Globalization and Law
Statutory laws are products of legislative processes within sovereign nation states and are thus conventionally associated with the state-centered national and international affairs. However, principles encoded into formal multilateral agreements between nations influence the lives of billions of people and in multifarious ways shape global patterns of human interaction. Normative globalization means the spreading acceptance across international boundaries of rules governing all manner of political, social, economic, cultural, and environmental relations, made possible through the ratification of international treaties and the development of complementary national legal codes, but also through customary states’ practice. To appreciate the relationship of law to globalization, we first need to recognize the dynamic processes by which such international laws are made, and remade, tested, and subverted by lawful as well as unlawful human agents. Globalization is not uniform, and thus, accordingly, the global landscape of law is marked by irregular patterns or contours of legal formation and declension, with towering summits of compliance matched by deep valleys of deviation from global norms. International law impacts upon administrative practice at all levels of government, and the organizational practices of private commercial and not-for profit actors. However, law is not simply a matter of codification and compliance. Law can also be conceived as a creative space in which social agents play a critical role in shaping global legal futures.
Law: A Conventional International Perspective
There is no global sovereign power to enforce law in the international system, and there is ample evidence of consistent and extensive transgressions by states behaving contrary to their international legal obligations (Kratochwil 2014; Blakeley and Raphael 2013; Krasner 1999). The International Criminal Court is empowered to impose criminal penalties for war crimes, genocide, and crimes against humanity, but only where the persons charged are either nationals of a state that is party to the Rome Statute (Which therefore excludes nationals of the United States, which signed but withdrew intention to ratify in 2002 https://2001-2009.state.gov/r/pa/prs/ps/2002/9968.htm) or have committed a crime within the territorial jurisdiction of the Court. While international humanitarian norms have legal force at the international level, international human rights norms stand on much shakier ground. The International Court of Justice (ICJ) has authority to determine if and where states have violated their obligations across the broad spectrum of international treaty law, but has no power to impose penalties for noncompliance. With the exception of international criminal law therefore, in order for international norms to be given effect, they must be adopted into national legal codes and enforced through national-level criminal and civil processes, except where regional courts have jurisdiction, such as the European Court of Human Rights. Observance is consequently uneven.
One could be forgiven for succumbing to the notion that the idea of international law as the embodiment of universally agreed principles of justice and right is simply too fantastical. Critics of a conservative and nationalist persuasion argue that humanist legal transnationalism shackles sovereign states and prevents democratically elected governments from implementing their mandate to protect their country from attack (Kyl et al. 2013, p. 125). Liberal transnationalists decry the fact that, for reasons of diplomatic process, representatives from states with poor human rights records can nonetheless serve on international human rights bodies like the UN Human Rights Council (The UN Human Rights Council comprises 47 national representatives elected for 3-year terms by the UN General Assembly which, so the Council claims, weighs “candidate States’ contribution to the promotion and protection of human rights…” http://www.ohchr.org/EN/HRBodies/HRC/Pages/Membership.aspx (Accessed June 2, 2016) (Neuer 2016). In the postdevelopment quarter, the so-called international human rights “empire” is denounced as an elite enterprise involving highly paid humanitarian lawyers and celebrity advocates for whom cases of human rights abuse are a cause célèbre (Hopgood 2013, p. 2, 119; Kapoor 2013). Worse still, arguably, the institutions of humanitarian and human rights merely uphold the status quo in a global system of extreme inequality represents an unconscionable denial of economic justice to the billions of people living in the Global South (Escobar 1995; Sklair 2002; Rajagopal 2004; Hardt and Negri 2000, 2005, 2009). International humanitarian and human rights regimes are criticized for undermining security and inhibiting justice, where the protection of fundamental rights becomes the pretext for military intervention (Duffield 2007, 2010).
Notwithstanding these omissions, deficiencies, or gaps, many bodies of international law are routinely effective, where they serve systemically significant ends, to keep money, goods, and people circulating around the world. The task, from a constructivist standpoint, is to realize the possibilities for “resistance” to the moral hegemony of global elites and for “recoding” laws to recognize the broad scope of human need and aspiration (Rajagopal 2004). International laws are made by global elites, but it is entirely possible to appropriate the discourses of liberal norms and use these to empower people to challenge unjust authority or the commercial exploitation of human vulnerability (Wheeler 2010; Falk 1999).
International Law and Human Rights
To reaffirm faith in fundamental human rights, in the dignity and worth of the human person, in the equal rights of men and women and of nations large and small
To establish conditions under which justice and respect for the obligations arising from treaties and other sources of international law can be maintained
To promote social progress and better standards of life in larger freedom
The Universal Declaration on Human Rights (1948) is the fundamental legal document underpinning the post-1945 human rights regime. Unlike the UN Charter, which binds member states to act in accordance with its principles, the Declaration is nonbinding in that it does not incur any formal legal obligations, even though all UN members are automatically party to it. However, it sets out minimum expectations for the recognition of fundamental rights defined positively as freedom of speech, association, religion, and movement, and negatively as the freedom from political oppression, from exploitation, and from discrimination. The document establishes equality of rights as a benchmark, from the equal right to a fair trial; to the right to a reasonable standard of living; to education and health care irrespective of social class, ethnicity, language, or religion; and to engage in representative politics. Two covenants spell out what are categorized as first-generation and second-generation rights. The International Covenant on Civil and Political Rights (ICCPR) articulates the rights of individuals to, inter alia, freedom of speech and of trial by jury and freedom from torture – termed first-generation rights because their recognition is seen as essential for the enjoyment of all other rights. The International Covenant on Economic, Social and Cultural Rights (ICESCR) sets forth second-generation rights, including the right to fair wages, the right to work, and the right to food and shelter, enjoyed free of any discrimination based on gender, ethnicity, or religion. Indeed, there has been a significant enumeration of human rights since the Declaration came into force addressing the rights of refugees, the rights of the child, labor rights, women’s rights, and the rights of peoples with disabilities (Clapham 2007).
What are called third-generation rights, the rights of peoples, emerged in recognition of the special collective rights of minorities and indigenous peoples. The principal instruments asserting this category of rights are the African Charter on Human and Peoples’ Rights (1981), the International Labour Organization Indigenous and Tribal Peoples Convention (1989), and the Declaration on the Rights of Indigenous Peoples (2007). Indigenous rights also come within the purview of conventions addressing biological diversity and intellectual property. While genetic research delivers indisputable human health gains, biotechnologies have given food and drug companies the means to distil and manipulate the genetic structure of plants known to people in traditional communities for their medicinal qualities. This “traditional” knowledge, incorporating “cultural expressions and genetic resources” is an integral part of an emerging indigenous rights regime, but while the principle appears uncontroversial, its codification requires that distinctions be made between what is traditional and natural and what is adapted or created through the application of scientific and technical know-how (The World Intellectual Property Organization (WIPO) has prioritized the development of specific protections for traditional knowledge in intellectual property rights law. See, http://www.wipo.int/tk/en/igc/ (Accessed June 9, 2016). For draft principles on intellectual property and genetic resources see, Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (2016) “Consolidated Document relating to Intellectual Property and Genetic Resources.” 30th Session, Geneva May 30–June 3, WIPO/GRTKF/IC/30/4.).
Implementation of international human rights laws is contingent upon recognition of treaty obligations by states but also the capacity of national and local level institutions to adopt human rights into practice. The United Nations Human Rights Based Approach to Development Cooperation (HRBA) makes explicit the need to absorb knowledge of international human rights law (IHRL) across the UN system, at all levels of operation, and, through this, transfer human rights norms at multiple points of contact within national governments and social institutions (UNDG 2003). Institutional processes can, in this way, encourage the globalization of international norms by transforming routine or “mundane” organizational behaviors, and by encouraging greater individual awareness and regard for rights norms.
International law is a dynamic space, where laws are evolving through the interactions of many social and political actors. The identification and elevation of women’s rights exemplifies this dynamism. In the Universal Declaration, the right to the presumption of innocence and a fair trial accords those charged the right to all legal means “necessary for his [emphasis added] defence” (Article 11.1). Both the ICCPR and the ICESCR use gendered language to confer rights specifically upon men. For example, Part 3, Article 6.1 of the ICCPR expressly states that “no one shall be arbitrarily deprived of his life [emphasis added]” (1976). The ICESCR, while striving to be balanced nonetheless also specifically asserts the rights of men with regard to trades union membership (Part 3, Art. 8.1a) and living standards (Part 3, Art.11.1), echoing a time when men predominated in industrial workforces and were the principal breadwinners in the family home (1976). Feminist writers charge that human rights laws, while claiming to accord equal rights to all irrespective of gender, religion, ethnicity, or social class, fail to accommodate the reality that each influence how rights are enjoyed in practice. Foundational international human rights laws are silent on the informal and deliberate exclusion and victimization of women, for which reason the Convention for the Elimination of all forms of Discrimination Against Women (CEDAW) was brought into being (Brems 2003, p. 103). But even then, rights accorded to women in this document are not hailed as universal. Currents of national politics inevitably affect the extent to which rights are enjoyed, and by whom.
International Humanitarian Law
How much harder is it to guarantee rights observances in armed conflict? One famous anti-war quote, from the American writer Ernest Hemmingway reads, “But never think that war, no matter how necessary, nor how justified, is not a crime” (1946, p. xv). Still, Hemmingway conceded that “to win a war you have to do things that are inconceivable in peace” (1946, p. xv). And yet bodies of law have emerged that seek to control the excesses of war, while falling short of outlawing war altogether. Whatever our views on the justifications for and the nature of armed conflict, war is a law-governed pursuit and military necessity is the caveat that permits the “inconceivable” to be conceived.
International humanitarian law (IHL), or the laws of war, is primarily concerned with conduct during and immediately after armed conflict (in bello and postbellum). The Geneva Conventions emerged out of a sense of common humanity and moral revulsion at the increasingly visible inhumanity of war. The first Convention (1864) established that the International Committee of the Red Cross (ICRC) should be granted access to war zones, where ICRC staff could provide medical aid to wounded soldiers on all sides – in effect codifying the principle of neutrality to the benefit of future generations of humanitarian workers – provided of course that neutrality can be established (Hilhorst and Pereboom 2016). Three more followed: the second codified protections (in effect rights) for shipwrecked and wounded sailors; a third established the rights of prisoners of war; and the fourth, in 1949, conferred specific protections on civilians in or near to combat zones. Central to the Geneva Conventions is the concept of protected persons being civilians or those with noncombatant status, who present no immediate military threat and are, therefore, not to be subjected to violence or inhumane treatment, and are entitled to safe passage or medical assistance or both within and beyond the field of battle. This requirement forms the substance of Common Article Three (so named because it is common to all four treaties). Two further protocols were included in the Conventions in 1977 to strengthen civilian and noncombatant rights, with the Second Additional Protocol refining and extending the scope of protection in noninternational armed conflicts (Cullen 2010).
The scope of humanitarian protection has increased markedly over the past century, creating global obligations to care of the wounded and the displaced in all forms of human conflict. The Geneva Conventions are binding on states parties but enforcement depends upon the willingness of states to recognize their obligations in practice and through their national justice systems. That said, Article Three is regarded as a peremptory norm which applies, in theory, to all states irrespective of whether they are signatories or not (Kolb 2015) (The Vienna Convention on the Law of Treaties (1969) defines peremptory norm as “a norm accepted and recognized by the international community of States as a whole as a norm from which no legal derogation is permitted” (Article 53, UNTS, 1980, p. 344).). The Conventions also apply to nonstate armed actors which, where meeting the criteria for a combat force, are recognized as legitimate and whose armed combatants are entitled to the same observances offered to state armed forces personnel. In addition to conferring certain privileges on all those caught in the horror of war, the Conventions imply a general responsibility to not act contrary to their intent.
International Criminal Law
In contrast to violations of nonbinding international laws, international crimes incur criminal penalties, meaning that persons found guilty of war crimes, crimes against humanity, and genocide, (The definitions of these crimes are lengthy but essentially in the Rome Statute the crime of genocide is the deliberate destruction “in whole or in part, a national, ethnical, racial or religious group” (Article 6); crimes against humanity include “murder,” “extermination,” “enslavement,” “torture,” and “rape” (Article 7); and war crimes are “grave breaches of the Geneva Conventions” (Article 8.2a).) as set down in the Rome Statute of the International Criminal Court (2002), face a custodial sentence commensurate with the harm or harms inflicted. These are crimes that, as the Preamble to the Statute claims, “threaten the peace, security and well-being of the world” (2002, p. 7). Besides the usual technicalities of sovereignty and jurisdiction, the effectiveness of the ICC and international criminal tribunals is limited by legal interpretation. Convictions for international criminal acts are rare but attention-grabbing cause célèbre, like the trial of former Bosnian President Radovan Karadzic, sentenced to 40 years in prison for complicity in the 1995 Srebrenica genocide (Borger and Bowcott 2016; Kendall 2015). The bar for proof of criminal complicity is set very high at international criminal tribunals, rightly so given the serious implications for those convicted. But this, and the ambiguities of the Rome Statute, leaves room for significant divergences of judicial opinion, and consequently significant obstacles to successful prosecution (Webb 2013) (Two such tribunals were established in the 1990s to try persons for genocide in the Balkans wars of 1992–1995, and the “Rwandan massacre” of 1994.). The ICC’s defenders stress the demonstration effect of international criminal cases. The Court’s existence “sends a message” that the perpetrators of international crimes will eventually be brought to justice. Political opposition to the ICC is gaining traction, however, with some African nations contemplating withdrawal for an alleged anti-Africa bias in Court proceedings (Monageng 2014; Robertson 2002).
Transnational Criminal Law
Crime has become a globalized and globalizing phenomenon. Hence, transnational criminal law is growing in international significance, supported by the entry into force of key crime conventions, the UN Convention Against Corruption (2004), and the UN Convention Against Transnational Organized Crime (CTOC) (2004). The first strengthens the liberal norms governing international trade and investment relations by seeking to curb the influence of bribery and patronage in global business dealings. The second is recognition by states that they have a common security interest in cooperating to address the growth of transnational organized crime, inter alia, all forms of trafficking and smuggling, money laundering, embezzlement, fraud, and official corruption, which have a corrosive effect on governance and law enforcement. The CTOC’s significance is amplified by international concern for the causes and the effects of globalized terrorism (Rice 2012). But while the CTOC furthers the hegemonic discourse of transnational organized crime as a convergent global security threat, it establishes international norms that can also potentially, and perversely, complement the pursuit of global justice.
Corruption undermines international development programs, skews wealth distribution, and weakens governance institutions. Victims of crime are entitled to protection and rehabilitation. The duty to protect civilian populations extends to the reduction of gun violence and other firearms offences in peacetime, which can be achieved by restricting the global trade in weapons through more effective policing. Annexed to the CTOC are protocols, which encourage states parties to act in ways consistent with these priorities. For example, the Trafficking in Persons Protocol advises states to “consider [emphasis added] the physical, psychological and social recovery of victims,” which, though falling short of requiring fair and just treatment imply an entitlement or right to specific protections (UNODC 2004, p. 43). The Trafficking in Firearms Protocol complements the Arms Trade Treaty (2014) in, among other things, calling for legislative and law enforcement steps to reduce the illicit manufacture and sale of “any portable barreled weapon” (UNODC 2004, p. 72). Admittedly, these norms are not couched in categorical language, leaving much latitude for states to determine how far they will comply, but they at the very least provide a basis for strengthening global justice claims.
The Transnational Space of Laws
The preceding sections set out some of the basic premises and issues raised by the evolution of international law over the twentieth century. Thinking more holistically about law, as both codified norms and socially embedded practice, we can imagine that law does not “function” in a neutral space but rather exists in creative tension with the complex environments in which it evolves. Law is part of a larger social system, or social ecology (Luhmann 2008, 2013), the largest of which the planetary or global social system that all of humankind inhabits. Documented or codified laws are formed through a process of argument, judgment, and interaction between a range of influencers and not merely through acts of judicial decision making. Law is arguably an evolutionary process in which nonlawyers and laypersons play an important role in fashioning norms, although not always with palatable consequences (Kennedy 2004; Alverez 2005, pp. 611–616). So, we can approach global justice aims by first positing fields or spaces where laws intersect. At a very rudimentary level for example, a person’s right to basic healthcare is affected by the degree to which international and transnational crimes are policed and minimized, the extent to which gender rights are valued and respected, and freedom of religion and other civil and political rights upheld.
Thinking divergently, and adopting an evolutionary and eclectic approach to law, development practitioners can discover fresh avenues for redress and new means to protect the vulnerable against abuses of power and privilege. This requires a basic grasp of the complementarities between bodies of international law, the capacity to connect law with practice, and a willingness to step outside legal convention.
International Trade and Investment Law
International trade and investment treaties complement the pursuit of humanitarian and other normative ends, which we might for convenience refer to a sustainable development. The 162 states party to the Marrakesh Agreement (1994), the founding document for the World Trade Organization (WTO), agree, in principle, to make “optimal use of the world’s resources in accordance with the objective of sustainable development, seeking both to protect and preserve the environment and to enhance the means for doing so in a manner consistent with their respective needs and concerns at different levels of economic development” (WTO 1994). While the language used does not impose binding obligations on WTO members, the Agreement implies an obligation to work in good faith towards the accommodation of sustainable development principles in the practices of international trade and investment. International treaties like the Convention on the Illegal Trade in Endangered Species (CITES) for example and national custom and environmental laws prohibiting importation of illegally sourced forest and marine resources demonstrate states’ interest in both preventing environmental destruction and further constraining the scope for transnational organized crime. Even though countries dependent upon timer and fisheries exports are concerned that the levels of documentation necessary to satisfy legal requirements stretch the limits of their regulatory and law enforcement capacities, such prohibitions do not constitute restraint of trade under WTO rules (Battersby 2014). Though we might expect all humanitarian, human rights, and sustainability norms to run second to state and private commercial priorities, these are not incompatible ends (Desierto 2015; Vadi 2010).
The responsibility to act in compliance with international treaty obligations is borne by juristic persons, individual and corporate, residing or registered in signatory states (Noortmann 2015; Wouters and Chané 2015). Extraterritorial provisions within national laws open opportunities for individuals and organizations to be called to account for their actions overseas where these transgress to treaty obligations of their state of residence, or business operation. One of the most well-known sources of extraterritorial authority, the US Alien Torts Statute (ATS) acknowledges US district courts’ jurisdiction to hear cases on criminal matters concerning acts “committed within their respective districts, or upon the high seas” and to grant “alien” persons the right to pursue a civil law suit for “violation of the law of nations or a treaty of the United States” (Annals of Congress 1789, pp. 2242–2243; USC Title 28, Pt. IV, Ch. 85, 1350). There have been many such torts cases brought before US district courts since the 1990s as lawyer activists representing alleged victims of US-registered TNCs began testing the limits of the ATS (For example, Wiwa v. Shell (Ogoniland, Nigeria); Sarai v. Rio Tinto PLC (Bougainville, Papua New Guinea); Doe v. Unocal (Myanmar). Extensive details, documents, and commentaries, on ATS and other legal proceedings against corporate entities can be found at http://business-humanrights.org/en (Accessed June 3, 2016)). While the tide of judicial opinion has shifted against an expansive interpretation of the scope of this statute, there is still ample opportunity for US-linked corporations to be held accountable for transgressions of international and national law in the US justice system.
On the question of knowing involvement in the crimes of corruption and fraud, the US Foreign Corrupt Practices Act (1977) invites the broadest possible interpretation, and the widest extraterritorial application. Here US criminal and civil law converge, and from which convergence, criminal penalties can arise, where a company’s directors fail to keep detailed records of their financial dealings at home or overseas and where there is strong circumstantial evidence to presume guilt (15 USC 2B, 78mb 2–5). Litigation risk is heightened in the post-9/11 era where laws to control transnational crime and compel corporate entities to comply with anti-terror legislation in the USA and many other western countries have been used to punish international corporate unlawfulness (U.S. Congress. Senate 2012; U.S. Congress, HOR 2001; Battersby 2014).
“Soft law” here encompasses the codes of conduct internal to transnational organizations which constitute yet further evidence of nonstate actor efforts to promote compliance with international laws (for example, Rio Tinto 2015). The specter of civil and criminal litigation is one reason for the increased attention given to human rights and humanitarian obligations by private companies (UKJCHR 2010). Leading the drive to encourage greater corporate respect for noncommercial norms, the OECD Guidelines for Multinational Companies, first issued in the 1970s, sets out a template for prudential transnational corporate governance which incorporates strong recommendations to uphold international sustainability and human rights principles (OECD 2008). The OECD’s Investment Committee furnishes the global corporate sector with “risk awareness” tools for operations in “weak governance zones,” which it defines as states in which the government “cannot or will not” govern according to their sovereign obligations, implicating many of the conflict-afflicted countries from which the world derives much of its mineral resources (OECD 2006, p. 11). There are of course no serious penalties for noncompliance, and many major transnational corporations continue to operate very close to the edge of their legal and ethical responsibilities. Still, these statements of principle can be construed into a larger view of international customary practice, to which appeals can be made, and obligations attributed, in efforts to challenge the abuse of power and privilege.
Unethical Offshore Clinical Trials
The development of new treatments for major diseases is undoubtedly a global human health good, but the means by which drugs are sometimes tested in faraway places violate fundamental human rights and conflict with established legal standards governing the use of human subjects in scientific research. Historically, clinical trials were activities undertaken by state governments upon citizens within their own borders. The most well-known examples of state-led unethical clinical trials are those undertaken in Nazi Germany and Tuskegee, USA. These cases and the codes of conduct that arose from them provide the modern day touchstone for ethical standards (Pressel 2003; White 2003). The world pharmaceutical industry has grown rapidly since the 1950s, with a current net worth of $300 billion per year (World Health Organization 2015). Choudhury (2005) considers this growth phenomenon to be largely a result of the pharmaceutical industry’s ability to take advantage of the creation of the increasingly liberalized global market along with innovations in transport and communication so readily associated with the globalization process. Consequently, “Big Pharma” assumed a primary role in drug research and development (Choudhury 2005, p. 43). Gatter (2006, p. 352) notes that regions such as Latin America, East Asia, and Africa have become targets for offshore clinical trials, where North American, Japanese, and European pharmaceutical companies can take advantage of substantially decreased costs (DuBois 2003); lack of regulation (Gatter 2006) and access to a larger pool of human subjects (DuBois 2003) in a bid to generate favorable trial results.
The practice of conducting clinical trials in developing countries is not a new phenomenon. The clinical trials of radioactive drugs on Alaskan villagers is an example of the US government sourcing clinical trial subjects from an offshore location. A second, better-known example is the US conducted drug trials on Guatemalan citizens, which saw subjects deliberately infected with sexually transmitted diseases (Aljazeera America 2015). What is new, however, is the extent of this offshore practice. This is particularly so in the case of US pharmaceutical companies, following the relaxing of US laws in 1994 to legitimize foreign testing (Dubois 2003). Since 1990, the conducting of clinical trials in foreign countries has increased over 2000% (Schuster 2015). While the exact extent of the offshore movement remains unknown, a report conducted by the Inspector General of the Department of Health and Human Services, Daniel Levinson, titled Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials found that at least 80% of the drugs approved for sale in the US market had been trialed either wholly or at least in part, in a foreign country (Levinson 2010).
Ethical issues in clinical trials arise from questions of: informed consent, lack of independent oversight, and failure to respond to a patient’s adverse reactions. Due to the cloaked nature of the clinical testing processes in developing countries, it is difficult to determine to what ethical standard these activities are being conducted. However, the well- documented activities of Pfizer in conducting medical experimentation in Kano, Nigeria, and the resulting litigation from these events (Abdullahi v Pfizer, Inc., 562 F 3d 163 2d Cir. (2009)) provide insight into the type of unethical practices that are being carried out. In 1996, pharmaceutical corporation, Pfizer, hearing of an outbreak of meningitis in a small town of Nigeria, took the opportunity to test their drug Toxacin (also known as Trovan) on young children infected with the illness (Patterson 2010). At this time, Trovan was prohibited from being tested in the United States, having presented serious side effects including liver damage and a degenerative bone condition (Patterson 2010). It is alleged that Pfizer was aware of the status of Trovan at the time but despite this recruited and tested the experimental drug on 200 Nigerian children. After conducting the trial for a period of 2 weeks, Pfizer left the site without any follow-up treatment (Patterson 2010). It has been reported that 11 children lost their lives as a consequence of the trials and a significant percentage of the 200 were left severely debilitated (Patterson 2010).
Obstructions to Universal Accountability
During the Trovan trial, there were numerous ways in which “Pfizer researchers departed from research practices understood to be customary within the pharmaceutical industry” (Bahir 2006, p. 160). Customary practices can generally be found in “soft law,” the formative sources of regulation that seek to control the conducting of clinical trials. The most notable of these include: The Nuremberg Code (1946), the World Medical Association Declaration of Helsinki: Ethical Principles for Research Involving Human Subjects (1964), and the World Health Organization, Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products (1995).
Soft law offers little protection against human rights abuse by pharmaceutical companies (Macklem 2005, p. 285). Bahir (2006, p. 169) attributes this namely to the voluntary nature of the guidelines, which do not “compel companies to abide by the rules,” imposing only a moral obligation to do so. Similarly, victims of unethical clinical trials can find little recourse in the context of international criminal law. While the ICC prosecutes the most serious abuses of human rights: crime of genocide, war crimes, and crimes against humanity, it is unlikely that unethical clinical trials would fall within these definitions, unless, according to Schipper (2009), their participants were coerced to take part in them by force. Further, the ICC does not have jurisdiction over legal persons, such as pharmaceutical companies.
Departure from these regulatory guidelines may, however, result in a violation of international human rights law, which, unlike soft law, does carry legal force and unlike international criminal law does have subject matter jurisdiction. There are various human rights standards pertaining to medical experimentation. The most prominent of these being: the Right to Freedom from Cruel, Inhuman and Degrading Treatment, the Right to Bodily Integrity, and the Right to the Highest Attainable Standard of Health. These rights are reflected within various international legal instruments including the UDHR, ICCPR, ICESCR, The African Charter on Human and Peoples’ Rights, The European Convention on Human Rights (ECHR), and The Convention on the Rights of the Child.
However, the international human rights law framework, as it currently stands, lacks the ability to hold nonstate actors (such as pharmaceutical companies) directly accountable (Salazar 2004, p. 115). Thus, as argued, in order for international human rights law to be given effect, they must be adopted into national legal codes and enforced through national-level criminal and civil processes. The host state (this being the state, which “hosts” the activities of pharmaceutical companies) holds actual physical and immediate jurisdictional powers over the pharmaceutical company operating within its own borders. However, host states in enacting and enforcing laws that bind powerful nonstate actors, like global pharmaceutical companies, face significant challenges. The relationship between pharmaceutical MNCs and developing country governments is extremely complex. The fact that “a global pharmaceutical company can provide (strong) services to a (weak) state’s people” (Lyons 2007, p. 8) by injecting health care delivery systems with necessary capital and providing what would otherwise be unaffordable drugs and services is something that cannot be ignored. It might be argued that developing countries should not be held hostage to the competitive interests of global pharmaceutical companies in serving the financial interests of their shareholders. Yet at the same time, movements towards the regulation of pharmaceutical companies’ activities in developing countries should not forgo the necessary health care benefits that they provide nor should it exclude the developing world from important medical advances.
Home states (those being the states where the pharmaceutical company headquarters or holding company is registered) have arguably minimal control over the offshore activities of pharmaceutical companies as evidenced by the lack of oversight of offshore trials. Dubois’ work considers the inefficiencies of home state regulation in protecting the rights of offshore participants, and he uses the shortcomings of United States regulatory systems to illustrate this lack of oversight issue. The USA, upon permitting foreign testing, failed to supplement this with adequate safeguards for regulation and control and therefore ensure the wellbeing of subjects abroad as well as consumers within its own borders (Dubois 2003). Further, there is presently no regularly invoked legal framework that has a demonstrated capacity to hold pharmaceutical companies to account for their activities offshore. The ensuing litigation from the activities of Pfizer in Nigeria was brought as an Alien Torts Statute (ATS) action in the New York District Court. This was a landmark decision that expanded the jurisdiction of the ATS by holding that “the prohibition in customary international law against non-consensual human medical experimentation can be enforced through the ATS” (Abdullahi v. Pfizer, Inc., 562 F 3d 163 2d Cir. (2009)). While the ruling in Abdullahi v Pfizer was considered a remarkable achievement in the context of pharmaceutical corporate accountability, the hopes for future cases of this kind were short lived. The subsequent decision of Kiobel v Royal Dutch Petroleum (621 F 3d, 111 2d Cir. (2010)) appears to have significantly curtailed the operation of the ATS by holding that corporations do not fall within its jurisdiction.
Transnational Legal Futures
Despite the obstructions to universal accountability for unethical offshore clinical trials as set out in the preceding paragraphs, optimism remains for curbing the unethical practices of pharmaceutical companies and achieving justice for their victims. The development of a transnational space of laws presents opportunities to clinical trial participants and, more broadly, to those who suffer human rights abuses at the hands of multinational corporations.
One of the more significant aspects to the evolution of this transnational space of laws is the development of transnational tort law made possible through the extended extraterritorial reach of domestic civil laws. This development is evidenced through the rise of transnational tort litigation, with advocacy organizations and tort lawyers experimenting with the jurisdictional boundaries of common tort law in an effort to attribute accountability to MNCs operating in developing countries. Since the decision in Kiobel, new cases are being brought before US district courts in an attempt to reinstate the broad scope of the ATS’ jurisdiction. Progressive movements also appear in transnational tort law in European jurisdictions. The recent Dutch case of Friday Alfred Akpan v Royal Dutch Shell C/09/337050/HA ZA 09–1580 (2013) in finding that Dutch Royal Petroleum can be held accountable for human rights violations offshore may set a precedent for transnational tort litigation. In the UK context, plaintiffs seeking compensation for injuries sustained in South Africa and inflicted by the Anglo-American mining company have brought class actions against these companies in the South African High Court and through the use of transnational tort litigation in the UK High Court (Vava & Ors v Anglo American South Africa Ltd., Claim No HQ11X03245).
A second relevant development in the transnational legal space relevant to human rights abuses by pharmaceutical companies is the increase of bilateral and multilateral agreements. A pertinent example of bilateral agreements includes the 1993 Agreement between the Government of Australia and the Government of Hong Kong for the Promotion and Protection of Investments (Hong Kong Agreement). This agreement has currently come into the public spotlight with the tobacco company, Phillip Morris’ unsuccessful claim that the Australian Government’s enactment of the Tobacco Plain Packaging Act 2011 (Cth) is in breach of its obligations under the agreement. Investor-state arbitration is on the rise by means of bilateral treaties, and there are concerns that disputes could increase further with the advent of new multilateral trade and investment agreements. The most recent of these is the controversial Trans-Pacific Partnership Agreement (TPP). The TPP contemplates a legal framework wherein a foreign company headquartered in one of the 11 signatory states can seek compensation for loss of profit from the government of another of the 11 signatory states should that government enact legislation that will impact the company’s future profit margins. While these examples of bilateral and multilateral agreements may not at this point bode well for the protection of human rights, they demonstrate how the space of international laws is constantly changing and the willingness of both states and nonstate actors to be held to account beyond nation-state borders.
However, the expensive, time consuming and uncertain nature of litigation demonstrates why the development of the transnational space of laws must go beyond the work of lawyers inside court rooms. In the context of unethical offshore clinical trials, important contributions are being made by academics, journalists, development workers, medical practitioners, and advocacy organizations. Investigative research is of critical importance in shedding light on the extent to which offshore clinical trials are being conducted unethically in developing countries. Journalist, Sonia Shah’s (2006) preeminent work, The Body Hunters: Testing Drugs on The World’s Poorest Patients, documents “how the multinational pharmaceutical industry, in its quest to develop lucrative new drugs, has begun quietly exporting its clinical research business to the developing world…” Dutch NGOs, Wemos, and the Centre for Research on Multi-National Corporations (SOMO) have undertaken a number of investigative reports on unethical clinical trials in developing countries (SOMO publications include: Examples of Unethical Trials (2008), Wemos publications include: The Clinical Trials Industry in Kenya: Realities, Risks and Challenges (2014); The Clinical Trials Industry in South Africa: Ethics, Rules and Realities (2013); The Globalization of Clinical Trials: Testimonies from Human Subjects (2010); and Examples of Unethical Trials (2008).). Further, the 2011 Report on Non-Consensual Medical Research in Africa published by the Rebecca Project details case studies of unethical clinical trials in Africa. These advocacy organizations further lobby their respective government bodies to seek better regulation and accountability. Wemos advocates for improved supervision at the European level to prevent unethically tested medicines to be marketed in Europe. SOMO’s Schipper (2009) in her report for the European Parliament on Clinical Trials in Developing Countries; How to Protect People against Unethical Practices? makes a series of recommendations, all of which are within the realm of the European Union’s regulatory powers and include investigations, marketing authorization processes, clinical trial databases, and penalties awarded against pharmaceutical companies. Similarly, The Rebecca Project, a US-based organization, proposes recommendations that involve lobbying US congress to direct the FDA to impose a stronger monitoring scheme, impose sanctions on countries and on individual practitioners, and hold congressional hearings. Schuster (2015) in her recent article For the Love of Drugs: Another Way to Make Profit Off the Poor proposes that a more significant role be played by the FDA by means of increased mandatory reporting with a public register and increased inspections in developing countries.
The argument presented in this chapter is that despite the many – valid – criticisms of the international legal establishment, the scope to pursue global justice through law is not exhausted or futile. Knowledge of international law can be a means to raise public awareness of rights and of injustices, and enable lay persons to conceive different legal pathways towards the realization of development and humanitarian ends. Thinking of international law as a creative space where there is scope for imagination and legal or regulatory innovation can generate incentives for development practitioners to engage with legal issues and work in closer cooperation with legal experts. The relationship between international law to development stretches far beyond war crimes trials in The Hague, or the human rights agendas of Amnesty International or Human Rights Watch, or indeed the UN’s Human Rights Based Approach. This relationship encompasses routine legal investigation, monitoring, and advocacy, the discovery of new regulatory possibilities in existing international treaties governing trade and investment. While this approach might be rejected as merely toying with a system that is fundamentally flawed because it is loaded in favor of states and transnational commercial interests, at the very least it opens fresh avenues to expose, challenge, and to restrain the exercise of arbitrary power.
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