The Food and Drug Administration, as a matter of long-standing policy, does not inform the public of instances whereby applications for new drugs or new indications for existing drugs have been rejected by the agency or withdrawn from consideration, nor does it disclose the agency’s analyses of the data submitted with such applications. This lack of transparency is unjustified and prevents patients, researchers, and healthcare providers from gaining insight into why a drug’s application was not approved. The FDA’s policy (...) is particularly troubling in cases where the agency has found a currently marketed drug to be ineffective or unsafe for a newly proposed indication. Disclosure of the FDA’s findings in such cases would promote public health by encouraging healthcare providers to avoid prescribing drugs for unapproved uses that the agency has deemed to be potentially dangerous or ineffective. The FDA’s counterpart agencies in Europe and Canada have demonstrated the feasibility of disclosing information on rejected and withdrawn drug marketing applications. The FDA should follow suit and allow the American public to know when a drug is deemed unsafe or ineffective for a certain use. (shrink)

In Switzerland, the importance of transparency in animal experimentation is emphasized by the Swiss Federal Council, recognizing the public’s great interest in this matter. Federal reporting on animal experimentation indicates a total of 585,991 animals used in experiments in Switzerland in 2022. By Swiss law, the report enables the public to learn about many aspects such as the species and degree of suffering experienced by the animals, but some information of interest to the public is missing, such (...) as the fate of the animals at the end of the experiment (e.g., euthanized, rehomed in a private home, reused in another experiment). When it comes to animals bred in facilities but not used in experiments, further information of interest is not required to be made public according to Swiss law, for example, the number and fate of “surplus” animals (i.e., animals bred but not used in experiments for a variety of reasons such as not carrying the phenotypical properties needed). Considering that the Swiss government has a duty to provide a full accounting of animal experimentation conducted on the public’s behalf, further relevant information should be disclosed. While efforts toward transparency, such as the STAAR Agreement, have been made in the scientific community, these mostly reflect the legal requirements already in force. If Switzerland is to move toward more transparency in public information on animal experimentation, an update of the legal requirements is needed. In this article, we give recommendations for Swiss law to move toward more transparency in public information on seven aspects: (1) the fate of the animals at the end of the experiment; (2) the sources of funding for animal experimentation; (3) the harm-benefit analysis performed by researchers and ethics committees to justify an experiment using animals; (4) the number of breeding/surplus animals; (5) the fate of breeding/surplus animals; (6) the harms experienced by animals in facilities; and (7) the funding of animal facilities. (shrink)

The obligation of the legalization of entrepreneurial activity from Article 14 of The Act of July 2, 2004 on the freedom of entrepreneurial activity caused deliberations regarding constitutive or declarative character of the legalization entry and as a result, created a problem with indication of the moment when the public law status of an entrepreneur is acquired. The answer to the question whether Central Register and Information of Entrepreneurial Activity or the register of entrepreneurs of the National Court Register (...) have also the creation function incites many controversies and is subject to discussions, in the process of which two main standpoints were formed. It is also important to note that the resolution of the discussed issue not only holds scientific value, but above all, it has significant importance in practice. Therefore, it is necessary and even essential. Furthermore, it is typical for this issue that concerns related thereto and arguments raised during the discussion have their basis in the legislation in force and in fact, encapsulate the favoured path of its interpretation. (shrink)

The Centers for Disease Control and Prevention’s goal is to develop a surveillance system of public health laws that would both support research and analysis among policymakers and legislators, and support the scientific basis for public health law. This session was convened, in part, to discuss the value of creating an electronic system to track public health legal information. Public health surveillance is the “ongoing, systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event (...) for use in public health action to reduce morbidity and mortality and to improve health. Data disseminated by a public health surveillance system can be used for immediate public health action, program planning and evaluation, and formulating research hypotheses.” There is currently no system available that meets the goals of this definition of “surveillance” for public health laws. (shrink)

On 19 December 2008 the Official Journal of Belgium published the ‘Law regarding the procurement and use of human body material destined for human medical applications or for scientific research purposes’. This paper will comment on various aspects of the Law: its scope of application (what is understood by ‘body material’?); its concept of ‘residual human body material’ (with far-reaching implications for the type of consent required for research); the nature of actions with and uses of human body material that (...) are explicitly prohibited; the right of donors to be informed of relevant information revealed by the use of their body material; and the special responsibilities placed on hospital ethics committees. As will be argued in this paper, several of these provisions are highly problematic from an ethical point of view, especially those relating to consent. Meanwhile, the Minister of Public Health has asked the Belgian Advisory Committee on Bioethics for advice on the incorporation of the ‘presumed consent’ model, that applies to post mortem organ donation, into the biobank Law’s provisions on post mortem removal and use of body material. This aspect of the Law effectively extends the ‘presumed consent’ regime, both from organs to body material in general, and from therapeutic uses to research uses. (shrink)

Can a country with a free press and a robust political debate provide its citizens with actionable information so that they can protect themselves from a threat to their health or safety? By actionable information, I mean accurate facts and reasonable interpretations of those facts upon which an individual should rely in making reason-based decisions. In the context of public health, this includes information that allows an individual to weigh the risk to one’s self, family, and community before deciding (...) to act in an uncertain environment under threatening conditions. The recent H1N1 pandemic, and in particular the government’s campaign for public acceptance of the vaccine, highlights the challenges in ensuring that individuals receive accurate information and perceive that such information should be the basis on which to make potential life-saving decisions. (shrink)

This paper is the companion to “Assessment of Information on Public Health Law Best Practices for Obesity Prevention and Control,” and the fourth of four action papers produced as part of the National Summit on Legal Preparedness for Obesity Prevention and Control, convened June 2008 by the Centers for Disease Control and Prevention, the Robert Wood Johnson Foundation, and the American Society for Law, Medicine Ethics. The four action papers present options to address gaps in the four core elements (...) of public health legal preparedness as outlined in the relevant companion papers. The four core elements are: laws and legal authorities; legal competencies for public health professionals to apply those laws and authorities; coordination of law-based efforts across jurisdictions and sectors, and information on public health law best practices. (shrink)

This paper provides an analysis of the complex global reproduction networks driving the rapidly expanding cross-border surrogacy industry in Asia’s reproductive bioeconomy. It sheds light on the unique features of informal surrogacy networks, notable for their flexible business ties and non-standardized surrogate mother recruitment. These factors contribute to heightened vulnerability for surrogate mothers operating within these networks. While previous literature has underscored the merits of labor law in regulating the surrogacy industry, its application in informal cross-border surrogacy remains under-examined. To (...) address this gap, this research delves into innovative labor law strategies with potential to better regulate the surrogacy sector. Drawing inspiration from progressive labor regulations and supply chain strategies in Bulgaria and Australia, the proposed model aims to redefine the traditional employment relationship. This shift is aimed at bolstering protection for surrogate mothers and enforcing accountability throughout the surrogacy business network. The model further advocates for a collective framework that fosters collaboration and mandates the documentation and registration of surrogacy contracts. Moreover, it underscores the critical significance of international collaboration in bridging regulatory gaps and distributing accountability across consumer and supply states. (shrink)

There have been debates across the globe for a social and culturally sensitive ethics to meditate a catalyst of template for informed consent (IC) in the conduct of social researches and clinical trial. The study adopted ethical relativism theory to explore social and cultural contingencies on IC with descriptive research design and snowball sampling techniques with a pool of 23 participants randomly and purposively selected amongst the stakeholders including researchers. Seven lecturers and 5 medical practitioners from selected universities, 5 clergy (...) members of different genders and denominations with 2 Imams, 1 chief and 2 traditional health practitioners completing the pool. The data were compiled separately with pseudonym to maintain the anonymity of the participants and content analysed thematically to probe awareness, understanding, patriarchy and religious dimensions on IC. The paper argued that ethics and law regulations must be strengthened to leverage on different individual values, norms and social indices. The paper concluded and suggested that researchers can avoid and resolve ethical dilemmas and maintain research regularity when ethical obligations are well understood and strictly adhered to, and to develop the Informed Consent Evaluation Feedback Tool (ICEFbT) with oversight function from Institution Review Board (IRB) in the universities and research institutes before the commencement of research and/or medical procedures. (shrink)

Throughout Iran’s modern history, control of the public sphere has remained in the hands of the state. With virtually no trace of a civil society, public opinion has played only a minimal role in influencing state affairs. The 1979 Islamic revolution could be viewed as a break in this historical trend, but public opinion retreated into the background once the clerics solidified their power -- and then kept it by invoking religious orthodoxy to deflect any challenges. Thus, (...) it should have been no surprise that the press revolution, which began in the late 1990s as Mohammad Khatami came to power, collapsed a few years later. While an array of newspapers and journals are still published in Iran today, the persecution of leading editors and publishers with pro-reform sympathies has successfully cleared the field of any real threat to the status quo.The early theorists of the reform movement that came to be identified with President Khatami saw a free and independent press as a vital part of an Islamic Repub lic. For centuries, they argued, the state had used its control over the media -- first the publication of books, then newspapers and finally radio and television -- to push society toward the rulers’ desired ends. In contrast, the reformers saw a free press as the best way to foster open debate and political and social pluralism, unleashing forces that would allow society at large to determine its own fate. In other words, there could be no pre-determined end, shaped by fiat. Their chosen weapon in the battle for a civil society was the newspaper, a medium with a rich history in Iran of social and political activism. Persian newspapers, particularly those published abroad and smuggled into Iran in the nineteenth and early twentieth centuries, had been responsible for remarkable changes in the political landscape. They introduced liberal social and political ideas from Europe and provided readers with a new, simplified language in which to debate such notions. Most important of all, the early press helped create the very idea of society as a political actor in its own right. Within months of Khatami’s move to the Presidential Palace, his new appointees in the Ministry of Culture and Islamic Guidance unleashed a “press revolution.” They quickly streamlined the issuing of publication licenses; countered Iran’s traditional centralism by encouraging the rise of local and provincial newspapers; eased the financial hardships of independent publishers; and sought protection under the existing Press Law for controversial editors and commentators facing the hostility of the ruling clerics. The result was a wave of entrepreneurial and journalistic creativity unmatched since the Constitutional Revolution of 1906-1911.By the spring of 2000, the hard-line clerics had had enough. They used their almost complete control of the public space to shut the door on the “press revolution” and to drive their critics, including many learned clerics, back into private dissent. Dozens of newspapers were closed and prominent journalists were prosecuted, most for violating so-called Islamic norms; anything like public discourse was forced back into the shadows. The ease with which the clerical establishment crushed the free press reflected the basic weaknesses and miscalculations of the reform movement. The senior theologians had established themselves as far back as the Constitutional Revolution as the final arbiters of freedom of expression under Islam. Without a wholesale re-evaluation of the role of the clergy and the very concept of freedom in a religious system of government, this power was destined to go unchecked. The reformers had also put too much emphasis on a free press, in the absence of any other real building blocks of civil society. Newspapers were expected to play the roles of political parties, of independent think tanks and, in the case of Jameah and Tous, of exemplars of social, political and economic independence. It was a burden the Iranian press was simply unable to carry. (shrink)

The relationship between Canadian administrative law and the Canadian Charter of Rights and Freedoms is complex and still unfolding. If a decision touches a Charter right, frontline decision-makers and reviewing courts alike determine the requirements of legality using the Charter, administrative law principles, or some combination of the two. There is an emerging consensus that the Charter does not replace the common law, but rather embodies and supplements fundamental legal principles contained within it.This chapter sets out various ways in which (...) judicial review at common law has influenced understandings of the Charter, as well as the manner in which the Charter has influenced review of administrative decisions when a Charter right is clearly at stake. The influence runs in both directions, and has significant implications for judicial review of both the procedure and substance of administrative action. In the realm of procedure, the courts rely on the common law doctrine of procedural fairness to interpret the principles of fundamental justice set out in s. 7 of the Charter. However, when courts review the substance rather than the procedural aspects of a decision that engages a Charter right, they tend to review the decision using the analytical framework developed in R. v. Oakes for testing the validity of legislation. Taken together, these general features of the relationship between Charter jurisprudence and administrative law suggest that each is porous and open-textured to the other. Put another way, the relationship between the Charter and administrative law exhibits a cross-fertilization of principles and approaches which inform judicial review of administrative action. (shrink)

We commonly think of presumptions as second-best inferential tools allowing us to reach conclusions, if we must, under conditions of limited information. Scholarship on the topic across the disciplines has espoused a common conception of presumptions that defines them according to their function within the decisionmaking process. This focus on the “private” face of presumptions has generated a predominantly critical and grudging view of them, perpetuated certain conceptual ambiguities, and, most important, neglected the fact that what we refer to as (...) “presumptions” have distinguishing features other than the defeasibility and burden-shifting effects associated with their use as inferential tools. When a decisionmaker gives reasons for a conclusion, the decisionmaker often cites a presumption among the reasons for that conclusion; in this guise – their “public” face – presumptions display different, and uniquely valuable, features that remain hidden if we understand them only as aids to inference. This essay both surveys recent approaches to the critical analysis of presumptions in law, philosophy, and discourse studies, and offers an account of how we might begin to think about this other, public face of presumptions. (shrink)

As the basis for federal and state freedom of information laws, the legal idea of a public right to know has been a blessing. As the often-invoked moral justification for the press's right to publish, however, it is dangerous, because an unfettered right to know would result in restrictions on the press's right to determine what to publish. By acknowledging their moral responsibility to provide audiences with information based on their need to know, journalists can avoid the hazards of (...) arguing that an unrestricted public right to know is the foundation of press freedom. (shrink)

In health care, the provision of pertinent information to patients is not just a moral imperative but also a legal obligation, often articulated through the lens of obtaining informed consent. Codes of medical ethics and many national laws mandate the disclosure of basic information about diagnosis, prognosis, and treatment alternatives. However, within publicly funded health care systems, other kinds of information might also be important to patients, such as insights into the health care priorities that underlie treatment offers made. While (...) conventional perspectives do not take this as an obligatory part of the information to be shared with patients, perhaps through viewing it as clinically “non-actionable,” we advocate for a paradigm shift. Our proposition diverges from the traditional emphasis on actionability. We contend that honoring patients as equal moral agents necessitates, among other principles, a commitment to honesty. Withholding specific categories of information pertinent to patients’ comprehension of their situation is inherently incompatible with this principle. In this article, we advocate for a recalibration of the burden of proof. Rather than requiring special justifications for adding to the standard set of information items, we suggest that physicians should be able to justify excluding relevant facts about the patient’s situation and the underlying considerations shaping health care professionals’ choices. This perspective prioritizes transparency and empowers patients with a comprehensive understanding, aligning with the ethos of respect for the patient as person. (shrink)

According to the House of Lords decision in Campbell v MGN Ltd, a misuse of private information claim may succeed even though public interest expression is at stake. The post-Campbell jurisprudence, however, does not reflect this central tenet. Cases are not determined by balancing the weight of each claim but by a binary approach in which claims succeed or fail depending on whether public interest expression is present or not. By charting this development, this article argues that a (...) greater sense of proportionality would be achieved if cases were decided not by the quality of expression but by the harm caused by it. By re-imagining Campbell as a four-part test, it will show how the current paternalistic and idiosyncratic influences on decision-making may be reduced significantly. (shrink)

In recent decades, increased attention has been given to the place of the victim within criminal justice systems. Advocates have called for recognition and participation for victims of crime, and widespread political support throughout common law jurisdictions has resulted in a number of reforms. While some have proven uncontroversial, the question of victim input into sentencing decisions has emerged as a highly contentious issue within scholarship. Scholars have been concerned with the potentially corrupting influence of victims’ private preferences and dispositions (...) on otherwise principled public decision-making. Exacerbating these concerns has been conceptual and normative ambiguity regarding the relationship of victims to public sentencing processes. Such questions relate to the proper relationship between individuals and public decision-making, and are thus usefully dealt with through political theory and the lens of citizenship. The present article applies deliberative democratic theory and argues that it accounts for scholars’ concerns while also providing direction through conceptual and normative clarity, reconciling in theoretical terms victim input with a public sentencing process. Moreover, it also argues that the framework highlights ways in which victims can make active contributions to processes of public deliberation by introducing novel perspectives and information, thereby enhancing the quality of sentencing decisions. Lastly, the article anticipates potential objections regarding the capacity of victims to meet civic standards in practice, pointing to a growing body of empirical research which suggests victims’ potential and emphasizes the importance of being attentive to questions of procedural design to realize it. (shrink)

The public interest in the administration of justice requires access to justice for all. But access to justice must be “meaningful” access. Meaningful access requires procedures, processes, and institutional structures that facilitate communication among participants and decision-makers and ensure that judges and other decision-makers have the resources they need to render fully informed and sound decisions. Working from that premise, which is based on a reconceptualization of the objectives and methods of the justice process, the author proposes numerous specific (...) changes in decision-making processes and practices. These changes are required to achieve a standard of decision-making that is consistent with the public interest in the administration of justice within a constitutional framework under the social and political conditions of the early 21st century. The essay illustrates the application of the principles and methods of legitecture to analysis of problems of institutional design in law. (shrink)

In 2008, Representative John Read of Mississippi recently co-sponsored state legislation that would ban restaurants from serving obese customers. He later admitted that the bill was a publicity stunt,meant to “shed a little light on the number one problem in Mississippi.” Although controversial, Read’s bill exemplifies both the current perception of obesity as a national public health problem and the general sentiment underlying the types of interventions that are being considered to address this issue. The proposed legislation also demonstrates (...) how policymakers can use or, in this case misuse, information about obesity to generate significant discussion on an issue along with ill-conceived legal interventions.Information sharing and the methods used to share best practices are components of the fourth core element of public health legal preparedness. (shrink)

The legal system affects behavior not just directly, by imposing sanctions, but also indirectly, by producing information on how people behave. For example, internal company documents exposed during litigation will help third parties assess whether they trust a company and want to keep doing business with it. The law therefore affects behavior by shaping reputations. Drawing on economics, communications, and a nascent multidisciplinary literature on reputation, Roy Shapira highlights how reputation works, and how information from the courtroom affects the court (...) of public opinion, with a particular emphasis on the role of the media. By fleshing out interactions between law and reputation, Shapira corrects common misperceptions about the ability of market forces to discipline corporate behavior and adds to timely, ongoing debates such as the desirability of heightened pleading standards or mandatory arbitration clauses. Law and Reputation should interest any scholar who invokes notions of market discipline in their work. (shrink)

As has been the case in Europe, increasing consumer demand for higher welfare products has resulted in improved conditions for farm animals raised for slaughter in the USA and Australia. Consumer awareness has been significantly aided by investigations of farm and slaughterhouse conditions by animal welfare organizations, often working undercover. These gains are now under very serious threat. In eleven states in the USA, and three in Australia, new legislation, coined “Ag-gag” law, has been enacted prohibiting public dissemination of (...) material depicting on farm animal use. In both countries, media corporations and private citizens are liable to up to three years’ imprisonment for publishing photographs or recordings depicting the conditions of animals on farms or at slaughter. Controls on the publication of information documenting animal use compromises transparency in the food chain, erodes the accountability of those involved in the management of animals and undermines the case for enhanced legislation and policy reform. This paper describes recent legal challenges in the USA to the constitutionality of “Ag-gag” laws and evaluates “Ag-gag” laws’ impact on animal welfare in agricultural facilities in the USA and Australia. (shrink)

The success of the health care system depends on the accuracy, correctness and trustworthiness of the information, and the privacy rights of individuals to control the disclosure of personal information. A national policy on health informational privacy should be guided by ethical principles that respect individual autonomy while recognizing the important collective interests in the use of health information. At present there are no adequate laws or constitutional principles to help guide a rational privacy policy. The laws are scattered and (...) fragmented across the states. Constitutional law is highly general, without important specific safeguards. Finally, a case study is provided showing the important trade-offs that exist between public health and privacy. For a model public health law, see www.critpath.org/msphpa/privacy. (shrink)

This paper examines the ethical issues faced by health workers managing a fictional case of a female sex worker who is hepatitis B positive with a high level of virus but is asymptomatic. According to guidelines she does not require treatment herself, but is potentially highly infectious to others. Recent legal cases in the UK show it can be criminal to pass on HIV or hepatitis B infection sexually if the risk is known and the partner has not been informed. (...) However, there is no statute or case law showing that health workers are required to intervene to prevent such a potential ‘crime’, particularly when the partners are unknown, as in this case. The health workers could respond in various ways. They could do nothing, thus making further infection probable. They could advise the sex worker to use condoms and to inform her clients. They could treat the sex worker to reduce her level of infectivity, although there is no benefit to her. They could disclose the sex worker's status, although breaking confidentiality is a serious matter ethically and may be of no benefit to the unknown client group. Regulating prostitution might help; but sex workers with infection may work off licence. This paper discusses the clinical, moral and ethical issues associated with such a scenario and concludes that the most beneficial course is to target clients, through health education, to recognise the potential risks of infection from a sex worker and to take suitable precautions including immunisation against hepatitis B. (shrink)

Drawing on Sir Ian Kennedy's extensive experience in healthcare law, ethics and public policy-making, this book explores vital issues in the law surrounding healthcare and regulation. The book contains a range of published and unpublished essays and speeches with the addition of notes and commentaries by the author that bring the pieces up to the present day. Those who want to understand developments, from transplants to confidentiality, from COVID-19 to public inquiries to regulation will find a rich seam (...) of rigorous, informed analysis. The author's unique range of experience allows him to share insights on a variety of issues; from the conduct of the disgraced breast surgeon, Ian Paterson, to research at Porton Down, to the economics of innovation in drug development at NICE. His abiding interest in the welfare of children informs his trenchant forensic examination of how children fare in the NHS. Those involved in or with an interest in law, moral philosophy, and public policy will find much food for thought. (shrink)

This timely book analyses and evaluates ethical and social implications of recent developments in reporting surgeon performance. It contains chapters by leading international specialists in philosophy, bioethics, epidemiology, medical administration, surgery, and law, demonstrating the diversity and complexity of debates about this topic, raising considerations of patient autonomy, accountability, justice, and the quality and safety of medical services. Performance information on individual cardiac surgeons has been publicly available in parts of the US for over a decade. Survival rates for individual (...) cardiac surgeons in the UK have recently been released to the public. This trend is being driven by various factors, including concerns about accountability, patients' rights, quality and safety of medical care, and the need to avoid scandals in medical care. This trend is likely to extend to other countries, to other clinicians, and to professions beyond health care, making this text an essential addition to the literature available. (shrink)

The purpose of this chapter is to analyse approaches to the sharing economy from the perspective of public policy science. In the first part of the text, attention is paid to perceiving the development of the emerging sharing economy not only as phenomenon with positive economic effects but also as a set of public problems (e.g., on the labour market and for existing economic structures) that require intervention at the level of national governments as well as at international (...) level. Subsequent sections identify possible actions for regulating the development of the sharing economy. The role of soft law, stakeholders’ networks, self-regulation and standardisation are discussed in the chapter. The summary includes potential directions for further research. (shrink)

In this paper I critically examine recent developments in intellectual property law. In particular, from a point of view informed primarily by Marx and Foucault, I study (a) the rhetoric surrounding the Metallica lawsuit against Napster; (b) a pair of conflicting trademark cases surrounding the ownership of a word on the Internet; and (c) the software industry's move to win approval for “shrink-wrap” or “click here” licenses. I conclude that these developments indicate a new form of disciplinary power, where people (...) are individuated ex ante as consumers. Despite the celebrations of market cyberlibertarians, this move actually masks an increase in overt state power as the state apparatus is invoked to force individuals to agree to behave as disciplined consumers and accede to the system in the first place. (shrink)

Argumentation as the public exchange of reasons is widely thought to enhance deliberative interactions that generate and justify reasonable public policies. Adopting an argumentation-theoretic perspective, we survey the norms that should govern public argumentation and address some of the complexities that scholarly treatments have identified. Our focus is on norms associated with the ideals of correctness and participation as sources of a politically legitimate deliberative outcome. In principle, both ideals are mutually coherent. If the information needed for (...) a correct deliberative outcome is distributed among agents, then maximising participation increases information diversity. But both ideals can also be in tension. If participants lack competence or are prone to biases, a correct deliberative outcome requires limiting participation. The central question for public argumentation, therefore, is how to strike a balance between both ideals. Rather than advocating a preferred normative framework, our main purpose is to illustrate the complexity of this theme. (shrink)

New modes of environmental regulation are said to have transcended the public/private divide. These new regulatory schemes - referred to as non-coercive orderings, self-regulation, co-regulation, metaregulation and social regulation - set aside the formal nature of the regulating entity, the regulated entity, and the tools of regulation. Instead of asking whether the means, objects and formulators of the regulation are public or private, the focus lies on the substance and effectiveness of the regulation in mitigating environmental harms. In (...) this Article we argue that despite these claims, often advanced by new governance proponents, the public/private divide in in fact alive and well, informing and impacting the ways in which various regulatory schemes are justified and legitimated. We exemplify this argument through an analysis of the role of three entities in international environmental regulation: the state, local governments, and civil society entities. This Article then suggests three consequences of the persistence of the public/private dichotomy and its denial: it produces a “tilt” towards the private; it tends to hide conflicts and disagreements, projecting an image of a frictionless world; and it prevents an imagination of a different world that transcends the structure of social life embedded in it. (shrink)

Access to legal information is fundamental to access to justice. Yet accessibility refers not only to making legal documents available to the public, but also rendering legal information comprehensible to them. A vexing problem in bringing legal information to the public is how to turn formal legal documents such as legislation and judgments, which are often highly technical, to easily navigable and comprehensible knowledge to those without legal education. In this study, we formulate a three-step approach for bringing (...) legal knowledge to laypersons, tackling the issues of navigability and comprehensibility. First, we translate selected sections of the law into snippets (called CLIC-pages), each being a small piece of article that focuses on explaining certain technical legal concept in layperson’s terms. Second, we construct a _Legal Question Bank_, which is a collection of legal questions whose answers can be found in the CLIC-pages. Third, we design an interactive _CLIC Recommender_. Given a user’s verbal description of a legal situation that requires a legal solution, CRec interprets the user’s input and shortlists questions from the question bank that are most likely relevant to the given legal situation and recommends their corresponding CLIC pages where relevant legal knowledge can be found. In this paper we focus on the technical aspects of creating an LQB. We show how large-scale pre-trained language models, such as GPT-3, can be used to generate legal questions. We compare machine-generated questions against human-composed questions and find that MGQs are more scalable, cost-effective, and more diversified, while HCQs are more precise. We also show a prototype of CRec and illustrate through an example how our 3-step approach effectively brings relevant legal knowledge to the public. (shrink)

Since its advent, predictive DNA testing has been perceived as a technology that may have considerable impact on the quality of people’s life. The decision whether or not to use this technology is up to the individual client. However, to enable well considered decision making both the negative as well as the positive freedom of the individual should be supported. In this paper, we argue that current professional and public discourse on predictive DNA-testing is lacking when it comes to (...) supporting positive freedom, because it is usually framed in terms of risk and risk management. We show how this ‘risk discourse’ steers thinking on the good life in a particular way. We go on to argue that empirical research into the actual deliberation and decision making processes of individuals and families may be used to enrich the environment of personal deliberation in three ways: (1) it points at a richer set of values that deliberators can take into account, (2) it acknowledges the shared nature of genes, and (3) it shows how one might frame decisions in a non-binary way. We argue that the public sharing and discussing of stories about personal deliberations offers valuable input for others who face similar choices: it fosters their positive freedom to shape their view of the good life in relation to DNA-diagnostics. We conclude by offering some suggestions as to how to realize such public sharing of personal stories. (shrink)

The two standard interpretations of Kant’s view of the relationship between external freedom and public law make one of the terms a means for the production of the other: either public law is justified as a means to external freedom, or external freedom is justified as a means for producing a system of public law. This article defends an alternative, constitutive interpretation: public law is justified because it is partly constitutive of external freedom. The constitutive view (...) requires conceiving of external freedom in a novel, second-personal way, that is, as an irreducibly relational norm. (shrink)

Objectives: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. Materials and methods: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and conduction of (...) a Delphi procedure. Results: The literature search identified a core set of relevant papers on privacy. Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an “aggregation by group of patients” was finally chosen, based upon the exchange of finely tuned summary tables. Conclusions: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe. (shrink)

A medical information commons is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.

This article examines life assurance and the politics of ‘big data’ in mid-19th-century Britain. The datasets generated by life assurance companies were vast archives of information about human longevity. Actuaries distilled these archives into mortality tables – immensely valuable tools for predicting mortality and so pricing risk. The status of the mortality table was ambiguous, being both a public and a private object: often computed from company records they could also be extrapolated from public projects such as the (...) census, or clerical records. Life assurance more generally straddled the line between private enterprise and collective endeavour, though its advocates stressed the public interest in its success. Reforming actuaries such as Thomas Rowe Edmonds wanted the data on which mortality tables were based to be made publicly available, but faced resistance. Such resistance undermined insurers’ claims to be scientific in spirit and hindered Edmonds’s personal quest for a law of mortality. Edmonds pushed instead for an open actuarial science alongside fellow travellers at the Statistical Society of London, which was populated by statisticians such as William Farr as well as by radical mathematicians such as Charles Babbage. The article explores Babbage’s little-known foray into the world of insurance, both as a budding actuary but also as a fierce critic of the industry. These debates over the construction, ownership, and accessibility of insurance datasets show that concern about the politics of big data did not begin in the 21st century. (shrink)

Amidst the ideology, efficiency and bitter contention of international economy, the importance of leadership or public administration had long been under-stressed as an avenue for any better solution. Nonetheless, within a changing mode of interaction in the global community, an increasing ethos for the kind of common basis of ethics or agreement, at least in the level of class administrators or noble citizenry including the academicians, business leaders, bureaucrats and so, could be congruent for the public good on (...) the national and international plane. A rapid transformation for the informative society or sharing and humanity or social justice generally is seen to enable the possibility of new openness against the divergences from various reasons. Typically, I consider the public administration other than law, inter alia, could have strands to leap for any grand promise or for any cosmopolitan public value since it tends progressive and less ideological. At the core of ambition underlie the ethics of public administrators or their responsibility for the constituents and global public. The paper deals with two illustrative cases from the experience of South Korea which matters at the negative and positive concept of liberty. They will be investigated, empirically at some extent and in view of the ethics of congressmen and public officers. I, then, turn to explore the western theories and tenets often associated with their moral standard. Finally, the context could be revisited for the global scale of transformation expanded to cover the Orient and West. (shrink)

This article examines the entanglement of British criminology and undercover policing (‘Spycops’) in the UK government's response to racism in 1981. The article discusses how criminology took a strategic role within the state's ‘ law and order’ information infrastructure by analysing archival materials related to a Home Office criminological study from that same year. This infrastructure involved an explicit logistical sensibility for gathering and analysing evidence, intelligence, and data about race and racism for a ‘law and order’ agenda focused on (...) policing public order and ‘subversion’. It examines how two senior Home Office officials treated the gathering and utilisation of informational resources produced by criminologists and the Metropolitan Police Special Branch for tactical operations and perception management strategies that targeted racism and anti-racist groups as threats to public order. Reflecting on recent scholarship about security practices enabled by Big Data and machine learning, the article argues for greater attention on criminology and human sciences’ strategic and unnoticed involvement in designing and servicing contemporary ‘law and order’ informational infrastructures. (shrink)

The law often calls on the concept of public interest for assistance. Privacy law makes use of this concept in several ways, including to justify consent waivers for secondary research on health information. Because the law sees information privacy as a means for individuals to control their personal information, consent can only be set aside in special circumstances. Ballantyne and Schaefer argue that only public interest, and only a broad conception of public interest, can do the special (...) ‘normative justificatory work’ to override consent requirements. Other, similar-sounding concepts, such as public benefit, public good and social value, also provide useful services. But none more so than public interest. In fact, they argue, public interest is the superior concept precisely because it can capture those concepts as well as a range of other interests. Our response focuses on this claim. We argue their strategy is not as promising as it might first seem. Ballantyne and Schaefer construe the important role that public interest plays in this context as their endpoint. They claim that unless the concept is open and content-rich, it will lose some of its importance. But by refusing to place limits around it, their inquiry leads us back to a catch-all concept that lacks clear focus or meaning. In reply, we argue that, for practically minded theorists, a narrow conception of public interest is more useful. Further, the narrowing of public interest in this context can be achieved by first analysing it in its legal, rather than ethical, sense. (shrink)

For decades, health information has been collected and shared for health care delivery and public health purposes. While the “primary use” of patient data for providing direct health care services is the cornerstone of health care practice, health departments rely on data sharing for research and analysis to support disease prevention and health promotion in the population. As the U.S. health system undergoes a digital revolution, health information that was previously captured in paper form now can be captured electronically. (...) Electronic health information has transformed the efficiency, capacity, and functions of the U.S. health system. For this reason, there is increased attention to the “secondary use” of electronic patient data for public health uses, including disease reporting and investigation, syndromic surveillance, and patient-specific or population-level communications about health conditions and their associated risk factors. Secondary uses may also encompass clinical research, licensure, and payment for services. (shrink)

Even though tacit legal norms are deeply important to our past, present, and future, the very idea of unwritten law has been difficult to pin down, and problematic in a range of ways. Existing discussions of the phenomenon fall short of adequacy on one of several fronts: either they have focused on describing the normative features of one kind of unwritten law, or completely conflated the study of unwritten law with natural law, or else offered examinations of unwritten social rules, (...) focussing on (mere) custom, ethics, and/or etiquette. A particular defect is the fact that unwritten law has not been given a treatment by those working in the tradition of analytical jurisprudence. My thesis introduces a novel means of analyzing and explicating the elusive concept of unwritten legal rules, striving thereby to advance the state-of-the-art. In what follows I argue that unwritten laws are informally publicized rules held on the threat of formal sanction by an appropriate political authority. I argue that a law is informally disseminated just in case the appropriate governing theory of law, known to subjects, provides those subjects with a set of instructions about who to defer to concerning the contents of the law, absent dissemination in official venues. I propose that there are at least five potential kinds of unwritten law routinely recognized in legal studies: operations, implicit constitutions, justice norms, fiat rules, and secret laws. Through careful examination of extant theories of law (Aquinas, Hobbes, Foucault, Marx, Austin, Fuller, Hart, and Dworkin), I argue that there are identifiable structural features of the contents of these theories that make them more or less likely to endorse the legal validity of each kind of unwritten law. Throughout the course of the dissertation, I show how we are able to diagnose the ways in which these structural features of our theories of law differentially support the validity of—and shed important, additional light upon—each potential variety of unwritten law. (shrink)

Background Investigative genetic genealogy (IGG) is a technique that involves uploading genotypes developed from perpetrator DNA left at a crime scene, or DNA from unidentified remains, to public genetic genealogy databases to identify genetic relatives and, through the creation of a family tree, the individual who was the source of the DNA. As policymakers demonstrate interest in regulating IGG, it is important to understand public perspectives on IGG to determine whether proposed policies are aligned with public attitudes.Methods (...) We conducted eight focus groups with members of the public (N = 72), sampled from four geographically diverse US regions, to explore general attitudes and perspectives regarding aspects of IGG practices, applications, and policies. Five major topics were explored in each focus group: when IGG should be used; who should perform IGG; how to approach consent for genetic database users; what systems of oversight should govern IGG practitioners; and whether to notify database users if their data are involved in law enforcement (LE) matching.Results Participants were supportive of IGG in most scenarios, especially for cold and violent cases. The favorable attitudes toward IGG were, however, tempered by distrust of law enforcement among some participants. All participants agreed that databases must inform users if IGG is allowed, but they did not agree on how individual database users should be allowed to opt out or whether to notify them if their data are involved in specific investigations. All participants agreed that IGG should be subject to some prescriptive guidelines, regulations, or accountability mechanisms.Conclusions These findings suggest broad public support for IGG, and interest in developing systems of accountability for its practice. Our study provides useful insight for policy makers, genomic database stewards, law enforcement, and other stakeholders in IGG’s practice, and suggests multiple directions for future research. (shrink)

The law of informed consent to medical treatment has recently been extensively overhauled in England. The 2015 Montgomery judgment has done away with the long-held position that the information to be disclosed by doctors when obtaining valid consent from patients should be determined on the basis of what a reasonable body of medical opinion agree ought to be disclosed in the circumstances. The UK Supreme Court concluded that the information that is material to a patient’s decision should instead be judged (...) by reference to a new two-limbed test founded on the notions of the ‘reasonable person’ and the ‘particular patient’. The rationale outlined in Montgomery for this new test of materiality, and academic comment on the ruling’s significance, has focused on the central ethical importance that the law now accords to respect for patient autonomy in the process of obtaining consent from patients. In this paper, we dispute the claim that the new test of materiality articulated in Montgomery equates with respect for autonomy being given primacy in re-shaping the development of the law in this area. We also defend this position, arguing that our revised interpretation of Montgomery’s significance does not equate with a failure by the courts to give due legal consideration to what is owed to patients as autonomous decision-makers in the consent process. Instead, Montgomery correctly implies that doctors are ethically obliged to attend to a number of relevant ethical considerations in framing decisions about consent to treatment, which include subtle interpretations of the values of autonomy and well-being. Doctors should give appropriate consideration to how these values are fleshed out and balanced in context in order to specify precisely what information ought to be disclosed to a patient as a requirement of obtaining consent, and as a core component of shared decision-making within medical encounters more generally. (shrink)

The Director of Public Prosecutions has recently released the Policy for Prosecutors in Respect of Cases of Encouraging or Assisting Suicide. These guidelines provide information on the factors that shall be considered when contemplating whether to bring a prosecution in the public interest in cases concerning assisting and encouraging suicide. While intended to clarify the potential liability of those engaged in or considering such practices, the guidelines have also stumbled into controversial and murky areas of law. As such (...) any potential positive outcomes the guidelines may produce must be weighed against the potential confusion they may also cause. (shrink)

There is scarce knowledge about the influence of the professional group, education, and age on public perspectives on the risks and benefits of forensic DNA databases. Based on data collected through an online questionnaire applied to 628 individuals in Portugal, this research fills that gap. More than three quarters of the respondents believed that the Portuguese forensic DNA database can help fight crime more efficiently and develop a swifter and more accurate justice, whereas only approximately half thought that it (...) could deter and prevent crime. Lack of security and control over access to data and the future unforeseen misuses of genetic information were the most relevant risks selected by the participants. Health care and life sciences professionals were more likely to agree with all the benefits, as opposed to those working in the field of law enforcement. More educated and older participants disagreed with benefits more often. Concerns with the risks increased with age. (shrink)

How did Romans perceive the changing relationships among leaders, the people, and the public sphere as their commonwealth (res publica) fell under the control of an emperor? This paper examines Ovid’s uses of the Latin adjective publicus, ‘public, common, open’, to explore strands of implicitly ‘republican’ political thought behind his poetic corpus. Ovid first celebrates Augustus’ material benefactions as common goods for private consumption; then dramatises the tragic consequences of arbitrary domination; and finally, from exile, treats the emperor (...) himself as a public property, subject to his people’s spectatorship and sovereignty of judgment. A final section draws on Ovid’s thinking on privacy, publicity, and information access to explore themes related to America’s ‘imperial presidency’, from the Founders’ emphasis on a free press to the recent interplay of secrecy, celebrity, and ‘sunshine’ laws. (shrink)

Waters aries that the demands of indigenous bio-prospecting programs need to be considered against the needs of indigenous communities. Issues of sovereignty and rights to self-determination need to be resolved in the context of negotiating bio-prospecting plans. By setting out clear guidelines and priorities, as determined through the eyes and values of indigenous peoples, indigenous communities may have an opportunity to participate in the global sharing of biomedical information and healing for all our relations. Before any projects get underway, however, (...) social, political, and legal issues ought to be settled so that informed decision can be made on the part of indigenous communities to partake of the invitation to bio-prospecting, or not. (shrink)

Current economic conditions have coincided with the implementation of the Health Insurance Portability and Accountability Act and forced public health officials to consider how to ethically incorporate compliance into their already strained budgets, while maintaining the integrity and intent of the legislation.As of April 14, 2003, the HIPAA Privacy Rule provides a new federal floor of protections for personal health information. The Privacy Rule establishes standards for the protection of health information held by many physicians’ offices, health plans, and (...) health care clearinghouses. The Rule protects personal health information by establishing conditions regulating the use and disclosure of individually identifiable health information by these entities, also referred to as covered entities. The Rule does not prevent the daily operations of health care establishments. (shrink)