Showing papers in "Journal of Law and the Biosciences in 2018"

May your drug price be evergreen.

Abstract: Presenting the first comprehensive study of evergreening, this article examines the extent to which evergreening behavior-which can be defined as artificially extending the protection cliff-may contribute to the problem. The author analyses all drugs on the market between 2005 and 2015, combing through 60,000 data points to examine every instance in which a company added a new patent or exclusivity. The results show a startling departure from the classic conceptualization of intellectual property protection for pharmaceuticals. Rather than creating new medicines, pharmaceutical companies are largely recycling and repurposing old ones. Specifically, 78% of the drugs associated with new patents were not new drugs, but existing ones, and extending protection is particularly pronounced among blockbuster drugs. Once companies start down the road of extending protection, they show a tendency to return to the well, with the majority adding more than one extension and 50% becoming serial offenders. The problem is growing across time.

State incentives to promote organ donation: honoring the principles of reciprocity and solidarity inherent in the gift relationship.

Abstract: Organ transplantation saves the lives of thousands of patients worldwide every year. However, a chronic organ shortage overshadows this success. We define the organ shortage as a public health problem due to its serious consequences on patients and society. This definition raises the question of the state's role in transplantation medicine. It leads us to formulate a public policy promoting organ donation through state incentives, ie regulatory instruments to reward individuals' willingness to donate. Incentives allow the state to express gratitude for the solidary act of the donor toward the recipient and society. In an original approach, we integrate sociological findings as to the act of donation-the concept of reciprocity most importantly-into the core attributes of such a public policy. Addressing regulatory design questions, we present incentives such as allocation priority, tax benefits, health insurance discounts, and coverage of funeral costs. We also examine the unique non-financial incentive successfully implemented in Israel. We then discuss the legal and ethical framework in which state incentives have to operate, concluding that normative constraints can be addressed through law reform. Finally, we focus on aspects neglected so far in public information campaigns and discuss the interaction between state policy and public opinion.

The impact of virtual reality on implicit racial bias and mock legal decisions.

Abstract: Implicit racial biases are one of the most vexing problems facing current society. These split-second judgments are not only widely prevalent, but also are notoriously difficult to overcome. Perhaps most concerning, implicit racial biases can have consequential impacts on decisions in the courtroom, where scholars have been unable to provide a viable mitigation strategy. This article examines the influence of a short virtual reality paradigm on implicit racial biases and evaluations of legal scenarios. After embodying a black avatar in the virtual world, participants produced significantly lower implicit racial bias scores than those who experienced a sham version of the virtual reality paradigm. Additionally, these participants more conservatively evaluated an ambiguous legal case, rating vague evidence as less indicative of guilt and rendering more Not Guilty verdicts. As the first experiment of its kind, this study demonstrates the potential of virtual reality to address implicit racial bias in the courtroom setting.

GINA at 10 years: the battle over 'genetic information' continues in court.

Abstract: Ten years ago, the Genetic Information Nondiscrimination Act ('GINA') came into law. While it was unclear how prevalent genetic discrimination was, GINA was enacted preemptively to prevent discrimination in insurance and employment. It also created uniform protections to remedy a confusing patchwork of state and federal protections. Finally, Congress hoped GINA would allay public fears of genetic discrimination that discouraged people from undergoing genetic testing and participating in genetics research. To address those fears, Congress enacted robust protections against genetic discrimination in health insurance and employment, in part, by defining 'genetic information' as broadly as possible. Over the last ten years, however, the courts have been battling over the meaning of 'genetic information'. One interpretive approach adheres strictly to GINA's statutory language; the second interprets the definition restrictively and contrary to the plain meaning of GINA and its underlying goals. While this interpretive conflict demonstrates the difficulty of distinguishing genetic information from non-medical information, this article argues for the broader interpretation. Such an interpretation reflects Congress's choice among imperfect definitional options and it furthers the goal of creating strong protections in health insurance and employment. Finally, definitional consistency is necessary to achieve uniform protections against genetic discrimination.

Creating life after death: should posthumous reproduction be legally permissible without the deceased's prior consent?

Abstract: Scientific advances enable to retrieve and use gametes of a deceased person, thereby creating a child after the death of a genetic parent. This article reviews and compares legislation governing posthumous reproduction in the United States, the United Kingdom, Australia, and Israel. It shows that each country has its own distinctive features, yet three common elements exist—legal ambiguity, a requirement for prior consent, and permission for the partner, but not the parents, to retrieve and use the deceased's gametes. The article demonstrates that courts often do not follow the legal requirements, and thus there are no clear guiding principles regarding posthumous reproduction. The article then discusses three justifications for permitting posthumous reproduction in the absence of the deceased's prior consent. The first justification relates to an interest in ‘genetic continuity’, which reflects people's desire in leaving a ‘piece’ of themselves in the world and maintaining a chain of continuity. The second justification concerns the ‘respect-for-wishes’ model of autonomy, according to which people must be treated in a way that we assume they would want to be treated. The third justification touches upon the interests of the deceased's partner and parents, as well as of the resulting child.

Cutting edges and weaving threads in the gene editing (Я)evolution: reconciling scientific progress with legal, ethical, and social concerns.

Abstract: Gene-editing technology, such as CRISPR/Cas9, holds great promise for the advancement of science and many useful applications technology. This foundational technology enables modification of the genetic structure of any living organisms with unprecedented precision. Yet, in order to enhance its potential for societal benefit, it is necessary to adapt rules and produce adequate regulations. This requires an interdisciplinary effort in legal thinking. Any legislative initiative needs to consider both the benefits and the problematic aspects of gene editing, from a broader societal and value-based perspective. This paper stems from an interdisciplinary research project seeking to identify and discuss some of the most pressing legal implications of gene-editing technology and how to address these. While the questions raised by gene editing are global, laws and regulations are to a great extent bound by national borders. This paper presents a European perspective, written for a global audience, and intends to contribute to the global debate. The analysis will include brief references to corresponding USA rules in order to place these European debates in the broader international context. Our legal analysis incorporates interdisciplinary contributes concerning the scientific state of the art, philosophical thinking regarding the precautionary principle and dual-use issues as well as the importance of communication, social perception, and public debate. Focusing mainly in the main regulatory and patent law issues, we will argue that (a) general moratoriums and blank prohibitions do a disservice to science and innovation; (b) it is crucial to carefully consider a complex body of international and European fundamental rights norms applicable to gene editing;

Uterus transplantation in and beyond cisgender women: revisiting procreative liberty in light of emerging reproductive technologies.

Abstract: Whilst internationally a growing body of literature is emerging on uterus transplantation as the latest advance in assisted reproductive technology, much of this has been devoted to responding to the ethical questions raised by this procedure in the context of its immediate purpose, to restore fertility in cisgender women. Very few have addressed whether it can be claimed that there is a right to gestate under the umbrella of procreative liberty, nor whether such a right, if it does exist, applies not only to cisgender women, but also transgender and gender variant individuals and cisgender men. In honour of Professor Robertson, I advance the debate further by examining the arguments put forward in his last paper and whether the right to gestate extends beyond cisgender women.

The stem cell market and policy options: A call for clarity

Abstract: The field of regenerative medicine is widely viewed as having the potential to improve treatment options for a broad range of conditions. Stem cell research in particular has been celebrated for its considerable clinical promise. Although measured enthusiasm surrounding this area of research is warranted, it must be balanced by patience and set in the context of a long-term perspective that is cognizant of the many steps required to bring safe and efficacious therapies to market. Creating therapeutic applications of stem cell technologies is an intricate process involving complex biology. It will require careful scientific investigation and evaluation under responsible ethical frameworks and regulatory standards in order to safely maximize their potential. Alongside the many promising avenues of responsible research currently underway in countries throughout the world, a global market has emerged where a wide range of putative stem cell-based interventions are sold on a direct-to-consumer basis and marketed over the internet.1,2,3,4 In this paper, we discuss a number of concerns associated with this market that stem from a lack of clarity in several key areas, and propose approaches for how they might be remedied. Although we are not the first to identify many of these concerns, their persistence demonstrates the need for clear and concise actions. The market for unproven stem cell-based interventions engages varied interests and crosses different regulatory, research, and clinical domains. We draw on the considerable body of work in this area to highlight the contributing factors to this problem and to facilitate actions to ameliorate some of the most concerning issues. Engaging the different groups and entities that are involved in this space, and clarifying and coordinating their actions, will be critical to the success of policy efforts aimed at mitigating the risks of this market while promoting responsible progress in stem cell research.5 Numerous issues and concerns with the market for unproven stem cell-based interventions have been identified. Many for-profit clinics selling unproven stem cell-based interventions directly to patients take advantage of the hyperbole surrounding stem cell research6,7,8 to advertise their products and services. In many cases, interventions are sold that have no established biomedical or scientific basis (eg stem cell-based treatments for autism). In other instances, the interventions offered may be rooted in basic scientific findings and preliminary clinical experience, but currently have insufficient formal clinical testing to justify widespread clinical use (eg adipose derived stem cells for treatment of orthopedic injuries). At times, it appears that uncontrolled and non-standardized products are being administered, without credible evidence that the products contain active stem cells or have demonstrated any regenerative effects. In addition to other concerns (eg potential fraud and financial loss), when these unproven interventions are advertised and administered without an adequate evidence base, they risk causing serious injury to patients and violating professional and legal standards.9,10,11 For example, recent reports of adverse results include lesions of the spinal cord12 and retinal detachments following intraocular injection of adipose-derived stem cells.13 A comprehensive analysis of reported adverse events from patients who received unproven stem cell-based interventions published in 2018 details 35 cases of acute or chronic complications or death, emphasizing the potentially serious consequences of these unproven interventions.14 Early research investigating this global online direct-to-consumer marketplace for purported stem cell interventions revealed a preponderance of clinics in China, India, and Mexico.15,16 More recent research documents a growth of the market in such countries as the United States, Canada, Australia, and Japan.17,18,19,20 For example, one empirical study of the US direct-to-consumer marketplace for unproven stem cell interventions found over 350 businesses marketing putative ‘stem cell treatments’ for a wide range of diseases and injuries, and a recent update describes 716 clinics operating in 45 of the 50 US states.21 The risks associated with different supposed stem cell-based interventions available on the private market vary tremendously and depend on numerous factors including the source and type of cells used; the quality of harvesting and processing procedures and facilities; levels of procedural reproducibility and quality control; the manner and site of cell administration; the training and expertise of the health care team and the degree and quality of post-procedure care and follow-up. Leading scientific bodies such as the International Society for Stem Cell Research (ISSCR) have made important strides in developing voluntary guidelines for stem cell research and clinical translation pathways.22 However, as the global market for stem cell interventions continues to expand and diversify, it is increasingly difficult to draw sharp lines between what may constitute responsible and ethical instances of medical innovation,23,24 and activities that are clearly unethical because of the inappropriate personal financial burden they may create for the patient, the risks they pose, the uncertainties about their risks, or the lack of any potential benefits. This murkiness and the growing difficulties associated with identifying clear ‘red flags’ of problematic commercial activity creates challenges for prospective patients, health care providers, and regulators alike. We suggest that there is a need for policy makers and stakeholders to focus on achieving informational clarity about stem cell interventions in three key and interconnected areas, each of which carries different responsibilities for those involved: (i) with regulation that is clear and comprehensive, as well as consistently and robustly enforced; (ii) with scientific and clinical transparency, and (iii) with patient communication and engagement strategies that prioritize informed decision-making, accurate representations, and realistic expectations. Improvements in each of these domains depends on progress in the others. Effective regulation requires scientific and clinical precision. Similarly, truly informed decision-making by patients demands a clear understanding of scientific and clinical realities, while responsible scientific and clinical progress is facilitated by clear and consistent regulation that oversees the production of a high-quality product, thus improving reliability, patient confidence, and decision-making. We situate our analysis and recommendations largely in the Canadian and US contexts. In both countries, we see opportunity for timely, strategic interventions to restrict proliferation of the most egregious and concerning forms of this market. We also note however that the global nature of this market demands an important role for international cooperation and coordination.

Political economy, stakeholder voices, and saliency: lessons from international policies regulating insurer use of genetic information.

Abstract: A decade ago, Congress passed the Genetic Information Nondiscrimination Act (GINA), with the goals to address fear of genetic discrimination and prevent adverse health insurance and employment decisions on the basis of one's genetic information. Yet, fear of discrimination remains because other insurers, notably life, long-term care, and disability insurers, are not covered by the law. Therefore, there have been persistent murmurings for a 'GINA 2.0' to extend the protections of the original law. Although it is plausible to assume that the insurance industry has the political economy to control future regulation, given the saliency of genetic discrimination, other stakeholders and bureaucrats may have greater influence. This paper explores the history of policy in four countries-the United Kingdom, Sweden, Australia, and Canada. Each country provides examples of continued policy debate and change following an initial period of reliance on insurance industry self-regulation, with change generally occurring over the objection of the insurance industry. This article argues that US insurers, regulators, and stakeholders should negotiate a consensus solution for insurer use of genetic information that balances between social and economic considerations. Without compromise, continued saliency and a weakened political economy of insurers will foster continued entrenched debate on the issue.

What do experimental simulations tell us about the effect of neuro/genetic evidence on jurors?

Abstract: Online simulations have their purpose and they are economically efficient to conduct. Indeed, participants recruited through Amazon’s Mechanical Turk will complete online studies for literally pennies. But these types of studies do not supply the type of evidence that is likely to affect the decisions made by legal professionals. If experimental simulations are to have a real-world impact, it is time for the field to ween off ecologically invalid experiments and invest more resources to better emulate the setting and conditions of a jury when studying the impact of neuro/genetic evidence on jurors.

Genetic research and applicable law: the intra-EU conflict of laws as a regulatory challenge to cross-border genetic research.

Abstract: EU law does not regulate genetic research per se, but the latter is governed to a certain extent by data protection law. Regardless of the harmonizing efforts of the General Data Protection Regulation (GDPR), research regulations remain fragmented in the data protection framework. This is mainly due to the vast discretion granted to Member States in this regard in the GDPR. Albeit the GDPR enabling data flows for research cooperation in the EU, it creates a hurdle for cross-border research by ignoring the intra-EU conflict of laws that inevitably arises in a fragmented regulatory framework. Imagining ways to solve the dilemma of applicable national law under the GDPR generally is not that difficult, but becomes trickier in a research context. Whether the national data protection law of one or the other Member State is to be applied, either the interests of data subjects or those of researchers might end up compromised.

The app will see you now: mobile health, diagnosis, and the practice of medicine in Quebec and Ontario.

Abstract: Mobile health applications are increasingly being used as tools of medicine. Outside of the clinic, some of these applications may contribute to diagnoses made absent a physician's care. We argue that this contravenes reservations of diagnosis to healthcare professionals in the law of two Canadian provinces: Quebec and Ontario. On the one hand, the law conceives of diagnosis in relatively broad terms. Drawing an association between symptoms and illness, for example, has been recognized in case law as sufficient. On the other hand, provincial law reserves diagnosis to physicians and other healthcare professionals. We argue that a number of health applications are capable of drawing associations between symptoms and disease and, in doing so, of delivering diagnoses in contravention of the law of Quebec and Ontario. This places mobile health applications in a poorly understood legal space. While prosecution is unlikely, the increasing ubiquity and technological sophistication of health applications promises to make such diagnosis widespread. We suggest that the legal status of such mobile health apps should be given serious attention. While our analysis focuses on the state of the law in Canada's largest provinces, we suggest that our argument will have implications in other jurisdictions.

Patenting nature-a comparative perspective.

Abstract: The landscape for patenting products and processes tied to the natural world has changed dramatically in recent times as a result of a series of decisions of the US Supreme Court, particularly Mayo Collaborative Services v Prometheus Laboratories 566 U.S. 66 (2012) and Association for Molecular Pathology v Myriad Genetics, Inc. 569 U.S. 576 (2013) (Myriad). This article critically analyses these decisions and the multitude of lower court decisions that have followed them. This analysis provides support for the growing concern in the United States that it will be increasingly difficult to use the patent system to encourage the development of therapies and research intermediates useful in developing new therapeutic interventions. One option being posited in the industry to deal with this problem is to lobby Congress to reform the threshold patent eligibility standard in US patent law. It is argued in this paper that a more nuanced approach is preferable. Using the experience in Australia as a case study, this paper argues that such an approach is feasible. Australia has been chosen for analysis because the threshold patent eligibility standard is similar in both countries, much more so that with the European Union, and because the highest court in Australia has ruled on essentially the same patent as in Myriad, in D’Arcy v Myriad Genetics, Inc [2015] HCA 35. In addition to the nuanced approach to eligibility currently exercised by the Australian courts and patent office, Australia also has a number of post-grant options for addressing the dynamics of patent monopolies. These include experimental use, compulsory licensing, and government use. It is concluded that, while it would be impractical to attempt to replicate the Australian environment in the United States, there is no reason why some lessons can’t be learned from the Australian experience with patenting nature.

Suicide and Death with Dignity.

Abstract: Suicide is a response to two, often-overlapping stimuli, pain and despair.1 Pain may be physical or psychological. In either aspect, it consumes the person until he seeks only release. A person experiences despair when he concludes that he can no longer hope for an acceptable experience of life. Cluster headaches, so called ‘suicide headaches’,2 typify the kind of pain that might drive a person to suicide. A person might despair in response to her prognosis of her glioblastoma multiforme, ‘the most aggressive and lethal form of brain cancer’.3 To provide relatively simple and painless relief, many states have permitted physicians to assist their patients in suicide.4 Oregon was the first American state to pass a PAS bill, which it titled ‘Oregon Death with Dignity Act.’5 The law permits Oregonian citizens with less than six months to live due to a terminal illness to request and receive lethal medication to end their own lives.6 More than ten years later, Washington became the second state with its ‘Washington Death with Dignity Act’, modeled

Is it 'gene therapy'?

Abstract: What, exactly, is "gene therapy"? Crystallizing a modern definition of "gene therapy" has now become critically important on several fronts. Following the recent of passage the 21st Century Cures Act, FDA now relies on the term to give regulatory incentives to sponsors of certain ‘regenerative medicines’, including ‘gene therapies’. NIH Director Francis S. Collins and FDA Commissioner Scott Gottlieb recently announced that Recombinant DNA Advisory Committee ("RAC") approval would no longer be required for "gene therapy" because "there is no longer sufficient evidence to claim that the risks of gene therapy are entirely unique and unpredictable." And in July 2018 FDA issued six draft guidance documents on "gene therapy" but none with a substantially new definition. We review the contours ofthe term here, and propose that "gene therapy"— in the lay, scientific, and legal sense — should be defined as an intentional and expected permanent alteration of a specific DNA sequence of the cellular genome — that is, the sum of DNA that exists within a cell — for a clinical purpose. We also propose that gene therapy, as we define it, can be further categorized into at least three types: direct,compensatory, and augmenting. Defining gene therapy in this fashion would provide clarity to scientists and regulators alike.

Surrogacy, Privacy, and the American Convention on Human Rights

Abstract: Under the Inter-American Human Rights System, individuals have a right to access reproductive technologies. However, the legal status of surrogacy agreements in State Parties to the American Convention on Human Rights (ACHR) is mostly uncertain. The article discusses whether a complete ban on surrogacy is compatible with the ACHR. It considers potential objections to surrogacy agreements: ‘corruption objections’—surrogacy denigrates the nature of what is being exchanged-, the potential exploitation of surrogates and welfare concerns of children born from surrogacy. The article concludes that States Parties to the ACHR should allow both altruistic and commercial surrogacy, but that regulatory schemes for appropriate protection of the rights of surrogates, intending parents, and children resulting from surrogacy ought to be secured.

Privatizing procreative liberty in the shadow of eugenics

Abstract: The late John Robertson is renowned for the theory of ‘procreative liberty’ that he expounded in his pioneering book, Children of Choice. Procreative liberty captures the ‘freedom to reproduce without sex’ above and beyond the ‘freedom to have sex without reproduction’ that are recognized by constitutional rights to abortion and birth control. Most controversial among Robertson's work on procreative liberty was its application to prenatal selection. Unless the state had very good reasons, he argued, people should be free to access reproductive medicine or technology to have a child who or would be born with particular traits. Prospective parents in the USA today face no official limits in using sperm banks, egg vendors, IVF clinics, or surrogacy agencies with an eye toward choosing for certain characteristics. But should they be protected, this essay asks, when mix-ups or misdiagnoses thwart the selection of offspring traits? The best answer to this question extends the theory of procreative liberty from government restrictions to professional negligence. It also demands sensitivity to genetic uncertainty, the limits of private law, and the history of eugenics in America. Or so I argue in this tribute to the inimitable John Robertson.

Protecting essential information about genetic variants as trade secrets: a problem for public policy?

Abstract: In 2013, the U.S. Supreme Court held that naturally occurring human genes are not patentable subject matter. This decision, invalidating patents held by Myriad Genetics involving genes affecting breast cancer, appeared to further the constitutional policy behind intellectual property protection to promote scientific progress and to make genetic testing more readily available to patients. However, the decision's ironic aftermath is continuing assertion by genetic testing companies of trade secrets protections over information about the significance of genetic variants. This article analyzes possible approaches to the assertion of trade secret protections over information about the significance of genetic variants. Specifically, we consider five approaches: voluntary responses from the scientific community; Food and Drug Administration (FDA) or CMS regulation; creation of additional march-in rights as under the Bayh Dole Act; compulsory licensing as under patent law; and creation of a public policy exception to trade secret protection. We explore what each approach would require legally if applied to break trade secret barriers, together with their advantages and disadvantages. While our analysis concerns genetic information, we conclude with some thoughts about its relevance to other types of big data now protected by trade secrets such as information about innovations in quality of care.

Assessing potential legal responses to medical ghostwriting: effectiveness and constitutionality.

Abstract: Pharmaceutical companies are extensively involved in shaping medical knowledge to market their products to physicians and consumers. Specialized planning is undertaken to produce scientific articles driven by commercial interests. Rather than the listed authors, hidden analysts and publication management firms hired by pharmaceutical companies are often responsible for the content of scientific articles. Such ghostwriting practices raise serious concerns regarding the integrity of knowledge and thus demand urgent attention. This paper analyses the strategies of legal regulation on medical ghostwriting and their comparative advantages and disadvantages. Many of regulatory proposals suffer from a lack of effectiveness, whereas others are subject to constitutional concerns. The analysis in this paper offers insights into framing adequate regulation; it supports the strategy for reforming the structure of information production while calling for cautiousness in shaping its regulatory outline. In addition, this paper contributes to the analysis of First Amendment jurisprudence, suggesting that the judiciary should allow a certain amount of leeway for political branches to develop effective regulation

The generic drug user fee amendments: an economic perspective

Abstract: Since the vast majority of prescription drugs consumed by Americans are off patent ('generic'), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I's FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II's implementation among other outcomes.

A clash at the petri dish: transferring embryos with known genetic anomalies.

Abstract: Advancing technologies in genetic testing of preimplantation embryos enable IVF patients to access detailed information about their future child's health status, facilitating and complicating their reproductive decision-making. Testing for embryonic genetic anomalies linked to future health has grown increasingly sophisticated. A patient's decision to seek transfer of a health-affected embryo may or may not be compatible with her physician's professional conscience, potentially resulting in a clash at the petri dish. This article sets out arguments in support of physician decisions to assist or decline to assist in the transfer of anomalous embryos upon patient request. Arguments in support of transfer include the preeminence of a patient's reproductive liberty, the value of equal protection as applied to pre- and post-implantation embryos, the allocation of dispositional authority over embryos, and the frailties of predicting a child's future health experience. Arguments that bolster a provider's decision to decline requests for transfer include the role of physician autonomy in the doctor-patient relationship, the theories of reproductive non-maleficence and procreative beneficence, and legitimate concerns over future legal liability. Regardless of a clinic's ultimate position, this article advocates that providers create or adopt detailed policies setting forth their preferences and practices regarding anomalous embryo transfer.

The tyranny of choice: reproductive selection in the future.

Abstract: This article explores the enormous challenges to reproductive decision making that could result from two emerging technologies: the potential capacity to create vast numbers of embryos for preimplantation genetic diagnosis and the ability to obtain ever more predictive information about the embryo. Together these technologies could change our reproductive experience, exacerbate existing inequities, and profoundly affect reproductive decision making. Simply comprehending the dizzying amounts of predictive information about the health and traits of future children will overwhelm future parents. But trying to choose embryos with the ‘best’ combination of genetic variants could be paralyzing. Nevertheless, numerous pressures will make this technology alluring, compelling providers to develop remedies to assist future parents with these difficult reproductive decisions. The remedies, however, will create their own challenges. Some might test the limits of reproductive autonomy and heighten social inequities. A particularly vexing remedy would be the development of algorithms for embryo selection, which could routinize reproductive decisions, reduce societal diversity, exacerbate ‘choice overload’ effects, challenge professional norms, and raise the specter of eugenics. Ultimately, this article is a cautionary tale urging circumspection as technological advancements seem to propel us inevitably toward a reproductive future that could create a tyranny of choice.

Addressing the needs of Canadians with rare diseases: an evaluation of orphan drug incentives

Abstract: It is uncertain whether a Canadian orphan drug policy, similar to those used in the US and EU, will be given further consideration. The justification for having an orphan drug policy is initially discussed, with this article proceeding on the basis that morality and a commitment to equality validate providing some form of orphan drug incentive(s) in Canada. That being said, it is unclear how ‘orphan drug’ should be defined and, accordingly, how incentives should be allocated. Three pharmaceutical industry incentives are then evaluated in order to identify how the needs of patients with rare diseases can be addressed. Market exclusivity has effectively encouraged investment in orphan drugs and therefore it is recommended that the incentive be implemented in Canada. Priority review voucher programs are still in their infancy, making it difficult to draw strong conclusions about these programs. Introducing a voucher program in Canada is nevertheless not recommended because priority review in Canada is unlikely to be sufficiently valuable. An orphan drug-specific tax credit offers a convenient means of subsidizing orphan drug development without being overly costly, given the narrow parameters within which the credit would operate. Therefore, a Canadian orphan drug tax credit is also recommended.

Author's Response to Peer Commentaries: Brain-based mind reading: conceptual clarifications and legal applications

Abstract: Glannon and Claydon have written thoughtful peer commentaries onmy article about possibilities and perils regarding brain-based mind reading in forensic psychiatry.1 Basedon their comments, Iwill provide two conceptual clarifications concerningbrainbased mind reading, followed by some further thoughts on legal applications. First, the term ‘brain-based mind reading’ does not at all imply that the mind is ‘based’ in the brain.2 The term merely expresses that the reading is, at least in part, based on brain-derived data.3 In otherwords, what is brain based is theway inwhichwe acquire information that tells something about a person’s mental state. In order to further elucidate this point, it may be helpful to look more closely at the notion of mindreading itself. Hank Greely writes: ‘Humans read minds. We constantly try to understand what our fellow humans are thinking and feeling—and how they are going to

Neuroscience, criminal responsibility and sentencing in an islamic country: Iran

Abstract: The implications of neuroscience in the legal context have been considered in many countries; however, there has been very little (if any) research on the use of neuroscience in criminal law in Iran. Furthermore, because Iran's legal system incorporates Islamic rules, the legal implications of neuroscience might be fundamentally different from those of other countries. Accordingly, this paper will discuss the potential use of neuroscientific evidence in the evaluation of criminal responsibility and the assessment of sentencing within the Islamic legal system of Iran. The study will conclude that while there are a number of issues that may prevent the use of neuroscience in Iran's criminal justice system, there is a potential for the neuroscience to be used for purposes such as establishing the insanity defense and mitigating the punishment.

Present-day posthumous reproduction and traditional levirate marriage: two types of interactions.

Abstract: The paper studies the position of Jewish law on posthumous reproduction and its mutual interaction with the legal and bioethical discussion of this issue. It examines two types of interactions: a direct, legal-positive interaction and a meta-legal interaction, which may be defined as inspiration. The first relates to how Jewish law responds to the new technology, as reflected in the practical laws of levirate marriage, and how this new technology affects a wider spectrum of laws and conceptualizations from a religious-law perspective. The paper points to two interesting phenomena: (1) how a legal definition in the religious realm (fatherhood for the purpose of levirate marriage) affects legal definitions in the civil realm (eg, inheritance), and (2) the significance of value-based principles in framing Jewish law as a legal system whose 'ways are ways of pleasantness'. The second (indirect interaction) deals with two rationales, individualistic and familial, behind the Israeli debate over posthumous sperm retrieval of fallen soldiers and their equivalents in the Jewish law discussion of the early 'forefather' of this technology: levirate marriage. The paper concludes that the complex interaction-both direct and indirect-provides us with a striking picture of the conjunction of modernity, law, and religion.

Disparate impacts and GINA: Congress's unfinished business.

Abstract: The Genetic Information Nondiscrimination Act of 2008 (GINA) deviated from preceding employment discrimination laws by excluding disparate impact liability, an important enforcement component to promote substantive equality. Nevertheless, Congress did not intend for this to be a permanent exclusion and, instead, assigned itself future work: after six years, a commission was to educate Congress on genetic discrimination incidents, update Congress on relevant scientific advances in genetics/omics, and provide recommendations to Congress on the need to enable disparate impact liability. Ten years after GINA became law, it seems appropriate to take a look back at the broader employment law context within which Congress made this decision to exclude disparate impact liability for genetic discrimination, explore how and why Section 208 became inserted into GINA, and provide a status update on the additional policy work mandated. After reasonable investigation, there is no information to indicate that Congress fulfilled its statutory obligation to appoint members to a Genetic Nondiscrimination Study Commission or that any policy work envisioned by Section 208 has commenced. To fulfill a promise of fairness and equality, Congress must revisit the issue and enable disparate impact liability to value genetic diversity and prevent any 'genetic underclasses' from forming.