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Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protection of Marketing Approval Data Under the TRIPS Agreement

Among the many trade conflicts that divide the postindustrial economies of Europe, the United States, Japan, and the Commonwealth from the less information-driven economies of the rest of the world, one of the most consequential is the debate over how to balance access to medicines with the intellectual property protection demanded by their developers. Among the many facets of this debate is the question of whether pharmaceuticals, vaccines, biologics, and other therapeutic or preventative health consumables (to which this article will refer collectively as “drugs”) should be patentable in developing countries. This debate was partly resolved by the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement), which allows signatories to exclude from patentability “diagnostic, therapeutic and surgical methods for the treatment of humans or animals” yet requires the patenting of pharmaceuticals after a transition period. Nonetheless, disagreement about access to medicines has plagued subsequent negotiations. The economically developed states, led by the United States, have demanded that WTO members cease liberal compulsory licensing practices and adopt patent protection regimes equivalent in most significant respects to those of the United States and Europe. Developing countries have requited these demands with insistence on better access to affordable drugs and medical technology originating in the economically developed states. The debate over patentability and compulsory licensing hinges partly on disagreement over whether patent protection in developing countries is a necessary incentive for optimal drug development and distribution. It is generally contended that the TRIPs Agreement has a significant effect in either promoting or retarding innovation necessary for pharmaceutical companies to invent and register drugs that prevent or treat diseases prevalent in developing countries. The WTO General Council has temporarily quieted this debate with its September 2, 2003, decision on paragraph 6 of the Doha Declaration, which sanctions compulsory licensing by the least-developed countries pursuant to notification requirements and other limitations. The Doha Round negotiations have not yet resolved, however, a second, equally contentious debate that focuses on whether similar incentives are needed to stimulate drug developers to seek marketing approval in developing countries.

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The Declining Significance of POW Status

What is the significance of prisoner-of-war (POW) status? Drawing on the substance, universal acceptance, broad-based institutionalization, and enforcement machinery of the Geneva Convention for the Protection of Prisoners of War (“POW Convention”), conventional wisdom maintains that denial of POW status to combatants has drastic protective and policy consequences. Contrary to this conventional wisdom, this Article argues that denial of POW status carries few protective or policy consequences, and that the gap in protection for those classified as POWs and those not so classified (e.g., those designated “unlawful combatants”) is closing. The only gaps that persist are: (1) that POWs are “assimilated” into the legal regime governing the armed forces of the detaining state; and (2) that POWs enjoy “combatant immunity.” The scope and significance of these gaps are, however, also diminishing—from both a protection and policy perspective. The Article further argues that this emerging “protective parity” has important implications for humanitarian law and policy: (1) it clarifies and consolidates debates about coverage gaps in the Geneva law; (2) it recasts debates about the proper procedure for determining “status” in humanitarian law (procedurally, POW status might be understood only as an affirmative defense to any prosecution for simple participation in hostilities); and (3) it underscores the escalating inefficiencies of approaches that calibrate treatment based on complex status determinations (and, in doing so, provides an explanation of why some states—including the United States—expressly incorporate elements of “protective parity” into their military policy). Finally, the Article offers a normative defense of “protective parity”—emphasizing whether it can be reconciled with the principle of distinction.

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Global Governance and the WTO

Since 1947 the General Agreement on Tariffs and Trade (GATT) and its successor, the World Trade Organization (WTO), have brought about a dramatic reduction in barriers to international trade. The WTO has become one of the world’s most dominant international institutions, established a reasonably effective system of dispute resolution, and developed a nearly universal membership. These achievements, however, have not protected the organization from external criticism or internal challenges.

Indeed, the remarkable success of the GATT/WTO system is, to a significant degree, responsible for the challenges now facing the WTO. Over time, and especially as a result of the Uruguay Round, the GATT/WTO has moved from a system of rules prohibiting trade measures to a system of rules requiring affirmative government actions. The consequence is a WTO engaged in monitoring and adjudicating the legality of domestic rules that are not primarily or exclusively about trade. The relevant WTO obligations include rules governing the protection of intellectual property, service industries, and health and safety measures. Though each of these WTO rules, with the possible exception of the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPs Agreement”), has an important connection to liberalized trade, their substance makes it impossible to consider them in strictly trade terms.

The impact of the trading regime is also felt in areas that are not subject to any specific WTO regulation. For example, environmental policy, human rights, labor, and competition policy are not directly within the jurisdiction of the WTO, but in each of these areas trade and the trading system have influenced policymaking. The influence of WTO obligations on non-trade issues has generated cries of protest from many quarters. Critics argue that the WTO remains a trade institution at heart, and that its forays into what were traditionally considered non-trade areas have caused the non-trade values at stake to be ignored in favor of trade concerns. Thus, the argument goes, the tremendous power of the organization, combined with its efforts to influence policies in non-trade areas, has elevated trade at the expense of other issues.

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Crossroads in the Great Race: Moving Beyond the International Race to Judgment in Disputes over Artwork and Other Chattels

Disputes over the ownership of artwork today tend to lead to litigation characterized by complex fact patterns, multiple parties, and a host of implicated jurisdictions. Consider a case where an Argentine citizen purchases an antique Italian tapestry in Switzerland, then lends it to a museum in the United States, and finally is threatened with suit by a Colombian citizen, who claims the object was stolen while in transit from Belgium. Most litigators would immediately ask, “What court has jurisdiction?” and then, “Which jurisdiction is best for my client?”

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From Legal Transplants to Legal Translations: The Globalization of Plea Bargaining and the Americanization Thesis in Criminal Procedure

Since the end of the Second World War, and particularly following the end of the Cold War, the American legal system arguably has become the most influential legal system in the world. American influences on the legal systems of other nations have ranged from general influences on jurisprudential approaches to law (e.g., legal realism and pragmatism, law and economics, rights discourse, etc.) to influences on specific legal areas (e.g., constitutional law, tax law, securities law, corporate law, patent law, international commercial arbitration, etc.); from legal education (e.g., a credits system for particular courses, or certain post-graduate studies leading to an LL.M. degree) and the structure of the legal profession (e.g., large law firms or the valorization of private practice) to the reform of the judiciary; from specific legal doctrines or legal tools (e.g., constitutional exclusionary rules, the doctrine of “actual malice” in the freedom of speech and of the press, class actions, etc.) to institutional arrangements such as the separation of powers and judicial review. These undeniable American influences on other legal systems have led a number of commentators, both in the United States and abroad, to announce that a substantial number of legal systems, both at the national and the international levels, may gradually come to resemble or mimic the American legal system and thus become “Americanized.” Other commentators, while acknowledging the predominant influence of the American legal system, have stopped short of asserting that American influence is actually recreating American legal practice in non-American jurisdictions. In this Article, I caution against the former thesis of Americanization (the “strong” thesis) through an examination of the introduction of American-style plea bargaining in four civil law countries—Germany, Italy, Argentina, and France.

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The Dynamics of International Trade Finance Regulation: The Arrangement on Officially Supported Export Credits

We are living through a defining moment in international law. The pace of globalization makes cooperation through international law and institutions vital. The recent SARS scare, exponentially magnified by the ease of international travel, poignantly illuminates the proactive, standard-setting role that international rules, such as World Health Organization regulations, can and should play. Yet public impatience with international law is mounting. Paradoxically, this unease may be the product of international law’s maturity and success. For the first time since World War II, states have consistently embraced international institutions to assist in the management of prominent international issues. From the International Criminal Tribunal for the former Yugoslavia to the World Trade Organization (“WTO”) to the U.S. engagement of the United Nations Security Council prior to the Iraqi conflict, states have turned to, or at least paused to reflect upon, international law, catapulting it prominently into public view. Admittedly, international law’s record in these cases is mixed at best. But precisely because of widespread reliance on international law in these high-profile roles, its failures have become a focal point for public skepticism and criticism.

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