This study examines the ethical position and behaviour of multinational mining companies regarding hazardous employment and health and safety of employees in the South African mining industry. Mining companies have long had a reputation for being unethical on health and safety issues. Too often there are occurrences of fatal accidents, which bring the ethical behaviour of multinational mining companies into question. The litmus test for the mining companies is to devise benchmark standards that will reduce accidents tremendously at their place (...) of operations. This study addresses this issue by examining measures and regulations set up to check the occurrences of mining accidents in South Africa. It follows that the remedy needs to be fundamental and thoroughgoing. (shrink)

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically (...) from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention has adopted guidelines that require Common Rule review for “research” but not “practice” activities. (shrink)

At a time when many international relations scholars are qualifying their premature predictions of the withering of the state, Daniel Drezner's new book makes a compelling case for the continued centrality of the state in the process of globalization.

Kevin Gray,Kafumu Kalyalya | : In this paper we challenge the role of consent in the global order by discussing current modes of international law making in the global order. We contend that the features of state consent in international law depart substantially from those assumed by theorists of the liberal order, who subscribe, in most cases, to the realist conception of state action. We argue, against those theorists, that state consents to coercive measures, and the state’s role in carrying (...) them out, has ceased to be central to an account of global law. We conclude that international law—often thought of as law beyond the state—now has expanded its scope to reach individuals and corporations, and that this change has important ramifications for theories of global justice. | : Dans cet article, nous interrogeons le rôle de l’accord dans l’ordre global en discutant les modes courants de constitution des lois internationales au sein de cet ordre. Nous prétendons que les fonctions de l’accord étatique en loi internationale s’écartent substantiellement de celles assumées par les théoriciens de l’ordre libéral, qui souscrivent, dans la plupart des cas, à la conception réaliste de l’action étatique. Contre ces théoriciens, nos posons que l’État consent à des mesures coercitives, et que le rôle de l’État d’effectuer celles-ci a cessé d’être central dans l’explication de la loi globale. Nous concluons que la loi internationale – souvent pensée comme une loi hors de l’État – a maintenant étendu son spectre jusqu’aux individus et corporations, et que ce changement a d’importantes ramifications que les théories globales de la justice devraient considérer. (shrink)

Dr Noel Semple, Professor Russell Pearce and Professor Renee Knake combine to compare legal profession regulation in the US with that of the countries closest to it institutionally and culturally: Canada, Australia, New Zealand, the United Kingdom and Ireland. This enables them to develop an illuminating taxonomy of legal professional regulation, and to describe the assumptions and objectives underlying the different approaches to regulation. The US and Canada provide a 'professionalist-independent framework' that centres on 'a unified, hegemonic occupation of lawyer' (...) which promotes self-regulation, and the exclusion of non-lawyers from partnership and investment in law practices. By contrast, in other countries that they examine, 'consumerist-competitive approaches' predominate, opening up the profession to co-regulation with executive government and allowing for different forms of legal occupations and non-lawyer influence and investment in law practices. Of course, as they show, in some countries there are combinations and hybrids of these two approaches. Unlike Rhode, who endorses England and Wales' consumerist-competitive approach to regulation in the Legal Services Act 2007, Semple, Pearce and Knake consciously avoid stating a preference for one approach over the other. (shrink)

Whistleblower bounty schemes that pay individuals a cash “bounty” for surfacing information about illegal conduct have rapidly gained public and scholarly attention, fueling calls to install a bounty approach across numerous regulatory areas, from workplace safety, environmental protection, and civil rights to political corruption, immigration, and antitrust. Yet despite the enthusiasm, bounty regimes have remained confined to the fraud context. This Article uses this fact as a jumping off point and, looking across the regulatory state, aims to (...) answer some basic questions about bounty regimes that have thus far eluded sustained scholarly attention: What features of a given regulatory area make it more or less conducive to a bounty approach? Given this, how might existing bounty regimes be revised? And if bounty regimes were to break out of the fraud area, where might they most profitably spread? It offers some initial answers to these questions by constructing a simple framework that shows how two features of the regulatory environment - the directness of the harm to be regulated and the determinacy of the legal mandate to be implemented - structure the choice among competing bounty approaches. These aspects of regulatory context, I argue, map onto the two most vexing challenges facing regulatory architects weighing a bounty mechanism or choosing among competing designs: optimizing the quantity and quality of information revelation and maintaining public control over the elaboration of legal mandates. The framework brings into relief some of the fault-lines in the growing scholarly debate about the optimal use and design of bounty schemes, including the choice between a simple cash-for-information scheme and a more elaborate qui tam scheme in which whistleblowers are vested with independent enforcement authority via a private right of action. It also yields a rough regulatory roadmap showing where existing bounty schemes might be revised and also the areas to which a bounty approach might be usefully exported. (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 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)

This paper addresses recent calls to study the role of the state in private regulation. Integrating current scholarship on the state as a catalyst of private regulatory regimes with prior literature on regulatory failure and self-regulation, it identifies and problematizes unsettled assumptions used as a starting point by this growing body of research. The case study traces the evolution of public debates and the interaction of different regulatory initiatives dealing with corporate social responsibility issues in Canada’s (...) mining industry. Findings reveal the conditions under which the state is more likely to encourage firm-level, fragmented initiatives than facilitate and promote industry-wide regulatory strengthening and consolidation. I discuss the need for greater analytical precision regarding the variation in regulatory policy preferences across time and branches of government and the interaction between public and private regulatory initiatives. The conclusion outlines suggested areas for future research as well as the likely outcome of Canada’s current CSR policy framework. (shrink)

How do “international” epistemic communities shape regulatory contests between transnational firms and civil society organizations in the Global South? With the establishment of the World Trade Organization, member states committed to basing trade-restrictive national regulations on science-based “international” standards set by “international” standard-setting bodies. Yet we know little about how the WTO regime has shaped the operation of epistemic communities within standard-setting bodies and, in turn, how standard-setting bodies articulate with national policy-making processes in the Global South. Building on (...) work in the new political sociology of science, I argue that neoliberal globalization and the establishment of the WTO have created incentives for Western epistemic communities to at once cast themselves as “international” under the WTO regime and orient their scientific agendas toward the priorities of transnational firms. Moreover, this transformation of epistemic communities has created opportunities for transnational firms facing contentious policy environments in the Global South to effectively outsource regulatory decision-making to “international” epistemic communities that can claim legal status under the WTO regime. Empirically, I focus on the case of one Western epistemic community—the Association of Analytical Communities International—and its claim to epistemic jurisdiction over pesticide residue standards for soft drinks in India. (shrink)

There is little doubt that the development and commercialisation of nanotechnologies is challenging traditional state-based regulatory regimes. Yet governments currently appear to be taking a non-interventionist approach to directly regulating this emerging technology. This paper argues that a large regulatory toolbox is available for governing this small technology and that as nanotechnologies evolve, many regulatory advances are likely to occur outside of government. It notes the scientific uncertainties facing us as we contemplate nanotechnology regulatory matters (...) and then examines the notion of regulation itself, suggesting new ways to frame our understanding of both regulation and the regulatory tools relevant to nanotechnologies. By drawing upon three different conceptual lenses of regulation, the paper articulates a wide range of potential regulatory tools at hand. It also focuses particularly on the ways various tools are currently being used or perhaps may be employed in the future. The strengths and weaknesses characterising these tools is examined as well as the different actors involved. The paper concludes that we will increasingly face debate over what is likely to work most effectively in regulating nano technologies, the legitimacy of these different potential approaches, and the speed at which these different regimes may be employed. (shrink)

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates (...) the regulation of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

The effects that artificial intelligence (AI) technologies will have on society in the short- and long-term are inherently uncertain. For this reason, many governments are avoiding strict command and control regulations for this technology and instead rely on softer ethics-based approaches. The Russian approach to regulating AI is characterized by the prevalence of unenforceable ethical principles implemented via industry self-regulation. We analyze the emergence of the regulatory regime for AI in Russia to illustrate the limitations of this approach. The (...) article is based on 50 interviews with policymakers, representatives of AI companies, and academics in the country. The findings show that this regulatory regime was formed under the strong influence of Russian big tech companies, which saw an opportunity to avoid regulatory oversight by washing out concrete regulatory measures from the policy. This approach is part of a broader protectionist sanction-proofing strategy for the local IT sector designed by the government, which can be characterized by lifting regulatory barriers for local companies. Unenforceable ethics-based self-regulation is a _regulatory gift_ from the Russian government to the industry. This _gift_ was intentionally designed because the government thought that prioritizing local innovation over consumer protection would benefit the public. However, the _gift_ can also unintentionally undermine the public interest by providing an opportunity for _ethics washing_. (shrink)

Media organizations are simultaneously key elements of an effective democracy and, for the most part, commercial entities seeking success in the market. They play an essential role in the formation of public opinion and the influence on personal choices. Yet most of them are commercial enterprises seeking readers or viewers, advertising, favorable regulatory decisions for their media, and other assets. This creates some intrinsic difficulties and produces some sharp tensions within media ethics. In this article, we examine such tensions (...) - in theory and practice. We then consider the feasibility of introducing an ethics regime to the media industry - a regime that would be effective in a deregulated environment in protecting public interest and social responsibility. In the article, we also outline a rationale and a methodology for the institutionalization of an acceptable and workable media ethics regime that aims to protect the integrity of the industry in a future of undoubtedly increasing commercial pressure. (shrink)

The recent Covid-19 global health crisis not only brings into sharp relief the current problems afflicting the international intellectual property regime (IIPR) but also calls into question its legitimacy as an international authority. Against this backdrop, the article aims to launch an investigation into the legitimacy of the IIPR, as an international co-ordinative authority, designed to protect IP rights without prejudice to international trade norms. Drawing on Raz’s service conception of authority, it explores whether the IIPR lives up to its (...) promises by enabling co-ordination between states over IP rights without undermining the initial balance on which it is founded, struck between developing and developed countries, as well as between international protection of IP- cum-trade rights and domestic regulatory autonomy. It does so by classifying the historical evolution of the IIPR under three different phases: (i) its foundation, (ii) before, and (iii) after the TRIPS-plus. Upon showing the legitimacy challenges inherent in its undemocratic foundation, the article points to the success of the regime in finding a balance between conflicting interests before the TRIPS-plus era. Later, it underlines the many challenges that come with linking the IIPR to the investment regime and argues that the FTAs and frequent regime-shifting activities put further pressure on the authority and legitimacy of the regime. Stressing the importance of democratic participation for the legitimacy of any co-ordinative authority, the article casts doubt on the IIPR’s legitimacy and concludes by raising some points to overcome the ongoing legitimacy challenges. -/- . (shrink)

Nanoscience has enabled the understanding of organisation of the atomic and molecular world. Due to the unique chemical, electronic and magnetic properties nanomaterials have wide applications in the chemical, manufacturing, medical sector etc., Single walled carbon nanotubes, buckyballs, ZnSe quantum dots, TiO 2 nanoparticle based products are nearing commercialisation. Research is on-going worldwide on suitable delivery systems for nanomaterial based drugs. Nanomaterials are highly reactive in biological systems due to the large surface area. While the benefits of nanomaterials are evident (...) there are studies which indicate the potential risk to biological systems. Substances known to be harmless in bulk can be potentially toxic in certain fibrous and nanoparticle form. Risk assessment studies with nanomaterials largely focus on mouse models. There are very few studies on their effects on aquatic species and plants which form the largest in the productivity chain with respect to the ecological pyramid. This study reviews the research done worldwide in the area of risk assessment of nanomaterials, particularly the effects on aquatic and plant systems. Risk assessment is the foundation for regulatory decision making. A general comparison of the regulatory regime in nanotechnology is performed to understand the extent of development. (shrink)

Powerful, technically complex international compliance regimes have developed recently in certain professions that deal with risk: banking (the Basel II regime), accountancy (IFRS) and the actuarial profession. The need to deal with major risks has acted as a strong driver of international co-operation to create enforceable international semilegal systems, as happened earlier in such fields as international health regulations. This regulation in technical fields contrasts with the failure of an international general-purpose political and legal regime to develop. We survey (...) the new global regulatory systems in the actuarial, banking and accounting fields, with a view to showing how the need to deal reasonably with risk has resulted in an international de facto law solidly based on correct abstract principles of probability. (shrink)

Abstract As non-state actors, PMSCs are not embraced by traditional state-dominated doctrines of international law. However, international law has itself failed to keep pace with the evolution of states and state-based actors, to which strong Westphalian notions of sovereignty are no longer applicable. It is argued that these structural inadequacies stand in the way of international regulation of PMSCs, rather than defects in international human rights and humanitarian law per se. By analyzing understandings of legal responsibility, where such structural issues (...) come to the fore, it is argued that, rather than attempting to resolve the essentially ideological dispute about the inherent functions of a state, regulatory regimes should focus on the positive obligations of states and PMSCs, and the interactions between them. Applying the results of this analysis, current and proposed regulatory regimes are evaluated and their shortcomings revealed. (shrink)

Little consensus exists about the effectiveness of transnational private governance in domains such as labor, the environment, or human rights. The paper builds on recent scholarship on labor standards to emphasize the role of labor agency in transnational private governance. It argues that the relationship between transnational private regulatory initiatives and labor agency depends on three competences: first, the ability of workers’ organizations to gain access to processes of employment regulation, implementation, and monitoring; second, their ability to insist on (...) the inclusion of employers and state agencies within such processes; and third, the ability of workers to effectively exercise leverage in pursuit of particular goals. The paper develops a framework, called hybrid production regime, for examining how workers’ capacity to act at the local level depends on how these three collective competences are addressed in the institutionalization of capital–labor relations between the transnational and national levels. (shrink)

Tirana, immediately after it was declared the capital of Albania on 11 February 1920, has undergone many changes in its morphology and city context. The capital is located in the heart of the country. During its lifespan, Tirana has adopted four important regulatory plans starting from 1923. The Western ideologies of the time influenced drastically the city development. The influence of such ideologies was stopped immediately though the imposition of communist ideas, after the Second World War. Rational building forms (...) were created which could be standardized in order to reduce construction costs. Meanwhile, in Western Europe, this current was implemented during the 1920s, as a response to social problems. The communist regime established strict anti-urbanization policy that aims to foster the development of rural areas and the suburban industrial districts in order to control urban growth and demographic mobility. All the regulatory master plans of Tirana, climate data of the city, the actual situation of the specific neighborhood, its orientation toward north, are considered in order to gather information and to implement the correct bioclimatic eco-renovation in the area. A special attention will be given to the underground tunnels which were constructed during the communist regime all over the city (1945–1983) as a response to a hypothetic nuclear attack, in order to shelter the inhabitance against bombing. These reinforced concrete tunnels will serve not only as an area for water collection and recycling strategies but also for cooling with zero energy expenditure for the inhabitants as a consequence of differences in temperature and air pressure. This strategy benefits from the underground air temperature in both seasons (winter and summer). It envisages the handover of these tunnels by the community. Nowadays, such structures are abandoned and denigrated. The realization of these structures required large amounts of money from the state budget. Considering that fact they need to be vitalized and reused, using different methodologies and strategies as part of the city. After the communist regime in the city of Tirana, two other regulatory plans were implemented which observe the city from another perspective, determining and evaluating Tirana’s real values as a city of the future, but not defining yet Tirana as an Ecocity. The ecological potential of Tirana including its outskirts is to be considered. Its flora and fauna are very rich, containing a mixt of species and plants. Regardless, the city of Tirana is suffering from different kinds of pollution such as air and noise pollution which are above EU and WHO norms. Tirana benefits from a Temperate Mediterranean climate. Furthermore, the benefits of the solar radiation are enormous. Unfortunately, nowadays, the city of Tirana is not profiting much from it. This chapter is in search of an overall view of the city of Tirana, and its great potential discovering its underground and upper ground historical secrets. (shrink)

We investigate whether enforcement is influenced by politics by comparing the severity of PCAOB sanctions of individual CPAs to the severity of related state-level disciplinary actions imposed by boards of accountancy. Our results provide evidence that when responding to PCAOB sanctions, BOAs under Republican regimes impose less severe penalties than do BOAs under Democratic regimes. Our data and analyses inform the regulatory and enforcement practices of the accounting profession and other professions. Most directly, motivated by improvements in (...) technology that facilitate the cross-jurisdiction practice of public accounting, states have adopted mobility laws where CPAs are only required to be licensed in their state of residence to practice in multiple states. These laws simplify licensing but may complicate enforcement. Beyond generalized red-state, blue-state differences in enforcement, we find that non-resident CPAs receive less severe disciplinary actions. If not reasonably consistent across BOAs, regulators may be unwilling to delegate responsibility for enforcement to another state’s BOA. (shrink)

Living systems employ several mechanisms and behaviors to achieve robustness and maintain themselves under changing internal and external conditions. Regulation stands out from them as a specific form of higher-order control, exerted over the basic regime responsible for the production and maintenance of the organism, and provides the system with the capacity to act on its own constitutive dynamics. It consists in the capability to selectively shift between different available regimes of self-production and self-maintenance in response to specific signals (...) and perturbations, due to the action of a dedicated subsystem which is operationally distinct from the regulated ones. The role of regulation, however, is not exhausted by its contribution to maintain a living system’s viability. While enhancing robustness, regulatory mechanisms play a fundamental role in the realization of an autonomous biological organization. Specifically, they are at the basis of the remarkable integration of biological systems, insofar as they coordinate and modulate the activity of distinct functional subsystems. Moreover, by implementing complex and hierarchically organized control architectures, they allow for an increase in structural and organizational complexity while minimizing fragility. Finally, they endow living systems, from their most basic unicellular instances, with the capability to control their own internal dynamics to adaptively respond to specific features of their interaction with the environment, thus providing the basis for the emergence of minimal forms of cognition. (shrink)

Michel Foucault's critical studies concerning regimes of power are of special interest when applied to architecture. In particular, he warned of the hazards of building surveillance into architectural structures for the purpose of monitoring people and took as his historical exemplar English philosopher Jeremy Bentham's ?Panopticon,? a structure originally used to assist in rehabilitating prisoners. He felt this kind of regulatory control resulted in maintaining power of one group over another. This article discusses what Foucault called the general (...) ordering of the visible and the invisible by examining architecture as he viewed it?as an operation of power, control, and domination. More to the point, it places this belief in the context of power constructions in both sacred and school architecture and how this, in turn, creates a carceral society. This article also puts forward some of Foucault's thinking on architecture and connects this to his ideas of perceptual visibles and invisibles. The suggestion of schools as institutions of conformity and how their built environment functions as a regulatory force for this conformity is also explored. (shrink)

Imposing Values provides an even-handed characterization of the differences between modern liberalism and classical liberalism about the proper scope of government. It also systematically and comprehensively discusses arguments for and against various regulatory regimes favored by modern liberals and opposed by classical liberals.

Living systems employ several mechanisms and behaviors to achieve robustness and maintain themselves under changing internal and external conditions. Regulation stands out from them as a specific form of higher-order control, exerted over the basic regime responsible for the production and maintenance of the organism, and provides the system with the capacity to act on its own constitutive dynamics. It consists in the capability to selectively shift between different available regimes of self-production and self-maintenance in response to specific signals (...) and perturbations, due to the action of a dedicated subsystem which is operationally distinct from the regulated ones. The role of regulation, however, is not exhausted by its contribution to maintain a living system’s viability. While enhancing robustness, regulatory mechanisms play a fundamental role in the realization of an autonomous biological organization. Specifically, they are at the basis of the remarkable integration of biological systems, insofar as they coordinate and modulate the activity of distinct functional subsystems. Moreover, by implementing complex and hierarchically organized control architectures, they allow for an increase in structural and organizational complexity while minimizing fragility. Finally, they endow living systems, from their most basic unicellular instances, with the capability to control their own internal dynamics to adaptively respond to specific features of their interaction with the environment, thus providing the basis for the emergence of minimal forms of cognition. (shrink)

If humans subject animals to painful, damaging, or frightening procedures to achieve scientific progress, then the very least that humankind can do is to insist that regulations be put in place to protect animals and that they be properly implemented and enforced. However, recent practice in the United Kingdom suggests that this is not the case. Europe’s new regime on the protection of animals used for scientific purposes—Directive 2010/63—must act as a catalyst for significant change and is a significant recognition (...) of the intrinsic value of animals. Before this Directive, the cost/benefit analysis undertaken in the United Kingdom allowed for a large margin of error so that animal welfare was an aggregated concept, and any aggregated finding of “adequate” animal welfare was not militated by individual cases of exacerbated animal detriment. The recognition that each animal has value as an individual means that the levels of animal welfare or protection expected of scientific establishments can no longer simply be those that are, in generic terms, appropriate for the aggregated mass of animals. Instead, the welfare standards applied are appropriate and rendered effectual for all individual animals. (shrink)

Victoria’s Model Litigant Guidelines aim to regulate the conduct of government parties in civil disputes in a manner that goes beyond the ethical duties of ordinary litigants. Despite the sheer number of disputes involving the Victorian government to which the regime applies, little academic attention has been given to Victoria’s MLGs. The article explores the nature and extent of the regulatory force exerted by the MLGs by applying regulatory theory to the MLG regime. Particular attention is given to (...) applying Ayers and Braithwaite’s theory of Responsive Regulation that includes situating the guidelines within their regulatory pyramid. The analysis finds that in the absence of a distinct regulator, the MLG regime is predominantly self-regulatory. The responsiveness of the MLGs appears to be restricted owing to an absence of public involvement in the MLG regime. The article also highlights that likely challenges to the MLG regime as a mode of regulation include the nature of the regulatory context, the decentralisation of government services, the lack of publicly available information on the government’s adherence to the MLGs and the content of the MLGs themselves. (shrink)

Scientific knowledge and technological expertise continue to evolve rapidly. Such innovation gives rise to new benefits as well as risks, at an ever-increasing pace. Within this context, regulatory regimes must function in order to address policymakers’ objectives. Innovation, though, can challenge the functioning and effectiveness of regulatory regimes. Questions over fit, effectiveness, and capacity of these regimes to ensure the safe entry of such technologies, and their products, onto the market will be asked in parallel (...) to their development. With this in mind, this article examines the strengths and weaknesses of current regulatory frameworks, including those designed for biotechnology, cosmetics, novel organisms, and foods, in order to inform and help shape Australia’s regulatory landscape around innovation. By focusing on Australia, the article illustrates the need to assess future changes to regulatory frameworks using a careful balancing of key factors. These include, for example, horizon scanning and monitoring, availability of appropriate data, existing health, safety, environmental, ethical, and social risks and impacts, and regulatory capacity. The article argues that rather than using one of these factors in isolation, a careful assessment of where each factor stands can lead regulators to an approach that properly manages the potential risks of emerging technologies. (shrink)

Soft regulatory measures are often promoted as an alternative for existing regulatory regimes for nanotechnologies. The call for new regulatory approaches stems from several challenges that traditional approaches have difficulties dealing with. These challenges relate to general problems of governability, tensions between public interests, but also (and maybe particularly) to almost complete lack of certainty about the implications of nanotechnologies. At the same time, the field of nanotechnology can be characterized by a high level of diversity. (...) In this paper, we discuss and compare two models for framing public policy in relation to technology regulation: the first is a deliberative model based on foresight knowledge and the second the wide reflective equilibrium model, developed by political philosopher John Rawls. In both models, the aim is to find consensus on (a framework for) policy measures and regulation. On the basis of a critical discussion of the strengths and weaknesses of both models, some tentative conclusions are drawn for effective policy making and implementation based on soft law. (shrink)

Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Regulations”). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity (...) was analysed. The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as “relative” had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area. (shrink)

The current regulatory regime for pharmaceuticals is criticized from a libertarian perspective for imposing the same risk–benefit analysis on all patients. The critics call for the abandonment of market access regulations. But the regulatory regime is also criticized by philosophers of science for applying too low epistemic standards, who call for stricter regulation. This article aims to engage the debate in a less polarized way, first by advancing the libertarian alternative to the current regime through an approach I (...) call Certified Capitalism for Pharmaceuticals (CCP), without endorsing this view in the end; second, by developing an argument against all regulatory regimes without market access regulations, including CCP, based on the possibility that the pharmaceutical industry could bend pharmaceutical science to its interests in such a regime. Whether this argument is successful, or whether CCP is able to circumvent it, cannot be decided on the basis of the empirical information currently available. Third, these arguments lead to two further insights for a philosophy of science that takes the social embeddedness of science seriously: Market access regulations limit the bending of research by industry by limiting epistemic diversity. The patent system can be seen as the thread of a well-functioning scientific system because it can give some agents enough resources to bend science through industrial selection. (shrink)

Organizations increasingly rely on algorithm-based HR decision-making to monitor their employees. This trend is reinforced by the technology industry claiming that its decision-making tools are efficient and objective, downplaying their potential biases. In our manuscript, we identify an important challenge arising from the efficiency-driven logic of algorithm-based HR decision-making, namely that it may shift the delicate balance between employees’ personal integrity and compliance more in the direction of compliance. We suggest that critical data literacy, ethical awareness, the use of participatory (...) design methods, and private regulatory regimes within civil society can help overcome these challenges. Our paper contributes to literature on workplace monitoring, critical data studies, personal integrity, and literature at the intersection between HR management and corporate responsibility. (shrink)

The Human Heredity and Health in Africa Consortium is a conglomeration of research and infrastructure projects spread throughout Africa whose aim is to apply genomic methodology to diseases affecting the people in the region. Its operation is innovative in the sense that it is doing something new; that is, filling a hitherto existing void in genomic research capability of African scientists and infusing resources and manpower to institutions and investigators across Africa. But aside from developing and sustaining capacity in genomic (...) research and biorepositories, H3Africa is also invested in developing appropriate ethical regulatory regime to govern research in these areas. This latter concern –research ethics governance – is the major subject of this paper. Specifically, the paper discusses protection of research participants as envisaged by H3Africa in the area of consent, safeguarding privacy, maintaining confidentiality of health information and sharing of data/biospecimens. The ultimate goal is to determine whether H3Africa initiatives and processes are consistent or at odds with international guidelines and best practices. (shrink)

Participative reforms to risk regulation are often argued to enhance the evidence base, improve the representation of the public interest, and build support for policy processes and outcomes. While rationales and mechanisms for participation have received most scholarly attention, less attention has been paid to the actual impact of participation on policy processes and outcomes. This article, therefore, considers the impacts of participation by examining the UK Food Standards Agency's Consumer Committee, which was created in 2002 to institutionalize consumer representation (...) within policy making, but which was disbanded as a failure in 2005. Using three case studies, the article identifies two broad institutional dimensions of regulation that shaped and constrained the committee's impact on the evidence base, policy outcomes and building support for policy, and contributed to its eventual failure. Those dimensions relate to the design and organization of regulatory regimes, and to the understandings and influence of regulatory actors. (shrink)

Ten years after the enactment of the Biologics Price Competition and Innovation Act, competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem (...) to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act, which is administered by the Environmental Protection Agency. The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets. (shrink)

This paper begins by describing recent controversies over cross-contamination of crops in the United States and European Union. The EU and US are both applying the principle of freedom of cropping to resolve these conflicts, which is based on an individualistic philosophy. However, despite the EU and the US starting with the principle of freedom of cropping they have very dissimilar regulatory regimes for coexistence. These contradictory policies based upon the same principle are creating different sets of winners (...) and losers. In the US the organic industry claims the system of coexistence is unfair and in the EU the biotech industry claims the system is unfair. It seems that states, despites claims to neutrality and freedom of choice, are prejudicing one system of agriculture over another in resolutions to the conflict over cross contamination. In this paper I will argue that if states cannot remain neutral in coexistence policies, there are conditional reasons for favoring the organic industry over the biotech industry in coexistence policies based in communitarian moral philosophy. (shrink)

In the last couple of years, serious controversies have raised doubts over the reliability of research supporting the efficacy and safety of Selective Serotonin Reuptake Inhibitors, popular drugs used for the treatment of depression and a variety of related conditions. These controversies have also evoked concerns over the promotional tactics used by industry to promote these drugs. In another article in this volume, David Healy argues that the tactics highlighted by these and some other recent controversies in psychiatry have brought (...) medical research itself to the level of commercial publicity. In the following article, I provide some additional first-hand information about controversies in which David Healy was involved. I then situate these controversies within the context of the increasing commercialization of medical research. I discuss how the controversies highlight the failure of existing regulatory regimes in curbing inappropriate industry influence over research. I critically analyse some of the measures recently promoted by the medical research community, such as the introduction of a clinical trial registry, and I indicate why these measures are insufficient. In conclusion, I highlight how a more radical reform of the clinical trials scene is needed. (shrink)

This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory (...) structure that has developed since the 1960s. In general product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility a product is harmful, whereas establishing liability in litigation requires proving that the product was actually harmful.As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control. (shrink)

Regulatory agencies aim to protect the public by moderating risks associated with innovation, but a good regulatory regime should also promote justified public trust. After introducing the USDA 2020 SECURE Rule for regulation of biotech innovation as a case study, this essay develops a theory of justified public trust in regulation. On the theory advanced here, to be trustworthy, a regulatory regime must (1) fairly and effectively manage risk, must be (2) “science based” in the relevant sense, (...) and must in addition be (3) truthful, (4) transparent, and (5) responsive to public input. Evaluated with these norms, the USDA SECURE Rule is shown to be deeply flawed, since it fails appropriately to manage risk, and similarly fails to satisfy other normative requirements for justified trust. The argument identifies ways in which the SECURE Rule itself might be improved, but more broadly provides a normative framework for the evaluation of trustworthy regulatory policy-making. (shrink)

This special issue brings together contributions from nine scholars who have been working at the frontiers of the comparative study of risk. Most of the papers that follow use a cross-national approach to investigate public attitudes to risk in a broad range of settings including Germany, Sweden, Denmark, England, and the United States. Two of the authors represented here adopt more creative interpretations for carrying out comparative studies that reach considerably beyond conventional methodologies of country-level contrasts. One contributor highlights the (...) temporal dimensions of novel forms of environmental uncertainty and a second selection, grounded in the sociology of language, compares the different objectives that lay people seek to satisfy when they speak about risk. In this sense, this issue provides a farrago of perspectives on the most befitting way to exploit the utility of comparative methodologies.Political scientists interested in the effects of different regulatory regimes and systems of governance have been responsible for most comparative risk research conducted to date. The papers in this issue depart from this tradition and instead draw on insights derived from social theory. There has been over the past decade a dramatic upswelling of interest in risk among theoretically-inclined sociologists and several writers have suggested that a pervasive sense of anxiety is a central feature of the current phase of modernity (e.g., Giddens, 1990; Beck, 1992). This collection represents an initial attempt to situate these recondite impressions in distinct contexts and to scrutinise them from a variety of comparative perspectives. (shrink)

Traditionally many systems subjected public employees to a separate and more restrictive labour law regime than their private sector counterparts. However, these status-based restrictions were generally modified or abandoned during the 1960s and 1970s. Greater homogeneity of treatment of public and private sector workers was also subsequently reflected in employment practices in Britain and elsewhere as a product of the «marketization» of public services, a strategy which involved replacing centralized regulation by greater local determination in accordance with «business» needs. More (...) radically, the provision of some public services was removed from the public sector altogether, either by contracting out particular elements of the service or by wholesale privatization, subject to some form of regulatory regime. These changes may appear to render otiose discussion of the case for special treatment of the employment relation in public services. This article expounds the proposition that, on the contrary, public services possess distinctive qualities which necessitate regulation of the employment relationship within those services in areas beyond those covered by the general law, and aims to provide a framework within which the justification for specific additional measures can be assessed. The article also considers the further questions which need to be addressed if the framework it proposes is accepted, including, in particular, the appropriate mechanisms for imposing and enforcing regulation. (shrink)

There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on human subjects is (...) in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)

This article analyses the current state of empirical legal research in the law and the regulation of financial markets. It aims to provide a brief survey of the main work done either by lawyers or by others but which is pertinent to the operation of law and regulation. It focuses on six main areas of research and debates. These are the debates on the efficient markets hypothesis and mandatory disclosure rules in securities regulation; studies on behavioralism and their impact on (...) disclosure as a tool for protecting investors; studies on the impact of rules relating to market misconduct on market development; research into the relationship between legal rules and securities market development; evidence of the unintended impacts of regulation; and research into the dynamics of financial market regulatory regimes. Finally, this article mentions that understanding the general context in which law and regulation operates deepens our understanding of the nature, potential, and limits of law and regulation themselves. (shrink)

This paper begins by describing recent controversies over cross-contamination of crops in the United States and European Union. The EU and US are both applying the principle of freedom of cropping to resolve these conflicts, which is based on an individualistic philosophy. However, despite the EU and the US starting with the principle of freedom of cropping they have very dissimilar regulatory regimes for coexistence. These contradictory policies based upon the same principle are creating different sets of winners (...) and losers. In the US the organic industry claims the system of coexistence is unfair and in the EU the biotech industry claims the system is unfair. It seems that states, despites claims to neutrality and freedom of choice, are prejudicing one system of agriculture over another in resolutions to the conflict over cross contamination. In this paper I will argue that if states cannot remain neutral in coexistence policies, there are conditional reasons for favoring the organic industry over the biotech industry in coexistence policies based in communitarian moral philosophy. (shrink)

This 2000 text applies modern advances in game theory to the analysis of competition policy and develops some of the theoretical and policy concerns associated with the pioneering work of Louis Phlips. Containing contributions by leading scholars from Europe and North America, this book observes a common theme in the relationship between the regulatory regime and market structure. Since the inception of the new industrial organization, economists have developed a better understanding of how real-world markets operate. These results have (...) particular relevance to the design and application of anti-trust policy. Analyses indicate that picking the most competitive framework in the short run may be detrimental to competition and welfare in the long run, concentrating the attention of policy makers on the impact on the long-run market structure. This book provides essential reading for graduate students of industrial and managerial economics as well as researchers and policy makers. (shrink)

If the Supreme Court affirms either Compassion in Dying v. State of Washington or Quill v. Vacco, state legislatures will be presented with a new and unwelcome task: regulating physician-assisted suicide. This article focuses on the states task of specific policy making in light of the due process reasoning in Compassion in Dying and the equal protection reasoning in Quill. Policy makers must try to predict whether a particular regulation would in practice achieve its intended objective. They must also try (...) to predict whether the regulation would survive constitutional review if challenged. Finally, they must consider the extent to which they could, or should, maintain two different regulatory regimes: a more permissive one for decisions to forgo life-sustaining medical treatments, and a more restrictive one for decisions to obtain a prescription for a lethal dose of medication. This last issue will be especially challenging if the equal protection analysis in Quill prevails. (shrink)

The “Lošinj Declaration on Biotic Sovereignty” is a novelty in the consideration of the environment and life in general and a unique document on a global scale. Until the advent of the Declaration, the environment was usually considered in an instrumentalist way, following the prevailing techno-scientific paradigm. The Declaration introduces biotic sovereignty as the starting point for the debate on GMOs, from which the harmfulness or potential benefits of genetic engineering can be assessed. The protection of biotic sovereignty should be (...) one of the crucial values that European and Croatian citizens should defend in the upcoming struggle to change and probably drastically reduce the regulatory regime for genetically modified crops in the European Union and thus also in Croatia. In this paper, we highlight the importance of the “Lošinj Declaration on Biotic Sovereignty” in the context of the emergence of new gene regulation techniques that are becoming a threat to biotic sovereignty. We analyse the lobbying process against the ruling C-528/16 using the example of the scientists united in the network EU-SAGE. The central part of the paper analyses the controversy over a new European Commission study on new genetic techniques and the political context of the conflict between the European Commission and the European Parliament over the authorisation of new seed varieties of genetically modified crops. (shrink)

This article aims to address challenges of translating emerging scientific technologies into legal terms and incorporate them into the existing North American regulatory regimes. A lack of full scientific knowledge about nanomedicine technologies results in the lack of development in legal discourse to describe products and to clearly set legal standards on their safety and efficacy. The increasing complexity and hybrid nature of technologies negatively impact the functionality of “law in action” leading to a legal uncertainty and ultimately (...) to a public distrust. Nanomedicine is an illustrative example of how law lags behind increasingly fast-paced scientific technologies making it difficult to find a balance between innovation and safety. This article argues that the boundary crossing nature of nanomedicine through different domains of science triggers a methodological and epistemological debate within science and law, suggesting that a critical revision is required in our traditional methods to learn, create, and categorize knowledge from breakthrough scientific advances. The highly disruptive nature of nanomedicine places stress on traditional conceptual frameworks, classifications of knowledge, and existing regulations. The legal challenge to identify definitions or to classify nanoapplications brings to light a conceptual vacuum surrounding nanomedicine. Moving away from confusing policies and obsolete classificatory models, this article suggests to undertake changes that are only the first steps of a more in-depth “epistemological transformation” that addresses knowledge as the process of not only gathering data, but also, as the process of elaborating new conceptual bases to better fulfill the legal language and facilitate the legal task of finding definitions and formulating criteria more adherent with scientific advances. This should compel regulators to explore new paradigms and develop new methodologies to evaluate data on nanomedicine applications in order to provide sustainable bases for a responsible development of nanomedicine. (shrink)