As a specialized agency of the UN, WIPO is required to contribute to the UN’s overall development mandate.³⁷ WIPO is “responsible for taking a more appropriate action in accordance with its basic instrument, treaties and agreements administered by it, inter alia, for promoting creative intellectual activity and for facilitating the transfer of technology related to industrial property to the developing countries in order to accelerate economic, social and cultural development.”³⁸ This mandate has emboldened WIPO to re-assert its authority (which was lost to the WTO) on matters of IP and development. The recent adoption of the Development Agenda by WIPO as part of its norm setting-activities is an apt illustration of this point.³⁹

This paradigm shift became possible because of pressure from the less developed world as well as civil society groups. One such force is the Group of Friends of Development that tabled a proposal for WIPO to pursue a development agenda, which takes account of a country’s level of development.⁴⁰ The proposal by the Group of Friends of Development stressed “the need to integrate the ‘development dimension’ into policy making on intellectual property protection.”⁴¹ It thus sought to reform WIPO so that its principles and norm-setting activities are development-oriented rather than the unidirectional approach of promoting IP whilst neglecting the public interest.⁴² After 3 years of negotiations, this proposal by the Group of Friends of Development was unanimously adopted in September 2007 as the WIPO Development Agenda. Without attempting to be exhaustive, what follows is a brief discussion of some the recommendations under the WIPO Development Agenda.

The WIPO Development Agenda has 45 recommendations. These recommendations have been grouped into topical clusters: A (Technical Assistance and Capacity Building), B (Norm-setting, flexibilities, public policy and public domain), C (Technology transfer, Information and Communication Technologies and Access to Knowledge), D (Assessment, Evaluation and Impact Studies), E (Institutional Matters including Mandate and Governance), and F (Other Issues). It is worth noting that these groupings do not signify that some of the recommendations are of a higher priority than others. Altogether, the recommendations under the Development Agenda attempt to rectify the imbalances associated with the international IP system, as ushered into force by TRIPS.

In particular, the Cluster B recommendations mandate that WIPO’s IP and development norm-setting activities shall:

The prevailing thinking, therefore, is that the Development Agenda creates a soft international law which rejects a one-size-fits-all approach to IP protection.⁴⁴ Soft law refers to certain categories of norms, technically non-binding, that states nonetheless follow in practice or to which they at least subscribe.⁴⁵ The Agenda thus recognizes that human development concerns cannot be addressed unless the globalized patent regime recognizes different levels of development among nations. This recognition has contributed to changing the patent and development landscape by advocating a balance between patent rights protection and access to medicines in less developed countries. The recommendations in the Development Agenda also suggest that WIPO has shifted focus from being a defender of the protection of IP rights to a global pro-development organization.

So far, developed countries have not patently exhibited any rejection of the forty-five recommendations in the Development Agenda. As soft law, the recommendations in the Agenda may have a moral effect on both developed and developing countries alike. Soft law can be a useful tool in interpreting the TRIPS Agreement.⁴⁶ In addition, soft-law approaches have proven to be a very reliable mechanism for consensus seeking among opponents and proponents of international patent norm-creating endeavors. Soft law initiatives have also become entry points for gaining access to the WTO and the WIPO in order to influence crucial patent and development initiatives. The recommendations in the Agenda may also influence the actual practices of states in formulating domestic patent/development policies to promote access to medicines.

Furthermore, some of the recommendations, especially those that seek to reorient WIPO towards development, are earmarked by the WIPO General Assembly for immediate implementation.⁴⁷ Presumably, those recommendations earmarked for immediate implementation do not require huge financial or human resources to move forward.⁴⁸ For example, recommendation 1 of the Development Agenda provides that WIPO’s technical assistance shall be development-oriented, demand-driven and transparent, taking into account the priorities and the health needs of countries as well as their levels of development. In addition, recommendation 12 mandates WIPO to mainstream development considerations into its substantive and technical assistance activities. Such development considerations include promoting the development goals agreed within the UN system, including the Millennium Development Goals (MDGs) to fight health inequality in less developed countries.⁴⁹

In addition, WIPO is obliged to take into account the flexibilities in international IP agreements, especially those that benefit less developed countries.⁵⁰ WIPO must also enhance the participation of civil society in its activities.⁵¹ The participation of civil society in WIPO’s technical assistance activities in SSA would enhance the public interest dimension of IP law jurisprudence, a point which I emphasize in chapter “Exploring the Conceptual Domains for Patent Discourse in Global Trade Relations” of this text. The central thrust of these recommendations is to move WIPO adroitly in the direction of a human-centered approach to development in international patent law making endeavors. By adopting the Development Agenda, WIPO has embraced the prevailing international human development goals of the UN.

Outside the corridors of the UN, scholars have shown interest in the implementation of the WIPO Development Agenda. They have begun to delineate the scope and contents of the Development Agenda, an approach that should facilitate its implementation.⁵² According to De Beer, defining the Development Agenda in negative terms—by what it is not rather than by what it is—could be counterproductive.⁵³ He thus defines the Development Agenda by four features: malleability (i.e., shaping the agenda to suit different stakeholders’ interests), complexity (i.e., viewing the development agenda in light of the larger framework of the IP regime complex), opportunity (i.e., presenting a platform for WIPO to recapture its lost image and to maintain its relevance to the less developed world), and gravity (i.e., implementing the development agenda in good faith will bring on board WIPO’s largest constituents, the developing world).⁵⁴

Also, development scholars have argued that implementing the Development Agenda presents an opportunity to incorporate a substantive equality principle and social justice concepts into global knowledge governance issues.⁵⁵ Although the Development Agenda does not make explicit reference to human rights and public health considerations, Haugen justifies the need for WIPO, as an agency of the UN, to mainstream human rights principles into the implementation of its IP norms and the Development Agenda.⁵⁶ The justification for integrating international norms on patents and human rights norms is that they share similar social functions and goals. Indeed, both bodies of norms seek to pursue the attainment of the social dimensions of human personhood.

In conclusion, the need to integrate the ‘development dimension’, including development principles extrinsic to WIPO, into international patent law making has received increased recognition at the international level.⁵⁷ Incorporating human development principles, including human rights principles, into WIPO’s norm-setting activities is consistent with the organization’s mandate as a specialized agency of the UN. In consequence, the WIPO Development Agenda is increasingly re-establishing the social/public policy dimension of patent protection, an approach that was subdued during the TRIPS negotiations. However, it will take years before such efforts bear fruits and also reverse the inequities inherent in the international patent system.

Given that WIPO lacks enforcement mechanisms against non-complaint member states, the WTO should play a key role in any attempts to mainstream development considerations into global trade-related IP matters.

The concept of development forms a core aspect of the WTO’s norm setting activities. For example, the Preamble to the Marrakesh Agreement Establishing the WTO provides that trade relations should be conducted “with a view to raising standards of living…while allowing for optimal use of the world’s resources in accordance with the objective of sustainable development.” As Cho explains, the WTO charter connotes a much broader idea of integration that ensures that both trade values and social values are upheld in a coherent and synergetic manner, rather than competing fashion.⁵⁸ In addition, the Preamble to the TRIPS Agreement recognizes “the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives” of WTO member states as part of global trade relations. To these ends, the WTO has become a forum for continued negotiations on the liberalization of trade-related matters, including international patent law making and global development.⁵⁹

More fundamentally, the post-TRIPS epoch has witnessed the conclusion of a number of human development-friendly initiatives that have sought to forge a more humane and equitable international patent regime. Notably, these post-TRIPS initiatives include the adoption of the Doha Ministerial Declaration, the Doha Declaration, and the WTO General Council’s ‘Augusts 30’ Decision. For example, under the Doha Ministerial Declaration, the trade ministers of the WTO member-states reaffirmed their commitment to the concept of sustainable human development as stated in the Preamble to the Marrakesh Agreement.⁶⁰ This Ministerial Declaration also sought to redress the marginalization of least developed countries (LDCs) in international trade and to improving their effective participation in the multilateral trading system.⁶¹ It also emphasized that countries should not be prevented from taking measures to protect human health, provided they are non-discriminatory.⁶² In this vein, the implementation and interpretation of TRIPS must support public health, by promoting access to medicines.⁶³

A more specific Declaration on the TRIPS Agreement and Public Health affirmed the sovereign right of governments to take measures to promote public health and ensure access to medicines for all.⁶⁴ This Declaration recognized that IP protection is important for the development of new medicines and also took note of the concerns about the effects of IP protection on the prices of new medicines.⁶⁵ The Doha Declaration explained that states have the sovereign right to determine the grounds upon which compulsory licenses are granted to tackle health related emergencies.⁶⁶ And also that states are not required to consult patent right holders before issuing compulsory licenses to address public health concerns.⁶⁷ The Doha Declaration further clarified that countries have the prerogative to decide whether they will allow a regime of international or national exhaustion of patents to be applied in their territories.⁶⁸

While some hail the Doha meeting as a post-TRIPS success, others disagree with that assertion. According to Hoen, Doha signalled a sea change in thinking about “IP as a social policy tool for the benefit of society as a whole, rather than [as] a mechanism to protect limited commercial interests.”⁶⁹ Similarly, other scholars contend that these post-TRIPS developments are indicative of the emergence of a new era of IP,⁷⁰ an era that promises to deliver human development outcomes for the less developed world. For Gold et al., this new era of IP reverses the old era which hinged on the core belief that if some IP is good, then more must be better.⁷¹ On the other hand, critics of the international patent system argue that the Doha meeting failed to achieve any meaningful success.⁷² Notably, Doha failed to allow for medicines to be exported to countries which lacked domestic manufacturing capacity; countries with manufacturing capacities were only allowed to use compulsory licenses to produce medicines ‘predominantly’ for the supply of the domestic market.⁷³ In essence, the implementation of the Doha declarations over time made it obvious that there were still some inflexibilities inherent in the international patent system.

In a further move to inject real flexibility into the globalized patent system, the WTO General Council issued the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health on August 30, 2003. This ‘August 30’ Decision allows for the export of medicines manufactured under compulsory licenses into countries that lack domestic production capacity. The ‘August 30’ Decision also became the key platform for the permanent amendment to Article 31 of TRIPS. Yet still, the ‘August 30’ Decision contains inflexibilities relating to the quantity of medicines to manufacture; limits on the quantity to export or import; and, then an added requirement for the payment of adequate remuneration by exporting members, among others. Srivastava & Satyanarayana have articulated these drawbacks thus:

The tedious process…includes: (i) prior negotiation necessary before compulsory license granted; (ii) anti-diversion measures to kill incentives for generic production; (iii) notification of intention to use August 30 Decision; and [sic] (iv) the decision is unrealistic; and (v) the decision is not automatic, but a succession of complex procedural steps.⁷⁴

Similarly, Sampath notes that having to go through the scrutiny of the TRIPS Council before a state can proceed further limits access to generic medicines.⁷⁵ This notification process unnecessarily exposes less developed countries to political pressure from industrialized countries, thereby creating a disincentive to use the ‘August 30’ mechanism.⁷⁶ The ‘August 30’ Decision has yet to roll back the adverse effects of the globalized patent system on public health and human development in poor regions such as SSA. The fact that Rwanda is the only country which has so far notified the TRIPS Council and utilized the ‘August 30’ mechanism to import generic medicines, Apo TriAvir, from Canada speaks volumes.⁷⁷ Even with this Rwandan experience, the rigid nature of the application procedures under Canada’s Access to Medicines Regime,⁷⁸ and the high cost of Canadian generics as compared to that of India made the whole deal unattractive.⁷⁹ For Chon, the protracted implementation of the ‘August 30’ Decision demonstrates an ongoing lack of enthusiasm within the WTO system to move towards a broader conception of development.⁸⁰

As earlier mentioned, following the ‘August 30’ Decision, Article 31 of the TRIPS Agreement has been amended to facilitate access to cheaper generics via the use of compulsory licensing schemes. This amendment known as Article 31bis comes into force when two-thirds of all WTO members ratify the change. However, doubts still remain about these ‘humanitarian’ prescriptions and the actual ability of African countries to make use of those prescriptions.⁸¹ In expressing skepticism about the amendment of Article 31 of the TRIPS Agreement, Mgbeoji posits that African countries have not fared much better in terms of developing local industrial manufacturing capacity and thus significantly addressing the dire health challenges in Africa.⁸² Far more worrisome, these modest gains made in the post-TRIPS era are in imminent danger of being reversed, owing largely to the recent imposition of TRIPS-plus obligations via bilateral trade and investment agreements between the west and countries in Africa.

In short, the adverse impacts of TRIPS on public health in poor regions such as SSA are emerging. Yet the WTO’s re-calibration measures have not fully addressed the gargantuan inadequacies associated with the globalized patent regime. Perhaps, more accurately, the WTO’s calibration process has left a sour taste in mouths of proponents of human development and public health policies in poor countries. The ad hoc suspension of the obligations to implement patent rules on pharmaceuticals for LDCs is evidence of the limitations or failures in the WTO’s approach. Still, those transitional arrangements fail to address how differential needs would be catered for in the post transition period. Presumably, the WTO’s formal suspension of TRIPS’ obligations for LDCs is likely to be renewed, as the organization strives to manage the welfare costs associated with the implementation of international norms on patents.

To address these persistent failures in the international patent system, the WTO must look beyond its sphere of operations and tap in to proposals that assure human development outcomes in less developed countries. More needs to be done through the incorporation of extrinsic human development principles into the agenda setting activities of the WTO. A move towards a broader conception of development in patent law making will facilitate access to medicines and other life-saving healthcare services in poor regions such as SSA.

As noted in chapters “Evolutionary Trajectories of Patents and the Politics of Exclusion in Sub-Saharan Africa” and “Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa” of this book, even though efforts have been made to extend the transition period of TRIPS’ implementation for LDCs, TRIPS’ non-discriminatory principles of Most Favoured Nation (MFN) treatment and national treatment must be complied with across the globe, be it in Kiribati⁸³ or Sudan. The MFN principle proscribes trade-related discrimination among foreign nationals. On the other hand, national treatment is a principle of non-discrimination barring internal discrimination in favour of domestic actors over non-nationals.⁸⁴ Both MFN and national treatment principles are termed ‘formal equality principles’, as they impose minimum standards on all countries regardless of their level of development.⁸⁵ Thus, under these non-discriminatory principles, states are deemed to be equal before the law despite inequalities in actual levels of states.⁸⁶ Formal equality principles under TRIPS promote a ‘one-size-fits-all’ approach to patent law making in a manner that is hostile to nuanced differentiation among states.⁸⁷ Hence, both MFN and national treatment principles have the insidious effects of rendering formal suspension of TRIPS’ implementation meaningless for many SSA countries.

Besides MFN and national treatment principles, there are other formal equality principles under TRIPS.⁸⁸ For example, TRIPS binds WTO members to grant patent rights without discrimination as to place of invention, the field of technology and whether the products are imported or locally produced.⁸⁹ Also, the WTO’s dispute settlement mechanism is rooted in ‘formal equality’ at the level of applicable legal principles.⁹⁰ WTO member states are considered as complete equals before the Dispute Settlement Body; countries compete on the same normative terms and condition. This arrangement favors developed countries both de jure and de facto: less developed countries are disadvantaged when it comes to employing complex and expensive legal processes to prosecute claims of bio-piracy.⁹¹ For instance, the EU is seen as a single entity within the WTO set-up. It has standing before the dispute settlement bodies. The economic power of one of the EU states is stronger than that of all SSA countries combined. Therefore, a dispute between the EU and a country in SSA is like killing a mosquito with a rifle.

In effect, TRIPS’ universal minimum standards epitomize what Chon calls a ‘universalist approach of deep integration’, a phenomenon which ties preferential treatment for poor countries to the ever-pervasive process of global economic liberalization.⁹² Since SSA countries are interested in participating in international trade under the aegis of the WTO, these patent-related formal equality principles are imported into domestic jurisdictions of states with few or no options. Moreover, chapters “Evolutionary Trajectories of Patents and the Politics of Exclusion in Sub-Saharan Africa” and “Patent Regulatory and Institutional Mechanisms in Sub-Saharan Africa” have shown that technical assistance initiatives have steered SSA countries to enact TRIPS-compliant and TRIPS-plus laws in their domestic jurisdictions. In light of these developments, the transition rules and patentability exceptions under TRIPS are honored more in the breach than in their observance. The net result is that the public interest and public health considerations of the globalized patent system remain imperiled.

To remedy these regulatory dysfunctions, Chon suggests that patent globalization must embody ‘substantive equality’ principles to counter the ‘myth’ (as defined in “The ‘Myth’ of Patent Justifications: Triumph and Failure Dichotomy in the North and South” as a defect) in the ‘formal equality’ principles under TRIPS.⁹³ Thus, in order for IP globalization to achieve human development outcomes, substantive equality norms must be incorporated into the trade-related decision-making itself.⁹⁴ This substantive equality principle posits that the goal of IP law should be to promote human development, by facilitating access to basic healthcare.⁹⁵ It ensures that patent law is construed and applied in a way that defers to the basic healthcare needs of those who require access to medicines.

A substantive equality principle is analogous to the doctrine of strict scrutiny in the judicial context of US constitutional law.⁹⁶ This strict scrutiny doctrine allows policy makers to accord much less deference and exercise much more skepticism towards government regulation, such as the grant of patents in the context of the provision of basic healthcare.⁹⁷ The strict scrutiny doctrines empower policy-makers to review and strike down a state-granted right which conflicts with the enjoyment of basic human development needs.

By application, Chon suggests that in measuring IP’s welfare-generating outcomes, we should not only be guided by economic growth but also by its distributional effects.⁹⁸ Thus, as a necessary corollary to the formal equality principles, a substantive equality principle must give heightened attention to distributional and social justice concerns that form the core of a human development-driven concept of ‘development’.⁹⁹ In the peculiar context of SSA, integrating substantive equality principles into domestic patent law making will require giving priority to the right to health in SSA. Given that public health is a prerequisite for any technological progress, access to medicines must have priority over the grant of exclusionary patent rights.¹⁰⁰ By emphasis, this vein of argument requires policy makers to give priority to both the short-term access and affordability to life-saving medicines and the long-term innovation policy goals in places such as SSA. It also implies maximizing TRIPS flexibilities and making nuanced distinctions among technologies despite the mandate of Article 27.1 of TRIPS.¹⁰¹ Finally, this substantive equality principle should inform IP norm-setting and implementation at both the domestic and international levels.

Scholars such as Sen and Nussbaum have theorized an approach to development that emphasizes the enhancement of human capabilities.¹⁰² This capabilities approach posits that a society is not developed until certain basic needs are provided for its people.¹⁰³ In regard to this capabilities thesis, Sen has propounded a model of development as freedom, which emphasizes the enhancement of human capability through the provision of basic needs such as education and health.¹⁰⁴ According to Sen,

Development requires the removal of major sources of unfreedom: poverty as well as tyranny, poor economic opportunities as well as systematic social deprivation, neglect of public facilities…Despite unprecedented increases in overall opulence, the contemporary world denies elementary freedoms to vast numbers – perhaps even the majority – of people. Sometimes the lack of substantive freedoms relates directly to economic poverty, which robs people of the freedom to satisfy hunger, or to achieve sufficient nutrition, or to obtain remedies for treatable illnesses….¹⁰⁵

In criticizing the use of GDP as the primary measure of development, Sen stresses that development should be measured based on the provision of basic services including healthcare that allow human beings to function and live fuller lives.¹⁰⁶ Thus, “development has to be more concerned with enhancing the lives we lead and the freedoms we enjoy.”¹⁰⁷

In the context of SSA, where epidemics have truncated human lifespan and also diminished human capacity to function, having access to medicines would play a pivotal role in the citizen’s quest to live a meaningful life. Further, Sen observes that development is a polycentric and integrative concept: while social opportunities including the provision of health care services facilitate economic participation, economic facilities help generate personal abundance as well as public resources needed for social facilities.¹⁰⁸ It goes without saying that economic growth is a necessary but not sufficient condition to achieve full development in SSA. In short, the work of Sen, as an alternative to the utilitarian focus on wealth maximization, must be central to discussions about the goals of patents and development, both at the domestic and international levels.

Similarly, Nussbaum propounds an approach to human development that emphasizes the improvement of living standards and quality of life.¹⁰⁹ For her, an individual should be “able to live to the end of a human life of normal length,” and be “able to have good health, including reproductive health.”¹¹⁰ In addition, Nussbaum has grounded this capabilities thesis in constitutional/social justice discourse by emphasizing the idea that “all human beings are precious, deserving of respect and support, and that the worth of all human beings is equal.”¹¹¹ As Nussbaum has perspicaciously observed,

[This capabilities approach] does…suggest that many of the most central human capabilities, given their enormous importance to basic social justice, should be placed beyond majority whim through constitutionally protected status….The special status of fundamental entitlements need not be guaranteed through a written constitution, but that is one common way of protecting them and ensuring that they are not held hostage to the vicissitudes of politics.¹¹²

In consequence, Nussbaum argues that there is a constitutional imperative for governments to supply basic human entitlements to their citizens.¹¹³ The corollary is that individuals also have the right to demand basic healthcare services, among others, from their governments. It remains to emphasize that some of the modalities for protecting/prioritizing the right to health guaranteed in national constitutions in SSA have already been analyzed in chapter “Pharmaceutical Patents, the Right to Health, and Constitutional Supremacy in Sub-Saharan Africa” of this text.

The above human capabilities model espoused by Sen and Nussbaum has featured prominently in the international development norm-making activities of the UN. As Barbosa et al. point out the capabilities model underlies the objectives of UN MDGs, which seeks to assure a certain basic threshold of respect for human development and dignity across the world.¹¹⁴ The reverse is true, however, with respect to the influence of the human capabilities model on international patent law making. Thus, the capabilities model has yet to inform the design, interpretation and implementation of the globalized patent system under the WTO system.¹¹⁵ Significantly, scholars and policy advocates have given directions on how the human capabilities model can mesh with international and domestic norms on patents.¹¹⁶ The point is that the contents of this human capabilities model should inform international and domestic patent law making vis-à-vis access to pharmaceuticals in SSA.

In reality, the work of the UNDP has been influenced by Sen and Nussbaum’s theorization of the human capabilities model.¹¹⁷ Consequently, the UNDP has, since 1990, propounded the approach of putting human beings at the center of development at both national and international levels. The UNDP’s approach is based on the use of the ‘human development index’, as measured in terms of life expectancy at birth, educational attainment, and the standard of living as determined by real per capita income. Specifically, the UNDP has employed its human development report to promote an equitable sharing of the benefits of globalization.¹¹⁸ This report has identified global inequality as the bane of human development, and has thus urged that sharing in the benefits of globalization requires the need to put human concerns and human rights at the centre of international policy and action.

In the year 2000, the UNDP dedicated its report to issues of ‘human rights and human development’. This report emphasized the point that the realization of human rights is indispensable to the attainment of human development.¹¹⁹ It noted that “when human development and human rights advance together, they reinforce one another – expanding people’s capabilities and protecting their rights and fundamental freedoms.”¹²⁰ It stressed further that, at all levels of development, “the three essential capabilities are for people to lead a long and healthy life, to be knowledgeable and to have access to the resources needed for a decent standard of living.”¹²¹ In effect, the UNDP’s exhibited experience in global developmental issues has significantly impacted on patent law making initiatives in the post-TRIPS period. The UNDP has, for instance, concluded that the “relevance of TRIPs is highly questionable for large parts of the developing world.”¹²² The UNDP has, therefore, urged developing countries to adopt a flexible approach to interpreting and implementing TRIPS while negotiating to replace the Agreement.¹²³ The point is that reconstructing the globalized patent regime along human development lines will enlarge the public domain and thus facilitate access to medicines for the poor in SSA.

Development economists have made suggestions for the integration of principles of equity and fairness into the global trade agenda. Such suggestions are especially relevant in addressing some of the dysfunctions associated with the workings of the globalized patent system. In particular, the preceding chapters of this text have made allusions to the inequities and inadequacies inherent in the globalized patent system. These inadequacies include the aggregation of pharmaceutical patents into price fixing cartels, non-recognition of states’ (in)capacities in patent law making, the presence of democratic deficits in the global patent law making processes, the lack of sufficient disclosure of the utility of inventions for future benefits, the lack of incentives in the development of drugs that treat diseases predominantly found in poor countries, and the rigid enforcement of pharmaceutical patent rights across the globe, among others. In consequence, the social dimension of the globalized patent regime to promote public health and human development has been subdued in international patent law making.