Access to essential medicines has become the single most important issue on the agenda for policy makers in Sub-Saharan Africa (hereinafter SSA or Africa).¹ This book deals with the complex issue of whether global patent protection has had negative and devastating impacts on persons in Africa facing challenges of access to essential medicines. It focuses on the pandemic situations in SSA by unravelling some of the not-so-evident patent regulatory lapses that impede access to medicines in Africa. It underscores the point that the patent system over-relies on property rights and/or efficiency-based utilitarian justifications with little or no regard to the social importance of limits on patent rights.² Equally the patent system, which is the most widely used form of juridical control of pharmaceuticals, privileges private property interests over the public interest to deliver medicines to those who need them the most. This traditional bias in favour of private proprietary interests in turn undermines the policy objective of patent law to promote social benefits. To achieve the social benefit goals of a functional (i.e. a well balanced³) patent regulatory regime, the globalized pharmaceutical patent system should be equitable and human-development oriented. This book will explore ways to achieve this objective.

The book makes a case for re-constructing the globalized pharmaceutical patent framework to be responsive to the needs of the citizens of SSA. This reconstruction implies the infusion of the human development considerations of the world’s poor into the formulation of pharmaceutical patent regulatory policies so as to achieve sustainable human progress. It proposes a framework that meshes multiple human development principles with the globalized pharmaceutical regulatory regime, including: one that is rooted in robust human rights and progressive human development principles; one that meets human needs and shows respect for communal interests; a model that admits of differences and is amenable to change in the light of socio-economic needs; a regulatory model that confronts ‘unfreedoms’ which constrain human development⁴; one that respects principles of substantive equality, fairness and equity⁵; one that is anchored on deliberative democracy and genuine participation by countries in SSA in international patent law making⁶; and, a model by which matters of public health and needs take precedence over private property right concerns. To achieve this vision, I propose and justify the creation of additional exceptions/limitations to patents with the goal of scaling up access to medicines to treat epidemics in poor regions such as SSA. This vein of argument stresses the positive gains that can be derived from an equitable and a human-oriented approach to pharmaceutical patent regulation in parts of Africa devastated by diseases such as human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), malaria, and tuberculosis (TB).

This book does not endorse the extremist position that pharmaceutical patents should be discarded outright as that is tantamount to legal nihilism. Machlup’s oft-cited locus classicus applies: “If we did not have a patent system, it would be irresponsible, on the basis of our present knowledge of its economic consequences, to recommend instituting one. But since we have had a patent system for a long time, it would be irresponsible, on the basis of our present knowledge, to recommend abolishing it.”⁷ Perhaps, more enlightening are studies that have concluded that the international patent system is economically and socially unsound for less developed countries if an overwhelming majority of patents are granted to foreign nationals and western corporations.⁸ Viewed this way, SSA countries would be encouraged to recalibrate the TRIPS⁹ benchmarks on patents in order to address public health challenges that confront their citizens. Also, given that TRIPS—and patents—are here to stay, the globalized patent regime and its domestic prototypes must be recalibrated to serve human development needs in SSA.

What distinguishes this text from other patent and development studies¹⁰ is that I advocate including human development principles as an integral part of pharmaceutical patent protection. As a consequence, the human development concepts that are articulated in this book are universal norms that transcend differences in domestic culture and class. For instance, Baruah, in commenting on the ‘human capabilities approach’¹¹ to development, perspicaciously observes that “universal norms are actually required if we are to protect diversity, plurality and freedom, treating each human being as an active agent instead of as a means to an end.”¹² The fundamental challenges posed by diseases in SSA, coupled with the lack of access to medicines to treat same, recur across the entire region. The globalized patent rules seemingly disregard the world’s cultural diversity and social values. Therefore, the proposed pharmaceutical patent regulatory prescriptions (meshed with practical human development-oriented concepts) can ameliorate human conditions across SSA, no matter the cultural differences and domestic conditions. The proposed patent regulatory framework can co-exist with a plurality of domestic culture, politics and history in SSA.

This book focuses on three epidemics—HIV/AIDS, malaria, and TB—that have ravaged, and continue to ravage, countries in SSA. Focusing on HIV/AIDS, malaria, and TB is not accidental; the trio constitute the most fundamental threat to human survival in SSA. They have also been consistently ignored by big pharma.²⁷ They are considered as neglected/tropical diseases, if not a black man’s burden, with its racial colorations. As a consequence, big pharma do not feel obligated to supply medicines to treat ‘neglected diseases’ as they are less of a problem in the developed world.²⁸ Also, those who suffer from diseases such as malaria and TB are overwhelmingly poor, a further disincentive for pharmaceutical corporations to invest capital in medicine research and development (R&D) efforts.²⁹

The good news is that, recently, a number of global initiatives to combat pandemics have focused on these three epidemics. For instance, recent World Health Organization (WHO) initiatives have focused on finding treatments for HIV/AIDS, malaria, and TB cases in Africa, among others.³⁰ An ongoing initiative by the international drug agency UNITAID to establish a patent pool to boost innovation and access to medicines has focused on the HIV/AIDS, malaria, and TB epidemics.³¹ Further, the UN Millennium Development Goals (MDGs) advocate the need to combat the HIV pandemic, malaria and other diseases in order to ensure sustainable development. The fact that there are available statistical data about these three pandemics makes them suitable for this enquiry.

A major drawback, however, is that most of the statistical data about HIV/AIDS, malaria, and TB are dated. The timelines between when the information was gathered and published make some of the data deceptive by understating the true extent of the pandemics. Quite naturally, some of the infections, as reported, have increased consonant with population increase.³² At times, the absence of up-to-date data in connection with these three pandemics gives a false sense of comfort as regards their impact on human development and leaves room for ‘global success-stories’ of dubious merit.

HIV/AIDS, malaria, and TB epidemics threaten the moral, economic and political fabric of societies in SSA. While for some like Nigeria’s ex-President, Olusegun Obasanjo, the prospect of extinction of the entire African continent looms larger and larger dues to the threat of the HIV/AIDS pandemic,³³ for others, Obasanjo’s assertion may be viewed as too polemical, as a UN report in 2011 has revealed that there had been a nearly 25 % decline in new HIV infections and a reduction in AIDS-related deaths during the past decade.³⁴ The relative success in improving access to life-saving medications has reduced HIV/AIDS-related mortality rates in SSA.

However, despite claims of progress in the fight against the HIV/AIDS epidemic in some parts of Africa, SSA still remains the epicenter of the AIDS epidemic.³⁵ By conservative estimates, two-thirds of the world’s HIV infection is in SSA, and more than three in four (76 %) AIDS-related deaths occur in SSA.³⁶ Worse still, the Africa region accounts for 67 % of the world’s Least Developed Countries (LDCs) and as a result millions of people infected with HIV do not have access to medicines. It has been estimated that only 2 % of persons needing antiretroviral treatments in Africa are actually receiving them.³⁷ People cannot afford to buy patented brand name medicines and, most often, people on antiretroviral regimen experience treatment interruptions due to financial difficulties.³⁸

There is also ample evidence to support the fact that HIV/AIDS has become a national emergency in parts of Africa, especially in Southern Africa, and it could as well become an uncontrollable epidemic in the future. For instance, Ganslandt et al. have revealed that:

In Botswana, 36 percent of adults are now infected with HIV, whereas in South Africa, the figure is 20 percent. South Africa has 4.2 million infected people, the largest number in the world. These figures are rising at alarming rates.…Economic studies suggests that the South African gross domestic product (GDP) will be 17 percent lower in 2010 than it would be without AIDS, removing US$22 billion in output from the economy. In Botswana, there could be a 13 to 15 percent reduction in the income of the poorest households.³⁹

HIV/AIDS is not the only challenge confronting countries in SSA. More conservative estimates of the number of malaria cases (over 300 million) show an alarming number of malaria-related deaths in Africa.⁴⁰ Presently, malaria remains the number-one killer-disease in SSA. Forty-five countries within the WHO African region were said to be endemic for malaria in 2008.⁴¹ Malaria maims children and causes millions of maternal deaths. The disease is reported to have accounted for nearly 1 million global deaths in 2008, with 91 % in Africa. Despite progress in malaria control interventions, through public health services, access to treatment and prevention is reportedly inadequate.⁴² This situation is further exacerbated by inequities in access to malaria prevention and treatment efforts in Africa.⁴³ In addition, there is insufficient R&D into new anti-malarial vaccines and medicines.⁴⁴ The high rate of malaria-related deaths in Africa does not, however, negate the possibility that HIV/AIDS epidemic in SSA (if unchecked) could surpass the threat of malaria in the near future.

Likewise, the threat of TB looms large across SSA. The Africa region accounted for 31 % of the global 9.27 million reported cases of TB in 2007.⁴⁵ Tuberculosis remains prevalent among infants in SSA. For example, the reported TB incidences in 2007 represented a modest increase in TB infections as compared to those of 2006 (9.24 million). Within that period, Nigeria and South Africa accounted for nearly 1 million of the global reported TB cases. What makes TB more lethal is that a sizeable number of persons infected and affected by TB are also HIV-positive, especially in SSA.⁴⁶

As the statistics suggest, the effects of diseases such as HIV/AIDS, malaria, and TB on SSA are not a simple health crisis; rather, those diseases represent the most immediate and long-term threats to sustainable human development in SSA.⁴⁷ The AIDS pandemic impacts on all sectors of national activity and on human lives: first, by killing the labour force at its prime; second, by increasing the costs associated with health care provision, prevention efforts, and the sustainability of health care institutions; third, by diverting money from other equally important initiatives like education and rural development.⁴⁸ Also, costs associated with the treatment of health-related afflictions caused by malaria and TB have ballooned and diverted resources away from other human development goals.

Supposed progress in combating the three pandemics cannot caricature the realities on the ground. The reality that confronts SSA is that countries lag behind in comfortably sharing in the ‘global success stories’ in the fight against the above epidemics. Generally, fears of discrimination, stigma, and social exclusion, coupled with limited access to medicines to treat those pandemics negatively affect the people in SSA. According to a recent UN report, “53% of Rwandans living with HIV have been verbally insulted, 33% of rural Zambians living with HIV have experienced physical violence, and 65% of Rwandans living with HIV have lost a job or income opportunity.”⁴⁹ Therefore, relieving countries of these human tragedies is perhaps the most important issue that should be on the agenda of policy-makers. An equitable and human-oriented patent regulatory framework can play that essential role in relieving these quagmires and helping to ensure sustainable human development in SSA. This text will thus seek to establish and elucidate the above contentious points through a multidisciplinary approach to legal research.

This book employs a multidisciplinary approach to legal research. It links seemingly disconnected pharmaceutical patent-related negotiations, processes and events that expose the continued alienation of persons and countries in SSA from the domestic and international patent polity. It draws on history, philosophy, law, economics, policy studies, and development theory as foundations for arguing for pharmaceutical patent reforms in SSA. It undertakes a detailed review of primary documents and secondary literature that portray the dire reality of the human situation in SSA of HIV infections, malaria and other debilitating diseases. The breadth of materials will ensure impartial and critical consideration of the pharmaceutical patents and development debate in a poly-centric manner. It is also hoped that relying on these multiple sources will assist in overcoming some of the limitations associated with disciplinary fixation (i.e., recounting legal rules without reflecting social reality). Elsewhere, researchers have sought to overcome this deficiency in patent law via the use of a ‘trans-disciplinary approach’⁵⁰ to investigate the subject of biotechnology protection.⁵¹

In addition to the above, this text will analyze relevant instruments belonging to regional institutional bodies, such as the African Regional Intellectual Property Organization (ARIPO)⁵² based in Harare, Zimbabwe, in order to understand the state of patent regulation in SSA. Similarly, available and relevant pharmaceutical patent-related instruments from ARIPO’s counterpart for nations of francophone Africa—Organisation Africaine de la Propriété Intellectuelle (OAPI)⁵³—will be examined. This will enrich my perspective and analysis of the context and the issues discussed.

Further, this research will employ practical evidence from patent administrators, scholars and practitioners in affirming its claims. The experience of policy-makers in SSA during negotiations that led to the establishment of the globalized pharmaceutical patent regime will be employed to substantiate other claims in the literature. The evidence from policy-makers will also assist in making concrete suggestions for improvements in pharmaceutical patent regulation in SSA. Additionally, the patent legislation of four countries in SSA will be examined in chapter “Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa” of this book. These countries include Ghana, Uganda, Botswana, and South Africa. The South African experience will lead the way in this discussion, however. The discussion of the statutory frameworks of the four selected countries will be employed to draw conclusions about patent protection vis-à-vis efforts to tackle epidemics in countries in SSA.

These four countries were chosen for three reasons. The first reason is geographical. At least one country from each sub-regional component of the Africa region should be chosen to give a balanced representation of the patent regulatory environments in the whole region. The second reason is that those four countries have relatively well established institutional and regulatory infrastructure that can facilitate this research. The third reason is based on the prevalence of the pandemics in SSA. A balanced portrayal of the pandemic situations across all parts of SSA will assist in making concrete proposals for change. Thus, focusing entirely on a country that is densely affected with, let’s say, an HIV/AIDS epidemic will distort the reality in other places that are less densely affected.

For instance, Ghana among all the four countries has the lowest reported HIV infection rate. The WHO’s estimated national rate of HIV infection as of 2005 stood at 2.7 %.⁵⁴ This estimate is based on 30 % of actual reported AIDS cases in Ghana. The prevalence rate among persons in Ghana between the ages of 25 and 29 years stood at 3.8 % and that of persons between the ages of 45 and 49 years stood at 5 %. A 2007 report by the UNAIDS however indicates a reduction in the national HIV prevalence to 1.9 %.⁵⁵

Uganda stands in the intermediate position with an infection rate of about 6.3 % among persons between the ages of 15 and 59 years.⁵⁶ This figure is hailed as a significant reduction in the HIV prevalence rate in Uganda since previous reports had quoted 30 %.⁵⁷ Botswana and South Africa represent the worst infection case scenario in SSA. The national averages for both Botswana and South Africa are estimated at 30 % or more.⁵⁸ The above reported cases of infections among the four countries give a fair indication about the trend of HIV/AIDS pandemic in SSA. Malaria and TB infections cut across the entire SSA but are very predominant in the western and southern parts.

In conclusion, extrapolating from multiple evidentiary sources has several virtues. It enables pharmaceutical regulatory policies to be examined from perspectives supported by concrete evidence which previous research has not undertaken. The practical evidence is also used to validate anecdotes and claims in other written sources from which this book draws heavily. It provides the opportunity to objectively analyze the peculiar circumstances of the world’s poorest region that has long been forgotten, both literally and figuratively. It also provides the opportunity to shed light on how marginalization of SSA in international patent polity has been replicated in policies pertaining to access to medicines in SSA countries. It is through this analysis that we can make concrete and realistic suggestions for patent regulatory and institutional changes in SSA.

The analysis of the above primary and secondary sources takes place against a framework of laws, institutions, practices, and politics employed in this book. The concepts of laws, institutions, practices, and politics (discussed in greater depth in chapter “Exploring the Conceptual Domains for Patent Discourse in Global Trade Relations”) are referred to as a ‘quadripartite framework.’ The interaction between laws, institutions, practices, and politics is employed as a methodological guide to elucidate the actual impact of the globalized patent regime on human lives in SSA and suggest realistic reforms. Thus, to fully understand the literature, the culture of western domination and the ensuing asphyxiation of the public access-to-medicine goals in SSA, one needs to appreciate the workings of the legal, institutional, political, and practical developments in the pharmaceutical patent industry, both at the domestic and at the international levels. Suffice it to say that this examination of the impacts of the globalized pharmaceutical patent regime and the quest for regulatory reforms to promote human development will be undertaken within the context of SSA, which I introduce below.