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The Law of Placenta
No full textOf the forms of reproductive labor in which legal scholars have been interested, placenta, the organ developed during pregnancy, has been overlooked. As placenta becomes an object of value for a growing number of individuals, researchers, clinicians, biobanks, and biotech companies, among others, its cultural meaning is changing. At the same time, these various constituencies may be at odds. Some postpartum parents and their families want to repossess their placenta for personal use, while third parties use placentas for a variety of research, medical, and commercial purposes
Pharmaceutical Pricing When Success Has Many Parents
No full textPharmaceutical companies claim that high prices for drugs are needed to offset the costs and risks associated with research and development. In most instances, though, the initial (basic) research that leads to new discoveries is conducted at public institutions and paid for with public funds. Drugmakers tend to take over the process of bringing new drugs to market when the prospects for gaining regulatory approval seem good. Because the public helps cover the cost of research, many people believe that it pays twice for drugs—once when tax dollars support research and a second time when patients buy drugs for personal use. This Article takes a hard look at this “paying-twice” critique. We present case studies of two expensive drugs, Sovaldi and PrEP, that were developed with a combination of public and private support. We then survey the broader literature that attempts to quantify and assess the relative importance of both contributions. We then discuss the general problem of evaluating the importance of multiple contributions to productive activities in the absence of market-based allocations of the resulting revenue streams. Finally, we discuss the possibility of protecting consumers from high drug prices and deadweight losses by using prizes instead of patents to incentivize drug development. A prize regime would take the sting out of the paying-twice critique as well
A Theory of Mandatory Rules: Typology, Policy, and Design.
No full textIn a perfectly competitive market, the law should simply give effect to the parties' agreements (assuming, that is, that efficiency is all we care about). Real-world markets and real people are often a far cry from this ideal. Market failures (including behavioral ones) call for serious consideration of regulation. For decades, market regulation has focused on disclosure duties. However, mounting evidence suggests that such duties are often ineffective. Alongside endless attempts to make disclosures more effective-driven in part by ideological aversion to other modes of regulation, and in part by regulatory capture-there is growing disillusion about this path, which is shared by some law-and-economics scholars.2 In the past decade or so, there has been much enthusiasm about the use of nudges-"low-cost, choicepreserving, behaviorally informed approaches to regulatory problems"'as a non-intrusive way to influence people's behavior in desirable ways. However, there are increasing doubts about the effectiveness of nudges as
well, especially when suppliers have an incentive to counter their effects.
In response to these realizations, some are inclined to conclude that regulation (or much of it) should be abandoned altogether, leaving the scene to market forces of reputation and competition.7 An alternative conclusion is that the failure of disclosure duties and the limited efficacy of nudges call for more serious consideration of the use of mandatory regulation of the content of transactions. This Article focuses on such measures, which we dub "substantive mandatory rules." Other regulatory means, such as disclosure duties and cooling-off periods, are also often nonwaivable. But these other means, which we dub "procedural mandatory rules," regulate the process by which contracts are formed.8 Regulation of the substantive content of transactions is unique in the sense that it does not content itself with improving the conditions under which people make contracts, but rather
intervenes in their content. Examples of substantive mandatory rules include usury laws, minimum-wage statutes, and statutes that set minimal liability of construction firms for building defects. Substantive mandatory rules sometimes respond to procedural defects in contracts, such as information problems, and sometimes aim at other goals. Some mandatory rules respond to defects in both the process of contracting and the substance of contractual provisions. A case in point is the doctrine of unconscionability, which limits enforcement where there is an improper admixture of procedural and substantive unconscionability
Artificial Intelligence and Climate Change
No full textAs artificial intelligence (AI) continues to embed itself in our daily lives, many focus on the threats it poses to privacy, security, due process, and democracy itself. But beyond these legitimate concerns, AI promises to optimize activities, increase efficiency, and enhance the accuracy and efficacy of the many aspects of society relying on predictions and likelihoods. In short, its most promising applications may come, not from uses affecting civil liberties and the social fabric of our society, but from those particularly complex technical problems lying beyond our ready human capacity. Climate change is one such complex problem, requiring fundamental changes to our transportation, agricultural, building, and energy sectors. This Article argues for the enhanced use of AI to address climate change, using the energy sector to exemplify its potential promise and pitfalls. The Article then analyzes critical policy tradeoffs that may be associated with an increased use of AI and argues for its disciplined use in a way that minimizes its limitations while harnessing its benefits to reduce greenhouse-gas emissions
Transformative Models to Promote Prescription Drug Innovation and Access: A Landscape Analysis
No full textThe patent-based pharmaceutical innovation system in the US does not incentivize the development of drugs with the greatest impact on patient or public health. It has also led to drug prices that patients and health care systems cannot afford. Three alternate approaches to promoting pharmaceutical innovation have been proposed to address these shortcomings. Delinkage models involve payments for drug innovation based on public health value rather than on a per-use basis. Public manufacturing models call upon governments and nonprofit organizations to lead drug discovery, development, and production. Public-private partnership models entail publicly-funded organizations working closely with for-profit partners on drug development and price-setting. Each model exhibits promise in promoting prescription drug innovation and access. This paper reviews these transformative models in detail, examining their key characteristics, advantages, and limitations
Hope, Maine Town Clerk Records, 1804-1848: A Literal Transcription / Cynthia S. DellaPenna, editor.
No full textHope Historical Society, 2020. 439 pages. Transcription of ledger in the Rare Book Collection, Lillian Goldman Law Library, Yale Law School. Gift of Lois S. Montbertrand, Yale Law School Class of 1985. Ledger includes information about the change of name from Barrettstown Plantation to Hope in 1804, and later information on the issue of separation from the Commonwealth of Massachusetts. The final vote, on July 26, 1819, favored separation, though earlier votes had been against it. The town of Hope sent a delegate to the Constitutional Convention in Portland in October 1819. In 1820 the state of Maine was created. Town clerks mentioned in the ledger: Samuel Reeves, 1804; Almond Gushe, 1805; Matthew Beveridge, 1806; Solomon Harwood, 1830; Asa Payson, 1835; Henry Hobbs, 1837, 1841; Abner Dunton Jr., 1839, 1842. http://morris.law.yale.edu/record=b137335
The Adjudication Business
No full textThe recent proliferation of international commercial courts around the world is changing the global business of adjudication. The rise of these courts challenges received accounts of the competitive relationships between and among courts and arbitral tribunals for this business. London and New York have long beenconsidered the forums of choice in international commercial contracts—whether parties opt for litigation or arbitration. More recently, however, English-language-friendly international commercial courts have been established in China (2018), Singapore (2015), Qatar (2009), Dubai (2004), the Netherlands (2019), Germany (2018), France (2010), and beyond. The emerging scholarship addressing these new courts tends to view them as engaged in a global competition with each other and with arbitration to create the most efficient dispute resolution mechanism. That account oversimplifies. The creation of each of these courts is driven by multiple factors on the ground. This Article makes four contributions to the study of international commercial courts and their relationship to arbitration. First, it offers a categorization of international commercial courts based on the forces apparently driving their creation. Second, it critiques the “race to the top” narrative both within the law-and-economics framework and outside of it, drawing attention to the range of domestic and international forces driving the courts’ rise. The courts’ success therefore will not necessarily be based on the excellence of the adjudication they provide, but rather on other metrics, such as the number of cases or amount of investment they attract, that reflect what drove States to create the international commercial court in the first place. Third, these courts challenge the traditional U.S. view that arbitration and litigation are opposites. In fact, international commercial courts borrow many features from arbitration, like expert adjudicators, confidentiality, and customizable procedures. These courts thus pose the questions: what characteristics of arbitration and litigation are fundamental, and what do parties prefer? Fourth, the Article celebrates procedural innovation but warns international commercial courts against becoming beholden to either sovereign or private interests.
Examining Pharmaceutical Exceptionalism: Intellectual Property, Practical Expediency, and Global Health
No full textAdvocates, activists, and academics have criticized pharmaceutical intellectual property ("pharma IP") rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, that do not rely on IP; and wealthy private individuals. Their resources could be used to aid patients by providing direct medical assistance, funding prizes or biomedical research, or purchasing pharmaceutical patents and granting rights to the disadvantaged
Reputation and Authority: The FDA and the Fight over U.S. Prescription Drug Importation
No full textThere is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts.
In this Article, we argue that prescription drug importation is a form of international regulatory engagement that can work, but not in the manner that recent congressional legislation or the Trump Administration has proposed. Importation of prescription drugs, even foreign versions of already-approved drugs, requires the importing nation to accept the marketing approval standards, processes, and product-specific decisions of the exporting nation as equivalent to domestic regulation. The FDA, however, has made far fewer determinations of foreign regulatory equivalence than its counterpart regulators. As a result, the statutory requirements for the FDA maintaining direct oversight over prescription drug imports from Canada are onerous and unlikely ever to be fulfilled.
Examining U.S. prescription drug importation as a form of reliance on the equivalence of foreign regulation is, as far as we can determine, a novel inquiry, and it offers useful insights. Foreign equivalence determinations have been successfully used in pharmaceutical regulation in two contexts: (1) trade initiatives and (2) circumstances in which regulatory agencies were unable to
fulfill their core institutional mandates without relying on the decision making of their foreign counterparts. The FDA has not fit neatly into either of these contexts. In contrast to many of its foreign counterparts, the FDA has consolidated authority over pharmaceutical regulation, which it sustains through its reputation among its constituents-appropriators, consumers, pharmaceutical product sponsors, and the relevant medical and scientific communities-for overseeing the safety, efficacy, and quality of medicines. The FDA has resisted risking any harm to that gatekeeper reputation that might follow from its pursuit of other policy objectives, such as lowering drug prices or facilitating trade. Furthermore, FDA officials describe themselves as "the
gold standard" for drug review-more thorough and rigorous about regulation than their counterparts-and, until recently, as able to fulfill their core institutional mandates without the cooperation of foreign counterparts.
Based on this analysis of the political economy of pharmaceutical regulation and international regulatory cooperation at the FDA, we propose that U.S. prescription drug importation could be successfully used to reduce generic drug shortages, a persistent public health problem that the FDA has struggled to solve independently. We argue that the same analysis can help identify other circumstances when the FDA might usefully engage foreign counterparts, such as foreign manufacturer inspections for the rapidly
increasing volume of U.S. drug imports, the growing complexity of global pharmaceutical supply chains, and the technological advances in personalized medicines
A Unified Constitutional View of Financial Punishment: Synthesizing the Excessive Fines Clause and Bearden-Based Protections
No full textThis Note coordinates the Eighth Amendment Excessive Fines Clause with the Fourteenth Amendment wealth-discrimination protection set forth in Bearden v. Georgia. It is generally assumed that the two protections operate independently: while the Excessive Fines Clause protects individuals against exorbitant financial obligations, Bearden limits the state from converting criminal debt into a severe liberty deprivation. But in recognizing how the two doctrines are normatively and functionally reinforcing, this Note proposes a single framework for considering financial punishment’s constitutionality. If the Eighth Amendment protection applies at the imposition of a financial punishment, Bearden provides a “second look” at the constitutionality of that punishment. Or, put another way, the Eighth Amendment is a preemptive look at the downstream poverty-based liberty deprivations that Bearden secures individuals against. Appreciating this relationship affords additional authority to both protections, and suggests a number of improvements to existing safeguards