Ensuring Pharmaceutical Accountability for Human Rights and Access to Medicines: The Dutch Duty of Care Standard Applied to Pharmaceutical Companies

Abstract

To effectively protect the human right to health, the global accountability gap for pharmaceutical companies regarding access to medicines must be addressed. Pharmaceutical companies have no formal obligations under human rights law; however, they do have responsibilities, and some companies (directly or indirectly) undermine the right to health and equitable access to medicines. We propose that pharmaceutical companies can be held accountable for human rights interferences by means of a provision in Dutch tort law containing an ‘unwritten duty of care’, an interpretation which is supported by the international human rights framework and recent Dutch jurisprudence. We propose a concrete example of how this duty could be applied in Dutch courts, which have previously held a private corporation accountable for contributing to dangerous climate change in the Milieudefensie et al. v Royal Dutch Shell case. To establish whether this duty could be applied to pharmaceutical companies, we use the court’s reasoning in Milieudefensie to assess the existence of a global consensus on the need for a pharmaceutical duty of care. We argue that human rights norms and soft law instruments that pharmaceutical companies themselves have endorsed prove that there is a growing consensus regarding the damage associated with excessively priced medicines, and an urgent need to establish a framework for holding pharmaceutical companies accountable for ensuring equitable access to medicines through legal measures.

1. Introduction

To effectively realize the human right to health, the global accountability gap for pharmaceutical companies regarding access to medicines must be addressed. States that have ratified the International Covenant on Economic, Social and Cultural Rights (ICESCR) (United Nations (UN) 1966): art. 12) have assumed binding duties to respect, protect, and fulfil the right to health, enshrined in its Article 12 and as interpreted by the UN Committee on Economic, Social and Cultural Rights (CESCR) (1990: General Comment (GC) 3; 2000: GC 14). States’ duty to protect requires them to regulate non-state actors to prevent their actions from interfering with the realization of this right (ibid.: GC 14). However, in practice, this is challenging. More so because pharmaceutical companies have no formal obligations under international (human rights) law (Office of the United Nations High Commissioner for Human Rights (OHCHR) 2011). These companies have historically failed to respect human rights and equitable access to medicines by prioritizing research and development of the most ‘profitable’ medicines and using patents and related exclusivities to create monopolies and drive up prices globally (Grover 2022). The World Trade Organisation (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (World Trade Organisation 1994) sets out the minimum standards for intellectual property protection that members need to provide. Such product monopolies tend to prevent the entry of generics in the markets. Generics enable lower prices thanks to the resulting market competition, which in turn promotes access in countries with fewer resources to pay for the expensive branded medicine (often low- and middle-income countries) (Diependaele et al. 2017: 11–21). Pharmaceutical companies also hold leverage over governments in the form of product monopolies, lobbying policymakers (promises of), investments in the local economy, and, in some cases, financial support to political parties (Morgan and Duffy 2019; Chaffin 2022). Thus, while pharmaceutical companies play a pivotal role in global medicines development, they lack corresponding duties to allocate these products at a ‘fair’ price—one that is affordable for people, communities, and health systems—which is problematic from the perspective of a rights-based approach to health.

Unsurprisingly, pharmaceutical company accountability has been dealt with extensively by authoritative human rights actors. Paul Hunt (2008), as United Nations (UN) Special Rapporteur on the right to health, developed the Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines, which identify the responsibilities of pharmaceutical companies under the right to health (UN General Assembly 2008; Grover et al. 2012). Legal scholars have also proposed accountability mechanisms leveraging the power of consumer and/or investor choice (Global Health Impact 2017; van Erp 2014; (Access to Medicine Foundation 2008; Pharmaceutical Accountability Foundation 2022). Civil society plays a key role in advocating for wider access to medicines, particularly since its involvement in the fight for access to antiretrovirals for HIV/AIDS treatment in the 1990s (Heywood 2009). However, these initiatives do not fill the legal enforcement and accountability gap. To do so, the State’s duty to protect the right to health must be translated into effective accountability mechanisms for pharmaceutical companies under national law. This article presents an innovative way to achieve this objective.

It draws inspiration from the climate change litigation field, which presents convincing examples of how to achieve this and is used here as a blueprint for our conceptual innovation. We propose that pharmaceutical companies can and should be held accountable for not respecting key elements of the human right to health by means of a provision in Dutch tort law containing an ‘unwritten duty of care’. Such an innovation is supported by international human rights law and recent Dutch jurisprudence. Dutch courts have held that private companies have breached the duty of care provision in tort law in the climate case Milieudefensie et al v Royal Dutch Shell (District Court of The Hague 2021). We suggest that the Netherlands could provide the right legal environment for applying such a duty of care to pharmaceutical companies. Section 1 outlines the international human rights framework, explaining the State’s duty to protect and the corporate responsibility to respect human rights. Section 2 outlines the intersection of climate change and access to medicines and introduces Dutch climate change jurisprudence. Section 3 explains the Milieudefensie interpretation of the Dutch duty of care, and Sections 4 and 5 apply the court’s reasoning to medicines, assessing the existence of a global consensus on excessive pricing. Finally, Section 6 illustrates how the Dutch example can serve as inspiration for other jurisdictions.¹

2. The international right to health: State duties and corporate responsibilities

Most States worldwide have committed to respect, protect, and fulfil the human right to health. In the following section we introduce this right and illustrate that access to affordable medicines is one of its core components. As this has been extensively addressed elsewhere, we keep this explanation brief (Sellin 2014: 65–142; OHCHR, 2024; Perehudoff 2020; Perehudoff and Forman 2019; Forman et al. 2022). We then explain the States’ duty to protect and the corporate responsibility to respect the right to health.

2.1 State obligations towards access to medicines

The ICESCR contains the right to the highest attainable standard of health and has been ratified by 171 States, demonstrating a broad global commitment to these norms (UN 1976: art. 12). The interpretation of the right to health was developed by the CESCR (2000: GC 14), the treaty monitoring body of the ICESCR. General comments, according to Keller and Grover (2012: 116–198), are non-binding but highly authoritative interpretations of human rights law by UN treaty bodies, which provide guidance for States on the implementation of human rights (OHCHR, 2024). In GC 14, the Committee explains that the right to health is not a right to be healthy but articulates a set of freedoms and entitlements necessary for individuals to live a life of dignity, including access to healthcare services and essential medicines ‘as from time to time defined under the WHO Action Programme on Essential Drugs’ (CESCR 2000: GC 14, para. 41(d)). Providing essential medicines is a ‘core obligation for States’ (ibid.: para. 43(d); Perehudoff and Forman 2019: 1–21). As stated by the CESCR (1990: para. 10), core obligations refer to essential levels of protection of human rights that States are obliged to prioritize, regardless of the resources at their disposal. The CESCR (2000: para. 12(a-d), has also identified four key elements for healthcare services and medicines: availability, accessibility, acceptability, and quality.

The UN Committee on the Rights of the Child (CRC) United Nations (UN) (1989), which monitors the implementation of the Convention on the Rights of the Child (UN 1990), recalls in GC 15 that States are required ‘to make all essential medicines on the World Health Organization Model Lists of Essential Medicines […] available, accessible and affordable’ (2013: para. 37) under the right to health, enshrined in article 24 of the CRC. The CRC is the most widely ratified human rights treaty, with 196 States Parties. The right of access to medicines has also been read into article 15 of the ICESCR (the right to science) through CESCR GCs 17 (2006b: para. 35) and 25 (2020: paras 58–62). Moreover, regional and domestic human rights law supports access to medicines as part of human rights: certain provisions of the Organization of African Unity (OAU) 1981; African Commission on Human and People’s Rights 2008: 58) have been interpreted as containing duties regarding access to medicines. Finally, as recognized by Forman (2022: 24), the right to access to medicines has been codified in at least 22 national constitutions.

The landmark case Minister of Health v. Treatment Action Campaign (2002: 5, 10) demonstrated the justiciability of this right in a domestic context, when the Constitutional Court of South Africa found that the restriction affecting the availability and accessibility of the drug Nevirapine to prevent mother-to-child transmission of HIV violated the South African Constitution (1996: art. 27), specifically, the right to health. Using human rights to advance equitable (financial) access to medicines thus has a broad scope and is applicable in different international, regional, and domestic contexts.

2.2 Legal responsibilities of non-state actors towards medicines

Traditional conceptions of the functioning of human rights law focussed on the vertical protection of individuals from government abuses. However, the last two decades have seen a shift to ‘horizontal application’, where the State has a duty to protect from human rights interference by private actors. John Ruggie (2007: 819–840), then UN Special Representative for Business and Human Rights, identified an evolution in the understanding of the State duty to protect by UN treaty bodies recognizing the increasing role of business actors in the realization of human rights. Non-state actors, in particular businesses, have been addressed with increasing frequency in the interpretations of UN treaty bodies, such as GC 31 (UN Human Rights Committee 2004), GC 18 (CESCR 2006a), and GC 24 (CESCR 2017).

In GC 24 (2017: para. 21), the CESCR calls on States to impose ‘strict regulations’ on private providers of public services including private healthcare providers, which ‘should be prohibited from denying access to affordable and adequate services, treatments or information’. These evolutions reflect an increasing acknowledgement of the potential of private actors to interfere with human rights. Even so, the primary focus of international (human rights) law remains predominantly State-centred.

It is not uncommon for international law to impose a duty on States to regulate non-state actors, particularly businesses whose products have a significant (negative) impact on human health. One such example is the Framework Convention on Tobacco Control (FCTC), the first global public health treaty to explicitly address the negative impacts of the private tobacco industry on health. Article 5(3) stipulates that ‘Parties shall act to protect public health policies with respect to tobacco control from commercial and other vested interests of the tobacco industry’ (World Health Organisation (WHO) 2005: art. 5(3)). The FCTC has, moreover, been labelled a human rights treaty by scholars and treated as such by international investment tribunals (Turkie 2022: 412) in cases like Philip Morris Brand Sàrl (Switzerland), Philip Morris Products SA (Switzerland) and Abal Hermanos SA (Uruguay) v. Oriental Republic of Uruguay (2016). At the global level, negotiations have been underway at the Human Rights Council since 2014 to negotiate a binding treaty on business and human rights (UN HRC 2014) (UN HRC 2011), which aims to more effectively regulate the conduct of business actors, through mandatory due diligence and human rights impact assessments. More recently, the International Commission of Jurists has supported the treaty, stating that ‘the creation of an international legally binding framework for States to maximize action and cooperation regarding human rights abuses in the context of business operations remains a compelling necessity of our times’ (ICJ 2019). Finally, at the EU level, the Corporate Sustainability Reporting Directive, through European Sustainability Reporting Standard S4, mandates companies to disclose the impact of their activities on consumers and end users, leading many companies to take action and implement due diligence to avoid reputational damage. Furthermore, the Corporate Sustainability Due Diligence Directive sets obligations for large companies operating within the EU to cease, prevent, and mitigate adverse impacts on human rights and the environment throughout its own operations and chains of activities (European Commission 2022, 2024). The directive represents an important milestone in the regulation of business through legally binding initiatives, but some fear that it will not be sufficient to prevent corporate abuses (European Coalition for Corporate Justice 2023).

2.3 Corporate human rights responsibilities: a blunt-edged sword?

The CESCR, in its GC 14 (2000: para. 42), has also recognized business’ responsibilities in relation to health, stressing that ‘while only States are parties to the Covenant and thus ultimately accountable for compliance with it, all members of society […] [including] the private business sector – have responsibilities regarding the realisation of the right to health’. Finally, the Guidelines formulated by Hunt (2008) outline the specific responsibilities of the pharmaceutical sector in relation to health and access to medicines. Hunt (2008: paras 6–14, 17–29, 26–38) argues that pharmaceutical companies have clear-cut human rights responsibilities and that ensuring access to medicines is a ‘shared responsibility’ between public and private actors. He outlines 47 recommendations for pharmaceutical companies to align their practices with human rights, covering areas such as patenting and licensing, transparency, pricing, monitoring and accountability, and lobbying (see also UN Human Rights Council (2009).

A breakthrough in the business and human rights landscape was the drafting of the UN Guiding Principles on Business and Human Rights (UNGPs) in 2010, which defines concrete steps for companies to align their practices with human rights (UN HRC 2011: 4). Today, the UNGPs represent an authoritative global standard on corporate human rights responsibilities, highlighting that companies have a clear ‘responsibility to respect’ and are required to undertake due diligence (ibid.: para. 24), which entails identifying any potential adverse human rights impacts related to a company’s activities and taking measures to prevent and mitigate those impacts (ibid.: principle 17). A year later, the Organisation for Economic Cooperation and Development (OECD 2000) developed its ‘Guidelines for Multinational Enterprises’: a set of recommendations backed by governments for companies to act responsibly, which were strengthened in 2023 (OECD 2023).

Pharmaceutical companies are therefore not formally subject to binding obligations under international human rights law, but they do have a (secondary) set of responsibilities to, at the very least, respect human rights. This means that ‘enterprises can go about their activities, within the law, so long as they do not cause harm to individuals’ human rights in the process’ (UN HRC 2011: 18). These responsibilities represent ‘a global standard of expected conduct applicable to all businesses in all situations’ and are not limited to compliance with domestic law (ibid.: 13).

This, however, does pose problems for ensuring access to medicines when it comes to upholding human rights against other potentially conflicting areas of law. Intellectual property law, for example, poses challenges for affordable access to medicines through mechanisms such as patents, which give the patent holder (e.g. pharmaceutical company) exclusive rights to produce and sell patented medicines and grant an initial period of market monopoly during which the price can often be set as high as the company decides (CESCR 2001; Hale 2018; World Intellectual Property Organization 2022). During this period, no lower priced generic versions of the patented drug can be made or sold in jurisdictions where valid patents exist and where licences (voluntary or compulsory) are not available. Paul Hunt draws attention to the need for patent-holding companies to comply with their human rights responsibilities:

Society has legitimate expectations of a company holding the patent on a life-saving medicine. In relation to such a patent, the right-to-health framework helps to clarify what these terms, and expectations, are. Because of its critical social function, a patent on a life-saving medicine places important right-to-health responsibilities on the patent holder. These responsibilities were reinforced when the patented life-saving medicine benefited from research and development undertaken in publicly funded laboratories. (Hunt 2008)

The difficulty of striking a balance between the protection of intellectual property and ensuring access to medicines was hotly debated during the early years of the HIV/AIDS crisis and has been on the international agenda ever since (Velásquez 2022).

The TRIPS Agreement clearly recognizes the need for balancing rights and obligations, that States may need to adopt measures necessary to protect public health, and that other ‘appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology’ (WTO 1994; see also ‘t Hoen 2022).

In 2001, the Doha Declaration on TRIPS and Public Health, adopted in the WTO context, affirmed that developing countries have the right to interpret the TRIPS agreement in a way that mitigates the negative effect that patents have on public health, by reiterating their right to exercise TRIPS ‘flexibilities’, such as through the use of compulsory licences.² Subsequently, the CESCR issued a statement clarifying that intellectual property is ‘a social product [with] a social function’, and that ‘the end which intellectual property protection should serve is the objective of human well-being, to which international human rights instruments give legal expression’ (CESCR 2001; CESCR 2006b: para. 35; Perehudoff and Sellin 2022: 24). The CESCR (2006b: para. 35), in its GC 17, reminded States of their duty to prevent the patenting of inventions ‘whenever their commercialization would jeopardise the full realisation of [the right to health]’.

This debate resurfaced during the COVID-19 pandemic, and the CESCR reiterated its position, reminding States of their duties to ‘prevent intellectual property and patent legal regimes from undermining the enjoyment of economic, social and cultural rights by, for example, making critical public goods, such as vaccines or medicines, inaccessible to developing countries or impoverished communities because of unreasonable cost structures’ (CESCR 2020: para. 7).

During the pandemic, several countries resorted to the use of TRIPS flexibilities to secure access to COVID-19 products (these are documented in the TRIPS flexibilities database, by Medicines Law and Policy; Medicines, Law and Policy 2024; see also Perehudoff et al. 2021). Despite these calls to action, there is a clear imbalance between the legal enforceability of international human rights law and the robustness of intellectual property protection surrounding medicines at a global level. Given this asymmetry, and the fact that respecting human rights is not companies’ main incentive, States cannot rely on pharmaceutical corporations to effectively self-regulate for the respect of human rights.

3. Towards a pharmaceutical duty of care

The lack of accountability of pharmaceutical companies for their human rights responsibilities is a major obstacle to achieving universal access to essential medicines. This article assesses the possibilities of holding pharmaceutical companies accountable for human rights by means of tort law, following the example of the Netherlands. The Dutch Civil Code, book 6, art. 162 holds that a person who commits a ‘tortious act’ must repair the damage that the act has caused. A tortious act can be ‘an act or omission in violation of a duty imposed by law or of what according to unwritten law has to be regarded as proper social conduct’ (Dutch Civil Code 1992: book 6, art. 162—own emphasis). This provision in tort law has been used in two landmark judgements by Dutch courts: Urgenda Foundation v State of the Netherlands (2015), in which the Dutch government was held liable for failing to limit greenhouse gas emissions to 25 per cent below 1990 levels by 2020, and Milieudefensie et al. v Royal Dutch Shell (2021), where oil company Shell was held accountable for its contributions to climate change.

Both Urgenda and Milieudefensie brought their cases with the broader goal of stimulating societal change and created important precedent regarding the responsibilities of both governments and private companies for adequately responding to climate change. Strategic litigation of this kind can bring about fundamental changes in policies and the interpretation of the law without creating new legislation. Dutch jurisprudence thus suggests that the Netherlands could provide the right legal environment for testing expanding a duty of care for pharmaceutical companies through strategic litigation. To analyse whether this duty could be applied to pharmaceutical companies, we first need to highlight the parallels between climate change and access to medicines.

3.1 Shared drivers and impacts of climate change and access to medicines

Identifying parallels between access to medicines and climate change is necessary for expanding the duty of care to pharmaceutical companies. Both a healthy climate and access to medicines are internationally recognized human rights. As explained above, the human right to health includes access to medicines and is codified in Article 12 of the ICESCR; meanwhile, the Human Rights Council has underscored that a healthy environment is ‘of fundamental importance to the full enjoyment of a vast range of human rights, including the right to [...] health’ (UNHRC 2018). In 2022, the UN General Assembly explicitly recognized a clean and healthy environment as a human right (UNGA 2022). Further, the right to health’s underlying determinants include a healthy environment, reinforcing the interdependence of these two rights. Finally, both rights are key stepping stones towards the full realization of human rights and for upholding human dignity, as climate change worsens health risks, and equitable access to medicines is necessary for mitigating those impacts. The Intergovernmental Panel on Climate Change (IPCC) specifically mentions the need to improve basic public health interventions in the face of climate-related risks, including by ‘ensuring essential medical supplies’ (Smith et al. 2014: 733).

The parallels between climate change and essential medicines continue in the areas of their root causes, drivers, and the nature of the threats they pose and of their impacts. First, both climate change and access to medicines are global issues where private industry plays an important role in both the causes and solutions to a societal problem. Big businesses, such as the pharmaceutical, food and fossil fuel industries, operate on a transnational level where they can exert significant political power over some governments and international organizations.³ Second, crises, such as the COVID-19 pandemic (also known as the coronavirus pandemic and COVID pandemic), caused by severe acute respiratory syndrome coronavirus 2) and climate change, are problems of collective action. They require a coordinated global response (WHO 2021)—in our globalized world, health in one part of the world is intrinsically tied to actions elsewhere. Third, public goods and technologies needed to address both global health needs and the climate change crises are often privatized, which inevitably means diminished State control over the R&D and marketing activities needed to deliver these goods and to have access to them (CESCR, GC 25, 2020: para. 58). Fourth, there is a critical need to address both climate change and access to medicines without delay: climate change is the most pressing issue of our times, requiring urgent action on the part of governments, industry, and society (UN High Commissioner, 2022). Access to medicines, particularly during pandemics and globalized epidemics (e.g. COVID-19, HIV/AIDS), has acquired some of the same urgency, with the WHO (2020) declaring the COVID-19 pandemic the ‘most severe’ global health emergency ever. Fifth, according to Hotchkin (2022), patent barriers, and an unwillingness of businesses to engage in technology transfer and knowledge-sharing, affect both access to medicines and green technologies (Hotchkin 2022; Médecins sans Frontières 2022; Garrison 2021). Finally, and crucially, both are human rights issues: they disproportionately affect the most vulnerable and marginalized segments of society, raising concerns about the protection and promotion of human dignity, non-discrimination and equality.

3.2 Dutch climate change jurisprudence and the duty of care

The parallels between climate change and access to medicines lay the groundwork for our analysis, which draws inspiration from the Dutch climate cases as a means of holding pharmaceutical companies accountable. This section delves deeper into the courts’ decision, in the landmark cases Urgenda v. The Netherlands I and Milieudefensie et al. v. Shell, to hold the Dutch government and Shell—a private actor—accountable, respectively.

Article 6:162 of the Dutch Civil Code (1992) refers to an ‘unwritten duty of care’ to hold an actor accountable for harmful behaviour. This open norm can be fulfilled by other principles of law. It forms part of the tort law system and defines this category of tort as:

a violation of someone else’s right (entitlement) and an act or omission in violation of a duty imposed by law or of what according to unwritten law has to be regarded as proper social conduct, always as far as there was no justification for this behaviour. (Dutch Civil Code, Book 6, Article 162, 1992 – own emphasis)

Article 6:162 defines ‘what constitutes tortious behaviour, which includes (negligent) behaviour that violates unwritten law regarding what is […] seemingly/becoming/desirable in societal interrelationships’ (Burgers 2022: 419–431). The duty of care in Dutch law is therefore a flexible concept, but ‘laden with normativity’ (Burgers 2022: 422). As such it is a standard that is filled in by the courts’ interpretation of concrete (normative) ideas regarding what is considered socially acceptable behaviour of that time.

The scope of article 6:162 is broad, meaning that it can be applied to a variety of issues. It has been invoked in repatriation claims (Parket bij de Hoge Raad 2020), and in relation to the Netherlands’ obligations under the WHO FCTC, for example (Rechtbank Den Haag 2015).⁴ In these cases, the duty of care was invoked against public bodies, as in Urgenda. However, it was in the Milieudefensie et al v Royal Dutch Shell (2021) case that the Court used international human rights norms to determine the standard ‘duty of care’ for a private entity, in this case Shell. The court’s reasoning in Milieudefensie, which will be explained in the following section, provides insight into the criteria which are important to establish a societal consensus on the duty of care.

4. The Milieudefensie interpretation: establishing a normative consensus around Shell’s duty of care

In 2019, a group of Dutch non-governmental organizations headed by Milieudefensie (Friends of the Earth Netherlands) brought a case against Royal Dutch Shell (RDS) based on the company’s failure to reduce its carbon emissions. The judgement handed down by the District Court of the Hague two years later set a major precedent for the Dutch framework of corporate liability. The court held that Shell’s contributions to climate change violated the duty of care in Dutch tort law and ordered it to reduce its emissions by 45 per cent by 2030 (Milieudefensie et al v Royal Dutch Shell 2021: para. 5.3). The judgement builds on the Urgenda ruling of 2019, in which the Dutch government was ordered to reduce emissions to comply with its human rights obligations and climate conventions (Urgenda Foundation v State of the Netherlands 2015). The legal standard used in both cases was the unwritten duty of care from article 6:162 of the Dutch Civil Code. Key to invoking the unwritten duty of care are the ‘Kelderluik’ criteria, a test which is used in Dutch tort law to establish whether a conduct equates to ‘unlawful endangerment’, to define the contours of the duty of care, and to determine the existence of an unlawful act.⁵

In Urgenda the court interpreted the Kelderluik test in the context of climate change to consist of the following considerations: ‘(i) the nature and extent of the damage ensuing from climate change; (ii) the knowledge and foreseeability of this damage; (iii) the chance that hazardous climate change will occur; (iv) the nature of the acts (or omissions) of the State; and (v) the onerousness of taking precautionary measures’ (hereafter called the ‘Kelderluik-Urgenda criteria’).

In Milieudefensie the court took these into account, as well as several additional factors to colour its own interpretation of Shell’s unwritten duty of care. The plaintiffs argued that ‘when reviewing specific conduct in the given circumstances of the case at hand, it must be determined what in that concrete situation is socially acceptable conduct’ (Milieudefensie 2021: para. 5). The court agreed with the plaintiffs and called for ‘an assessment of all circumstances of the case in question’ (Milieudefensie 2021: para. 4.4.1). Consequently, the court used ‘the best available science on dangerous climate change and how to manage it, and the widespread international consensus that human rights offer protection against the impacts of dangerous climate change and that companies must respect human rights’ (ibid.: para. 4.1.3) to interpret the duty of care applicable to Shell. It considered 14 circumstances⁶ in total to find an existing consensus on the substance of this duty (Burgers 2022). The legal norms relied upon in the judgement, though not all formally binding on Shell, served as factual evidence of the normative consensus that emissions must be reduced by 45 per cent by 2030. This was a key factor in identifying the extent of Shell’s duty to care and subsequently holding Shell liable for breaching it (Burgers 2022: 430).

To apply the duty of care to pharmaceutical companies, we must, therefore, first examine whether there is an existing consensus on the need for fair medicines pricing. In the next section, we apply several of the criteria used by the court to establish the existence of such a consensus.

5. Towards a global consensus on the need for fair medicines pricing?

This section demonstrates that there is an emerging global consensus regarding the risks and damage associated with excessively priced medicines, and hence a need for medicines to be priced fairly. First, we use human rights norms and soft law instruments to show that, in the absence of formally binding norms, pharmaceutical companies have, at a minimum, a social responsibility to price their medicines fairly. Secondly, we consider the existence of a consensus on the damages caused by excessively priced medicines, and how companies should behave vis-a-vis the risk of this damage manifesting. Finally, we demonstrate how the Court’s reasoning in Milieudefensie et al. v. Royal Dutch Shell, specifically the Kelderluik-Urgenda criteria, can be applied to the behaviour of pharmaceutical companies.

5.1 The pharmaceutical duty of care to act responsibly and price medicines fairly

A remarkable and commendable aspect of the Milieudefensie judgement is the court’s inclusion of human rights law and environmental standards that are not formally binding on Shell. The court weighed these legal instruments to define the contours of article 6:162 and determine whether Shell violated its unwritten duty of care to reduce greenhouse gas (GHG) emissions. Despite stating that human rights ‘apply in relationships between states and citizens’ and therefore cannot be directly invoked in relation to Shell, the court found nonetheless that ‘human rights may play a role in the relationship between Milieudefensie et al. and [Royal Dutch Shell]’, and that ‘therefore, the court will factor in the human rights and the values they embody in its interpretation of the unwritten standard of care’ (Milieudefensie 2021: para. 4.4.9). It drew on the Urgenda decision and statements by international human rights bodies to find that there is a global consensus that human rights apply to climate change, and that there is ‘a need for non-state action, because states cannot tackle the climate issue on their own’ (Milieudefensie 2021: para. 4.4.26).

Importantly, the Milieudefensie judgement is one of very few to explicitly refer to the UNGPs. Indeed, there are only 3 examples across Europe,⁷ and Milieudefensie is the only judgement in which the UNGPs had a bearing on the judge’s decision (Debevoise and Plimpton 2021). Though the court recognized that the UNGPs do not create new binding obligations, it nonetheless found them to be ‘suitable as a guideline’ to interpret the unwritten duty of care applicable to companies (Milieudefensie et al. v Royal Dutch Shell 2021: para. 4.4.11). The court firmly stated that the UNGPs set standards for businesses that exist independently of States’ obligations under human rights law and that businesses have ‘an individual responsibility’ to take measures themselves to comply with their human rights responsibilities in relation to climate change (ibid.: para. 4.4.13). It supported its argument with other soft law instruments including the OECD Guidelines (OECD 2000). Central to this argument is UNGP 13, which mandates that companies avoid causing or contributing to adverse human rights impacts through their activities and address any such impacts if they occur. The UNGPs, the OECD Guidelines, and articles 2 and 8 (the right to life and the right to private and family life, respectively) of the European Convention on Human Rights (Council of Europe 1950: arts. 2, 8) were considered by the court together with other scientific facts and international environmental norms, and treated as factual evidence of a normative consensus around Shell’s unwritten duty to mitigate climate change (Milieudefensie 2021: para. 4.1.3).

A similar normative framework can be distilled for medicines: the overwhelming majority of States have human rights duties to provide access to safe, affordable, and good quality care and medicines, and as a result, there is growing acknowledgement that pharmaceutical companies should not undermine the realization of this right. During the COVID-19 pandemic, the UN treaty bodies issued a joint statement calling for vaccines to be treated as ‘global public goods’,⁸ requiring States to develop

‘stronger strategies to make private actors involved in the COVID-19 response such as holding pharmaceutical companies accountable for violations of human rights as a result of the harmful impacts of their pricing and distribution policy’ (OHCHR 2021).

This is one of the most far-reaching statements issued by a human rights body on the corporate responsibilities of pharmaceutical companies, implying that when dealing with public goods such as medicines, States should regulate pharmaceutical companies’ behaviour to the extent necessary to realize social rights. In parallel to the joint treaty body statement, the CESCR held that:

business entities (…) have specific responsibilities to enable the realization of the right to health, including in relation to access to medicines and vaccines. In particular, pharmaceutical companies, including innovator, generic and biotechnology companies, have human rights responsibilities in relation to access to medicines, comprising active pharmaceutical ingredients, diagnostic tools, vaccines, biopharmaceuticals and other related health-care technologies. (CESCR 2020)

Quoting Paul Hunt, the CESCR clearly frames the responsibilities of the pharmaceutical sector in terms of enabling the realization of the right to health—a stronger term than simply ‘not interfering’. Linking these two statements forms both a moral and a legal argument that as developers and producers of essential healthcare commodities, for example, public goods, pharmaceutical companies have a responsibility towards society. Moreover, many pharmaceutical companies themselves have pledged to acknowledge the UNGPs and other international human rights standards, incorporating commitments in their publicly disclosed human rights reports and policy documents (e.g. Pfizer 2020; Novartis 2022; Novo Nordisk 2023). Pfizer’s shareholders have called on the company to conduct human rights due diligence, reinforcing the acknowledgement of the company’s responsibility to meet broader obligations in line with its pre-existing human rights policy commitments (Mercy Investment Services 2024). There is therefore strong support in the human rights framework for the idea that pharmaceutical companies have a duty of care to act responsibly, which includes pricing their products fairly. This aspect will be discussed further below—next, we discuss the existence of a normative consensus regarding excessive medicines pricing.

5.2 Setting the threshold: what is a fair price?

Determining what constitutes a fair price in the pharmaceutical industry requires a nuanced approach that takes into account not only human rights law but also a broader legal and ethical framework that is grounded in empirical evidence from pharmaceutical policy.

The normative power of article 6:162 as interpreted by the court in Milieudefensie lies in the societal consensus as to what is considered socially acceptable behaviour for Shell. In its judgement, ‘the court observes that a large consensus exists that the desirable global reduction path should be set at 45 per cent by 2030 compared with 2010’, and in doing so, it is ‘concretely reconstructing what is the normative consensus’ to interpret the standard of article 6:162 (Burgers 2022).

To apply a similar reasoning to medicines pricing, it is necessary to explore whether a similar consensus on fair pricing exists that would provide the objective standard to which pharmaceutical companies can be held to account in court, drawing on multiple legal frameworks and mechanisms. Within commercial transactions, there are many definitions of what constitutes a fair price, which consider ‘the characteristics intrinsic to the product, market, and transaction at a point in time, and the perceptions of consumers and suppliers’ (Moon 2020). There is some support for the view that ‘unfair’ pricing can generally be defined as drug prices that far exceed a ‘reasonable’ compensation for the company’s investment (Morgan 2020). Conversely, an unfair price can also be one that is too low to cover the cost for the company to bring a product to the market (Moon 2020). Below, we outline the various attempts to define a threshold for a fair price, with a focus on excessive pricing, and the legal tools that substantiate the growing consensus around this threshold.

5.2.1 Establishing standards for assessing excessiveness.

Policymakers, patient associations, experts, civil society, and the pharmaceutical industry itself are attempting to define the threshold of a ‘fair’ medicine price. Precedents and standards set in the field of competition law offer useful tools for evaluating excessive pricing. For example, Article 102 of the Treaty on the Functioning of the European Union (TFEU)—a pillar of EU competition law—prohibits the abuse of a dominant market position. The 1978 United Brands v Commission judgement established a landmark test for determining whether a price is excessive, determined by the difference between the cost of production and the selling price of the product (European Court of Justice 1978: paras 251–252). Assessing ‘excessiveness’ under the United Brands test involves ‘compar[ing] revenues to costs plus a reasonable measure of profitability’ and is ‘typically referred to as […] costs-plus’ (Veraldi 2023). Using this threshold, five out of the eight allegations of excessive pricing of pharmaceuticals investigated by the European Commission since 1974 have found infringements of the Article 102 prohibition.⁹ In the 2021 Aspen (EU) case (European Commission 2021), the pharmaceutical company Aspen made an average profit of 280–300 per cent on each product in a given period of time, which is beyond the threshold of 23 per cent above the cost-plus set by the European Commission considered to be a fair profit. Consequently, a settlement was agreed upon between the Commission and Aspen, which required the company to reduce its prices on the concerned products by 73 per cent. In the same year, the Dutch National Competition Authority (NCA) held that Leadiant had misused its economic market position for increasing the price of medicine Chenodeoxycholic acid or CDCA 500-fold, promptly after it obtained exclusive marketing rights in the EU (ACM 2021). In this judgement, the NCA ‘used a 15 per cent return on investment (ROI) figure as a reasonable measure of profitability’ (Veraldi 2023). These examples demonstrate that national and regional competition authorities are setting boundaries on what constitutes an excessive price, relying on methodologies that compare revenues to production costs plus a reasonable margin of profitability. As a result, the notions of ‘reasonable profit’ and ‘excess profit’ have thus been considered, calculated, and justified by the EU and national competition authorities, which have established legally binding (upper) limits to the fair price of a medicine.

Experts have also attempted to define formulas for establishing what constitutes a ‘fair’ or ‘excessive’ price. WHO organizes ‘Fair Pricing Forums’ every 4 years to engage with stakeholders about how to improve access to medicines through better affordability.¹⁰ A key theme emerging from the forum is that ‘stakeholders must clarify definitions and metrics of affordability to facilitate global discourse on access’, and that ‘a common understanding on affordability could potentially yield more objective metrics for assessing fair pricing’. (WHO 2021).

Pharmaceutical companies themselves have acknowledged this need for fair pricing. Many companies, particularly during the COVID-19 pandemic, have committed to aligning their practices with the United Nations Guiding Principles (UNGPs) on Business and Human Rights, which includes making their products available at fair and affordable prices (Pharmaceutical Accountability Foundation 2021). The need for pharmaceutical companies to engage in fair pricing practices is therefore not only implied by international norms and policies but is also (explicitly) acknowledged by these very companies, some of which have even adopted policies designed to bring their practices further in line with human rights (Mayer 2022). Based on the above evidence and analysis, we propose that the threshold of excessive pricing can be established when the price far exceeds a fair ROI or necessary profit margin. While this article does not aim to establish a precise numerical global threshold for excessive pricing, it is clear that different actors are working with specific thresholds.

5.2.2 Legal tools for addressing high medicines prices.

Further to the establishment of a reasonable or fair price of a medicine, national and international law offers legal tools for addressing excessive medicine prices, which further substantiates the growing consensus around the existence of a legally binding threshold and tools to address the damage caused by crossing such a threshold. In the USA, excessive pricing is also addressed through the application of ‘march-in rights’ under the Bayh-Dole Act. Under this law, the US government has the authority to intervene if a patent holder does not make a patented product available on reasonable terms, which can include excessive pricing. Although rarely exercised, march-in rights represent a legal tool that allows the government to ensure that patents, especially those derived from publicly funded research, are not used to price essential medicines out of reach for consumers (Knowledge Ecology International 2023). Additionally, many countries have national mechanisms in place to combat excessive pricing, such as anti-gouging laws, which allow governments to issue limits on price hikes by pharmaceutical companies (Republic of the Philippines 1970; Perehudoff et al. 2019; German Bundestag 2022; Koyoncu and Herold 2022).

Internationally, the TRIPS Agreement offers another legal avenue for addressing excessive drug pricing. TRIPS flexibilities, such as compulsory licensing, allow countries to bypass patents in cases of public interest, such as emergencies or crises, to ensure access to affordable medicines. These flexibilities have been invoked by several states, including during the HIV/AIDS epidemic, and more recently, in discussions around access to COVID-19 treatments and vaccines (Perehudoff et al. 2021; ‘t Hoen et al. 2018). The possibility to invoke these flexibilities, enshrined in the TRIPS Agreement and agreed to by all 164 members of the WTO, as well as their implementation in national law and practice, underscores that, globally, there is a recognition of the need to act in the public interest on medicines that are not fairly or reasonably priced as a result of intellectual property protection.

In conclusion, we put forward that there is widespread recognition and an emerging global consensus around the damage associated with excessively priced medicines and the need to establish standards for pharmaceutical company behaviour vis-a-vis this damage, so that excessive prices do not undermine human rights. Furthermore, there is growing agreement that a fair price should balance affordability for health systems and patients with adequate market incentives for innovation, as affirmed by the WHO (2021). Although the precise numerical global threshold for what constitutes an ‘excessive’ price has not yet been definitively established, the necessary elements to reach such an agreement are found in various global and national legal frameworks. Legal actions taken in different jurisdictions, such as those by competition authorities and under patent laws, have already begun to define boundaries for fair pricing. Having established that there is a consensus on the need for fair medicines pricing, the next section will show how this duty of care can be applied to pharmaceutical companies, using the Milieudefensie interpretation of the Kelderluik criteria.

5.3 How the Shell Court reasoning applies to medicines

Several elements of the Kelderluik-Urgenda test considered in Milieudefensie et al v Shell can be applied to pharmaceutical companies. First, the court considered ‘the consequences of CO2 emissions for the Netherlands and the Wadden region’ (Milieudefensie: 4.4.6–4.4.8) (corresponding to the Kelderluik criteria of ‘the nature and extent of the damage’ of company behaviour). It relied on the reports of the IPCC—a technical expert group that assesses the science on climate change—as evidence of the fact that ‘climate change caused by CO2 emissions will have serious and irreversible consequences for the Netherlands and the Wadden region’, and the risks associated include ‘health risks and deaths due to climate change-induced hot spells as well as health problems and an increased mortality risk due to increasing infectious diseases, deterioration of air quality, increase of UV exposure, and an increase of water-related and foodborne diseases’ (ibid.: 4.4.6–4.4.8).

Damage is considered to entail ‘serious and irreversible consequences’ (ibid.: 4.4.6) for citizens, including health risks and death, and evidence to establish this is drawn from international legal norms and scientific evidence of the anticipated consequences of climate change.

Excessively high medicine prices also cause damage. The cost to healthcare systems that such high medicines create has the follow-on effect that care is foregone in other areas, known as ‘displacement of care’. The prices of medicines have risen exponentially over the last 20 years, and health systems worldwide are straining under their weight. In the Netherlands, for example, intramural medicines (in hospitals)¹¹ cost 2.71 billion euros in 2021, an increase of 8.4 per cent compared to previous years (GIP Databank 2022) and are predicted to increase on average by 7 per cent per year from 2021.to 2026 (Zorginstituut Nederland 2022). An example of displacement of care is the UK’s policy on sofosbuvir, a drug used to treat hepatitis C, which became so expensive that the National Health Service chose to phase it in instead of making it available to all patients who needed it (Guardian 2015). Consequently, expensive medicines can significantly undermine the human right to health. They compromise healthcare budgets, which may result in displacement of care when health ministries pay for an expensive drug but are forced to forgo another form of care (e.g. preventative care, another expensive drug, and so on) to afford it. In countries that lack comprehensive state-funded healthcare, expensive medicines may lead to unaffordable out-of-pocket costs for individual patients that can force households to forgo their medicines (and their health), pushing them (deeper) into poverty (Wirtz et al 2017). For example, a 2020 study from the US Council for Informed Drug Spending Analysis found that ‘high drug prices are estimated to contribute to 70400 premature deaths from chronic kidney disease, 69300 premature deaths from chronic obstructive pulmonary disease, and 62700 premature deaths from diabetes among seniors by 2031’ (Council for Informed Drug Spending Analysis 2020) due to high out-of-pocket costs. The damage caused by excessively priced medicines to human health is therefore observable and considerable, and just like climate change, leads to further follow-on problems affecting the sustainability of healthcare systems and human development.

Second, the court considered ‘foreseeability’. The damage caused by excessive medicines pricing is foreseeable: there is international recognition and awareness among high-level bodies that the lack of affordability of essential medicines is a global problem that needs to be addressed. The UN General Assembly has repeatedly indicated that lack of access to affordable medicines is a global concern, that ‘millions of people are driven below the poverty line each year because of catastrophic out-of-pocket payments for health care, and that excessive out-of-pocket payments can discourage the impoverished from seeking or continuing care’ (UN General Assembly 2013).

It has repeatedly called on Member States to remedy this by ensuring that ‘all people have access, without discrimination, to […] affordable, effective, and quality medicines’ (UN General Assembly 2013; UN General Assembly 2014; UN General Assembly 2017). Sustainable Development Goal 3.8 aims to achieve ‘access to safe, effective, quality and affordable essential medicines and vaccines for all’, in light of the global nature of the problem United Nations (UN) (2015). The WHO notes that ‘medicines are not affordable for those who need them in many low- or middle-income countries, and many new medicines are too expensive even for the health systems of high-income countries’ (WHO-EURO 2017).

Third, the court considered the risk that the damage would manifest itself. The damage resulting from excessive medicine pricing is already self-evident, as demonstrated above. There is further evidence that the health systems currently in place will not resist the strain caused by expensive medicines in the future either. A 2015 OECD report finds that ‘public health spending in OECD countries has grown rapidly over most of the last half century’, and ‘is set to increase from around 6 per cent of GDP today to almost 9 per cent of GDP in 2030 and as much as 14 per cent by 2060’ (OECD 2015: 2). These costs are expected to ‘become unaffordable by mid-century without reforms’ (ibid.: press release). The OECD recommends that governments adopt a ‘tougher negotiating stance’ on pharmaceutical prices, and make ‘greater use of generic drugs’, which cost 20 to 70 per cent less than brand-name drugs (ibid.). One study finds that ‘global expenditure on pharmaceuticals reached 1.135 trillion dollars in 2017, up 56 per cent from 2007’, and that ‘drug prices often exceed value for money and reasonable compensation for firms’ investment in research’, ‘calling into question the sustainability of the systems that are supposed to drive pharmaceutical innovation’ (British Medical Journal 2020). There is thus evidence from international organizations, experts, and national public health bodies that drug prices are rising to such unsustainable levels that they are threatening the survival of health systems and therefore everyone’s health and well-being.

Fourth, the Court considered the nature of the company’s conduct ( Milieudefensie: 4.4.22–4.4.39). The Court affirms that ‘through the corporate policy of the Shell group RDS is able to exercise control and influence over [its suppliers’] emissions’ (ibid.: 4.4.25). Moreover, though the Paris Agreement (UNFCCC 2015) is not binding on Shell, ‘since 2012 there has been broad international consensus about the need for non-state action, because states cannot tackle the climate issue on their own’. Furthermore, the Court holds that ‘much may be expected of RDS […], considering it is the policy-setting head of the Shell group, a major player on the fossil fuel market and responsible for significant CO2 emissions, which incidentally exceed the emissions of many states and which contributes to global warming and climate change in the Netherlands and the Wadden region, with serious and irreversible consequences and risks for the human rights of Dutch residents and the inhabitants of the Wadden region’ (ibid.: 4.4.37).

Thus, the Court concludes that ‘on [Royal Dutch Shell] rests an obligation of results as regards the […] emissions of the Shell group’ (ibid.: 4.4.37).

In parallel, pharmaceutical companies exert considerable influence over the production, distribution, and pricing of medicines, even more than governments themselves. In 2013, the CEO of drug company Bayer made a disturbing statement regarding India’s compulsory licensing of Nexavar (sorafenib), a cancer treatment: ‘We did not develop this medicine for Indians. We developed it for Western patients who can afford it.’ (Financial Times 2013)—showing that the company acted with intent when developing and commercializing its product, with a clear focus on who it was aimed at and who could afford it.

A salient example of this is the USA, where most clinical trials are funded and run by pharmaceutical companies. This can create a bias towards the approval of their drug, as well as downplay the potential risks associated with it (Llamas 2015). Another example is the negotiation of COVID-19 vaccine contracts between the pharmaceutical industry and the European Commission, which has recently come under scrutiny for lack of transparency, leading to an investigation being opened by the European Public Prosecutor’s Office (EPPO 2022). We, therefore, argue that multinational pharmaceutical companies exert greater and more direct control over the production, distribution, and pricing of medicines than governments, and that the nature of their conduct has the potential to benefit as much as damage society, legitimizing the imposition of ‘stringent’ duty of care requirements on these companies.

Some pharmaceutical CEOs have publicly called for a change in the drug pricing system and stated that the industry needs to improve the affordability of their products because patients are suffering (Sagonowsky 2018; Ell 2018; Limitone 2018). Andrew Witty, the CEO of GlaxoSmithKline, stated in 2013 that the 1 billion dollar price tag for developing new medicines was ‘one of the great myths of history’ (Reuters 2013). As Benoit Mayer points out: ‘the concept of ‘proper social conduct in Article 6:162(2) BW has been understood as pointing to the standard that a “reasonably acting person” would follow in the same situation’ (Mayer 2022). The fact that some pharmaceutical companies are making statements regarding how the system should be changed to promote affordability shows that even some members of the industry recognize that their conduct can be damaging to patient health and overall well-being.

Finally, the Court considered the onerousness of taking precautionary measures to prevent the damage from occurring. The plaintiffs held that ‘Shell can still be a profitable company if its oil and gas company were only half of the current size in 2030’ ( Milieudefensie: 2022: para. 260), an argument that has not yet been addressed by the court (Shell’s appeal is pending), but which Shell itself did not dispute. Moreover, Shell has stated that it is ‘positioned for the transition to renewable energy and renewable electricity generation’, which are equally as profitable as oil and gas (Milieudefensie 2022: para. 261). The court took this into account when assessing whether the reduction order—that Shell must reduce its emissions by 45 per cent by 2030, relative to 2019—is ‘unreasonably onerous’. The Court found that, indeed,

this could curb the potential growth of the Shell group. However, the interest served with the reduction obligation outweighs the Shell group’s commercial interests, which for their part are served with an uncurtailed preservation or even growth of these activities. Due to the serious threats and risks to the human rights of Dutch residents and the inhabitants of the Wadden region, private companies such as RDS may also be required to take drastic measures and make financial sacrifices to limit CO2 emissions to prevent dangerous climate change. (Milieudefensie 2021: 4.4.53)

In Milieudefensie (4.4.53), the court clearly states that the serious human rights and existential threats caused by climate change to Dutch residents ‘outweighs the Shell group’s commercial interests’. A similar reasoning can be applied to pharmaceutical companies by weighing the societal benefits of pricing medicines fairly with the potential damage caused to their future profit margins. We argue that the damage caused by high medicine prices is likely to outweigh that inflicted on pharmaceutical companies’ profits. Most pharmaceutical companies would, moreover, continue to be profitable even if they were subject to a legally binding duty of care to make their products available and affordable to all (Globaldata 2021).

6. The Dutch example: inspiration for other jurisdictions?

The duty of care provision is already embedded in the Dutch legal system, and it is not unique to the Netherlands (e.g. Belgian Civil Code 2019: article 1382). It is the way that courts have interpreted it to hold companies to account that deserves attention, as its application in the Netherlands has allowed for filling the accountability and enforcement gap regarding private companies and human rights. Our proposal builds on the Milieudefensie interpretation to propose an innovative way of enforcing corporate human rights responsibilities and the States’ duty to protect. Other courts could take inspiration from the Dutch example: legal transplants, ‘the moving of a rule or a system of law from one country to another, or from one people to another’ (Watson 1994), can be used ‘to promote desirable social or legal changes which have been observed to arise from the implementation of such a law in other countries’ (Sánchez Cordero 2010). Other jurisdictions can thus draw inspiration from legal developments happening outside their borders: the South African case Minister of Health v Treatment Action Campaign, for example, created important jurisprudence within the South African legal framework and has also informed litigation in other countries regarding the enforceability in court of the right to access to medicines (Constitutional Court of South Africa 2002). In Kenya, the TAC case was used to assert that ‘any legislation that would render the cost of essential drugs unaffordable to citizens would […] be in violation of the state’s obligations under the Constitution’ (Republic of Kenya in the High Court of Kenya at Nairobi 2009: para. 66). The Milieudefensie case has already stimulated further lawsuits against Shell, including a derivative action claim brought in the UK by a shareholder of the company itself (ClientEarth 2022).

The manner in which States choose to give effect to their human rights obligations is largely their own prerogative. In the face of global challenges such as ensuring equitable access to medicines, States can and should therefore draw inspiration from (and build on) each other’s innovations in implementing their human rights obligations. While human rights law alone is not sufficient to regulate the complexities of pharmaceutical pricing, a whole menu of other bodies of law support a legally enforceable standard for the fair pricing of medicines. Thus, a multifaceted legal approach, led by the normative force of human rights, can serve as a foundation for the emergence of a coherent and enforceable standard for regulating the cost of essential medicines.

7. Conclusion

Global disparities in access to medicines are a continuing human rights problem that can be countered by assigning accessibility and affordability duties to the pharmaceutical companies that produce and market drugs. The increasing control exercised by private corporations over access to medicines means that it is time to redefine accountability for health within domestic healthcare systems. Ensuring that pharmaceutical companies are held to account for their human rights responsibilities will contribute to driving forward health equity at a global level. In this article, we have outlined the respective duties and responsibilities of the State and private actors under international human rights law for access to medicines and proposed a legal procedure at the domestic level for meeting these obligations and enforcing corporate responsibilities. The Dutch legal culture is a promising environment to advance the question of pharmaceutical accountability, as the legal concept of a duty of care already exists in tort law and has been enforced against a private actor in Milieudefensie, paving the way for applying this provision to pharmaceutical companies. Stimulating the discussion in the Netherlands around the need and possibilities for establishing a pharmaceutical duty of care can have a transboundary effect, raising the issue in other countries and providing an example of how domestic legislation can respond to it. Our proposal attempts to bring fresh thinking to a long-standing problem: we now call for further discussions on embedding accountability for pharmaceutical companies under national law—whether through a mandatory duty of care or other initiatives.¹²

Acknowledgements

We would like to thank Unitaid for their financial support during the production of this article.

Other Contributors

Wilbert Bannenberg (MD), chairperson of the Pharmaceutical Accountability Foundation: technical support and writing assistance.

Conflict of Interest

No conflicts of interest to declare.

Funding

This work was supported by Unitaid. Unitaid had no role in the study design. We have not been paid to write this article by a pharmaceutical company or any other agency. Authors were not precluded from accessing data in the study and they accept responsibility to submit for publication.

References

Footnotes

Author notes