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)

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.

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)

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)

ZusammenfassungDer „Entwurf eines Gesetzes zur strukturellen Weiterentwicklung der Pflegeversicherung“ vom 17. 10. 2007 sieht Regelungen zur Einbeziehung von stationären Pflegeeinrichtungen in die ambulante ärztliche GKV-Versorgung vor. Der vorliegende Beitrag analysiert und bewertet den Ansatz zur „heimärztlichen Versorgung“ unter rechtlichen Aspekten vor dem Hintergrund der Problematik der Psychopharmakaversorgung von Heimbewohnern und schon bestehender Möglichkeiten der Verzahnung der ambulanten ärztlichen und der stationären pflegerischen Versorgung. Das geplante Modell verfolgt das begrüßenswerte Ziel, die gelegentlich als unzureichend beschriebene ambulante ärztliche Betreuung von Pflegebedürftigen in (...) Pflegeheimen zu verbessern, Schnittstellenprobleme abzubauen und gleichzeitig der gesetzlichen Krankenversicherung unnötige Transport- und Krankenhauskosten zu ersparen. Es ist jedoch nur ein rudimentäres Heimarztmodell, da es gerade keine flächendeckende Versorgung der Heimbewohner mit Heimärzten erreichen will. Auch fehlen Anreize für eine Optimierung der ärztlichen und der pflegerischen Zusammenarbeit. Insofern können die Probleme, die sich im Rahmen der Psychopharmakaversorgung von stationär zu pflegenden Heimbewohnern abzeichnen, nur punktuell durch diese Reform verbessert werden. (shrink)

Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and Drug Administration has (...) taken the lead in encouraging increased competition in the nation's prescription drug marketplace, most recently with its release of the agency's Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health. (shrink)

America has a serious drug problem. The problem is not abuse of prescription stimulants by students cramming for the SATs, nor is it the recent spate of violent attacks associated with the use of so‐called bath salts. Rather, the problem is a shortage of critical medicines. The American Society of Health System Pharmacists reports that over two hundred drugs are in short supply. The frequency and number of drug shortages are also increasing steadily, as seen in a recent (...) Food and Drug Administration study that found that the number of reported drug shortages has nearly tripled, from sixty‐two in 2005 to 178 in 2010. There are few quick solutions to the crisis, and the long‐term effect of pending legislation and regulatory changes is unclear. (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)

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)

Today's clinical AIDS research is in trouble. Principal investigators are confronted with young and frequently highly knowledgeable patients. Many of these people with AIDS are often unwilling to adhere to the trial protocols. These PWAs believe they are ethically justified in breaching trial protocols because they do not consider themselves true volunteers in such trials. PWAs argue that they do not really volunteer because existing legislation prevents them from buying and using experimental drugs or from testing alternative treatment strategies. Their (...) only access to such agents is participation in clinical trials. (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 article tracks the transformation of beagle dogs from a common breed in mid-twentieth century American laboratories to the de jure standard in global toxicological research by the turn of the twenty-first. The breed was dispersed widely due to the expanding use of dogs in pharmacology in the 1950s and a worldwide crisis around pharmaceutical safety following the thalidomide scandal of the 1960s. Nevertheless, debates continued for decades over the beagle’s value as a model of carcinogenicity, even as the dogs (...) became legislated stand-ins for human beings in multiple countries. Situating beagles as a biocommodity, the article calls for more sustained attention to the “political economy” of laboratory organism breeding, use, and production. The story of American commercial breeder Marshall Farms offers insight into the role of for-profit companies in contemporary laboratory animal provision, as the article makes a case for the value of a global perspective on transnational corporations as key sites of scientific practice and collaboration. (shrink)

Lithuania’s legislation, establishing criminal liability for illegal disposition of narcotic drugs and psychotropic substances, uses two different terms while identifying the subject matter for criminal deeds: “narcotic and psychotropic substances” and “plants, incorporated into the lists of controlled substances.” The legislation in article 269 of the Lithuanian criminal code explains that narcotic and psychotropic substances, indicated in the respective chapter of the Lithuanian criminal code, shall be those substances that are included in the lists of narcotic and psychotropic substances as (...) approved by the Ministry of Health of the Republic of Lithuania. Plants having narcotic drugs and psychotropic substances are not introduced into this definition although the exception of the coca bush is enumerated in the lists of controlled substances. This described present position brings in a certain intricacy when deciding when a perpetrator should be punished only for illegal cultivation of plants and when he should be punished also for other illegal acts with narcotic and psychotropic substances. (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)

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)

Polish medical law does not explicitly regulate the possibility of off-label use of medicines. Such procedures therefore raise doubts in medical practice, where medicines are often prescribed beyond the Characteristic of Medicinal Product. This phenomenon particularly affects the treatment of children, as there is a lack of registered medicines in this age group, but they are registered for use in adults. Since such treatment goes beyond the scope of registration, a dilemma arises as to whether it is permissible and, if (...) so, under what conditions and whether sanctions are imposed on the medical professional using the off-label medicine. These issues are addressed in an article by Dr Maria Gutowska-Ibbs, entitled 'Off label - practical consequences of unclear legislation". The present study complements these considerations and is in part an ad vocem statement. The article attempts to differentiate between the use of off-label medicines and medical experiments, following the criterion of the purpose for which a given medical action is performed. The limits of admissibility of such actions under criminal law are also discussed in more detail. Off-label treatment is considered through the prism of the required precautionary rules, compliance with which is the antithesis of inadvertence. It is assumed that if the drug was administered in accordance with current medical knowledge and the treatment is adequate to the patient's condition, there is no violation of these rules, which excludes the imputation of inadvertence. An extensive section of the study is devoted to the issue of the patient's consent to treatment outside the indications. Above all, it emphasises the need to explain in detail to the patient the circumstances of prescribing such a drug and, on this basis, to obtain informed consent. It also stresses the importance of the written form of consent, which can have a significant evidentiary impact in potential litigation. (shrink)

Pharmaceutical firms seek to fulfill their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation-mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical studies (...) from journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated. We propose that the U.S. Food and Drug Administration and Congress should work together to abolish regulations and policies that require animal use. Doing so will benefit pharmaceutical industry stakeholders, including patients whose health depends on drugs and the many people who rely on the financial well-being of pharmaceutical firms. (shrink)

In recent years, the biopharmaceutical industry has seen an increase in the development of so-called orphan drugs for the treatment of rare and neglected diseases. This increase has been spurred on by legislation in the United States, Europe, and elsewhere designed to promote orphan drug development. In this article, we examine the drivers of corporate social responsibility (CSR) activities in orphan drug markets and the extent to which biopharmaceutical firms engage in these activities with a strategic orientation. The (...) unique context of orphan drugs constitutes a research opportunity to test the applicability of existing theoretical perspectives on CSR and strategic CSR. Using Schwartz and Carroll’s (Bus Ethics Q, 13(4):503–530, 2003) three-domain approach to CSR and the literature on strategic CSR as a theoretical background, we employ a combination of semi-structured interviews and a quantitative website content analysis to study practices of biopharmaceutical firms in the United States and European Union. Our findings show that both US- and EU-based companies engaged in orphan drugs development perceive their involvement as a responsible business activity beyond the economic dimension of CSR. However, for the majority of these companies their CSR activities do not qualify as strategic according to the criteria established in the literature. We also find significant differences between larger and smaller firms in their use of CSR. Based on these findings, we make several suggestions regarding orphan drug legislation and other measures that might help firms exploit strategic CSR benefits. (shrink)

Through a fieldwork study of the practice of methadone substitution at a French addiction clinic, the classic ‘theory of action’ is criticized and an alternative one proposed. A sketch of the debates among French drug specialists, drug users and legislators shows the pertinence for these practitioners of such a theoretical question; further, the ethnographic data suggest that they can be seen as actually trying out an alternative to this ‘theory of action’.

In recent years, Oregon and Washington have enacted so-called Death with Dignity (DWD) statutes that permit patients whose doctors certify that they have less than six months to live to commit suicide with the aid of a physician.1 The laws allow a doctor, upon the patient’s request, to prescribe a lethal dosage of drugs, which the patient then self-administers.2 Oregon’s law went into effect in 1997, and over five hundred terminal patients have ended their lives pursuant to it since then (...) (Oregon Public Health Division 2011).3 Washington’s law took effect in March of 2009, and by the end of 2010, some 87 terminally ill citizens of that state had brought their lives to a close with the permission of the law .. (shrink)

There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post-trial access (...) and participants and community members. Given that clinical trials conducted in low-income countries will likely continue, there is an urgent need for consideration of post-trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available. (shrink)

The recent withdrawals of Vioxx, Celebrex, and other drugs from the market have spurred high-profile hearings in Congress and increased concern over the state of drug regulation in consumer protection and academic circles. This renewed focus on national drug safety has translated ineluctably into new legislation designed to mitigate that outcry. The most notable example, the passage of the Food and Drug Administration Amendments Act this past September, is at least partly intended as a response to an (...) apparent lack of public confidence in existing drug safety practices.Of the many provisions in the FDAAA, perhaps none carries greater implications for drug safety than the reauthorized Prescription Drug User Fee Act. Now in its fourth iteration, the newest PDUFA differs in important respects from the statute it supersedes. (shrink)

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)

For many years, the subject of aggressive marketing campaigns conducted by pharmaceutical companies has been raised in Poland. Drug ads are everywhere, on television, the radio, magazines and on the Internet. Therefore, it is extremely important is to ensure both their legal and ethical dimension. In my article I will present the differences between direct-to-consumer advertising of medicines in Poland and in the US. The dissimilarities result mainly from differences in legislation. In Poland the law is much stricter than (...) in the US. For example, in the United States companies are allowed to advertise prescription drugs directly to patients. In the whole of the European Union, and thus in Poland, it is strictly prohibited. The article will present other regulations existing in Poland and in the United States and it will compare them. It will show examples of violations of the law and ethics in the advertising of medicine in both countries. It will briefly outline the negative consequences of unacceptable pharmaceutical marketing. (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)

Prozac's introduction in the late 1980s, caused a furor and focused debate on the acceptability of a drug that could do more than merely cure illness, pharmacological mood enhancement – that is, the use of drugs to improve mood beyond a level that is merely normal or healthy. As the possibilities and demand for mood enhancement increase, existing legislation will prove inadequate, designed as it is to regulate pharmaceuticals mainly for therapeutic use. This chapter explains why mood enhancement might (...) be desirable, explores some key ethical issues associated with it, and suggests how policy makers can respond to ensure that people use mood enhancement safely and responsibly. Whether it is appropriate to enhance one's mood might also depend on the manner in which the mood is experienced. While unpleasant states like depression may be appropriate and valuable in some cases, they can be disruptive and disabling if they continue indefinitely. (shrink)

The base rate fallacy is a fallacy that occurs in probabilistic reasoning when available general information is omitted from the calculations and attention is given to specific information only. To illustrate this concept, this chapter discusses the scenario in Philip K. Dick's short story “Minority Report”, with some details augmented by the 2002 movie daptation by Steven Spielberg. The legislative approach seems to be based not just on the base rate fallacy but on assuming a base rate that is divorced (...) from reality, that the drug use rate among welfare applicants is significantly higher than the national rate. Once the accurate base rate is applied (be it the proportions between the races in the US population, or the percentage of drug users among the people receiving government welfare, etc.), one can clearly see that the original conclusion does not follow. (shrink)

Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration’s (FDA) classification structure for ‘‘drugs’’ and ‘‘devices.’’ The last major modification to these terms was in 1976, (...) with the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by ‘‘chemical action.’’ We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies. (shrink)

In a wide-ranging, provocative anatomy of modern society and its origins, novelist and historian John Ralston Saul explores the reason for our deepening sense of crisis and confusion. Throughout the Western world we talk endlessly of individual freedom, yet Saul shows that there has never before been such pressure for conformity. Our business leaders describe themselves as capitalists, yet most are corporate employees and financial speculators. We are obsessed with competition, yet the single largest item of international trade is a (...) subsidized market in armaments. We call our governments democracies, yet few of us participate in politics. We complain about "invasive government," yet our legal, educational, financial, social, cultural and legislative systems are breaking down. While most observers view these problems separately, Saul demonstrates that they are largely manifestations of our blind faith in the value of reason. Over the last 400 years, our "rational elites" have gradually instituted reforms in every phase of social life. But Saul shows that they have also been responsible for most of the difficulties and violence of the same period. This paradox arises from a simple truth which our elites deny: far from being a moral force, reason is no more than an administrative method. Their denial has helped to turn the modern West into a vast, incomprehensible, directionless machine, run by process-minded experts - "Voltaire's bastards"--Whose cult of scientific management is bereft of both sense and morality. Whether in politics, art, business, the military, entertainment, science, finance, academia or journalism, these experts share the same outlook and methods. The result, Saul maintains, is a civilization of immense technological power whose peoples increasingly dwell in a world of illusion. Already known to millions of readers as the author of novels which portray the overwhelming effects of this power on the modern individual by weaving together international finance, the oil and arms business, guerrilla warfare, drug traffic, and the world of art, here Saul lays aside the mask of fiction to speak in his own voice. Only by withdrawing from our addiction to "solutions," he argues, reclaiming the citizens' right to question and participate in public life, and recovering a common sense capacity for intelligent panic, can we find a way out of our permanent crisis. (shrink)

Train crashes cause, on average, a handful of deaths each year in the UK. Technologies exist that would save the lives of some of those who die. Yet these technical innovations would cost hundreds of millions of pounds. Should we spend the money? How can we decide how to trade off life against financial cost? Such dilemmas make public policy is a battlefield of values, yet all too often we let technical experts decide the issues for us. Can philosophy help (...) us make better decisions? Ethics and Public Policy: A Philosophical Inquiry is the first book to subject important and controversial areas of public policy to philosophical scrutiny. Jonathan Wolff, a renowned philosopher and veteran of many public committees, such as the Gambling Review Body, introduces and assesses core problems and controversies in public policy from a philosophical standpoint. Each chapter is centred on an important area of public policy where there is considerable moral and political disagreement. Topics discussed include: Can we defend inflicting suffering on animals in scientific experiments for human benefit? What limits to gambling can be achieved through legislation? What assumptions underlie drug policy? Can we justify punishing those who engage in actions that harm only themselves? What is so bad about crime? What is the point of punishment? Other chapters discuss health care, disability, safety and the free market. Throughout the book, fundamental questions for both philosopher and policy maker recur: what are the best methods for connecting philosophy and public policy? Should thinking about public policy be guided by an ‘an ideal world’ or the world we live in now? If there are ‘knock down’ arguments in philosophy why are there none in public policy? Each chapter concludes with ‘Lessons for Philosophy’ making this book not only an ideal introduction for those coming to philosophy, ethics or public policy for the first time, but also a vital resource for anyone grappling with the moral complexity underlying policy debates. (shrink)

Are public officials morally justified in threatening violence, engaging in deception, or forcing citizens to act for their own good? Can individual officials be held morally accountable for the wrongs that governments commit? Dennis Thompson addresses these questions by developing a conception of political ethics that respects the demands of both morality and politics. He criticizes conventional conceptions for failing to appreciate the difference democracy makes, and for ascribing responsibility only to isolated leaders or to impersonal organizations. His book seeks (...) to recapture the sense that men and women, acting for us and together with us in a democratic process, make the moral choices that govern our public life. Thompson surveys ethical conflicts of public officials over a range of political issues, including nuclear deterrence, foreign intervention, undercover investigation, bureaucratic negligence, campaign finance, the privacy of officials, health care, welfare paternalism, drug and safety regulation, and social experimentation. He views these conflicts from the perspectives of many different kinds of public officials - elected and appointed executives at several levels of government, administrators, judges, legislators, governmental advisers, and even doctors, lawyers, social workers, and journalists whose professional roles often thrust them into public life. In clarifying the ethical problems faced by officials, Thompson combines theoretical analysis with practical prescription, and begins to define a field of inquiry for which many have said there is a need but to which few have yet contributed. Philosophers, political scientists, policy analysts, sociologists, lawyers, and other professionals interested in ethics in government will gain insight from this book. (shrink)

BackgroundAlthough some of the most radical hypothesis related to the practical implementations of human enhancement have yet to become even close to reality, the use of cognitive enhancers is a very tangible phenomenon occurring with increasing popularity in university campuses as well as in other contexts. It is now well documented that the use of cognitive enhancers is not only increasingly common in Western countries, but also gradually accepted as a normal procedure by the media as well. In fact, its (...) implementation is not unusual in various professional contexts and it has its peak in colleges. Even when certain restrictions in the legislation of a country are indeed in place, they are without doubts easy to overcome. The legitimacy and appropriateness of such restrictions will not be the focus of our investigation.DiscussionOur concern is instead related to the moral and social reasons to publicly acknowledge the use of cognitive enhancers in competitive-selective contexts. These reasons are linked to a more neutral analysis of contemporary Western society: it is a fact that an increasing number of competitive-selective contexts have a substantial number of contenders using cognitive enhancers.SummaryThrough the use of five explicative examples, in this paper we want to analyse the problems related to its use. In particular, it will be our aim to show the tension between one of the main argument used by bio-liberals and the actual implementation of the drugs in competitive, or semi-competitive contexts. (shrink)

This chapter contains sections titled: The Pirate and Performance‐Enhancing Drugs Life and Times Performance‐Enhancing Drugs The Paternalistic Argument The Argument from the Harm Principle The Argument from Distorted Values The Argument from the Prisoner's Dilemma Why r‐EPO Should Continue to be Banned The Pirate's False Treasure Notes.

In its essence, post-trial obligations describe a duty by research sponsors to provide a successfully tested drug to research participants who took part in the relevant clinical trials after the trial has been concluded. In some instances,this duty is extended beyond the research participants. This article is divided into three main parts. The first part outlines the legal basis for post-trial obligations by looking at international guidelines, including those issued by the World Medical Association. National legislation is exemplified through (...) resolutions and guidelines issued by Brazil and South Africa respectively. The second part analyses the ethical foundation for post-trial obligations, in particular the attempt to minimize exploitation of research subjects. The third part raises obstacles and challenges for the implementation of post-trial obligations. The jury is still out on whether post-trial obligations in the form of access to drugs for clinical trial participants is the best, or even a good way, to avoid exploitation in medical research. (shrink)

Policy‐makers, bioethicists, and patient advocates have been engaged in a fierce battle about the merits and potential harms of a federal right‐to‐try law. This debate about access to investigational medical products has raised profound questions about the limits of patient autonomy, appropriate government regulation, medical paternalism, and political rhetoric. For example, do patients have a right to access investigational therapies, as the right‐to‐try movement asserts? What is government’s proper role in regulating and facilitating access to drugs that are still in (...) development? In this review, we analyze the history of the right‐to‐try movement, review the arguments put forth by supporters and opponents of the legislation, and consider the movement’s consequences. Two possible scenarios may emerge. One is that the right‐to‐try pathway may fail to meaningfully increase patient access to investigational products. Alternatively, certain companies may attempt to rely on the federal right‐to‐try legislation to sell investigational products, taking advantage of the provision that allows for direct costs, as there is currently no clear mechanism for enforcement or monitoring of cost calculations. (shrink)

In Martin v. Ortho Pharmacetrtical Corp. ), the Supreme Court of Illinois held that, although a federal regulation requires pharmaceutical manufacturers to provide direct warnings to consumers about the dangers associated with oral contraceptives, this regulation does not constitute an exception to the learned intermediary doctrine and the manufacture will not be held strictly liable. The court declined to recognize an exception for manufacturers of contraceptives due to important policy considerations and the legislative intent underlying the learned intermediary doctrine. The (...) doctrine is based on the assumption that prescribing physicians, not pharmaceutical manufacturers, are in the best position to provide direct warnings to patients concerning the dangers associated with prescription drugs. The decision may affect patients whose medical care providers are unable to account for drug propensities or patient susceptibilities. Additionally, patients with forgetful or inarticulate health care providers are at risk. (shrink)

Objectives Potentially life-shortening medical end-of-life practices ) remain subject to conceptual vagueness. This study evaluates how physicians label these practices by examining which of their own practices they label as euthanasia or sedation.Methods We conducted a large stratified random sample of death certificates from 2007 . The physicians named on the death certificate were approached by means of a postal questionnaire asking about ELDs made in each case and asked to choose the most appropriate label to describe the ELD. Response (...) rate was 58.4%.Results In the vast majority of practices labelled as euthanasia, the self-reported actions of the physicians corresponded with the definition in the Belgian euthanasia legislation; practices labelled as palliative or terminal sedation lack clear correspondence with definitions of sedation as presented in existing guidelines. In these cases, an explicit life-shortening intention by means of drug administration was present in 21.6%, life shortening was estimated at more than 24 h in 51% and an explicit patient request was absent in 79.7%.Discussion Our results suggest that, unlike euthanasia, the concept of palliative or terminal sedation covers a broad range of practices in the minds of physicians. This ambiguity can be a barrier to appropriate sedation practice and indicates a need for better knowledge of the practice of palliative sedation by physicians. (shrink)

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. This paper discusses wild-card patent extensions as a means to incentivize research and development of new antibiotics. The thesis defended in the paper is that the implementation of such patent extensions is an appropriate legislative response to the problem of antibiotic resistance. The general idea of wild-card patent extensions is presented in the first (...) part of the paper. A number of objections to the idea are thereafter discussed and rejected. (shrink)

Developing a simple test to identify swiftly neonates with sepsis who carry the genetic variant which means that one dose of the recommended antibiotic, gentamicin, will cause the child to become profoundly deaf looks like an admirable objective. The baby needs antibiotics and needs them within 1 hour of admission to the neonatal intensive care unit (NICU). Conventional genetic tests take much longer to yield results. The test being trialled produces results in 25 min; a baby who carries the variant (...) can be treated with a different antibiotic. All the test requires is a gentle swab of the baby’s inner cheek. Babies can be treated for potentially fatal sepsis without the risk that the drugs designed to save their lives will cost them their hearing. Parents and healthcare staff are relieved of worry—a great idea? PALOH is not a trial of the safety or efficacy of the test, only to assess how feasible it will be to carry out this test in a busy NICU, without disrupting the care of the baby. A tiny painless ‘scrape’ will take a sample of DNA—what’s the fuss about? Several other invasive and painful procedures will be carried out without a fuss.1 The problem is DNA. Genetic information must be safeguarded from falling into the wrong hands. In section 45 of Human Tissue Act 2004 (HTA), Parliament legislated to prohibit non-consensual DNA testing.1 It fits uncomfortably in a statute designed to regulate retention and uses of human material, after revelations that organs and tissue from the …. (shrink)

The 21st Century Cures Act is a major act of legislation that contains numerous changes to drug and device regulation. The House of Representatives passed the Act after considerable interest group lobbying, but the bill and the key changes made during its drafting remain controversial. Using publicly disclosed records of written comments on the bill, we reviewed the key areas of lobbying activity and the compromises made in the final text. We focused on legislative provisions relating to management of (...) the National Institutes of Health, incentives for medical product development, and approval standards for new drugs and devices. By the end of the first comment period, the Committee received 118 comments. Most respondents were patient organizations, professional societies, and pharmaceutical and device companies. Overall, the majority of public comments were positive, although public health and consumer organizations were underrepresented in the number of submitted comments. As the legislative process continued, the draft bill underwent several changes relating to NIH funding, market exclusivity provisions, and scrutiny of regulatory evidentiary standards. Understanding the key statutory provisions and how they have evolved could help patients, researchers, and advocates make more informed comments on the bill and future health care legislation. (shrink)

In their response, The role of the church in developing the law: response to commentators, Professors Skene and Parker make a number of criticisms of my commentary, some contestable, some plainly mistaken.1Their first criticism is that I am “incorrect” and “misleading” in describing the New South Wales Crimes Act as “[a] statute which provided that abortion was a criminal offence”. They give as their reason that: “The criminal offence created by section 83 of the Crimes Act 1900 is not abortion. (...) It is unlawful abortion. Because the word ‘unlawfully’ appears in the act, it is clear that the law states that it is sometime lawful to undertake an abortion.” They then explain the interpretation of the cognate provision in the Victorian legislation provided by Justice Menhennit in R v Davidson [1969] VR 667.The reason they offer for their criticism fairly summarises the moves made by Macnaghten J in his direction in R v Bourne and by Menhennit J in R v Davidson. But it is far from “clear” that the use of the word “unlawfully” supports those moves. It was and remains a matter of real controversy whether the use of the expression “unlawfully” has the meaning which Menhennit J attached to it.Section 83 of the Crimes Act provided:"Whosoever—unlawfully administers to, or causes to be taken by, any woman, whether with child or not, any drug or noxious thing; or unlawfully uses any instrument or other means, with intent in any such case to procure a miscarriage, shall be liable to penal servitude for ten years."Consider that provision alongside other provisions in the Crimes Act 1900 which also make use of the term …. (shrink)

Involuntary commitment links the healthcare, public health, and legislative systems to act as a “carceral health-service.” While masquerading as more humane and medicalized, such coercive modalities nevertheless further reinforce the systems, structures, practices, and policies of structural oppression and white supremacy. We argue that due to involuntary commitment’s inextricable connection to the carceral system, and a longer history of violent social control, this legal framework cannot and must not be held out as a viable alternative to the criminal legal system (...) responses to behavioral and mental health challenges. Instead, this article proposes true alternatives to incarceration that are centered on liberation that seeks to shrink the carceral system’s grasp on individuals’ and communities’ lives. In this, we draw inspiration from street-level praxis and action theory emanating from grassroots organizations and community organizers across the country under a Public Health Abolition framework. (shrink)

Background: Although nurses worldwide are confronted with euthanasia requests from patients, the views of palliative care nurses on their involvement in euthanasia remain unclear.Objectives: In depth exploration of the views of palliative care nurses on their involvement in the entire care process surrounding euthanasia.Design: A qualitative Grounded Theory strategy was used.Setting and participants: In anticipation of new Belgian legislation on euthanasia, we conducted semistructured interviews with 12 nurses working in a palliative care setting in the province of Vlaams-Brabant.Results: Palliative care (...) nurses believed unanimously that they have an important role in the process of caring for a patient who requests euthanasia, a role that is not limited to assisting the physician when he is administering life terminating drugs. Nurses’ involvement starts when the patient requests euthanasia and ends with supporting the patient’s relatives and healthcare colleagues after the potential life terminating act. Nurses stressed the importance of having an open mind and of using palliative techniques, also offering a contextual understanding of the patient’s request in the decision making process. Concerning the actual act of performing euthanasia, palliative care nurses saw their role primarily as assisting the patient, the patient’s family, and the physician by being present, even if they could not reconcile themselves with actually performing euthanasia.Conclusions: Based on their professional nursing expertise and unique relationship with the patient, nurses participating as full members of the interdisciplinary expert team are in a key position to provide valuable care to patients requesting euthanasia. (shrink)

"The largest Ebola outbreak to date—first detected in December 2013 and still ongoing as of April 2015—has cast new light on the shortfalls of international public health systems.1 As in previous health crises, scrutiny has reemerged over the pharmaceutical industry’s ability and willingness to innovate new medicines for underserved disease areas. The public debate has intensified following revelations that promising drug candidates to treat Ebola had gone undeveloped despite compelling preclinical results.2 This lack of development is especially troubling because (...) it occurred after a recently implemented U.S. incentive scheme—the Food and Drug Administration’s (FDA) tropical disease priority review voucher program—designed to counteract exactly this problem. Taking Ebola as a case in point, it is useful to examine the short history and ongoing refinement of this voucher program, since it represents one of the most significant legislative efforts to systematically address the relative absence of com- mercial rewards for drugs targeting tropical diseases. This analysis evaluates the voucher program’s effectiveness for both stimulating private sector innovation and achieving positive health impacts among populations most severely burdened by tropical diseases. It then proposes specific recommendations for how law- makers can improve the program’s legislation to better achieve these objectives. ". (shrink)

Background: End-of-life decision-making for terminally ill neonates raises important legal and ethical issues. In Greece, no recent data on nurses’ attitudes and involvement in end-of-life decisions are available. Research question/aim: To investigate neonatal nurses’ attitudes and involvement in end-of-life decisions and the relation to their socio-demographic and work-related background data. Research design: A survey was carried out in 28 neonatal intensive care units between September 2018 and January 2019. A structured questionnaire was distributed by post. Participants and research context: The (...) questionnaire was answered anonymously by 312 nurses (response rate, 71.1%) and returned to the investigators. Ethical considerations: The study was approved by the Bioethics and Research Committee of Aretaieio Hospital in accordance with the Helsinki Declaration. Findings: Nurses more often reported involvement in various end-of-life decisions, such as continuation of treatment without adding further therapeutic interventions for terminally ill neonates, while less reported were mechanical ventilation withdrawal and drug administration to end life. Nurses with a high attitude score, reflecting a more quality-of-life approach, were more likely to be involved in setting limits to intensive care. α low score was consistent with life preservation. Nurses’ religiousness ( p = 0.097), parenthood ( p = 0.093), involvement in daily practice ( p = 0.03), and position on the existing legal framework ( p < 0.002) influenced their attitude score. Discussion: The likelihood of nurses to support interventions in neonates with poor prognosis in neonatal intensive care units was related to their attitudes. After adjusting for potential confounders, the most important predictors for nurses’ attitudes were parenthood, involvement in daily practice, and position supporting current legislation reform. Conclusion: Variability in involvement in end-of-life decisions among nurses exists on a national level. (shrink)

United States public health experts have long expressed concern about the prevalence of the human immunodeficiency virus among injection drug users. The United States has the largest reported IDU population in the world: 1.1 to 1.5 million. Recent estimates from the Centers for Disease Control and Prevention suggest that 50 percent of incident HIV infections occur among IDUs, with additional infections occurring among their sex partners and offspring. More than 33 percent of new AIDS cases occur in IDUs, their (...) sexual partners, and their children. Almost one half of all women diagnosed with AIDS in the United States are IDUS. Many of the remaining infected women were infected as a result of sex with a male IDU.While public health agencies, legislators, community leaders, and religious groups have engaged in vigorous debate over the merits of needle exchange programs as an intervention to reduce HIV transmission, the programs, some legal and some illegal, have been implemented in fifty-five cities across the country. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 16.4 (2006) 379-396MuseSearchJournalsThis JournalContents[Access article in PDF]Pharmacists and Conscientious Objection *In March 2005, a Wisconsin pharmacist's act of conscience garnered headlines across the United States. After a married woman with four children submitted a prescription for the morning-after pill, the pharmacist, Neil Noesen, not only refused to fill it, but also refused to transfer the prescription to another pharmacist or to return the prescription (...) to the customer. As more such incidents occurred, many states "... decided to consider and enact laws setting the bounds of pharmacists' and other health care workers' professional obligations" (III, Grady 2006, p. 327). Discussions of objector legislation, also referred to as "conscience clauses," "refusal clauses," and "abandonment laws" (III, Appel 2005, p. 279), are not limited to professional ethics, but also draw from philosophical, theological, and legal perspectives. The purpose of this Scope Note is to present a wide variety of viewpoints on the health provider's right to conscience.More than 40 years ago the development of "The Pill" as the first reliable method of birth control not only ushered in a feminist revolution, but also provided a new focus for concerns of conscience for those who were part of the anti-abortion movement based on religious belief in the sanctity of life. Similarly, in the past ten years, worldwide, and seven years (1999) since the emergency contraception "morning after" pill first became available as a prescription item, there has been an upsurge in the number of medical personnel who refuse to prescribe or dispense it on grounds of personal conscience, whether for religious reasons or not. Their actions bring into play issues of power and control for health care personnel and for patients—in this case women, which also raises women's rights issues. Ironically, studies in France, Sweden, and the United Kingdom have shown that emergency contraception does not reduce the abortion rate—it is too infrequently used (II, Glasier 2006).It is important to underline the difference between the "morning-after" pill or "Plan B," which is made up of two progestin pills containing levonorgestrel (a synthetic derivative of the female hormone progesterone), and RU-486 (Mifiprex [End Page 379] or mifipristone with misoprostol). Plan B, if taken within 72 hours post-coitus prevents implantation, and therefore pregnancy, by suppressing the output of luteinizing hormone, the hormone that triggers the ovulation process. Scientists have been unable to determine whether this action could destroy already fertilized eggs, but even if it does, it uses the same mechanism as occurs with the birth-control pill, that was developed some 45 years ago. By contrast, RU-486 acts up to 49 days after implantation by blocking the action of progesterone in order to terminate the pregnancy and as such is an abortifacient (II, US FDA 1).On 24 August 2006, the U.S. Food and Drug Administration announced approval of the Plan B pill for over-the-counter (OTC ) sales (II, US FDA 2). Although this action makes the drug more widely available, it remains to be seen whether pharmacists who are conscientious objectors and who refuse to dispense it also will refuse to provide it OTC.A survey article by Rebecca Dresser (II, 2005, p. 9) succinctly sums up the problem for conscientious objectors: "Because emergency contraception can act to block implantation of a fertilized egg, people who believe in protection of human life after conception find it morally objectionable."When conscientious objections are raised over abortion or birth control services performed, prescribed, or dispensed, they affect not only the health professionals—physicians, pharmacists, nurses, and health technicians—who may object, as well as their colleagues and/or managers, but also the consumers: the female patients who are then forced to reconsider or to seek an alternative supplier, as well as their spouses or partners. Alta Charo (II, 2005, p. 2473) makes the point that the patient needs to have access to a system of counseling and referral "so... (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 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)

In the summer of 1998, the Wisconsin State legislature amended its child protection laws. Under new child abuse provisions, Wisconsin judges can confine pregnant women who abuse alcohol or drugs for the duration of their pregnancies. South Dakota enacted similar legislation almost simultaneously. The South Dakota statute requires mandatory drug and alcohol treatment for pregnant women who abuse those substances and classifies such activity as child abuse. In addition, the South Dakota legislation gives relatives the power to commit pregnant (...) women involuntarily for two days; a court order can place the pregnant women in custody for up to nine months. These recent legislative “successes” follow scores of failed attempts by legislators in other states to establish fetal protection laws aimed at women who use and abuse drugs and alcohol during pregnancy. (shrink)