This paper explores two main methods, employed for the analysis of regulatory law, empirical and systems-theoretical approaches. These two approaches are often portrayed in the literature as very different, mainly for two reasons. First, it is contended by some authors that systems-theoretical approaches—in contrast to empirical approaches—do not see a role for individuals in shaping social reality and regulatory law as one aspect of it. This paper, however, claims that systems-theoretical accounts do provide for human agency while empirical (...) accounts have limitations in their analysis of the role of ‘real individuals’ in shaping regulatory law. The paper argues that both empirical and systems-theoretical approaches need to provide a deeper analysis of the notion of ‘the individual’. This requires taking into account how ‘feeling rules’ influence the management of emotions. Secondly, empirical and systems-theoretical approaches are portrayed as distinct because they are considered as employing different methodologies. While systems theory involves speculative grand theory, empirical approaches are based on specific techniques of empirical data collection and analysis. This paper argues, however, that systems-theoretical ideas on how knowledge about the social world can be generated are close to qualitative empirical approaches, which stress the relativity and subjectivity of the meaning systems of the particular actors studied. (shrink)

Regulatory Competition -- The Economic Case for Regulatory Competition -- Regulatory Competition and Utilitarianism -- Political Values under Competitive Pressure -- Law as a Contested Commodity -- Conclusion.

In April 2018, Japan’s first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law’s application brings numerous complications, (...) including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field. (shrink)

Two major regulatory changes are affecting the provision of undergraduate legal education in England and Wales. On the one hand, the Qualifying Law Degree is being deregulated, meaning law schools are free to make significant changes to how and what they teach. On the other hand, higher education in England has seen a significant overhaul through the creation of the Office for Students, which treats students as consumers. Now more than ever, law schools need to ask themselves existential questions (...) which will not only test their continued relevance or indeed viability within the ‘market’ for higher education, but also the status of the discipline of law as a whole. The regulatory landscape may indeed present a significant threat, but it is also an opportunity to reflect on what law schools are for, and consequently what changes could result from the academic freedom that comes with deregulation. Whilst different law schools will interpret their mission differently, they should caution against either generalised inertia or succumbing to an outcomes-oriented provision that simply prepares students for the new Solicitors Qualifying Examination. Instead, law schools will find their proper purpose in critical reflection and academic self-grounding, providing undergraduate students with a ‘question everything’ mentality, and showing them that law is something to be experienced and not merely learnt. (shrink)

Some sharing economy firms have adopted a strategy of “regulatory entrepreneurship,” openly violating regulations with the aim of rendering them dead letters. This article argues that in a democracy, regulatory entrepreneurship is a presumptively unethical business strategy. In all but the most corrupt political environments, businesses that seek to change their regulatory environment should do so through the democratic political process, and they should do so without using illegal business practices to build a political constituency. To show (...) this, the article defends a qualified moral obligation for businesspeople to obey the law even in societies that fall short of ideal democracy and that are rife with economic injustice. Owners and managers of successful businesses have strong moral reasons to obey laws concerning resource allocation. Such laws include not only property law, but also tax laws, environmental regulations, and other laws that regulate businesses in competitive markets. The moral reasons to obey such laws apply even to laws that business leaders think unfair or inefficient, provided that the laws in question have reasonable, good faith defenders. (shrink)

Criminal liability for acts committed by AI systems has recently become a hot legal topic. This paper includes three different contributions. The first contribution is an analysis of the extent to which an AI system can satisfy the requirements for criminal liability: accomplishing an actus reus, having the corresponding mens rea, possessing the cognitive capacities needed for responsibility. The second contribution is a discussion of criminal activity accomplished by an AI entity, with reference to a recent case involving an online (...) bot, the Random Darknet Shopper. This discussion will provide the context for the analysis of commonalities and differences between criminal activities by humans and by artificial systems. The third contribution concerns the evaluation of different ways of addressing criminal activities by AI systems in a regulatory perspective. (shrink)

Increasingly, taxonomies are being developed and used by industry practitioners to facilitate information interoperability and retrieval. Within a single industrial domain, there exist many taxonomies that are intended for different applications. Industry specific taxonomies often represent the vocabularies that are commonly used by the practitioners. Their jobs are multi-faceted, which include checking for code and regulatory compliance. As such, it will be very desirable if industry practitioners are able to easily locate and browse regulations of interest. In practice, multiple (...) sources of government regulations exist and they are often organized and classified by the needs of the issuing agencies that enforce them rather than the needs of the communities that use them. One way to bridge these two distinct needs is to develop methods and tools that enable practitioners to browse and retrieve government regulations using their own terms and vocabularies, for example, via existing industry taxonomies. The mapping from a single taxonomy to a single regulation is a trivial keyword matching task. We examine a relatedness analysis approach for mapping a single taxonomy to multiple regulations. We then present an approach for mapping multiple taxonomies to a single regulation by measuring the relatedness of concepts. Cosine similarity, Jaccard coefficient and market basket analysis are used to measure the semantic relatedness between concepts from two different taxonomies. Preliminary evaluations of the three relatedness analysis measures are performed using examples from the civil engineering and building industry. These examples illustrate the potential benefits of regulatory usage from the mapping between various taxonomies and regulations. (shrink)

Digital privacy scholars tend to bemoan ordinary people’s limited knowledge of and lukewarm interest in what happens to their digital data. This general lack of interest and knowledge is often taken as a consideration in favor of legislation aiming to force internet companies into adopting more responsible data practices. While we remain silent on whether any new laws are called for, in this paper we wish to underline a neglected consequence of people’s ignorance of and apathy for digital privacy: their (...) potential to encourage capture by industry interests. In particular, we argue that such laws may be at increased risk of capture because they are unlikely to be democratically responsive. We make this claim on a twofold basis: first, well-known theoretical mechanisms explaining how the absence of responsiveness leads to capture, identified in prior political science and political philosophy literature, yield the prediction that digital privacy legislation is likely to be unresponsive and thus captured; second, empirical data concerning the European Union’s digital privacy laws, with a special focus on the General Data Protection Regulation, appears to confirm these predictions: the bloc’s (world’s?) flagship privacy protection law seems more responsive to corporate than citizen interests. (shrink)

Digital privacy scholars tend to bemoan ordinary people’s limited knowledge of and lukewarm interest in what happens to their digital data. This general lack of interest and knowledge is often taken as a consideration in favor of legislation aiming to force internet companies into adopting more responsible data practices. While we remain silent on whether any new laws are called for, in this paper we wish to underline a neglected consequence of people’s ignorance of and apathy for digital privacy: their (...) potential to encourage capture by industry interests. In particular, we argue that such laws may be at increased risk of capture because they are unlikely to be democratically responsive. We make this claim on a twofold basis: first, well-known theoretical mechanisms explaining how the absence of responsiveness leads to capture, identified in prior political science and political philosophy literature, yield the prediction that digital privacy legislation is likely to be unresponsive and thus captured; second, empirical data concerning the European Union’s digital privacy laws, with a special focus on the General Data Protection Regulation, appears to confirm these predictions: the bloc’s (world’s?) flagship privacy protection law seems more responsive to corporate than citizen interests. (shrink)

This book explores the intersection of legal frameworks, healthcare innovation, and computational intelligence, shedding light on how emerging technologies like AI and ML are reshaping the medical landscape. It presents real life challenges such as patient privacy, data security, and compliance issues in smart healthcare by engaging into associated ethical and regulatory implications. Comprising the concepts of predictive analytics, regulatory compliance algorithms, and legal decision-making processes, this book offers a roadmap for stakeholders to navigate the evolving landscape of (...) healthcare innovation responsibly and ethically. Investigates how artificial intelligence supports legal decision-making processes in smart healthcare, addressing ethical and accountability concerns Demonstrates the use of smart contracts and automation tools powered by computational intelligence to streamline legal processes and ensure compliance in smart healthcare initiatives Focuses on managing healthcare data within legal frameworks, emphasizing computational intelligence's role in ensuring privacy and security. Examines how computational intelligence enables predictive analytics models to anticipate legal challenges and compliance issues in smart healthcare. Highlights the development and implementation of computational algorithms for navigating evolving legal frameworks in healthcare. This reference book is a useful resource for scholars and researchers working on smart healthcare. (shrink)

This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research.This thought-provoking book provides new perspectives on the regulation of health research by demonstrating how RECs and other regulatory actors seek (...) to fulfil these two functions by performing a role of 'regulatory stewardship'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application.This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action. (shrink)

This chapter contains sections titled: What I s Regulation? How Should We Morally Evaluate Regulation? Welfarism; the Pareto Principle; Kaldor‐Hicks Efficiency versus Social Welfare Functions The Two Fundamental Theorems of Welfare Economics and the Market Failure Framework Externalities Public Goods and Monopoly Power The Coase Theorem Information and Paternalism as Rationales for Regulation Regulatory Forms and Regulatory Choice Criteria References.

First paragraph: The awesome range of Heike Jung’s work—over different aspects of criminal law, different jurisdictions and traditions, different disciplines and languages—makes life both easier and harder for contributors to his Festschrift: easier, because one can choose almost any criminal law topic and be confident that it will connect to his work; harder (for those with the British vices of monolingualism and intellectual parochialism), since one’s paper will display the linguistic, jurisdictional or intellectual limitations that Heike Jung’s work so impressively (...) transcends. In an attempt to overcome some of those limitations, I will discuss a topic that concerns criminal trials and the scope of the criminal law, through the distinction between crimes (Straftaten) and ‘regulatory offences’ (Ordnungswidrigkeiten) which is more often formally drawn in Germany and other continental European systems than in English law. (shrink)

Robots are slowly, but certainly, entering people's professional and private lives. They require the attention of regulators due to the challenges they present to existing legal frameworks and the new legal and ethical questions they raise. This paper discusses four major regulatory dilemmas in the field of robotics: how to keep up with technological advances; how to strike a balance between stimulating innovation and the protection of fundamental rights and values; whether to affirm prevalent social norms or nudge social (...) norms in a different direction; and, how to balance effectiveness versus legitimacy in techno-regulation. The four dilemmas are each treated in the context of a particular modality of regulation: law, market, social norms, and technology as a regulatory tool; and for each, we focus on particular topics? such as liability, privacy, and autonomy? that often feature as the major issues requiring regulatory attention. The paper then highlights the role and potential of the European framework of rights and values, responsible research and innovation, smart regulation and soft law as means of dealing with the dilemmas. (shrink)

To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.

On June 5, 2024, the Australian Capital Territory passed a law to permit voluntary assisted dying (“VAD”). The Australian Capital Territory became the first Australian jurisdiction to permit nurse practitioners to assess eligibility for VAD. Given evidence of access barriers to VAD in Australia, including difficulty finding a doctor willing to assist, the Australian Capital Territory’s approach should prompt consideration of whether the role of nurses in VAD should be expanded in other Australian jurisdictions. Drawing on lessons from Canada, which (...) currently permits nurse practitioners to assess patient eligibility, we argue that the time has come for Australian jurisdictions to expand the role of nurses in VAD systems. This would be an important step in ensuring access to VAD for patients in practice. Attention, however, must also be paid to ensuring adequate remuneration of nurses (and doctors) if this goal of promoting access is to be achieved in practice. (shrink)

First paragraph: The awesome range of Heike Jung’s work—over different aspects of criminal law, different jurisdictions and traditions, different disciplines and languages—makes life both easier and harder for contributors to his Festschrift: easier, because one can choose almost any criminal law topic and be confident that it will connect to his work; harder (for those with the British vices of monolingualism and intellectual parochialism), since one’s paper will display the linguistic, jurisdictional or intellectual limitations that Heike Jung’s work so impressively (...) transcends. In an attempt to overcome some of those limitations, I will discuss a topic that concerns criminal trials and the scope of the criminal law, through the distinction between crimes (Straftaten) and ‘regulatory offences’ (Ordnungswidrigkeiten) which is more often formally drawn in Germany and other continental European systems than in English law. (shrink)

In law school we often focus on the importance of carefully crafting statutory and regulatory language. Textual ambiguities or sloppiness can significantly impair the efficacy of laws and regulations. Just as important as meticulous drafting, however, is the government’s ability to enforce its rules. In the absence of adequate enforcement resources, the government’s regulatory initiatives may well fail. The ability to promote public welfare depends as much on regulatory compliance as it does on the text of the (...) regulations themselves. (shrink)

This chapter contains sections titled: Introduction Background Incentives and guidance from the criminal law Other regulatory incentives and guidance Civil incentives Conclusion.

In the 20th century, public health was responsible for most of the 30-year increase in average life expectancy in the United States.1 Most of the significant advances in public health required the combined effort of scientists and attorneys. Scientists identified public health threats and the means of controlling them, but attorneys and policymakers helped convert those scientific discoveries into laws that could change the behavior of industries or individuals at a population level. In tobacco control, public health scientists made the (...) groundbreaking discovery that smoking caused lung cancer, but attorneys and policymakers developed and implemented the policies and litigation strategies that helped reduce smoking rates by more than half over the past 50 years. (shrink)

This is the first book to comprehensively analyze the work of Hans Micklitz, one of the leading scholars in the field of EU economic law. It brings together analysts, academic friends and critics of Hans Micklitz and results in a unique collection of essays that evaluate his work on European Economic Law and Regulation. The contributions discuss a wide range of Micklitz' work: from his theoretical work on private law beyond party autonomy, with a special focus on its regulatory (...) function, to the illustration of how his work has built the basis for current solutions such as used in solving the financial crisis. The book is divided into sections covering foundations of private law, regulatory law, competition and intellectual property law, product safety law, consumer contract law and the enforcement of law. This book clearly shows the enormous impact of Hans Micklitz' work on the EU legal system in both scholarship and practice. (shrink)

The globalization of securities markets has resulted in a rapid increase in securities transactions that cut across the national borders of more than one country. Individual country regulators cannot avoid the question of how regulatory authority should be allocated for such transactions. Rather, they continue with the present territorial regime, which allocates regulatory authority based on the location of a particular transaction and the effects associated with the transaction. This article assesses a range of alternate responses to globalization. (...) Some have argued that a company’s home country should regulate all transactions in the company’s securities regardless of location. Others have argued for increased harmonization across different country securities regulatory regimes. The article instead contends that giving issuers a greater degree of freedom to select among the securities regulatory regimes of different countries will result in both more desirable levels of investor protections as well as increased social welfare. Arguments have been raised against a move toward greater issuer choice in securities regulation. The article responds to such criticism, pointing out that the present territorial regime suffers from even greater flaws. (shrink)

This paper examines the role of the consensual model in law and argues that if substantive justice is to be the goal of law, the use of individual choice as a legal criterion for distributive and retributive purposes must be curtailed and made subject to substantive considerations. Substantive justice arguably requires that human rights to life, well-being, and the commodities essential to life and well-being, be given priority whenever a societal decision is made. If substantive justice is a collective societal (...) responsibility, the individual cannot be justly rewarded or punished for his or her choices with respect to life, well-being and essential commodities insofar as these choices are justified or excused by standards of substantive justice. Societal conditions and institutional arrangements should be recognized as grounds for justification and excuse because they may impose limits and constraints on the choices available to an individual that are as unavoidable and compelling as those imposed by chance or by another human being. (shrink)

This Article examines the regulatory state through the lens of evolving political economy, arguing that a significant reconstruction is now underway. The ongoing shift from an industrial mode of development to an informational one has created existential challenges for regulatory models and constructs developed in the context of the industrial economy. Contemporary contests over the substance of regulatory mandates and the shape of regulatory institutions are most usefully understood as moves within a larger struggle to chart (...) a new direction for the regulatory state in the era of informational capitalism. A regulatory state optimized for the information economy must develop rubrics for responding to three problems that have confounded existing regulatory regimes: platform power — the power to link facially separate markets and/or to constrain participation in markets by using technical protocols; infoglut — unmanageably voluminous, mediated information flows that create information overload; and systemic threat — nascent, probabilistically-defined harm to be realized at some point in the future. Additionally, it must develop institutions capable of exercising effective oversight of informationera activities. The information-era regulatory models that have begun to emerge are procedurally informal, mediated by networks of professional and technical expertise that define relevant standards, and financialized. Such models, however, also have tended to be both opaque to external observation and highly prone to capture. New institutional forms that might ensure their legal and political accountability have been slow to develop. (shrink)

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided (...) to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. (shrink)

The use of preimplantation genetic diagnosis, the powerful technique employed during fertility treatment to select embryos based on their genes, is currently unregulated in the United States—unlike in nearly all other countries where PGD is available. Of course, the analytical quality of the genetic tests, the laboratories where they are performed, and the technicians who carry them out are subject to the Clinical Laboratory Improvement Amendment requirements. And as the Food and Drug Administration prepares to begin regulating laboratory‐developed tests, including (...) many genetic tests, the clinical validity of the tests may also need to be demonstrated. But neither CLIA nor the U.S. Food and Drug Administration is responsible for governing medical practice, and state law and the relevant medical associations have largely fallen silent on the questions of when and why PGD ought to be performed. The result of this regulatory lacuna is that while PGD was originally intended for screening embryos for severe heritable disorders, it is now also employed for a variety of more controversial purposes. (shrink)

Crowdsourced regulation has been discussed to date by legal and social science scholars mainly in the context of legislation and rulemaking, without paying sufficient attention to non-legislative regulatory functions. This article provides a richer theory of crowdsourced regulation which extends to all regulatory functions, focusing on monitoring and enforcement. Regulatory agencies worldwide harness the power of the public using digital platforms to carry out monitoring and enforcement tasks in regulated markets and sectors. For example, agencies operate online (...) complaint databases that invite the public to report mistreatment of consumers and environmental nuisances by regulated firms. Agencies also publish information concerning corporate misbehavior to publicly shame companies into compliance. Crowdsourcing regulatory monitoring and enforcement can help minimize some prominent ailments of the regulatory task, such as poor resources, diminishing deterrence, declining legitimacy, and capture. It can also promote goals and values such as public participation, increased transparency, public trust in regulators, administrative efficiency, and effectiveness in achieving regulatory objectives. However, crowdsourcing regulatory monitoring and enforcement is subject to a new set of legal, administrative, and democratic failures that need to be acknowledged and addressed. The article develops a theory of crowdsourced regulation that supplies justifications and rationales for crowdsourced regulatory monitoring and enforcement, points out its main pitfalls, and normatively evaluates law and policy implications. (shrink)

It is clear that where a disease affects men and women differently, research on potential therapies or cures should include both men and women and should examine whether the therapy is effective and safe for both sexes. In this paper we consider whether there is an appropriate role for law in regulating to ensure an examination of these sex- and gender-specific aspects in health research. We consider the relative advantages and disadvantages of pursuing a regulatory approach to achieving gender (...) equity in the field of women’s health by exploring first, the meaning of gender equity, and second, the regulatory mechanisms that might be best suited to promoting the goal of gender equity. Within our examination of different regulatory forms and mechanisms, we also interrogate the shift from gender-neutral provisions relating to sex in favor of generalized notions of fairness that remove any specific consideration of sex. (shrink)

This article deals with the gamut of international law. Empirical research on international law, charts three main factors—states and bureaucracies, private actors, and international institutions, specifically international tribunals. International law maintains the centrality of the state, which is also the functioning ground for various sub-state structures, governmental actors, and institutions. Private actors such as corporations and non-governmental organizations are instrumental in influencing the construction and outcome of international law. Regarding the relevance of international laws, some opine that while states do (...) infact deliver on obligations, they only choose those that are easy to comply by. Hence, efficiency becomes doubtful. Further, it is claimed that state's compliance only reflects its intentions, not a behavioral shift. These opinions merit questions regarding the relevance of international law. Studies in this field concern, broadly, international human rights law, criminal law, war laws, trade laws, investment law, and regulatory laws. (shrink)

This Article explores several meanings of a regulatory preference for government inaction. It explains the rise to dominance of this inaction preference in the United States and its distorting influence on the perception and understanding of regulation. Specifically, the Article demonstrates how basic terms in regulation, such as “government failure,” “regulatory capture,” and “deregulation,” acquired misleading connotations suggesting that government inaction is always superior to government action. The Article further explains how, through government inaction, the U.S. legal system (...) accommodates rent extraction - the profitable exploitation of market imperfections and favorable laws. Several developments in recent decades have considerably improved the capacity of very small groups in society to collect rents, namely, use talent and positional advantages to gain increasing levels of earnings. The Article argues that the parallel rise of the inaction preference has contributed to this trend, primarily because the availability of rent extraction opportunities draws talent that utilizes them with growing effectiveness. The purpose of the Article is to clarify several aspects of the relationships between regulation and rent extraction or, more precisely, to emphasize that government inaction may entail undesirable income effects. (shrink)

This fourth edition of Law in Context not only updates the text by reference to the latest thinking and developments in the broad area of 'law in context', but also introduces readers to the wider social, political and regulatory contexts of law.Bottomley and Bronitt, as in previous editions, expose readers to the multitude of contexts (some explicit, others implicit) that affect how law is made, broken and enforced by the state or individual citizens. The fundamental ideals of law - (...) such as the Rule of Law - rest on cherished liberal values, though the authors constantly encourage readers not to accept uncritically the rhetoric of law, but to test these assumptions through empirical eyes.This contextual and critical approach to law, laid out in Chapter 1 and 2, is further developed through specific studies of Gender and Race. Complementing these substantive critiques of law, later chapters examine some of the institutional limitation of law and justice through chapters on access to justice, the law-making process, and regulation. The final chapter, which serves as an epilogue, looks to the broader challenges for law in an age of globalisation through case studies on terrorism and global business regulation. (shrink)

Biomedical research has a strong impact on a country’s scientific-technological and socioeconomic development. It can make a significant contribution at three different levels: promotion of public health; the exchange of knowledge within the scientific community; and economic/ financial profitability. Africa only attracts ~3.3% of the world’s clinical research. This small proportion is due to, among several factors, the absence of two fundamental aspects: specific robust legislation and capacity for regulatory and ethical evaluation. There are five Portuguese- speaking African countries (...) – Angola, Cabo Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe. Despite presenting different degrees of clinical research development, these countries show a common serious insufficiency in the minimum conditions necessary for hosting, collaborating or leading biomedical research projects. These countries are also excluded from the support of international organisations for capacity building because of the language barrier. The Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese-Speaking African Countries project has developed methods to build capacity and partnership through research on national law, comparisons with international standards and by issuing recommendations at a national level. Through collaborative intensive training, trainees are taught to become educators at a national level. This, in turn, creates a sustainable impact at country level. BERC-Luso is a pioneering project, owing to a combination of innovative features. The partnership project: was developed exclusively in Portuguese; involves a large number of African countries, and national and international institutions; has been further enhanced by the diversity and complementarity of its action plans; and has also benefited from a broad participatory methodology based on resolution of recipients’ problems by the recipients themselves. It thus stands out as a model for similar future projects. (shrink)

The notion of validity fulfils a crucial role in legal theory. In the emerging Web 3.0, Semantic Web languages, legal ontologies, and normative multi-agent systems are designed to cover new regulatory needs. Conceptual models for complex regulatory systems shape the characteristic features of rules, norms, and principles in different ways. This article outlines one of such multilayered governance models, designed for the CAPER platform, and offers a definition of Semantic Web Regulatory Models . It distinguishes between normative-SWRM (...) and institutional-SWRM. It also compares existing principles in privacy by design, linked open data , legal information institutes , and online dispute resolution . The article concludes by proposing the notion of Relational Law to summarize the ethical dimension of SWRM. Ethics are the only regulatory way to constitute a global space, out of the jurisdictional public domain set by national, international, or transnational law, and opposed to the private one. (shrink)

This chapter notes the complex and unsatisfying efforts to distinguish between punishment and regulation, and reframes the discussion of punishment and regulation by labeling the former law and the latter police. Doing so relocates this classification in a particular historical genealogy. Reconceptualizing the terms of the discussion suggests that while law operates on the individual, the object of police regulation tends to be collective. One of the distinctions frequently invoked as crucial to the difference between punishment and regulation is the (...) difference between private and public. However, the notion of private law and public regulation relies on an overly simplistic model and history of law. Comparing punishment and regulation is like comparing apples and oranges, because they are two fundamentally different things. Regulation is an empty label unless it is combined with a mode of governance. That mode of governance, which parallels and complements law, is the concept of police. Police and law are contemporary manifestations of the ancient Greek distinction between household governance and public governance. (shrink)

The Leibniz Center for Law is involved in the project Digitale Uitwisseling Ruimtelijke Plannen [DURP (http://www.vrom.nl/durp); digital exchange of spatial plans] which develops a XML-based digital exchange format for spatial regulations. Involvement in the DURP project offers new possibilities to study a legal area that hasn’t yet been studied to the extent it deserves in the field of Computer Science & Law. We studied and criticised the work of the DURP project and the Dutch Ministry of internal affairs on metadata (...) for regulatory documents, and made an inventory of issues related to legal knowledge representation that it felt were not sufficiently covered by current initiatives in the Geographic Information Systems (GIS) field. This inventory was an input to the DURP standardisation effort. In a second phase of the project we extended the METALex XML schema (cf. Boer et al. 2002; Boer et al. 2003) for ‚regular’ legal sources that we developed in the past for geospatial regulatory information, in order to support exchange of spatial regulations, including the associated geospatial information in the form of maps. We developed a prototype application and demonstrated how the spatial planning information in GML can be combined with XML with only minimal changes, using the Web Ontology Language (OWL). This paper describes our experiences. (shrink)

Generally, when thinking of artifacts, one imagines “technical artifacts”. Technical artifacts are those artifacts that perform a mere causal function. Their purpose is to instrumentally help and support an action, not to change behaviour. However, technical artifacts do not exhaust the set of artifacts. Alongside technical artifacts there are also artifacts that we can call “cognitive artifacts”. Cognitive artifacts are all those artifacts that operate upon information in order to improve human cognitive performances. Artifacts of a further, different kind are (...) what we may call “regulatory artifacts”; that is, material artifacts devised and made to regulate behaviour. Consider a roundabout, a traffic light or a speed bump. These artifacts do not make us stronger, faster, or more intelligent. They are placed on the road surface to regulate traffic. This article investigates artifacts of this third kind and, especially, the functions that they perform. (shrink)

The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of the (...) American Society of Law, Medicine & Ethics to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief. (shrink)

While neurorights are emerging as a potentially novel set of human rights in an age of neurotechnologies, most scholarly and policy debate to date has focused on defining and justifying these norms and their connection to existing rights. This article instead assumes some form of neurorights claims will find recognition in at least some existing or novel law and seeks to anticipate potential legal and regulatory hurdles to the successful implementation of this class of norms. After reviewing the ongoing (...) conversations around neurorights and reflecting on the move towards their legal construction, we draw on insights from fields including international law, political economy, and regulatory theory to identify and consider likely hurdles or coming challenges to implementation, including rights balancing, legal fragmentation, appropriate remedies, and issues around transnational and nonstate action and enforcement. The article then presents a research agenda calling for further analysis of these and other implementation challenges and reflects on how assessing these considerations in advance could inform better policy and advocacy. (shrink)