Relationship between TRIPS and International Human Rights Law in the Context of Access to Medicines
Relationship between TRIPS and International Human Rights Law in the Context of Access to Medicines
The relationship between TRIPS and human rights has often been conceived as conflicting. This chapter begins with a brief overview of the debate about TRIPS and human rights. In order to enhance conceptual clarity, a clarification is provided as to distinctive features of the entitlements under the existing intellectual property system, in comparison to the right to the protection of the moral and material interests of the author under Article 15.1(c) of the ICESCR. Also, the relationship between intellectual property rights on one hand, and the right to property recognised in international human rights instruments on the other is briefly discussed. This chapter then redirects its attention to TRIPS and human rights concerning the issue of access to medicines. It considers the definition of normative conflicts in international law, drawing upon recent relevant studies, and examines how norms in TRIPS and norms in international human rights law relate to each other in the context of access to medicines. Stress is placed on the importance of interpreting TRIPS in light of international human rights law. Inquiry is made as to whether the understanding of TRIPS has evolved or is able to evolve so as to be responsive to values and concerns intrinsic to international human rights law. While a harmonised interpretation of TRIPS and international human rights enables the State to utilise appropriate policy measures that promote access to medicines, this chapter also notes, it may be of limited benefit to the issue of health innovation and access to its outcome in developing countries, which requires the development of an alternative or complementary R&D system.
The Early Interface between TRIPS and Human Rights
UN Sub-Commission on Human Rights
The adoption of TRIPS in 1994 and the following bilateral and regional ‘TRIPS-plus’ treaties has revealed that the way intellectual products are regulated through the grant of exclusive rights may have significant human rights implications. The first response to the issue, directly devoted to the relationship between human rights and intellectual property, came from the UN Sub-Commission on the Protection and Promotion of Human Rights (‘Sub-Commission’) in 2000. In its resolution 2000/7 ‘Intellectual property rights and human rights’1 with its focus on TRIPS, the Sub-Commission warned that ‘actual or potential conflicts exist between the implementation of TRIPS and the realization of economic, social and cultural rights’.2 The Sub-Commission listed as areas of human rights concern: (a) impediments to the transfer of technology to developing countries; (b) the consequences for the enjoyment of the right to food of plant variety rights and the patenting of genetically modified organisms; (c) ‘bio-piracy’ and the protection of traditional knowledge; and (d) the implications for the right to health of restrictions on access to patented pharmaceuticals.3
To resolve potential conflicts between intellectual property and human rights, the Sub-Commission urged all States to recognise ‘the primacy of human rights over economic policies’ when designing national law and policy concerning intellectual property.4 Furthermore, the Sub-Commission requested the WTO to ‘take fully into account the existing State obligations under international human rights’.5 The various UN bodies, including the Secretary-General, the High Commissioner for Human Rights, the Committee on Economic, Social and Cultural Rights (CESCR), and the World Intellectual Property Organization were recommended to analyse the human rights implications of TRIPS.6 A significant number of reactions from other UN human rights bodies, various intergovernmental organisations, governments and NGOs followed.7
WTO and WIPO
The WTO drew an analogy between the intellectual property system and human rights in its reply to the Sub-Commission’s critique of TRIPS. It took special note of authors’ rights to the protection of moral and material interests resulting from their work under Article 27(2) of the UDHR and Article 15(1)(c) of the ICESCR.8 The WTO stated that ‘it can be argued that TRIPS also seeks to give effect … to article 15(1)(c) [of the ICESCR]’.9 It also considered that Article 7 setting out the objectives of TRIPS ‘corresponds with the objectives of article 15(1)(a) and (b) of the ICESCR’ recognising the right of everyone to take part in cultural life and to enjoy the benefits of scientific progress and its applications.10 Article 7 of TRIPS (Objectives) states that ‘the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations’.11 The WIPO, similarly, stated that intellectual property and human rights both require ‘resolving tensions and striking balances’ between ‘the rights of creators and those of users’,12 referring to Article 15 of the ICESCR and Article 27.2 of the UDHR.13
UN High Commissioner for Human Rights
The UN High Commissioner for Human Rights also recognised that there exist links between TRIPS and human rights. However, the High Commissioner posed a question as to ‘whether TRIPS strikes a balance that is consistent with a human rights approach’.14 On this question, the High Commissioner for Human Rights made several preliminary remarks, which can be summarised as follows: (1) ‘The promotion of public health, nutrition, environment and development’, which has close links with human rights, ‘are generally expressed in terms of exceptions to the rule’ in TRIPS, whereas ‘a human rights approach … would explicitly place the promotion and protection of human rights … at the heart of objectives of intellectual property protection’.15 (2) TRIPS does not provide the content of the responsibilities of intellectual property holders, as opposed to the detailed rules of their rights, and thus the balance under TRIPS may not be consistent with a human rights approach.16 (3) TRIPS might restrict States’ capacities to protect and promote human rights.17 (4) The protection of traditional knowledge is not provided for in TRIPS.18 Further, the report of the High Commissioner for Human Rights provided an analysis of the impact of TRIPS in the context of the right to health, substantiating the need to review TRIPS in light of human rights.
Other UN Human Rights Bodies
Besides the responses from the WTO, WIPO and the UN High Commissioner for Human Rights, a series of reports and resolutions of UN human rights bodies have addressed the issue of human rights and intellectual property since the adoption of the Sub-Commission’s resolution 2000/7. The CESCR released a ‘statement on Human Rights and Intellectual Property’19 in 2001 and provided a preliminary analysis of the relationship between human rights and intellectual property. From 2001 to 2003, the UN Commission on Human Rights adopted three annual resolutions on ‘Access to medication in the context of pandemics such as HIV/AIDS, tuberculosis and malaria’, and requested States and the relevant intergovernmental organisations to ensure access to essential medicines.20 The UN Special Rapporteur on the Right to Food mentioned ‘concerns that patents on seeds limit the access of peasant farmers to seeds for replanting’ in his 2002 and 2003 reports.21 The UN Special Rapporteur on the Right to Health recommended States make use of provisions in TRIPS, such as compulsory licensing, with a view to promote access to affordable drugs, and further cautioned the potential negative impact of ‘TRIPS-plus’ legislation on the right to health.22
These early debates concerning the relationship between intellectual property and human rights, described so far, have given rise to the need for clarification as to how intellectual property relates to human rights, whether there is conflict between TRIPS and human rights, and if so, how it can be resolved. These questions are central to characterising and reshaping the relationship between intellectual property and human rights. The following sections of this chapter ask these questions, specifically in the context of access to medicines.
Distinction between Intellectual Property Rights and Human Rights
Intellectual Property Rights and the Right to Benefit from the Protection of the Moral and Material Interests of the Author (Art. 15.1(c) of the ICESCR)
Different types of intellectual property
It is necessary to clarify the distinctive features of intellectual property rights in comparison to human rights, before exploring the issue of normative conflicts. The mention of Article 15.1(c) of the ICESCR and Article 27 of the UDHR, in the responses from the WTO and WIPO to the Sub-Commission’s resolution 2000/7, indicates a tendency to equate intellectual property rights with the right to benefit from the protection of the moral and material interests of the author, recognised in international human rights instruments.23 There are various types of intellectual property rights and each of them may have a different relationship with human rights. For instance, the moral rights of authors in Article 6bis of the Berne Convention may share the characteristics of human rights,24 although the provisions on copyrights in TRIPS have excluded the protection of the moral interests of authors from its scope.25 On the other hand, corporate trademarks, one type of intellectual property right, may share few commonalities with the human right under Article 15.1(c) of the ICESCR, since they are not to protect intellectual creations of individuals but to facilitate competition by distinguishing different goods and services.26 The scope of analysis here is restricted to patent rights among other types of intellectual property since patent rights are of particular relevance in the context of access to medicines.
Differing foundational principles
The fact that the human person is the central subject and primary beneficiary of human rights distinguishes human rights, including the right of authors to the moral and material interests in their works, from legal rights recognized in intellectual property systems. Human rights are fundamental, inalienable and universal entitlements belonging to individuals, and in some situations groups of individuals and communities. Human rights are fundamental as they derive from the human person as such, whereas intellectual property rights derived from intellectual property systems are instrumental, in that they are a means by which States seek to provide incentives for inventiveness and creativity from which society benefits. In contrast with human rights, intellectual property rights are generally of a temporary nature, and can be revoked, licensed or assigned to someone else. While intellectual property rights may be allocated, limited in time and scope, traded, amended and even forfeited, human rights are timeless expressions of fundamental entitlements of the human person. Whereas human rights are dedicated to assuring satisfactory standards of human welfare and well-being, intellectual property regimes, although they traditionally provide protection to individual authors and creators, are increasingly focused on protecting business and corporate interests and investments. Moreover, the scope of protection of the moral and material interests of the author provided for under article 15 of the Covenant does not necessarily coincide with what is termed intellectual property rights under national legislation or international agreements.27
This statement by the UN CESCR succinctly describes differences between intellectual property and the right under Article 15.1(c) of the ICESCR.28 What follows further elaborates these distinctive features of patent rights and the right under Article 15.1(c) of the ICESCR.
Most significantly, patent rights and the right to the protection of moral and material interests are different from each other in terms of foundational principles. As the CESCR identified, a human right ‘derives from the inherent dignity and worth of all persons’, ‘whereas intellectual property rights are first and foremost means by which States seek to provide incentives for inventiveness and creativity, encourage the dissemination of creative and innovative productions, … for the benefit of society as a whole’.29 The historical overview of intellectual property in Chapter 1 has shown that patent rights are created to serve a social function, and are not an end in themselves. This is illustrated by section 6 of the Statute of Monopolies of 1623 (England),30 the foundation of the modern patent system, and section 8 of the US Constitution.31 The analysis of different perspectives on patents in Chapter 2 has also indicated that the main ground for a patent is that it is a policy tool to stimulate knowledge creation, balancing with access to knowledge. Objectives set out in Article 7 of TRIPS reflect this perspective.32
Patents as a policy instrument
Distinctive features of patent rights follow from their instrumental nature. States, through legislative acts, grant the exclusive rights, adjust the scope and duration of those rights, permit exceptions to the exclusive rights, and may even make provisions for the revocation or forfeiture of the rights.33 Not all inventions are patentable.34 One important criterion for patentability is industrial applicability, which reflects the main purpose of patents, i.e. encouraging inventions useful to society. The life of a patent is limited, and after a certain period of time, the subject matter of the patent belongs to the public domain.35 Determining the duration of the patent protection is a balancing exercise between private interests and public interests. An applicant for a patent is also required to disclose the details of the invention he or she is seeking a patent for, which is to facilitate further innovation.36 A patent system provides exceptions and limitations to the exclusive rights, such as compulsory licensing.37 Chapter 3 of this book has elaborated various exceptions and limitations to the exclusive rights, provided in Articles 27(2) and (3), 30 and 31 of the TRIPS Agreement. All these features illustrate that patent rights are granted, protected and limited, with a view to achieving social ends. While the human right under Article 15.1(c) is not without limitations, human rights require stringent rules regarding limitations.38 Even among human rights, the scope of permissible limitations differs according to the moral importance of the right in question. The scope of limitations upon human rights is discussed in detail in Chapter 7.
Who is entitled to a right is another major issue distinguishing patent rights from the right under Article 15.1(c). Under the patent system, a patent right is granted to the first to file an application, with the exception of the US where the first to invent is granted a patent. Neither the first-to-file nor the first-to-invent system provides a patent right to other independent inventors of the same or similar piece of invention. Such systems are justified by several reasons, e.g. promoting prompt disclosure of inventions, providing sufficient incentives to innovation, and easing the burden of administration.39 However, in case several persons or groups independently come up with a same invention, all independent inventors, not only the first applicant of a patent, are within the scope of Article 15.1(c) of the ICESCR.40
Whether assignees and corporations can be the right holder highlights a further difference between the patent rights and the human right under Article 15.1(c). According to the CESCR, the protection of Article 15.1(c) requires a personal link between the creators and the creations, and thus can be enjoyed only by ‘individuals and, under certain circumstances, groups of individuals and communities’,41 as discussed under ‘Authors’ in Chapter 5. On the other hand, patent rights are mostly held by corporations.42 The corporations may hold the patent rights ‘by assignment from the actual, human creators’.43 While patent rights can be assigned to someone else and traded,44 the human right owed to the inventor is inalienable.45 The CESCR has noted that ‘[u]nder the existing international treaty protection regimes, legal entities are included among the holders of intellectual property rights. However, … their entitlements, because of their different nature, are not protected at the level of human rights’.46
Issue of traditional knowledge
The issue of traditional knowledge also exposes a divergence between the human right under Article 15.1(c) and patent rights. While traditional knowledge is within the scope of Article 15.1(c),47 it does not easily fit with the existing intellectual property system. Most traditional knowledge would be considered to belong to prior art, thus failing to meet the novelty criteria for the protection of intellectual property.48 A sui generis intellectual property system, that is, ‘a legal regime “of its own kind” which is specifically adapted to the nature and characteristics of traditional knowledge’,49 can be established in order to protect traditional knowledge holders.50 However, for the most part, traditional and indigenous communities may not pursue private ownership over their knowledge. Instead, they may seek other measures to preserve and safeguard traditional knowledge, e.g. the identification, documentation, transmission, revitalization and promotion of traditional knowledge.51 Therefore, the grant of exclusive rights, a typical form of the existing intellectual property system, may not be one of the essential features of the protection of the moral and material interests of traditional knowledge holders under Article 15.1(c).
So far, it has been discussed that a patent right under the existing intellectual property system is different from the human right under Article 15.1(c) of ICESCR, in terms of the foundation and purpose of each right, and the manner in which each right is implemented.52 To the extent that these differing features are recognised, a patent system can be used as a means to protect the human right of the inventor. Nonetheless, it is worth revisiting some of the points explained in Chapter 5 on material interests within the meaning of Article 15.1(c) of the ICESCR.53 What is protected as a human right under Article 15.1(c) is adequate and just remuneration for intellectual labour so as to enable the author/inventor to enjoy an adequate standard of living.54 These basic material interests of the author/inventor under Article 15.1(c) can be satisfied by other measures, such as one-time payments, as well as the grant of exclusive rights for a limited period of time.55 When a patent system is used to protect the material interests of the inventor, States must make sure that it does not negatively affect other independent inventors.
Patent Rights and the Human Right to Property
There is a separate question of whether a patent falls within the right to property under international human rights law. If the answer to this question is positive, a discussion has to follow as to the scope of permissible limitations of a patent right. A similar question was raised when 39 global pharmaceutical companies brought a legal action against the South African government, claiming that the Medicines Act 1997, limiting a patent right with a view to increasing access to medicines, contravenes, inter alia, the right-to-property provision of South Africa’s Constitution (section 25).56 The lawsuit was, however, dropped by the companies as a consequence of mounting pressure from civil society worldwide. What follows briefly discusses the relationship between a patent and the right to property in the context of international human rights law.
The right to property in international human rights law
Article 17 of the UDHR recognises everyone’s right to own property alone as well as in association with others, and prohibits arbitrary deprivation of property.57 There is no provision on right to property, however, in either the ICESCR or the ICCPR. The drafting history indicates that although there was a consensus on the recognition of the right to property, disagreement over the formulation of the right and the scope of limitations upon the right was insurmountable.58 The Annotations on the text of the draft International Covenants on Human Rights59 are instructive in understanding differing views about the right to property that can be characterised as a human right.
The Annotations report three different views about the formulation of the universal human right to property. One view proposes the formulation of the right in broad and general terms, modelling Article 17 of the UDHR, considering ‘the differences of views regarding property rights embodied in the social and political systems of various States’.60 Another view was in favour of the formulation ‘drafted in precise legal terms and spel[t] out the necessary qualifications and limitations to which the right of property would be subject’, and proposed texts which ‘would not only provide that States parties should undertake to respect the right of property, but would indicate that the right was not absolute and would specify the conditions under which a person might be deprived of his property’.61 A third view was that the article should delineate the scope of the right to property that is qualified as a human right. From this point of view, only to the extent that is ‘necessary for decent living and for maintaining the dignity of the individual and the home … could the right of property be regarded as fundamental and inviolable’.62
What was generally agreed was that ‘the right to own property was not absolute’63 and ‘the right to own property was subject to some degree of control by the State’.64 However, it was not possible to reach an agreement on the extent of not only the limitations of the right, but also the restrictions on State action.65 In the absence of the right to property provision in the two Covenants, Eibe Riedel suggests that the right to property in the UDHR can ‘still serve, for instance, to legitimize the concept of “smaller ownership”, i.e. property rights limited to subsistence guarantees of individuals, but it could not be utilized as a justification for large-scale capital accumulation’.66
While ‘it was not possible to reach a consensus on the permissible restrictions in the context of a universal convention’, the similar ‘legal and social traditions’ within geographical areas made it possible to include the right to property and relevant limitation clauses in regional human rights treaties.67 Thus, the right to property is provided in Article 23 of the American Declaration68 and Article 21 of the ACHR.69 The right to property was included in Article 1 of Protocol 1 to the ECHR70 and in Article 17 of the Charter of Fundamental Rights of the European Union.71 Article 14 of the African Charter on Human and Peoples’ Rights72 and Article 31 of the Arab Charter on Human Rights73 also recognise the right to property. All the above provisions in regional human rights instruments include limitation clauses. This indicates that while the right to property is widely recognised since the security of individual possession is necessary for one’s autonomy and personal development, a property system is constantly adjusted according to the economic and social policies of States on e.g. land, tax, welfare and the environment.74 For this reason, Catarina Krause observed that, in the context of international human rights law, ‘there will always be a certain amount of reluctance towards international supervision of these rights [property rights]’.75
An expectation of obtaining a patent
When examining a question of whether a patent right is within the scope of the human right to property, a distinction should be made between those who have an expectation of obtaining a patent on one hand, and those who have acquired a patent on the other. The human right to property does not apply to those who seek a patent over an invention, since there is no existing property.76 The formulations of the right to property provisions in international human rights instruments are commonly understood to protect only ‘acquired property rights’ from arbitrary interference by the State.77 This implies that the right to property in international human rights law does not give rise to a positive obligation upon States to provide a specific form of property to a person.
The scope of the right to property may be extended so as to imply that everyone is entitled to a certain minimum of property necessary for a decent standard of living and a life with dignity.78 Such a reading can be supported by how the right to property is phrased in Article 23 of the American Declaration.79 With this universal right to have a minimum of personal property as a potential exception, the right to property provisions in international human rights conventions ‘emphasize the negative aspects of the right by spelling out the conditions for permissible interference with one’s property’.80 It is doubtful that an expectation of acquiring a patent falls within the scope of a potentially justifiable positive right to property.
Moreover, Article 17 of the UDHR suggests that the right to property is not predicated on a specific form of property, by containing the phrase ‘alone as well as in association with others’. The drafting history confirms this reading.81 Peter K. Yu noted that this article can provide ‘an equally compelling basis for the creation of a rich public domain and for unrestricted access to protected materials [intellectual products]’.82 The natural right to property argument, based on Locke’s theory, also does not favour private property in intellectual products over the common ownership, as discussed in Chapter 2. Therefore, determining what kind of property rights in intellectual products should be prescribed by the relevant law is a matter of social agreement.
In fact, a modern patent system does not grant all inventors the exclusive right in their invention. It combines time-limited exclusive rights and public domain, as explained earlier in chapters 1, 2 and 3. A set of criteria for patentability is set out by the relevant domestic law, subject to the TRIPS Agreement.83 These criteria for patentability may change, reflecting relevant policy changes. Any patent claim over an invention is subject to an examination by the granting office as to whether it satisfies the criteria for patentability. Therefore, some inventions become part of the public domain from their inception, and other inventions, those that have met the conditions for patentability, are subject to the exclusive rights for a certain period of time and then belong to the public domain.
This question of an expectation of holding a patent was examined by the European human rights system. In British-American Tobacco Company Ltd v. the Netherlands, the Commission was of the opinion that an application for a patent was not covered by the right to property provision in Article 1 of Protocol No. 1 to the ECHR.84 This view was reiterated by the European Court of Human Rights in a case concerning a trade mark, stating that ‘the applicant company could not be sure of being the owner of the trade mark in question until after final registration and then only on condition that no third party raised an objection, as the applicable legislation permitted. … Prior to such registration, the applicant did, of course, have a hope of acquiring such a “possession”, but not a legally-protected legitimate expectation.’85
An acquired patent
Does the human right to property apply to the person having acquired the patent after having met the conditions set out by relevant law? First of all, this question has to surmount a conceptual difficulty raised by the fact that patents are mostly held by corporations. As seen above in relation to the right to the protection of moral and material interests, the CESCR is of the view that human rights are ‘fundamental entitlements of the human person’86 and intellectual property rights, held by legal entities, ‘are not protected at the level of human rights’.87 Article 1.2 of the ACHR clarifies that ‘2. For the purposes of this Convention, “person” means every human being’. However, Article 1 of the First Protocol to the ECHR is extended to claims by corporations. This is the only provision of the ECHR that expressly recognises the rights not only of natural persons, but also of legal persons.88
Specifically regarding intellectual property, the European Commission and Court of Human Rights have been requested, very occasionally, to examine the applicability of Article 1 of the First Protocol to intellectual property. The resultant case law has ruled that patents, copyrights and trademarks are ‘possessions’ in the sense of Article 1 of Protocol 1 to the Convention,89 often referring to Smith Kline and French Laboratories Ltd v. the Netherlands:90 ‘The Commission notes that under Dutch law the holder of a patent is referred to as the proprietor of a patent and that patents are deemed, subject to the provisions of the Patent Act, to be personal property which is transferable and assignable. The Commission finds that a patent accordingly falls within the scope of the term “possessions” in Article 1 of Protocol No. 1.’ The Charter of Fundamental Rights of the European Union, adopted in 2000, specifically included intellectual property in the right to property provision.91