Rule-makers, rule-shapers, and rule-takers: what role for Asia in the global governance of intellectual property rules and global health?

Abstract

In an era of increasing interconnectedness and exchange, global regimes have emerged to govern actor behavior in domains that have come to be seen as transnational, such as trade, climate change, human rights, and health. We define global regimes as the formal and informal principles, norms, rules, and decision making procedures” (Krasner, 1982) that govern the behavior of state and non-state actors at the global level. Such regimes signal the coming into being of a “global” domain of public policy making -- a set of rules that is no longer purely based on Westphalian principles of interaction between sovereign nation states, but based on networked coalitions between a diverse set of players -- governmental and non-governmental, private and public (Ruggie, 2004). The emergence of such regimes raises important questions for global governance. For example, how are global regimes created, amended, and enforced? Who shapes and is shaped by them? How do various actors influence global rule-making, and what role do health considerations play? The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), a set of formal rules on intellectual property (IP) that have profoundly impacted the field of pharmaceuticals, is a useful case for shedding light on these questions. Negotiated by member states of the General Agreement on Tariffs and Trade during the Uruguay Round of trade negotiations, TRIPS was one of the core treaties that came into force with the creation of the World Trade Organization (WTO) in 1994. By requiring all WTO Members to provide a minimum level of IP protection domestically, TRIPS was intended to harmonize IP policies across industrialized and developing countries against the backdrop of economic globalization. However, its introduction sparked a major public health controversy: TRIPS required the introduction of patents on medicines in many developing countries, which would enable patent-holders to sell medicines at high prices that could easily exceed a country’s ability to pay. Especially in the context of the HIV/AIDS pandemic, these new global trade rules sparked a vociferous response from a global network of civil society organizations (CSOs) and public health advocates. According to its critics, TRIPS imposed a global intellectual property regime on developing countries that was unsuited to meet their development needs in general, and threatened access to medicines in particular. While the formal provisions of TRIPS provided developing countries with some degree of flexibility to bring their national patent policies into compliance with the treaty, the exact shape and scope of this policy space, i.e., the informal rules governing how the provisions could be used, were undefined and a subject of heated political contestation (Deere, 2008). For example, a powerful safeguard explicitly allowed within TRIPS is “compulsory licensing,” in which a government may authorize use of a patent without the permission of the patent-holder in order to protect the public interest. Compulsory licensing is intended to counteract the potential abuse of monopoly power by patent-holders, and is a standard feature of industrialized country patent systems. This measure could be used, for example, to authorize a generic version of an essential medicine if the patent-holder refused to supply it or to make it available at a price affordable to the local population. While TRIPS expressly permitted national governments to employ compulsory licensing and other public interest safeguards, the political space for developing countries to do so was extremely constricted in the late 1990s. National governments of developing countries found themselves in a grey zone shaped by three disparate forces: first, external pressure from industrialized countries seeking to secure worldwide protection for their intellectual property; and second, considerations of their own national economic and trade interests, which often included gaining access to markets and attracting investors from the industrialized countries. The combination of these factors made many governments unwilling to make use of TRIPS flexibilities. However, there was also a third factor: public health needs. Increasingly well-networked and proactive civil society organizations often pressured national governments to adopt more flexible IP policies that would make medicines more affordable.