TRIPs Waiver as Tackling Public Health Crisis:To be,or Not to be

Ma Le,Lu Lvjing(School of International Law,East China University of Political Science and Law,Shanghai 200042,China)

Abstract: TRIPs waiver proposal was controversial as soon as it was presented as a response to COVID-19.TRIPs waiver aims to exempt WTO members'obligations to protect intellectual property rights related to Part 2 of the TRIPs Agreement to ensure that these IPRs do not create barriers to the timely access to affordable medical products or to the scaling-up of research, development, manufacturing, and supply of medical products essential to combat COVID-19. Unfortunately, the severity of the global ravages of the pandemic did not make it easier to reach a consensus on the legitimacy and necessity of the TRIPs waiver. On the contrary, the TRIPs waiver has been strongly resisted by some developed members of WTO and IP holders.The opinions of proponents and opponents are opposed on whether the TRIPs waiver can perform the function of dealing with COVID-19 or not. The contradiction reflected in this discussion reveals the practical dilemmas the TRIPs waiver encountered,including the difficulty of reaching a prerequisite consensus, the significant divergence in functional perceptions, and the obvious procedural hurdles. The dilemma proves that the strategic role of IPRs and the fundamental objective of the TRIPs Agreement in protecting IPRs have not changed, which is the real cause of the hardships faced by the TRIPs waiver. As an important multilateralism achievement, the TRIPs flexibilities are even more valuable and may play a more significant role. The Ministerial Decision on the TRIPs Agreement of WTO MC12, which ends up partly waiving the patent right of COVID-19 vaccines,is more like a forced comeback to compulsory licensing rather than a way out of the dilemma mentioned above.

Keywords:TRIPs waiver;public health;COVID-19;TRIPs flexibility;compulsory licensing

1 Introduction

On October 2, 2020, South Africa and India submitted a proposal about waiving specific provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (hereinafter referred to as "TRIPs Agreement")to the Council for Trade-Related Aspects of Intellectual Property Rights (hereinafter referred to as "TRIPs Council"), to curb the development of COVID-19 Pandemic (hereinafter referred to as "COVID-19" or "the pandemic").The proposal put forward by South Africa and India (hereinafter referred to as "the Proposal" or "the TRIPs waiver proposal") suggests waiving WTO members' obligations of implementing or applying certain provisions of the TRIPs Agreement, which are Sections 1, 4, 5 and 7 of Part II or the obligations under Part III to implement these provisions, covering most of the obligatory requirements of the TRIPs Agreement imposed on membersPart II Standards Concerning the Availability, Scope and Use of Intellectual Property Rights (Section 1 Copyright and Related Rights,Section 4 Industrial Designs,Section 5 Patents,Section Protection of Undisclosed Information);Part III Enforcement of Intellectual Property Rights (Section 1 General Obligations,Section 2 Civil and Administrative Procedures and Remedies, Section 3 Provisional Measures, Section 4 Special Requirements Related to Border Measures, Section 5 Criminal Procedures). Unless otherwise specified, TRIPs waiver in this article refers to the TRIPs waiver proposal, differentiated with the COVID-19 vaccine patent waiver under Ministerial Decision on the TRIPs Agreement adopted at the 12 Ministerial Conference of WTO. The latter will be discussed specifically in the 4 part of this article.. The Proposal has been hotly debated after it was proposed, and members have submitted communications to the TRIPs Council setting out their views. Arguments for and against the TRIPs waiver are opposed.

1.1 Pro-Waiver Viewpoints

Proponents suggest that difficulties in accessing medical products related to COVID-19 in many countries, including but not limited to medicines, vaccines, machinery, and equipment, are an essential reason for weakening the ability of governments to respond quickly to the pandemic, notably in developing and least developed countries. These medical products, including drugs and vaccines in the development stage, are protected by different types of intellectual property rights (IPRs). Such IPR protection has constituted a barrier to the accessibility of medical products according to the current disputes that have arisen related to COVID-19. Therefore, one of the purposes of the TRIPs waiver is to prevent pharmaceuticals and vaccines in the future from being hindered by IPRs in their production, use, etc. In addition to pro-waiver countries, there are other entities favoring it. Dr. Tedros, Director-General of the World Health Organization (hereinafter referred to as "WHO"), has stated that "it is not wrong that we say there should be waivers; it was for the common good. So, we ask for this IP to be made available". In an open letter to the Chair of TRIPs Council, 129 civil societies worldwide urged to eliminate the block adopting the Proposal.

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Supporters acknowledge the vital role that TRIPs flexibilities have played in promoting access to medicines.Still, they argue that these flexibilities were not designed for a global public health crisis from the outset. They only address regional difficulties in accessing medicines, and these flexibilities appear to be of limited use for a worldwide public health crisis such as COVID-19. To sum up, from the proponents' view, the variants of COVID-19 are spreading faster across the world, causing tens of thousands of infections and deaths. Faced with this situation,the world needs to maximize the sharing of technology, knowledge, and information and the maximization of existing production capacity. It means that addressing the current public health crisis requires WTO members to go beyond the existing legal options under the TRIPs Agreement and attempt a broader and more profound means of achieving complete freedom of operation instead of just using Article 31 and itsof the TRIPs Agreement. TRIPs waiver is the exact way which can ensure that the complications arising from IPRs protection do not delay the pandemic or lead to a less satisfactory response to the pandemic in countries around the world, which would further threaten people's lives.

1.2 Opposing Views

Opponents of the Proposal dispute that there is little evidence that IPRs are delaying the production and distribution of medical products and creating an impediment to resolving this pandemic at present. Conversely, motivated by various funding and intellectual property protection, pharmaceutical companies worldwide are building on their expertise to find drugs and vaccines against COVID-19. This is best demonstrated by the successful development of several safe and effective COVID-19 vaccines. The Position Statement of the Max Planck Institute for Innovation and Competition of 7 May 2021 argued that IP has so far played an enabling and facilitating role rather than a hindrance. The international community has not benefited from IP waivers either during or after the pandemic. In another open letter written to the company's employees, Albert Bourla, CEO of Pfizer, made it clear that the Proposal to abandon IPRs for vaccines would only derail the global vaccination process and create more problems without improving the global vaccine supply shortage.

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Despite acknowledging COVID-19 as a global health and economic crisis, opponents do not believe the concerted international effort needed amounts to implement a TRIPs waiver. They stress that the existing global trading system can meet the need for rapid expansion of production and equitable access to COVID-19 vaccines and drugs. The WTO should focus on improving the current system of rules to ensure that "the rules-based global trading system plays its role in response to the crisis". To this end, the EU proposed a global trade initiative for equitable access to COVID-19 vaccines and therapeutics using trade facilitation and disciplines on export restrictions,expansion of production, including through pledges by vaccine producers and developers, and clarification and facilitation of TRIPs Agreement flexibilities relating to compulsory licenses. EU further put forward on how to improve the critical licensing regime that the established procedures for the use of compulsory mandatory should be as efficient and streamlined as possible, such as eliminating the requirement for pre-negotiation under Article 31(b) of the TRIPs Agreement and rationalizing royalties according to the situation of lower and middle-income countries.

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2 The Content of TRIPs Waiver

2.1 Waiver in the Whole WTO System

Nonetheless, opponents of the TRIPs waiver argue that IP is not and should not be a barrier to equitable access to COVID-19 vaccines and treatments during the pandemic. The EU believes that "limited manufacturing capacity, access to raw materials and other inputs are the main bottlenecks as regards the production of COVID-19 vaccines". The value of IPRs protection in stimulating R&D and innovation is instead an essential factor in advancing epidemic control. Stéphane Bancel, CEO of Moderna, raised the point that infrastructure capabilities had been the most significant impediment to increasing access to affordable vaccines, not patents. Steve Bates, chief executive of the Bioindustry Association, argued that removing IPRs protection was "not a panacea". It is reckless not to remove IPRs protection at the first sign of a public health crisis. Vaccine production is a complex process involving complicated raw materials and components along the value chain. Even if the vaccine formulas are provided to the government, the COVID-19 vaccines cannot be made without "the ingredients, safeguards, infrastructure,and sizable workforce with the high skills" and cannot solve the current dilemma. Moreover, the COVID-19 vaccines require a high level of logistics and storage conditions. For instance, Pfizer's vaccines must be shipped at -90°C to -60°C with dry ice. Likely, Moderna's vaccines need to be stored at -50°C and -15°C. But some underdeveloped countries have difficulty meeting these conditions. In addition, the TRIPs waiver may shift raw materials from well-established, efficient supply chains to less efficient manufacturing sites where productivity and quality can be problematic. The quality of the vaccines produced in these sites may be an issue due to the lack of proven technology. As a result, the limited raw materials for vaccine production are wasted while "opening the door for counterfeit vaccines to enter the supply chain around the world".

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Second, the objects of WTO waivers are specific. Generally, most WTO waiver requests are for obligations under particular provisions of the WTO Agreement and other multilateral trade agreements. However, a request for a waiver can also be made in respect of specific commitments made by individual countries to join the WTO. In 1997 the General Council waived the commitments on agricultural export subsidies made by Hungary upon accession to the WTO. In 2004 Albania requested a waiver of its market access commitments under Article 16 of GATS about public voice telephony services made upon its accession to the WTO, which was adopted by the General Council. In 2007 the General Council adopted a waiver to exempt Mongolia from the commitment to phase out tariffs on raw cashmere exports within ten years of accession and instead extended the deadline until 29 January 2012. WTO Agreement does not oblige members to adhere to their accession commitments, but accession commitments are part of the deals reached during WTO accession negotiations. These countries expressed their willingness to fulfill their commitments, and thus the obligation to fulfill specific commitments is attached to them.

Third, the function of WTO waivers is limited. From the scope of validity, waivers are limited to the acts of WTO members applying the law. In other words, waivers are for using WTO obligations rather than WTO obligations per se. In terms of purpose, WTO waivers are a precautionary measure to avoid disputes. Once the waiver decision is adopted, the actions were taken by members under the decision, whether legal or not, are precluded from being reviewed by the Dispute Settlement Body or from being challenged by other members. Therefore, members invoke the waiver clause to provide a "legal certainty" to the domestic measures they have implemented or are about to implement. Besides, the duration of each waiver must be specific and cannot be extended indefinitely. According to Article 9(4) of the WTO Agreement, a waiver decision should clearly state the date on which the waiver will terminate. Waivers with a duration of more than one year are subject to an annual review by the Ministerial Conference or the General Counsel.

2.2 Waiver in TRIPs

In addition to the huge disagreement among stakeholders about the necessity of the TRIPs waiver, its adoption as a proposal depends on the WTO's decision-making mechanism. According to Article 9 of the WTO Agreement,the WTO shall continue the practice of decision-making by consensus followed under GATT 1947. Theoretically,any individual member has a veto on the proposed matter. Consensus reflects the fundamental feature of WTO as a member-driven international organization and has a positive effect on guaranteeing the broad participation and democracy in the decision-making process. Especially in the period of GATT 1947 and the early stage of WTO establishment, it was easier for parties (members) to reach a consensus on proposed matters with solid consensus. Its use as a WTO decision-making mechanism has not been much challenged. However, the disadvantages of consensus gradually become apparent when simple issues have been dealt with, and more controversial difficulties are on the table. Throughout the history of the WTO, multilateral agreements were established in the Uruguay Round of Multilateral Trade Negotiations (hereinafter referred to as "the Uruguay Round") and after that, it has become increasingly difficult for WTO members to reach multilateral trade agreements. With the exception of the Agreement on Trade Facilitation in 2013 and the Agreement on Fisheries Subsidies adopted at the 12Ministerial Conference in 2022,no new multilateral agreements have been signed by WTO members. Admittedly, this is not unrelated to the complexity of the proposed topics and the differences in stake with different members. However, it is a fact that the requirement of consensus makes the outcome of negotiations out of reach in terms of the decision-making mechanism. To make it worse, an agreement has been turned into a tool for the individual member as, undermining the multilateral system. The situation in which the United States blocked the election and renewal of Appellate Body members and thereby stalled the appellate process was precisely because it could exercise its veto and prevent the consensus requirement from being met.

There is some practice about waivers of certain obligations under the TRIPs Agreement. In 2003, a waiver rerelease to the commitments set out in paragraphs (f) and (h) of Article 31 of the TRIPs Agreement concerning pharmaceutical products was adopted by WTO members, which was later replaced by an amendment. The TRIPs waiver in 2003 addressed a highly controversial issue: how to manage the access to patented medicines by members that lack or cannot produce to alleviate the public health crisis that has erupted in their territories? Article 31 of the TRIPs Agreement provides a means of manufacturing and marketing patented medicines without the permission of the patent holders, known as the compulsory license of pharmaceutical patents. However, paragraph (f) of this article states that any medicine produced under a compulsory license is only for "use in the domestic market of the member". Indeed, many developing countries where essential medicines are in short supply lack or cannot produce them when it comes to practice. Their access to critical medication relies on importing generic drugs with the same or highly similar efficacy to patented medicines. In 2001, paragraph 6 ofacknowledged 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" and requested the TRIPs Council to find an "expeditious solution" to the lack of capacity for effective use of compulsory licensing by some members and to report to the General Council at the end of 2002. In 2003, the TRIPs Council adopted(hereinafter referred to as "the Implementation Decision"). Collectively, these documents consist of Doha System as tackling public health problems. The Implementation Decision determines a waiver of the requirement to authorize compulsory licenses to manufacture drugs for use in the domestic market only and a waiver of the obligation of eligible importing countries to pay required license fees to patent holders. The "pharmaceutical product" described in the waiver means "any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address the public health problems as recognized in paragraph 1 of the Doha Declaration, including active ingredients necessary for its manufacture and diagnostic kits needed for its use". In addition, "eligible importing Member" in the waiver means "any least-developed country member and any other member that has made a notification to the TRIPs Council of its intention to use the system as an importer".

In accordance with the provisions of the WTO Agreement and its practice, WTO waivers are characterized as follows. First, WTO waivers are exceptional. "Exceptional circumstances" are a substantive requirement for a waiver decision, which suggests WTO waivers are intended to legalize non-compliant measures taken by individual members in concrete situations of urgency in which compliance is not a feasible option. It has been either ambiguously applied or automatically assumed to be fulfilled. During the London Preparatory Conference for an International Trade Organization, the representative of the United States suggested that exceptional circumstances in waivers were meant to "cover exceptional cases that caused particular hardship to any particular member and were not covered by the other escapes provided in the charter".

From the perspective of the scope of WTO members covered by the waiver decision, both the TRIPs waiver proposal in response to COVID-19 and the TRIPs waiver established by the Implementation Decision in 2003 are collective waivers. The intended legal effects of both waivers are the suspension of certain IPRs protection obligations under the TRIPs Agreement. In contrast, the latter only covers exemptions from the obligations of Article 31(f)and (h) of the TRIPs Agreement. At the same time, the former waive the obligations of protection in copyrights and neighboring rights, industrial designs, patents, undisclosed information, and the enforcement requirements to achieve these protections. Accordingly, any prohibitive obligations imposed to protect these IPRs would be waived,and users will no longer be held liable for infringement for unauthorized enforcement of IPRs, as long as such enforcement is related to the prevention, control, or treatment of COVID-19. Moreover, the latter was achieved based on a series of members' efforts, such as the Doha Round negotiations, the Doha Declaration, the Implementation Decision, and the TRIPs Amendment, while the former not only lacks such a consensus basis but also has to face the situation that incidents threaten the WTO multilateral system. In this sense, the TRIPs waiver proposal in response to COVID-19 is more thorough than the TRIPs waiver established by the Implementation Decision in its scope and extent, and the difficulties it faces are unprecedented.

3 Practical Dilemmas in the Functional Realization of TRIPs Waiver

3.1 Prerequisite Debate of TRIPs Waiver

The primary reason why the TRIPs waiver is highly controversial is that different stakeholders have different views on the role of IP in the pandemic response. South Africa and India proposed in paragraph 3 of the Proposal that "it is important for WTO members to work together to ensure that IPRs such as patents, industrial designs,copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or scaling-up of research, development, manufacturing, and supply of medical products essential to combat COVID-19".In the view of the proponents of the TRIPs waiver,IPRs protection may create a barrier to access to the products where it attaches. Taking vaccines, for instance, almost every step in the R&D, production, and use of vaccines, such as raw materials, processing of ingredients, process technology, and methods of using vaccines, can be patented. According to a news flash posted on the Nature Reviews Drug Discovery, 113 patent families relevant to mRNA vaccine were filed between 2010 and 2020, based on statistics from the International Patent Documentation Center (INPADOC). Under Article 28 of the TRIPs Agreement, the patent holder has the right to prohibit third parties not having the owner's consent from making, using, offering for sale,selling, or importing that product for these purposes. Thus, if the relevant patent holders of the vaccine exercise their prohibitive rights, access to the vaccine will be impeded. The resulting disputes have already been reflected in reality. For instance, Regeneron, Pfizer, and BioNTech had been sued by Allele Biotech over patent infringement of fluorescent protein used to develop their COVID-19 vaccine and antibody cocktail. Data exclusivity is another obstacle. Inovio, a pharmaceutical company in the U.S.A, sued VGXI, another pharmaceutical company, for its refusal to provide relevant data information needed to produce the vaccine candidate "INO-4800".

The meaning of "waiver" in the context of international law can be divided into two concepts. Firstly, it refers to a complete waiver, renunciation, or abandonment of a right or claim. Secondly, it is a temporary suspension of a member's obligations under an international treaty, and the parties should take the relevant decisions to suspend the treaty or the competent organ of the international organization. Some scholars have defined the second type of waiver as a legal act that must be authorized by the other contracting parties or by an organ responsible for monitoring treaty implementation. It permits "a contracting party temporarily not to meet certain treaty requirements owing to the difficulties it is encountering in fulfilling them as a result of special circumstances". The "waiver" under the WTO legal system discussed in this article should be understood as an act of authorization to suspend obligations. TRIPs Agreement does not specify how to waive obligations thereunder, but waivers can be more explicit when focusing on the whole WTO system. WTO is an international organization that has an important influence on the international trade order, and waiver clauses have existed since its inception. According to Article 9(3) of the(hereinafter referred to as "WTO Agreement"),WTO waivers are decisions made by the Ministerial Conference and the General Council to suspend members' obligations required by the WTO Agreement or any multilateral trade agreement in exceptional circumstances.

3.2 Challenges to the Function of TRIPs Waiver

With the globalization of the economy, there was an urgent need for a set of international rules for the private sectors to advance the globalization of IPRs protection. The best way to build such strategic linkage is to elevate personal interests to national interests and then to use the voice of the state in international trade negotiations to integrate its interests into specific international rules for reasonable protection. Specifically, the government supports and protects the interests of the private sector, such as companies, enterprises, and research institutes, by elevating them to the national interest, while at the same time, the private sector could use its industrial strengths to help the government solve specific difficulties. The private sectors expressed their interests through direct infiltration into the government departments and sought to elevate individual claims into international law by lobbying their governments and international organizations through transnational cooperation. Their efforts have achieved some success, with the 1994 TRIPs Agreement a tailored example.

The reason for the current supply and demand problems, such as the uneven distribution of vaccines, is attributed to ineffective implementation. Even if specific procedural issues related to compulsory licenses are identified as factors that limit the use of this kind of flexibility, it can still work as it should be in response to the pandemic by varying some conditions or provisions. The EU has proposed several considerations to provide more legal certainty and enhance the effectiveness of the compulsory licensing regime using waiving the requirement to negotiate with the right holder, determining the remuneration for patent holders based on the economic level of each country, and covering any exports by compulsory licensing destined to countries that lack manufacturing capacity, including via the COVAXfacility.

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Regarding the adverse impact on innovation of TRIPs waiver, commentators take an investment of vaccines, for instance, to rebut. The R&D of the Moderna vaccines, for example, almost relies on the U.S. government funding.These companies have been tremendously rewarded through multi-billion-dollar procurement contracts with U.S.and foreign governments. It seems likely that these companies have recovered their R&D costs and are sitting on substantial subsequent returns. Governments have spent at least €93 billion on COVID-19 vaccines and therapeutics globally since the pandemic's beginning; a new study has found.

The TRIPs waiver proposal again puts the role of intellectual property under the spotlight. Discussing the role of IPRs in the context of TRIPs requires not only observing the power operation statuses of IPRs microscopically,but also recognizing the existence of IPRs as a soft power for individual members. The sponsors of the Proposal were developing members, while the primary opponents were set, members. Even if the United States later proposed to support the TRIPs waiver, it does not mean that it agreed to give up the advantages of IPRs, but more of a consideration for its "reputation".

3.3 Procedural Hurdles of TRIPs Waiver

TRIPs Agreement is an integral part of the WTO Legal Framework, and the provisions on waivers are equally applicable to this agreement. Based on the Proposal, TRIPs waiver refers to waiving members' obligations of implementing or applying Sections 1, 4, 5, and 7 of Part II of the TRIPs Agreement or enforcing these Sections under Part III of the TRIPs Agreement but excludes the protection of Performers, Producers of Phonograms (Sound Recordings) and Broadcasting Organizations under Article 14 and does not affect the rights of LDCs under Article 66(1) of the TRIPs Agreement for the duration of COVID-19. Once a TRIPs waiver has been granted, "no member may challenge any measures taken under the waiver decision by subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994, or through the WTO's dispute settlement mechanism". Namely, when the waiver decision is in force,any action taken to tackle COVID-19 that does not grant or protect the IPRs covered by the waiver decision will be exempted from legal liability. The Proposal does not give a definite end date for the waiver, but it should last until it "widespread vaccination is in place globally, and the majority of the world's population has developed immunity".

Although the WTO Agreement provides for voting on decision-making other than by consensus, it sets corresponding restrictions. Under Article 9(3) of the WTO Agreement, in exceptional circumstances, decisions on waiver proposals require the consent of a three-fourths majority of the members participating in the Ministerial Conference, subject to the applicable time limits. As of December 2021, 65 supporters out of 164 members for the TRIPs waiver proposal, which is still far from the criterion. Although members agreed to keep the agenda of the TRIPs Council open on the TRIPs waiver proposals on the table and were willing to continue discussing it, the Proposal seems challenging to pass. Despite that, the majority of WTO members are developing and least developed countries or regions, members’willingness to vote depends not only on the relevance of the proposed issue to their own interests but also on political, economic, diplomatic, and other factors.

4 Implications and Anticipations

4.1 Intellectual Property is the Strategic Power to Countries

However, the argument against the TRIPs waiver proposes that innovation is a significant source of long-term economic growth and improvement in the quality of human life. The knowledge from innovations inspired by IPRs spills over to inspire other innovations. Protecting IPRs promotes the diffusion of innovative technologies and knowledge both domestically and internationally. While in the short term, the destruction of IPRs protection will affect accelerating the distribution of goods and services, the long-term collapse will undoubtedly undermine the incentive to innovate and thereby discourage the development of new products and services that are needed worldwide. The most direct way to motivate pharmaceutical companies to innovate is profits, and the source of profits is the IPRs attached to the products. Therefore, the loss of profits to pharmaceutical companies due to the TRIPs waiver is significant. Opponents further suggest that many pharmaceuticals would not exist at all if IPRs were not protected. During a pandemic or other global health emergency, it is possible to temporarily subjugate IPRs protection to pressing public needs, but it would certainly be myopic to suggest that profit margins for related products should be eliminated entirely.

Developed countries have always been the major holders of IPRs, and companies, scientific research institutes,and other private sectors continue to acquire various types of IPRs through R&D, especially in the fields of biological medicine, data processing and so on. In a ranking about the number of invention patent applications in the bioengineering and pharmaceutical industry jointly published by IPR daily and incoPat in 2020, developed countries almost occupied the top 100, among which the United States accounted for 48%, Japan accounted for 12%, and some European countries such as Germany, the United Kingdom, and France accounted for from 1% to 7%. To protect IPRs and satisfy their interests, these private sectors seek to work together to gain a more excellent voice.Industry associations and interest groups have emerged, such as IFPMA and IPC. They strongly influence changing national IP laws and policies to meet the needs of industry interests.

The necessity of a TRIPs waiver mainly lies in the existing flexibilities in TRIPs Agreement. Despite criticism on article 31 of TRIPs as applied in a case-by-case way, failure to cover other IPs like trade secrets, and vague process of licensing, opponents of TRIPs waiver argue that, confronted with COVID-19, members should place more focus on existing legal measures under the TRIPs Agreement rather than TRIPs release, including the flexibilities identified in the Doha System. EU makes it clear in the communication to the TRIPs council that in cases where the voluntary license is difficult to achieve, "compulsory licensing is a perfectly legitimate tool, and governments in need can use the system during the pandemic"and for members lacking or not having manufacturing capacity, the special export compulsory license under Article 31of the TRIPs Agreement can also provide a fasttrack access to medicines in public health emergencies. The mandatory licensing regime based on Article 31 and itsof the TRIPs Agreement has been used many times when public health crises erupt.

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4.2 The Fundamental Purpose of the TRIPs Agreement is to Protect IP

Despite the character of the public good of vaccines, the globality of the public health crisis has not dissipated the territoriality of IP as a national interest, as evidenced by the multiple obstacles to the TRIPs waiver proposal. The international protection of intellectual property, a core resource that highlights national interests, remains the primary legislative purpose of international intellectual property law based on the TRIPs Agreement, and the sharing of intellectual property products through restrictions on IPRs is, at best, an exceptional rule that is difficult to implement.

In addition to the fact that developed countries seek excessive IPRs protection by TRIPs negotiation history,TRIPs Agreement has always supported the former when IPRs conflict with the public interest, which is reflected in three aspects. Firstly, the TRIPs Agreement defines IPRs as private rights, which states in the 4paragraph of its preamble. Without this characterization, the complex nature of IPRs can be interpreted as carrying the attributes of human rights and public goods. In other words, the very definition makes it difficult to unleash the public interest in IPRs. For COVID-19, many proponents of the TRIPs waiver have argued that the COVID-19 vaccine was developed with substantial public funding and deserved to be a kind of public good available for everyone, including the IPRs of the vaccine. Unfortunately, this argument pales in comparison to the characterization that IPRs are private rights. Secondly, restrictive provisions on IPRs are attached with strict conditions for their application. Article 31 states that the initiation of compulsory licensing procedures shall be pre-conditioned by negotiating with the holders. The generic products manufactured under this article can only be applied to the country's domestic market. In addition, according to the particular export compulsory licensing procedure under Article 31, generic products must be clearly distinguished from patented products in the outer packaging, product description, and other parts.Thirdly, considering the public interest is only a declarative wording in the preamble and principles. Article 8 allows members to "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". The preamble to the TRIPs Agreement also expresses respect for "the underlying public policy objectives of national systems for the protection of intellectual property". However, such provisions are not specified in the core part of the TRIPs Agreement. Consequently, this declarative wording and principled provisions do not provide sound guidance in practice.

4.3 Reemphasis of TRIPs Flexibilities

From 2001 to 2017, the "battle" between public health and IPRs in WTO took 16 years to come to a temporary end. The flexibilities established regarding public health were an essential achievement for developing members in pursuit of their interests. TRIPs flexibilities result from the language of Article 1.1 of the TRIPs Agreement.As interpreted by WIPO, flexibility can provide a legal basis for WTO members to "exploit creative solutions" in certain areas, thereby "transposing into national law and practice those concepts that the TRIPs Agreement simply enunciates but does not define". Specifically, exceptions to patentability, compulsory licensing, exhaustion of rights, and even national security clause can be used as flexibilities. Admittedly, the use of the TRIPs flexibilities reached with great difficulty is not all plain sailing in practice. For instance, while the compulsory licensing process was frequently initiated in past practice, there had been few cases where the procedure was ultimately applied to resolve a health crisis. Most cases ended due to price reduction commitments with drug companies or trade costs. The Brazilian government, for instance, abandoned the compulsory license because of a price reduction agreement with Merck. There is only one example of a particular export licensing mandatory regime established through the TRIPs Amendment, namely the 2007 Canada-Rwanda export case for HIV/AIDS drugs. However, complaints emerging from Rwanda and the pharmaceutical company hardly proved a successful example.

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The moment she looked at him, the queen also felt that he was no ordinary man, and she welcomed him graciously, and asked him what had brought him to the city

Nevertheless, the debate over the TRIPs waiver amounts to an opportunity for the international community to re-examine and recognize the value of the TRIPs flexibilities. For developing countries, the resistance to the TRIPs waiver from IP holders and the trade associations and governments behind them not only highlights the difficulty of achieving a TRIPs waiver at the multilateralism level but also emphasizes the value of the TRIPs flexibilities already in force, which creates a "fallback" incentive to invoke TRIPs flexibilities instead. On the other hand, for developed entities opposing the TRIPs waiver, although they can use the WTO decision-making mechanism to block the adoption of the TRIPs waiver proposal, the strong appeal and promotion of developing countries will still form the pressure that cannot be ignored. In the face of this pressure, the opponents have to consider other alternatives,and applying TRIPs flexibilities is certainly a worthy option. In addition, both sides will recognize the complexity of institutional support required to realize the TRIPs waiver. In other words, even if WTO members agree on the TRIPs waiver, it does not mean that the waiver will be implemented smoothly, on which the problematic enforcement of compulsory licensing may ideally shed light. Therefore, reemphasized and improved TRIPs flexibilities may provide a buffer for consensus on the hedges triggered by the TRIPs waiver.

Notably, a quad outcome document which ends up with the Ministerial Decision on the TRIPs Agreement adopted at the 12Ministerial Conference shows that a compromise has been reached between the United States, the European Union, South Africa, and India to improve access to the COVID-19 vaccine, which is reported to be hailed as the breakthrough by the DG of WTO. The decision, which merely addresses waiving patent rights of the COVID-19 vaccine to a restricted extent, is hardly a continuation of the TRIPs waiver proposal but a further optimization and facilitation of the implementation procedures of TRIPs flexibilities, especially the compulsory licensing regime. The decision enables patent waiver of COVID-19 vaccines by eliminating restrictions on mandatory licensing under article 31 of the TRIPs Agreement, such as authorized use of patents without prior negotiation with right holders. Despite the criticism of its narrow scope, ironically strict eligibility criteria, export barriers, and burdened necessity test for developing countries, this newly adopted approach can be regarded as a new development about TRIPs flexibilities, namely the reform of compulsory licensing clause. And it shows the compromise to ease the current TRIPs waiver deadlock by reemphasizing the use of TRIPs flexibilities.

5 Conclusion

The tension between IPRs protection and public health conservation has been with TRIPs since its inception.Both the Doha Declaration and TRIPs Amendment seek to achieve the objective of safeguarding public health by restricting IPRs. Despite the controversy that accompanied it, this was eventually agreed on among WTO members and consolidated in the form of WTO rules. However, the TRIPs waiver, a more radical and sweeping restriction on IPRs, has not sustained this consensus in the face of COVID-19. Presently, the pandemic continues to show a spreading trend. Serious illness and mortality rates have declined in some countries and regions due to the vaccine.Still, the resurgence of the pandemic and even localized backlashes triggered by variants such as Delta and Omicron are eroding hopes that the pandemic will end soon. According to WHO, by the end of December 2021, the Omicron variant, which has emerged in 110 countries, is spreading significantly faster than the Delta variant and has the potential to "immune escape" existing vaccines; WHO states that the rapid emergence and spread of the Omicron variant is a stark reminder that the public health crisis posed by the evolution of the COVID-19 pandemic continues to threaten the world and reinforces the critical need to achieve high levels of immunization coverage in all countries, including in highly vulnerable populations, in a timely manner. Given the international criticism of the lack of equity in vaccination and the recurrence of the pandemic, looking into the dilemma of the TRIPs waiver has positive implications for current and future responses to global public health crises. Despite its appearance as a "TRIPs waiver", to what extent the newly adopted Ministerial Decision on the TRIPs Agreement can work is still uncertain. Whereas the value of TRIPs waiver to address public crisis and challenges therein should be highlighted, there could be an opportunity for reemphasis on improving TRIPs flexibility. Comparing the two approaches,, TRIPs flexibility may easily play a more significant role.