Poku AduseiPatenting of Pharmaceuticals and Development in Sub-Saharan Africa2013Laws, Institutions, Practices, and Politics10.1007/978-3-642-32515-1_6© Springer-Verlag Berlin Heidelberg 2013
Pharmaceutical Patents, the Right to Health, and Constitutional Supremacy in Sub-Saharan Africa
(1)
Faculty of Law, University of Ghana, Accra, Ghana
Abstract
The last half-century has spawned a considerable debate about human rights and its regime complex. This regime complex consists of a web of interlocking national laws, constitutions, customs and practices, judicial decisions, and international and regional agreements regarding human rights. Also prominent in the human rights rhetoric is a growing body of academic literature describing human right norms as: jus cogens, global morality, obligations erga omnes, universal entitlements, the ‘veritable Magna Carta’ of humanity, and the inherent dignity and worth of humans. In legal circles, the concept of human rights has attained a high priority status in the hierarchy of international legal norms as compared to private interests in pharmaceuticals. Indeed, human rights norms are universal ideals that transcend any limitations and inadequacies associated with the western concept of property ownership. Equally, the concept of human rights is immune to the criticisms levelled at the globalized patent regime. In consequence, this chapter aims to emphasize that access to medicine will be enhanced by relying on the universal ideals/norms from other disciplines such as human rights law to regulate the grant of pharmaceutical patents.
I. Introduction
The last half-century has spawned a considerable debate about human rights and its regime complex.1 This regime complex consists of a web of interlocking national laws, constitutions, customs and practices, judicial decisions, and international and regional agreements regarding human rights. Also prominent in the human rights rhetoric is a growing body of academic literature describing human rights norms as: jus cogens, global morality, obligations erga omnes, universal entitlements, the ‘veritable Magna Carta’ of humanity, and the inherent dignity and worth of humans.2 In legal circles, the concept of human rights has attained a high priority status in the hierarchy of international legal norms as compared to private interests in pharmaceuticals. Indeed, human rights norms are universal ideals that transcend any limitations and inadequacies associated with the western concept of property ownership. Equally, the concept of human rights is immune to the criticisms levelled at the globalized patent regime. In consequence, this chapter aims to emphasize that access to medicine will be enhanced by relying on the universal ideals/norms from other disciplines such as human rights law to regulate the grant of pharmaceutical patents.
However, despite the superior legal status of human rights norms and the frequent use of pro-human rights metaphors in policy and academic discourse, the realization of the fundamental right to health,3 which includes the right to access medicine, treatment and prevention measures, still faces significant challenges in SSA. The lack of adequate healthcare arises partly because patents make the cost of access to life-saving medicines prohibitively expensive for the sick population in less developed countries.4 The preference for patents as a regulatory tool does not encourage efforts to develop other regulatory policies aimed at promoting the affordability of and/or access to essential life-saving medicines in SSA. In consequence, access to medicine as a human right5 is constrained by the grant of pharmaceutical patent rights to private corporations, which regulate the prices of patented medicines on the market. Worse still, the public health crises epitomized by the HIV/AIDS, malaria, and TB epidemics add another layer of complexity to the already fragile healthcare services in SSA. Conceivably, the incidences of HIV/AIDS, malaria, and TB epidemics have outpaced governments’ treatment capacities, and millions of people in SSA are deprived of their fundamental right to health.6
The goal of this chapter is to explore the intersections between human rights law and patent law in light of the access to medicine challenges in SSA. It proceeds on the premise that HIV/AIDS, malaria, and TB epidemics raise fundamental human rights issues both in terms of the rights of persons infected and the lack of access to medicines to treat these pandemics in SSA.7 It argues that the protection of the fundamental right to health should serve as a corrective measure against excessive exploitation of pharmaceutical patent rights in SSA. Human rights offer a framework for action to compel governments to provide healthcare services to their citizens and to alter the conditions, including unfair industry practices, which create, exacerbate, and perpetuate deprivation and marginalization in SSA.8 Indeed, adopting a human rights-based approach to patent law-making will provide specific guidance to policy-makers to create exceptions to private pharmaceutical patent rights in SSA. In addition, a rights-based paradigm justifies trumping rigid pharmaceutical patent rules in favour of the right to health guaranteed in transnational human rights instruments and national constitutions in SSA. The salient point here is that human rights norms, with particular emphasis on the right to health, have a higher normative and constitutional value than WTO patent law.9
Against the backdrop of this introduction, Part II of this chapter discusses the general intersections between patent law and human rights law. In recent years, the use of patents as instruments to promote public health has attracted significant attention and recognition in international patent polity. This part contributes to that debate and also responds to controversies surrounding the role of patents in promoting access to medicines in SSA. From this account, I adopt the perspective that a well-functioning patent system will play a key role in resolving the access-to-medicine problems in SSA. Thus, increasing access to effective, safe and affordable medicines is considered to be a crucial element of healthcare delivery in SSA.
Part III details the provisions in international instruments, which oblige states to respect, protect and fulfil their obligations regarding health and healthcare. Specifically, I discuss the scope of the provisions on the right to health guaranteed in international documents, such as the Universal Declaration of Human Rights, 1948 (UDHR),10 the International Covenant on Economic, Social and Cultural Rights, 1966 (ICESCR),11 and the International Covenant on Civil and Political Rights, 1966 (ICCPR).12 In addition, I analyze the normative content of the right to health in human rights discourse.
Part IV discusses the obligations of SSA countries to protect the fundamental right to health under the African Charter.13 Here, I discuss how the right to health guaranteed under the African Charter has been interpreted by the African Commission on Human and Peoples’ Rights (African Commission) in human rights jurisprudence. The African Commission has the mandate to promote and ensure the protection of human rights throughout the African continent.14 This part also alludes to other sub-regional instruments in Africa that mandate SSA states to protect the fundamental right to health of their citizens. I conclude by discussing some states’ practices that support the proposition that the right to health has become a general principle of international law.
Part V moves the discourse from the realms of transnational law into the field of domestic protection of the right to health in SSA. It posits that the fundamental right to health has been enshrined in many national constitutions in SSA and this trend gives especial significance to the right to health in human rights discourse at the domestic level. As a consequence, I employ the twin concepts of constitutional supremacy and the primacy of human rights to justify why the right to health should trump any patent limitations in order to facilitate access to medicines for the masses affected by epidemics in SSA. Here, I employ the South African constitutional jurisprudence on the protection of the right to health to inform this discussion. Part VI concludes this chapter.
II. On the Intersections Between Patents and Human Rights
Historically, patent law and human rights law evolved as relatively distinct concepts. Whereas patents are considered to be strict private property rights and thus not deserving unwarranted public interference, the right to health is viewed as human aspirations for which a state should endeavor to provide. Perhaps, patent law and human rights practitioners failed in the past to fully appreciate how either body of law could aid or threaten each other’s sphere of influence or opportunities for expansion.15 For Koopman, what accounts for this jurisprudential separation is that patent law is not rooted in morality, but rather in economic instrumentality.16 On his part, Mgbeoji has remarked that “patents are not founded on human rights, global morality, or obligations erga omnes.”17 This assumed dichotomy between patents and human rights law has historically manifested in the legal community: few patent lawyers got involved with human rights law, and few human rights specialists dealt with patent issues.18 Nevertheless, as noted in chapter “The ‘Myth’ of Patent Justifications: Triumph and Failure Dichotomy in the North and South,” the influence of natural law theory in the design of the globalized patent rules highlights [or should have heightened] this interplay between patents, the price of essential medicines, and human rights law.
Today, the grant of patents and its broader impact on society in terms of access to life-saving medicines is increasingly being articulated in academic and policy discourse. Several factors coalesced to accentuate this synergy between patents and the right to access medicine. Most notably, the threat of the HIV/AIDS epidemic and the efforts in the late 1990s by the South African government to provide antiretroviral medicines to its citizens and the resulting trade dispute with pharmaceutical corporations and the US government was a significant factor in stressing this interface between patents and human rights. The South African experience drew significant attention to the effects of strong patent rights for pharmaceuticals on the citizens of SSA; it also made pharmaceutical companies accountable for their actions and inaction towards people threatened with pandemics, such as HIV/AIDS.19 Further, the adoption of the Doha Declaration and the ‘August 30’ Decision, and the recent amendment to TRIPS highlight this overlap between patents and access to medicine issues, especially as it pertains to less developed countries. These ‘humanitarian’ initiatives sought to mitigate the hardships associated with the implementation of the TRIPS Agreement in order to promote public health in less developed countries. The point here is that the use of human rights rhetoric in connection with patent regulation emphasized the idea that the dignity of individuals must be central to the grant of pharmaceutical patent rights in domestic jurisdictions.
The concept of patent law intertwines with human rights law in three significant respects. The first intersection is based on the idea that patent rights should be treated as a basic human right. This notion of treating patents as a human right is rooted in the natural law rationale for patent protection and also shares experience with traditional (Eurocentric) human rights theory.20 The second intersection between patents and human rights appears in the form of a conflict: the grant of exclusive patent rights in pharmaceuticals tends to undermine the realization of the right to access medicine. And, the third intersection between patents and human rights law involves efforts to reconcile both concepts in legal and policy discourse. This third approach thus seeks to promote a synergy between patent concepts and human rights law since both serve a common purpose in promoting human development. The following sections analyze these intersections in turn.
A. Patents-as-Human-Rights
Proponents of the patents-as-human-rights view employ natural law arguments to justify and expand their claims for strong IP protection.21 They assert that patent rights must be recognized as a basic human right and must thus be introduced as part of the fundamental bill of rights in domestic jurisdictions.22 This argument for patents to be protected as a basic human right is further grounded on the need to foster security, protect individual autonomy, prevent piracy/theft, and protect other human rights such as the right to privacy.23 On that score, proponents rely on international documents, which assert that the grant of exclusive patent rights over pharmaceuticals will eliminate trade barriers and foster international trade.24 For them, the state has an obligation to respect, protect and enforce patents as private property rights of inventors against theft.25 In light of these arguments, some scholars have even ventured to (mis-)characterize the TRIPS Agreement as a ‘charter of rights’ for patent holders,26 thereby re-enforcing the ideals of the western concept of property ownership.
In addition, proponents of patents-as-entitlement thesis rely on both the UDHR and ICESCR in support of their claims for patents to be recognized as a human right. In particular, Article 27(2) of the UDHR provides that “everyone has the right to the protection of the moral and material interests resulting from any scientific…production of which he is the author [or inventor].” In a somewhat identical language, Article 15(1)(c) of the ICESCR requires each state party to “recognize the right of everyone…to benefit from the protection of the moral and material interests resulting from any scientific…production of which he is the author [or inventor].” The Committee on Economic, Social and Cultural Rights (which monitors implementation of the ICESCR) interprets Article 15(1)(c) of the ICESCR as granting regulatory discretion to states to implement IP systems in a manner that takes account of their economic, social and cultural conditions.27 Thus, the implementation of the above knowledge-protection provisions is expected to be balanced against the need to promote the public right to enjoy the benefits of scientific progress and access to inventions.28
Critics on several fronts have assailed this approach of treating patents as human rights. According to Drahos the ‘instrumental’ character of the regime for protecting patent rights established by the provisions in the UDHR and ICESCR cannot rightly be said to be a ‘fundamental’ human rights regime.29 Besides the nebulous and permissive character of the above provisions, a careful and nuanced analysis of the drafting history of Article 27(2) of the UDHR and Article 15(1)(c) of the ICESCR confirms that the knowledge protection-related provisions are strictly not ‘fundamental’ human rights provisions.30 While these provisions allow states to design IP protection systems in a manner that meet local needs, interests and goals, they do not oblige states to adopt a patent system that is exclusive for twenty years, as is presently the case under TRIPS.
Indeed, unlike classic human rights which are vested in natural persons and thus inalienable, the bulk of pharmaceutical patent rights are vested in artificial entities. The true character of patent rights is that they are creatures of statute and cannot rightly fit any notion of fundamental human rights. As private property rights, patents can be assigned, licensed, sold, or revoked; patent rights have thus been reduced to the status of trade law, a move that does not dovetail well with the notion of human rights.31 Human rights can neither be granted nor repealed by any legislator.32 Worth emphasizing is that the presence of the knowledge protection-related provisions in human rights instruments, such as the UDHR and the ICESCR, cannot change the nature of patents as temporary property interests.
Another possible objection to the patents-as-human-rights thesis is that the TRIPS Agreement does not describe patent rights as ‘human rights’ or ‘fundamental human rights’; rather, it refers consistently to the rights over inventions as: ‘rights’, ‘private rights’, and ‘exclusive rights’. Based on the basic rule of interpretation, generalia specialibus non derogant [the universal shall not detract from the specific], there is support for the argument that the phrasing of TRIPS prevails over that contained in any general human rights document on matters of IP. This approach to interpretation is in line with the Vienna Convention,33 which codifies customary international law on treaty law. The Vienna Convention allows TRIPS’ provisions to take priority in matters of patents due to its specific character.34
Notwithstanding these lines of argument, chapter “The ‘Myth’ of Patent Justifications: Triumph and Failure Dichotomy in the North and South” has shown that the rhetorical significance of the natural law/human rights rationale in patent discourse has not yet diminished. Yu predicts that IP rights will be elevated to the status of human rights in rhetoric even if that status will not be elevated in practice as fundamental human entitlements.35 Again, treating patent rights as fundamental human entitlements, whether in theory or practice, could hamper access to essential medicines in less developed countries. As Ostergard put it, the obligation to give priority to the well-being of the citizens of a country militates against any notions of treating patent rights as human rights.36 This perceived conflict between patents and human rights is discussed next.
B. Conflict Between Patents and Human Rights
The second intersection between patents and human rights law is that the former severely undermines the realization of the fundamental human right to healthcare in poor countries. According to Helfer, strong patent protection undermines—and is therefore incompatible with—a broad spectrum of human rights obligations, especially in the area of economic, social, and cultural rights.37 Take, as an example, Article 8 of TRIPS and fundamental human rights provisions of national constitutions that mandate countries to adopt measures necessary to protect public health. On the flip side, Article 27 of TRIPS and national patent laws protect the right of patentees to exploit their inventions. Also, “The ‘Myth’ of Patent Justifications: Triumph and Failure Dichotomy in the North and South” has demonstrated that patent law interferes with the right to health by creating regulatory dysfunctions such as excessive pricing of life-saving medicines and monopoly rents. The complaint brought before the South African Competition Bureau against GlaxoSmithKline and Boeringer Ingelheim for excessive pricing of antiretroviral medicines exemplifies this. Evidence also suggests that patent protection does not encourage research into diseases prevalent in less developed countries. Moreover, the globalized patent regime does not discourage the surge of biopiracy, but rather disdains matters of traditional knowledge.38 Safe to say, trade restrictions affect the pursuit of non-trade objectives, including respect for the right to health.39
This conflicting view is confirmed by UN Sub-Commission Resolution 2000/7, which indicates that “actual or potential conflicts exist between the implementation of the TRIPS Agreement and the realization of economic, cultural and social rights.”40 Accordingly, efforts are being undertaken to resolve this supposed conflict between patents and human rights law. For Helfer, the prescription for resolving this conflict is to recognize the normative primacy of human rights law over IP law in areas where specific treaty obligations conflict.41 Amani notes that “states should not be discouraged by the threat of trade sanctions in giving human rights obligations priority over trade in domestic law and policy.”42 For her, this universal trumping of human rights norms over WTO patent rules will maximize states’ comparative advantage and lead to greater welfare.43 It needs to be mentioned that these conclusions draw support from the UN Charter, which many classify as the Constitution of the international community and thus contains binding and universally accepted human rights norms.44 The UN Charter provides that in the event of a conflict between obligations under the UN Charter and obligations under any other international agreement, the obligation under the Charter shall prevail.45
The resolution of this patents/human rights conflict by the UN supports the approach that primacy should be given to human rights obligations over “economic policies and agreements”46 and that “governments and national, regional and international economic policy forums [must] take international human rights obligations and principles fully into account in international economic policy formulation.”47 This prescription is also supported by the Report of the UK Commission on Intellectual Property Rights: “there are no circumstances in which the most fundamental human rights should be subordinated to the requirements of IP protection.”48 Therefore, less developed countries can interpret human rights norms to impose limits on the grant of strong patent rights.49 As I explain further below, the right to access medicine had become a norm of general international law and constitutional law. As such, the right to health can serve as a justification for states threatened with epidemics to limit pharmaceutical patent rights in order to cater to the needs of their citizens. That way, state agencies can correct some of the regulatory imbalances discussed in chapter “The ‘Myth’ of Patent Justifications: Triumph and Failure Dichotomy in the North and South.” A human rights-based patent paradigm will also promote co-existence (i.e., a measured balance) between the protection of patent rights and the protection of the fundamental right to health in SSA.
C. Co-existence Between Patents and Human Rights
The third intersection between patent law and human rights adopts a co-existence approach. This co-existence approach is based on the axiom that every human right has an economic substratum. Without that economic substratum the right cannot possibly exist in practical terms, no matter how grounded its theory might be.50 Likewise, patent law is relevant to the realization of the right to health because it provides the economic/juridical substratum for regulating pharmaceuticals, which grease the wheels of life. In this sense, patent law and human rights law share a common social goal of promoting access to medicines and enhancing human development. Thus, resolving the patent/human rights conflict in a manner which enhances access to essential medicines at prices affordable to the poor will promote coexistence between both concepts. In this regard, policy-makers must seek to achieve human rights ends through the instrumentality of patents.51
This notion that patents serve the social benefit goal of promoting access to medicines and public health has wide acceptance in international law, especially under Articles 7 and 8 of the TRIPS Agreement. Both provisions stress the need to maintain a balance between the public interest in access to medicines and the private interest in reaping pecuniary benefits from innovations. Although I will discuss the scope of the objectives (Article 7) and principles (Article 8) of TRIPS in chapter “Pharmaceutical Patents and Human Development in Sub-Saharan Africa” of this book, TRIPS must be read as permitting states to give priority to public health and human development concerns in the design of domestic patent policies. A well-functioning patent regime must help to improve the living conditions and standard of health of persons in a manner consistent with the ‘curative goals’ of human rights. For Amani, patents should exist as “rights of inclusion, participation and access that reasonably complement, rather than undermine, the realization of other human rights.”52 That way, the TRIPS Agreement will not only be seen as trade-related, but also health-related.53
More importantly, the WTO favours this co-existence approach. For instance, the Appellate Body has ruled that the WTO Agreement should not be read in isolation from public international law.54 This decision is congruent with suggestions that the WTO should apply the entire corpus of international law, including human rights norms in its dispute resolution mechanism.55 The drawback in the WTO’s approach, however, is that the organization tends to limit itself to the use of the built-in ‘flexibilities’ under TRIPS to promote public health. As I will elaborate in chapter “Pharmaceutical Patents and Human Development in Sub-Saharan Africa” of this text, this limited worldview of the WTO distorts the organization’s understanding of the public health debacle confronting countries in SSA, the region worst affected by the HIV/AIDS, malaria, and TB epidemics. For Stiglitz, the WTO’s notion of flexibilities is tantamount to a blind appreciation of the “inflexibilities in [the] flexibilities” under TRIPS.56
From a different perspective, the Report of the UN Secretary General has concluded that “the TRIPS Agreement also promotes other values deemed essential for the realization of human rights.”57 Those values include TRIPS’ rules against discrimination and the requirement of due process. This supposed complementarity between human rights and trade law has emboldened scholars to posit that violators of human right are also WTO rule violators.58 A less radical proposition, however, is that WTO law must be interpreted consistently with universally recognized human rights. The interactions between human rights law and patent law would generate promising results if each were viewed as complementary to the other. However, the issue is not only that we must protect public health, but also how to go about it in order not to stifle innovation and research into epidemics afflicting the masses in SSA.
D. The Role of Patents in the Access Landscape
The above analysis of the intersections between patents and human rights law only represents the general story. The specific aspect of the story comes from scholars who contend that the problem of access to medicines to combat HIV/AIDS, malaria, and TB epidemics in SSA cannot be attributed to patents.59 The thrust of this argument is that “the impact of patents is de minimis: 95 per cent of the WTO’s essential drugs have never been or are no longer patented and most AIDS, malaria, or tuberculosis medication is not patented in the countries that are hardest hit.”60 For example, a study by Attaran and Gillespie-White in 2001 concluded that since most antiretrovirals were not patented in Africa (except South Africa) patent protection was not a major barrier to access.61 This study is often (mis)-interpreted as supporting claims that patents do not hinder access to medicines in SSA.62 Further, the argument goes that in several African countries essential medicines are not patented. Alternatively, some pharmaceutical companies do not enforce patents on their essential medicines in SSA.63 For his part, Gervais contends that since many countries in SSA need not adopt pharmaceutical patents until 2016, such countries have the latitude to utilize the flexibilities within the WTO system to supply medicines to their citizens.64 Thus, the problems of access to medicines in SSA are exacerbated mainly by the lack of manufacturing capacity, non-existent distribution and delivery networks, and the absence of political will in less developed countries.
The assertion that patents are a de minimis contributor to the lack of sufficient access to medicines to alleviate human suffering in SSA is misplaced, however. First, the Doha Ministerial Declaration, the Doha Declaration, and the ‘August 30’ Decision confirm that patents on pharmaceuticals are a key factor in the lack of access to medicines in less developed countries.65 These post-TRIPS developments acknowledge the inhibiting effects of patents on access to medicines and also urge states to place the public health interests of their citizens above the private interests of pharmaceutical companies. As net importers of patented and generic medicines, SSA countries, like other less developed countries, spend as much as 70 % of their health budgets on medication as compared to 15 % spending on medication by the developed world.66 Yet still, millions of people in SSA do not have access to medications due to the high prices of medicines.
The WHO, for instance, cites the high cost of medicines as a major hurdle that countries face in obtaining access to medication.67 This viewpoint is confirmed by the WHO-Health Action International survey which has predicted that essential medicines will be very expensive and not universally available due to the prevailing patent regime.68 Thus, on the preponderance of the empirical evidence, the major impediments to access to essential life-saving medicines are the strong global patent rules and the new trade-related barriers that are being erected to stifle the pipeline of drugs to African countries.69 Accordingly, proposals have been made to the Council for TRIPS to extend the list of exceptions to patentability in Article 27.3(b) of TRIPS to include the WHO’s essential drugs list in order to enhance the public health principles established in Article 8 of the TRIPS Agreement.70
Second, a number of strategies that hitherto allowed states to scale up access to medicines are no longer an option under TRIPS. As Hestermeyer aptly puts it, “cheap generics can only be manufactured where the medication is not protected by patents.”71 The fact that all countries with manufacturing capacity have become TRIPS-compliant since 2005 has significantly altered the access landscape. Major generic suppliers such as India, Brazil, and China now comply with TRIPS, a post-2005 development that renders the continuing validity of the study by Attaran and Gillespie-White questionable. The trend, according to Stiglitz, is that big pharma have resorted to a vigorous campaign to impede generic companies from manufacturing drugs that drive down the prices of brand name medicines.72 Illustrative of this new protectionism is the recent seizure of generic medicines bound for developing countries by the Netherlands government, a move that incurred the displeasure of the governments of India and Brazil.73 Another seizure affected the shipment of 49 kg of abacavir sulphate—a generic antiretroviral drug—by Dutch customs officials on the grounds that the drug was counterfeit and infringed patent rights.74 The medicines in question were intended to be used for treating HIV/AIDS patients in Nigeria.
Closely related to the common seizure of medicines-in-transit is the establishment of an anti-counterfeiting body called the International Medical Product Anti-Counterfeit Taskforce (IMPACT) to police cross-border shipment of IP materials.75 It needs to be mentioned that the operations of the IMPACT have come under severe criticism for its inability to distinguish between counterfeit and generic medicines. The argument is that such seizures may violate Articles 41 and 42 of TRIPS, which prohibit acts that create barriers to trade, permit abuse of rights conferred on patentees, are unfair and inequitable, and create unwarranted delays. For Outterson, the work of IMPACT forms part of a new secret anti-piracy agenda that is being used to delay global access to generic medicines.76
Third, and as a corollary, many SSA countries lack the capacity to manufacture drugs needed to combat epidemics. As such, the reluctance to patent drugs (as claimed by Attaran and Gillespie-White) in SSA countries is misleading and in fact inconsequential. Pharmaceutical companies need only obtain patents in countries with the manufacturing capacity to monopolize the world market.77 And, in reality this approach of seeking pharmaceutical patent protection in countries with the manufacturing capacities has become the modus operandi of the pharmaceutical companies. By strategically obtaining patents in all countries that have the capacity to manufacture drugs, pharmaceutical companies inhibit efforts by less developed countries to procure cheaper generics from abroad.
Fourth, the reality in SSA is that many countries have in place patent regimes for protecting pharmaceuticals, to the extent that some have been compelled to assume more obligations than the minimum standards required by TRIPS.78 This reality is not lost on some commentators who have confirmed that all but three of Africa’s LDCs have implemented laws for pharmaceutical patents as of 2004.79 Countries in SSA have acquired patent laws and patent offices as a result of processes of colonization or more recently globalization.80
Indeed, chapter “Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa” of this text shows that many countries in SSA comply with TRIPS, a fact that renders Gervais’ contention that many SSA countries need not be TRIPS-compliant merely academic. Even SSA countries that do not have patent regimes are mandated to provide what is called a ‘mailbox’ system for exclusive marketing of pharmaceuticals for 5 years in consonance with TRIPS.81 Presently, there are also in force patent rules on non-discrimination, such as the national treatment and MFN principles, to which all countries must adhere. Finally, and again, SSA countries such as South Africa that have the capacity to manufacture drugs and possibly supply medicines to other countries in the African region do not enjoy a supposed patent-free regime of pharmaceuticals. Also India, which is the leading supplier of generic drugs to the world, is TRIPS-compliant. Needless to say, the existence of strong patent systems in places where countries in SSA can procure medicines crucially affects the realization of the right to access medicine.
In short, the discussion so far drives home the point that patents and human rights are not mutually exclusive; they share similar social functions and goals. In addition, the patent system, which is the most widely used form of juridical control of pharmaceuticals, plays a significant role in matters of access to medicines in SSA. The pharmaceutical industry would not spend huge resources promoting the globalization and influencing the content of patent rules, if they did not matter.82 A strong patent system can perpetuate high prices for medicines and also hinders access to essential life-saving medicines in SSA. Conversely, a flexible patent system should thus be employed to achieve human rights ends by providing avenues for citizens to receive medical treatment. This goal can be achieved if policy-makers in SSA countries and the developed world understand their obligations to provide essential medicines to the masses affected by epidemics. The next task, then, is to provide a synthesis of the right to health obligations guaranteed in international human rights documents. Knowledge of the right to health obligations of states is not only important for the protection and enforcement of the right to health, but also crucial for patent law-making in SSA.
III. The Right to Health in International Human Rights Instruments
Many international human rights instruments protect the right to health. This protection is justified on the grounds that human beings have an inherent dignity that is inviolable.83 The major sources of authority for the international human right to health include the UDHR, the ICESCR, and the ICCPR. These human rights documents form the core of the International Bill of Human Rights; the trio obliges states to respect, protect, and fulfil their obligations to provide healthcare services to their citizens. The obligation to respect requires states to refrain from interfering indirectly or directly with the right to health. The obligation to protect requires states to take measures that prevent third parties from interfering with the right to health. And, finally, the obligation to fulfil requires states to adopt appropriate legislative, administrative, budgetary, and other measures that ensure the full realization of the right to health.84
The UDHR, though not a treaty, remains a key human rights document that guarantees the right to health at the international level. In particular, Article 25(1) of the UDHR explicitly proclaims the universal right of every person “to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services.” This declaration is complemented by other provisions in the UDHR that guarantee the right to life,85 the right to social security,86 and the right to share in scientific advancement and its benefits.87 Generally, the provisions of the UDHR serve as the model for codifying human rights protection in multilateral human rights treaties.88
Subsequent to the UDHR, the international health-related provisions have been solidified in the ICESCR in an effort to accord the right to health more normative force. In particular, Article 12 of the ICESCR obliges states to “recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.” States must achieve the full realization of the right to health by adopting measures for “the prevention, treatment and control of epidemic, endemic…and other diseases.”89 They must also create “conditions which would assure to all medical service and medical attention in the event of sickness.”90 In all this, access to essential medicines in situations of epidemics forms part of a state’s minimum core obligations towards the right to health.91 The minimum core obligations should thus be understood as mandating SSA states to adopt patent regulatory standards that are tailored to meet the access-to-medicine needs and goals of their citizens.
Recently, the ESCR Committee has significantly clarified and fleshed out the scope of the obligations attendant to the fundamental right to health guaranteed in the ICESCR.92 For instance, the ESCR Committee has interpreted the constitutive elements of the right to health to include: (a) the availability of the medication in sufficient quantity; (b) the accessibility of the medication to everybody; (c) the acceptability of treatment with respect to the culture and ethics of the individual; and (d) the appropriate quality of the medication.93 According to the ESCR Committee, a state is in violation of Article 12 of the ICESCR if it adopts “legislation or policies which are manifestly incompatible with pre-existing domestic or international legal obligations in relation to the right to health.”94 The adoption of strong patent laws constitutes such incompatible legislation.95 Also, a state is in violation of international law if that state fails to take into consideration its legal obligations regarding the right to health when entering into bilateral or multilateral agreements.96 It follows that bilateral TRIPS-plus agreements that limit the ability of governments in SSA to make use of compulsory licensing and parallel import flexibilities violate international human right obligations regarding health.
As a consequence, the ESCR Committee advises that health facilities, goods and services must be affordable for all and that poorer households should not be disproportionately burdened with health care costs as compared to richer households.97 Further, the ESCR Committee provides that a state in which any significant number of individuals is deprived of essential primary health care is, prima facie, in violation of its international obligations.98 The legal obligations regarding health require the adoption of patent systems that facilitate the supply of essential medicines to the population at affordable prices. The above interpretations should serve as a guide and a focal point for change among national legal systems in the design of patent policies that affect access to essential medicines. According to Helfer, the interpretation by the ESCR Committee has imbued the right to health, among other socio-economic rights, with greater prescriptive force.99
Furthermore, the WHO envisions that the attainment of the highest available standard of health for all people is integral to human survival. The Constitution of the WHO defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”100 The WHO emphasizes that human health is “the most important world-wide social goal whose realization requires the action of many other social and economic sectors in addition to the health sector.”101 Accordingly, “governments have a responsibility for the health of their peoples which can be fulfilled only by the provision of adequate health and social measures.”102 For Amani, a state thus has an obligation to adopt patent policies that take cognizance of issues of need, access and production of healthcare services within its jurisdiction.103 It thus follows that a state should not fear WTO complaint in adopting measures necessary to protect public health by promoting access to essential medicines.
Progressively, human rights advocates have linked the enjoyment of socio-economic rights to the enjoyment of civil and political rights. For example, the right to health has been linked with the fundamental right to life as enshrined in the ICCPR.104 The emerging thinking is that access to life-saving medicines is part of the right to life. As I show below, the constitutional jurisprudence of South Africa adopts this approach of treating the right to health as a right to life. According to the Human Rights Committee (which monitors compliance with the ICCPR), the right to life requires that states “take all possible measures to reduce infant mortality and to increase life expectancy, especially in adopting measure to eliminate malnutrition and epidemics.”105 Without access to life-saving medicines for the citizens of SSA, where epidemics are rampant, the right to life is somewhat meaningless. As Nnamuchi aptly notes, “to contend that an individual possesses the right to life in the absence of the ingredients necessary for its sustenance (such as health care) is, on many levels, vacuous.”106 A related point is that the right to life is so recognizable by the international community that it has become jus cogens, a peremptory norm of international law.107 Therefore, interpreting the right to life to include access to life-saving medicines imbues the latter with especial normative value from which no derogation must be permitted in situations of epidemics. These interpretations thus re-affirm the notion that the concept of human rights is indivisible, interrelated and interdependent.
Finally, there are also other international human rights documents that recognize the right to health. These human rights instruments include, inter alia, the UN Charter (Articles 1, 55 and 56), the UN Convention on the Rights of the Child (Article 24), International Labour Organization Convention No 169 (Article 25), and the International Convention on the Elimination of All Forms Racial Discrimination (Article 5).108 A detailed analysis of these human rights documents fall outside the parameters of this book. Suffice it to say that they re-enforce the emerging thinking that states must protect and enforce the social rights of individuals. Moreover, the recent adoption of the Optional Protocol to the International Covenant on Economic, Social and Cultural Rights,109 when in force, will allow persons to petition the ESCR Committee about the violation of the right to health under the ICESCR. The procedure for challenging an alleged violation of the right to health via the ICESCR Protocol is similar to that of the ICCPR Protocol.110 This latter Protocol has long been used to investigate alleged violations of civil and political rights of individuals. The ICESCR Protocol will likely contribute to resolving some of the controversies surrounding the justiciability of socio-economic rights in human rights jurisprudence.
IV. The Right to Health in the African Context
Regional human rights instruments, such as the African Charter, provide additional impetus for SSA countries to protect the right to health. The African Charter states that “every individual shall have the right to enjoy the best attainable state of physical and mental health.”111 This Charter also provides that state parties shall take the necessary measures “to protect the health of their people and to ensure that they receive medical attention when they are sick.”112 As I show below, the right to health obligations under the African Charter are interlinked with other supervisory and monitoring mechanisms to ensure compliance by states.
Presently, 53 countries, including those in SSA, are parties to the African Charter. These countries have thus undertaken to adopt legislative or other measures to give effect to the right to health, among other fundamental rights, guaranteed under the African Charter.113 The African Charter also implores states to pay particular attention to the basic right to development.114 Given the strong links between improving the basic health of a country’s people and improving its developmental prospects, SSA countries are required to provide life-saving medicines to their citizens. Conversely, a state is in violation of its obligations under the African Charter if it adopts patent regulatory and institutional frameworks that stifle access to life-saving medicines for its citizens.
The right to health obligations guaranteed in the African Charter has recently become a subject matter of litigation before the African Commission, which has the mandate to interpret the African Charter to protect and promote human rights. In Social and Economic Rights Action Centre and the Centre for Economic and Social Rights v Nigeria 115 a communication was filed by the applicants on behalf of the people of Ogoniland, citing, alleged violations of the right to health and the right to a healthy environment through oil exploration activities by Shell Petroleum Development Corporation with the connivance of the Government of Nigeria. The African Commission found, inter alia, that the government of Nigeria had violated the right to health and the right to life of the people of Ogoniland by not insisting on environmental impact studies prior to allowing an oil exploration and by failing to monitor the project.116 The African Commission observed in paragraph 53 of its decision that,
Government compliance with the spirit of Articles 16 [right to health] and 24 [right to clean environment] of the African Charter must also include ordering or at least permitting independent scientific monitoring of threatened environments, requiring and publicising environmental and social impact studies prior to any major industrial development, undertaking appropriate monitoring and providing information to those communities exposed to hazardous materials and activities and providing meaningful opportunities for individuals to be heard and to participate in the development decisions affecting their communities.
Subsequent to the SERAC decision, the government of the Gambia was found to have violated human rights norms for protecting persons who are mentally ill or disabled under the Mental Health Acts of the Republic of the Gambia.117 In paragraph 80 of its ruling, the African Commission noted that the enjoyment of the right to health is vital to all aspects of a person’s life and well-being, and is crucial to the realisation of all the other fundamental human rights and freedoms. Without doubt, both decisions demonstrate that socio-economic rights under the African Charter are justiciable and for that matter enforceable against governments.118 Further, the recent coming into force of the Protocol on the Establishment of an African Court on Human and Peoples’ Rights 119 will provide additional avenues for individuals to seek remedies for alleged violations of the right to health, among others socio-economic rights, in SSA.
Finally, several other sub-regional instruments touch on the right to health in SSA. These human rights-supportive instruments include: the constitutive treaties of ECOWAS,120 SADC,121 and the EAC.122 The constitutions of these sub-regional bodies make specific references to the promotion and protection of human rights as the foundations for the enhancement of economic integration. In addition, SSA countries have adopted specific Protocols to strengthen and enhance the right to health in domestic jurisdictions. For example, the Charter of Fundamental Social Rights in SADC, 2003,123 the SADC Protocol on Health,124 and the Protocol Establishing the ECOWAS Community Court,125 all in various forms mandate SSA countries to protect the right to health, by combating HIV/AIDS and other epidemics. However, it remains to be seen whether these measures will be sufficient to tackle the threats posed by the HIV/AIDS, malaria, and TB epidemics in SSA.
A. Global Commitments to Healthcare and the Status of the Right to Health
The foregoing discussion of the right to health in transnational law demonstrates that a state’s obligation to respect, protect and fulfil the right to health is not only morally imperative but also legally enforceable. In implementing WTO patent rules, governments bear a strong responsibility to guarantee healthcare to their citizens. Without purporting to lessen the responsibility of governments to provide healthcare to their citizens, a trend is emerging toward recognizing the responsibilities of private actors in the health sector (including pharmaceutical companies) to adopt policies that promote access to medicines for the public.126
Furthermore, global commitments with respect to access to life-saving medicines in national health emergencies support the point that the right to health has become a general principle of law from which no derogation is encouraged.127 Hestermeyer chronicles a number of measures by states and international agencies across the globe to combat epidemics, namely, HIV/AIDS, malaria, and TB, as supportive of the claim that the right to health has attained the character of general principle of law.128 For instance, there is presently in place a UN Global Fund to Fight AIDS, Tuberculosis and Malaria, a public/private partnership designed to attract, manage and distribute resources to mitigate the impact of these pandemics.129 The WHO has also canvassed support for increased research into tropical diseases such as the HIV/AIDS, malaria, and TB epidemics, and has further highlighted the role of patents in global health inequity.130 In addition, the World Bank, the US President’s Emergency Plan for AIDS Relief (PEPFAR), the Clinton Foundation, and the European Union (EU), have all financed the procurement of health related products to treat epidemics in Africa. To some degree, these access support initiatives show the willingness of western governments and other philanthropic organisations to contribute to the provision of medicines to countries in need. Nonetheless, giving aid to provide medicines to SSA countries is different from revising patent rules and policies with a pro-poor and pro-health emphasis so that medicines will be more affordable and accessible in the future.131
Also, there is an ongoing initiative by the international drug agency UNITAID132 to establish a patent pool to boost innovation in and access to antiretroviral medicines. This initiative involves bringing a number of patent rights together so that they become available on a nonexclusive basis to manufacturers and distributors of medicines, in return for the payment of royalties. Patent pools facilitate generic competition and access, by allowing voluntary licences from two or more patent holders so that third parties do not have to go to all patent holders individually.133 Pools also serve as an effective mechanism for financing research and development of medicines. Indeed, co-funding medicine research and development costs, through a patent pool, will make it easier for generic manufacturers to enter the market and also give sufficient voice to governments in matters pertaining to drug pricing to promote access.134 Patent pools can also provide mechanisms for free sharing of technical information relating to pharmaceutical patents and lead to a more effective and efficient allocation of limited resources.135
In the specific case of SSA countries, there are several domestic initiatives to combat HIV/AIDS, malaria and TB epidemics. Some of these measures include but are not limited to: South Africa’s policy to supply antiretrovirals to pregnant women to prevent mother-to-child transmission of HIV. In the South African situation, the government was even compelled by the Constitutional Court to make the program available in all public health institutions.136 Also, the South African Medicines and Related Substances Control (Amendment) Act, 1997: (1) promotes parallel imports of patented medicines in order to reduce drug prices, (2) compels pharmacists to dispense cheaper generics, unless otherwise requested by the doctor, and (3) establishes a pricing committee to supervise local drug pricing by big pharma.137 The South African government has also successfully negotiated and signed voluntary licenses with GlaxoSmithKline and Boehringer Ingelheim for increased availability of pharmaceutical products. As Yu has remarked, South Africa has been “instrumental in putting the access-to-medicines issue on the human rights and public health agendas.”138
Another domestic initiative is Botswana’s National Policy on HIV/AIDS (1998) and the National Strategic Framework for HIV/AIDS, which support (1) the initiation of Isoniazid Tuberculosis Preventive Therapy (ITP) for HIV-positive patients, (2) the introduction of a Prevention of Mother to Child Transmission (PMTCT) program,139 and (3) the prevention of HIV infection. There is also a joint initiative program—the African Comprehensive HIV/AIDS Partnership—between the government of Botswana, the Bill & Melinda Gates Foundation and Merck & Co Inc that seeks to support and enhance Botswana’s response to the HIV and AIDS epidemic through a comprehensive approach to HIV/AIDS and TB prevention, treatment, care and support and impact mitigation.140
Kenya has also initiated a project to produce generic medicines.141 This initiative, when implemented, will permit Cosmos Pharmaceuticals to supply cheaper generics to the East African market, which includes Burundi, Rwanda, Tanzania and Uganda. This comes against the backdrop of the fact that Boehringer Ingelheim has pre-empted the Kenyan process by entering into a voluntary license with Cosmos to produce generic versions of medicines in question. Further, despite the challenges to the use of compulsory licensing mechanisms in SSA, countries such as Ghana, Zambia, Mozambique and Zimbabwe have all resorted to compulsory licensing or government use for purposes of scaling up access to life-saving medicines for their citizens.142
Ghana also operates a national health insurance scheme under its National Health Insurance Act, 2003 (Act 650). This scheme seeks to provide basic healthcare services to persons resident in Ghana through a mutual and private health insurance schemes. The public option allows poor households to buy into a mutual health scheme in order to have access to medications, including some of the medicines described by the WHO as essential. Presently, an adult pays about US$100 and children pay about US$30 per annum as fees for access to basic healthcare. It must however be pointed out that the scheme does not cover access to antiretroviral medicines. Also, recent developments have doubted the sustainability of the Ghana health insurance scheme.143 There are also national treatment programs in Burkina Faso, Central African Republic, Malawi, and Swaziland that rely heavily on generic medicines from India.144 It must suffice here to say that several studies have well documented the existence of national health programs in SSA countries that are geared towards scaling up access to essential medicines and combating pandemics, namely, HIV/AIDS, malaria, and TB.145
The evidence thus far supports the emerging thinking that essential medicines must be made available to the poor in situations of epidemics. Given the threat posed by the escalating HIV/AIDS, malaria, and TB epidemics, access to essential medicines has become a worldwide priority. And, recent states’ practices and global strategies to combat epidemics suffice to support a customary international law norm guaranteeing access to life-saving medicines in the face of national health emergencies, such as HIV/AIDS, malaria, and TB epidemics.146 Collectively, human rights instruments, state practice and global initiatives to combat epidemics have arguably propelled the right to health into the category of general international law norm, a clear manifestation of the global recognition of the right to health.147 As I elaborate below, this global recognition of the right to health has given additional boost to the content and status of the right to health in national constitutions in SSA.
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