Poku AduseiPatenting of Pharmaceuticals and Development in Sub-Saharan Africa2013Laws, Institutions, Practices, and Politics10.1007/978-3-642-32515-1_2© Springer-Verlag Berlin Heidelberg 2013
Exploring the Conceptual Domains for Patent Discourse in Global Trade Relations
(1)
Faculty of Law, University of Ghana, Accra, Ghana
Abstract
As mentioned in chapter “General Introduction and Overview”, the possibility of promoting social benefits through patents is highly debated by scholars and researchers. This debate has elicited calls for steps to be taken to make the globalized patent legal regime more equitable in order to scale up access to medicines to treat pandemics in poor regions such as SSA. The debate evidences the re-directed focus of international patent discourse from one concerned with ‘pure’ free trade to a discourse that also considers public health and development. This chapter revisits the discourse about pharmaceutical patents and also nuances that debate in the context of a quadripartite framework of patent laws, patent institutions, patent practices, and patent politics.
I. Introduction
As mentioned in “General Introduction and Overview”, the possibility of promoting social benefits through patents is highly debated by scholars and researchers. This debate has elicited calls for steps to be taken to make the globalized patent legal regime more equitable in order to scale up access to medicines to treat pandemics in poor regions such as SSA. The debate evidences the re-directed focus of international patent discourse from one concerned with ‘pure’ free trade to a discourse that also considers public health and development. This chapter revisits the discourse about pharmaceutical patents and also nuances that debate in the context of a quadripartite framework of patent laws, patent institutions, patent practices, and patent politics.
In consequence, Part II of this chapter introduces the contentious debates between proponents and opponents of pharmaceutical patents at the WTO and in policy and academic discourse. It concludes that the literature and policy discourse on patents would further be enriched if viewed through the prism of laws, institutions, practices, and politics, both at the domestic and at the international levels. Doing so would also provide a more reliable way to evaluate the globalized pharmaceutical patent system and its domestic prototypes in SSA. Part III then discusses in detail the conceptual and operational interconnections between patent laws, patent institutions, patent practices, and patent politics, and explains how they tie in with the other chapters of this book. The final Part IV concludes this discussion.
II. On Patents and Conflicts
Patents have become a new regulatory frontier in the quest for sustainable human development in SSA. Pharmaceutical patents in particular have evolved into a strongly protective mechanism for biotechnology innovators in the global economy; patents involve the grant of a legal monopoly to patentees (which include many pharmaceutical companies), thereby preventing others from using, making, selling or importing the patented product or process (or their hybrid) for a set period of time within a jurisdiction. This grant of patent monopoly makes the cost of access to essential medicines, under the ubiquitous liberalized trade regime, prohibitively expensive for the most needy consumers of pharmaceuticals in parts of Africa. In consequence, scholars and commentators have had mixed reactions to the suitability of the globalized patent regulatory framework as it relates to SSA.1
On the one hand, critics have accused the patents regime of placing private property rights over public access goals, and have, as a result, failed to make life-saving medicines available to those who need them the most.2 Heller for his part argues that patents contribute to the reduction in the capacity of the pharmaceutical industry to generate new products.3 In support of this assertion is a 2006 Report by the US Government Accountability Office which has concluded that the “current patent law discouraged drug companies from developing new drugs by allowing them to make excessive profits through minor changes to existing pharmaceuticals.”4 This prognosis is worrisome given that millions of people die from diseases largely because they are unable to afford life-saving medicines in SSA.5 For many in SSA, access to medicines to combat diseases such as HIV/AIDS, malaria, and TB can be the difference between life and death.6 Cullet’s conclusion is that “[patents] derogate from the principle of free trade by offering exclusive rights to an inventor to use the invention and to stop others from using it without his/her consent.”7 Therefore, for critics of pharmaceutical patents, the grant of an exclusive right of exploitation to a patent is prima facie incompatible with the public welfare ideals of the concept of free trade.8
In stark contrast to the above criticisms, proponents of private property rights concerns justify the grant of exclusive rights over pharmaceutical patents in the market-place. Their argument is that granting monopolistic rights over inventions incentivises innovative research and development (R&D) for the benefit of society.9 For example, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) argues that “without patent protection, the world would have been deprived of the innovative medicines which have saved countless of lives.”10 This property rights justification has also been framed in terms of the international benefits to be derived from granting robust patent protection to pharmaceuticals. International documents such as TRIPS further assert that the grant of exclusive patent rights over pharmaceuticals will eliminate trade barriers and foster international trade.11
A more moderate position is that researching and developing a new product should draw inspiration from the social environment.12 Therefore, claiming robust protection for inventions may create short term benefits for the patent holder, but in the longer term is likely to create social inequities and imbalances.13 As Gold et al. poignantly observe: “the recognition that innovation is a social, collaborative phenomenon changes the way that policy-makers, researchers, industry and technology consumers ought to view and appreciate IP: as something to be shared and built upon rather than as something to accumulate for its own sake.”14 Herder and Gold further write that “even if we are willing to accept that IP rights (especially patents) provide a necessary incentive for biotechnology companies to engage in an R&D process, it is unmistakably clear that they are insufficient incentives to address the particular health and industrial needs of the world’s poor.”15
In this book, I adopt the perspective that this “extension of property rights to fruits of mental exertion has, in and of itself, the entire gamut of the characteristics of western liberal political ideology of freedom, individualism, capitalism, and free market economics.”16 It is a neoliberal expression of property rights, which imposes western knowledge systems over southern countries’ knowledge and cultural values.17 The pursuit of western ‘economism’18 and the propertization of various forms of knowledge can thus be blamed for the plight of people in the global south.19 In this respect, the grant of protection to IP rights, for instance, is criticized as a protectionist measure that neglects the fact that countries entering into the international trading system are at different stages of development.20 Thus, unrestrained commoditization of IP rights is viewed as insensitive to the needs of people in third world countries. This continuous drift away from the raisons d’être of patents (i.e., to promote social benefits) raises fundamental questions which challenge the legitimacy of the neoliberal approach21 to pharmaceutical patent protection in the global economy.
Scholars and researchers have waded into the debate, and are equally divided over pharmaceutical patents and their implications for access to medicines in poor regions affected by epidemics. Discussions on patents, access to medicines, human rights and development continue to occur across a vast range of academic disciplines, including law.22 Naturally, while some of the discourse on pharmaceutical patent regulation and development has been progressive, other aspects of the discourse have been slow-paced. It is, however, safe to say that this growing attention from scholars opens new vistas for fresh dialogue over the impact of the globalized legal order on human development needs in SSA, as well as a minefield on which one needs to tread cautiously. It is also worth emphasizing here that any perceived disconnectedness between pharmaceutical patents, development, human rights, and poverty-related issues has now decidedly abated.
Also, notwithstanding ideological differences and the lack of precision about the impacts of pharmaceutical patents on access to medicines in SSA, one thing is certain: that imposing barriers to access medicines to treat pandemics is detrimental to human development and progress. Patents are more than a de minimis contributor to the lack of sufficient access to medicines to alleviate human suffering in SSA.23 As Fisher and Syed put it, there are strong links between improving the basic health of a country’s people and improving its development prospects.24 Thus, putting aside arguments for or against the grant of exclusive property rights over pharmaceutical products and processes, there is an increasing recognition of the nexus between patent rules and the role of access to medicines in promoting development. By virtue of their intimate relatedness, pharmaceutical patent regulation and progressive development principles are now considered as complementary pillars for human subsistence, warranting serious examination.
A major drawback to entering this discussion is that much of the pharmaceutical patent regulation and development discourses are enveloped in a complex conceptual and analytical quandary.25 The literature and policy discourse on patents are not fully informed by the nuanced perspectives of laws, institutions, practices, and politics that help shape the direction of the globalized patent regime. Although a number of critiques have addressed the excesses of the globalized pharmaceutical legal order, they fail to suggest mechanisms as to how those excesses could be remedied.26 Also, many of the theoretical conjectures contained in the literature lack concrete evidentiary support.27 Additionally, much scholarship has focused on the developing world as a whole and does not examine regions specifically.28 Thus, some of the real impacts of pharmaceutical patents on human lives in SSA, as the world’s poorest region,29 have been missed. This fact is even more concrete in countries in SSA that are technologically deficient. As one commentator crudely expresses it, “the saying goes that if one cannot invent, at least one can copy. For many sub Saharan countries, copying technologies for producing antiretroviral treatment (ARVs) remains a distant aspiration.”30
In light of these lacunae, this text urges the need to ground international patent discourse within the conceptual frameworks of laws, institutions, practices, and politics. It implies drawing from the nuanced perspectives of laws, institutions, practices, and politics to help comprehend fully the intricate domains for regulating pharmaceuticals in the marketplace. In consequence, this text employs the concepts of laws, institutions, practices, and politics as a methodological guide in evaluating the globalized pharmaceutical patent system and its domestic prototypes in SSA. As I explain in depth below, an examination of the regime of patents in light of this quadripartite framework gives a sound grounding to the discourse on patents within the world trading system. It also brings to the fore the various inequities inherent in the globalized patent system as regards the protection of pharmaceutical products and processes. By providing a holistic explanation as to why the globalized pharmaceutical patent regulatory framework is dysfunctional, one can conveniently suggest mechanisms to get out of that quagmire.
A. Towards an Informed Patent Discourse
This section takes up the argument that drawing from the nuanced perspectives of laws, institutions, practices, and politics makes our understanding of pharmaceutical patent protection more precise and reasoned. The reason/justification for this assertion is that the regime of patents does not function in isolation; the workings of the regime of patents implicate a gamut of legal, institutional, practical, and political developments, both at the national and international levels. The quadripartite domains of laws, institutions, practices, and politics form the bedrock of the innovation system by dictating “the type of results that we want as against those that we do not want.”31 Hence, the concepts of laws, institutions, practices, and politics provide formidable foundations for any research that seeks to appraise the workings of the globalized patent system and its reflections in domestic jurisdictions. It follows that one cannot adequately evaluate the impacts of the regime of patents on societies without analyzing the legal, institutional, practical, and political dynamics involved in patent law- and policy-making. Similarly, the conceptual and operational dynamics of laws, institutions, practices, and politics should serve as foundations for making nuanced arguments for pharmaceutical patent reforms at the WTO and in policy and academic discourse. Although such nuanced perspectives may not completely eliminate controversies, they can provide an enriched understanding of patents.
This suggestion for a broad-based re-conceptualization of patents is further supported by the International Expert Group on Biotechnology, Innovation and Intellectual Property (IEGBIIP). According to the IEGBIIP, the conceptual and operational interconnections between laws, practices, institutions, and politics 32 provide
[a] comprehensive way to examine how IP affects knowledge production, sharing and use within biotechnology innovation system. It points to ways in which laws, practices, and institutions confirm one another, such as when patent offices do a good job of applying the legal criteria of what constitutes an invention. It also shows how these laws, practices, and institutions can complement one another, for example, when broad infringement by researchers is tolerated by patent holders in order to offset what would otherwise be a harsh rule.33
Further, the IEGBIIP avers that the use of such multi-disciplinary perspectives as foundations for pharmaceutical patent regulation helps to anticipate/pre-empt potential pitfalls. This is because laws, institutions, practices, and politics can “contradict one another, as when the high cost of litigation undermines the ability of a user to invalidate a patent that should never have been granted in the first place.”34 It goes without saying that the influences of the various components of this quadripartite framework are mutually reinforcing; they provide a more reliable way for evaluating the globalized pharmaceutical patent system and its domestic prototypes in SSA. In consequence, viewing patent regulation through the prism of laws, institutions, practices, and politics offers a complete understanding of the global pharmaceutical patent norm making endeavours.
Specifically to this text, the use of the above quadripartite framework has several benefits. First, it provides a comprehensive foundation to analyze pharmaceutical patent regulation and development from the perspective of the world’s poorest region which previous researchers and academics have not undertaken. It helps to unmask systemic developments that have created and perpetuated the prevailing regulatory system over a period of time, rather than viewing it as a single/autonomous phenomenon. Indeed, the current state of pharmaceutical patent protection reflects deep rooted actions of hegemonic states and their pharmaceutical corporations that have evolved over decades. Therefore, being cognizant of the processes of domination that have culminated in the globalized product/outcome is crucial to prescribing solutions for the present oligarchic maladies.
Second, the quadripartite framework allows for human rights and development-oriented concepts, which are scattered throughout the legal, political, economic and historical discourses, to be invoked to inform both domestic and international policies respecting pharmaceutical patent regulation. It provides an entry point for making a case for the integration of human development considerations into global and national patent law- and policy making. Also, drawing from such multidisciplinary sources portrays a holistic picture of the problems confronting people who lack access to basic health care in parts of Africa. In the particular case of this text, I draw from non-legal sources because studies about the negative repercussions of pandemics such as HIV/AIDS, malaria, and TB take place across a vast range of academic disciplines other than law.
Third, relying on the quadripartite framework exposes the reality that the international and domestic pharmaceutical patent regulatory arrangements are not devoid of politics and other western economic influences. There are established domestic and international actors who, in some cases, hold entrenched positions against the south on matters of global economic law making. Some speculate that ardent protectionists (disguised as trade liberalists) lurk behind the international scenes and pull the strings during deliberations which border on pharmaceutical patent policies; they frustrate efforts to make the globalized pharmaceutical legal order more equitable for people of the global south.35 For his part, Chen notes that appeals for the complete elimination of inequities in the international order are blocked and confounded by western powers, which have sought to maintain established neo-colonial hegemony in international politics.36 A divergent viewpoint, however, is that generally less developed countries accept global trade arrangements because they serve their interests.37
And fourth, employing the concepts of laws, institutions, practices, and politics provides an informed basis for making a case for pharmaceutical patent regulatory reforms, if there is any hope of achieving human development in SSA. Considering issues from multiple perspectives of laws, institutions, practices, and politics will allow for multi-pronged reform strategies to be devised in tackling patents and human development challenges in Africa. Additionally, it allows for the coordination of domestic and international strategies in order to ensure greater participation of countries in SSA in international patent law making. Suffice it to say that an in depth explanation (as done below) of the domains of laws, institutions, practices, and politics will further highlight the benefits of using this quadripartite framework to inform any discourse on patents and development.
What then are the nuanced-components of this quadripartite framework? I turn now to discuss each of its four components and explain how they tie in with the other chapters of this book.
III. Explaining Laws, Institutions, Practices, and Politics as the Conceptual Domains for This Text
A. Law in a Global Economy
Like most of the discourses on patents, this text seeks to understand the impact of law on society. It treats ‘international patent law’ as law properly so-called. In so doing, I am aware that the nature of the interaction between law and humans is ambiguous and unclear, especially as to how the former regulates the acts and omissions of persons in society. Suffice it to indicate that the discourses of the efficacy of law in solving human problems, and why people obey the dictates of law is an ongoing discussion.38 How does law (i.e., international law, domestic law, regulation) that merges into different iterations of one norm in patent law affect humans? The salient point is that for a law to be effective, it must express societal standards accurately,39 and the globalized pharmaceutical patent regime is no exception. It is for this reason that this section critiques the TRIPS Agreement, which has become an instrument for the globalization of patent norms in both developed and developing countries alike.
Further, the question as to whether international law is law properly so-called remains a site for debate among scholars and commentators. Austin, for instance, is renowned for defining law as the command of the sovereign backed by threats of sanctions.40 According to him, international law is no law because it does not emanate from a single sovereign. He observes that positive laws (as law properly so called) are unilaterally set by political superiors for political inferiors.41 Bork makes a similar claim to the effect that international law is only politics.42 As I discuss below, both the Austinian and the Borkian claims are highly contestable.
Notwithstanding its shortcomings, international law is both law and politics. Indeed, it is difficult to disagree with the counter-Austinian discourses which regard international law as law properly so-called.43 After all, people comply with international law like most national laws. As Oppong ably demonstrates, the legal subjects of ‘community laws’ in Africa comply with the requirements of supranational law because of the benefits that compliance brings, rather than any inherent force of the law or sanctions attached to it.44 What guarantees compliance with the dictates of law among persons in society is the faith that policy-makers vest in it.45 Perhaps, more accurately, law’s imperatives are not triggered by any gunman’s situation writ large, as there are many instances where the law does not involve a command. But, “in this dialogue of patent laws, powerful states and important global actors, mainly from the United States, have [had] the capacity to influence the trajectory of patent laws in less powerful states.”46
Yet another basic understanding of law is Hart’s conclusion that the acceptance of a rule finds expression when viewed from an ‘internal perspective’, and not on the basis of any moral justification.47 By contrast, Dworkin considers the application of a legal rule to specific facts as the foundation for unearthing its specific consequences.48 And, the success or failure of any legal system (both domestic and international) is reliably measured by the future and not the present.49
The globalized pharmaceutical legal order is animated by similar complex ideals; the legal rules of domestic and international patent law define the formal relationships between players within the industry. As it is, the rules seek to promote legal and regulatory coherence among nations and institutions. Presently, the rules are being harmonized and/or globalized, even though such an approach is not needed. The globalized patent rules have thus circumscribed the ability of policy-makers to tailor patent protection to address social needs in the domestic context.50 In consequence, the internationalization of law and its corresponding domestication renders discourses about whether international law is ‘law properly so-called’ to be a superfluous academic exercise. In a globalized world, national patent laws have become increasingly subservient to supranational law, including WTO rules, such that there is difficulty in distinguishing the two. International patent law now functions almost like domestic law. In that sense, international patent law is also law.
This blurring of the lines between international patent law and domestic patent law (traditionally recognized as law properly so-called) is emblematized by the TRIPS Agreement of the WTO. TRIPS, one of 28 agreements of the Uruguay Round’s Final Act, marked the beginning of the global property epoch51; it forms the bedrock of the globalized pharmaceutical patent regulatory regime. As Drahos succinctly expresses it this universalist conception of the one patent system has to some extent gained practical expression in the project of patent harmonization under TRIPS.52 As such, the contours of pharmaceutical patent protection under TRIPS in relation to those across WTO member-states are significantly uniform. The reason is that the international regulatory framework introduced by TRIPS drives the domestic systems.
TRIPS itself incorporates earlier pro-harmonization treaties such as the Paris Convention,53 the Berne Convention,54 the Rome Convention,55 and the IPIC Treaty,56 all of which protect diverse IP rights. These property right treaties have substantially lifted IP matters out of the province of domestic law and subjected them to the control of international law.57 And, through TRIPS, SSA states have further been insulated from exercising their national prerogatives over matters of pharmaceutical patent protection and policies. In addition, recent bilateral and regional trade agreements have imposed further obligations on countries in SSA to protect pharmaceutical products and processes.58
Presently, the TRIPS provisions relating to patents are laid down in Articles 27–34. These provisions oblige states to provide effective and adequate protection and enforcement procedures against the infringement of patent rights.59 TRIPS also requires that states comply with standardized administrative rules and procedures. Also, far-reaching are provisions that required compliance with the national treatment and most-favoured-nation principles.60 These provisions, as will be shown, grant exclusive protection to pharmaceutical products and processes by putting private interests before the public good. Thus, exclusive patent protection measures mean that there would be increased demands for royalty payments by private rights holders in return for access to essential medicines.
In addition, TRIPS allows states to grant protection for medicinal test data, thereby creating an additional form of monopoly for data needed to obtain marketing approval for medicines.61 To this end, all new health related products and processes, such as medicines, vaccines and diagnostics, are enclosed by the ‘fence’ of protection of the TRIPS-based patent framework.62 The grant of such pharmaceutical patents confers exclusive rights on the owner to make, use, sell and/or import protected medicines.63 This harmonization has thus curtailed the powers of national governments over IP rights protection and regulation. And to ensure compliance with all of these, deadlines were imposed on states as part of their trade obligations. Also, by associating IP with trade, the TRIPS Agreement effectively globalised the principles contained therein and compelled WTO members to comply with the treaty.64 In consequence, TRIPS fails to properly promote the interests of the world’s poor as a means to promote innovative and sustainable societies.65 It circumscribes the quest for regulatory diversity, by insisting on compliance with high western standards of patent protection, while at the same time ignoring matters of traditional knowledge.66
Although one cannot strictly talk about ‘international patent law’, as if there is a single legal order that regulates every action and omission of states and humans, harmonization has inched the world closer to such a phenomenon. TRIPS’ macro-management of national patent systems has rendered the principle of territoriality in patent law virtually otiose. The harmonized rules give assurance as to the rights available to the patent right-holder and also inform the right-holder about the procedures to follow to vindicate those rights when infringed. And, “as a legal matter, the failure to comply with international IP standards is punishable through the international trade enforcement mechanisms inherited from the GATT and amplified in the World Trade Organization (WTO).”67
In the province of pharmaceutical patent protection and related institutional arrangements, more than a decade and a half has passed since the WTO’s TRIPS Agreement entered into force, and states have consequently ‘embraced’ the international normative order as part of their laws. Given that the TRIPS Agreement constitutes a framework treaty which regulates matters appurtenant to international and domestic patent law, this text subjects the Agreement to a critical review to ascertain its functionality in human development discourse. The salient point to add here is that the globalization, if not imposition, of the TRIPS-based patent concepts has aroused controversies with regard to the impact on social agendas in less developed countries.
TRIPS’ North–South Dichotomization
There is a north–south dichotomy over the impact of the globalized patent rules under the TRIPS Agreement. Since entry into force, the TRIPS Agreement has generated contentious debates between developed and less developed countries at the WTO. This division has convinced Mgbeoji to conclude that TRIPS-engineered patent rules have split the world into two camps.68 As if such polarization is not enough, there is also an ongoing attempt to further harmonize patent law by WIPO in what will be referred to as ‘Substantive Patent Law Treaty (SPLT).69 The proposed SPLT seeks to harmonize the substantive requirements of patent law, including having the same definition/standards for novelty, inventive step and non-obviousness, industrial applicability and utility. Dutfield opines that, if successful, such a substantive harmonization will mean that “patent standards will be exactly the same to the extent, for example, of having identical definitions of novelty, inventive step and industrial application.”70 This proposed patent law treaty also contains relatively fewer exceptions to patentability than those contained in the TRIPS Agreement. Predictably, this so-called ‘WIPO substantive harmonization’ will generate vociferous opposition and counter-narratives. According to Dutfield, such harmonization would move the world towards a unitary patent system, which the world is not prepared for.71
More importantly, while many view the harmonization of IP rights as economically benign, others consider it socially malignant. In the extreme cases, calls have been made, and to some extent justifiably so, for the TRIPS regime to be suspended in favour of developing countries, not to mention LDCs.72 However, any suggestions for the suspension of TRIPS is not likely to receive support within the WTO system because of the potential for such acts/omissions to distort global trade governance; it is thus safe to say that the globalized patent rules under TRIPS have come to stay. Admittedly, globalization aids homogenization, but the converse is that globalization should also facilitate the flourishing of diversity.73 It is through such diversity that contradictions and conflicts can be resolved to promote harmonious north-south interdependence and co-operation in the field of pharmaceutical patent regulation and development.
Nonetheless, the depth of harmonization under TRIPS “marked a paradigmatic shift from the status quo when IP issues which hitherto were the subject matter of national laws and instruments of national and social policy were located at the World Trade Organization (WTO)-supervised international trade regime.”74 TRIPS succeeded in universalizing the scope of patent protection, enforcement mechanisms and institutional frameworks. The UN agency—WIPO, which until 1995 was principally tasked to oversee IP issues, lost its mandate over IP/trade-related issues to the WTO. The supervisory power of WIPO was viewed as too frail to demand compliance with rigorous IP standards. This phenomenon of moving international norm setting activities and treaty negotiations from one international venue (i.e., WIPO) to another (i.e., GATT/WTO75) is what Helfer refers to as ‘regime shifting.’76 The shift in the negotiations of trade-related aspects of IP norms from WIPO to the GATT/WTO was intended to enhance the powers of the US and EU and to bolster the economic fortunes of their multinational corporations.77
Besides those controversies generated as a result of the globalized patent regime, the US and the EU continue to push less developed countries to the brink of accepting higher standards of protection for pharmaceuticals (otherwise known as TRIPS-plus obligations) through ‘freer’ bilateral and investment deals. Maskus argues that the TRIPS-plus agenda eliminates discretion on the part of public-health authorities in matters of compulsory licensing, parallel imports, and generic competition.78 The question as to whether TRIPS’ globalization measures and its latter-day ‘freer’ trade deals have promoted social benefits in SSA will further be explored in this book. Suffice it to say that the TRIPS’s global benchmark of patent protection of pharmaceutical products and processes is evidence of globalization. On the flip side, forced globalization has serious implications for the pursuit of domestic social agendas in SSA. This is especially pronounced in SSA since the WTO’s globalized patent rules have not worked for the citizens of SSA countries.
Globalization and the Pursuit of Social Agendas
The prevailing pharmaceutical patent regime—emblematized by TRIPS—is the product of such a neoliberal agenda.79 The TRIPS legal framework has played a monumental role in removing national barriers and policies as regards pharmaceutical patents. This deconstruction of territorial control over pharmaceuticals was meant to “reduce distortions and impediments to international trade…and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade.”80 As shown below, governments and national institutions therefore serve as the agents to dismantle such national barriers.
Economic globalization, however, has its ardent followers and vociferous critics.81 In the field of patents, it is implicated in furthering inequalities in the global south while promoting the economic interests of big pharma in the north. Mgbeoji’s conclusion is that globalizing “strong patent regimes result in a net economic loss for the south and a net economic gain for the north.”82 While Stiglitz perspicaciously recounts “the devastating effect that globalization can have on developing countries, and especially the poor within those countries,”83 Bhagwati grandiosely contends that globalization’s perils are based on ‘“gotcha’ examples…with fears masquerading as evidence.”84 According to Stiglitz, the level of pain in less developed countries as a result of globalization is far greater than necessary. He avers further that poverty levels have increased despite the promises of human benefits from globalization; the result is that some of the poorest countries in Africa have plunged deeper into misery.85 In the field of patents, Stiglitz concludes that the TRIPS regime overwhelmingly reflects the interests and perspectives of pharmaceutical companies as opposed to the users.86 Therefore, the cries of the voiceless and the sick in Africa for greater social justice and equity have fallen on deaf ears.
In a subtle but blistering response to Stiglitz, Bhagwati posits that those who consider globalization as lacking a human face are mistaken.87 For him, globalization is part of the solution to human problems, not the problem; therefore, emphasis should be on policies to enhance, supplement, complement and accentuate globalization’s good outcomes.88 For globalization’s negative outcomes, Bhagwati does not follow up fully. Nonetheless, Bhagwati admits that IP was not a proper subject matter for the GATT/WTO to consider. For him, making IP part of the WTO was like introducing cancer cells into a healthy body: while GATT (trade in goods) and GATS (General Agreement on Trade in Services) certainly belonged in a trade body TRIPS did not. 89 IP rights are not a ‘trade issue’ as they inhibit or stifle a competitive environment.90 In explaining why TRIPS then became ‘trade-related’, Bhagwati further writes that “the corporate lobbies in pharmaceutical and software…distorted and deformed an important multilateral institution [WTO)], turning it away from its trade mission and rationale and transforming it into a royalty collection agency.”91
In light of these disagreements and the specific focus of this book on SSA, I argue that critics’ concern about the international patent regime is not a false alarm. The patent system plays a significant role in the pricing of essential medicines and thus affects the right to access medicines in SSA. For example, Novartis’ patented-medicine such as Coartem® (artemether 20 mg/lumefantrine 120 mg), which has proven effective for treating the malaria parasites in SSA, costs almost US$10 per every treatment cycle. The generic versions of the same medication (Artefan 20/120) manufactured by Ajanta pharma limited in India costs US$1 in SSA per every treatment cycle. The point here is that patented drugs are significantly more expensive than generic drugs. And this trend affects the attainment of the three basic dimensions of human livelihood, notably, a long and healthy life, knowledge, and a decent standard of living.92
In sum, within the world trading system, a case has been made that globalization from above favours the North and its pharmaceutical industries, and this trend severely limits the powers of countries in SSA to effectively help their citizens.93 The views of other scholars are far from sanguine; they dismiss as unfounded the claim that the top-down approach to globalization within the WTO has diminished the autonomy and authority of southern states.94 Lai has also expressed the view that the TRIPS minimum standards are far from being classified as global harmonization.95 He further observes that, even if that is the case, harmonizing patent protection is necessary for global economic efficiency.96
Whichever spectacles one may wear, recent developments confirm that globalization under the WTO system poses enormous challenges for the citizens in poor regions such as SSA. With efforts underway to reverse unjust paths, via the Doha Round of trade negotiations and the WIPO Development Agenda, globalists should be aware of the possible harms of globalization. Preliminary indications of such reversals are beginning to emerge and are alluded to below.
Mitigation Measures: The Doha Round?
This section articulates the point that supposed mitigation steps under the Doha Declaration, the Doha Ministerial Declaration and the WTO General Council’s ‘August 30’ Decision have yet to roll back the enormous challenges that confront policy-makers in tackling the pandemic situations in SSA. Since the 2001 Doha Round of trade negotiations, dubbed ‘the Development Round’, efforts have been made to give development agendas a more humane face in order to rectify some of the imbalances of the past. The Doha Declaration symbolizes the first global acknowledgement of the existence of serious health problems faced by less developed nations and their link to increased levels of patent protection.97 Most importantly, at the launch of Doha, the less developed countries succeeded in negotiating a mandate that had the promise of delivering a development outcome.98 This attempt at rectification of the past imbalance is partly echoed by the Doha Declaration that TRIPS “can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”99 Indeed, there was recognition of the gravity of public health problems afflicting many developing nations and LDCs, with particular emphasis on HIV/AIDS, malaria, and TB epidemics.
Also, as part of the shift at Doha, the trade ministers of the WTO member-states reaffirmed their commitment to the concept of sustainable human development.100 These declarations, however, could not roll back the adverse effects of TRIPS on public health and development programs in SSA. There are still fundamental limitations on the ‘humanitarian’ objectives of the Doha Declaration and its subsequent implementing WTO General Council Decision on August 30, 2003.101 In practice, domestic policy-makers in many SSA countries do not also understand their international patent obligations and have, as a result, assumed more obligations than legally required. As shown in chapter “Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa” of this text, the provisions on compulsory licensing and parallel imports under the patent laws of Ghana, Uganda, and Botswana are not consistent with the post TRIPS mitigation measures agreed to under the WTO system.
Further, intractable disagreements between developed and less developed countries over key issues of development in general and access to medicines in particular has stalled the progress of patent negotiations, among others. As will be further elaborated in chapters “Evolutionary Trajectories of Patents and the Politics of Exclusion in Sub-Saharan Africa” and “The ‘Myth’ of Patent Justifications: Triumph and Failure Dichotomy in the North and South,” the imposition of increased levels of IP protection in recent bilateral agreements has asphyxiated the already fragile ‘flexibilities’ under TRIPS and Doha.
In light of the above, this text will examine laws through the prism of a globalized or harmonized patent regime, implemented via TRIPS, the WIPO Development Agenda and Doha type accommodations, and assess their impact/manifestation in SSA. It will also urge the point that more needs to be done to bridge the north-south gulf if there is any prospect of achieving sustainable human development in SSA through the instrumentality of pharmaceutical patent regulatory frameworks. Though the primary focus of previous and dominant development agendas has been on neoliberal prescriptions for economic development,102 it must suffice here to emphasize that development, in the context of this book, is about improving human lives and enabling people to have access to medicines and other life-saving health care services. The fact that the globalized patent regulatory regime operates within institutional arrangements takes us to the next trigger for comprehending the domains of patent law—institutions.
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