Scholarship @ GEORGETOWN LAW Copyright (c) 2013 Georgetown University Law Center All rights reserved. http://scholarship.law.georgetown.edu Recent documents in Scholarship @ GEORGETOWN LAW en-us Tue, 18 Jun 2013 01:33:51 PDT 3600 Towards a Framework Convention on Global Health: A Transformative Agenda for Global Health Justice http://scholarship.law.georgetown.edu/ois_papers/53 http://scholarship.law.georgetown.edu/ois_papers/53 Mon, 03 Jun 2013 12:20:46 PDT International law has responded weakly to the inequities in health care, public health, and the broader determinates of health that collectively cause the greatest loss of lives and human potential every year. Approximately one-third of global deaths can be attributed to enduring and unconscionable inequities. Despite significant progress in improving global health over the past several decades, these inequities persist. Current global governance for health is inadequate to the task of resolving these inequities, from lack of accountability and enforcement to inadequate funding and the absence of leadership required to respond to the threats to health that arise from other sectors. The risk of a persisting global health underclass looms large.

Human rights law, with its universally accepted right to health, can underpin new norms and structures to dramatically reduce health inequities and ameliorate the factors that give rise to them. Four fundamental questions can clarify national and international responsibilities under the right to health and offer guidance to new legal instruments to resolve these health inequities:

  1. What are the health services and goods guaranteed to every human being under the right to health?
  2. What do states owe for the health of their own populations?
  3. What responsibility do states have for improving the health of people beyond their borders?
  4. What kind of global governance mechanisms are required to guarantee that all states live up to their mutual responsibilities to provide health goods and services to all people?

To capture the answers to these questions, we offer ideas for the contents and structure of a new global treaty grounded in the right to health and with the principal purpose of ameliorating health disparities among the world’s rich and poor. This Framework Convention on Global Health (FCGH) would set global health norms and priorities, with a robust vision of making available and accessible to all: universal the health care, public health measures, and the social determinants required for good health.

The FCGH would embed equity as a key principle in binding international law; establish targets and benchmarks, tailored to individual countries through inclusive and flexible processes, including the critical involvement of civil society and communities; ensure sustainable funding backed by clear national and international responsibilities; strengthen global governance for health including by responding to health threats in other sectors and strengthening the World Health Organization; and establish a robust regime of accountability at local and national levels along with effective enforcement and compliance mechanisms for the FCGH itself.

The path towards an FCGH will be arduous, with multiple barriers posed by politics and special interests. However, the treaty offers an innovative path we should forge, propelled by social mobilization. An inclusive process will be central in establishing the treaty, with a campaign driven by social movements committed to the right to health.

]]> Lawrence O. Gostin et al. Towards a Framework Convention on Global Health: A Transformative Agenda for Global Health Justice http://scholarship.law.georgetown.edu/facpub/1224 http://scholarship.law.georgetown.edu/facpub/1224 Mon, 03 Jun 2013 12:13:16 PDT International law has responded weakly to the inequities in health care, public health, and the broader determinates of health that collectively cause the greatest loss of lives and human potential every year. Approximately one-third of global deaths can be attributed to enduring and unconscionable inequities. Despite significant progress in improving global health over the past several decades, these inequities persist. Current global governance for health is inadequate to the task of resolving these inequities, from lack of accountability and enforcement to inadequate funding and the absence of leadership required to respond to the threats to health that arise from other sectors. The risk of a persisting global health underclass looms large.

Human rights law, with its universally accepted right to health, can underpin new norms and structures to dramatically reduce health inequities and ameliorate the factors that give rise to them. Four fundamental questions can clarify national and international responsibilities under the right to health and offer guidance to new legal instruments to resolve these health inequities:

  1. What are the health services and goods guaranteed to every human being under the right to health?
  2. What do states owe for the health of their own populations?
  3. What responsibility do states have for improving the health of people beyond their borders?
  4. What kind of global governance mechanisms are required to guarantee that all states live up to their mutual responsibilities to provide health goods and services to all people?

To capture the answers to these questions, we offer ideas for the contents and structure of a new global treaty grounded in the right to health and with the principal purpose of ameliorating health disparities among the world’s rich and poor. This Framework Convention on Global Health (FCGH) would set global health norms and priorities, with a robust vision of making available and accessible to all: universal the health care, public health measures, and the social determinants required for good health.

The FCGH would embed equity as a key principle in binding international law; establish targets and benchmarks, tailored to individual countries through inclusive and flexible processes, including the critical involvement of civil society and communities; ensure sustainable funding backed by clear national and international responsibilities; strengthen global governance for health including by responding to health threats in other sectors and strengthening the World Health Organization; and establish a robust regime of accountability at local and national levels along with effective enforcement and compliance mechanisms for the FCGH itself.

The path towards an FCGH will be arduous, with multiple barriers posed by politics and special interests. However, the treaty offers an innovative path we should forge, propelled by social mobilization. An inclusive process will be central in establishing the treaty, with a campaign driven by social movements committed to the right to health.

]]> Lawrence O. Gostin et al. Egypt's New Constitution: The Islamist Difference http://scholarship.law.georgetown.edu/facpub/1223 http://scholarship.law.georgetown.edu/facpub/1223 Thu, 30 May 2013 12:40:36 PDT The paper discusses the distributional impact of the rules of the new Egyptian constitution (2012). It specifically addresses the way such rules, substantive and (potentially) procedural, can influence Egyptian law's identity and the underlying relations between the state and individuals and among individuals themselves that such identity implies.

]]> Lama Abu-Odeh Better Health, But Less Justice: Widening Health Disparities After <i>National Federation of Independent Business v. Sebelius</i> http://scholarship.law.georgetown.edu/ois_papers/52 http://scholarship.law.georgetown.edu/ois_papers/52 Thu, 30 May 2013 10:01:02 PDT At the time it was enacted in 2010, the Patient Protection and Affordable Care Act (ACA) was widely applauded by health activists, as it meant that the United States would at last join the overwhelming majority of industrialized countries in providing its population with guaranteed access to affordable health care. Roughly half of the increase in access to health insurance was to come from the expansion of Medicaid eligibility to all U.S. citizens and legal residents with income below 138% of the Federal Poverty Level. However, the Supreme Court’s 2012 ruling in National Federation of Independent Business v. Sebelius (NFIB) essentially converted the Medicaid expansion into an option for states, and many (fourteen at the time this article went to press, including states with enormously high rates of uninsured residents, such as Texas) have chosen not to participate. Since NFIB, the Congressional Budget Office has reduced its initial estimate of the number of individuals who were to gain coverage under the ACA, from thirty-two to twenty-nine million. But the accuracy of these estimates is subject to question; given the number of states that are opting out, the number could well be far higher. In a turn of events entirely unanticipated when the ACA was enacted, the legacy of the ACA may be that it contributes to widening health disparities rather than the reduction that had been expected by its supporters.

This result is an injustice that cries out for reform. A first step in that direction is ensuring that states are in possession of—and made to acknowledge—accurate information regarding the economic costs of the Medicaid expansion, which are far less than the potentially bankrupting amount that has been portrayed in some corners. A second step is to emphasize the importance of the incorporation of public health in health policy analysis and design; in addition to benefiting individual health, universal access to health services improves public health. Finally, and most critically, strong voices must demand that health policy be implemented such that it achieves justice for the poorest and most vulnerable among us. Without action to rectify the ACA’s unintended consequences, the United States seems likely to consign its poorest and most vulnerable residents to a continued tenuous health status, in which the only options for care are emergency rooms and those institutions that are willing to provide free or nearly free health services.

]]> Emily W. Parento et al. Better Health, But Less Justice: Widening Health Disparities After <i>National Federation of Independent Business v. Sebelius</i> http://scholarship.law.georgetown.edu/facpub/1222 http://scholarship.law.georgetown.edu/facpub/1222 Thu, 30 May 2013 08:52:30 PDT At the time it was enacted in 2010, the Patient Protection and Affordable Care Act (ACA) was widely applauded by health activists, as it meant that the United States would at last join the overwhelming majority of industrialized countries in providing its population with guaranteed access to affordable health care. Roughly half of the increase in access to health insurance was to come from the expansion of Medicaid eligibility to all U.S. citizens and legal residents with income below 138% of the Federal Poverty Level. However, the Supreme Court’s 2012 ruling in National Federation of Independent Business v. Sebelius (NFIB) essentially converted the Medicaid expansion into an option for states, and many (fourteen at the time this article went to press, including states with enormously high rates of uninsured residents, such as Texas) have chosen not to participate. Since NFIB, the Congressional Budget Office has reduced its initial estimate of the number of individuals who were to gain coverage under the ACA, from thirty-two to twenty-nine million. But the accuracy of these estimates is subject to question; given the number of states that are opting out, the number could well be far higher. In a turn of events entirely unanticipated when the ACA was enacted, the legacy of the ACA may be that it contributes to widening health disparities rather than the reduction that had been expected by its supporters.

This result is an injustice that cries out for reform. A first step in that direction is ensuring that states are in possession of—and made to acknowledge—accurate information regarding the economic costs of the Medicaid expansion, which are far less than the potentially bankrupting amount that has been portrayed in some corners. A second step is to emphasize the importance of the incorporation of public health in health policy analysis and design; in addition to benefiting individual health, universal access to health services improves public health. Finally, and most critically, strong voices must demand that health policy be implemented such that it achieves justice for the poorest and most vulnerable among us. Without action to rectify the ACA’s unintended consequences, the United States seems likely to consign its poorest and most vulnerable residents to a continued tenuous health status, in which the only options for care are emergency rooms and those institutions that are willing to provide free or nearly free health services.

]]> Emily W. Parento et al. Defending Those People http://scholarship.law.georgetown.edu/facpub/1221 http://scholarship.law.georgetown.edu/facpub/1221 Fri, 24 May 2013 13:37:54 PDT Many practitioners and scholars have written perceptively about the motivations of criminal defenders. Some have written eloquently. I have my own body of work on this and related questions.

This essay is about why the author has devoted her professional career--her life--to defending people most of society would just as soon banish and forget. After nearly thirty years of criminal law practice, her reasons are such a part of her that they are nearly inarticulable. The author is a criminal defender in her soul. She also has been teaching and writing about criminal defense for almost as long as she has been doing it.

]]> Abbe Smith Decision Theory and <i>Babbitt v. Sweet Home</i>: Skepticism About Norms, Discretion, and the Virtues of Purposivism http://scholarship.law.georgetown.edu/facpub/1220 http://scholarship.law.georgetown.edu/facpub/1220 Wed, 22 May 2013 08:41:19 PDT In this writing, the author applies a “decision theory” of statutory interpretation, elaborated recently in the Yale Law Journal, to Professor William Eskridge’s illustrative case, Babbitt v. Sweet Home Chapter of Communities for a Great Oregon. In the course of this application, she takes issue with the conventional wisdom that purposivism, as a method of statutory interpretation, is inevitably a more virtuous model of statutory interpretation. First, the author questions whether we have a clear enough jurisprudential picture both of judicial discretion and legal as opposed to political normativity. Second, she argues that, under decision theory, Sweet Home is a far easier case than either Justice Stevens’s or Justice Scalia’s opinions reveal. Finally, the author critiques both opinions for failing to rely on norms borrowed from Congress’s actual decisions in the 1982 Endangered Species Act Amendments. The question then, is not “norms or not,” but whose norms, Congress’s or the courts’, should apply.

]]> Victoria Nourse Strange Bedfellows: The Convergence of Sovereignty-Limiting Doctrines in Counterterrorist and Human Rights Discourse http://scholarship.law.georgetown.edu/facpub/1219 http://scholarship.law.georgetown.edu/facpub/1219 Mon, 20 May 2013 10:39:07 PDT It is hard to imagine two groups with less in common than national security hawks and human rights activists. They represent different cultures with different views on the use of force, the role of rights, and the constraining power of international law. Yet despite their differences, the two groups seem to be converging on an understanding of state sovereignty as limited and subject to de facto waiver—an understanding that appears to legitimize military inter­ventions even in the absence of state consent and Security Council authorization.

This convergence is reached via different routes in each community: for the national security community, counter terrorism provides the sovereignty-limiting logic, while for the human rights and humanitarian law communities, it is the prevention of atrocities that leads to sovereignty-limiting doctrines.

In this essay, the author traces how this convergence has come about in two very different discourse communities, and points out some of the unintended consequences and unresolved problems that result.

]]> Rosa Brooks Be Careful What You Wish For: Changing Doctrines, Changing Technologies and the Lower Cost of War http://scholarship.law.georgetown.edu/facpub/1218 http://scholarship.law.georgetown.edu/facpub/1218 Mon, 20 May 2013 10:03:54 PDT The collective security structure created by the U.N. Charter is becoming shakier than ever, and two recent trends pose particular challenges to Charter rules on the use of force. The first trend involves a normative shift in understandings of state sovereignty, and the second trend involves improvements in technology--specifically, the rapid evolution of unmanned aerial vehicles, precision weapons, and surveillance technologies. Each trend on its own raises difficult issues. Together, they further call into question international law’s ability to meaningfully constrain the use of force by states.

]]> Rosa Brooks Moral Conflict and Conflicting Liberties http://scholarship.law.georgetown.edu/facpub/1217 http://scholarship.law.georgetown.edu/facpub/1217 Wed, 15 May 2013 11:45:13 PDT The authors' goal in this chapter is to surface some of the commonalities between belief liberty and identity liberty and to offer some public policy suggestions for what to do when these liberties conflict. She first wants to make transparent the conflict that she believes exists between laws intended to protect the liberty of lesbian, gay, bisexual, and transgender (LGBT) people so that they may live lives of dignity and integrity and the religious beliefs of some individuals whose conduct is regulated by such laws. The author believes those who advocate for LGBT equality have downplayed the impact of such laws on some people's religious beliefs and, equally, she believes those who have sought religious exemptions from such civil rights laws have downplayed the impact that such exemptions would have on LGBT people.

Second, the author wants to suggest that the best framework for dealing with this conflict is to analyze religious people's claims as belief liberty interests under the Due Process Clauses of the Fifth and Fourteenth Amendments, rather than as free exercise claims under the First Amendment. There were important historical reasons for including the First Amendment in our Constitution, with its dual Free Exercise and Establishment Clauses. But the First Amendment should not be understood as the sole source of protection for religious people when the claims such individuals raise also implicate the type of liberty interests that should legitimately be considered under the Due Process Clauses of our Constitution.

The authors' argument in this chapter is that intellectual coherence and ethical integrity demand that we acknowledge that civil rights laws can burden an individual's belief liberty interest when the conduct demanded by these laws burdens an individual's core beliefs, whether such beliefs are religiously or secularly based. Acknowledging that these liberty interests exist and can be burdened by civil rights laws does not necessarily mean that such laws will be invalidated or that exemptions from the law will always be granted to individuals holding such beliefs. Rather, as she hopes to demonstrate below, Justice Souter's concurrence in Washington v. Glucksberg offers us a useful approach for engaging in an appropriate substantive due process analysis that provides us with a means of seriously considering the liberty interest at stake without necessarily invalidating the law burdening that interest.

Finally, the author offers her own assessment of how these conflicts might be resolved in our democratic system. She has no illusions that either LGBT rights advocates or religious freedom advocates will decide that she has offered the correct resolution. The authors primary goal in this chapter is simply to argue that this conflict needs to be acknowledged in a respectful manner by both sides, and then addressed through the legislative processes of our democratic system. Whether the authors particular resolution is ultimately accepted feels less important to her than helping to foster a fruitful conversation about possible resolutions.

]]> Chai R. Feldblum Performance Anxiety: Copyright Embodied and Disembodied http://scholarship.law.georgetown.edu/facpub/1216 http://scholarship.law.georgetown.edu/facpub/1216 Mon, 13 May 2013 09:05:08 PDT The primary economic and cultural significance of copyright today comes from works and rights that weren’t contemplated by the Framers of the Constitution’s Copyright Clause. Performance—both as protected work and as right—is where much of copyright’s expansion has had its greatest impact, as new technologies have made it possible to fix performances in records and films and as cultural change has propelled recorded music and audiovisual works to the forefront of the copyright industries. Yet copyright has never fully conceptualized performance, and this has led to persistent confusion about what copyright protects.

One key problem of performance from copyright’s perspective is how to identify the creative elements that make a work of performance original and protectable, as distinguished from elements that make it a work (a fixed artifact). A major variant of this question involves authorship: who is sufficiently responsible for a work of performance to be deemed its author, and thus its default owner? In a world where works require dozens and even hundreds of people to complete them, this question will often be difficult to answer while both respecting creativity and recognizing economic imperatives. Another set of questions involves whether there are ways to recognize performers’ creative contributions without contributing to copyright’s bloat, and how to assess claims of infringement in a performance context when the alleged copying isn’t exact. This article addresses these puzzles of performance, arguing that manageability rather than creativity is generally the basis for the rights allocations and distinctions copyright law makes. The recent controversy over the film Innocence of Muslims, along with other instances in which subjects of audiovisual works claimed copyright in those works, demonstrate the limited role played by creativity in copyright law.

]]> Rebecca Tushnet Are Prosecutors Born or Made? http://scholarship.law.georgetown.edu/facpub/1215 http://scholarship.law.georgetown.edu/facpub/1215 Fri, 10 May 2013 12:03:34 PDT In more than thirty years of criminal law practice--from public defender in Philadelphia to professor running a criminal law clinic in New York, Boston, and DC--the author has had countless encounters with prosecutors and countless conversations. Early in her career, the encounters and conversations were noteworthy--something to rail about back at the office, or to "dine out on" with friends. Soon enough they became commonplace, not even worthy of mention, just the way things were. But the author felt it important to pick a few examples and talk about them.

]]> Abbe Smith Top 10 Law School Home Pages of 2012 http://scholarship.law.georgetown.edu/facpub/1214 http://scholarship.law.georgetown.edu/facpub/1214 Wed, 08 May 2013 07:55:08 PDT For a fourth consecutive year, every website home page of every ABA-accredited law school is evaluated and ranked based on objective criteria. The goal is to identify well-executed sites adopting best practices. For the 2012 report, twenty-six elements are evaluated across these three categories: Design Patterns and Metadata, Accessibility and Validation, & Marketing and Communications. For 2012, there are four new elements, two prior elements have been combined, and one element was dropped.

For 2012, forty-six schools now use the HTML5 doctype, which is up from thirteen in 2011 and just one in 2010. Eighteen schools achieve perfect scores in an adjusted web accessibility evaluation, which is a slight increase over previous years. One of the new elements awards points for use of Responsive Web Design practices, which is a page layout method that shifts the order and number of elements on a page, based on the screen size displaying the content. Our survey discovered fourteen home pages using responsive web design.

As has been the case since this annual study launched in 2009, there is still no objective way to account for good taste. For interpreting these results, please decide for yourself whether any home page is greater or less than the sum of its evaluated elements.

]]> Roger V. Skalbeck et al. Gideon's Muted Trumpet http://scholarship.law.georgetown.edu/facpub/1213 http://scholarship.law.georgetown.edu/facpub/1213 Tue, 07 May 2013 12:47:33 PDT Once the darling of the legal academy, criminal procedure has fallen into disrepute. Thirty-five years ago, when Gideon was decided, criminal procedure was the flagship of constitutional law, criminal defense attorneys were heroes, and courts and lawyers were perceived as themselves agents of social justice. Today, there are still heroes. But the conventional wisdom, within the academy and the country at large, no longer associates criminal law or procedure with heroism. Indeed, in some quarters, criminal procedure has become the enemy. Increasingly, scholars urge revisionism, popular pundits brand procedural innovations as a loss of "common sense," and philosophers warn that the "procedural republic" has helped us to lose our way.

Striking is this scholarly skepticism when compared to the disturbing fate of those who spawned this conference: they are vulnerable, poor, friendless; they have never seen a lawyer and they have talked to a judge speaking from a remote televised location. They sit in jail for ten or twenty or thirty days, losing their jobs and their families, only to have the charges ultimately dismissed. Douglas Colbert's cases raise important questions about a failed legal revolution. For when the charges have been dismissed, what will Colbert's defendants understand about "criminal procedure"? The majesty of Gideon? The wisdom of the Warren Court? No doubt, the jailed and abandoned defendant would agree with critics of criminal procedure. How else could he see the "process" except as his punishment?

]]> Victoria Nourse The "Normal" Successes and Failures of Feminism and the Criminal Law http://scholarship.law.georgetown.edu/facpub/1212 http://scholarship.law.georgetown.edu/facpub/1212 Tue, 07 May 2013 10:25:11 PDT To write of feminist reform in the criminal law is to write of simultaneous success and failure. We have seen marked changes in the doctrines and the practice of rape law, domestic violence law, and the law of self-defense. There is not a criminal law casebook in America today, nor a state statute book, that does not tell this story. Yet for all of this success, we also live in a world in which reform seems to suffer routine failures. Many believe, for example, that feminist reforms have rid rape law of the resistance requirement; however, recent scholarship makes it clear that the resistance requirement has not disappeared. Similarly, many believe that feminism has rid us of the marital rape exemption; in fact, there is evidence that marital rape immunities remain on the statute books. Finally, many believe that reform has brought widespread judicial acceptance of battered women's self-defense claims; but the battle over this defense in the law reviews and popular media testifies to the continuing lack of settlement of the underlying issues.

]]> Victoria Nourse Law's Constitution: A Relational Critique http://scholarship.law.georgetown.edu/facpub/1211 http://scholarship.law.georgetown.edu/facpub/1211 Mon, 06 May 2013 13:54:32 PDT It is a simple fact: we begin from others. Without others we, quite literally, could not live, feel, be born. Every mother, every mother's partner, every father, every child, knows this. But law sees these relations as something lesser, as foreign. Mention the word "relationship" to the average lawyer and she will likely assume that you are talking about sex, dating, or perhaps marriage. She may even wonder what "relationship" has to do with the law at all.

In this paper, the author wonders whether it is possible to flip that equation, to think of the relational as central, rather than peripheral, to law's most ambitious public projects. Her hypothesis is two-fold: first, that the relational question is known by, and important to, feminism; and, second, that the relational is important beyond feminism, indeed that it is important to our ideas of constitution and law itself. If this is right, then focusing on relationships is far from the marginal project that it is often assumed to be. Indeed, it may allow feminism to predict new ways of seeing law. The author offers examples from her own legal experience--in criminal law and constitutional law--that shows what she calls (for lack of a better term) the "relational critique." What she mean by this is two things: (1) that many of the concepts that we see in law, that seem mundane, natural or given, stand as proxies for normative relations; (2) that by disaggregating the natural object--by seeing relations in naturalized descriptions--we can see the law creating/ generating/constituting. Put another way, this paper is about thinking relationally—the author wonders whether it is possible or wise to substitute the "relational" question for the "sameness" question or the "difference" question--not only in cases of concern to feminists but cases elsewhere in the law.

]]> Victoria Nourse Equality's Future: An Introduction http://scholarship.law.georgetown.edu/facpub/1210 http://scholarship.law.georgetown.edu/facpub/1210 Mon, 06 May 2013 09:55:09 PDT We stand at an extraordinary moment: never before have so many powerful men wished to be women. For the first time in history, a massive number of male and female voters--18 million in fact--cast their ballots to nominate a woman, Senator Hillary Clinton, to be President of the United States. Disappointed at Senator Clinton's failure to win the Democratic Party's nomination, many women threatened to bolt the party. Sensing opportunity, the Republican Presidential candidate, Senator John McCain, promptly named as his vice-presidential running mate the first woman ever nominated by the Republican Party to a Presidential ticket. And, not to be outdone, the other vice-presidential candidate, Senator Joe Biden, with characteristic candor, openly wondered whether his running mate might have been better off choosing a woman.

]]> Victoria Nourse Supreme Court Institute Annual Report, 2012-2013 http://scholarship.law.georgetown.edu/sci_papers/3 http://scholarship.law.georgetown.edu/sci_papers/3 Mon, 06 May 2013 08:30:52 PDT During the 2012-2013 academic year–corresponding to the U.S. Supreme Court’s October Term (OT) 2012–the Supreme Court Institute (SCI) provided moot courts for advocates in 100% of the cases heard by the Court this Term, offered a variety of programs related to the Supreme Court, and hosted several delegations of foreign visitors. A list of all SCI moot courts held in OT 2012–arranged by argument sitting and date of moot and including the name and affiliation of each advocate and the number of student observers–follows the narrative portion of this report.

]]> Georgetown University Law Center, Supreme Court Institute Countering the Problem of Falsified and Substandard Drugs http://scholarship.law.georgetown.edu/ois_papers/51 http://scholarship.law.georgetown.edu/ois_papers/51 Wed, 01 May 2013 12:51:06 PDT The adulteration and careless manufacture of medicines is an old problem, vastly aggravated by globalization. The US Food and Drug Administration commissioned the Institute of Medicine to investigate the global problem of falsified and substandard drugs, considering the causes and possible solutions to this international public health crisis. In its consensus report, the committee identified two main categories of drug quality failures of public health concern. Falsified drugs carry a false representation of identity or source; substandard drugs fail to meet the specifications set in the national pharmacopeia or the manufacturer’s dossier. In practice, these categories overlap, but they are sufficiently precise for public discourse.

It is difficult to measure the global market for falsified and substandard drugs, but there is good evidence that they are a problem in poor countries with weak drug regulatory systems. All classes of drugs are compromised, especially inexpensive antibacterial and antimalarial treatments. When fake antimicrobials contain sub-therapeutic doses of active ingredients, they encourage drug resistance, shortening the effective life of a drug and hastening the expense of new drug development. The trade in fake medicines erodes patient confidence in allopathic medicine and the public health system. The organized fraud that allows the drugs to circulate undermines all public institutions and conveys money and power to criminals.

Investment in drug manufacturing could improve drug quality in low- and middle-income countries, and development finance organizations are well positioned to make these investments. Changes to procurement practices could also help guarantee that honest manufacturers get the largest market share. Most of all, low- and middle-income countries need better regulatory systems. The first step to building these systems is developing a strategic plan for the agency improvement. Changes to the drug distribution system could protect the drugs supply. In the United States, licensing only wholesalers that meet National Association of Boards of Pharmacy accreditation standards would reduce the hazards of secondary wholesale, as would a congressionally mandated track-and-trace system. In developing countries, governments should use franchising, accreditation, low-interest loans, and task shifting to create an environment conducive to quality drug retail. There is also a need for sturdy and inexpensive detection technologies that can be used to detect fake medicines in the field. A WHO International Code of Practice on falsified and substandard drugs would facilitate international cooperation against falsified and substandard drugs.

]]> Gillian J. Buckley et al.