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The Elections Clause Obligates Congress to Enact a Federal Plan to Secure U.S. Elections Against Foreign Cyberattacks
Get PDFWhile foreign adversaries continue to launch cyberattacks aimed at disrupting elections in the United States, Congress has been reluctant to take action. After Russia interfered in the 2016 election, cybersecurity experts articulated clear measures that must be taken to secure U.S. election systems against foreign interference. Yet the federal government has failed to act. Congress’s reticence is based on a misguided notion that greater federal involvement in the conduct of elections unconstitutionally infringes on states’ rights. Both state election officials and certain congressional leaders operate under the assumption that federalism principles grant states primacy in conducting federal elections. This Comment dispels the myth that Congress must defer to states to regulate federal elections. The text of the Elections Clause in Article I, Section 4 of the U.S. Constitution confers to Congress final authority in determining the “Times, Places and Manner” of federal elections. Therefore, the system of administering federal elections is based on decentralization rather than federalism. The risk of foreign interference in U.S. elections was a precise reason the founders bestowed on Congress ultimate control over federal elections. States and municipalities lack the capacity to effectively combat foreign cyber invasion. This Comment makes the case that Congress has a responsibility to exercise its power under the Elections Clause to create a federal plan to secure voter registration databases and voting mechanisms against cyberattacks in order to protect the integrity of American democracy
Regulatory Malfunctions in the Drug Patent Ecosystem
Get PDFPatent protection for several of the world’s best-selling and most promising drugs—biologics—has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena and argues for a novel solution: a timelier response provided by the U.S. Food and Drug Administration (FDA) in the form of license revocation when follow-on innovators fail to compete. In one significant case, the FDA approved several biosimilar versions from different manufacturers that would in principle compete with the biologic drug Humira—the largest-grossing drug in the United States and worldwide—but the manufacturer of Humira entered into multiple agreements with biosimilar manufacturers to keep the drug out of the U.S. market until 2023, while making it available elsewhere from 2018 onward. An abundant stream of scholarship has examined the relationship between pharmaceutical markets and antitrust mechanisms to curb anticompetitive behaviors. This Article moves the debate in a new direction. Because antitrust responses generally face a time lag, this Article posits that an additional regulatory intervention is needed outside antitrust law, and it argues that the FDA is institutionally well-placed to provide a first-line checkpoint for anticompetitive agreements that result in non-commercialization of approved drugs. While novel, this proposal incorporates a solution that has been hiding in plain sight: the FDA regulatory framework allows the Agency to revoke licenses under certain circumstances, including some forms of inaction on the part of the licensee. This Article shows that the FDA not only has the authority, but also the statutory obligation, to revoke the licenses of biosimilar manufacturers who deliberately fail to bring their products to market within a reasonable period of time. Many of the biologics slated to lose patent protection in the first half of the 2020s are routinely used in the treatment of some of the most challenging medical conditions, including certain cancers and auto-immune diseases. At a time when concerns over drug prices are at the forefront of political and social debates, finding ways to instill competition into post-patent markets remains a crucial task. The solution put forth in this Article furthers the interests of different parties, as it clears the pathway for motivated biosimilar manufacturers to bring their products to a profitable market while bringing down overall costs for health systems and, in particular, for patients in need of extremely expensive pharmaceuticals
Presentation of Award to Jay Alix
Get PDFThe word “superhero” is overused in our culture. I know that because my young grandsons, Isaac and Adam, use it all the time and because it was probably the first multisyllabic word that they uttered. So, I won’t use it. But I will say this: Jay Alix is my hero. And Jay Alix is your hero. I am proud and honored to present the Emory Bankruptcy Developments Journal’s 2020 Distinguished Service Award for Lifetime Achievement to our hero, Jay Alix
The Debt Paradox: In Debt but Society Owes You a Debt--An Exoneree\u27s Path to Holistic Relief Through the Bankruptcy System
Get PDFWhat do the bankruptcy system and the criminal legal system have in common? Both aim to provide fresh starts to those who have moved through them. The bankruptcy system does so by rewarding honest but unfortunate debtors with discharge from debt. The criminal legal system attempts to provide a fresh start through reentry programs to those exiting prison. Yet neither system successfully ensures a blank slate, which is in part due to the history of racial bias in both systems. A limited subset of debtors benefits from the bankruptcy system, while the criminal legal system makes reentry very difficult for convicted felons. The wrongfully convicted are also not provided the necessary tools to obtain a fresh start as they reenter society. With restricted access to reentry programs, further injury due to barriers they face upon reentry, and debt stemming from their wrongful conviction, exonerees require a more holistic approach to ensure that they have a fresh start. The bankruptcy system offers an opportunity to meaningfully improve reentry for the wrongfully convicted. This Comment proposes that exonerees should be entitled to an expedited chapter 13 discharge of the debt stemming from their wrongful conviction. Further, this Comment argues that states should provide more holistic reentry programs that include access to bankruptcy attorney services. Discharging this debt would relieve exonerees and their families of some of the misfortune caused by wrongful conviction. By doing so, the bankruptcy system would promote its goal of providing a fresh start to the honest but unfortunate debtor
The Build Act: A Shift in U.S. Global Investment Strategy and Its Impact on Sub-Saharan Africa
Get PDFThis Comment consists of six parts. Part II discusses the BUILD Act and the establishment of the IDFC, which is the mechanism through which the US is shifting its global investment strategy. In Part III, China’s approach to global economic development is explored in a discussion of China’s RBI initiative, the primary motivation for the US change in global investment strategy. Part IV analyzes investments in health systems and the opportunity the U.S. has to invest in health system projects in Sub-Saharan Africa. Part V proposes the implementation of guidelines and regulations on the IDFC during the transition period as the detailed plan of IDFC awaits approval from Congress. Finally, Part VI then reaches the conclusion that the direction that the IDFC appears to be taking is detrimental regarding its foreign relations with Sub-Saharan Africa as the US shifts from an aid to trade-based approach
Law, Religion and the Environment in Africa
No full textThis volume explores themes of ecotheology, ecofeminism, environmental pollution and degradation, climate change, human and environmental rights, sustainable development, human-animal relations through totem and taboo, sacred sites and spaces, and other environmental topics in ways that add immeasurably to the study of African environmentalisms and the interaction of law and religion. In terms of religion, the capability of humans not only to sin and destroy the earth, but also to repair and redeem it, is very much in evidence across Christianity, Islam and Africa’s many indigenous religious and cultural traditions. In terms of law, the need for effective policies and for states and governments to work with indigenous groups and communities towards environmental solutions is also apparent.https://scholarlycommons.law.emory.edu/cslr-books/1130/thumbnail.jp
Christianity and Global Law
No full textThis book explores both historical and contemporary Christian sources and dimensions of global law and includes critical perspectives from various religious and philosophical traditions. Two dozen leading scholars discuss the constituent principles of this new global legal order historically, comparatively, and currently. The first part uses a historical-biographical approach to study a few of the major Christian architects of global law and transnational legal theory, from St. Paul to Jacques Maritain. The second part distills the deep Christian sources and dimensions of the main principles of global law, historically and today, separating out the distinct Catholic, Protestant, and Orthodox Christian contributions as appropriate. Finally, the authors address a number of pressing global issues and challenges, where a Christian-informed legal perspective can and should have deep purchase and influence. The work makes no claim that Christianity is the only historical shaper of global law, nor that it should monopolize the theory and practice of global law today. But the book does insist that Christianity, as one of the world’s great religions, has deep norms and practices, ideas and institutions, prophets and procedures that can be of benefit as the world struggles to find global legal resources to confront humanity’s greatest challenges.The volume will be an essential resource for academics and researchers working in the areas of law and religion, transnational law, legal philosophy, and legal history.https://scholarlycommons.law.emory.edu/cslr-books/1000/thumbnail.jp
Christianity and Criminal Law
No full textThis collection, by leading legal scholars, judges and practitioners, together with theologians and church historians, presents historical, theological, philosophical and legal perspectives on Christianity and criminal law. Following a Preface by Lord Judge, formerly Lord Chief Justice of England and Wales, and an introductory chapter, the book is divided into four thematic sections. Part I addresses the historical contributions of Christianity to criminal law drawing on biblical sources, early church fathers and canonists, as far as the Enlightenment. Part II, titled Christianity and the principles of criminal law, compares crime and sin, examines concepts of mens rea and intention, and considers the virtue of due process within criminal justice. Part III looks at Christianity and criminal offences, considering their Christian origins and continuing relevance for several basic crimes that every legal system prohibits. Finally, in Part IV, the authors consider Christianity and the enforcement of criminal law, looking at defences, punishment and forgiveness. The book will be an invaluable resource for students and academics working in the areas of Law and Religion, Legal Philosophy and Theology.https://scholarlycommons.law.emory.edu/cslr-books/1001/thumbnail.jp
Can We Learn to Incentivize Morality?: A Discussion of Biotechnology on an International Level
Get PDFThis Comment argues that if a group of people, or the international community as a whole, should at any point wish to prevent the ownership of morally controversial biotechnology, then the international community should take steps towards international uniformity. Uniformity in these decisions would arguably need to include uniformity on subject matter eligibility decisions across countries
The Elusive Distinctivenes of Trade Dress in EU Trademark Law
Get PDFThis Article provides a systematic analysis of the case law in which the CJEU has created specific rules for assuming product trade dress as distinctive without market use and thus eligible for registration as EU trademark. Under the CJEU’s modified distinctiveness standard, EU average consumers are ordinarily assumed not to have predisposition to trade dress as source-indentifier in the absence of more conventional marks such as words or labels. For a large number of EU applicants, this “departs significantly” criterion represents a significant barrier for registration even though the proposed trade dress may arguably be free of a non-functionality objection. This Article unpacks the policies underpinning the “departs significantly” criterion and challenges deep-seated misconceptions about its meaning and purpose