Gaps, inexperience, inconsistencies, and overlaps: crisis in the regulation of genetically modified plants and animals

The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured and inefficient--transgenic plants and animals are governed by at least twelve different statutes and five different agencies or services. The deficiencies resulting from this piecemeal approach to regulation unnecessarily expose society and the environment to adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. These deficiencies also increase the risk of further unnecessary biotechnology scares, which may cause public overreaction against biotechnology products, preventing the maximization of social welfare. With science and society poised to soar from first-generation biotechnology (focused on crops modified for agricultural benefit), to next-generation developments (including transgenic fish, insects, and livestock, and pharmaceutical-producing and industrial compound-producing plants and animals), it is necessary to establish a comprehensive, efficient, and scientifically rigorous regulatory system. This Article details how to achieve such a result through fixing the deficiencies in, and risks created by, the current regulatory structure. Ignoring many details, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be closed with new legislation and regulation. Second, regulation of genetically modified products must be shifted from a haphazard model based on statutes not intended to cover biotechnology to a system based upon agency expertise in handling particular types of risks.     

‘Factual causation’ and ‘scope of liability’: What's the difference?

According to a dominant view, for the negligent defendant to be held liable for the plaintiff's harm the plaintiff must establish first, that the breach was the ‘factual cause’ of the harm, and second, that the harm is within the ‘scope of liability’. On this view, factual causation is purely factual, while scope of liability is normative and non‐causal. This article accepts the basic two‐step approach, but argues that the distinction is overstated. A close analysis of the principles shows that factual causation may require value judgment, and that scope of liability often involves an assessment of the strength and nature of the causal connection between breach and harm.     

风险社会大规模损害责任法的范式重构——从侵权赔偿到成本分担

风险社会是人类利用科技从事创造活动而产生的人为风险成为影响人类生活乃至生存和发展的主要因素的社会,如何缓解与分配风险损害成为风险社会的核心问题。风险社会的大规模损害以事故型和累积型大规模公害为主导。侵权法解决的损害问题是私人对私人利益的侵害,其主要功能在于补偿受害者,其制度运行有赖于损害的确定性、有限性、可计量性、可预期和可控制性、私人性。风险损害所具有的不确定性、无限性、不可计量性、不可预期性、不可控制性和社会公共性颠覆了这些条件,对风险损害主要以规制法予以事前防范。规制法防治私人对公共利益的侵害,其主要通过事前预防责任的分担降低风险损害,事后责任作为补充。规制法责任的实质是对风险成本的分担。分担应遵循社会分担、有效分担、平衡分担以及预防为主、救济为辅的原则。规制法的责任制度包括预防责任和补救责任。     

Risks and Realities of Working with Alienated Children

Involvement in custody cases that include accusations of parental alienation—whether as an evaluator, expert witness, lawyer, judge, therapist, provider of a specialized intervention, or researcher—incurs both professional and personal risks. Some risks relate to false negative or false positive identifications of parental alienation that can lead to regulatory agency complaints and public condemnation by the parent who feels wronged by the case outcome. Other risks stem from providing services in an emerging area of practice and working with children who overtly oppose repairing the relationship with their rejected parent. These risks include: unfounded accusations of mistreating children; negatively biased commentary and sensationalist attacks in the media and in social media, professional conferences and journals, and in courtroom testimony; harassment, vilification, and invasion of privacy; threats of violence and public humiliation; shunning and rumor spreading by colleagues; and complaints to regulatory agencies. This article examines circumstances, beliefs, and dynamics that give rise to these risks, suggests precautions to reduce the risk of false accusations against professionals, and offers recommendations for dealing with regulatory agencies. Criticisms that a court or service provider has mistreated a child merit careful scrutiny in the context of the case evidence and empirical data. While some interventions for alienated children raise legitimate concerns, others have been maligned by anecdotal complaints that studies show do not represent the experience of most participants.     

'FATCATS' and Prosecution in a Regulatory Agency: A Footnote on the Social Construction of Risk1

This paper explores what, in the context of occupational health and safety regulation, the idea of risk means to legal actors whose task is to assess and act upon risks. It argues that while the occupational risk to the worker is important because it may prompt a regulatory response and it informs decisions about enforcement strategy, the decision-maker contemplating formal legal action will become preoccupied with the risks posed by the legal process to the successful prosecution of the case. The legal risks arise from the nature of regulatory work and the form and character of regulatory law. Legal decisionmakers respond to these risks in a systematic fashion preferring to prosecute cases which are quick, straightforward and unlikely to be defended. This leads to the selection of cases which are breaches of absolute (rather than general) duties and violations of provisions relating to safety rather than health, thereby skewing the application of enforcement.     

中国政府监管机构构建中的缺失与前瞻性思考──兼议政府监管领域"大部门体制"的改革方向

中国目前虽然成立了一些冠以"监管"或"监督管理"之名的机构,但与现代意义上的监管机构还有相当大的差距。中国政府监管机构的设立应坚持"立法先行"的原则,避免"三定方案"带给监管机构的尴尬境地;中国政府监管机构不宜采用美国的独立管制委员会模式或以英国为代表的公法人模式,现阶段比较现实和稳妥的做法是在国家行政体制框架内设置行政机构类型的监管机构,最好采用隶属于国务院的监管机构模式,并通过法律机制保障其独立性;面对产业汇流的趋势,在经济性监管领域,应设立综合性的监管机构。     

Duty to warn of genetic harm in breach of patient confidentiality

Harm caused by the failure of health professionals to warn an at-risk genetic relative of her or his risk is genetic harm. Genetic harm should be approached using the usual principles of negligence. When these principles are applied, it is shown that (a) genetic harm is foreseeable; (b) the salient features of vulnerability, the health professional's knowledge of the risk to the genetic relative and the determinancy of the affected class and individual result in a duty of care being owed to the genetic relative; (c) the standard of care required to fulfil the duty to warn should be the expectations of a reasonable person in the position of the relative; and (d) causation is satisfied as the harm is caused by the failure of intervention of the health professional. Legislation enacted subsequent to the Report of the Commonwealth of Australia, Panel of Eminent Persons (Chair D Ipp), Review of the Law of Negligence Report (2002) and relevant to a duty to warn of genetic harm is considered. The modes of regulation and penalties for breach of any future duty to warn of genetic harm are considered.     

Business Response to Regulation: An Economist's Perspective

This chapter presents an economist's perspective on the interrelationship of the compliance and enforcement decisions of business and regulators in the context of regulations governing occupational health. Assuming profit-maximizing firms and harm-minimizing enforcement agencies, it is argued that a degree of preventive activity would be undertaken by businesses even in the absence of regulation. However, if employees are not fully informed about the risks of the workplace, it is likely that the profit-maximizing level of prevention will be less than socially optimal, and consequently there will be a need for regulation. An enforcement agency which attempts to minimize harm through inducing compliance with regulatory standards will be faced with similar informational difficulties to individual employees, and this suggests some scope for cooperative gains with individual firms through negotiated compliance, rather than prosecution.     

Causation, ‘Humean’ Causation and Emptiness

One strategy Mādhyamikas use to support their claim that nothing has intrinsic nature (svabhāva) is to argue that things with intrinsic nature could not enter into causal relations. But it is not clear that there is a good Madhyamaka argument against ultimate causation that understands causation in ‘Humean’ terms and understands dharmas as tropes. After exploring the rationale behind the intrinsic-nature criterion of dharma-hood, I survey the arguments Mādhyamikas actually give for their claim that anything dependently originated must be devoid of intrinsic nature, and suggest that none actually succeeds in ruling out this hypothesis about how ultimate causation might work.     

An Enforcement Taxonomy of Regulatory Agencies

A variety of multivariate techniques were used to develop a taxonomy of regulatory agencies from the first comprehensive study of the disparate enforcement strategies employed by business regulatory agencies in one country. Seven types of agencies were identified: Conciliators, Benign Big Guns, Diagnostic Inspectorates, Detached Token Enforcers, Detached Modest Enforcers, Token Enforcers and Modest Enforcers. Agencies were distinguished primarily according to their orientation to enforcement versus persuasion, according to their commitment to detached (or arms length) command and control regulation versus cooperative fostering of self-regulation, and according to their attachment to universalistic rulebook regulation versus particularistic regulation. Nevertheless, it is not unreasonable to view regulatory agencies as lying on a single continuum from particularistic non-enforcers who engage in cooperative fostering of self-regulation to rulebook enforcers whose policy is detached command and control. This approximates the suggestions of Hawkins and Reiss for distinguishing regulatory agencies according to a "sanctioning/deterrence" versus "compliance" dimension. The predominant regulatory style in Australia, however, is distant from both poles, being a perfunctory regulatory approach which is neither distinctively diagnostic and educative nor litigiously "going by the book"; rather it amounts to "going through the motions". The typology also partially conforms to Black's categorisation of social control as penal, therapeutic, conciliatory and compensatory.     

英联邦国家医疗侵权诉讼中因果关系之证明及评价

在因果关系的证明上，英联邦国家司法总体上贯彻了法律与科学有别、司法者与医学专家有别的观念。传统的因果关系证明规则在医疗诉讼中面临挑战和困境。在寻找解决此类困境的方法中．“举证负担转移”方法因其操作生硬、对传统规则的过于颠覆以及可能对医学、医疗诉讼和医疗保险产生不良影响而未能在英联邦司法中获得普遍认可：“风险的实质性增加”方法和“机会丧失”视为损害的方法能否适用于医疗侵权案件尚未得到确定。与前些方法相比，“因果关系的推断”在英联邦司法中获得了较大程度的认可。该方法的优势在于弹性强、对传统规则的偏离较为缓和且充分利用了法庭的事实认定过程。它进一步增加了法院的自由裁量．减弱了对医疗专家意见的依赖。     

信用评级机构的法律定位及其国际监管改革研究

信用评级机构是金融市场日益专业化过程中不可或缺的一员,通过其专业化的评价体系,对解决投资者和证券发行人之间的信息不对称问题发挥了很大的作用。但是,随着评级机构日益深入地参与到金融证券化的过程中,不可避免的利益冲突使其中立性、客观性等在一定程度上有所缺失。次贷危机发生后,对信用评级机构加强监管的呼声日益高涨,各国金融监管机构开始对信用评级机构进行全面的严格的监管,但是,由于评级业本身的自然垄断属性以及评级业务的专业性,使其定位上存在模糊之处。在分析信用评级机构存在的缺陷基础之上,对其法律定位进行探讨,并预测国际监管改革与合作的发展趋势是十分必要的。     

刑法因果关系研究

因果关系问题是刑法理论研究中的一个重要且复杂的问题。长期以来 ,我国刑法因果关系研究一直围绕着“必然性”和“偶然性”、“内因”和“外因”等哲学命题争论不休 ,于司法实践的意义不大。因此 ,如何切换我们的研究视角 ,构建新的研究模式 ,是本文关注的问题之所在。我们通过对英美和欧陆两大法系因果关系理论的介绍和比较 ,认为以英美刑法的“双层次原因”模式为借鉴来建构我国刑法的因果关系理论体系 ,也许是我国刑法因果关系研究走出“必然性”和“偶然性”、“内因”和“外因”等哲学迷障的最优选择     

Causing harm: Criminal law

This paper offers two related things. First, a theory of singular causal statements attributing causal responsibility for a particular harm to a particular agent based on the conjunction of a positive condition (necessitation) and a negative condition (avoidability) which captures the notions of sufficiency and necessity in intuitive ideas about agent causation better than traditional conditio sine qua non based theories. Second, a theory of representation of causal issues in the law. The conceptual framework is that of Game Trees and Games in Extensive Form. Causal conditions are defined set-theoretically over Game Trees; causal issues and fundamental distinctions (dependent versus independent intervening causes, foreseeability or not of harm etc.) arising in legal cases are accommodated by the device of a probability distribution over the game-tree representation of cases.This theory of causing harm, or agent causation is presented in greater detail in L. Aqvist & P Mullock, Causing Harm: a logico-legal study (forthcoming, de Gruyter, Berlin) dealing primarily with causation in tort law.     

The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s

The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.     

Editor's Introduction: Toward a Sociolegai Paradigm of Risk

Increasingly, law and legal institutions must deal with hazards and their attendant risks. This special issue of Law and Policy examines a variety of organizational responses to this challenge. Examples of the behavior of firms and of regulatory agencies suggest the outlines of a sociolegai paradigm of risks and risk-related behavior.     

我国法律援助机构设置中存在的主要问题及对策建议

目前,我国法律援助机构设置中存在的主要问题是法律援助机构性质不统一、职能不统一以及在同一层次上法律援助机构和法律援助管理机构并行.本文针对这些问题提出了解决思路和办法,认为名称应为法律援助机构、政府性质、单一系统模式即可.     

The determinants of health policy, a case study: regulating safety and health at the workplace in Sweden

This article analyzes and criticizes the " technocratic " view of occupational health and safety policies, which sees the values of the personnel in "post-industrial" regulatory agencies as the most important determinant of those policies. It takes an alternate position, which explains occupational health and safety policies as primarily resulting from the different degrees of political power of the two major classes (capital and labor), and from the set of influences exerted on the regulatory agencies by the instruments (e.g., parties, unions, trade organizations) of those classes. It shows how an analysis of the historical evolution of those classes in Sweden and their conflict in both civil and political societies explains Swedish occupational health and safety policies better than a mere analysis of the regulators' views. And it concludes that the occupational health and safety policies in Sweden are not identical to those in the U.S.--as the " technocratic " theorists assume--but rather offer more protection to the workers than U.S. policies do. This situation is a result of labor having more power in Sweden than it has in the U.S. The different class formations and class behavior in the two societies are compared, and the implications of this comparison for occupational health and safety policies are discussed.     

CAUSATION IN EC MERGER CONTROL

"there are ever so many ways that a world might be; and oneof these many ways is the way that this world is" (David Lewis,1986)

This article looks at two areas of merger control under EC Lawwhere the principles of causation are applied and, in our view,misapplied. The article traces the development of the conceptof the "counterfactual" in antitrust law. It then draws on thisanalysis in considering the operation of the "failing firm defense,"and in particular the standard of proof employed by the Commissionwhen analyzing the "counterfactual" in relation to the failingfirm defense. We argue that the Commission employs an excessivelyhigh standard of proof, and that this standard of proof contributesto the drawing of the failing firm defense too narrowly, througha misapplication of the principles of causation. We then proceedto contrast and prefer the approach of the UK Competition Commissionin recent cases. In the final part of the article we considerscenarios where two or more mergers are contemplated in thesame market at the same time, in cases of both parallel andoverlapping mergers. In these complicated scenarios, which requireprospective, multifaceted analysis, we set out in detail how,despite inherent difficulties, a similarly rigorous applicationof the principles of causation produces coherent results.