ACCESS TO MEDICINES: CONCEPTS, THEORIES AND LEGAL HISTORICAL FOUNDATIONS

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CHAPTER THREE ACCESS TO MEDICINES AS A HUMAN RIGHT

Introduction

In the previous chapter we focused on basic concepts, distinctions and theories of intellectual property. The chapter also touched on aspects of international patent law under the auspices of the World Trade Organisation TRIPS Agreement and the World Intellectual property Organization (WIPO) and access case studies to medicines. The foregoing chapter’s main aim was to contextualize the study and this contextualization continues in this chapter albeit with a different focus.
In this chapter, the access to medicines debate is pursued from a different conceptual and normative perspective and the human rights dimension is introduced and its potential applicability to resolving the access problem explored. The conflict between intellectual property rights and human rights, namely the right to health, is explored against the backdrop of both an international and SADC dimension. The main question which this chapter seeks to answer is whether the access to medicines problem for the SADC region may not be resolved through the adoption of the rights-based approach. It is appropriate to explore the link between human rights and intellectual property so that the TRIPS flexibilities as potential solutions to the access problem may be viewed in their proper context in chapter four below.
For the foregoing reasons, this chapter explores the nature of intellectual property rights and lays bare some of the theoretical arguments that seek to equate intellectual property rights to mainstream human rights. Secondly, intellectual property rights are juxtaposed with the right to health and the main international human rights provisions dealing with the right to health are analysed and linked to the problem of access to medicines. Thirdly, the concept of a rights-based approach is exposed and its potential applicability to resolving the access problem cursorily pursued. Finally, African and SADC regional instruments that have been identified are analysed in order to explore the potential of their deployment to resolving the access problem using the right to health as a legal normative tool.
It is envisaged that once a strong case for the link between human rights and intellectual property has been made in the context of access to medicines, it will then be appropriate to pursue an access solution for the SADC region through the deployment of TRIPS flexibilities outlined in chapter four below. Some of the documented flexibilities, namely compulsory licenses, parallel importation and differential pricing, initially proffered as possible solutions to the SADC access problem in chapter four, influenced the direction of this study in chapters five, six and seven. The solutions that have been proffered in chapter seven have taken into account human rights norms. Hence, laying the human rights foundation and establishing a rational link is an indispensable inclusion in this chapter.

Establishing the Link between Human Rights and Intellectual Property Law

Conceptual linkages

Intellectual property law and human rights law share a related Western European societal developmental origin.1 Therefore, in the context of this study, intellectual property rights which, together with other access barriers continue to militate against access to medicines are western impositions which remain an access encumbrance to be dislodged through the deployment of a rights-based approach. Dogmatically speaking, intellectual property law is based on private law while human rights, addressing primarily states, are of a public law nature.2 If one accepts that the right to property is a human right,3 it is surely doubtful that the right to property can routinely outweigh the rights to life and health.
The World Intellectual Property Organisation (WIPO), United Nations Human Rights Council, the Committee on Economic Social and Cultural Rights, the World Health Organisation (WHO) and the Food and Agriculture Organisation (FAO) are now aware of the human rights dimension of intellectual property.4 Some governments, courts and public interest non-governmental organisations view intellectual property protection as implicating potential violations of the right to life,5 health, food, privacy, and freedom of expression and the enjoyment of the benefits of scientific progress.6
Applied directly to the aims and objectives of this study, the implication of the above submission by Helfer and Austin is that ‘the denial of access to essential drugs threatens the enjoyment of the right to life’,7 protected in Article 6 of the International Covenant on Civil and Political Rights (ICCPR).8 Furthermore, the denial of access to essential drugs militates against the right to ‘the highest attainable standard of physical and mental health’,9 as spelt out in the pertinent provision of the International Covenant on Economic Social and Cultural Rights (ICESCR).10
Both legal fields originated and grew quite apart out of social developments which were not interrelated.11 However, the modern contemporary reality is that the relationship between intellectual property rights and human rights has now evolved into a problematic one.12 The problematic aspect is exemplified, on the one hand, by the view that intellectual property rights and human rights are in conflict since the legal protection of private intellectual property rights is considered incompatible with community-based human rights; with human rights on the other hand viewed as legal instruments that limit and restrict the enforcement of intellectual property rights.13 If this view is pursued to its extreme ends, then human rights must always trump intellectual property rights. Applied to the context of this study, the implication would be that the problem of access to medicines would be easily resolved if intellectual property rights were to give way to human rights. However, matters are not that simplistic as the next paragraph shows.
The other opposing view is that intellectual property rights and human rights are compatible because they pursue the same aim. Therefore, intellectual property rights are embodied in human rights.14 In the access to medicines context, this view requires striking a balance between the protection of intellectual property rights and access to medicines. The major question that remains in the context of the aims of this study is: How should a proper balance be struck between the protection of intellectual property rights and access to products of intellectual property, namely medicines? I have attempted to answer this question cursorily in this chapter and in detail from chapter four to chapter seven.15

Intellectual Property and Human Rights in the International Context

Human rights protect the fundamental rights of individuals and groups.16 ‘Fundamental rights can be defined as entitlements that belong to all human beings by virtue of their being humans’.17 This is in direct contrast to property rights (like intellectual property rights), which can always be ceded in voluntary transactions.18 While human rights are said to be universal (exist irrespective of implementation), there seems to be two categories of human rights emerging namely, fundamental rights and non-fundamental rights.19 Whether a right is classified as fundamental or non-fundamental largely depends on whether the classifier thereof is a positivist or a naturalist.20 Whether viewed through the eye of a naturalist or positivist, the whole concept of human rights is a fruit of western thinking which does not concur in every respect with non-western thinking.21 If the Western thinking is pursued to its extreme end, the implication for access to medicines will be that governments of poor countries must protect intellectual property rights at all costs, even when upholding such “universal” rights will result in extinguishing the right to life for citizens. This will be inequitable and will militate against access to affordable medicines for those in dire need of it hence it is this study’s thesis that a departure from this conception of human rights and IP rights is called for.22
Conceptualising something as a human right signifies its importance as a social or public good.23 Rights focus on the dignity of persons, equality and non-discrimination.24 Rights imply entitlement and are almost never absolute and may be limited, such limitation being subject to strict scrutiny.25 A right ‘trumps’ many other claims or goods.26 Health issues, especially issues around access to medicines are, therefore, important to warrant categorisation as rights, hence health may be regarded in this context as a ‘social good’.27 The fact that the right to health is recognized locally and internationally gives legal and political legitimacy to the claims for its enjoyment.28 Rights only have a meaning if it is possible to enforce them.29
Human rights constitute the basic framework guiding state actions on the domestic and international levels.30 Human rights are the ‘rights a person has by simply being born.’31 Human rights are minimum standards understood to be necessary for individuals to live in dignity.32 In terms of the United Nations Charter,33 the United Nations shall promote universal respect for and observance of, human rights and fundamental freedoms for all without distinction as to race, sex, language or religion. The Charter is important in that human rights which were once only a matter of domestic concern have now been elevated to a subject of international treaty obligations.34
The Universal Declaration of Human Rights (UDHR)35 enumerates the basic rights of the individual and was the first international legal instrument to do so.36 It took almost two decades to move the aspirational concepts laid out in the UDHR into legally binding obligations.37 The ‘right to freely participate in the cultural life of the community, to enjoy the arts and to share in the scientific advancement and its benefits is the most relevant to intellectual property generally and to this study in particular.38
It is important to highlight that the UDHR was passed by the General Assembly as a resolution with no force in law because it was never intended to create binding legal obligations.39 Notably, it was not signed because it was never intended to be signed.40 Today, however, the UDHR imposes some legal obligations on nation states.41 There is legal uncertainty over whether all rights proclaimed in the UDHR are binding and under what circumstances. Furthermore, there is no settled legal position on whether the obligatory character of the UDHR derives from its status as an authoritative tool for interpreting human rights as contained in the Charter or its status as customary international law.42
Be that as it may, there are specific covenants which have been passed with the aim of transforming the general principles in the UDHR into binding treaty obligations.43 The covenants also seek to establish the international machinery to ensure governmental compliance. Very pertinent to this study is the fact that the International Covenant on Economic Social and Cultural Rights guarantees the right to enjoy the highest attainable standard of physical and mental health.44 The realisation of the right, however, has to take place progressively within the limits of the state’s available resources.45 This provision is directly relevant to access to medicines.
Historically, the protection of intellectual property rights was viewed in the context of the territorial, international and global periods.46 The territorial period was inward looking and the protection of intellectual property rights remained largely a matter for domestic legislation through statutes. Therefore, the protection of rights did not extend beyond the borders where the rights had been granted in the first place.47 On the other hand, the international period was characterized by growing interest in cooperation between nation states in the domain of intellectual property law.48 This period saw the introduction of the required international legal regulatory framework such as the Berne and Paris Conventions.49 The global period was driven by a bid to transform the existing international framework for intellectual property law into a harmonized intestate regulatory regime in sympathy with international commercial interdependency of the developed world.50 The move from the international to the global period saw a proliferation of international intellectual property regimes leading to harmonization in specific areas.51
The Berne52 and Paris53 conventions are silent on human rights and this may be due to human rights having been a non-issue at the time of signing the conventions.54 The TRIPS Agreement generally does not “expressis verbis” refer to either any human rights law instrument or any human right in particular.55 However, in the preamble to the TRIPS, reference is made to protections granted to authors and inventors as ‘rights’ (‘recognising that intellectual property are private rights’). If intellectual property rights are regarded as property rights as implicated in the preamble of TRIPS, they would then fall under article 27 of the Universal Declaration of Human Rights56 and article 1 of the First Protocol to the European Convention for the Protection of Human Rights and Fundamental Freedoms.57 The International Covenant on Economic Social and Cultural Rights (ICESCR)58 establishes one’s right to:
take part in the cultural life,
the protection of moral and material interests resulting from any scientific, literary or artistic production of which he is the author, as a human right.59
Rights granted under paragraphs (a) and (b) of Article 15 of the ICESCR converge with the objectives of the WTO Agreement to which the TRIPS Agreement is an annex; more specifically with reference to the emphasis put on the public interest rationale of intellectual property protection.60 The United Nations Committee on Economic, Social and Cultural Rights reflected on Article 15.1 (c) of the ICESCR and produced General Comment no. 17,61 wherein intellectual property rights were cited as different from human rights due to their general temporary nature which can be revoked, licensed or assigned to someone else.62 Human rights do not have the above characteristics and are timeless expressions of fundamental interests of the human person.63
Focusing specifically on the TRIPS Agreement, it does not reflect the fundamental nature and indivisibility of human rights, including the ‘right of everyone to enjoy the benefits of scientific progress and its applications’.64 Hence, there is an apparent conflict between the intellectual property rights regime embodied in TRIPS, on the one hand, and international human rights law on the other.65 The attention of the human rights system was first drawn to the TRIPS Agreement in 2000.66 The debate led to the adoption of the Resolution on Intellectual Property and Human Rights.67 The resolution is critical of the TRIPS Agreement and states that ‘actual or potential conflict exists between the implementation of’ the treaty ‘and the realization of economic, social and cultural rights’.68 Specific areas causing the conflict include inter alia, transfer of technology to developing countries, the right to food and plant variety rights, genetically modified organisms, bio-piracy, reduction of commercial control over own genetic and natural resources and restrictions on access to patented pharmaceuticals and implications for the enjoyment of the right to health (my emphasis).69
To resolve the conflict, the Sub-Commission urged states, inter-governmental organisations and NGOs to recognize that human rights have ‘primacy….over economic policies and
agreements’.70 However, it is disheartening that Sub-Commission resolutions are by their very nature non-binding. Hence, they do not impose immediate legal consequences.71
In the decade since the resolution’s adoption, the overwhelming positive responses it has elicited have been reflected in numerous resolutions,72 reports,73 comments74 and statements75 relating to TRIPS and intellectual property protection more generally. The most important reaction which goes to the core of this study was the publication in 2008, of Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines.76 The publication urges pharmaceutical companies to ‘make and respect a public commitment not to lobby for more demanding protection of intellectual property interests than those required by the TRIPS’.77
The Council for Europe’s Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR)78 and the First Protocol thereto, are both silent on intellectual property.79 However, there is one notable case of the European Commission on Human Rights dealing with intellectual property as a right.80 In this case, a patent right is recognized as a property right in the context of the ECHR. There is likely to be a practical legal enigma if a corporation can be regarded as an owner of intellectual property and hence an enjoyer of human rights.81
In the European Union (EU) context, the recently adopted Charter of Fundamental Rights82 provides that intellectual property shall be protected. However, the provision falls short of introducing the human right to intellectual property rights because it is addressed to institutions of the EU rather than the right holders.83
Constitutional and related legislations of many countries pay attention to acknowledging and securing the promotion and protection of creativity and innovation in various ways.84 However, in the constitutional context, what is contemplated is the vertical application and enforcement of the intellectual property rights against the state rather than the horizontal application of the rights between citizens.85
3.1.3 Intellectual Property and Human Rights in Legal Literature: Some Problematic Areas Having briefly traced the background to the relationship between intellectual property law and
human rights above, it is now appropriate to give a brief overview of the converging and diverging scholarly views on the problematic relationship. Many scholars have made incisive and telling contributions that attempt to unravel the conceptual and paradoxical relationship between intellectual property rights and human rights. In the following paragraphs, a summary of some of the leading views is given.
Intellectual property rights are instrumental in promoting and protecting human rights, hence they need to be implemented into domestic law.86 Human rights can be used as instruments to deflect the moral appeal of certain affirmative rights of intellectual property holders by, for example, justifying compulsory licences in the interest of public health.87 This submission would make more sense when viewed against Chapman’s analysis of Article 27 (2) of the UDHR and Article 15.1 (c) of the ICESCR, wherein he opines that participating states are under an obligation to develop intellectual property law regimes that have an explicit human rights orientation.88
Intellectual property rights are not first and foremost ‘economic commodities’ but have an intrinsic value as an expression of human dignity and creativity.89 An understanding of intellectual property as a human right is lacking in the WTO and by extension in the TRIPS Agreement.90 There is, therefore, a need to take a non-uniform view of intellectual property since not all intellectual property rights can be considered as human rights.91 The imposition of WTO-wide minimum standards for intellectual patent protection has been contested on the basis that public health concerns require weaker or more flexible patent protection in the pharmaceutical field.92 This argument has often been advanced by or on behalf of developing countries.93
If corporations are bound by human rights norms, then pharmaceutical companies would be bound by the right to access medicine, if it exists (see below) and thus be held accountable where their pricing violates the obligations imposed under the right.94 However, it will be difficult to attribute state-like attributes to corporations in the absence of an express categorization of human rights obligations in light of the fact that international law traditionally binds states.95 Fundamental rights would not only serve as a guide for the application of intellectual property law but also for the reorganization of intellectual property law in future.96
If intellectual property is viewed as a ‘right to benefit’, due to the intellectual property system having been established as the primary means by which to access this ‘benefit’, then, intellectual property rights are in effect aligned with human rights.97 This view and the others expressed before it sharply contrasts with Drahos’ view in which he argues that intellectual property rights are universally recognized notwithstanding the fact that this does not make them universal human rights, since they depend on legislative declaration and are for a limited time (usually 20 years). It is notable, therefore, that they do not belong to all human beings and also that not all intellectual property rights protect personal interests of their originators.98
While the UDHR recognizes intellectual property as a human right,99 promoting universal intellectual property protection is incompatible with the promotion of human physical wellbeing.100 Indeed, if intellectual property is regarded as a guaranteed human right, developing countries would be put at a disadvantage, both in developing policies to sustain economic growth and in increasing global markets.101 It is submitted that in the same way as there is a hierarchy of laws, there is also a hierarchy of human rights hence it should be conceded that some human rights take priority over other human rights. In the context of this study, it would seem likely that the right to physical wellbeing (read medicines) will have to trump intellectual property rights. For developing countries generally, and specifically those in the SADC region, recognising that this hierarchy exists will go a long way towards resolving the access to medicines enigma.
There is a need to protect everyone who is likely to be negatively affected by strengthened intellectual property rights standards (like Ostergard) and also to consider the broader question of the role of science and technology in a human rights framework.102 The ability of WIPO and the WTO to infuse human rights into the intellectual property legal regime they promote is in serious doubt.103 The main reason for this could be due to the fact that both organisations have been established to promote the facilitation of international commerce at the behest of the private sector in the West rather than to promote human welfare in the world, especially in the South.
On the other hand, characterizing intellectual property as a human right implies construing the right to enjoy monopoly right and rent as a human right even if it is at the expense of society at large.104 This goes against the basis of Article 15.1 (c) of the ICESCR which talks of striking the balance between intellectual property and human rights. Viewed in this light, intellectual property rights and human rights are incompatible because intellectual property rights get in the way of countries seeking enforcement of human rights.105
The above outline highlights the problematic relationship between intellectual property and human rights and summarizes some of the major juridical views on the subject. It is generally not desirable to highlight problems without proposing solutions thereto. Therefore, the following section continues outlining the major writings on intellectual property and human rights but with a bias towards offering solutions to the problematic relationship. Where possible, the solutions are contextualized to the access to medicines problem, in order not to blur the focus of the study.

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Table of Contents
DECLARATION
DEDICATION
AKNOWLEDGEMENTS
SUMMARY
KEY TERMS
LIST OF ABREVIATIONS AND ACRONYMS
CHAPTER ONE INTRODUCTION
1. Background to the Study
2. Statement of the Problem
3. Preliminary Literature Review
4. Assumptions Underlying the Study
5. Aims and Objectives of the Study
5.1 Aims
5.2 Objectives
6. Research Methodology
7. Mode of Citation
8. Justification and Limitations of the Study
8.2 Justification of the Study
8.3 Limitations
9. Ethical Issues
10. Organisation of the Rest of the Study
CHAPTER TWO  ACCESS TO MEDICINES: CONCEPTS, THEORIES AND LEGAL HISTORICAL FOUNDATIONS
2. Introduction
2.1 Intellectual Property Law: Basic Concepts and Distinctions
2.2 Theories and Rationales for Intellectual Property
2.3 Theories of Intellectual Property and Access to Medicines: A very Brief Contextual and Preliminary Evaluation
2.4 International Patent Law in the Context of Patents and Access to Medicines
2.5 The Legal Historical Evolution of the Access to Medicines Debate – Access to Medicines Narratives
Conclusion
CHAPTER THREE  ACCESS TO MEDICINES AS A HUMAN RIGHT
3. Introduction
3.1 Establishing the Link between Human Rights and Intellectual Property Law
3.2 Access to Medicines in the Context of the Right to Health
3.3 Is there a Right to Have Access to Medicines?
3.4 The Rights-based Approach and its Potential Utility in Resolving the access Problem
3.5 The Right to Health and Access to Medicine in Africa and the SADC Region
Conclusion
CHAPTER FOUR  AN OVERVIEW OF WTO TRIPS FLEXIBILITIES AVAILABLE FOR USE BY SADC MEMBER STATES
4. Introduction
4.1 Preliminary Remarks on WTO TRIPS Flexibilities Generally
4.2 Public Health, the Doha Declaration and the August 2003 Decision
4.3 Public Health and General TRIPS Flexibilities in Detail
Conclusion
CHAPTER FIVE  THE ACTUAL USE OF TRIPS FLEXIBILITIES IN SELECT SADC COUNTRIES
5. Introduction
5.1 The Use of TRIPS Flexibilities: Brief Overview of Pertinent SADC Instruments
5.2 Availability of Patents for Pharmaceuticals and New use Patents in SADC
5.3 An Overview of the use of TRIPS Flexibilities in SADC Member States’ Laws
5.4 Domesticating TRIPS Flexibilities: The Case of Botswana
5.5 Government Issued Compulsory Licenses as an Access Tool: The Case of Zimbabwe
5.6 The South African Access to Medicines Experience
Conclusion
CHAPTER SIX  LITIGATING ACCESS TO MEDICINES: THEMATIC LESSONS FOR THE SADC REGION FROM OTHER DEVELOPING COUNTRY JURISDICTIONS
6. Introduction
6.1 Limiting ever greening and Incremental Patenting: Novartis AG v Union of India and Others
6.2 Effective use of Patent Opposition in Thailand
6.3 Effective Post-grant Opposition: the Didanosine Patent Case
6.4 Anti-Counterfeiting Laws as Access to medicines Barriers: The Kenyan Experience as Reflected in P.A.O and Others v Attorney General and Another
Conclusion
CHAPTER SEVEN SUMMARY, RECOMMENDATIONS AND AREAS FOR FURTHER RESEARCH
7. Introduction
7.1 A brief Restatement of the Research Problem, Aims and Objectives
7.2 Summary and discussion of the Main Findings
7.3 Recommendations
7.4 Areas for Further Research
7.5 Valedictory Note on Recommendations
7.6 Chapter Summary
BIBLIOGRAPHY OF WORKS CITED
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