Current Regulatory System Research Articles

The ExTORTion of dentistry--is litigation and over-regulation best for our patients?

This article examines the current trends within UK dentistry for increased litigation and regulation. The law of tort when applied to dental negligence falls short of attaining justice for patients in a way which is focused on their best interests. It also has the effect of causing demoralisation and encouraging defensive practice. The introduction of a no-fault compensation scheme, such as that found in New Zealand, may be a solution to this issue, but this would come with questions around how it could be funded. The current system of high litigation and regulation, which shows no signs of relenting, seems to be in no-one's best interests. Therefore there is a real need to consider and propose alternatives that may break the continuum of increasing trends.

The shipwreck of the singular.

In 1962, Louis Lasagna was one of the central figures in the creation of our current drug regulation systems. His influence on the practice of modern medicine, through a series of unanticipated consequences of these systems, has been profound. In the 1960s, he was one of the most progressive thinkers in medicine. By the 1980s, he had apparently become one of the most reactionary. This article attempts to delineate the dilemmas he believed he was dealing with, dilemmas that stemmed from a system he had helped create, that produced this apparent change in orientation. The problems with which he grappled are ones that remain unresolved and indeed, have become more acute. The example of how he attempted to remedy what had gone wrong may provide pointers as to how to solve or how not to solve current difficulties.

Problem of China's Nuclear Security Supervision System

In the perspective of public administration study, intends to explore and analyze the problems rooted in China's current nuclear safety regulatory system, which are associated with such respects as inter-ministerial coordination mechanism, legal construction and personnel allotment. The absence of authoritative department overseeing nuclear safety, the omission of The Atomic Energy Act, and the inefficiency of nuclear safety regulatory personnel are important factors restraining China’s progress on the reform of nuclear safety regulatory system.

Current regulatory systems for clinical trials in Japan: Still room for improvement

A main characteristic of the regulatory environment for clinical trials in Japan is that governmental regulations only apply to trials required for the approval of drugs or medical devices. Investi...

Video Marketplace Regulation: A Primer on the History of Television Regulation and Current Legislative Proposals

The television distribution marketplace has been substantially regulated since the advent of broadcast television in the 1940s and 1950s. The Federal Communications Commission and Congress have relied on several justifications for the regulatory protection of the system of local broadcasters envisioned post-World War II, namely, (1) universal service; (2) localism; (3) free television; and (4) competition. These policy goals are at odds with one another and can only be supported simultaneously through far-reaching regulations like compulsory copyright licenses, network nonduplication rules, retransmission consent regulations, and industry concentration prohibitions. We describe the history of these and other regulations. We argue that regulatory repeal would improve distorted television markets and improve consumer welfare. Finally, we describe pending video legislation and explain how various pending bills would affect the current regulatory system.

Do UK television alcohol advertisements abide by the code of broadcast advertising rules regarding the portrayal of alcohol?

The aim of the study was to assess the extent to which members of the UK general public perceive television alcohol advertisements to comply with the regulatory code governing these: the Advertising Standards Authority Code of Broadcast Advertising (BCAP Code). The Code provides a general principle and 16 rules to prevent such adverts implying, condoning or encouraging immoderate, irresponsible or anti-social drinking. Quota sample of 373 adults, representative of the UK population aged 18-74 years in terms of age and gender, were recruited at a train station. Participants were shown one of seven advertisements that had been broadcast in the previous month on the two leading commercial television channels, and then completed a questionnaire with 40 statements representing the BCAP Code rules. Overall, 75% of the participants rated the advertisements as breaching at least one rule from the BCAP Code. Breaches were observed for all the seven advertisements, ranging from 49 to 91% non-compliant. Rules regarding alcohol being presented as contributing to popularity or confidence, and implying that alcohol is capable of changing mood, physical condition, behaviour, or as nourishment, were seen as being breached by over 50% of participants. A clear majority of the UK general public perceive alcohol advertisements to breach the BCAP Code, suggesting that the current regulatory system for UK television alcohol advertisements is inadequate.

Regulation of alcohol advertising: Policy options for Australia

This article reviews the regulation of alcohol advertising (and its effectiveness) in Australia and three comparison countries - and finds some disappointing regulatory failures. Abstract A systematic search of academic databases was conducted to identify all refereed papers published between 1990 and 2012 on the regulation of alcohol advertising in Australia and three comparison countries (New Zealand, Canada and the UK). This paper reviews the codes that apply to alcohol advertising in each of the four countries, research into the effectiveness of these codes, and the small body of research into consumer attitudes towards alcohol advertising regulation. This review adduces considerable evidence that alcohol advertising influences drinking behaviours, and that current regulatory systems based on co-regulation and voluntary regulation (as is the case in Australia) are ineffective. Recommendations are provided regarding the three pillars of regulation: volume restrictions, content restrictions, and infrastructure to support the regulatory environment.

Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection.

Ecclesiastical Colony: China’s Catholic Church and the French Religious Protectorate by Ernest P. Young (review)

Overseas Chinese Christians, whether imbued with zealous evangelical passion or not, may bring in new religious ideas or introduce various resources that can change local Chinese Christianity through everyday interactions, informal contacts, or mutual engagement in other forms. Although this is sensitive in the current religious regulation system, ethnographers have reported that this kind of interaction between the overseas and the native in Chinese Christianity has proceeded significantly, maybe by using different tactful strategies to circumvent the political supervision. In sum, this carefully executed case study provides several well-stated interesting findings, which should not be missed by those who are interested in Overseas Chinese, Christianity in China, and economic behaviors related to religious values. KE-HSIEN HUANG Max Planck Institute for the Study of Religious and Ethnic Diversity, Göttingen ERNEST P. YOUNG, Ecclesiastical Colony: China’s Catholic Church and the French Religious Protectorate. New York: Oxford University Press, 2013. xii, 383 pp. US$74 (hb). ISBN 978-0-19-992462 This excellent monograph is no cure for the summer time blues; in fact, the more the central theme of the work is developed over the eleven chapters, the more depressed this reader felt. The growth of the Catholic Church in China from the nineteenth century until the ultimate demise of foreign control in the 1940s is shown to have been the product of scandalous behavior on behalf of the predominantly French religious and bureaucratic institutions that relied so heavily on the French Religious Protectorate. Furthermore, Professor Young works his way carefully through a thicket of bilingual treaties to show that both the foundation and the maintenance of this protectorate occurred through dubious legal means. I write more on the deliberate obfuscations of the French parties below. For now, I must also state that for all the heaviness of the work—one filled with rigorously documented tales of sexual malfeasance by priests, political intrigue, property theft, and blatant racism—there are also some rays of hope. Young’s work argues that even in the midst of an oppressive colonizing regime, the members of the Chinese Catholic Church were able to exercise their own agency and eventually take significant control of their destiny. Along the way we meet famous Chinese Catholics like Ma Xiangbo 馬相伯 and Ying Lianzhi 英斂之, foreign supporters like Vincent Lebbe and Anthony Cotta, and Vatican diplomats like Celso Costantini and Mario Zanin. The aptly named Ecclesiastical Colony is also marked by extensive use of Chinese voices to flesh out the narrative. Even this feature is notable as the privileging of local actors is not routine in works about Christian history in what were once mission lands (although the more recent secondary sources Young cites by authors like Robert Tiedemann, Henrietta Harrison, and Daniel Bays, among others, do strive hard to achieve this). The development of an inculturated church was a painful, uncertain process. Furthermore, even when Chinese Catholics had finally seen off the worst of the Protectorate’s influence, they were then faced with the militantly atheist 254 BOOK REVIEWS Communist Party. Yet, even so, the church communities have survived even this challenge. Young’s work shows how these communities weathered the troubles of the Protectorate and the terrors of their subsequent persecutions. While this work does not deal with the post-1949 period, Young’s persuasive argument illustrates how the Chinese Catholic Church was able to endure the vicissitudes of its existence. This book is thus essential reading for all who wish to understand the history, presence, and vitality of Chinese Catholicism today. So what then was the French Protectorate, and why did it matter? Young quotes the words of a French diplomat, Monsieur G. Cogordon writing to a superior in 1886, after a series of treaties between 1842 and 1865: ‘‘Thanks to this ingenious scheme that gives the appearance of Chinese ownership to lands bought by the missionaries, the latter could make themselves purchasers of real estate without any difficulty’’ (p. 32). The protectorate essentially revolved around defending two supposed rights. First, missionaries travelling under a French passport could journey wherever they wished in China. Second, they could not only buy new properties but also lay claim to church buildings that had been owned in earlier...

Prevalence of transcription factors in ascomycete and basidiomycete fungi

BackgroundGene regulation underlies fungal physiology and therefore is a major factor in fungal biodiversity. Analysis of genome sequences has revealed a large number of putative transcription factors in most fungal genomes. The presence of fungal orthologs for individual regulators has been analysed and appears to be highly variable with some regulators widely conserved and others showing narrow distribution. Although genome-scale transcription factor surveys have been performed before, no global study into the prevalence of specific regulators across the fungal kingdom has been presented.ResultsIn this study we have analysed the number of members for 37 regulator classes in 77 ascomycete and 31 basidiomycete fungal genomes and revealed significant differences between ascomycetes and basidiomycetes. In addition, we determined the presence of 64 regulators characterised in ascomycetes across these 108 genomes. This demonstrated that overall the highest presence of orthologs is in the filamentous ascomycetes. A significant number of regulators lacked orthologs in the ascomycete yeasts and the basidiomycetes. Conversely, of seven basidiomycete regulators included in the study, only one had orthologs in ascomycetes.ConclusionsThis study demonstrates a significant difference in the regulatory repertoire of ascomycete and basidiomycete fungi, at the level of both regulator class and individual regulator. This suggests that the current regulatory systems of these fungi have been mainly developed after the two phyla diverged. Most regulators detected in both phyla are involved in central functions of fungal physiology and therefore were likely already present in the ancestor of the two phyla.

Primary hip replacement prostheses and their evidence base: systematic review of literature

Objective To determine the extent to which prostheses with no readily available evidence to support their use are being implanted in primary total hip arthroplasty.Design Systematic review of the literature.Data...

Managing Pension Funds in Zimbabwe: Ethical Issues and Challenges

This article is motivated by the predicament that hit pensioners in Zimbabwe following the introduction of the multi-currency system. Zimbabwe experienced economic woes which rendered the Zimbabwean dollar worthless and consequently necessitating a switch to stable currencies. The pension assets and liabilities were invested in the local currency before the currency reform, and the result of the multi-currency system was a mismatch of the assets and liabilities of the pension funds financial position which led to paltry pension benefits. The nature of pension funds places a great responsibility on the stakeholders who are involved in running these schemes and therefore ensuring that reasonable expectation by beneficiaries is met. The article focuses on the core aspects surrounding the structure and managing of pension funds in Zimbabwe. The researcher investigated the roles of important stakeholders in the Zimbabwean pension industry, namely, government, trustees, investment managers, and actuaries. The article further delves into the ethical issues and challenges faced by those managing Zimbabwean pension funds. The researcher conducted a total of 30 personal interviews to collect primary data from professionals in the Zimbabwean pension industry which were split as follows: 10 trustees, 10 investment managers, and 10 actuarial consultants. Secondary data were also used in this study and it comprised of journals, newspaper articles, investment reports, and textbooks. The researcher recommends that pension funds develop sound corporate governance mechanisms that will encourage the best ethical practices among all of their stakeholders. The findings provide evidence for a need to empower pension fund trustees through training and introduction of a pension protection scheme. In addition, the current regulatory system needs to be reviewed to capture the changing economic environment upon which pensions funds operate.

Governance Strategies for Living Technologies: Bridging the Gap between Stimulating and Regulating Technoscience

The life sciences present a politically and ethically sensitive area of technology development. NBIC convergence-the convergence of nanotechnology, biotechnology, and information and cognitive technology-presents an increased interaction between the biological and physical sciences. As a result the bio-debate is no longer dominated by biotechnology, but driven by NBIC convergence. NBIC convergence enables two bioengineering megatrends: "biology becoming technology" and "technology becoming biology." The notion of living technologies captures the latter megatrend. Accordingly, living technology presents a politically and ethically sensitive area. This implies that governments sooner or later are faced with the challenge of both promoting and regulating the development of living technology. This article describes four current political models to deal with innovation promotion and risk regulation. Based on two specific developments in the field of living technologies-(psycho)physiological computing and synthetic biology-we reflect on appropriate governance strategies for living technologies. We conclude that recent pleas for anticipatory and deliberative governance tend to neglect the need for anticipatory regulation as a key factor in guiding the development of the life sciences from a societal perspective. In particular, when it is expected that a certain living technology will radically challenge current regulatory systems, one should opt for just such a more active biopolitical approach.

Our Toxics Regulatory System and Why Risk Assessment Does Not Work: Endocrine Disrupting Chemicals as a Case in Point

Our current toxics regulatory system is based on the fundamental premise that the public expects a high degree of safety -- close to absolute safety -- in the regulation of toxins in our environment. To implement a system based on this fundamental assumption, we assume further that we can use risk assessment to develop health-based safety standards and use command and control regulation to implement them. This Article suggests that the fundamental premise that we can and should develop and apply standards that ensure safety to human health in our toxics regulatory schemes5 has little basis in current political and scientific reality. Politically, human safety is not the true goal of toxics regulation, and scientifically, human safety is not an achievable goal. Rather, politicians obfuscate the true regulatory goal-to regulate toxins so that they present acceptable risk-by using terminology and standards that imply safety. Even if safety were the true goal of toxics regulation, the creation of safety-based standards to regulate toxins is not a particularly practical goal. This Article asserts that, at least as to chemicals that disrupt the human endocrine system-chemicals that have the potential for grave harm to humans-it is not currently feasible to determine exposure levels in the complex and interrelated world in which we live. Second, even if we could determine such levels, we would still face the enormously difficult task of ensuring compliance with these predetermined safe exposure levels. This article specifically highlights the inherent problems with quantitative risk assessment in toxics regulation, as it has been applied to toxic chemicals in general and will likely be applied to endocrine disrupting chemicals. The article ultimately suggests that political and societal honesty is needed in the future regulation of toxic chemicals. Our normative position must be to admit publicly that toxies regulation is not designed to ensure safety to human health, but to regulate toxins so that they present a level of risk that is acceptable to the public. Rather, our goal has been to regulate and manage the risk of toxins so that they present politically acceptable risk. If this regulatory goal were more transparent, the public could realistically assess the current regulatory paradigm, and consider alternatives. I thus suggest a fundamental shift in the philosophy of toxics regulation. Our society must have an open discussion about the dangers of synthetic chemicals and must move toward reducing our overall use and discharge of these chemicals-particularly those suspected of disrupting our endocrine systems. This shift in thinking would force chemical manufacturers to initiate voluntary screening of existing and new chemicals before they are produced and marketed for use and to reduce the overall discharge of chemicals suspected of endocrine disruption. Barring such voluntary action by the chemical industry, the government must make screening for endocrine effects mandatory for new chemicals and must require manufacturers to begin screening existing chemicals for endocrine effects.

Discretionary compliance with mandatory environmental disclosures: Evidence from SEC filings

We examine the determinants of adherence to U.S. Securities and Exchange Commission (SEC) mandated disclosures of environmental sanctions. Our sample includes non-superfund U.S. Environmental Protection Agency (EPA) sanctions between 1996 and 2005. Our results suggest that firms are more likely to provide sanction disclosures if they operate in environmentally sensitive industries, are subject to larger penalties and are voluntarily participating in a supplemental environmental project. Our results also suggest that firms are less likely to disclose sanctions involving judicial proceedings. Overall, we find that voluntary disclosure incentives impact compliance with mandatory reporting requirements. Although incentives exist for firms to comply with mandatory disclosures, our results suggest that increases in mandatory environmental accounting disclosures may not be effective under the current regulatory system despite the use of bright-line materiality thresholds. Our study contributes to the current and ongoing debate about the role and effectiveness of environmental risk disclosure mandates in providing information to the marketplace, as well as “mandated disclosure” rules in general. The value attributed to current and potential environmental disclosure regulations cannot be thoroughly understood without examining disclosure compliance with existing regulations. From an environmental and sustainability disclosure perspective, our findings are particularly germane since these disclosures focus on risks, liabilities, or other reputational shortcomings of the firm.

Decentralizing Environmental Administration: A Common Law Approach

This paper intends to explore whether government regulation hinders rather than serves the goals of environmentalism by inhibiting possible free market mechanisms. The primary focus will be upon the tort aspects of environmental law, and whether these might be expanded to allow for litigation to serve as both the arbiter and the primary deterrent mechanism for environmental torts. In order to accomplish such a system, the viability of two current facets of environmental regulation will be examined.First, the imposition of environmental standards by centralized federal agencies will be examined to the extent that they limit efficiency and local responsiveness. The intention is to explore whether allowing state courts and local governments to administer environmental law will have the effect of opening up litigation and producing more reactive local results. Second, the institution of limiting standing to government actors, especially with regard to the Lujan decision will be examined as a mechanism that provides polluters a potential escape where government resources fail. Further, creating a generalized property right in environmental interests will be presented as a solution to the standing question. The aim is to determine the effect of centralized administration in preventing pollution control as well as presenting decentralization as a more effective and efficient means of pursuing this goal. Finally, the paper will present four suggestions for addressing some of the faults of the current regulatory system: empowering state courts to litigate environmental disputes to replace the federal regulatory system; loosening restrictions of standing; imposing a private damages regime; and applying strict liability to environmental claims.The paper will draw from United States jurisprudence on environmental law as well as drawing heavily from scholarly writing on environmental law and the economics of environmentalism.

Corporate Dystopia: The Ethics of Corporate Political Spending

This paper is concerned with the moral permissibility of corporate political activities under the existing legal framework in the United States. I unpack and examine the standard case for and against the involvement of business in lobbying and electoral activities. And I provide six objections against the standard arguments and propose that the wrongness of corporate political activities does not have much to do with its potential social consequences but rather with non-consequentialist considerations. My ultimate aim is to make sense of the intuition that corporate political spending is morally objectionable. I argue that my case against corporate political spending fares better than the standard case. What is wrong with the current system of regulation of corporate lobbying and campaign finance is that it is inconsistent with the principles of political equality and consent. It follows that by taking advantage of this unfair regulatory framework, business firms are making a contribution to undermine the basis of a robust democratic regime at both the societal and the corporate level.

Corporate Dystopia

This article is concerned with the moral permissibility of corporate political activities under the existing legal framework in the United States. The author unpacks and examines the standard case for and against the involvement of business in lobbying and electoral activities. And the author provides six objections against the standard arguments and proposes that the wrongness of corporate political activities does not have much to do with its potential social consequences but rather with nonconsequentialist considerations. The author’s ultimate aim is to make sense of the intuition that corporate political spending is morally objectionable. The author argues that his case against corporate political spending fares better than the standard case. What is wrong with the current system of regulation of corporate lobbying and campaign finance is that it is inconsistent with the principles of political equality and consent. By taking advantage of this unfair regulatory framework, business firms are making a contribution to undermine the basis of a robust democratic regime at both the societal and the corporate level.

The Unbelievable Rightness of Being in Clinical Trials

AbstractMuch of what Ruth Faden and colleagues say squarely meshes with the ideas of the U.S. Department of Health and Human Services about reforming the system for protecting research subjects. Having said that, I want to turn to a very different part of the research universe, the elephant in the room, as it were: the world of interventional randomized clinical trials. Under the current regulatory system, these research subjects receive substantial protections. Most importantly, they are generally enrolled only after they give their informed consent. The rationale for this approach is that research subjects are denied the core ethical protection provided to patients: there is no requirement that everything done to them be in their best interests. Faden and colleagues appear to be proposing to eliminate this informed consent requirement for a significant range of such trials.

Pre‐market approval and post‐market direct‐to‐consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices

While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence.