this is a little elevation from compulsory licensing [70].

What began as a call for global solidarity and health equity concluded with a minimal outcome shaped by developed countries and acceptable to patent-holding corporations. The Decision was not only limited in scope but also incomplete, as no consensus could be reached on extending the waiver to COVID-19 diagnostics and therapeutics, despite nearly two years of negotiations during the height of the pandemic. The delay in addressing this extension reflects poorly on the WTOs capacity to respond effectively to urgent public interest issues.

The shortcomings of the TRIPS waiver process during COVID-19 echo earlier challenges seen during the HIV/AIDS crisis. In the early 2000s, access to antiretroviral (ARV) treatments was limited by similar patent barriers, until the Doha Declaration affirmed the right of WTO Members to prioritize public health. That episode eventually led to broader use of compulsory licensing and greater access to generics. In contrast, the COVID-19 waiver process yielded far fewer practical outcomes, suggesting that the global intellectual property regime may have become more resistant to reform. This comparison underscores the need for stronger institutional mechanisms that automatically activate access safeguards during global health emergencies.

Looking forward, WTO Members must consider codifying pre-approved waivers or fast-track protocols for intellectual property suspension during future pandemics, whether related to infectious diseases, antimicrobial resistance, or climate-related health crises. The experience of COVID-19 should inform a new global compact - one that does not leave access to essential technologies at the mercy of prolonged negotiations or political brinkmanship.

Deviation from WTO rules relating to TRIPS waiver

The extended discussions on the TRIPS waiver initiative and the resulting postponement in the endorsement of the final Decision after nearly 20 months also highlight systemic issues concerning the gap between regulations and actual procedures in the WTO with respect to the mechanism of approving a waiver.

Article IX(3) of the Marrakesh Agreement provides that the Ministerial Conference may opt to waive such responsibilities under the covered agreements, in extraordinary situations. What qualifies as extraordinary situations are not clarified in the legal provision. Hence, it is left to the judgment of the Ministerial Conference to assess whether an extraordinary situation is present, which would justify the waiver of specific responsibilities under a covered agreement.

Furthermore, although ordinarily decisions are to be made by consensus as outlined in Article IX(1), a decision on waiving an obligation under a covered agreement may be reached without consensus if three-fourths of WTO Members vote to approve the waiver. This is evident from the fact that while Article IX(3)(a) mentions that a waiver of an obligation under the Marrakesh Agreement must be decided by consensus, Article IX(3)(b) does not explicitly mandate a consensus-based decision for waiving obligations under a covered agreement. This implies that a decision to waive an obligation under a covered agreement may be approved by a three-fourths majority. Therefore, Article IX(3) is structured to ensure that absence of consensus does not hinder the approval of a waiver if a sufficient majority of WTO Members support the waiver of an obligation under a covered agreement.

The Marrakesh Agreement also specifies the timeframe within which a decision on a waiver must be made. In relation to waivers of any responsibility under a covered agreement, the corresponding WTO body associated with that agreement is obligated to examine a waiver request and submit a report to the Ministerial Conference within a duration not exceeding 90 days from the date of the request [3]. There is no stipulation for consensus in the concerned body regarding a requested waiver. The concerned body is merely required to present a report to the Ministerial Conference outlining the opinions shared by members during the evaluation of the waiver request [70].

It should further be observed that the WTO body overseeing the covered agreement in connection with which a waiver request is submitted is neither mandated nor anticipated to decide on the waiver [70]. It is solely tasked with reviewing the request and submitting a report to the Ministerial Conference. When the Ministerial Conference is not convened, such a report is to be presented to the General Council acting in the capacity of the Ministerial Conference. The determination on whether to approve the waiver is to be made by the Ministerial Conference (or the General Council fulfilling the role of the Ministerial Conference). This determination does not have to rely on the recommendation of the relevant WTO body.

Hence, from a legal standpoint, the Ministerial Conference may approve by a three-fourths majority a decision granting an exemption from specific responsibilities under a covered agreement, provided that the waiver application has been submitted for review within a timeframe not exceeding 90 days, in the appropriate WTO body. Once a waiver application has been reviewed in the appropriate WTO body within the prescribed 90-day period, the Ministerial Conference is required to make a decision promptly, either through consensus or, in the absence of consensus, by a majority vote. It is not within the members’ prerogative to request a decision by vote [71]. The provisions implicitly oblige the Ministerial Conference to decide by vote and not postpone the decision to allow for the possibility of future consensus by referring the application back to the appropriate WTO body.

Nevertheless, the TRIPS waiver application was not resolved in accordance with the procedure prescribed under WTO law. The waiver application was reviewed in the TRIPS Council, which forwarded a report to the General Council recommending continued examination of the issue, a recommendation that was accepted by the General Council. This resulted in prolonged deliberations in the TRIPS Council that yielded no tangible resolution but effectively postponed decision-making. The approach taken by WTO Members in handling the waiver application conflicted with both the literal interpretation and underlying intent of the Marrakesh Agreement.

In its initial report to the General Council on the result of the examination of the waiver proposal, the TRIPS Council highlighted the presence of differing opinions between developed and developing countries and asked the General Council to allow additional time for reviewing the proposal [72]. Although the General Council accepted this request, it marked the first violation of the procedure under Article 9 of the Marrakesh Agreement related to decision-making on a waiver under a covered agreement. Once the proposal had been reviewed in the TRIPS Council and 90 days had passed since its submission, Article IX of the Marrakesh Agreement mandates that a decision be made by the Ministerial Conference, or by the General Council when the Ministerial Conference is not convened. In the event of no consensus within this timeframe, Article IX obliges that a decision be reached through a majority vote [3]. Article IX(3)(a) explicitly provides that, ‘If consensus is not reached during the time-period, any decision to grant a waiver shall be taken by three fourths of the Members’ (emphasis added) [3].

Instead of making a decision to address an emergency for which the waiver was proposed, although the Marrakesh Agreement had adequately authorized the Ministerial Conference and the General Council to take such a decision without indefinitely pursuing consensus, the conduct of WTO Members was inconsistent with this provision. This allowed WTO Members who opposed or questioned the validity of the TRIPS waiver proposal to prolong the deliberations in the TRIPS Council.

Therefore, it will be essential that the process of decision-making concerning a waiver under a covered agreement is further refined to remove discretionary conduct by WTO Members that could hinder timely decision-making on a waiver application under the guise of fostering consensus. This could be pursued as part of the pledge made by the 12th Ministerial Conference to overhaul the operations of the WTO in all dimensions. As an element of these reforms, WTO Members should explore enhancing the decision-making provisions related to a waiver to avoid any further prolongation of the period for reviewing the application in the relevant Council.

Expansion of the TRIPS decision to include therapeutics and diagnostics

It is noted in Paragraph 8 of the Decision that: ‘No later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics’ [67]. Members had until December 17, 2022, to reach this decision. Nevertheless, even after the deadline was postponed by the General Council, consensus could not be achieved on extending the Decision at the thirteenth Ministerial Conference (MC13) held in Abu Dhabi in 2024.

On December 16, 2022, the USTR requested the USITC to carry out an investigation regarding the merit of extending the Decision to COVID-19 diagnostics and therapeutics [73]. It is difficult to comprehend why the USTR did not initiate this investigation earlier, given that it had been reviewing the waiver application since October 2020 and the unresolved matter of diagnostics and therapeutics since June 2022. Although the USITC has undertaken a significant responsibility, the deliberations of a single institution from a single Member should not disproportionately shape a decision of global importance.

The USITC report released in October 2023 found that, ‘Determining a definitive scope of what products are covered by the terms “diagnostics” and “therapeutics” as they pertain to COVID-19 and what constitutes relevant COVID-19 diagnostics and therapeutics covered by patents is complicated and subject to interpretation’ [43]. Regarding the future demand for COVID-19 diagnostics and therapeutics, the report notes that such an assessment would rely on the consideration of several underlying factors [43]. Indeed, there is considerable variation in the projections of the demand for COVID-19 therapeutics and vaccines compiled from the different sources cited in the report [43]. The report also highlights the extensive scope of patenting related to COVID-19 diagnostics and therapeutics [43].

Diagnostics and therapeutics form a vital component of the WHOs COVID-19 response framework [74]. On January 30, 2023, the 14th session of the WHO International Health Regulations (IHR) Emergency Committee advised that Members should enhance access to COVID-19 diagnostics and therapeutics for their populations [75]. During this meeting, the Director General of WHO voiced concern that ‘the COVID-19 response remains hobbled in too many countries unable to provide these tools [vaccines, diagnostics, and therapeutics] to the populations most in need’ [75]. He earlier stated in December 2022 that ‘access to diagnostics and life-saving treatments for COVID-19 remains unacceptably unaffordable and unequal’ [76]. This illustrates that there was a necessity to promptly and unequivocally broaden the scope of the Decision to include these tools.

Although WHO ended the public health emergency declaration in 2023, it issued Standing Recommendations [77] that have been extended till 30 April 2026 [78, 79] urging continued equitable access to COVID-19 tools. Legally, the Decision was not tied to WHO’s emergency status but to defined timelines (for 5 years, renewable) and product categories under WTO law. Re-evaluation of the waiver remains necessary to ensure lasting access, especially with variants continuing to emerge and vulnerabilities persisting across populations [80].

There was no legal obstacle to broadening the scope of the Decision beyond vaccines to include diagnostics and therapeutics. On the contrary, it would have constituted a balanced legal approach to promote global equitable access by allowing other companies the operational freedom to export diagnostics and therapeutics to developing countries without the risk of patent-related litigation. It would have also offered legal clarity to WTO Members, assuring them that they would not be subject to complaints from other Members under WTO regulations. This section examines the legitimacy of the arguments opposing the extension of the Decision to COVID-19 diagnostics and therapeutics.

Limited global demand for COVID-19 diagnostics and therapeutics

The pharmaceutical sector maintained that availability is not a concern. The interest in COVID-19 tests and treatments is minimal as indicated by the quantity of purchases. The opposing view was that the interest in COVID-19 tests and treatments has been deliberately limited. The costs of tests and treatments are prohibitive for countries with low and middle incomes. The expense of these resources and the absence of reasonably priced supply alternatives are the primary factors behind limited interest [81]. As illustrated by Wallach, ‘the lack of formal demand measured in orders is a measure of lack of affordable supply, not lack of need’ [65]. Likewise, Baker noted that the determination of required quantities should be based on actual need rather than on expressed market demand, which has been adversely affected by high pricing and supply constraints [82].

The cost of treatments affects their real-world demand. A senior health official in South Africa said that the government had no plans to buy Paxlovid for public sector patients because of its ‘extremely expensive’ price [83]. Dr Marco Tovar, Medical Director at Socios en Salud (Partners in Health) said, ‘so long as the [COVID-19] medicines are expensive, they are not going to include them (in the treatment regimen)’ [84]. Although there was a worldwide demand for WHO-recommended COVID-19 treatments, the high price largely benefited wealthier countries. For example, the initial half-year supply of Paxlovid was allocated to affluent countries, particularly the United States [82].

The majority of current COVID-19 therapies are extensively protected by patents [85]. Generic production of existing COVID-19 treatments is limited by numerous patents issued in developing countries with the capability to produce generic medicines [85]. There are global shortages of treatments, such as Paxlovid [37, 72, 81]. Baker noted in March 2023 that a significant proportion of individuals in developing countries continued to face delays in accessing therapeutics and diagnostics mainly because of high costs, supply shortages during periods of heightened demand, and the lack of commercial interest among major diagnostics and biopharmaceutical corporations in making their products available across many developing country markets [82].

The cost of current COVID-19 tests is significantly above the expense of manufacturing. As noted by Baker, ‘the estimated cost of production for Cepheid’s GeneXpert COVID-19 diagnostic test is just US$3–5 per test, yet Cepheid is charging US$14.90 in developing countries, at least 3 times the estimated cost of production’ [82]. It is worth highlighting here that Cepheid secured no less than USD 252 million in governmental and charitable support to create GeneXpert [86].

The lack of access to testing also plays a role in the limited uptake of treatments. In the absence of diagnostics, cases remain undocumented. As per the WHOs estimation, six out of every seven COVID-19 cases go undetected in Africa [87]. As reported by the UN, by the close of 2022, developing countries had conducted 468,767 COVID-19 tests per million people, in contrast to 3,340,753 tests per million individuals in developed countries [88]. If infections go unreported, the need for treatments does not correspond to the true population-level requirement because there is no precise measurement of infection prevalence within the community [41].

The argument of limited demand does not hold true for numerous upcoming diagnostics and therapies that are still in development and not yet introduced to the market. As highlighted by the United States Food and Drug Administration (FDA) in June 2023, ‘many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19’ [89]. Based on the BIO COVID-19 Therapeutic Development Tracker, as of June 2023, 35 therapies were in the advanced clinical trial stage, while 55 were undergoing preclinical evaluation [90].

Negative impact of the TRIPS waiver on commercial revenues and profitability

One of the objections to broadening the scope of the Decision to include diagnostics and therapeutics was the concern that it would result in significant financial losses for patent holders. Corporations holding patents attempted to convey the misleading notion that the Decision had nullified the entire TRIPS Agreement, suggesting that their technologies would be freely distributed without any legal safeguards [5]. However, this interpretation is inaccurate, as the Decision only waived a single provision related to compulsory licensing, and its scope remains very narrow. Expanding the Decision could have facilitated greater access by simplifying the process of using compulsory licences to export COVID-19 diagnostics and therapeutics to developing countries. Under Article 31(h) of the TRIPS Agreement, patent holders would still receive royalty payments. Paragraph 3(d) of the Decision explicitly confirmed the requirement for ‘adequate remuneration’. As Wallach correctly observed, ‘the reason for the pharmaceutical industry’s unhinged response is that even something as modest as a right to export generics that the WTO already permits to be produced is viewed as a threat to industry’s absolute monopoly control over access to medicines’ [65].

Broadening the scope of the Decision to include COVID-19 diagnostics and therapeutics would not have negatively impacted the earnings of pharmaceutical companies based in developed countries, due to the Decision’s limited and purpose-specific nature, which applies exclusively to developing countries [67]. To safeguard the commercial interests of patent-holding corporations in developed countries, the Decision incorporated an additional protective measure in the form of anti-diversion provisions. Specifically, Paragraph 3(c) of the Decision prohibited the re-export of products that were manufactured and imported under its terms: ‘Members shall ensure the availability of effective legal means to prevent the importation into, and sale in, their territories of products manufactured under the authorization in accordance with this Decision, and diverted to their markets inconsistently with its provisions’ [67, 87].

Furthermore, expanding the scope of the Decision would not have undermined incentives for innovation, as the majority of COVID-19 treatments are not newly developed compounds resulting from substantial research and development efforts. Instead, they are based on existing compounds that are used to treat various medical conditions. According to WIPO’s patent landscape report, most COVID-19 therapeutics were adapted for new applications through repurposing [37]. Repurposed drugs for COVID-19 include Remdesivir, Tocilizumab, Itolizumab, Casirivimab/Imdevimab, Sarilumab, and Baricitinib [91]. These drugs, developed to treat other medical conditions, showed some positive effects on COVID-19 patients. Some other existing drugs may also be included in the prescription for COVID-19 patients. As noted by the FDA, ‘researchers are studying drugs that are already approved for other health conditions as possible treatments for COVID-19’ [92]. This approach of repurposing existing treatments arguably involved relatively low research and development expenditure.

An additional argument raised against extending the Decision is the concern that it could impact the revenues of patent-holding corporations, as therapeutics authorised for COVID-19 treatment might be redirected for use in addressing other medical conditions [93]. The Decision can only be used for COVID-19 [67]. As noted by Wallach, ‘even if treatments have multiple uses, the TRIPS Decision text very specifically applies only to COVID-19 uses. There is no possibility to use the Decision text or its prospective extension to treatments and tests to treat other diseases’ [65]. In addition, Article 31(c) of the TRIPS Agreement specifies, in the context of compulsory licensing, that ‘the scope and duration of such use shall be limited to the purpose for which it was authorized’ [94].

Concerns relating to product safety and quality assurance standards

Patent-holding corporations contended that extending the Decision to include COVID-19 diagnostics and therapeutics could compromise the safe and effective production of these medical tools. They argued that such concerns might undermine public confidence in treatments due to the potential risk of counterfeit products or a decline in quality and regulatory standards.

The assertions regarding a potential decline in quality and standards are largely speculative. Across various regions, numerous facilities possess the capability to produce safe and effective diagnostics and therapeutics. Several developing countries - including India, South Africa, Brazil, Indonesia, and Thailand - have established manufacturing capacity for these medical products [95]. Generic manufacturers in the Global South have a long-standing history of producing generic medicines that match the quality of original branded products. Their reliability is widely recognised and trusted by populations around the world.

The biopharmaceutical industry operates under strict regulatory oversight. The quality of COVID-19-related products could not have been compromised, as all new manufacturers are subject to rigorous pharmaceutical standards and compliance requirements [66]. Manufacturers would have been required to secure marketing authorisation from the national drug regulatory authority in each respective country. Therefore, the argument concerning compromised safety appears to be a baseless and exaggerated narrative advanced by patent-holding corporations.

The WHO’s declaration marking the end of the COVID-19 pandemic

It may also be argued that there was no longer a need to expand the Decision to include therapeutics and diagnostics, given that the COVID-19 pandemic had officially ended. Although the WHO Director-General declared in May 2023 that COVID-19 no longer constituted a public health emergency of international concern, the WHO issued Standing Recommendations in August 2023. These recommendations, among other points, urged States Parties to the International Health Regulations (2005) to continue efforts to ensure equitable access to safe, effective, and quality-assured medical countermeasures for COVID-19 [96]. In January 2024, Dr. Maria Van Kerkhove, the technical lead for COVID-19 response at the WHO, wrote that COVID-19 was ‘… still a pandemic causing far too many (re)infections, hospitalizations, deaths and long covid when tools exist to prevent them. … Cases and hospitalisations for #COVID19 have been on the rise for months; hospitals in many countries are burdened and overwhelmed from COVID and other pathogens, and deaths are on the rise’ [97]. Dr. Van Kerkhove emphasised that both governments and individuals must remain vigilant and avoid complacency. Therefore, the imperative to ensure equitable access to COVID-19 diagnostics and therapeutics persisted. Additionally, it is important to note that the Decision was not contingent upon the duration of the pandemic as defined by the WHO, but rather applied for a specified period during which eligible members could utilise the Decision for products falling within its scope.

Inadequate use of TRIPS flexibilities in the global response to COVID-19

One of the major hurdles in securing a waiver at the WTO is that even though the legal framework permits swift decision-making without requiring consensus, WTO Members generally adhere to the norm of reaching decisions through consensus. Consequently, waiver proposals become subject to prolonged discussions and concessions. The outcome of such concessions may result in less-than-ideal solutions.

If a waiver cannot be insulated from the unpredictability of political bargaining where business interests might override public health priorities, how can WTO Members guarantee that the stipulations of the TRIPS Agreement do not hinder their capacity to act swiftly, sufficiently, and effectively during health emergencies like a global pandemic and adopt all measures they consider necessary to secure access to medicines, vaccines, and diagnostics?

Importantly, the TRIPS Agreement offers considerable leeway to WTO Members to create policy space for addressing public health priorities. In this regard, alongside efforts to improve the decision-making process on waiver proposals, WTO Members should also explore how to best utilise the TRIPS flexibilities to tackle a global pandemic.

The leeway within the TRIPS Agreement is to be drawn from interpreting the extent of TRIPS duties and the exceptions embedded in various clauses of the Agreement. This interpretation is chiefly the responsibility of member States when applying the provisions of the TRIPS Agreement.

Though TRIPS offers public health flexibilities, their effectiveness hinges on national implementation. Some developing countries have underdeveloped intellectual property frameworks or lack the political will to operationalize these flexibilities [98]. However, while acknowledging domestic legal shortcomings, the need for global-level interventions to address inequity in technology access.

While WTO Members are free to determine how to implement the provisions of the TRIPS Agreement in their domestic laws and practice [94], the scope of this freedom is further clarified in the context of public health needs by the Doha Declaration on TRIPS and Public Health [95]. Accordingly, ‘… the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health’ [99]. In Australia-Tobacco, the WTO panel held that this affirmation in the Doha Declaration constituted a subsequent agreement among WTO Members in terms of international treaty law, and hence each provision of the TRIPS Agreement should be so interpreted as stated in the Doha Declaration [100].

Therefore, WTO Members have the ability to interpret and implement the provisions of the TRIPS Agreement in ways that advance public health goals and enable a timely, sufficient, and effective response to health emergencies, including a global pandemic. Below are several approaches that could be adopted in a public health-oriented reading of the scope of TRIPS flexibilities for health-related purposes.

Excluding disease-specific pharmaceutical products from patent protection during health emergencies

Article 27.1 of the TRIPS Agreement states that ‘… patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced’ [91]. If this obligation is interpreted in light of the interpretative principle outlined in the Doha Declaration, it may be feasible to treat patent filings related to health technologies essential for pandemic response differently from other medical technologies. While Article 27.1 clearly prohibits discrimination based on the technological field, differentiated handling of a subset of health technologies crucial to public health efforts could be viewed as not amounting to discrimination that excludes an entire technological domain. This distinction, especially when grounded in public health imperatives, would align with the Doha Declaration.

Therefore, in the event of a pandemic or a public health crisis, a WTO Member experiencing the impact could lawfully halt the procedures for granting patents on medical technologies required to address the emergency.

The enforceability of issued patents could likewise be suspended as an exception under Article 30 of TRIPS. This provision permits WTO Members to introduce exceptions to patent rights that are narrow in scope, do not unreasonably interfere with the standard use of a patent, and do not unfairly harm the legitimate interests of the patent owner, while also considering the valid interests of third parties. The vague wording of Article 30 allows for broad interpretation of its boundaries. In light of the Doha Declaration, such interpretation would also need to incorporate a public health perspective.

In WTO jurisprudence, Article 30 of the TRIPS Agreement has been interpreted only once, in the Canada–Patent Protection for Pharmaceutical Products dispute. In that case, the WTO panel adopted a restrictive interpretation of Article 30s scope, concluding that the conditions outlined in Article 30 are cumulative, with each condition representing a distinct and independent criterion that must be fulfilled for a measure to qualify as an exception [101].

Nonetheless, it is important to recognise that a WTO panel’s interpretation of the provisions of a covered agreement does not amount to an authoritative interpretation. It does not serve as binding precedent but may carry persuasive value. In fact, respected scholars have later argued that the conditions under Article 30 of TRIPS should not be viewed as cumulative [102]. Thus, non-fulfilment of one of the three conditions does not necessarily invalidate the exception. Such an interpretation would also align with the interpretative approach proposed by the panel in Australia–Tobacco.

As held by distinguished publicists that are signatories to the Max Planck Declaration on Patent Protection – Regulatory Sovereignty Under TRIPS [102], an exception under Article 30 could be interpreted as limited if its scope is reasonably aligned with its intended objective. It must serve a legitimate aim, be suitable for achieving that aim, and not go beyond what is necessary and sufficient to accomplish it. In this context, we propose that a measure suspending the enforcement of patents on pharmaceutical products targeting a specific disease responsible for a health emergency or pandemic could be regarded as a limited exception under Article 30. Furthermore, it would also qualify as a limited exception in the sense that it would not extend to patent protection for pharmaceutical products addressing other illnesses or medical conditions.

The second criterion under Article 30 involves evaluating whether the exception unduly interferes with the regular use of the patent. The wording of Article 30 itself indicates that some level of reasonable interference with the patent’s normal exploitation is permissible. This prompts the question: could the commercial use of the patent in the midst of a health emergency or pandemic be regarded as its normal exploitation?

In Canada-Patents, the panel had held that ‘“exploitation” refers to the commercial activity by which patent owners employ their exclusive patent rights to extract economic value from their patent. The term “normal” defines the kind of commercial activity Article 30 seeks to protect’ [101]. The panel further held that, ‘The normal practice of exploitation by patent owners, as with owners of any other intellectual property right, is to exclude all forms of competition that could detract significantly from the economic returns anticipated from a patent’s grant of market exclusivity’ [101]. However, a different reading of what constitutes normal exploitation can emerge in the light of the objects and purpose of the TRIPS Agreement and the rule of interpretation laid down in the Doha Declaration, as held in Australia-Tobacco.

Article 7 of the TRIPS Agreement affirms that, ‘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’. Article 8.1 of the TRIPS Agreement clearly states that, ‘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’ [91]. As emphasised in the Doha Declaration, ‘… the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, … the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all’ [99].

If the requirement in Article 30 is interpreted in conjunction with Articles 7 and 8 of TRIPS and the Doha Declaration, it becomes clear that preventing all forms of competition through patent rights over a pharmaceutical product essential for a public health response during a health emergency or pandemic cannot be regarded as ‘normal exploitation’. Therefore, any action that excludes such patents from enforcement during a health crisis would not represent an unreasonable interference with the normal use of the patent.

Regarding the third requirement under Article 30, it is necessary to evaluate whether the exception unjustifiably harms the legitimate interests of the patent owner, while also considering the legitimate interests of third parties. The language of Article 30 clearly indicates that this evaluation must be based on a balance between the rights of the patent holder and those of third parties. Here too, the interpretation should be guided by Articles 7 and 8 of TRIPS and the Doha Declaration. In this context, during a health emergency or pandemic, the legitimate interests of third parties in swiftly ending the crisis by expanding production of patented products would outweigh the legitimate interests of patent holders.

Pharmaceutical production for export-oriented markets

Article 30 of TRIPS might also be construed as permitting WTO members to lawfully authorise (with or without compensation) the domestic manufacturing by external entities of patented goods for the purpose of export. This is due to the fact that under Article 28 of the TRIPS Agreement, the entitlements granted by a patent do not encompass the authority to restrict exports. Nevertheless, Article 28 forbids unauthorised manufacturing by external entities. Therefore, a provision enabling external entities to produce and distribute to overseas markets would not amount to a limitation of the standard utilisation of the patent [103].

Invoking the security exception clause under international trade law

At the outset of the COVID-19 crisis in April 2020, the Executive Director of the South Centre had called upon the Director-Generals of the WTO, WIPO and WHO to endorse the invocation of Article 73(b) of the TRIPS Agreement to ‘suspend the enforcement of any intellectual property rights (including patents, designs and trade secrets) that may pose an obstacle to the procurement or local manufacturing of the products and devices necessary to protect their populations’ [104].

Article 73(b) of the TRIPS Agreement, which reflects Article XXI of the General Agreement on Tariffs and Trade (GATT), permits WTO Member States to provisionally set aside their intellectual property obligations. It functions primarily as a safeguard clause which states as follows:

Nothing in this Agreement shall be construed:

…

(b) to prevent a Member from taking any action which it considers necessary for the protection of its essential security interests;

• (i)relating to fissionable materials or the materials from which they are derived;
• (ii)relating to the traffic in arms, ammunition and implements of war and to such traffic in other goods and materials as is carried on directly or indirectly for the purpose of supplying a military establishment;
• (iii)taken in time of war or other emergency in international relations;

This TRIPS provision enables WTO Member States to temporarily set aside their core responsibilities by citing the need to safeguard their vital security concerns. The trade-related security clauses were originally formulated in the Charter for an International Trade Organization (ITO) or Havana Charter 1948. Defence and strategic priorities were central to these clauses, as the discussions surrounding them took place within the broader geopolitical tensions of the Cold War between the United States and the Soviet Union. The security clauses from the unsuccessful ITO Charter were incorporated into the GATT under Article XXI. These same clauses were subsequently embedded into the TRIPS Agreement under Article 73. The ambiguous wording of the clause, crafted during the Cold War era, indicates that the strategic adversaries aimed to preserve broad autonomy and adaptability in matters of national security [105].

The WTO Member States possess considerable flexibility due to the expansive interpretation of the unclear expressions such as ‘which it considers’, ‘essential security interests’, and international ‘emergency’ embedded in this clause. The use of security exceptions is, however, not totally self-judging as it is reviewable and subject to dispute-settlement proceedings by the WTO Dispute Settlement Body (DSB). The recent Panel Report in Russia – Measures Concerning Traffic in Transit [106] provided a comprehensive interpretation of security exceptions under Article XXI of GATT and set out a two-step framework: the existence of a war, emergency or other basis for invoking the provision, which is subject to objective determination; and the necessity of the trade-related security measure, which is subject to a good-faith test. Although the good-faith standard has not been clearly articulated, diplomacy and appealing to members’ good faith are regarded as the most effective limitation on trade-related security actions. The WTO Panel in Saudi Arabia – IPRs also examined the security clause under Article 73 of TRIPS by referencing the Russia-Transit dispute. In both cases, the United States maintained as a third party that the security clause is not subject to judicial review. This stance might prevent the United States from taking an opposing position if the security clause is applied to pharmaceutical patents [45].

To justify a security exception, the presence of an emergency in international relations within the scope of Article 73(b)(iii) of TRIPS must be established. Since the WHO recognised COVID-19 as a public health emergency of international concern under the International Health Regulations, and in August 2023 the WHO Director-General issued Standing Recommendations addressing the long-term threats posed by COVID-19, it is evident that COVID-19 represented a pandemic threat capable of constituting an emergency in international relations. Furthermore, as the health of the domestic population is unequivocally an essential security interest - as expressed by WHO member States in the discussions for a pandemic treaty within the WHO - the TRIPS compatibility of a measure aimed at addressing the health security challenge as necessary to protect an essential security interest can be substantiated [45]. Consequently, WTO Members are permitted to implement actions affecting patent entitlements associated with pharmaceutical goods in response to a health crisis as a security exception under Article 73 of TRIPS.

Limitations

Although this study provides a comprehensive legal and policy analysis of the TRIPS waiver debate during the COVID-19 pandemic, its scope is inherently confined to the WTO’s decision-making process and the interpretation of TRIPS flexibilities in a global context. The research adopts a doctrinal and normative approach, drawing upon WTO texts, ministerial decisions, and secondary literature, but does not incorporate empirical data such as interviews with negotiators, quantitative modeling of trade or health outcomes, or country-specific case studies. Consequently, while the arguments presented are grounded in authoritative sources, they cannot fully capture the practical challenges faced by individual states in implementing TRIPS flexibilities or the political dynamics that shaped negotiations behind closed doors. The reliance on publicly available documents, rather than confidential negotiation records or industry data, further constrains the depth of insight into the strategic considerations of key actors.

Another limitation relates to the absence of economic and technological impact assessments. Although the paper critiques monopoly control and pricing practices, it does not quantify the potential effects of a broader waiver on global supply chains, innovation incentives, or pharmaceutical revenues.

Finally, the temporal scope of the manuscript is restricted to developments up to October 2025. It does not account for subsequent WTO reforms, pandemic treaty negotiations, or evolving intellectual property norms that may influence future waiver processes. The discussion of TRIPS flexibilities is primarily normative, and while it identifies interpretative possibilities, it does not explore the institutional capacity or political will required for their implementation in diverse national contexts. These limitations highlight the need for future research that integrates empirical evidence, economic modeling, and comparative legal analysis to evaluate how proposed reforms could operate in practice and whether they can deliver equitable access to health technologies during global emergencies.

Conclusion

The COVID-19 pandemic exposed structural weaknesses in the global intellectual property regime and highlighted the limitations of relying solely on waiver negotiations during emergencies. While the TRIPS waiver debate underscored the urgency of equitable access, the eventual TRIPS Decision was narrow in scope and delayed in adoption, reflecting systemic challenges in WTO decision-making. These shortcomings reaffirm that intellectual property rules, when left unmodified during crises, can impede timely and affordable access to essential health technologies. However, the solution cannot rest exclusively on waivers, which are inherently political and unpredictable.

Future strategies must consider a broader toolkit of TRIPS flexibilities and complementary mechanisms, but it is important to acknowledge their practical limitations. While compulsory licensing under Article 31 and export-oriented licensing under Article 31bis remain legally available, experience during the COVID-19 pandemic, illustrated by the Bolivia–Biolyse case, demonstrates that these mechanisms are far from straightforward. They involve complex procedural requirements, case-by-case negotiations, and significant regulatory hurdles, which make them ill-suited for rapid deployment during a global health emergency. The administrative burden, coupled with the risk of trade retaliation and the need for specialized legal and technical capacity, has discouraged many developing countries from using these flexibilities effectively. Therefore, while these tools should not be abandoned, their current design cannot guarantee timely and equitable access in crisis situations without substantial reform. Streamlining procedures, reducing transaction costs, and creating coordinated regional frameworks could enhance their utility, but such reforms require strong political will and international cooperation.

Strengthening domestic legal capacity to implement these flexibilities, coupled with international support for technology transfer and regulatory harmonization, can reduce dependence on protracted waiver negotiations. In parallel, voluntary initiatives such as patent pools and technology access platforms should be revitalized, supported by incentives and transparency measures to overcome industry resistance.

The experience of COVID-19 should inform a forward-looking reform agenda that balances innovation incentives with public health imperatives. WTO Members could explore codifying expedited protocols for waivers, clarifying timelines for decision-making, and embedding public health safeguards into the interpretation of TRIPS provisions. Equally important is the need for global cooperation to invest in manufacturing capacity, diversify supply chains, and promote open innovation models that complement the patent system. These measures, taken together, can help ensure that future responses to pandemics or other global health crises are timely, equitable, and resilient - advancing both the right to health and the objectives of sustainable development.

Biographies

Nirmalya Syam

is a Senior Programme Officer with the Health, Intellectual Property and Biodiversity Programme at the South Centre, Geneva, Switzerland. An earlier draft of this manuscript was published as South Centre Research Paper No. 191 TRIPS Waiver Decision for Equitable Access to Medical Countermeasures in the Pandemic: COVID-19 Diagnostics and Therapeutics (25 January 2024), available at (https://www.southcentre.int/research-paper-191-25-january-2024/).

Dr Muhammad Zaheer Abbas

Chief Investigator with the Australian Centre for Health Law Research (ACHLR), is a Lecturer in Law at the Faculty of Business and Law, Queensland University of Technology (QUT), Brisbane, Australia.

Author contributions

N.S conceptualised the paper and wrote sections ‘Introduction’ ,‘Deviation from WTO rules relating to TRIPS waiver’ , ‘Inadequate use of TRIPS flexibilities in the global response to COVID-19’ and ‘Limitations’. M.Z.A wrote sections ‘The TRIPS waiver proposal in the context of the COVID-19 pandemic’, ‘Assessing the Principal counterarguments to the TRIPS waiver proposal’, ‘The TRIPS decision: dilution of the original waiver proposal’ and ‘Expansion of the TRIPS decision to include therapeutics and diagnostics’. Both authors read and approved the final manuscript.

Funding

The authors did not receive support from any organization for the submitted work. No funding was received to assist with the preparation of this manuscript. No funding was received for conducting this study. No funds, grants, or other support was received.

Data availability

No datasets were generated or analysed during the current study.

Decleartion

Ethics approval

Not applicable. Ethical approval was not required for this study.

Competing interests

The authors declare no competing interests.