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Regulatory Diversity as Key to the “Myth” of Drug Patenting in Sub-Saharan Africa

Published online by Cambridge University Press:  04 March 2010

Poku Adusei
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Abstract

This article critiques the subject of patent protection of drugs in the light of the threat posed by HIV/AIDS in sub-Saharan Africa. It contends that the basis for sustaining the prevailing international patent system in developing countries is a “myth”: one of deception. This “myth” is validated by highlighting the dysfunctions associated with the prevailing international patent system. The article proposes the adoption of diverse patent systems that would suit the cultural and human development needs of countries in sub-Saharan Africa. Such diversity implies a drug patent model that meets human needs and shows respect for communal interests, a model that permits differences and is amenable to change in the light of socio-economic needs, a model that confronts “unfreedoms” which constrain human development, and a model that ensures respect and protection for the fundamental right to health care.

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Type
Research Article
Information
Journal of African Law , Volume 54 , Issue 1 , April 2010, pp. 26 - 50
Copyright
Copyright © School of Oriental and African Studies 2010

INTRODUCTION

Patent protection is justified by multiple related economic assumptions. It is assumed that: patent protection leads to technology transfer and knowledge dissemination;Footnote 1 that it serves as an incentive for further research and development;Footnote 2 that it leads to increased foreign direct investment;Footnote 3 that it provides incentives for the advancement of indigenous knowledge and innovation;Footnote 4 and that it creates wealth.Footnote 5 In accord with the lofty ideals of contemporary capitalism, these inter-related assumptions have been used by neo-liberal scholars to justify the prevailing international patent regime and its reflections in domestic law. Further, proponents of these assumptions have asserted that tightened protection spurs economic growth and development.Footnote 6

Packaged as pro-development policies, the economic assumptions have induced developing countries to cede their autonomy, and consequently embrace the dictates of the prevailing international patent regime as provided by the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)Footnote 7 of the World Trade Organization (WTO). The WTO rules have, since 1995, thus become the foundation of legitimacy for patent systems in developing countries by, among others, imposing limitations on the regulatory patent framework of states.Footnote 8 The limitations on an individual state's autonomy took the form of compulsion that caused developing countries to comply with the international obligations they have “assumed” under TRIPS. In so doing, deadlines were imposed on states to enact express domestic legislation to give effect to the treaty or to accept whole-heartedly the treaty as part of domestic law. While the former approach prevails in the dualist-states, the latter approach prevails in the monist-states.Footnote 9 However, the key point is that states have ceded sovereignty in matters of domestic intellectual property (IP) law and policy to the WTO.Footnote 10

This is in sharp contrast to the situation that prevailed under the Paris Convention,Footnote 11 which made the first international attempt at “harmonization” of patent rules, among others. The Paris Convention still permitted “the existence of asymmetries in the national systems of industrial property, particularly in the field of patents”.Footnote 12 Under the Paris Convention, there were differences in the terms and scope of patents, and the requirements for their exploitation.Footnote 13 Thus, pharmaceutical patent laws, policies and practices differed significantly among developed and developing countries until 1995, when TRIPS successfully harmonized IP standards.Footnote 14 This globalization became successful because giant US corporations portrayed themselves as embattled innovators who faced an uncertain future in a world where mercenary southerners were unwilling to engage in fair business activities.Footnote 15 They therefore lobbied for the acceptance of an international regime that recognized the western standards of patent protection. On the flip side, the frontline of developing countries was utterly divided. Like the Tower of Babel,Footnote 16 from which everyone speaks but with a different voice, developing countries failed to pursue a common anti-liberalization agenda.

As it turned out, developing countries were misled to believe in the neo-liberal rhetoric. They were deceived into adopting strict drug patent regulations that permit no meaningful alternatives and options; it is a system that privileges protectionism over diffusion.Footnote 17 This deceit is synonymous with the promise of the Enlightenment thinking that human reason is the primary source of, and provides the legitimacy for, authority.Footnote 18 According to Horkheimer and Adorno, this promise of the Enlightenment is a “myth”, one of deception.Footnote 19

The “myth” (deceit) regarding patents is borne out by the fact that the promises made to developing countries to sign TRIPS in return for agricultural and textile subsidies have not been met. Similarly, assurances that developed countries would refrain from resorting to unilateral and bilateral pressures against developing countries if the latter signed up to TRIPS have become illusory.Footnote 20 A recent increase in bilateral trade and investment agreements which impose higher levels of IP protection (commonly known as TRIPS-plus obligations) shows the troubling dimensions of the west's broken promises.Footnote 21 The deceit has caused developing countries to adopt deleterious domestic patent policies in compliance with strict WTO rules on drug patenting. Consequently, the prevailing international patent system has effectively turned developing countries into toll collectors for the west while their citizens remain impoverished and die from diseases such as HIV/AIDS and malaria.Footnote 22

Indeed, by embracing the promises of the economic rhetoric, developing countries have reversed, or have been forced to reverse, the pursuit of human needs as the ultimate source of rights.Footnote 23 This has led to a “corresponding neglect of the social dimensions of human personhood”.Footnote 24 However, the neo-liberal patent system continues to perpetuate and reproduce itself because of the faith that policy makers (who also live under the “myth”) vest in it.Footnote 25 Also, the literature and several academic discourses on drug patenting continue to perpetuate this “myth”; the mythic assumptions have been repeated over and over again to the extent that they seem to have attained a semblance of credibility. This false sense of optimism among policy makers in developing countries is part of the neo-liberal ideology of deception that has entrenched itself for years.

Ordinarily, the much trumpeted economic assumptions fail to glitter when tested against the prevailing circumstances in sub-Saharan Africa.Footnote 26 There is evidence that the continued implementation of strict WTO patent rules, among other things, has caused or contributed to hunger and disease in developing countries in Africa.Footnote 27 Conservative estimates indicate that two-thirds of the world's HIV infection rate is in sub-Saharan Africa, and more than three in four (76 per cent) AIDS-related deaths occur in the Saharan region.Footnote 28 Worse still, the Saharan region accounts for 67 per cent of the world's least developed countries and millions of its inhabitants infected with HIV do not have access to medicines. This gives credence to scholars who have argued against some of the assumptions used to justify the prevailing patent system.Footnote 29 But, almost oblivious in the wealth of literature is the argument that the prevailing circumstances in sub-Saharan Africa call for the injection of diversity in drug patent regulation as a means to achieve sustainable human development. This article seeks to fill this virtual lacuna in the discourse.

The article contends that, in an environment of remarkable opulence and “ingenuity” in the developed world as against one of extreme deprivation, disease and scarcity in the developing world, it is unworkable to adopt a western-archetype patent system across the board. Consequently, it proposes the adoption of diverse patent systems that would suit the cultural needs and human development aspirations of countries in sub-Saharan Africa. As is elaborated on in the section Toward Diverse Drug-Patenting Systems In Sub-Saharan Africa below, the proposed regulatory diversity should underscore five overlapping considerations: the adoption of a drug-patent model that meets human needs and shows respect for communal interests; a model that permits differences and is amenable to change in the light of socio-economic needs; a model that confronts “unfreedoms” which constrain human development; a model that ensures respect and protection for the fundamental right to health; and a model that makes drug patent regulation fit social standards instead of making social standards fit rules. This proposed model would offer policy makers in the Saharan region an alternative model with the capacity to respond more effectively to secure both procedural and substantive rights for their citizenry. It will also lead to an expansion of the capabilities of people affected by HIV/AIDS in sub-Saharan Africa and make them more productive.

Structure

This article is divided into five sections. Following this introduction, there is a comprehensive appraisal of the havoc that strong patent protection policies wreak on the economies of countries in sub-Saharan Africa. This discussion is based within the framework of TRIPS, by highlighting the dysfunctions associated with the prevailing international patent system. The next section discusses post-1995 responses to mitigate the hardships associated with the implementation of TRIPS and concludes that those mitigation measures remain inconclusive and disappointing. The fourth section draws on the discussions in the preceding parts and presents the central argument of the article: the adoption of diverse drug patent systems that would suit the cultural experiences and human development needs of countries in sub-Saharan Africa. The final section concludes the discussion.

PATENT DYSFUNCTIONS

Without discounting the influence of other factors, such as bad governance, corruption, economic mismanagement, poverty and conflicts,Footnote 30 TRIPS is the genesis of the dysfunctionsFootnote 31 associated with the prevailing patent systems in sub-Saharan Africa. TRIPS emerged as part of the Uruguay round of trade negotiations that ushered into force the full-blown liberal trade policies of the WTO in 1995. Consequently, TRIPS rules have since become the foundation of patent systems across the globe. TRIPS established minimum standards that, among other things, introduced high levels of patent protection and expanded the scope of patentable products and processes. For instance, TRIPS makes it obligatory for all WTO members to grant patent protection for micro-organisms and micro-biological processes for 20 years.Footnote 32 It also grants 20 year patent protection to pharmaceutical products, among others.Footnote 33 In addition, TRIPS allows states to grant protection for medicinal test data, thereby creating an additional form of monopoly over data needed to obtain marketing approval for medicines.Footnote 34 By expanding the scope of patent protection and privatizing the “intellectual commons”, TRIPS also reduced the options available to developing states in their quest to benefit from the lax system which developed countries once enjoyed.Footnote 35

Additionally, the existing legal regimes in developing countries were considered to be relaxed and therefore in urgent need of reform to comply with polished western standards. Consequently, when TRIPS came into force, developing countries were given an initial moratorium of five years to conform their laws with international law or face trade sanctions.Footnote 36 This moratorium was extended to the end of 2004. In order to ensure utmost respect for the “assumed” international obligations, supposed experts were sent to developing states to assist in drafting TRIPS-compliant laws. For the least developed countries, the moratorium will last until 2016.Footnote 37 The moratorium, however, did not make an exception for the immediate application of the national treatment principleFootnote 38 and the most favoured nation treatment principle in developing and least developed countries.Footnote 39 Although least developed countries have the option of not complying with TRIPS until 2016, once a state commits to grant full patent protection, that protection must be TRIPS-compliant. The reality is that a number of those least developed countries in sub-Saharan Africa do comply with the treaty, to the extent that some have been compelled to assume more obligations than the minimum standards required by TRIPS.Footnote 40 The reason is that these countries were deceived into accepting that greater protection would serve their interests better, by encouraging increased investment and other support from developed countries.Footnote 41

After more than a decade of TRIPS implementation, various authors, scholars and researchers have proven that the rules show scant regard for the human development needs of developing countries.Footnote 42 In particular, the WTO regulation reflects little awareness of development problems in sub-Saharan Africa. In the Saharan region, prices charged for essential life-saving drugs make the difference between life and death. Per capita annual incomes in these countries are as low as $300; yet, a year's “treatment” of HIV/AIDS with patented, brand name antiretrovirals can cost up to $10,000 per person.Footnote 43 Stiglitz sagely commented:

“As it is, not only do the [WTO] rules make it difficult for developing countries to get access to these vital medicines at prices that they can afford, but the United States exacerbates the problem by coming down hard on any country that attempts to use a compulsory license. The United States threatens to take all kinds of other actions … even when the country is complying with all the rules of TRIPS. So, it is not just how the rules were designed but also the way they are being implemented that has made it more difficult to get access to these generic medicines.”Footnote 44

Patent regulation has therefore put the price of life-saving drugs beyond the means of the masses. Local companies are also unwilling and unable to manufacture generic types of such antiretroviral vaccines, which may sell for less than $200 a year per person, for fear of litigation from giant pharmaceutical patent holders.Footnote 45

Further, TRIPS's minimum standards of protection for patents have coerced and tied the hands of developing countries in their efforts to recover from hunger, disease and under-development. Thus, the TRIPS minimum standard of patent protection provides perverse incentives for economic and human development in sub-Saharan Africa. Not only have the rules caused a decline in the fortunes of developing countries, they have also given them additional problems.Footnote 46 According to Sell, it is regrettable that developing countries, as primary consumers of intellectual property, should sign up to TRIPS.Footnote 47 Certainly, most developing countries did not have a clear understanding of their interests and also failed to appreciate the intricacies of TRIPS.Footnote 48 They were simply deceived. As noted earlier, the west did not deliver on its promises to give developing countries agricultural and textile subsidies in return for signing TRIPS.

Flowing from the above, one can say that Fuller was right when he observed that “for a given social context one form of law may be more appropriate than another, and … the attempt to force a form of law upon a social environment uncongenial to it may miscarry with damaging results”.Footnote 49 In spite of Fuller's admonishment, the drivers of neo-liberal ideology have refused to acknowledge that the western-style patent system does not work in parts of Africa. The system advances a “one-size-fits-all” approach to the protection of IP rights across countries. This, in the view of Pound, is tantamount to a blind application of law (in this case international law) without regard to the consequences in developing countries.Footnote 50 Though countries in Africa are making efforts through domestic initiatives such as NEPADFootnote 51 to counter the spread of disease and other afflictions, they are effectively constrained by WTO rules such as TRIPS.

In effect, stringent patent protection policies have exacerbated conditions in countries in sub-Saharan Africa, the region most devastated by HIV/AIDS.Footnote 52 According to the Joint United Nations Programme on HIV/AIDS and the World Health Organization, more than 95 per cent of all HIV-infected people live in the developing world.Footnote 53 As a corollary, 95 per cent of all AIDS-attributable deaths occur in the developing world. Indeed, it has been predicted that less than half of the population of Africa currently alive will reach the age of 60.Footnote 54 Other commentators have lamented for instance that:

“In Botswana, 36 per cent of adults are now infected with HIV, whereas in South Africa, the figure is 20 per cent. South Africa has 4.2 million infected people, the largest number in the world … Economic studies suggest that the South African gross domestic product (GDP) will be 17 per cent lower in 2010 than it would be without AIDS … In Botswana, there could be a 13 to 15 per cent reduction in the income of the poorest households.”Footnote 55

Today, these statistics have become gloomier with the rate of infection increasing on a daily basis. The number of people infected in South Africa alone is now conservatively estimated at 5.5 million.Footnote 56 King Mswati III, in spite of his many marital unions, has lamented that “[t]here is a very real possibility that the Swazi nation will cease to exist [because of AIDS]”.Footnote 57

Developing countries are therefore at the receiving end of a dysfunctional patent system which has proven detrimental to the human development needs of sub-Saharan Africa. The system is dysfunctional because: it fails to take cognizance of the differences in the (in)capacities of individual states; it establishes a monopoly that allows the west to reap all the benefits while people suffer in the south; it is based on an economic ideology of self-interest that obliterates human values and the practices of indigenous communities;Footnote 58 it fails to acknowledge the communal nature of ownership interests in resources in developing countries; and it fails to treat access to life-saving drugs as part of the necessaries of life. The fact that the prevailing patent system creates dysfunction is further illustrated in the discussion below.

Non recognition of states' (in)capacities

The prevailing patent system fails to recognize that there is a wide gulf between developed and developing countries in terms of the HIV/AIDS infection rate and the accessibility / availability of drugs. Similarly, it fails to take cognizance of the differences in states' capacities as well as incapacities when it comes to available knowledge and innovation. Admittedly, a state can be classified as least developed, developing or developed. So, if a system which is based on developed country's IP standards is implemented across the board, it will hinder economically poor countries from benefiting.

An explanation for this dysfunction is not far-fetched: developing and developed countries have different goals. Ostergard articulated the differences in the goals of developing and developed countries as:

“Developed countries have attained a level of economic and political development that provides a high standard of living for their people. Their goal, at minimum, is to maintain that level of development. Developing countries have not attained the same level of economic or political development. Their goals reflect the desire to improve the standard of living for their people.”Footnote 59

Most countries in sub-Saharan Africa fall within the category of least developed states. Indeed, if there were any classification worse than being least developed, some of the states in the Saharan region may fall within it. Also, the HIV/AIDS infection rate in this region is much higher than that of the developed world. While some countries in sub-Saharan Africa have an HIV/AIDS prevalent rate of about 30 per cent, others in the west have a low rate of about 0.1 per cent.Footnote 60 Therefore, what is good for the west could be the reverse (and most often is so) in countries that are hardest hit by the HIV/AIDS pandemic. Consequently, forcing least developed or developing states to adopt western-style patent protection of medicines, which in turn inhibits access, is unjust and deserves rethinking.

Monopoly

Once upon a time, patent protection was considered to be a grant of privilege.Footnote 61 The grant of protection therefore signified societal sacrifices in offering legal protection to an otherwise unprotected private property right. But now, protection is considered to be a claimed right.Footnote 62 In treating patent protection as a claimed right, the prevailing patent system has created a monopoly in the hands of a few persons.Footnote 63 This is echoed by Prindle who remarked that “[p]atents are the best and most effective means of controlling competition. They occasionally give absolute command of the market, enabling their owner to name the price without regard to cost of production”.Footnote 64

The effect of a monopoly is that it stifles innovation and creates rent-seeking behaviour. Boldrin and Levine expressed the following reservations about patent monopoly:

“Intellectual monopoly has historically given and still gives all the rewards to a lucky and often undeserving person who manages, in one way or other, to get the patent and grab the monopoly power … [I]ntellectual monopoly is absolutely not necessary for great inventions to take place. It is damaging for society, as valuable productive capacity is literally destroyed and thrown away … [I]t is also awfully unfair.”Footnote 65

The irony is that most developing countries do not have antitrust (anti-monopoly) legislation to check patent abuses. This creates what Drahos and Braithwaite refer to as “biogopolies”Footnote 66 or what Temin calls “oligopoly”: a price fixing cartel.Footnote 67

The aggregation of pharmaceutical patents into a cartel becomes a great enemy to good management.Footnote 68 It works to the advantage of a few but not to the general good of society. It causes the markets to be under-stocked and regulated at a level that keeps the prices of drugs very high.Footnote 69 This affects the efficiency and innovativeness of the economy in developing countries.Footnote 70 It also lessens consumer choice because of the high costs of brand name drugs. Regulating pharmaceutical markets from the unilateral angle of producers without corresponding consideration for the interests of consumers creates distortions.Footnote 71 A monopoly thus makes the public worse off and creates a false incentive for a few.Footnote 72 The converse is that the public would be better off without a monopoly and the patent industry would grow by leaps and bounds. In bestowing a patent monopoly, countries should ensure that they get their money's worth through other regulatory trade-offs.Footnote 73

Western patent concepts impede access to necessaries of life

Stringent patent protection does not only create monopoly; it also impedes access to the “necessaries of life”. Necessaries of life refer to those things without which a person cannot reasonably exist.Footnote 74 They include food, clothing, shelter and other essential services such as medical services. In Ghana, for instance, necessaries are statutorily defined as “goods suitable to the condition in life of the person to whom they are delivered and to his actual requirement at the time of the delivery”.Footnote 75 Essential life-saving medicines, such as antiretrovirals, it is argued, fall within the category of goods considered as necessary for human survival in sub-Saharan Africa. Certainly, medicines are important for an individual to survive and should therefore be distinguished from luxurious goods such as compact discs.Footnote 76 Presently, antiretroviral drugs are urgently needed for human survival. The HIV/AIDS pandemic has reached such proportions in sub-Saharan Africa that, without access to antiretroviral drugs, it is impossible to ensure any meaningful human survival. It is therefore essential that life-saving medicines are included as part of the necessaries of life. Such a move would also force drugs manufacturers to reduce prices for fear of compulsory licensing by governments in sub-Saharan Africa.

Biopiracy

Communities in sub-Saharan Africa are rich in indigenous ideas and traditional knowledge. It is estimated that over 70 per cent of the world's biological resources are located in local and indigenous communities.Footnote 77 As knowledge or ideas held and used by people who identify themselves as indigenous, traditional knowledge differs from formal knowledge in the ways it is acquired, stored and transmitted.Footnote 78 However, ideas are not patentable, because it is considered that “the public interest is best served if abstract ideas circulate freely”.Footnote 79 It is, however, important to observe that ideas in communities in Africa go beyond abstract ideas. They consist of rich, traditional knowledge, lived and practised by indigenous communities. They develop as collective property of society, and are passed on to generations by word of mouth or through community practices. Unfortunately, the patent laws of most countries generally do not grant protection to traditional knowledge, because it is not considered scientifically valid. Traditional knowledge is considered terra nullius [land belonging to no-one], because patent law is based on the western concept of ownership. This lack of protection for indigenous knowledge in developing countries provides avenues for industrialized nations to plunder native lore.Footnote 80 For Shiva, the failure of the western patent system to protect traditional knowledge promotes biopiracy.Footnote 81 Also, western appropriation of traditional knowledge (biopiracy) results in the enclosure of the commons.Footnote 82

What is worse is that countries in the south have been coerced into granting protection to rights that are individualistic, contrary to the communal nature of traditional knowledge in those countries. Indeed, individualism is the mantra of neo-liberalization. It is in accord with this spirit that patent protection is granted to natural and artificial persons but not to communities. For Oguamanam, TRIPS's disregard for traditional knowledge leaves it open to unbridled appropriation.Footnote 83 In reality, modern inventors and researchers feed on the common resources of indigenous communities, but fail to acknowledge the traditional owners.

The commonly trumpeted “defence” is that traditional knowledge is unreliable because it has not been mentioned in previously published materials.Footnote 84 This is gibberish. Writing is not, and has never been, a sine qua non [essential condition] for measuring the utilitarian value of traditional knowledge. Consequently, the claim for reciprocal reward and acknowledgement by developing countries (as owners of traditional knowledge) cannot be said to be unwarranted. In essence, (mis-)appropriating traditional knowledge and patenting it after scientific tinkering, without recognizing its true source and factoring in the interest of dispossessed communities, is unethical, if not illegal. Further, exclusionary criteria, such as newness, novelty, non-obviousness, inventiveness and industrial applicability, which are used as sine quibus non for patent protection to deny any legal status to local knowledge, deserve rethinking.Footnote 85 The reason is that these exclusionary criteria are premised on erroneous assumptions about IP and over-generalized notions about local knowledge.Footnote 86

Insufficient disclosure / utility

To obtain patent protection, the inventor is obliged to disclose sufficient information during the patent application process. The inventor is promised that, upon disclosure, the state will grant an exclusive monopoly in the exploitation of the patented invention. This exploitation takes the form of the grant of an exclusive right to make, import, sell or use the patented invention. This exclusive monopoly is granted in the hope that the disclosure will aid future advancement of science and technology. Thus, monopolistic protection is granted so that the public can have access to the information for further research and the development of other inventions. Unfortunately, inventors subvert this requirement by making insufficient disclosure. Worse still, inventors are also granted patent protection for a patentable product which is otherwise not fully developed.

The Supreme Court of Canada appears to lend support to such anti-competitive practices. In the case of Apotex Inc v Wellcome Foundation Footnote 87 it had to decide whether a patent should be granted to an antiretroviral drug, AZT, whose utility in the “treatment” of HIV/AIDS was in its early stages. The appellants had argued that protection should not be granted for AZT on the grounds that the necessary utility of the drug had not been fully established as at the priority date of the patent application. The court held that the respondents (Glaxo / Wellcome) had, at the time of the application, sufficient information about the usefulness of AZT in fighting HIV in human cells and were therefore entitled to patent protection. The court added that: “requiring Glaxo / Wellcome to demonstrate AZT's efficacy through the clinical tests required for the approval of a new drug for medical prescription would have been unfair to Glaxo / Wellcome”.Footnote 88

The implication of this decision is that unqualified disclosure and proof of the utility of the product is not now what the law envisages before patent protection can be granted for a drug. All that is required of the inventor, according to the Canadian Supreme Court, is the ability to show “a sound prediction” of the usefulness of the invention, before its utility has been fully verified by tests. In the opinion of the court, this allows the inventor to do further work on the invention.

Though the Canadian Supreme Court upheld the need to grant legal protection to an “invention” that shows signs of prospect, the court did not set guidelines as to how the futuristic opportunity to perfect the supposed invention will be checked to ensure compliance. By granting patent protection to antiretroviral drugs before their utility has been fully verified by tests, a private fence was created, and the public has to wait for the fruits to develop over time. This, in the view of the author, is unsatisfactory because, once patent protection has been granted, the public is disabled from meaningfully exploring the supposed invention. The public thus has to wait for additional work to be done by the supposed inventor to perfect the “invention”, failing which expensive legal processes must be followed to overturn the grant of protection before others can explore the “invention”.

Inflexible flexibilities

The argument has been made that TRIPS contains flexibilities that permit developing countries to have access to HIV/AIDS medicines. This argument is a ruse and a subtle mask to deceive policy makers in the developing world. Rather, TRIPS makes it difficult for developing countries to use automatic compulsory licences that would allow easy access to life-saving medicines.Footnote 89 For Stiglitz, signing TRIPS amounts to “signing the death warrants on thousands of people in sub-Saharan Africa and elsewhere in the developing countries”.Footnote 90 This situation will improve if producers are allowed to produce and sell generic versions of drugs in countries whose income levels fall below what Stiglitz calls “a critical threshold”.Footnote 91 With low income levels and the high rate of HIV/AIDS in sub-Saharan Africa, most of the countries in that region will fall within Stiglitz's critical threshold. Consequently, the governments of these countries must adopt compulsory licensing measures to counter the HIV/AIDS quandary.Footnote 92 Also, the re-introduction of stricter levels of patent protection of medicines via bilateral trade agreements must be condemned and rejected, if there is to be any prospect of promoting access to medicines in sub-Saharan Africa.

POST-TRIPS MITIGATION MEASURES

Over the years, concern and outrage have been expressed about the rigidities associated with TRIPS. As noted earlier, TRIPS makes access to antiretroviral medicines in sub-Saharan Africa difficult. These concerns attracted international attention, and efforts were made in Doha, Cancún and Hong Kong to address some of the inflexibilities associated with TRIPS. It is, however, worth stressing that the supposed mitigation measures taken to bring sanity into the system remain inconclusive and disappointing, while HIV/AIDS continues to devastate the human race in Africa.

The reality is that the minor gains made under the Doha declaration and the decision reached by the WTO General Council on 30 August 2003 (both discussed below) 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. For instance, trade agreements being negotiated with countries of the Southern African Customs Union show a push for TRIPS-plus conditions.Footnote 93 Also, the European partnership agreements with African, Caribbean and Pacific countries impose new TRIPS-plus obligations that could have negative effects on access to medicines.Footnote 94 For Morin, the imposition of TRIPS-plus obligations via bilateral free trade agreements represents the frontline of impeding access to affordable medicines in developing countries.Footnote 95

Doha

In November 2001, efforts were made at the fourth WTO ministerial conference in Doha, Qatar to address the apparent rigidity in the global patent system. The Doha round of negotiations sought to redesign and re-position the international patent regime to meet the health care needs of individuals in developing countries and thus promote development. There, a group of developing countries “sought a legally binding declaration that would affirm an interpretation of TRIPS that would permit them to pursue policies affording access to essential medicines without fear of retribution from other WTO members”.Footnote 96 However, the move was met with stiff resistance from the United States of America and Switzerland on the grounds that TRIPS does not hinder access to essential medicines. Eventually, a declaration was agreed which emphasized that: “The TRIPS Agreement does not and should not prevent member governments from acting to protect public health. It affirms governments' right to use the agreement's flexibilities in order to avoid any reticence the governments may feel.”Footnote 97

It was also admitted that countries with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing schemes. Consequently, the TRIPS Council was instructed to find an expeditious solution to this problem and to report to the General Council.Footnote 98 As will be noted later, no such solution came until late 2003.Footnote 99

While some hail the Doha meeting as a post-TRIPS success, others contend that it failed to achieve any meaningful success.Footnote 100 It is worth noting that the alleged post-TRIPS improvement is insignificant; developing countries still face difficulties in taking advantage of the humanitarian provisions under TRIPS to allow for the manufacturing of generic versions of patent-protected medicines on grounds of public health and policy. Further, the imposition of higher levels of IP protection in recent bilateral agreements has asphyxiated the already fragile “flexibilities” under TRIPS and Doha.

The bulk of the complaint has always regarded article 31 of TRIPS. It is this article which sets the strict requirement for compliance before a country can take advantage of the humanitarian provisions in TRIPS. It allows compulsory licensing to be used predominantly for the purposes of supplying the domestic market of the country so licensed. This means that compulsory licences cannot be granted to produce generic medicines for export. As a consequence, countries in sub-Saharan Africa that lack the technological capacity to make their own generic versions of HIV/AIDS drugs were disabled from using compulsory licensing to their benefit.

Having recognized this inequity, the WTO General Council decided on 30 August 2003 (30 August decision) that countries with insufficient or no manufacturing capacities in the pharmaceutical sector could use compulsory licensing, provided they report to the General Council for approval.Footnote 101 It is after such approval that additional restrictions would be triggered into operation. The new restrictions after the 30 August decision relate to, among other things: the quantity to be manufactured; limits on the quantity to export or import; and an added requirement for the payment of adequate remuneration by exporting members. Srivastava and Satyanarayana articulated these drawbacks thus: “The tedious process … includes: (i) prior negotiation necessary before compulsory license granted; (ii) anti-diversion measures 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.”Footnote 102 It must be emphasised that the permission under the 30 August decision was only a temporary waiver.

On 6 December 2005 the supposed TRIPS flexibilities were accepted as a permanent amendment to the TRIPS agreement, which is expected to come into force following ratification by two thirds of WTO members.Footnote 103 The new provision will become article 31bis of TRIPS. Notwithstanding this amendment, some of the earlier mentioned TRIPS inflexibilities remain. Additionally, the new amendment has introduced the bureaucratic process of notifying the WTO TRIPS Council of the decision to use parallel import and export mechanisms. For Sampath, having to go through the scrutiny of the TRIPS Council before a state can proceed, further slows the process.Footnote 104 This notification process unnecessarily exposes developing countries to political pressure from industrialized countries, thereby creating a disincentive to use the mechanism.Footnote 105 The fact that Rwanda is the only country which has so far notified the TRIPS Council that it intends to use the mechanism to import generic medicines from Canada speaks volumes.Footnote 106 This notification was used to import antiretroviral therapy, TriAvir, from Canada. Indeed, the obstacles Rwanda had to surmount make the whole mechanism unattractive.Footnote 107

Cancún

Two years after the fourth WTO ministerial conference in Doha, a fifth one was organized in Cancún, Mexico to take stock of progress, and to lead negotiations into the next stage. The Cancún meeting was overshadowed by disagreements between developed and developing countries. The United States made concessions on TRIPS so that the pharmaceutical industry would agree to relaxed patent protection in developing countries. This however failed to placate countries such as South Africa and Brazil into reducing agricultural trade barriers. This disagreement caused the meeting to end with a mere affirmation of some parts of the Doha declaration and other decisions of the WTO General Council. It is worth noting that the mere affirmation of a dysfunctional patent regulatory framework was not meant to be a solution, if that was what was intended. Bhagwati has noted that the collapse of the Cancún meeting was partly because of the inclusion of IP in the WTO negotiations.Footnote 108 He has however expressed optimism that the collapse of the Cancún negotiations will serve as a lesson for future negotiations.Footnote 109

Hong Kong

The story of the sixth WTO ministerial conference is not much different from the Cancún story. This sixth conference was held in Hong Kong, China in December 2005. On the issue of TRIPS and public health, the meeting reaffirmed the 30 August decision. The ramifications of that decision have been alluded to above. Suffice it to indicate that TRIPS and public health concerns were not dominant at the Hong Kong meeting; rather, agricultural / non-agricultural product negotiations, trade and other matters dominated the meeting. Moreover, the mere affirmation of the 30 August decision, which is in itself riddled with gargantuan inadequacies, was indicative of the lack of concern for human development needs in the world's poorest region.

TOWARD DIVERSE DRUG-PATENTING SYSTEMS IN SUB-SAHARAN AFRICA

Having recounted the trajectory of the 21st century WTO ministerial conferences that sought to ameliorate the faults of TRIPS, this article now turns to its core proposal: diversity as a key to addressing the dysfunctions associated with the prevailing international patent system. The author's view is that this proposed diverse regulatory model could address some of the inadequacies or dysfunctions inherent in the prevailing international patent and institutional frameworks.

As indicated earlier, this article argues against the continued implementation of a western type patent system across the board in developing and developed countries. It proposes the adoption of diverse patent systems that suit the cultural needs and human development aspirations of countries in sub-Saharan Africa. Regulatory diversity here emphasizes five overlapping considerations: the adoption of a drug-patent model that meets human needs and shows respect for communal interests; a model that allows differences and is amenable to change in the light of socio-economic needs; a model that confronts “unfreedoms” which constrain human development;Footnote 110 a model that ensures respect and protection for the fundamental right to health; and a model that makes drug patent regulation fit social standards instead of making social standards fit rules.Footnote 111

So conceived, a diverse patent system should treat the protection of the right to health as the foundation for the enjoyment of all other rights. The right to health, as part of the provisions of human rights, should trump IP rights.Footnote 112 This is confirmed by the report of the UK Commission on Intellectual Property Rights: “there are no circumstances in which the most fundamental human rights should be subordinated to the requirements of IP protection”.Footnote 113 Similarly, respect for human rights should be made to trump TRIPS limitations without attracting any trade sanctions or WTO complaints. This was eloquently articulated by Amani: “states should not be discouraged by the threat of trade sanctions in giving human rights obligations priority over trade in domestic law and policy”.Footnote 114 This, according to her, will maximize a state's comparative advantage and lead to greater welfare.Footnote 115

Patent regulatory policies should also consider human beings as subjects and not merely as objects of sustainable development. Holmes calls this: “the Kantian injunction to regard every human being as an end in himself and not as a means”.Footnote 116 This prescription accords with the principle that “human beings are at the center of concerns for sustainable development”.Footnote 117 By treating human beings as the central concern of development, patented products such as medicines will be viewed as social products located within a cultural context. Therefore, an individual should have a positive right to a fair share of his community's scarce resources.Footnote 118 Thus, policies that affect drug pricing should treat human development needs as superior in order to make medicines accessible to a large number of people.

Indeed, the need to ensure respect and protection for the right to health and human development has become more imperative as progressive judicial decisions have been handed down by courts for socio-economic rights to be enforced in Africa. One instance is the South African case of Minister of Health & Others v Treatment Action Campaign & Others.Footnote 119 The applicants in this case sought to challenge the government's policy on accessibility to antiretroviral drugs that prevented the risk of mother-to-child transmission of HIV. The policy allowed the drugs to be administered at designated locations, thereby making them unavailable at other public health institutions. In deciding whether the policy fell short of the government's obligation under the South African Constitution, the Constitutional Court found that this was indeed the case, and ordered the government to remove the restrictions. In another case,Footnote 120 a High Court in Ghana ordered the release of a 25 year old woman who had delivered a baby at a polyclinic but was being detained at the clinic due to her inability to pay her medical bill of about $150. These two cases exemplify the dilemma of some African governments: TRIPS holds them to ransom for bringing down the cost of access to health care, while their domestic constitutional obligations are being enforced against them at the behest of the domestic courts. This dilemma must be resolved in favour of more superior socio-economic rights guaranteed in most national constitutions in sub-Saharan Africa.

Further, the diverse model will require countries with high rates of HIV/AIDS infection to use compulsory licensing for the domestic manufacture of antiretroviral medicines on the grounds of public health and policy. This should be done without the need for compliance with preconditions set by the developed world and its giant pharmaceutical corporations. States must thus use their prerogative to determine the conditions for the grant of such licences. As a flexible model, it should allow states in Africa to regain their autonomy and ensure respect for human development needs in sub-Saharan Africa. This is the only solution if there is to be any prospect of Africa achieving the Millennium Development Goals (MDGs) by 2015, contrary to Ray Bush's pessimism that the MDGs will not be met.Footnote 121

Countries in sub-Saharan Africa should also avoid TRIPS-plus obligations which impede access to medicines and agricultural products in their countries. TRIPS-plus demands maintain dominant market positions for giant pharmaceutical companies, and create substantial obstacles to the introduction of generic medicines.Footnote 122 Moreover, since the majority of the countries in Africa are least developed, they should avoid religious compliance with TRIPS, not to mention TRIPS-plus obligations.

A diverse patent model also entails limiting the scope of protectable subject matter under patent systems in countries in sub-Saharan Africa. This restriction must take cognizance of the socio-cultural needs of countries in the Saharan region. For instance, if Canada upholds patent protection for genetically modified canola seeds (as it did in the case of Monsanto Canada Inc v Schmeiser)Footnote 123 developing countries in Africa, the vast number of whose people are subsistence farmers, need not chart that course. Also, if the US grants patent protection to basmati rice (as it has done),Footnote 124 patenting plant varieties should be resisted by developing countries whose populations are largely subsistence rice farmers. Additionally, patent protection should not be granted to medicines whose utility has not been established beyond doubt at the time of the application, contrary to the decision of the Supreme Court of Canada that such protection should be granted “even before their utility has been fully verified by tests”.Footnote 125

A diverse model should allow developing countries to recognize the primacy of indigenous culture and traditional knowledge over individual rights derived from the illegal expropriation of indigenous resources. This is consistent with the Convention on Biological Diversity, which provides for the protection of:

“innovations … and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and to promote their wider application with the approval and involvement of the holders of such knowledge, innovation and utilization of such knowledge, innovation and practices.”Footnote 126

Diversity in patent protection should also allow developing countries to halt the appropriation, if not theft, of traditional medicines by giant corporations under the guise of invention. Boyle refers to the practice of privatizing something that was in the public domain as “enclosing the commons”.Footnote 127 This enclosure happened with respect to the hoodia cactus plant known to the Kung Bushmen of South Africa as a cure for obesity.Footnote 128 It also happened to neem tree oil in the US. In Europe, patent protection for the neem tree was granted to a US pharmaceutical corporation until India's challenge before the European Court caused its reversal.Footnote 129 In most developing countries in Africa and in India, the neem tree serves as communal medicine for treating various illnesses. Granting patent protection to the neem tree so that, in subsequent years, people in developing countries beg for neem-medication from the west defies any sense of justice.

The unique strength of the proposed model is that it would go a long way to ameliorate crumbling health care systems and re-integrate countries in sub-Saharan Africa meaningfully in future international patent negotiations. It would also expand the human development capability of developing countries in Africa and enhance substantive freedoms.Footnote 130 Indeed, robbing people of the opportunity to obtain treatment for illnesses impedes the realization of human development. This is consistent with Adam Smith's observation that “[n]o society can surely be flourishing and happy, of which the far greater part of the members are poor and miserable”.Footnote 131 The best acts are those that maximize human welfare.Footnote 132 Developing countries must thus put human need at the centre of drug patent regulation and relegate TRIPS autocracy to legal history.

The proposed diverse model can be implemented through legislative and institutional reforms across countries in sub-Saharan Africa. Also, countries must use competition legislation to check patent abuses in the market place. Reforms must be embodied in domestic policy documents which set out clear avenues to explore to promote access to medicines and food for impoverished populations. The proposed reforms and policy regulations must fit social conditions, rather than making social conditions fit rules. They must limit the scope and terms of pharmaceutical patents. Also, countries must work through regional groups such as the Economic Community of West African States, Southern African Development Community and East African Community to take advantage of compulsory licensing mechanisms and promote the parallel importation of relatively cheaper generic versions of antiretroviral drugs for their citizenry. Such a south-south co-operation would enable countries in the Saharan region to harness economies of scale for the purposes of building local innovative capacity. Further, most countries in sub-Saharan Africa must recognize their situation as least developed countries so as to avoid assuming unwarranted international obligations under TRIPS.

Such bold initiatives have been taken before. You only need a government with the guts to withstand the veiled threats from special interest groups. For instance, in 1997, Nelson Mandela's government passed the Medicines and Related Substances Control (Amendment) Act to allow the health minister to use compulsory licensing for the manufacture of generic versions of antiretroviral drugs. The act also permits the parallel importation of cheaper generic versions of vaccines from other countries so as to reduce medical costs. This generated immense anger from lobbyists, capitalists and maximalists. The government was sued by 39 pharmaceutical companies and the US government exerted mounting pressure for its repeal. When the government failed to succumb to the incessant pressure, the US put South Africa on its Special 301 watch list for possible trade sanctions: South Africa was blacklisted. The pressure, however, never paid off because the South African government stood by its policy. Eventually, the US government removed South Africa from its Special 301 watch list. The suit was also shelved. Such a determined experience is also chronicled elsewhere to serve as a lesson for governments in Africa.Footnote 133

CONCLUSIONS

This article has stressed that WTO rules on drug patenting have become a drawback to human development in sub-Saharan Africa. It has argued for the adoption of diverse systems of patent protection that make essential medicines, such as antiretroviral drugs, available and accessible to improve the health and wellbeing of persons in Africa. This diverse model should take account of cultural and human development needs in the sub-Saharan region. It must also take cognizance of the constitutional and fundamental right to health as the basis for creating exceptions in response to strict WTO rules that make it difficult for persons in sub-Saharan Africa to afford life-saving medicines.

Footnotes

Ibid.
Ibid.
Ibid.
Ibid.
ibid.
Ibid.

References

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114 Amani, B“Merchants and missionaries: Patenting life, competing international obligations and the proselytization of a realistic Utopia” (SJD dissertation, University of Toronto, 2007)Google Scholar, abstract available at: <http://proquest.umi.com/pqdweb?did=1367837881&sid=1&Fmt=2&clientId=10843&RQT=309&VName=PQD> (last accessed 12 December 2008).

115 Id at 330.

116 OW Holmes “Ideals and doubts” in Henson (ed) Landmarks of Law, above at note 50, 207 at 207.

117 Principle 1 of the Rio Declaration on Environment and Development 1992, available at: <http://www.unep.org/Documents.Multilingual/Default.asp?DocumentID=78&ArticleID=1163> (last accessed 13 December 2008).

118 Woods “Justiciable social rights”, above at note 23 at 775.

119 2002 (5) SA 721 (CC).

120 Republic v Chief Admin Officer, La Polyclinic; Minister of Health; Attorney General (High Court, 2003) (unreported).

121 Bush Poverty & Neoliberalism, above at note 27 at xiv.

122 Abbott and Reichman “Access to essential medicines”, above at note 94.

123 2002 SCC 34, [2004] 1 SCR 902.

124 Stiglitz “Economic foundations of intellectual property rights”, above at note 2 at 1704. For a detailed exposition on the patenting of basmati rice, see Chandola, HV “Basmati: Geographical indication or mis-indication” (2006) 9 Journal of World Intellectual Property 166CrossRefGoogle Scholar.

125 Apotex Inc v Wellcome Foundation Ltd, 2002 SCC 77, [2002] 4 SCR 153.

126 Art 8(j) of the UN Convention on Biological Diversity 1992.

127 Boyle, JThe Second Enclosure Movement and the Construction of the Public Domain (2003) 66 Law & Contemporary Problems 33 at 39Google Scholar.

128 See Kihwelo “Indigenous knowledge”, above at note 78 at 347.

129 See Stiglitz “Economic foundations of intellectual property rights”, above at note 2 at 1716, citing Shiva, V and Brand, R “The fight against patents on the neem tree” in von Weizsäcker, EU et al (eds) Limits to Privatization: How to Avoid Too Much of a Good Thing (2005, Earthscan)Google Scholar.

130 Sen Development as Freedom, above at note 110 at 3.

131 Smith The Wealth of Nations, above at note 68 at 110–11.

132 Ostergard The Development Dilemma, above at note 35 at 21, citing Kymlicka, WContemporary Political Philosophy: An Introduction (1990, Clarendon Press)Google Scholar.

133 See Ostergard, id at chap 7; Sell Private Power, Public Law, above at note 17 at 154–57; and Drahos and Braithwaite Information Feudalism, above at note 4 at 6–8 and 88–90.