As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules (...) of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards. (shrink)

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 The book contains a range of published and unpublished essays and speeches with the addition of notes and commentaries by the author that bring the pieces up to the present day.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

Biobanks are proliferating rapidly worldwide because they are powerful tools and organisational structures for undertaking medical research. By linking samples to data on the health of individuals, it is anticipated that biobanks will be used to explore the relationship between genes, environment and lifestyle for many diseases, as well as the potential of individually-tailored drug treatments based on genetic predisposition. However, they also raise considerable challenges for existing legal frameworks and research governance structures. This book critically examines the current governance (...) structures in place for biobanks in England and Wales. It shows that the technologies, techniques and practices involved in biobanking do not always conform neatly to existing legal principles and frameworks that apply to other areas of medical research. Using a socio-legal approach, including interview data gathered from the scientific community, this book provides unique insights and makes recommendations about appropriate governance mechanisms for biobanking in the future. It also explores the issues around the secondary use of information, such as consent and how to protect privacy, when biobanks are accessed by a number of different third parties. These issues have relevance both within England and Wales and to a wide international audience, as well as for other areas where large datasets are used.--Back cover. (shrink)

Why is the American policy debate not focused more intensely on the relative merits or demerits of our current approach to drugs and of possible alternatives to it? The lack of discussion of this issue is rather striking, given that America has the most serious drug problem in the world, that alternatives to a prohibitionist approach are under serious consideration in other countries, and that the grounds for reconsidering our current approach are, I shall argue, so weighty. -/- One (...) consideration that tells against our present approach to drugs is that prohibition simply does not work. For we have, after all, been pursuing this approach in the case of heroin since the Harrison Narcotic Act of 1914, and what has been the outcome? We have the worst heroin problem in the world. Moreover, our brief experiment in banning the consumption of what is undoubtedly our most harmful drug, alcohol, during Prohibition, turned out to be an utter failure. -/- A second consideration, often noted is the striking difference in our treatment of drugs such as alcohol and nicotine, on the one hand, and drugs such as marijuana, heroin, and LSD, on the other. This difference is so familiar that it may no longer seem strange. If so, it is worth asking the following question. If you were on a desert island, with a plentiful supply of both tobacco plants and opium poppies, and you knew that your son or daughter was going to wind up addicted either to nicotine or to heroin, which would you prefer? If your choice is nicotine you have chosen a drug that, according to the testimony of most heroin addicts, is the more addictive of the two drugs. In addition, given access to heroin that has not been combined with dangerous chemicals, your son or daughter could be a lifelong addict without suffering serious organ damage. But a lifelong addiction to tobacco is often, of course, a very different story. -/- In this article, then, I consider in detail perhaps the two most important reasons for reconsidering our current drug policy: first, the difficulty of providing any adequate justification for the restrictions that prohibitive laws place on people's liberty, and secondly, the enormous social and personal cost associated with a prohibitionist approach. (shrink)

The proposed article provides an overview of European and North American states’ legislation, which regulates the procedure for pre-clinical research, clinical trials and state registration of medicinal products, as well as responsibility for its violation, analysis of the problems and prospects of adaptation of the national legislation to European legal space, particularly in the field of criminal and legal regulation of relations in the sphere of pre-clinical trials, clinical trials and state registration of medicine. The emphasis is put on the (...) matter that inclusion of Article 321-2 into the Criminal Code of Ukraine leads to a false concurrence with other provisions of the Code. The author proposes to introduce recent EU legislation (Acquis Communautaire) on legal regulation of clinical trials and circulation of medicine into the law of Ukraine, clarify terminology related to Fundamentals of Ukrainian Legislation on Health Protection and the Special Part of criminal law, introduce criminal liability for legal entities that will provide effective control over negative effects of research centers’ activity. It is suggested to develop legislative proposals to improve the provisions of the Criminal Code of Ukraine, which provide legal protection of relations arising in connection with pre-clinical research, clinical trials and state registration of medicinal products. (shrink)

This volume provides a comprehensive analysis of the history, development and other legal aspects relating to International Medical Law and covers issues arising from not only the physician-patient relationship, but also with many wider juridical relations involved in the broader field of medical care in the international arena.00After a general introduction, the book examines the evolution of medical law in different civilizations that existed all over the world. It systematically describes the sources of this law from conventions, treaties along with (...) discussing the important role played by the courts, international institutions and other bodies related to the medical field. The comprehensive coverage includes public health law, international spread and prevention of diseases. This volume covers medical ethics and clinical ethics; considerations to facets of the medical professionals and patients relationship such as rights and responsibilities of the physicians, beneficence, consent, privacy, rights of patients and risk management. Also covered are issues of international concern like medical criminal activities, human and drug trafficking, trade in human organs, human medical research, as well as matters dealing with bio-technology in relation to bio-safety, bio-security, bio-genetics, bio-ethics, and the role of medical personnel in armed conflicts. (shrink)

ABSTRACTThis article investigates a virtue-centered approach to normative legal theory in the context of legislation. The core idea of such a theory is that the fundamental aim of law should be the promotion of human flourishing, where a flourishing human life is understood as a life of rational and social activities that express the human excellences. Law can promote flourishing in several ways. Because peace and prosperity are conducive to human flourishing, legislation should aim at the establishment and maintenance of (...) these conditions. The human excellences are developed in childhood and young adulthood by stable and nurturing families and by educational institutions: therefore, the law should support and foster families and schools. Although some critics have argued that an aretaic theory of legislation must support so-called “vice laws,” this is not the case. A virtue-centered approach must take into account the effects produced by criminalization of alcohol, drugs, gambling, and prosti... (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)

Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other (...) states various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. (shrink)

This paper surveys the conceptions of law and of legislation to be found in the philosophy of Julian the Emperor. A hierarchy of levels of law is described, going from transcendent divine orders and paradigmatic laws down to the laws of nature, laws innate in human souls and regional laws. Julian’s ideal legislator is discussed, as inspired by transcendent, paradigmatic laws and as subordinate to law and its protector. An example of Julian’s legislation is discussed. Attention is paid to Julian’s (...) use of Plato’s Republic, Statesman, and Laws. (shrink)

Brand-name prescription drug manufacturers use various strategies to extend their market exclusivity periods by delaying generic or biosimilar competition. Recent Congressional legislation has targeted four such tactics. We analyze these proposals and assess their likely effect on competition in the U.S. drug market.

We are unlikely to stop seeking pleasure, as this would prejudice our health and well-being. Yet many psychoactive substances providing pleasure are outlawed as illicit recreational drugs, despite the fact that only some of them are addictive to some people. Efforts to redress their prohibition, or to reform legislation so that penalties are proportionate to harm have largely failed. Yet, if choices over seeking pleasure are ethical insofar as they avoid harm to oneself or others, public health strategies should (...) foster ethical choice by moving beyond current risk management practices embodied in the harm reduction movement. The neuroscience of pleasure has much to offer neuroethics and public health strategies. Distinguishing between ‘wanting’ and ‘liking’ fosters new understandings of addiction. These hold promise for directing the search for pharmacotherapies which prevent addiction and relapse or disrupt associated neuromechanisms. They could inform new research into creating lawful psychoactive substances which give us pleasure without provoking addiction. As the health and well being of human and other animals rests upon the experience of pleasure, this would be an ethical objective within public health strategy. Were ethical and neurobiological obstacles to ending addiction to be overcome, problems associated with excessive consumption, the lure of unlawful psychoactive substances and the paucity of lawful means to achieve pleasurable altered states would remain. Non-addictive designer drugs, which reliably provided lawful access to pleasures and altered states, would ameliorate these public health concerns insofar as they fostered citizens’ informed, ethical choices according to a neurobiological taxonomy of pleasures. (shrink)

The high price of drugs is receiving due consideration from ethicists, policymakers, and legislators. However, much of this attention has focused on the difference between the cost of drug development and company profits and the possible laws and regulations that could limit a drug’s price once it reaches market. By contrast, little attention has been paid to the ethical implications of high drug prices for the research subjects whose bodies were essential to the drug’s development. Indeed, the future price (...) of a drug is routinely ignored and treated as unknowable during the ethical evaluation of the clinical trials that support its development. In this paper, I will argue that ignoring the future price of a drug during the research process is in tension with all three of the major principles of research ethics: it fails to show respect for the research participants, undermines the quality of risk/benefit judgements made by ethical review committees, and makes it impossible to judge future patient access and assess justice. (shrink)

Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively.

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies (...) into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. (shrink)

Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug (...) and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and to (...) pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and to (...) pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

The experience of the twentieth century bears witness to the abuse, mutilation and homicide of the vulnerable made possible by the power of the state, mass markets, and medical and financial interests. Suggestions for reform of the law regarding food and fluids typically take place in the context of utilitarian personistic “quality-of-life” presuppositions, and interests in shifting legal responsibility for life-and-death decisions, medical research, drug trials, organ harvesting as well as more mundane bureaucratic concerns like bed-clearing. With the Western world (...) undergoing massive demographic change and a growing ageing and non-productive population, it cannot be assumed that these alterations to the positive law are problem-free. By allowing new agents power to require that food and fluids be withdrawn, non-therapeutic research and other procedures (like abortion and sterilisation) be performed on non-consenting patients, novel legislation such as that discussed cannot be regarded as autonomy enhancing so much as a threat to human rights. These laws although touted as progressive, more often than not invite routine abuse and destruction of the vulnerable, obscure accountability and create an inconsistent body of law, with conflicting obligations for health professionals. (shrink)

This paper describes the different dimensions of the relation between moral reflection and legislative processes. It discusses some examples of the institutionalisation of moral reflection. It is argued that the relation between ethics and law is still an actual and relevant question. Ethics also has to reflect on its own role in political life. The paper defends the relevance of a theological perspective on the relation between law and ethics. In the last part it is argued that the modality of (...) relation between ethics and law depends on the specific character of social domain. (shrink)

In few other areas of bioethical inquiry exists as close a connection between bioethical professional advice and policy development as is the case with HIV and AIDS. Historically, the reasons for this have much to do with one of the groups initially affected most severely by HIV and AIDS, namely well-educated middle-class gay men in developed countries. This particular group of people, highly sophisticated and used to political activism in its pursuit of civil rights-related objectives, engaged the medical profession as (...) well as regulatory agencies such as the US Food and Drug Administration, and legislators (more so in the USA than in other countries) in a number of bioethically interesting policy areas. Many of the controversies of the times were framed as civil rights and/or ethical disputes. The initial areas of concern and inquiry focused on: informed consent to HIV testing and trial participation, the confidentiality of HIV test results, access to trials as a means of access to experimental drugs, the length of time it took to get an experimental drug to the market approval stage, and end-of-life decision-making. This line-up of issues explains why AIDS has become such an interesting topic for bioethicists. Bioethicists concerned about the traditional breadand- butter themes of medical ethics themes of the doctor - patient relationship (e.g., Daniels, 1991; Boyd, 1992), as well as bioethicists more concerned about policy and regulatory issues in the drug research and approval process (e.g., Edgar & Rothman, 1990; Salisbury & Schechter, 1990), found research topics worthy of vigorous pursuit. No surprise, then, that HIV/AIDS led to a probably unprecedented number of books and articles in professional journals (Manuel et al., 1990). HIV/AIDS has become a permanent fixture in all major mainstream bioethics textbooks (e.g., Kuhse & Singer, 1998; Arras & Steinbock, 1999). Reference series in medicine, ethics and law provide for dedicated volumes on AIDS.1 Even specialist bioethics textbooks, for instance those directed at dentistry students, carry chapters on HIV/AIDS (Ozar & Sokol, 2002). 128 Udo Schuklenk AIDS, designated by the medical profession a pandemic lives up to its classification. It did not stop at the borders of developed countries. As one would expect of a primarily sexually transmitted illness in the age of globalisation, it spread rapidly across the globe. Indeed, in many countries it has become one of the main causes of death, as in sub- Saharan Africa (Shisana & Simbayi, 2002). Dramatic increases in the number of AIDS cases are predicted for many Eastern European countries as well as for the two most populous nations on earth, India and China. Some of the HIV/AIDS-related bioethical and policy issues of concern to developed countries remain the same for developing countries. However, in ethically important ways they are dwarfed by concerns over drug prices, intellectual property rights, and affordable access to essential AIDS drugs for the impoverished masses of infected people in such countries. Of increasing importance have become ethical issues pertaining to the ever-growing research industry associated with clinical trials undertaken in developing countries. Indeed, major funding initiatives both in the USA and UK have brought clinical research in developing countries into focus. Some have questioned whether this attention is appropriate, considering other bioethical problems of arguably greater importance to developing countries (Chadwick & Schuklenk, 2003). Standards of clinical care in a study, and after a trial has concluded, as well as community benefits and access to the trial regime after the trial’s conclusion remain contentious issues. It is worth noting that more often than not it was an AIDS-related trial or policy decision that led to a great deal of bioethical analysis, yet the issues discussed almost always have ramifications far beyond AIDS. For instance, decisions about the question of what (if any) standards of care failures in preventive trials (of HIV vaccines or microbicides) ought to receive have important implications for non-AIDS prevention trials. (shrink)

These essays, first presented at a conference, “Coping with Sickness,” held in Italy in 1997, address ethical and regulatory medical issues within a historical context. Many of the essays, while addressing interesting topics, combine policy analysis and critical cultural theory. Critical cultural theory can be intellectually engaging at times but is generally irrelevant to public officials concerned with specific policy issues.Coping with Sickness is the third and final volume derived from a series of conferences cosponsored by the European Science Foundation (...) and the Euroconferences Activity of the European Union. The eight essays are organized chronologically and cover a range of disparate topics: medical practitioners and the Spanish Inquisition , the history of autopsy legislation in German since 1800 , the history of “sadism” as a medical term in the nineteenth century , folk medicine in Holland in the late nineteenth century , abortion in Weimar Germany , drug testing in Africa in the early twentieth century , comparative policies toward STDs , and the debate over brain death in Germany . As might be expected in an anthology of this sort, the quality varies considerably. Nonetheless, the subjects addressed in this volume are engaging—much to the credit of the editors.Two pieces in particular represent the range of these collected essays. In “Vacher the Ripper and the Construction of the Nineteenth‐Century Sadist,” Angus McLaren, one of the best historians writing on the history of sexuality today, explores the “discovery” of sadism in the late nineteenth century by focusing on the dramatic trial of Joseph Vacher, who was charged in 1895 for the brutal sexual murder of a woman in Champuis. He later confessed to the murder and the sexual violation of another seven females and four males. Vacher had a long history of mental illness; indeed, he had been institutionalized in July 1893 following a failed attempt at suicide that left a bullet lodged in his head. At the trial the criminologist Alexandre Lacassagne was brought in as an expert witness to testify that Vacher was not insane but an antisocial sadist, as revealed by his dabbling in anarchism, vagabondism, and homosexuality. As a consequence, Vacher was found guilty and given a death sentence.McLaren finds in this trial an example of the social construction of a new medical concept, “sadism.” The emergence of the concept of sadism, he argues, reflected a “gendered notion” of defining appropriate male and female behavior; physicians at the turn of the century believed that “civilized men were most threatened, not by excess passion, but by the enervation spawned by urban life” . The concept of sadism was also employed by doctors to enhance their own authority and to alert the public to the dangers of a male manifesting “feminine traits” and to “beat back” homosexuality.There is much interesting conjecture to McLaren's study, but what policy lessons should be drawn from this remains unclear. If every concept is actually a social construction, reflecting the social anxieties of the age, then is the fashionable concept of social construction itself socially constructed to enhance the authority of the medical historian?More interesting methodologically is Claudia Wiesemann's absorbing essay on the historical debate in Germany over “brain death.” Relying on Ulrich Beck's social theory of simple and reflexive modernization, she shows that, when confronted with complex scientific questions, the public has to decide between competing plausible scientific claims; as a result, political groups make use of scientific expertise and counterexpertise to push their favorite practical and legal solutions. (shrink)

Legislation for dementia care needs to be continually rethought, if the rights of older persons and other persons with dementia are to be addressed properly. We propose a theoretical framework for understanding vulnerability and dependency, which enables us to problematize the currently prevailing legal conception of adults as always able — irrespective of health or age — to act autonomously in their everyday lives. Such an approach gives rise to difficult dilemmas when persons with dementia are forced to make decisions (...) on their own about basic living conditions, such as housing and care, without decision-making support. In Sweden, for example, such matters are frequently left to the person him- or herself to decide, often without any assistance from social workers, and with family members serving as caregivers of last resort.Using vulnerability theory as the framework for our discussion, we argue that policymakers should not apply a group-oriented approach (based on factors like age, legal status, or mental capacity) to persons suffering from dementia. The needs of such individuals are as complex and varied as they themselves are. We discuss our findings from an interdisciplinary (law/social work) research project in which we examine the dilemma that social workers face when they are required, under the terms of the Swedish Social Services Act, to determine whether persons with dementia are to be granted support.We argue further that a cross-disciplinary approach — in which vulnerability theory furnishes the framework — opens up for new ways of understanding and developing social welfare law and practice. This, we believe, can help us better address the rights, interests, and needs of people with dementia, of their families, and of professionals in the social welfare system. Finally, many of the problems faced by ageing societies in general can be understood on the basis of such an approach. (shrink)

In this paper, I present and criticize several historical arguments in favour of prohibition and criminalization of illicit psychoactive substances. I consider several versions of Charles Brent’s argument from drug harms and an argument from addiction based on Kantian view on autonomy. My criticism will mainly rely on empirical evidence on drugs, drug use, and addiction. I think that in light of this evidence, all of the arguments lose their cogency or can be refuted altogether. Moreover, the evidence reveals (...) an inconsistency in the international drug law framework. In conclusion, I therefore provide a general argument challenging the legitimacy of the existing distinction between licit and illicit drugs based on the inconsistency. (shrink)

Law, often neglected in treatments of the Republic, is essential to the philosopher-kings’ rule. Only law accomplishes the partial divinization of citizens at which philosophical politics aims. Socrates’ interrogation of Thrasymachus and Glaucon reveals law to be a command whereby citizens participate in philosophical knowledge and limit the pleonexia congenital to humanity. Law does so primarily by instilling in souls a true opinion resistant to pleonectic passion, producing a state of political virtue. This primary work is supported by the musical (...) and poetical education, itself shaped by law for the sake of law. Law persuades and compels the soul by appealing to both reason and spiritedness, enabling them to overcome the appetites. The soul’s consequent acceptance of truth and resistance to the passions indeed makes it resemble divinity. In so transforming the citizens through the law, the philosopher-king also unifies the city and makes it happy under his rule. (shrink)

The year 2014 brought a new development in the bioethics “laboratory of the states.” Five states adopted “right to try” laws intended to promote terminally ill patients' access to investigational drugs. Many more state legislatures are now considering such laws. The campaign for right to try laws is the latest move in an ongoing effort to give seriously ill patients access to drugs whose safety and effectiveness remain largely unknown. Although scientists and policy‐makers oppose the right to try (...) approach, it has proven quite popular among state legislators and the public. (shrink)

A critical survey of arguments for and against the morality and the legality of recreational drug use, deploying Feinberg's analysis of liberty-limiting principles.

Author Jeremy Waldron has thoroughly revised thirteen of his most recent essays in order to offer a comprehensive critique of the idea of the judicial review of legislation. He argues that a belief in rights is not the same as a commitment to a Bill of Rights. This book presents legislation by a representative assembly as a form of law making which is especially apt for a society whose members disagree with one another about fundamental issues of principle.

As Alexander D’Entrees observed over forty years ago, the case for natural law “is not an easy one to put clearly and convincingly.” Furthermore, even if one can make the case for natural law in a clear and convincing manner, one should not expect such an argument to be clear and convincing for all time. Instead, the case for natural law must be an ongoing argument, addressing itself perpetually to the needs of the time as these needs shift and change. (...) In short, the case for natural law “must needs appear in a different light according to the angle in time or in place from which it is looked at.” With this precept in mind, I seek to examine Thomas Aquinas’s natural law teaching on the legislation of virtue in light of concerns that are especially acute from the perspective of contemporary liberalism. (shrink)

This study uses a Corpus Assisted Discourse Studies methodology to provide the first systematic analysis of how trust is discursively constructed in crypto-drug markets. The data come from two purpose-built corpora. One comprises all the forum messages posted on the flag ship crypto-drug market Silk Road during the years in which it traded on the hidden net. The other corpus comprises all the reports published by the United Nations Office on Drugs and Crime during the same period. Our analysis (...) of trust focuses on the identities of those buying and selling drugs. The findings reveal that the Silk Road community members regularly discussed vendors’ identities alongside a continuum of trust–risk calculation, explicitly identifying both ‘good’ and ‘bad’ practices and hence engaging in self-regulatory discourses, and mainly constructed drug users’ identities in relation to values of expertise, integrity and benevolence. The findings also suggest that hard law enforcement activity, such as crypto-drug market closure, may encourage technological innovation within these markets. Moreover, our results show a disconnect between the discursive reality of the policy-making documents we examined and the very crypto-drug markets that they seek to legislate. (shrink)

Background -- Overview of legal sources -- Summary of recent prosecutions and investigations -- Applications of law and professional and trade association standards to physician relationships with industry -- Legal and ethical aspects of specific physician's industry financial relationships -- Approaching and adopting effective compliance plans.

Chasing Medical Miracles" is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.1 (2001) 91-112 [Access article in PDF] Scope Note 40 Animals in Research and Education: Ethical Issues Laura Jane Bishop and Anita Lonnes Nolen Scientific enquiry is inexorably tied to animal experimentation in the popular imagination and human history. Many, if not most, of the spectacular innovations in the medical understanding and treatment of today's human maladies have been based on research using animals. (...) However, the use of animals in research and experimentation has been debated, defended, and protested by both individuals and organizations at various levels. Responses range from personal lifestyle decisions and fervent philosophical treatises to strident arguments, violent demonstrations, and direct action. The continuum of attitudes about animals and the human relationship with animals spans the range between those who support no regulation of the human use of animals and those who advocate absolute animal liberation from all human use (see II, Orlans 1993, p. 22). History The first recorded experimentation on animals occurred in ancient Rome, but not until the Renaissance did scholars begin serious study of how the body works. Leonardo da Vinci (1452-1519) and other artists and anatomists pursued anatomical investigations of muscle and bone structure. William Harvey (1578-1657) discovered the circulation of the blood via his experiments on live deer. During this period, much live animal experimentation both in England and France was based on the view of French philosopher René Descartes (1596-1650) that animals are incapable of feeling pain. Jeremy Bentham (1748-1832), the English utilitarian philosopher, thought otherwise. In his "Introduction to the Principles of Morals and Legislation" in 1789, Bentham declared, "The question is not, can they reason? Nor, can they talk? But can they suffer? Despite Bentham and others, the belief that animals could not perceive pain persisted in many quarters into the twentieth century. Nineteenth century French physiologist Claude Bernard [End Page 91] (1813-1878)-and his teacher, François Magendie (1783-1855)-conducted wide-ranging animal experiments including surgery, use of drugs, and removal of body parts from many species. Bernard argued that while no amount of benefit could justify any harm to human research subjects, even extreme harm and pain for animal research subjects could be justified by the potential benefit to human beings. Although he did use anesthetics in his work after their discovery in 1847, even Bernard's later work was controversial because of the numbers of animals used and the repetitive nature of his research. The experiments of Magendie and Bernard both laid the foundations for animal experimentation as a practice for scientific advance and contributed in large measure to the emergence of the anti-vivisection movement. Public protests over animal experiments conducted in France and the fear that these might come to England led to the passage of the first law controlling animal experimentation, the "1876 Cruelty to Animals Act" in England. This history and the dynamic tension between scientific inquiry and public concern set the stage for the activism and scholarship of the twentieth century.Since the 1960s, the amount of attention, activism, and scholarship related to animal use has increased at a rapid pace. The modern animal protection movement, led by the Australian philosopher Peter Singer in his book, Animal Liberation (II, 1975), based its advocacy on animals' ability to experience pain and suffering (Bentham's argument). Singer's book and other investigations into animal research, such as LIFE magazine's photojournalism piece on pet theft, animal cruelty, and animal experimentation (Concentration Camps for Dogs. LIFE (4 February 1966), pp. 22-29), brought the use of animals in research, testing, and education to the attention of the general public. Activists, advocates, laypersons, scientists, lawmakers, and animals themselves, have created the interesting, complicated, and complex history of animal rights and animal welfare over the last several decades. Current Statistics Worldwide, approximately 35 million animals are used in research each year; the United States alone uses 12 million animals annually--more than any other country. In 1998, the official number of research animals recorded in the United States was 1... (shrink)

BackgroundEvolving medical technology, advancing biomedical and drug research, and changing laws and legislation impact patients’ healthcare options and influence healthcare practitioners’ (HCPs’) practices. Conscientious objection policy confusion and variability can arise as it may occasionally be unclear what underpins non-participation. Our objective was to identify, analyze, and synthesize the factors that influenced HCPs who did not participate in ethically complex, legally available healthcare.MethodsWe used Arksey and O’Malley’s framework while considering Levac et al.’s enhancements, and qualitatively synthesized the evidence. We searched (...) Medline, CINAHL, JSTOR, EMBASE, PsychINFO, Sociological Abstracts, and ProQuest Dissertations and Theses Global from January 1, 1998, to January 15, 2020, and reviewed the references of the final articles. We included articles written in English that discussed the factors that influenced physicians and registered nurses (RNs) who did not participate in end-of-life (EOL), reproductive technology and health, genetic testing, and organ or tissue donation healthcare areas. Using Covidence, we conducted title and abstract screening, followed by full-text screening against our eligibility criteria. We extracted the article’s data into a spreadsheet, analyzed the articles, and completed a qualitative content analysis using NVivo12.ResultsWe identified 10,664 articles through the search, and after the screening, 16 articles were included. The articles sampled RNs (n = 5) and physicians (n = 11) and encompassed qualitative (n = 7), quantitative (n = 7), and mixed (n = 2) methodologies. The care areas included reproductive technology and health (n = 11), EOL (n = 3), organ procurement (n = 1), and genetic testing (n = 1). One article included two care areas; EOL and reproductive health. The themed factors that influenced HCPs who did not participate in healthcare were: (1) HCPs’ characteristics, (2) personal beliefs, (3) professional ethos, 4) emotional labour considerations, and (5) system and clinical practice considerations.ConclusionThe factors that influenced HCPs’ who did not participate in ethically complex, legally available care are diverse. There is a need to recognize conscientious objection to healthcare as a separate construct from non-participation in healthcare for reasons other than conscience. Understanding these separate constructs will support HCPs’ specific to the underlying factors influencing their practice participation. (shrink)

Under a policy first enacted in 1988 and expanded in 1996, federally funded public housing authorities (“PHAs”) and private landlords renting their properties to tenants receiving federal housing assistance have been required to include a provision in all leases under which drug-related criminal activity as well as criminal activity that in any way poses a threat to other tenants or nearby residents constitutes ground for initiating eviction proceedings. This strict liability eviction policy, which has become known as the “One-Strike Rule,” (...) was part of a broader congressional effort to combat the “reign of terror” that Congress believed drug dealers were imposing on public housing and assisted housing tenants. Like many of the crime-related policies enacted in the 1980s and 1990s, the One-Strike Rule has done little to reduce crime rates, but has been wildly successful in ensuring that the situation of poor households receiving federal assistance remains highly precarious. Calls for reform of the One-Strike Rule are almost as old as the policy itself, but given the political outlook of the current administration, the prospects for reform at the federal level are dim. While federal law and a combination of gridlock and unwillingness in the congressional and executive branches foreclose a range of possible strategies for reform, there is nonetheless room to mitigate the socially corrosive effects of the One-Strike Rule through legislative efforts at the state and local level. Courts in various jurisdictions have upheld state laws that protect vulnerable tenants despite the federal strict liability policy, and these holdings help to provide a framework for how state and local governments seeking to protect tenants can do so without their efforts necessarily falling prey to the Supremacy Clause. This article describes that framework and proposes three concrete measures that fit it. The article is structured as follows: after explaining the One-Strike Rule and the threat it poses to vulnerable tenants (Section II), the article discusses the burden the Rule imposes on tenants and the benefits it is supposed to bring to other parties, and argues that the resulting distribution of burdens and benefits is unjust (Section III). The article then lays out three concrete measures that state and local governments can enact to protect tenants who face eviction for criminal activity under the Rule without falling prey to a federal preemption challenge: requiring “good cause” for eviction, giving tenants the right to cure a breach of their lease, and providing tenants with free counsel in landlord-tenant court (Section IV). (shrink)

This article addresses a set of exploratory questions related to emergency contraception and the right to refuse to dispense such drugs. The paper first addresses the roles of the pharmacist in American society, i.e., as professional, employee, and business owner, and the pharmacists’s identity and belief system; second, the paper reviews the status of state law and proposed legislation concerning patient/consumer access to emergency contraceptives; third, it offers an in-depth stakeholder analysis of the ethical and legal responsibilities of pharmacies (...) to stakeholders; and fourth, the paper provides overview of the salient ethical and legal issues concerning patient/customer access to emergency contraceptives relevant to management. The conclusions discuss questionsfor further research as well as strategic/human resource management policy recommendations that balances the economic, legal, and ethical concerns of all primary stakeholders of the company/business, such as designing a management system which refers customers in a timely fashion; recognizing “conscience clauses,” while ensuring that pharmacists “do no harm” to the consumer; and disseminating management “best practices” on “conscience clauses” through joint professional/industry sponsorship. (shrink)

Antipsychotic medications are sometimes imposed on psychiatric patients deemed dangerous to themselves and others. This is based on the assumption that treatment is safe and effective, and that recovery depends on biological adjustment. Under new laws, patients can be required to remain on these medications after leaving hospitals. However, survivors attest that forced treatment used as a restraint can feel like torture, while the consequences of withdrawal can also be severe.

This new edition of Law and Medical Ethics continues to chart the ever-widening field that the topics cover. The interplay between the health caring professions and the public during the period intervening since the last edition has, perhaps, been mainly dominated by wide-ranging changes in the administration of the National Health Service and of the professions themselves but these have been paralleled by important developments in medical jurisprudence.

This article addresses a set of exploratory questions related to emergency contraception and the right to refuse to dispense such drugs. The paper first address the roles of the pharmacist in American society, i.e., as professional, employee, and business owner, and the pharmacists's identity and belief system; second, the paper reviews the status of state law and proposed legislation concerning patient/consumer access to emergency contraceptives; third, it offers an in-depth stakeholder analysis of the ethical and legal responsibilities of pharmacies (...) to stakeholders; and fourth, the paper provides overview of the salient ethical and legal issues concerning patient/customer access to emergency contraceptives relevant to management. The conclusions discuss questions for further research as well as strategic/human policy recommendations that balances the economic, legal, and ethical concerns of all primary stakeholders of the company/business, such as designing a management system which refers customers in a timely fashion; recognizing "conscience clauses," while ensuring that pharmacists "do no harm" to the consumer; and disseminating management "best practices" on "conscience clauses" through joint professional/industry sponsorship. (shrink)

Book reviewed in this article: Sex, Drugs, Death and the Law: An Essay on Human Rights and Overcriminalization. By David A. J. Richards. Totowa, NJ: Rowman and Littlefield, 1982. xii + 316 pp. $26.95.

This paper aims to clarify the nature and contents of 'civil ethics' and the source of the binding force of its obligations. This ethics should provide the criteria for evaluating the moral validity of social, legal and morally valid law. The article starts with observing that in morally pluralist Western societies civil ethics already exists, and has gradually started to play the role of guiding the law. It is argued that civil ethics should not be conceived as 'civic morals' which (...) is in fact rather 'state ethics', nor as 'public ethics' which is said to reach its perfection when it becomes law, nor as ethics applicable primarily to the basic structure of a society, but instead as a citizens' ethics. Subsequently the paper attempts to show what the contents of this ethics are, and which ethical theory would be able to ground its obligations. (shrink)

This paper connects to Jon Bing’s great vision of an integrated national legal information system. The intention of this paper is to variegate Bing’s vision of an integrated information system by shifting the focus to the lay users, thus to those, who are subject to the law. The modified vision is an integrated information system that supports intelligible access to law for the citizens. This presupposes however an unambiguous and transparent legal system. Accordingly, it is also stressed that intelligent legal (...) knowledge engineering has high potential to increase precision and rationality in law, and hence safeguard the predictability of law and legal certainty. The central hypothesis is that putting the person who is subject to the law at the centre provides more rational reason to aim for the greatest possible precision of law by exploiting the means and technologies of our time than to uphold strategic vagueness. On this basis, the paper proposes the development of a basic set of controllable and justiciable basic legal drafting standards on EU and on national level, and promotes a transparency by design approach for legal knowledge engineering in order to enhance precision, integrity, comprehensibility and accessibility of law. Similarly to Jon Bing’s vision, this modified vision of an integrated legal information systems is, most probably, also likely to remain unfulfilled. However, what would science be without visions and (science) fictions? (shrink)

Illegal drugs are not inherently unclean, any more than alcohol, tobacco, or canola oil. All of these are simply chemicals that people choose to ingest for enjoyment, and that can harm our health if used to excess. Most of the sordid associations we have with illegal drugs are actually the product of the drug laws: it is because of the laws that drugs are sold on the black market, that Latin American crime bosses are made rich, that (...) government officials are corrupted, and that drug users rob others to buy drugs. (shrink)

Illegal drugs are not inherently unclean, any more than alcohol, tobacco, or canola oil. All of these are simply chemicals that people choose to ingest for enjoyment, and that can harm our health if used to excess. Most of the sordid associations we have with illegal drugs are actually the product of the drug laws: it is because of the laws that drugs are sold on the black market, that Latin American crime bosses are made rich, that (...) government officials are corrupted, and that drug users rob others to buy drugs. (shrink)