Upon its adoption, the *Agreement on Trade-Related Aspects of Intellectual Property Rights* (*TRIPS Agreement*)<fnref n="1" /> enhanced the protection afforded to several intellectual property rights (IPRs). Prior to the adoption of the *TRIPS Agreement*, under the *Paris Convention*,<fnref n="2" /> the Contracting Parties were allowed to adopt a level of patent protection in accordance with their level of national development (provided the same protection was granted to citizens of other Contracting Parties as that afforded to nationals). This led to “asymmetries” in the patent system i.e., different standards among Contracting Parties.<fnref n="3" /> Moreover, before the Uruguay Round of negotiations, when the *TRIPS Agreement* was adopted, some fifty countries granted no intellectual property (IP) protection whatsoever, including Brazil, India, and Mexico. For those that did grant IP protection, the patent term was increased to 20 years from roughly 15 to 17 years in most countries and from 5 to 7 years in developing countries. Also, some fifty countries did not include products in the patentable subject matter (only processes), with the implication that products could be manufactured as soon as an alternative process was identified.<fnref n="4" />

While countries with research-intensive industries allegedly benefitted from the IPRs system, poorer countries lacking certain education opportunities, manufacturing or marketing tools, could not benefit from the enhanced protection in the same way, as they had few patentable products.<fnref n="5" /> Consequently, transition periods were established for developing countries, exempting them from granting IPRs protection. For a long time, the enhanced IPRs protection was apparent only for certain World Trade Organization (WTO) Members who, upon implementing the *TRIPS* provisions in their national legislation, also had the opportunity to adapt to differing levels of IP protection, according to their economic development, trade profile and strategic needs. The *TRIPS* *Agreement* was narrowly implemented in certain states, for instance by setting a high bar for novelty and inventiveness. For example, the Indian Supreme Court famously ruled in the case *Novartis* *v Union of India* that under Indian law, it does not constitute an invention

> the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.<fnref n="6" />

When it introduced an augmented level of IP protection, the *TRIPS Agreement*came in equipped with the tools to employ these enhanced IPRs in social service. It contains a built-in balancing exercise enshrined in Articles 7 “Objectives” and 8 “Principles”, which attempts to reconcile the exclusive rights conferred by IPRs with access to intellectual property, including for the purposes of providing access to affordable medicines. Particularly, the *TRIPS Agreement*encourages, through Articles 7 and 8, “the transfer and dissemination of technology”, “a balance of rights and obligations”, invokes the need to “protect public health” and allows for “appropriate measures […] to prevent the abuse of intellectual property rights […] or the resort to practices which unreasonably restrain trade.”<fnref n="7" /> Such provisions may be seen, from a policy perspective, as the “why” behind the legislative options laid before WTO Members in the shape of flexibilities offered by the *TRIPS Agreement*. Prior to the inclusion of Articles 7 and 8 in the *TRIPS Agreement*, there were no binding commitments in international law on matters of dissemination of technological knowledge for purposes of technological development, which underscores the importance of these provisions for interpreting the *TRIPS Agreement*. Likewise, it was also recognised that the transfer and dissemination of technology, if done, should not be engaged into in an abusive manner. To address this issue, also as a matter of novelty, the *TRIPS Agreement* included Article 40, to prevent abusive licensing practices.<fnref n="8" />

The so-called “flexibilities” offered for certain policy objectives are not formally defined in the *TRIPS Agreement* or in other parts of the *WTO Agreement.*<fnref n="9" /> The concept has so far been used merely to design, for example, the additional transitional period accorded to least-developed countries (“LDCs”) until fully implementing intellectual property protection.<fnref n="10" /> It is the Doha*Declaration on the TRIPS Agreement and Public Health* that articulates the notion of “flexibilities” as such and lists, non-exhaustively, several *TRIPS* provisions that constitute flexibilities.<fnref n="11" />

In practice, World Intellectual Property Organization (WIPO) has identified four clusters of flexibilities: (i) methods for implementing *TRIPS* obligations in the national law to accommodate national interests;<fnref n="12" /> (ii) substantive standards of protection; (iii) mechanisms of enforcement, which can indirectly lead to compulsory licensing (including compulsory licensing for export) and (iv) areas not covered by the *TRIPS Agreement* e.g., exhaustion regimes. In these four clusters, specific flexibilities to protected IPRs are: compulsory licensing; government use; exhaustion regimes of IPRs (potentially leading to the permission of parallel imports which, in the case of pharmaceuticals, depends also on the regulatory framework);<fnref n="13" /> the research “Bolar” exemption; exemptions from patentability (or other patent protection standards); limits on data exclusivity; or transition periods (grace periods allowing certain WTO Members to delay implementation of the protection accorded by the *TRIPS Agreement*). The scope of these specific flexibilities, together with the right to license IPRs, depend on the one hand, on the particular policy objectives of the legal framework embodying them. On the other hand, their scope depends on how the provisions enshrining them are interpreted. This article focuses on licences, be they voluntary or compulsory.

The above-mentioned *TRIPS* principles and objectives inform the interpretation of the *TRIPS Agreement*, both as to the rights it confers and as to the exceptions to these rights, such as the *TRIPS* flexibilities. In addition, it is worth exploring whether the *TRIPS Agreement* might also be read in light of the right to health. This article analyses the sources of the right to health and how the concept of access to medicines is reflected therein, to determine how it influences the implementation of the *TRIPS* flexibilities to contribute to achieving access to affordable medicines. Improving the application and management of the *TRIPS* flexibilities is likely to directly contribute to access to affordable medicines and ultimately to the realization of the right to health.

<footnote n="1">*Agreement on Trade-Related Aspects of Intellectual Property Rights*, Annex 1C of the*Marrakech Agreement Establishing the World Trade Organization*, 15 April 1994, 1867 UNTS 154, online: <wto.org> [perma.cc/BP9G-K2U3] [*TRIPS Agreement*] [*Marrakesh Agreement*].</footnote>

<footnote n="2">*Paris Convention for the Protection of Industrial Property*, 20 March 1883, 828 UNTS 305.</footnote>

<footnote n="3">World Intellectual Property Organization, “Public Policy-related Assistance—Flexibilities”, online: <wipo.int> [perma.cc/GLV7-ZMVF] [WIPO, “Public Policy”].</footnote>

<footnote n="4">Law Explorer, “Uruguay Round Negotiations and the Adoption of TRIPS” (4 November 2015), online: <lawexplores.com> [perma.cc/7HEG-2Z2J].</footnote>

<footnote n="5">Lawrence Gostin, *Global Health Law* (Cambridge: Harvard University Press, 2014) at 290.</footnote>

<footnote n="6">*Novartis Ag* *v* *Union of India & Ors,*AIR 2013 SC 1311 at para 95, (2013) 6 SCC 1 (SC India)*,*online: <indiankanoon.org> [perma.cc/C43R-9TYW].</footnote>

<footnote n="7">*TRIPS Agreement*, *supra* note 1, arts 7—8.</footnote>

<footnote n="8">Jayashree Watal, *Intellectual Property Rights in the WTO and Developing Countries* (The Hague: Kluwer Law International, 2001) at 387—88, where the author highlights that “these provisions recognize, for the first time in international law that there are two sides to the balance on IPRs: the rights of IPR owners and the needs of users of technology, balancing rights with obligations.”</footnote>

<footnote n="9">*Marrakesh Agreement*, *supra*note 1.</footnote>

<footnote n="10">*TRIPS Agreement*, *supra*note 1, art 66(1); more recently, in the *Annual Report (2021) of the Council for TRIPS*, IP/C/92, 2021.</footnote>

<footnote n="11">WTO, *Declaration on the TRIPS Agreement and Public Health*, WT/MIN(01)/DEC/2 (2001) at para 5, online: <wto.org> [perma.cc/7V5T-8GSP] [*Doha Declaration*].</footnote>

<footnote n="12">*TRIPS Agreement*, *supra*note 1, art 1(1); they result from this article and pertain to the implementation of concepts merely enunciated, but not defined by the *TRIPS Agreement* such as criteria for patentability or “situations of extreme urgency” for the purposes of compulsory licences (WIPO, “Public Policy”, *supra* note 3).</footnote>

<footnote n="13">*TRIPS Agreement*, *supra*note 1, art 6: “Exhaustion” provides: “For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.”</footnote>
# I. The Concept of “Access to Medicines”

The concept of “access to medicines” stems from the right to health recognized at international and national level<fnref n="14" /> and entails, in the terms of the United Nations, availability of quality medicines at affordable prices.<fnref n="15" /> There is extensive literature<fnref n="16" /> on the right to health which lays out the history of how it has been first read in the *Charter of the United Nations* (1945) in Articles 55 and 56,<fnref n="17" /> the *World Health Organization Constitution* (1948),<fnref n="18" /> the United Nations’ *Universal Declaration of Human Rights* (1948) in Articles 25 and 27,<fnref n="19" /> subsequently developed in the *International Covenant on Economic, Social and Cultural Rights* (1966) in Articles 12 and 2<fnref n="20" />—as further expanded in the *General Comment No 14*and*No 3* of the Human Rights’ Committee.<fnref n="21" />

Also, various soft law sources may be cited, such as various examples among the UN’s Sustainable Development Goals (SDG).<fnref n="22" /> Three of them directly refer to health: SDG 3,<fnref n="23" /> SDG 6, SDG 17. SDG 3 (Good Health and Well-being) aims to ensure healthy lives and promote well-being for all at all ages. It includes targets related to reducing maternal and child mortality, combating communicable diseases, ensuring universal access to sexual and reproductive healthcare services, and achieving universal health coverage. SDG 6 (Clean Water and Sanitation) while primarily focused on water and sanitation, also has a significant impact on health. Access to clean water and proper sanitation facilities is crucial for preventing waterborne diseases and promoting overall health and hygiene. SDG 17 (Partnerships for the Goals) is not solely focused on health but recognizes the importance of global partnerships and collaboration in achieving all the SDGs, including those related to health. It emphasizes the need for multi-stakeholder partnerships, knowledge sharing, capacity building, and financial support to enhance health systems and address health challenges. In addition to these specific goals, health is also interlinked with various other SDGs reflecting the interconnected nature of health with broader sustainable development. For instance, SDG 1 (No Poverty) and SDG 2 (Zero Hunger) address factors that influence health outcomes, such as poverty, malnutrition, and food security. Similarly, SDG 4 (Quality Education) aims to ensure inclusive and equitable education, which can have positive impacts on health literacy and health outcomes.<fnref n="24" />

Neither the SDGs (nor the previous Millenium Development Goals) are binding for UN members, but most of them, among which the EU, have issued statements to commit to achieving them.<fnref n="25" /> Also, the WTO’s Appellate Body has already relied in its practice on instruments of soft law to interpret the *WTO Agreement*.<fnref n="26" />

These instruments either create outright obligations under international law, to various extents, to both states and private entities or, in the case of soft law sources, serve as sources for interpretation of the binding instruments. How and to what extent is addressed in the following section.

<footnote n="14">According to the UN Secretary General’s High-Level Panel on Access to Medicines, the right to health is enshrined in at least 115 national constitutions, see UN Secretary-General’s High-Level Panel on Access to Medicines, *Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines*: *Promoting innovation and access to health technologies* (2016) at 16, online: <unsgaccessmeds.org> [perma.cc/KA57-CRGL] [UN Secretary-General, *Promoting innovation*].</footnote>

<footnote n="15">WHO, *Road Map for Access to Medicines, Vaccines and Other Health Products 2019*—*2023* (Geneva: World Health Organization, 2019) at 2, online: <iris.who.int> [perma.cc/SPK5-ET9U] [WHO, *Road Map*]; see also generally UNDP, *Using competition law to promote access to health technologies*:*A supplement to the Guidebook for low- and middle-income countries* (New York, 2022), online: <undp.org> [perma.cc/5GYM-WTBF] and in particular as to how competition law plays a role in regulating prices in less regulated markets such as the market of OTC medicines and thus contributing to ensuring access to medicines.</footnote>

<footnote n="16">John Tobin, “Still getting to know you: global health law and the right to health” in Gian Luca Burci & Brigit Toebes, eds, *Research Handbook on Global Health Law* (Cheltenham, UK: Edward Elgar, 2018) 56; Gostin, *supra* note 5; Gabrielle Marceau, “WTO Dispute Settlement and Human Rights” (2002) 13:4 Eur J Intl L 753 at 786—88, online: <academic.oup.com> [perma.cc/HCV7-JZWS] [Marceau, “WTO Dispute”].</footnote>

<footnote n="17">*UN Charter*, 26 June 1945, Can TS 1945 No 7, arts 55—56.</footnote>

<footnote n="18">*Constitution of the* *World Health Organization,* 22 July 1946, 14 UNTS 185 at para 2 of its preamble, reads that “The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”</footnote>

<footnote n="19">*Universal Declaration of Human Rights*, UNGA, 3rd Sess, UN Doc A/810 (1948) GA Res 217A (III), art 25(1) reads as follows: “Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including […] medical care […].”</footnote>

<footnote n="20">*International Covenant on Economic, Social and Cultural Rights*, 19 December 1966, 993 UNTS 3, art 12(1), read as follows: “The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” [*ICESCR*].</footnote>

<footnote n="21">*CESCR General Comment No 14: The Right to the Highest Attainable Standard of Health (Art 12)*, UNESC, 2000, UN Doc E/C.12/2000/4 [*General Comment No 14*]; *CESCR General Comment No 3: The Nature of States Parties’ Obligations (Art 2, Para 1, of the Covenant)*, UNESC, 1990, UN Doc E/1991/23.</footnote>

<footnote n="22">UN, “The 17 Goals”, online: <sdgs.un.org> [perma.cc/RW2K-3B5J] [UN, “17 Goals”]; for a comprehensive exposé, see *The right of everyone to the enjoyment of the highest attainable standard of physical and mental health*, UNESC, 2003, UN Doc E/CN.4/2003/58 at 6—8; UN Secretary-General, *Promoting innovation*, *supra* note 14 at 16—17, Box 3.</footnote>

<footnote n="23">See especially SDG 3.8: “Achieve universal health coverage, including financial risk protection, access to quality essential health care services, and access to safe, effective, quality and affordable essential medicines and vaccines for all”: WHO, “SDG Target 3.8”, online: <who.int> [perma.cc/X77W-4EEP].</footnote>

<footnote n="24">UN, “17 Goals”, *supra* note 22.</footnote>

<footnote n="25">See e.g. *Joint statement by the Council and the representative of the governments of the Member States meeting within the Council, the European Parliament, and the Commission on European Union Development Policy:* *The European Consensus*, [2006] OJ, 2006 C 46/1; EC, *The EU as a global partner for pro-poor and pro-growth development*—*EU Agenda for Action on MDGs*, 11096/08 (2008). Target 8.E of the Millennium Development Goals mentioned that “from 2007 to 2014, on average, generic medicines were available in 58 percent of public health facilities in low-income and lower-middle-income countries” which showcases the important role played by generics in ensuring access to medicines: UN, “Goal 8: Develop a global partnership for development” (2015), online: <un.org> [perma.cc/5UDK-6HHH].</footnote>

<footnote n="26">Through a broad reading of art 31(3)(c) of the *Vienna Convention on the Law of Treaties*, 23 May 1969, 1155 UNTS 331 [*VCLT*], the Appellate Body relied on more than formal treaties to read obligations in international environmental law: *United States*—*Import Prohibition of Certain Shrimp and Shrimp Products* (1998), WTO Doc WT/DS58/AB/R at para 158 (Appellate Body Report), online: <docs.wto.org> [perma.cc/NPR5-LQSA] [*US*—*Shrimp*].</footnote>
# II. The Interpretation of WTO Law Through the Lens of the Right to Health

The primary duty-bearers of human rights in general and of the right to health in particular are the states. In terms of the measures to be adopted as a concretization of the right to health, states have the obligations to respect, protect and fulfil, whereby the latter encompasses dimensions such as to facilitate, provide and promote.<fnref n="27" /> States’ duties to protect and fulfil require them to act i.e., to actively take the necessary measures in order to ensure the effective protection of a human right.

The *International Covenant on Economic, Social and Cultural Rights* (*ICESCR*)<fnref n="28" /> and most international instruments for the protection of human rights focus on the negative dimension of state obligations i.e., to refrain from infringing action. However, it is nowadays widely recognized in doctrine and practice that human rights treaties also impose positive obligations on states. This, not only against interference caused by the states itself, but also against natural hazards or, importantly, interferences by individuals.<fnref n="29" />

As emphasized by the ECOSOC in its *General Comment No 14*, the positive obligations to fulfil the right to health place a duty on states to take appropriate legislative, administrative, budgetary, judicial, advocacy and other measures aimed at the full realization of this right.<fnref n="30" /> The *General Comment* goes beyond recognizing the existence of positive obligations and provides a (non-exhaustive) list of measures that states must take based on their duties to protect and fulfil. Specific duties to protect encompass for instance legislative measures for granting equal access to private health-related services or for the oversight and regulation of medicines and medical equipment marketed by third parties.<fnref n="31" /> Pursuant to the *General Comment No 14*, political and legal systems of states must be shaped in light of the right to health.<fnref n="32" /> Arguably, this means shaping interconnected fields of competition law, trade law, intellectual property law—including with a view to realise the right to health. It may amount, for example, to providing for grounds to apply competition rules and approaches to interpret them in light of the right to health. Or shaping the scope of intellectual property rights and creating exceptions to protection in light of the right to health.

However, can the right to health and the non-WTO instruments encompassing it be used in the reading of WTO provisions concerning the above-mentioned fields? Related questions have also been asked before such as: “does human rights law have direct application in the WTO system of law and before WTO adjudicating bodies? Can a WTO Member invoke human rights considerations in its interpretation of WTO rights and obligations? Can a WTO panel accept human rights allegations when there are no references to human rights in the *WTO Agreement*? Does WTO law or international law allow WTO Members to adopt measures that take into consideration situations relevant from a human rights perspective, occurring exclusively in another state and with no direct effect in that member’s territory?”<fnref n="33" />

The questions are essential because WTO law is conceived as a “self-contained” system, functioning as *lex specialis* in relation to international law and obligations contained in international law.<fnref n="34" /> The corollary is that it cannot be overruled by other systems of law like human rights law. WTO adjudicating bodies have a limited jurisdiction and are thereby incapable of applying and enforcing norms other than those of the WTO. This means that WTO adjudicating bodies do not have the competence to: (i) formally assess whether a trade measure is compatible with human rights law or reach any formal conclusion that a non-WTO norm has been violated; (ii) require any positive action pursuant to a human rights treaty; (iii) reach any conclusion that would enforce a non-WTO norm over WTO provisions.<fnref n="35" /> Otherwise, it would lead to effectively adding, diminishing, or amending the WTO covered agreements<fnref n="36" /> which is prohibited by Article 3.2 of the *Dispute Settlement Understanding* (*DSU*).<fnref n="37" />

However, the manner in which WTO Members (and adjudicating bodies) must interpret WTO law is another matter.

First, based on the international law principle *pacta sunt servanda*, WTO Members must comply with all their international obligations, including their human rights obligations, at all times<fnref n="38" /> so that WTO provisions should be interpreted in light of these other obligations of states.<fnref n="39" /> Second, even though the WTO dispute settlement system currently does not work as it used to, the *DSU* remains a relevant legislative source for matters of treaty interpretation. According to Article 3.2 of the *DSU*, WTO provisions must be clarified “in accordance with customary rules of interpretation of public international law.”<fnref n="40" /> Third, as stated by the Appellate Body in its first dispute, “the *General Agreement* is not to be read in clinical isolation” and it must be interpreted by applying the customary rules of interpretation.<fnref n="41" /> The Appellate Body recognises that the general rule of interpretation provided for in Article 31 of the *Vienna Convention on the Law of Treaties* (*VCLT*)<fnref n="42" /> has attained customary international law status because over time it has been relied upon by all of the participants and third parties to the dispute, as necessary.<fnref n="43" />

In this landscape, where all the interpretation rules of Articles 31—33 of the *VCLT* must be considered cumulatively,<fnref n="44" /> Article 31(3)(c) of the *VCLT* is particularly relevant for considering the human rights instruments previously mentioned in the interpretation of WTO law. It provides that “There shall be taken into account, together with the context: (c) any relevant rules of international law applicable in the relations between the parties.”<fnref n="45" /> Article 31(3)(c) is relevant because it allows considering in the interpretive process what some call “remote content” in relation to the treaty or rule being interpreted. While an assessment cannot be suggested as definitive and must be discussed on a case-by-case basis, several elements are worth discussing. Such remote content can be described, based on the wording of Article 31(3)(c), as follows. It can be “any rule” i.e., not necessarily an international law instrument, such as a treaty. However, it must be an “applicable” rule in that it must be the outcome of a consensus; a sort of agreement such that the rule is binding and enforceable and “the parties” can rely on this rule as grounds for claims. Contrary to Article 31(2)(a), which refers to “all parties” or to Article 31(2)(b) which refers to “one or more parties”, Article 31(3)(c) refers to “the parties”, potentially suggesting that the said rule needs to be comprised in an instrument between all the parties to the treaty being interpreted.<fnref n="46" /> However, it seems sufficient that the rule serving as source of expansive interpretation be comprised in an instrument between those parties which are also parties to the treaty being interpreted. This, as opposed to all parties to the treaty being interpreted.<fnref n="47" /> To note also that Article 31(3)(c) reads that such rules “shall” be taken into account, which, in light of Article 3.2 of the *DSU*<fnref n="48" /> and the *US—Gasoline* case,<fnref n="49" /> is to mean that such “relevant rules” must be considered and it is not within the discretionary power of the interpreter to consider them or not.

Therefore, in interpreting WTO law, rules comprised for example in a WHO statement or UN’s SDGs must be taken into account and inform the interpretation of WTO rules. Their weight in the interpreting process will vary depending on the relevance for the situation at hand and the rule being interpreted.<fnref n="50" />

Under the general exceptions of Article XX of the *General Agreement on Tariffs and Trade* (*GATT 1947*),<fnref n="51" /> among which also lies the protection of health, interpreters of WTO law may look at other treaties or reports of international bodies as factual matters, to assess compliance with the exception provisions. For example, in order to determine if measures restrictive of trade are necessary for the protection of public health, an interpreter will assess “necessity” in light also of the respective WTO Member’s other obligations, including those stemming from instruments issued by other international organisations that the WTO Member is party to.

Article 31(3)(c) is the door left open for flexibility in the interpretation of WTO law. At the same time, this examination of principles of general law is to be done solely to the extent necessary to interpret WTO law and to determine compliance with WTO law. To illustrate, it is worth mentioning that a 1997 WTO dispute reflects how the European Communities had been granted an exception for certain of their obligations under the *GATT* *1947* to the extent necessary to comply with the Lomé Convention, to which they were a party.<fnref n="52" />

Under WTO law, it seems that a choice was made for an authentic equilibrium between trade and human rights, through a balancing exercise in the reading of the WTO applicable law. Therefore, in adopting appropriate policies, WTO Members must balance aspects of international human rights law (in particular, the right to health), trade rules (in medicines and health technologies), IPRs (pertaining to the research, development and delivery of medicines and health technologies), public health objectives (including in emergency scenarios) and competition law (by reconciling objectives such as proper market functioning and consumers’ welfare).

At the same time, an interpreter can (and likely should) also take into account and examine national law for the purposes of determining if a WTO provision has been complied with.<fnref n="53" />

In interpreting trade rules, including those related to intellectual property rights, in light of human rights law, a fine balance must be grasped because it may seem that the policy objectives of each field of law are at odds with each other. However, this is not necessarily the case because these fields of law may together be conducive to social welfare. For example, trade rules and intellectual property protection drive innovation<fnref n="54" /> and economic growth albeit, at times, at the expense of public health goals.<fnref n="55" /> In turn, public health goals are better served in economically developed societies, whose growth is driven by trade and economic performance of IPRs. Conflicts between trade and human rights law were considered to likely occur very rarely. When that happens, or in order to avoid that a formal conflict occurs, “through good faith interpretation [pursuant to Article 31 of the *VCLT*], the WTO law and human rights law can generally be applied harmoniously and effectively.”<fnref n="56" /> It is not the aim of this article to argue that one policy objective is better to pursue than another.<fnref n="57" /> Instead, it seeks to suggest how a certain balance must be struck in order to lead to long-term human welfare in an authentic, sustainable fashion.

WHO seems to adopt a similar balancing approach, underlining that “[t]here is an increasing need to ensure the sustainable availability of health products through careful management of affordable pricing for health systems and fair pricing for producers.”<fnref n="58" /> Arguably, this means that the availability of health products depends on robust intellectual property rights as an incentive for pharmaceutical companies and efficient trade rules to allow the circulation of health products. At the same time, the rights recognised to private entities should be interpreted considering the content of the right to health. Fair pricing (for suppliers) is not the same as affordable prices (for end users). Balancing the two is arguably welfare-enhancing (both economically and from the standpoint of the right to health) and thereby a legitimate policy goal in the adoption of legislation.

Likewise, while patent owners have the right to conclude licensing contracts under Article 28(2) of the *TRIPS Agreement*, this provision can be interpreted in light of the right to health. For example, by ensuring that licensing contracts concluded by private entities equally pursue goals such as providing health products at affordable prices, depending on the essentiality of the medicines in question, the channels of supply (arguably enabling preferential prices for the public sector as opposed to the private sector) and the level of economic prowess or development of the territory covered by the licence. It can be argued that WTO Members, other than adopting appropriate policies, also have a positive obligation to monitor compliance (with, for example, public health goals) by private entities. States’ omission to prevent non-state actors from infringing human rights, could be considered a violation of the right to health.<fnref n="59" /> However, in determining an appropriate level of intervention by the state, one should also consider whether appropriate support has been provided by such state actors in the development of those final products such as investment in research and development, facilitation of registration formalities for the marketing of the product or other measures contributing to an enabling environment for the industry to provide a final product to the consumer. A give and take approach should inform policy measures as opposed to purely economic or purely social-oriented goals.

<footnote n="27">*General Comment No 14*, *supra* note 21 at para 33.</footnote>

<footnote n="28">*ICESCR*,*supra*note 20.</footnote>

<footnote n="29">Dinah Shelton & Ariel Gould, “Positive and Negative Obligations” in Dinah Shelton, ed, *The Oxford Handbook of International Human Rights Law* (Oxford: Oxford University Press, 2013) 562 at 569.</footnote>

<footnote n="30">*General Comment No 14*, *supra* note 21 at paras 30—44.</footnote>

<footnote n="31">*Ibid*at para 35.</footnote>

<footnote n="32">*Ibid* at para 36.</footnote>

<footnote n="33">Marceau, “WTO Dispute”, *supra* note 16 at 755.</footnote>

<footnote n="34">*Ibid*at 766.</footnote>

<footnote n="35">*Ibid* at 791—802.</footnote>

<footnote n="36">Those expressly mentioned in Article 1.1 of the *Understanding on Rules and Procedures Governing the Settlement of Disputes*, 15 April 1994, 1869 UNTS 401, Annex 2 of the *Marrakesh Agreement*, *supra* note 1 [*DSU*] according to which “[t]he rules and procedures of this Understanding shall apply to disputes brought pursuant to the consultation and dispute settlement provisions of the agreements listed in Appendix 1 to this Understanding (referred to in this *Understanding* as the “covered agreements”).</footnote>

<footnote n="37">*DSU*, *supra* note 36, art 3.2 reads in its last sentence: “Recommendations and rulings of the DSB [Dispute Settlement Body] cannot add to or diminish the rights and obligations provided in the covered agreements”; see Marceau, “WTO Dispute”, *supra* note 16 at 763—64.</footnote>

<footnote n="38">*VCLT*, *supra* note 26, art 26: “*Pacta sunt servanda*” provides that “Every treaty in force is binding upon the parties to it and must be performed by them in good faith”; see also Marceau, “WTO Dispute”, *supra* note 16 at 800.</footnote>

<footnote n="39">Marceau, “WTO Dispute”, *supra*note 16 at 779.</footnote>

<footnote n="40">*DSU*, *supra* note 36, art 3.2.</footnote>

<footnote n="41">*United States*—*Standards for Reformulated and Conventional Gasoline* (1996), WTO Doc WT/DS2/AB/R at 17 (Appellate Body Report), online: <docs.wto.org> [perma.cc/DU3S-DHLR] [*US*—*Gasoline*].</footnote>

<footnote n="42">*VCLT*, *supra* note 26.</footnote>

<footnote n="43">*US*—*Gasoline*, *supra* note 41 at 17, n 34.</footnote>

<footnote n="44">These elements are not carried out in steps, but holistically by the interpreter in that each element influences the other; see *United States*—*Measures Affecting the Production and Sale of Clove Cigarettes (Complaint by Indonesia) (2012)*, WTO Doc WT/DS406/AB/R at para 273 (Appellate Body Report), online: <docs.wto.org> [perma.cc/K7FX-C4VU].</footnote>

<footnote n="45">*VCLT*, *supra* note 26, art 31(3)(c).</footnote>

<footnote n="46">*VCLT*, *supra* note 26, art 31.</footnote>

<footnote n="47">“An interpretation of ‘the parties’ in Article 31(3)(c) should be guided by the Appellate Body’s statement that ‘the purpose of treaty interpretation is to establish the common intention of the parties to the treaty.’ This suggests that one must exercise caution in drawing from an international agreement to which not all WTO Members are party. At the same time, we recognise that a proper interpretation of the term ‘the parties’ must also take account of the fact that Article 31(3)(c) of the *Vienna Convention* is considered an expression of the ‘principle of systemic integration’ which, in the words of the ILC, seeks to ensure that ‘international obligations are interpreted by reference to their normative environment’ in a manner that gives ‘coherence and meaningfulness’ to the process of legal interpretation. In a multilateral context such as the WTO, when recourse is made to a non-WTO rule for the purposes of interpreting provisions of the WTO agreements, a delicate balance must be struck between on the one hand, taking due account of an individual WTO Member’s international obligations and, on the other hand, ensuring a consistent and harmonious approach to the interpretation of WTO law among all WTO Members” (*European Communities and Certain Member States—Measures affecting Trade in* *Large Civil Aircraft (Complaint by the United States)* (2011), WTO Doc WT/DS316/AB/R at para 845 (Appellate Body Report), online: <docs.wto.org> [perma.cc/TSK4-G43H]); see also Gabrielle Marceau, Maria George & Vishaka Raj, “Application of the General Rule of Interpretation by the WTO Dispute Settlement System”, in Panos Merkouris, Sotirios-Ioannis Lekkas & Nina Mileva, eds, *The Practice of Interpretation in International Law: Unity, Diversity, and Evolution*(Cambridge University Press, forthcoming 2025).</footnote>

<footnote n="48">I.e., that existing WTO provisions must be clarified in accordance with customary rules of interpretation.</footnote>

<footnote n="49">Whereby the *GATT* “is not to be read in clinical isolation” and will have to be interpreted by applying the customary rules of interpretation (*US*—*Gasoline*, *supra* note 41 at 17).</footnote>

<footnote n="50">“Article 31(3)(c) would potentially reach a series of international norms. What finally determines which international law rules are to be used for the interpretation of a specific treaty is rather the relevance of the particular rule of international law in light of the nature of the WTO provisions that are being interpreted in the dispute. (In the context of human rights, many of the relevant provisions are customary or included in treaties with very broad membership.)” (Marceau, “WTO Dispute”, *supra* note 16 at 783).</footnote>

<footnote n="51">*General Agreement on Tariffs and Trade*, 30 October 1947, 55 UNTS 187 art 20 [*GATT 1947*].</footnote>

<footnote n="52">*European Communities—Regime for the Importation, Sale and Distribution of Bananas (Complaint by Ecuador, Guatemala, Honduras, Mexico, United States)* (1997), WTO Doc WT/DS27/AB/R at paras. 162-164 (Appellate Body Report), online: <docs.wto.org> [perma.cc/QWJ9-AEN5], referring to the *Lomé Convention*, 15 December 1995.</footnote>

<footnote n="53">For example, in *India*—*Patents (EC)*, the AB considered that “[t]here was simply no way for the Panel to make this determination without engaging in an examination of Indian law. But […] in this case, the Panel was not interpreting Indian law ‘as such’; rather, the Panel was examining Indian law solely for the purpose of determining whether India had met its obligations under the *TRIPS Agreement*” (see *India*—*Patent Protection for Pharmaceutical and Agricultural Chemical Products (complaint by The European Communities)* (1997), WTO Doc WT/DS50/AB/R at paras 66 (Appellate Body Report)); similarly, in *United States*—*Anti-Dumping Act of 1916 (Complaint by the European Communities)* (2000), WTO Doc WT/DS136/R at para 6.48 (Appellate Body Report), the panel examined the domestic application, historical context and legislative history and subsequent declarations of state authorities with regard to what was otherwise considered a clear text, in order to determine its compatibility with WTO law.</footnote>

<footnote n="54">By certain accounts, of 12 industries, patents are essential in two: the pharmaceutical and chemical industries, with the former at the high-end of IP-dependent industries; see Edwin Mansfield, “Patents and Innovation: An Empirical study” (1986) 32:2 Management Science 173 at 174; Wesley M Cohen, Richard R Nelson & John P Walsh, “Protecting Their Intellectual Assets: Appropriability Conditions and Why US Manufacturing Firms Patent (or Not)” (2000) National Bureau of Economic Research, Working Paper No 7552, online: <nber.org> [perma.cc/9BRK-WZ89]; see also J Thomas Rosch, “The Role of Static and Dynamic Analysis in Pharmaceutical Antitrust” (New York: Federal Trade Commission, 2010) at 7—8, online: <ftc.gov> [perma.cc/EE3X-QFN2].</footnote>

<footnote n="55">UN Secretary-General, *Promoting innovation*, *supra* note 14 at 7.</footnote>

<footnote n="56">Marceau, “WTO Dispute”, *supra* note 16 at 778.</footnote>

<footnote n="57">In defining the mandate of the High-Level Panel with regard to access to medicines, it is recognised at UN level that the task (of achieving access to affordable medicines) is particularly complex namely due to “the incoherencies between international human rights, trade, intellectual property (IP) rights and public health objectives” (UN Secretary-General, *Promoting innovation*, *supra* note 14 at 7).</footnote>

<footnote n="58">WHO, *Road Map*, *supra* note 15 at 15.</footnote>

<footnote n="59">Sarah Joseph, “Pharmaceutical Corporations and Access to Drugs: The ‘Fourth Wave’ of Corporate Human Rights Scrutiny” (2003) 25:3 Hum Rts Q 425 at 438—39; see generally on the scope of States’ duties with regard to the realization of human rights, *Report of the Special Representative of the Secretary-General on the issue of human rights and transnational corporations and other business enterprises*, UN Doc A/HRC/17/31 (2011) [*Report of the Special Representative*].</footnote>
# III. Private Entities’ Obligations Related to the Right to Health

Notwithstanding that human rights primarily establish binding obligations for states, a number of international law provisions demonstrate that the observance of human rights by private entities plays an important role in the effective realisation of these rights.

In this sense, the preamble to the *UDHR*—which, according to the UN*Guiding Principles for Business and Human Rights*,<fnref n="60" /> represents the first point of reference to determine the material human rights covered by corporate social responsibility—stipulates the responsibility of all society members and implicitly of corporations to respect human rights.<fnref n="61" />

This guiding rationale is also affirmed by the UN *Global Compact*, according to which “businesses should support and respect the protection of internationally proclaimed human rights […] and make sure that they are not complicit in human rights abuses.”<fnref n="62" /> In doing this, companies should use international human rights instruments to benchmark corporate conduct.<fnref n="63" />

The UN*Guiding Principles on Business and Human Rights*, adopted by the UN Human Rights Council in 2011, play a crucial role in addressing human rights violations committed by private companies. While not legally binding, these *Principles* hold significant normative force and serve as a source of inspiration for numerous international and national regulations.<fnref n="64" /> On the one hand, the *Principles* focus on the responsibility of states to protect human rights and require them to protect individuals from human rights violations by businesses.<fnref n="65" /> On the other hand, the *Principles* also place responsibility on corporations, emphasizing the importance of compliance with legal norms and respect for fundamental rights.<fnref n="66" />

Thus, in addition to states’ duty to protect the right to health against infringement by third parties, the United Nations Sub-Commission on the Promotion and Protection of Human Rights reiterates that “transnational corporations and other business enterprises, as organs of society, are also responsible for promoting and securing the human rights set forth in the *Universal Declaration of Human Rights*.”<fnref n="67" /> Therefore, not only do states have to adopt appropriate legislation, but transnational corporations also have an obligation to “promote and secure” human rights, including the right to health, arguably by adopting a business conduct driven not only by economic or business considerations, but by a certain endeavour to contribute to the realisation of the right to health as well.

However, since the conclusion of a binding human rights instrument is still pending, leaving the human rights duties of corporations mainly covered by soft-law and corporate social responsibilities enshrined therein, it remains unclear what this means for individuals and what is the extent of an individual right to remedies for abuses by non-state actors.<fnref n="68" /> Therefore, in the absence of a direct horizontal effect of the right to health as enshrined in international human rights instruments such as the *ICESCR*, the main component of this right remains its realisation by states through appropriate policies, regulation and adjudication.<fnref n="69" /> At the same time, such measures must be balanced against the need to create an enabling environment for thriving advancements in innovation, including through the availability of intellectual property protection as incentivising tool for the industry’s research and development investments.

Nevertheless, corporations do at least have an indirect duty to collaborate to the realisation of the right to health through appropriate and effective application of legislation protecting it and through business strategies that also contribute to the materialisation of certain human rights. For example, this may amount to proactive initiatives and collaboration in good faith to the conclusion and effective performance of voluntary licences, to reasonably practicable extents from a business perspective. Likewise, as to the conclusion and performance (including, ideally, through cooperation regarding data sharing) of compulsory licences. This does not mean that, in protecting rights of individuals, states do not, at the same time, also have the right to grant compulsory licences on reasonable terms which also protect licensors from abuse.

For example, at EU level, new legislation has been enacted in 2024. The *Corporate Sustainability Due Diligence Directive* (*CSDDD*)<fnref n="70" /> sets human rights standards for large companies operating in the European Union. With the transposition of the directive into the legislation of EU Member States, companies are compelled to identify and assess actual and potential adverse impacts on human rights, the environment, and other specified areas within their value chains. This includes impacts related to their own operations, as well as impacts associated with their business relationships, including suppliers and subcontractors. The directive may arguably nudge corporations into concluding voluntary licences that contribute to effective technology transfers so as to enhance access to affordable medicines through local and potentially cheaper production, to shorten supply chains and therefore reduce environmental impact of complex logistical operations while accessing new markets or fostering collaborations with licensees with capacity to carry further the status quo in innovation.

<footnote n="60">*Guiding Principles on Business and Human Rights: Implementing the United Nations “Protect, Respect and Remedy” Framework*, OHCHR, UN Doc HR/PUB/11/04 (2011) at 14, online: <ohchr.org> [perma.cc/8B84-ZC6G] [*Guiding Principles*].</footnote>

<footnote n="61">*UDHR*,*supra*note 19, Preamble.</footnote>

<footnote n="62">UN Global Compact, “The Ten Principles of the UN Global Compact”, Principles 1 and 2, online: <unglobalcompact.org> [perma.cc/XPE8-XTVX].</footnote>

<footnote n="63">Emmanuel Decaux, “Présentation” in Emmanuel Decaux, ed, *La responsabilité des entreprises multinationales en matière de droits de l’homme* (Bruxelles: Anthémis, 2010) 11 at 11-12.</footnote>

<footnote n="64">Petru Emanuel Zlătescu, “Die Konzernverantwortungsinitiative im internationalen Kontext” (2020) Jusletter.</footnote>

<footnote n="65">*Guiding Principles*, *supra* note 61 at 3.</footnote>

<footnote n="66">*Ibid* at 13.</footnote>

<footnote n="67">*Norms on the responsibilities of transnational corporations and other business enterprises with regard to human rights*, UNESC, 2003, UN Doc E/CN.4/Sub.2/2003/12/Rev.2 at 1, online: <digitallibrary.un> [perma.cc/Y68V-CGTW]; along the same lines, see also *General Comment No 14*,*supra*note 21 at para 42 which reads as follows: “[w]hile only States are parties to the Covenant and thus ultimately accountable for compliance with it, all members of society—individuals, including health professionals, families, local communities, intergovernmental and non-governmental organizations, civil society organizations, as well as the private business sector—have responsibilities regarding the realization of the right to health. States parties should therefore provide an environment which facilitates the discharge of these responsibilities.”</footnote>

<footnote n="68">*Report of the Special Representative*, *supra* note 59 at 4.</footnote>

<footnote n="69">*ICESCR*, *supra* note 20, art 2(1) according to which State Parties must in particular adopt legislative measures for progressively achieving the full realization of the rights recognised in the *ICESCR*; see also *Report of the Special Representative*, *supra* note 59.</footnote>

<footnote n="70">EU, *Proposal of the European Parliament and of the Council on Corporate Sustainability Due Diligence and amending Directive (EU) 2019/1937*, COM(2022)71.</footnote>
# —

Assuming a right to health exists, further to the need to enhance access to affordable medicines it also implies to elaborate multilateral institutional and legal solutions to improve sustainability of the pharmaceutical sector in general and particularly support countries’ preparedness for achieving global health security in case of potential challenges.

Trade remains the most relevant framework to tackle access to medicines and excessive pricing because while the WTO is the most appropriate forum to deal with cross-border issues, access to affordable medicines is inherently about exports and imports of essential health goods and services. WTO has the potential to create equitable access in situations otherwise characterized by asymmetrical access to medicines by people of unequal economic background. Also, because global health security concerns do not respect national boundaries, thus requiring international response which implies cross-border trade.

Therefore, there is room to argue that the WHO legal framework and in particular the *TRIPS Agreement* allows an interpretation, in light of human rights law, that leads to an application of *TRIPS* flexibilities such as compulsory licences or competition rules in a manner that is conducive to access to affordable medicines. At the same time, while not directly enforceable by WTO Members, voluntary collaboration by private entities is advisable. It is meant to level the playing field and avoid more protectionist measures such as localisation requirements or an excessive application of remedies by state authorities. Voluntary mechanisms rely on the belief that (more) trade produces (more) growth and thereby promotes individuals’ welfare.<fnref n="147" /> In the legislative framework driven by the need to balance fair pricing with affordable prices, it is not only states who must adopt appropriate policies, but also private entities, while considering that states also have a positive obligation to monitor compliance by the industry. At the same time, in concluding licences, companies should equally consider goals such as access to affordable medicines.

<footnote n="147">Douglas Irwin, “Does Trade Reform Promote Economic Growth? A Review of Recent Evidence” (2024) National Bureau of Economic Research, Working Paper 25927, online: <nber.org> [perma.cc/HZQ9-SYGF].</footnote>