Since the 1980s, developed countries, led by the United States and the countries of the European Union, have sought to incorporate intellectual property rights provisions into global trade agreements. These countries successfully negotiated the World Trade Organization's 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which required developing countries to adopt intellectual property provisions comparable to developed countries. In this manuscript, we review the policy controversy surrounding TRIPS and examine the two main ethical arguments articulated in its support (...) — a theory of natural rights and a utilitarian argument. We contend that these theories provide insufficient bases for an intellectual property rights regime that compromises access to essential medicines in the developing world. While the policy community has engaged in active debate around the policy effects of TRIPS, scholars have not thoroughly considered the full ethical underpinnings of those policy arguments. We believe that a more robust understanding of the ethical implications of the agreement should inform policy discussions in the future. (shrink)

In recent decades, advances in information technology have given rise to a post-industrial society in which emphasis on the manufacture of material goods has been supplanted by the creation of intellectual property. Indeed, this new “knowledge economy” can be tracked by the exponential growth in patented products across a range of sectors since the 1980s. According to the United States Patent and Trademark Office, the number of annual patent applications submitted grew from 112,379 to 520,277 over the past three decades, (...) a 464% increase.The transformation in the industrial markets has been accompanied by the rise of a new, global institution for coordinating intellectual property rights : the World Trade Organization. (shrink)

Despite a high and growing global average income, billions of human beings are still condemned to lifelong severe poverty, with all its attendant evils of low life expectancy, social exclusion, ill health, illiteracy, dependency, and effective enslavement. This problem is solvable, despite its magnitude.

In the first sentence of the first section of A Theory of Justice Rawls writes that “justice is the first virtue of social institutions.” He soon elaborates.

Although access to medicines is a vital feature of the right to the highest attainable standard of health (“right to health”), almost two billion people lack access to essential medicines, leading to immense avoidable suffering. While the human rights responsibility to provide access to medicines lies mainly with States, pharmaceutical companies also have human rights responsibilities in relation to access to medicines. This article provides an introduction to these responsibilities. It briefly outlines the new UN Guiding Principles on Business and (...) Human Rights and places the human rights responsibilities of pharmaceutical companies in this context. The authors draw from the work of the first UN Special Rapporteur on the right to the highest attainable standard of health, in particular the Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines that he presented to the UN General Assembly in 2008, and his UN report on GlaxoSmithKline (GSK). While the Guiding Principles on Business and Human Rights are general human rights standards applicable to all business entities, the Human Rights Guidelines for Pharmaceutical Companies consider the specific human rights responsibilities of one sector (pharmaceutical companies) in relation to one area of activity (access to medicines). The article signals the human rights responsibilities of all pharmaceutical companies, with particular attention to patent-holding pharmaceutical companies. Adopting a right-to-health “lens,” the article discusses GSK and accountability. The authors argue that human rights should shape pharmaceutical companies' policies, and provide standards in relation to which pharmaceutical companies could, and should, be held accountable. They conclude that it is now crucial to devise independent, accessible, transparent, and effective mechanisms to monitor pharmaceutical companies and hold them publicly accountable for their human rights responsibilities. (shrink)

The Constitution of the World Health Organization affirms that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.” The Universal Declaration of Human Rights lays the foundations for the international framework for the right to health. This human right is now codified in numerous national constitutions, as well as legally binding international human rights treaties, such as the International Covenant on Economic, Social and Cultural Rights.Although medical care and access to (...) medicines are vital features of the right to health, almost two billion people lack access to essential medicines, leading to immense avoidable suffering. Improving access to essential medicines could save 10 million lives each year, four million of them in Africa and South-East Asia alone. Gross inequity is a shocking feature of the world pharmaceutical situation. (shrink)

This paper examines the extent to which the voluntary adoption of codes of conduct by multinational corporations (MNCs) renders MNCs accountable for the performance of actions specified in a code of conduct. In particular, the paper examines the ways in which codes of conduct coordinate the expectations of relevant parties with regard to the provision of assistance by MNCs on grounds of rescue or justice. The paper argues that this coordinative role of codes of conduct renders MNCs more accountable for (...) the performance of actions specified in a code of conduct than they would be without a code of conduct. This interpretation of the significance of codes of conduct is contrasted with the view that codes of conduct render MNCs accountable for performing actions specified in a code of conduct by grounding contractual obligations for the performance of such actions. (shrink)

This paper examines the extent to which the voluntary adoption of codes of conduct by multinational corporations rendersMNCs accountable for the performance of actions specified in a code of conduct. In particular, the paper examines the ways in which codes of conduct coordinate the expectations of relevant parties with regard to the provision of assistance by MNCs on grounds of rescue or justice. The paper argues that this coordinative role of codes of conduct renders MNCs more accountable for the performance (...) of actions specified in a code of conduct than they would be without a code of conduct. This interpretation of the significance of codes of conduct is contrasted with the view that codes of conduct render MNCs accountable for performing actions specified in a code of conduct by grounding contractual obligations for the performance of such actions. (shrink)

This paper examines the extent to which the voluntary adoption of codes of conduct by multinational corporations (MNCs) renders MNCs accountable for the performance of actions specified in a code of conduct. In particular, the paper examines the ways in which codes of conduct coordinate the expectations of relevant parties with regard to the provision of assistance by MNCs on grounds of rescue or justice. The paper argues that this coordinative role of codes of conduct renders MNCs more accountable for (...) the performance of actions specified in a code of conduct than they would be without a code of conduct. This interpretation of the significance of codes of conduct is contrasted with the view that codes of conduct render MNCs accountable for performing actions specified in a code of conduct by grounding contractual obligations for the performance of such actions. (shrink)

ABSTRACT Most of the world's health problems afflict poor countries and their poorest inhabitants. There are many reasons why so many people die of poverty‐related causes. One reason is that the poor cannot access many of the existing drugs and technologies they need. Another, is that little of the research and development (R&D) done on new drugs and technologies benefits the poor. There are several proposals on the table that might incentivize pharmaceutical companies to extend access to essential drugs and (...) technologies to the global poor.1 Still, the problem remains – the poor are suffering and dying from lack of access to essential medicines. So, it is worth considering a new alternative. This paper suggests rating pharmaceutical and biotechnology companies based on how some of their policies impact poor people's health. It argues that it might be possible to leverage a rating system to encourage companies to extend access to essential drugs and technologies to the poor. (shrink)

All people have human rights and, intuitively, there is a close connection between human rights, needs, and autonomy. The two main theories about the natureand value of human rights often fail to account for this connection. Interest theories, on which rights protect individuals’ important interests, usually fail to capturethe close relationship between human rights and autonomy; autonomy is not constitutive of the interests human rights protect. Will theories, on which human rights protect individuals’ autonomy, cannot explain why the nonautonomous have (...) a human right to meet their needs. This paper argues that it is possible to account for the close connection between human rights, needs, and autonomy if human rights at least protect individuals’ ability to live minimally good lives. It argues that people need whatever will enable them to live such lives and autonomy is partly constitutive of such a life. This argument also has importantimplications for some other key debates in the human rights literature. (shrink)

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms (...) exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which can be corrected through compulsory licensing. Open licenses that permit any qualified firm to supply the market on the same terms, such as may be available under licenses of right or essential facility legal standards, can be used to mitigate the negative effects of government-granted patents, thereby increasing overall social welfare. (shrink)

Not all intellectual property rights grant the right to exclude that is indicative of “property rules,” as that term was used by Guido Calabresi and A. Douglas Melamed in their seminal article. Some intellectual property rights are “liability rules,” in which the right holder has an entitlement to compensation for use of the protected invention, not a right to preclude the use. Although patent laws normally grant a right to exclude others from use of the protected invention as a default, (...) most countries’ laws allow the government to convert the patent property rule into a liability rule through a compulsory license. It has been noted, for example, that by the end of the 1950s, the U.S. had issued compulsory licenses covering 40 to 50 thousand patents, including substantial portions of the patent portfolios of AT&T, General Electric, IBM, and Xerox. The U.S. Supreme Court recently expressed a willingness to accept liability rules over injunctions in some patent infringement cases. (shrink)

Firms possessing a unique competency to rescue the victims of a human catastrophe have a minimum moral obligation to devote substantial resources toward best efforts to aid the victims. The minimum amount that firms should devote to rescue is the largest sum of their most recent year’s investment in social initiatives, their five-year trend, their industry’s average, or the national average. Financial exigency may justify a lower level of investment. Alternative social investments may be continued if they have an equally (...) compelling rationale. These duties apply to the global pharmaceutical companies in the context of the AIDS pandemic in sub-Saharan Africa. (shrink)

Firms possessing a unique competency to rescue the victims of a human catastrophe have a minimum moral obligation to devote substantial resources toward best efforts to aid the victims. The minimum amount that firms should devote to rescue is the largest sum of their most recent year’s investment in social initiatives, their five-year trend, their industry’s average, or the national average. Financial exigency may justify a lower level of investment. Alternative social investments may be continued if they have an equally (...) compelling rationale. These duties apply to the global pharmaceutical companies in the context of the AIDS pandemic in sub-Saharan Africa. (shrink)