Human Right to Access to Medicines

Chapter 4
Human Right to Access to Medicines

Introduction

About 30 per cent of the world’s population remains without regular access to essential medicines.¹ Most countries with low access to essential medicines have very low health outcomes.² Many people are not only suffering from poor health but also dying due to a lack of access to medicines. A widely known, but not isolated, example indicating the problem of access to medicines is HIV/AIDS. Despite progress in access to HIV treatment in the past decade, in 2012 the HIV treatment coverage in low- and middle-income countries was only 34 per cent of all eligible for treatment under the 2013 WHO HIV treatment guidelines and 1.6 million people died from AIDS-related causes worldwide in the same year.³ This is a human rights problem. As Alicia Yamin observes, seeing access to medicines as a human right ‘forces us to face the momentous suffering and loss of life that is occurring in developing countries due to HIV/AIDS, tuberculosis, malaria, and other diseases as not just a tragedy; it forces us to recognize it as a horrific injustice’.⁴

Access to medicines is a human right. Access to medicines constitutes one of the essential conditions for one’s life and health in the event of sickness, as well as for prevention and treatment of diseases. This chapter examines the human right to access to medicines as a legally binding norm that flows from the right to health, the right to life, and customary international law respectively. It offers an analysis of the obligations of States with respect to the right to access to medicines. This analysis categorises the obligations of States in four different ways: access to essential medicines under the right to health; access to non-essential medicines under the right to health; access to essential medicines under the right to life; access to medicines in the context of pandemics as a customary rule. They are not exclusive of each other, but are regulated by different norms. Furthermore, it also discusses the responsibility of pharmaceutical companies to ensure access to medicines as an emerging norm.

Access to Medicine: An Element of the Right to Health

The right to health is generally used as a shorthand expression for the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The Constitution of the WHO,⁵ adopted in 1946, provided the foundations for the right to health for most international human rights instruments by laying down that ‘the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being …’.⁶ Article 25.1 of the Universal Declaration of Human Rights (hereinafter UDHR), adopted in 1948, affirms health as a subject of human rights.⁷ The right to health, since then, has been firmly embedded in a myriad of legally binding international and regional human rights treaties, as well as numerous national Constitutions.

One of the most comprehensive provisions on the right to health is found in Article 12 of the International Covenant on Economic, Social and Cultural Rights (hereinafter ICESCR),⁸ which requires States parties to recognise ‘the right of everyone to the enjoyment of the highest attainable standard of physical and mental health’. In addition, the right to health is provided for in a number of other human rights treaties for particular vulnerable groups that include Article 5(e)(iv) of the International Convention on the Elimination of All Forms of Racial Discrimination,⁹ Articles 11.1(f) and 12 of the Convention on the Elimination of All Forms of Discrimination against Women,¹⁰ Article 24 of the Convention on the Rights of the Child,¹¹ Articles 25, 28, 43(1)(e), 45(1)(c) of the International Convention on the Protection of the Rights of Migrant Workers and Members of their Families,¹² and Article 25 of the Convention on the Rights of Persons with Disabilities.¹³ Furthermore, the right to health is recognised in several regional human rights instruments, including Article 11 of the revised European Social Charter,¹⁴ Article 16 of the African Charter on Human and Peoples’ Rights (known as the ‘Banjul Charter’: ACHPR)¹⁵ and Article 10 of the Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights (known as the ‘Protocol of San Salvador’).¹⁶ More than 60 national Constitutions include provisions on the right to health or the right to health care.¹⁷

The linkages between human rights and health have increasingly been examined by academic commentators and practitioners.¹⁸ There have been remarkable efforts made to elaborate the normative content of the right to health, particularly regarding the right to health provision in the ICESCR. The ICESCR binds 164 counties as of March 2015. General Comment No. 14¹⁹ of the UN Committee on Economic, Social and Cultural Rights (CESCR), the primary body responsible for the interpretation and implementation of the ICESCR, and numerous reports of the Special Rapporteur on the Right to Health²⁰ significantly contributed to the normative development of the right to health. General Comments issued by the CESCR are not legally binding but provide authoritative guidance in clarifying the content of specific rights and delineating the correlative obligations. The normative evolution and implementation of the right to health has been subject to an in-depth analysis by several authors in recent years.²¹ Before analysing access to medicine under the right to health, it is necessary to identify the contours of the right to health enshrined in the ICESCR.

Article 12 of ICESCR states:

(1) 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.

(2) The steps to be taken by the State Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:

(a) The provision of the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child;

(b) The improvement of all aspects of environmental and industrial hygiene;

The right to health, as mentioned earlier, is a shorthand expression of the right to the highest standard of health that a person can achieve given his/her biological preconditions. The CESCR comments that this definition of the right to health takes into account an ‘individual’s biological and socio-economic preconditions and a State’s available resources’.²² In order to ensure for everyone the enjoyment of the highest attainable standard of health, the right to health has to guarantee not only ‘timely and appropriate health care’, but also ‘the underlying determinants of health, such as access to safe and potable water and adequate sanitation, and adequate supply of safe food, nutrition and housing, healthy occupational and environmental conditions, and access to health-related education and information, including on sexual and reproductive health’.²³ The right to health has both elements of freedom and entitlements. The freedom includes the right to control one’s health and body and to be free from interference.²⁴ Entitlements include the right to a system of health protection (health care and underlying determinants of health) that provides equal opportunity for people to enjoy the highest attainable standard of health.²⁵

Access to Medicines

Medicines are an indispensable part of any medical service, both in the event of sickness and in the prevention, treatment and control of diseases,²⁶ although access to medicines alone is not sufficient to ensure everyone an equal opportunity for good health. The CESCR considers the provision of essential drugs to be part of the measures necessary for ‘the creation of conditions which would assure to all medical service and medical attention in the event of sickness (Article 12.2(d))’.²⁷ Numerous resolutions of the UN Human Rights Council (and its predecessor, the Commission on Human Rights) also confirm that ‘access to medicines is one of the fundamental elements in achieving progressively the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health’.²⁸ In short, access to medicines is an integral part of the right to health.²⁹

The Responsibilities of States

The general obligations of the State parties to the ICESCR, to which the right to health is also subject, are set out in its Article 2(1), which reads:

Each State Party to the present Covenant undertakes to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures.

Understanding of the obligations of the State parties with respect to access to medicines is enhanced by the CESCR’s interpretative comments on the nature of States parties’ obligations (General Comment No. 3)³⁰ and on the Right to Health (General Comment No. 14).³¹ More specifically as to access to medicines, the Special Rapporteur on the Right to Health fleshed out the obligations of States.³² What follows are the key elements of the content of the right to access to medicines.

Progressive realisation

The wording of ‘achieving progressively the full realization of the rights’ in Article 2(1) reflects the reality that ‘full realization of all economic, social and cultural rights will generally not be able to be achieved in a short period of time’.³³ The duty of progressive realisation obliges States to ‘move as expeditiously and effectively as possible’ towards the full realisation of economic, social and cultural rights without ‘any deliberate retrogressive measures’ which would require a high level of justification.³⁴ Nevertheless, Article 2(1) imposes an immediate obligation to ‘take steps … to the maximum available resources’. The principle of non-discrimination in Article 2(2) and Article 3 of the ICESCR is also an obligation of immediate effect.³⁵

Limited resources are one major factor that gives rise to the concept of progressive realisation of many human rights, including the right to health. That everyone has the right to health does not imply that everyone is entitled to access to every treatment that may improve their health. The provision of health care and underlying determinants of health, such as access to water and sanitation, involves resources and thus inevitably requires priority setting even in high-income countries, let alone in low-income countries.³⁶ Limited resources have to be allocated with careful consideration of competing claims to different human rights and interests, as well as competing claimants to the same right.

In relation to the right to health, decisions have to be made about the amount of resources to be allocated for health care and underlying determinants of health, and how these resources are spent. As the CESCR states, ‘[t]he right to health is closely related to and dependent upon the realization of other human rights, … including the rights to food, housing, work, education, human dignity, life, non-discrimination, equality, the prohibition against torture, privacy, access to information, and the freedoms of association, assembly and movement’.³⁷ Resources for health care cannot be allocated in isolation from these other areas.

Once the health budget is determined, it has to be utilised in full knowledge of the fact that granting some people access to a particular treatment might have the effect of denying other people access to the same or other treatments that benefit them. While there is no one firm answer to this difficult task of priority setting, the Special Rapporteur provided a useful starting point for the discussion from the right-to-health perspective.³⁸ What is necessary is to make the process of priority setting consistent with key human rights elements, such as equality, participation and accountability, each of which is further discussed later. A human rights approach requires the full consideration of the totality of human rights, the analysis of the potential impact of any given option on the right to health of different groups of people with special attention to people in vulnerable situations, the participation of those affected in the priority-setting process, and the accountability of government and relevant organisations. Such a process would also help to distinguish between States’ unwillingness and inability to promote the right to health.

The jurisprudence of national courts sheds light on the principle of progressive realisation in relation to access to medicines. The Bermúdez case of the Venezuelan Supreme Court addressed the issue of progressive realisation, including the adequacy of the allocated health budget.³⁹ In this case, the Ministry of Health defended its failure to provide antiretroviral treatment for people living with HIV/AIDS on the ground of its financial constraints and argued that it was progressively making improvements in relation to HIV/AIDS.⁴⁰ The Court also acknowledged that ‘the budgetary capacities of the [Ministry] have been insufficient to fulfil the duty to assist the HIV/AIDS patients’.⁴¹ Nevertheless, the Court observed that the government did not comply with its duty under the right to health in that the Ministry had not sought additional funds available under Venezuelan law.⁴² As this case suggests, the principle of progressive realisation does not legitimise all failures of the government on the basis of a lack of financial resources. On the contrary, it requires a government to prove that it has taken all the steps available to fulfil its duty. In relation to the right to health, consideration should be given to the question of whether the overall allocation of resources to health is reasonable and equitable, rather than taking for granted the given resources to health.

The Soobramoney case in the Constitutional Court of South Africa⁴³ dealt with one of the difficult but quite commonly raised issues: whether everyone is entitled to access to expensive treatment or drugs regardless of the limits of available resources. In this case, the Court stressed that ‘the State has to manage its limited resources in order to address all these claims [to access to health care, housing, food and water, employment opportunities and social security]’ and ‘this requires it to adopt a holistic approach to the larger needs of society rather than to focus on the specific needs of particular individuals within society’.⁴⁴ Research by Octavio Luiz Motta Ferraz about right-to-health litigation in Brazil illustrates how the lack of such a holistic approach that takes into account the health needs, health system and resources in society has led to the reallocation of health budgets in favour of the better off in society, worsening inequalities in health outcome.⁴⁵

Core obligations

The CESCR’s interpretative comment states that the rights in the Covenant give rise to ‘a minimum core obligation to ensure the satisfaction of, at the very least, minimum essential levels of each of the rights is incumbent upon every State party’ (emphasis added).⁴⁶ The CESCR provides an illustration that ‘a State party in which any significant number of individuals is deprived of essential foodstuffs, of essential primary health care, of basic shelter and housing, or of the most basic forms of education is, prima facie, failing to discharge its obligations under the Covenant’.⁴⁷ According to the CESCR, without imposing a minimum core obligation, the Covenant would lose ‘its raison d’etre’.⁴⁸ Minimum core obligations are, according to the definition given in General Comment No. 3, not subject to progressive realisation. Such an approach echoes with a general concept of rights, that each right, however vague the scope of a right may be, has a core that is, if not absolute, resilient to permissible infringement.⁴⁹ Nevertheless, there may be circumstances beyond the control of States, such as natural catastrophes, where States fail to meet even minimum core obligations. The CESCR, in its General Comment No. 3, envisages such circumstances, in which case the State has to prove that it has committed ‘all resources that are at its disposition in an effort to satisfy, as a matter of priority, those minimum obligations’.⁵⁰ However, the concept of minimum core obligations does not entirely remove the task of priority setting even at the level of minimum core obligations because the precise scope of these obligations has to be determined contextually. In any event, the concept of minimum core obligations must inform the priority setting and helps to prevent the concept of progressive realisation from becoming a convenient excuse for States’ unwillingness to take measures to realise human rights.

The provision of essential medicines is among the minimum core obligations of States parties to the ICESCR, in accordance with General Comment No. 14.⁵¹ The WHO defines essential medicines as ‘those that satisfy the priority health care needs of the population’. Essential medicines are selected considering ‘disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness’.⁵² It is a national responsibility to prepare a national essential medicines list, guided by the WHO Model Lists of Essential Medicines.⁵³ A State must, as a minimum core obligation, make the essential medicines on its national list available and accessible throughout its jurisdiction.⁵⁴ Access to non-essential medicines is subject to progressive realisation.⁵⁵ As discussed above, in General Comment No. 14, the CESCR has stressed the normative supremacy of minimum core obligations by stating that ‘a State party cannot, under any circumstances whatsoever, justify its non-compliance with the core obligations … which are non-derogable’.⁵⁶

There has been scant national jurisprudence on a minimum core content of the right to health. The Colombian Constitutional Court has adopted the approach of distinguishing an essential minimum core of the right to health and other elements to be progressively realised in its recent decision regarding the country’s health system.⁵⁷ Contrary to this approach, the South African Court did not accept the minimum core approach in the Minister of Health v. Treatment Action Campaign case.⁵⁸ The Court has taken a view that the test under its Constitution is whether the measures adopted by the government were reasonable.⁵⁹ However, the Court has suggested that a minimum core content of a specific right could be taken into account in assessing the reasonableness of the measures taken by the government.⁶⁰

Availability, accessibility, acceptability and good quality

The CESCR sets out four elements of the right to health that have to be ensured; that is, all health care facilities, goods, and services, including medicines, shall be (1) available in sufficient quantity within the State party; (2) accessible to everyone without discrimination economically as well as physically; (3) acceptable culturally and in light of medical ethics; and (4) of good quality.⁶¹ The first Special Rapporteur on the Right to Health has elaborated these four elements in relation to medicines as follows:⁶² (a) not only should existing medicines be available in sufficient quantity within the territory of States parties, but also States have to take reasonable measures to develop new medicines addressing priority health needs of people and thus make them available within a framework of international assistance and cooperation.⁶³ The issue of availability of medicines is acute regarding diseases predominantly affecting people in developing countries, known as ‘neglected diseases’, ‘poverty-related diseases’, or ‘tropical diseases’;⁶⁴ (b) medicines must be accessible in all parts of the country, economically affordable to all, and without discrimination; reliable information about medicines has to be accessible; (c) medicines must be respectful of medical ethics and of the culture of individuals and communities, which bears upon, for instance, the treatment of traditional medicine or clinical trials; (d) safety and good quality of medicines must be ensured; thus effective medicine regulation has to be in place to ensure the safety, efficacy and quality of medicines.⁶⁵ Similarly, the UN Human Rights Council requested States ‘to ensure access to all, without discrimination, of medicines, in particular essential medicines, that are affordable, safe, effective and of good quality’.⁶⁶

The following cases highlight the issue of availability and accessibility of medicines, albeit that each case does not involve exclusively one element. The Argentinean case of Mariela Viceconte v. Ministry of Health and Social Welfare⁶⁷ concerns availability of a vaccine for addressing an endemic disease.⁶⁸ Three-and-a-half million inhabitants of the Pampa region of Argentina were potentially exposed to Argentine haemorrhagic fever. However, a WHO-certified vaccine (Candid-1) for this disease was not sufficiently available due to interruption of the production by the government. The Argentinean Federal Court of Appeal ordered the government to produce Candid-1 and make it available. On the other hand, in the South African case of Minister of Health v. Treatment Action Campaign, a central issue was accessibility of the antiretroviral drug Nevirapine, which had proved to be effective in the prevention of mother-to-child transmission of HIV.⁶⁹ Although the drug had been offered to the public health system free of charge by the manufacturers, the South African government limited the provision of Nevirapine to only two research and training sites per province. The Constitutional Court found that such a policy ‘fails to address the needs of mothers and their newborn children who do not have access to these sites’,⁷⁰ and is thus unreasonable and in contravention of the State’s obligations under the Constitution.⁷¹

The duties to respect, protect and fulfil⁷²

States have duties to respect, to protect and to fulfil the right to access to medicines as they have with regard to other rights.⁷³ The duty to respect requires States to refrain from action that interferes with the right to access to medicines. For example, discriminating against women, ethnic minorities or other disadvantaged people in terms of access to medicine and raising prices to the level that the medicine becomes unaffordable would be in breach of the duty to respect.⁷⁴ The duty to protect obliges States to ensure that third parties do not hinder access to medicine.⁷⁵ States have to adopt legislation or measures that safeguard availability, accessibility, acceptability and quality of medicines from any limitation by third parties. The adoption of a stringent form of pharmaceutical patent law that allows private companies to impose high prices on medicines without alleviating economic burdens placed on people could constitute a violation of the duty to protect the right to access to medicines. The duty to fulfil requires States to adopt appropriate legislative, administrative, budgetary and other measures towards the realisation of access to medicines.⁷⁶ For example, States have to provide adequate information on essential medicines. The duty to fulfil includes a duty to provide people living in poverty with essential medicines when the medicines would not be affordable otherwise.⁷⁷ Furthermore, States have to ensure the availability of new essential medicines addressing the unmet primary health needs of people through the promotion of relevant medical research and development.⁷⁸

Access to Essential Medicines: An Element of the Right to Life

The Right to Life

The right to life is one of the most basic human rights, and it is a prerequisite to the realisation of all other human rights. The right to life is firmly embedded in international human rights instruments.⁷⁹ Article 3 of the UDHR sets forth the right to life⁸⁰ and Article 6(1) of the International Covenant on Civil and Political Rights (ICCPR)⁸¹ states that ‘[e]very human being has the inherent right to life. This right shall be protected by law. No one shall be arbitrarily deprived of his life.’ The right to life is also enshrined in numerous regional human rights instruments: Article 4 of the ACHPR,⁸² Article 2 of the European Convention on Human Rights (ECHR),⁸³ and Article 4 of the American Convention on Human Rights (ACHR).⁸⁴ The right to life is a non-derogable right under Article 4 of the ICCPR, Article 15 of the ECHR, and Article 4 of the ACHR.⁸⁵ Even in times of public emergency, no derogation to the right to life is permitted.

The right to life is not limited to prohibiting the State from killing persons and protecting individuals from murder. It also encompasses protection against deprivation of life by lack of access to the means essential for survival.⁸⁶ The Human Rights Committee, in its interpretative comment on the right to life, states:

… the right to life has often been too narrowly interpreted. The expression “inherent right to life” cannot properly be understood in a restrictive manner, and the protection of this right requires that states adopt positive measures. In this connection, the Committee considers it would be desirable for States parties to take all possible measures to reduce infant mortality and to increase life expectancy, especially in adopting measures to eliminate malnutrition and epidemics.⁸⁷

Such interpretation of the right to life is also found in the jurisprudence of the regional human rights bodies. The former European Commission of Human Rights considered that the right to life in Article 2 of the ECHR imposes on the State not only a duty to refrain from taking life ‘intentionally’, but also a ‘positive duty to take appropriate steps to safeguard life’.⁸⁸ According to the Commission, the obligation to protect the right to life includes the provision of adequate and appropriate medical care. The broad interpretation of the right to life is reiterated by the Commission in the case of Tavares v. France.⁸⁹ The African Commission on Human and Peoples’ Rights has also reasoned that, inter alia, pollution and environmental degradation ‘to a level humanly unacceptable’ constituted violations of the right to life.⁹⁰ Further, the Inter-American Court, in the case of Morales v. Guatemala, has affirmed that the right to life requires not only negative obligations but also a positive obligation ‘to take all necessary measures to protect and preserve the right to life.⁹¹ Two judges of the Inter-American Court, in a joint concurring opinion on the same case, clarify that the language ‘arbitrary deprivation of life’ in Article 4 of the ACHR extends to ‘the deprivation of the right to live with dignity’.⁹²

Access to Essential Medicines

The jurisprudence of the UN Human Rights Committee and regional human rights bodies confirms that the right to life encompasses access to minimum conditions necessary for survival. F. Menghistu argues that ‘[s]urvival requirements [for the right to life] are minimum requirements which are related to the concept of basic needs’.⁹³ Following this line of argument, access to essential medicines, defined earlier in this chapter, constitutes one of the minimum conditions for survival, and thus a part of the right to life. The scope of access to essential medicines is narrower than the scope of access to life-saving medicines. Life-saving medicines entail very expensive ones that can be made accessible to only a small number of people even in resource-rich countries.

In a number of national courts, the right to life has been successfully invoked, along with the right to health, in cases where a particular treatment was potentially life saving or life sustaining. The Constitutional Court of Colombia has held that denial of antiretroviral treatment under the social security system of the country violates the constitutional right to life.⁹⁴ The Indian Supreme Court, in Samity v. State of West Bengal, affirmed that ‘[a]rticle 21 (of the Constitution) imposes an obligation on the State to safeguard the right to life of every person.⁹⁵ … Failure on the part of a Government hospital to provide timely medical treatment to a person in need of such treatment results in violation of his right to life guaranteed under Article 21.’⁹⁶ In short, the State’s obligations to safeguard the right to life include the obligation to ensure everyone has access to essential medicines.

The Right to Access to Medicines as Customary International Law

Customary International Law

Custom is a source of international law. According to the Statute of the International Court of Justice (ICJ), customary international law is ‘a general practice accepted as law’.⁹⁷ While treaty law binds only the parties to it, customary international law binds all States regardless of their express consent, with the exception of a persistent objector.⁹⁸ Is the right to access to medicines a norm of international customary law, as well as of treaty law?

It is generally considered that, in order for a norm to be a rule of customary international law, it has to have two elements: an objective element – consistent State practice – and a subjective element known as opinion juris sive necessitates. In this regard, the ICJ stated in the North Sea Continental Shelf cases that ‘[n]ot only must the acts concerned amount to a settled practice, but they must also be such, or be carried out in such a way, as to be evidence of a belief that this practice is rendered obligatory by the existence of a rule of law requiring it’.⁹⁹ There have been debates among scholars about what acts of States count as State practice, and the relationship between practice and opinio juris.¹⁰⁰

State practice

This book takes the view that both physical and verbal acts of States constitute State practice. Verbal acts include national legislation, national case law, statements made by governments, and positions taken by governments with regard to resolutions of international organisations or international treaties.¹⁰¹ This approach is based on the view taken by leading bodies in the field of international law, including the ICJ, the International Law Commission, the International Law Association, and the International Committee of the Red Cross.¹⁰² The ICJ looked for evidence of custom in official statements in numerous cases, including the North Sea Continental Shelf cases,¹⁰³ the Fisheries Jurisdiction cases,¹⁰⁴ the Nicaragua case,¹⁰⁵ and the Gabčíkovo-Nagymaros Project case.¹⁰⁶ The International Law Commission has also considered verbal acts to contribute to the formation of custom by listing the following categories as evidence of customary international law: international instruments; decisions of national and international courts; national legislation, including the regulations and declarations promulgated by executive bodies; diplomatic correspondence; opinions of national legal advisers; and the practice of international organisations.¹⁰⁷ The International Law Association has stated that ‘verbal acts, and not only physical acts, of States count as State practice’.¹⁰⁸

Density of State practice

One of the requirements for State practice to contribute to the formation of customary international law is that the practice has to be uniform, extensive and representative.¹⁰⁹ A long period of time is not necessarily required for a norm to solidify into a rule of customary international law. The ICJ stated in the North Sea Continental Shelf cases that

the passage of only a short period of time is not necessarily, or of itself, a bar to the formation of a new rule of customary international law … an indispensable requirement would be that within the period in question, short though it might be, State practice, including that of States whose interests are specially affected, should have been both extensive and virtually uniform in the sense of the provision invoked …¹¹⁰

The requirement of uniformity or consistency does not require State practice to be identical or perfect with a rule in question. If the State practice is in general similar or consistent with the rule in question, it suffices.¹¹¹ The ICJ observed in the Nicaragua case that ‘[i]n order to deduce the existence of customary rules, the Court deems it sufficient that the conduct of States should, in general, be consistent with such rules, and that instances of State conduct inconsistent with a given rule should generally have been treated as breaches of that rule, not as indications of the recognition of a new rule’.¹¹² As extensive and representative participation has to be demonstrated, the number of States taking part in a practice is important. However, there can be no precise criterion regarding how many States participate in a practice. The important question is, as the ICJ states in the North Sea Continental Shelf cases, whether the practice includes ‘that of States whose interests are specially affected’.¹¹³

Opinio juris

The other requirement for State practice to create customary international law is that it has to be coupled with evidence of opinio juris; a sense that the practice is undertaken by States as a legal duty. In the words of the ICJ, opinio juris plays a role in distinguishing legal obligations from obligations out of ‘courtesy, convenience or tradition’.¹¹⁴ This subjective element, however, does not have to exist separately from State practice.¹¹⁵ State practice itself may include, within that practice, legal conviction indicating that ‘certain conduct is permitted, required, or forbidden by international law’.¹¹⁶

The Right to Access to Medicines in the Context of Pandemics

This section analyses the customary nature of the right to access to medicines, but it confines the scope of the analysis to the right to access to medicines in the context of pandemics. It does not suggest any conclusion about the customary nature of the right to access to medicines in general, as that requires separate research. In order to assess whether the right to access to medicines in the context of pandemics forms part of customary international law, this chapter assesses the following sources of State practice: resolutions and declarations adopted by the UN General Assembly, human rights bodies, World Health Assembly, multilateral treaties, national Constitutions, national case law, and policy documents made by governments.

State practice

There are numerous declarations and resolutions adopted by representatives of States or governments which recognise the right to access to medicines in the context of pandemics, such as HIV/AIDS, tuberculosis and malaria. The UN General Assembly adopted a resolution titled ‘Declaration of Commitment on HIV/AIDS’ in 2001, without a vote.¹¹⁷ In the resolution, representatives of States recognised that ‘access to medication in the context of pandemics such as HIV/AIDS is one of the fundamental elements to achieve progressively the full realization of the right [to health]’¹¹⁸ and declared their commitment to make every effort to provide progressively and in a sustainable manner, the highest attainable standard of treatment for HIV/AIDS, including the prevention and treatment of opportunistic infections’.¹¹⁹ This resolution emphasised the obligation of conduct by States in relation to access to medicines in the context of pandemics. Although the full realisation of the right to access to medicines can be ensured only progressively, steps towards fulfilling the commitment must be taken. This approach is in line with Article 2(1) of the ICESCR, which sets out the obligations of States parties.¹²⁰

In 2003, the UN General Assembly adopted resolution 58/179, which extended the scope of the commitment to tuberculosis and malaria, beyond that of HIV/AIDS, and reaffirmed that access to medication in the context of pandemics is ‘one fundamental element for achieving progressively the full realization of the right of everyone to the enjoyment of the highest attainable physical and mental health essential to ensuring the right to health’.¹²¹ This resolution called upon States to ‘develop and implement national strategies … to progressively realize access for all to prevention-related goods, services and information as well as access to comprehensive treatment, care and support for all individuals infected and affected by pandemics such as HIV/AIDS, tuberculosis and malaria’.¹²² It comprehensively incorporates human rights elements of access to medicines and accordingly requires States to ensure the availability, accessibility, affordability and good quality of pharmaceutical products and medical technologies used to treat pandemics.¹²³ States are required to refrain from taking measures that would deny or limit equal access to medicines, to safeguard access to medicines from any limitations by third parties, and to take all appropriate measures, to the maximum available resources, to promote effective access to medicines in the context of pandemics.¹²⁴ This resolution was adopted by a vote of 181 to 1 against. The US was the only country that voted against. While one vote against this resolution does not change the fact that it was adopted with a wide acceptance, the position of the US with regard to this issue is separately considered below.

In 2006, the General Assembly, in its resolution 60/262, explicitly reiterated the right to health commitment of States that was expressed in the Declaration of Commitment on HIV/AIDS (2001) and pledged to move towards the goal of universal access to comprehensive prevention programmes, treatment, care and support by 2010.¹²⁵ The States committed themselves ‘to finding appropriate solutions to overcome barriers in pricing, tariffs and trade agreements, and to making improvements to legislation, regulatory policy, procurement and supply chain management in order to accelerate and intensify access to affordable and quality HIV/AIDS prevention products, diagnostics, medicines and treatment commodities’.¹²⁶ The right-to-health commitments continued to be centred at the 2011 UN General Assembly resolution 65/277 on HIV and AIDS.¹²⁷

The Millennium Development Goals (hereinafter MDGs),¹²⁸ the most prominent initiative on global development, also include a commitment of States that is related to the right to access to medicines in the context of pandemics by setting a goal to halt and begin to reverse the spread of HIV/AIDS, malaria and other major diseases (goal 6). The MDGs also include a target specifically related to access to essential drugs (8e).¹²⁹ The MDGs derive from the Millennium Declaration, which was adopted by the UN General Assembly on 8 September 2000, at a Millennium Summit attended by 147 heads of State or government.¹³⁰ States repeatedly reaffirmed their commitments to these goals at various UN meetings.¹³¹