Intellectual Property Rights, the Right to Health, and the UDHR: Is Reconciliation Possible?
Since the signing of the 1994 Marrakesh Agreement establishing the World Trade Organization (WTO) and the included Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), activists, scholars and policymakers have expressed concerns over how the global protection of intellectual property rights (IPR) may affect access to essential medicines. On 31 March 2009, the United Nations (UN) Human Rights Council’s Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, Anand Grover, issued his report on the right to health and TRIPS.1 Grover concluded that the TRIPS and Free Trade Agreements (FTAs) had negatively affected pharmaceutical prices and availability, making it difficult for states to meet their obligations to fulfil the right to health.2 The report was the latest volley in the debate over what appears to be two contradictory aspects of human rights protection: the right to health and the right to intellectual property. As such, reaction to the special rapporteur’s report, predictably, has been split between developed and developing countries. While states such as Egypt and India were supportive of the findings, and particularly critical of the evergreening3 of existing patents, the USA and Switzerland were particularly critical of the findings, arguing that intellectual property has not had an adverse effect on the availability of pharmaceuticals and that the report did not take into account the concerns of states that manufacture medicines.4 While it is likely that no country would deny the human right to health care, the interpretation of its scope is certainly in dispute. For instance, regarding the USA’s response to the rapporteur’s report, Chargé d’Affaires Mark C. Storella stated:
While the United States recognizes this right, we do not agree, as a legal and policy matter, with the way in which the contours of the right are described in the report. The United States believes in the importance of non-discriminatory access to medicines as an integral component of an effective health care system. We note, however, that the report focuses on a narrow aspect of health: medicines that are patented in certain countries. We strongly disagree with the report’s contention that intellectual property protections, as embodied in TRIPS and Free Trade Agreements, have had an adverse impact on access to medicines. The report’s perspective fails to acknowledge intellectual property protections as highly positive to the availability of medicines, of health innovations, and of improving health care. The United States also believes that the report also raises serious institutional concerns related to the interpretation of WTO agreements, in particular the TRIPS agreement.5
Following the rapporteur’s report, Brazil introduced a resolution (sponsored by several countries, including Cuba, Egypt, India and South Africa among others) that
Calls upon States, at the international level, to take steps, individually and/or through international cooperation, in accordance with applicable international law, including international agreements, to ensure that their actions as members of international organizations take into due account the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, and that the application of international agreements is supportive of public health policies that promote broad access to safe, effective and affordable medicines.6
France, speaking on behalf of the European Union (EU), objected that the resolution did not focus on other aspects of health care such as systems to provide health care.7 The US chargé d’affaires, Douglas Griffiths, expressed regrets that the resolution was so narrowly drawn as to emphasize only intellectual property and trade.8 The resolution highlights the significant differences in perspectives that the two groups of countries have on the right to health and how IPR affects it. In part, the differences in policies can be explained by structural differences in the economies of developed and developing countries. Developed countries experiencing shifts in the nature of their national economies from a manufacturing base to a services base see intellectual property as a key means to protect domestic employment and expanding overseas markets for their IPR-dependent products (i.e. software, pharmaceuticals, mp3 audio files, movie DVDs, etc.). Developing countries experiencing economic and social difficulties that hinder providing basic health care to their populations see global IPR protection as a further impediment to health care for their people. Given these differences, the question that has to be asked is: can these two perspectives on human rights be reconciled?
In recent years, there has been growing support in many circles to make health care a universal human right and a ‘global public good’ since all societies benefit immensely from a healthy population. Yet, the present IPR system has a detrimental impact on the right to health, since it reduces the availability of pharmaceuticals, especially for individuals suffering from curable diseases in developing countries, hence pitting the needs of the poor who require medicine to live against the profit-maximizing goals of pharmaceutical firms.
Though few publicists and policymakers would argue against the right to health care on moral grounds, this chapter argues that the greater problem has been over the feasibility of such an idea, especially where the ‘right to health’ has never been clearly defined. We discuss the numerous practical impediments to balancing the two values – the right of creators to protect their intellectual property and the right of everyone to enjoy the highest attainable standard of health care. We argue that to strike a balance between these important values, all countries must work to develop policies that take into account the basic health and developmental interests of developing countries. We also argue that important changes must be made to the current IPR system, especially with respect to the production and pricing of basic goods and services needed to fulfil health subsistence rights. These changes must include allowing developing countries access to essential medicines that support the realization of basic health, welfare, and economic development. Since one of the goals of development is the improvement of people’s physical well-being and the expansion of their capabilities, the restricted production of particular medicines under the current IPR system conflicts with these important goals. The implementation of international agreements must also be made more consistent with the goals of public health policies that promote broad access to safe, effective and affordable medicines, and conflicts between the types of rights enumerated in these agreements must be worked out for the broader benefit of human society if the right to health will ever be fully realized. For example, the UDHR9 declares both intellectual property and health to be human rights.10 A number of incentives exist for pharmaceutical and biotechnology companies to focus more of their research on the development of drug protocols that treat diseases afflicting poor people in developing countries. However, there are a number of important drawbacks to these proposals, which we discuss.
Before elaborating on the arguments outlined above, this chapter explores the differences between traditional property rights and intellectual property, as well as the benefits and drawbacks of supporting stronger IPR for developed and developing countries, which tend to have differing national priorities over the issue of IPR protection. We explore the historical origins of the concept of ‘right to health’ in human rights discourse and how this right received greater attention during the 1990s. During this period, an important conceptual shift occurred in this discourse that increasingly emphasized the promotion of basic subsistence rights. Yet, this shift in focus has not been without controversy, as some writers are opposed to the idea of the right to health, not necessarily on moral grounds since one would be hard-pressed to advocate profits over human life, but on more practical grounds since such rights are, arguably, not easily implementable and are costly. This chapter reviews a number of criticisms of viewing health care as a basic subsistence right (or a type of positive right) on a par in importance with civil and political rights (negative rights), the latter of which have been historically considered morally superior to the former, and less costly and easier to implement. As this chapter illustrates, subsistence and civil and political rights do not fit neatly into the positive/negative dichotomy, since all human rights require both positive action and restraint by the state if they are to be effectively implemented, and all human rights require governments to take costly action.11 Hence, the argument that health subsistence rights are impossible to implement in developing countries that experience significant resource constraints should not be used as a reason to continue denying more than half the world’s population access to basic health care.
This chapter concludes with the potentially controversial argument that we need to replace the dominant state-centric paradigm that views the right to health care in strictly nationalistic terms (as simply problems of the state) with a more cosmopolitan paradigm that reflects the true nature of the relationship between IPR and human rights as a ‘global public good’. Anything short of that goal would leave the universal right to health care unrealizable for a significant segment of the world’s population.
2. The Nature and Variable Importance of IPR
Traditional property theory holds that property is equated with individual possession. However, property represents a relationship between the owner and other individuals relative to some item. The relationship is a right that can protect the owner’s property. What makes intellectual property (IP) unique in this regard is its intangible nature. With traditional forms of tangible property, formal law is not necessary to protect it; people may protect their property from encroachment by others. IP differs from simple tangible property in this sense because there is no way to protect it; or, rather, the only way to protect IP completely is to keep it secret. Hence, one of the primary characteristics of IP is that it is non-exclusive because a person cannot prevent others from using the property once it is disclosed. In the case of IP, the state must guarantee the exclusive ownership of the idea or work, artificially creating a relationship of exclusion (or monopoly) between IP owners and others who may want to utilize the IP.12 For instance, if plans for a new invention are disclosed, there is no way to prevent a person from utilizing the idea.
Another distinction between traditional property and IP is supply. For instance, no one can use land that has already been appropriated. Furthermore, the supply of land is finite, which means that market forces of supply and demand have a significant (though not final) role in determining realestate prices. Contrast this with the chemical formula for a particular medicine. Individuals can use that formula repeatedly and its supply will remain unchanged. No matter how many people pass along the formula, its supply will never diminish. Likewise, there is absolutely no cost involved in an additional person using the formula, and, as Hettinger points out, modern technology has made the transmission of such ideas practical with few limitations.13 Hence, without state protection, IP possesses fundamental differences from simple property. The state establishes laws to protect people’s property from others. These laws assign rights to exclude others from using one’s property. Similarly, IPR give individuals the right to exclude others from using their ideas, works, and inventions. IP laws alter the essential nature of intangible property by eliminating nonexclusive property. To this end, IPR grant exclusive control over some object (whether it is literary, mechanical, or procedural). The possessor is then able to exclude others, to control the output, and to establish a monopoly price within the limits that product demand will allow.14 The supply of the intangible object has thus been artificially limited by the introduction of exclusive control over distribution. As Hettinger points out, it is the non-excludable attribute of intellectual objects that is key to understanding the nature of and justifications for IP.15 Without formal protections of IPR that the state can impose and enforce, IPR producers are left with no guaranteed ways to ‘secure’ their property against infringement. This situation can present real problems of investment return for producers who may spend millions of dollars developing a product only to have the product mass-produced by producers who did not incur the initial start-up cost of production. Or, to put it relative to pharmaceuticals, the first pill of a new medication may cost $200 million to produce; each pill after that initial pill may have a production cost of a few cents. Nonetheless, the pharmaceutical producer still has to make up the $200 million for the first pill.
From a practical, macro-perspective, strong IPR supporters tend to focus on the economic benefits that states and societies can derive from protecting IPR. Most often, supporters cite Joseph Schumpeter’s research, which focuses on innovation and technology as the driving forces of industrial development for modern states.16 Those supporting stronger IPR protection argue that it has several benefits, including increased domestic research and development, increased flows of new products, enhanced value in patent rights, greater inward investment and technology transfers, and improved local knowledge.17 These benefits, however, are most often associated with developed countries that do not face some of the specific, and more pressing, issues that confront developing countries. Most developing countries do not have the capacity for domestic research and development; in fact, the notion of product variety for developing countries is, in the short term, limited to the variety of ways that they can feed and care for their people. Even if developing countries want and can afford new products, the more pressing issue is whether those products are necessarily appropriate for countries that are seeking simply to provide basic provisions, such as food, water, shelter, and health care, to their people. Does a country such as Mali or Namibia need the latest Windows software on new laptops when the available resources could be better used to ensure the right of access to health facilities; access to minimum essential food which is nutritionally adequate and safe; access to basic shelter, housing and sanitation; and an adequate supply of safe and potable water, especially for vulnerable or marginalized groups? The example is a bit extreme, but it serves to highlight the disjoint in national priorities between developed and developing states overall.
While national-level IPR may provide this incentive structure for innovation in developed countries, when IPR protection is provided equally across all countries, such as the case with TRIPS under the WTO, the incentive structures become much more complex for developed states and may actually work against their interests. For instance, if copyright protection is provided to producers no matter where they are located, it is in the interest of producers to take advantage of lower production costs if they are afforded equal protection no matter where they produce their product. Thus, while IPR may be critical for long-term state economic advancement, in the short term, IPR may, in fact, be detrimental to advanced states. For instance, if a software producer such as Apple or Microsoft can get the same copyright protection in India as they would in the USA, all else being equal, the labour market dynamics would promote the shifting of production from the USA to India. Engineers and programmers in India make a relatively small amount of money compared to their counterparts in the USA or the UK.18 But this situation is not just a problem for easily copied software or music. Even the pharmaceutical industry has displayed patterns of shifting high-paying pharmaceutical development jobs to areas around the globe that have a lower prevailing wage. The shift in employment can be attributed to several factors, but prominent among them is the emergence of strong IPR regimes in states such as Singapore, India and China.19 Hence, while the IPR incentive structure may promote innovation, it may also promote certain negative externalities for developed countries seeking to promote job growth and overall economic growth.
3. Prioritizing Rights: The Right to Health as a Subsistence Right
One of the emerging areas in the discourse on human rights is the right to health. The concept has a long history, dating to the nineteenth-century Industrial Revolution.20 Edwin Chadwick, a student of Jeremy Bentham, had argued that disease promoted poverty and that poverty promoted social ills, disorder and ultimately higher taxes. Friedrich Engels, Karl Marx’s friend and collaborator, reversed Chadwick’s causal relationship and promoted the idea that poverty caused disease in his Condition of the Working Class in England.21 The modern incarnation of the right to health as an institutionalized ‘human right’ dates only from the UDHR of 1948.22 But what this right to health means is not clear, and scholars and practitioners have been struggling to define its scope for some time now.
In early work on the concept, scholars debated what was termed the ‘absurdity’ of the term, which, some argued, implied a right to ‘perfect health’.23 Such debates led to discussions that made the concept more precise in meaning such that the concept of a ‘right to health’ implied a ‘right to health care’ or a ‘right to health protection’.24 By the 1990s, a shift in the human rights discourse started to give greater attention to economic, social and cultural (ESC) rights (so-called second-generation or positive human rights). Prior to this expansion in the discourse, the primary objective of human rights specialists was working toward the protection of civil and political rights (so-called first-generation or negative human rights).25 As the concept received greater attention from international organizations, the idea of feasibility began to enter into the discourse. The UN recognized the growing importance of rights to health when it appointed the UN special rapporteur on the right to the highest attainable standard of health in 2002. Brazil had pushed to appoint this special rapporteur, and the UN approved the post despite the two votes against it from the USA and Australia.26 The first special rapporteur, Paul Hunt, began to shape the context of the right to the highest attainable standard of health, which has been shortened to the ‘right to health’.27 As Hunt contended:
While the right to health includes the right to health care, it goes beyond health care to encompass the underlying determinants of health, such as safe drinking water, adequate sanitation, and access to health-related information. The right includes freedoms, such as the right to be free from discrimination and involuntary medical treatment. It also includes entitlements, such as the right to essential primary care. The right has numerous elements including child health, maternal health and access to essential drugs. Like other human rights, it has a particular concern for the disadvantaged, the vulnerable and those living in poverty. The right requires an effective, inclusive health system of good quality.28
The rights listed by Hunt require state action that includes provisions for these rights and the monitoring of indicators and benchmarks. In short, they are implicitly recognized rights that must be worked towards, meaning that they are ‘expressly subject to both progressive realisation and resource availability’.29
While the right to health may be gaining traction in international discourse and attention from non-governmental and intergovernmental organizations, it has been subject to criticism, along with the whole category of ESC rights, from liberal scholars, who contend that ESC rights are not rights, but goals or objectives for states to achieve.30 Since the post-World War II era, the normative foundations of human rights have been expanded to include not only civil and political rights, but also a broad array of other types of human rights, notably ESC rights.31 Both types of rights form two subsets of the broader concept of human rights.32 International declarations, covenants, and treaties, notably the International Bill of Rights, list a wide catalogue of civil, political, economic, social, and cultural human rights.33 Notable examples include the right to life and liberty and security; the rights to freedom of speech, conscience, and religion; the right to education; the right to participate in community affairs; the right to vote; the right to health care and social insurance; the right to work; and the right to property, among others.34
Despite the obvious grounding in international human rights law and in national constitutions, some commentators criticize support for a full menu of human rights because of factors of impracticability; cultural insensitivity; and difficulty in implementation, identifying duty bearers, and specifying the division of labour of duties.35 For example, for many years, scholars and practitioners studying Asia have argued that some international human rights norms are fundamentally incompatible with ‘Asian values’, which, in their view, should receive priority over so-called Western-oriented rights.36 Others have challenged the notion that ESC rights are genuine human rights or on a par, in significance, with civil and political rights. As Donnelly notes,
Such critics argue that economic, social, and cultural rights, entitlements to socially provided goods, services, and opportunities such as food, health care, social insurance, and education, are at best less important than civil and political rights, such as due process, freedom of speech, and the right to vote, and probably not human rights at all.37
Henry Shue disputes the notion that ESC rights are not really human rights or that they are lesser rights in his seminal work, Basic Rights: Subsistence, Affluence, and U.S. Foreign Policy.38 He identifies both civil and political rights and ESC rights as forming a set of ‘basic rights’ to which all individuals are entitled. For Shue, basic rights are those minimal reasonable demands that everyone can place on the rest of humanity to ensure personal self-respect and survival.39 Because of this, Shue argues that ‘basic rights are necessary for the enjoyment of all other rights, and it is this link that justifies basic rights.’40 There are two kinds of basic rights: security rights and subsistence rights. Security rights refer to freedom from murder, torture, rape and assault and correspond primarily to civil and political rights. Subsistence rights, which are meant to provide minimal economic security, refer to the rights to unpolluted air and water; adequate food, clothing, and shelter; and minimal preventive health care.41 These rights correspond primarily with ESC rights.42 Taken together, both kinds of rights – security and subsistence – are indivisible in the sense that both are equally necessary for the enjoyment of any other right.43 Basic rights are interdependent in the sense that all other rights are dependent on security and subsistence rights being fulfilled.44 While Shue does not elaborate on how basic rights are dependent upon one another, interdependence clearly follows from his arguments. One cannot enjoy subsistence rights if one is not also free from murder, torture, and incarceration, just as one cannot enjoy security rights if one is malnourished or has starved to death. As Shue observes,
In the absence of physical security people are unable to use any other rights that society may be said to be protecting without being liable to encounter many of the worst dangers they would encounter if society were not protecting the rights.45
Deficiencies in the means of subsistence can be just as fatal, incapacitating, or painful as violations of physical security. The resulting damage or death can at least as decisively prevent the enjoyment of any right as can the effects of security violations.46
However, as stated earlier, there have been numerous criticisms of Shue’s basic rights thesis, particularly with respect to his emphasis on subsistence rights. If they recognize these rights at all, critics see them as less important than civil and political rights. This belief in the superiority of the latter type of rights is based upon the assumption that there is a significant moral difference between so-called positive rights (subsistence rights) and so-called negative rights (civil and political rights), and that negative rights are more important than positive rights, and are less costly and easier to implement since they simply require refraining from certain types of actions whereas positive rights require undertaking certain types of actions. Negative rights supposedly require only the forbearance of others to be realized.47 Commonly cited examples include the right to be free from restrictions on speech, movement, association, and so forth. On the other hand, positive rights require that others provide active support for the realization of these rights such as the provision of shelter, food and clothing. Liberals argue that universal human rights are limited to negative rights, and positive rights are limited to being the aspiration of all peoples.48 The best way to achieve these aspirations is through the realization of negative rights that promote greater levels of economic growth, higher income and lower unemployment. Hence, the priority is negative rights, with positive rights being ‘aspirations’.49
Likewise, Maurice Cranston harshly criticized subsistence rights as devaluing real human rights (civil and political), because the former depend on a government’s ability to pay, especially for health care, which is a significant public expense.50 He claims that it is relatively easy to transform civil and political into positive rights, but that in most countries it is ‘utterly impossible’ to do the same for ESC rights.51 Moreover, the identities of those holding negative obligations are clear: the government and everyone else have the obligation not to interfere with others’ exercise of their civil and political rights. Supposedly, the same cannot be said for positive obligations. The important question is this: who is obligated to provide the aid required to fulfil subsistence rights?52