In 2001 the Italian Government defined Essential Assistance Levels (LEA), which can be considered as an important step forward in the health care system. The Italian health care system would provide payment of essential and uniform aid services in order to safeguard many values such as human dignity, personal health, equal assistance and good health practices. The Ministry of Health has worked to rationalize the National Formulary and to define evaluation methods for drugs in order to choose what (...) to reimburse without penalizing the rights of the individual and society.This paper describes how this job of rationalization was done and tries to illustrate the choices made in Italy by the use of two meaningful examples (statins and rivastigmine). (shrink)

Gerald Dworkin provides an insightful starting point for determining acceptable paternalism through his commitment to protecting our future autonomy and health from lasting damage. Dworkin grounds his argument in an appeal to inherent goods, which this paper argues is best considered as a commitment to human flourishing. However, socialconnectedness is also fundamental to human flourishing and an important consideration when determining the just limits of paternalistic drug controls, a point missing from Dworkin’ essay. For British philosopher Thomas Hill Green, (...) regulation of alcohol sales emerged from the social ideal. Green argued that policy interventions, including restricted opening hours and locations, improved the conditions for humans to flourish. Green offers a compelling political vision but fails to account for the fact pleasure is also an inherent good. He focused excessively on our social nature, excluding our more pleasure-seeking and egoistic characteristics. In contrast, a more realistic and complete vision of human flourishing can be found in an amended version of Gerald’s Dworkin’s arguments. In conclusion, this paper argues drug policy makers should remain committed to the harm principle as applied to criminal law whereby a person should never be criminalized for self-harm. Such a limit on paternalistic interventions is deemed necessary when eudaimonia is the end of government action. In practical terms, this means that the criminalization of drug use, as opposed to drug production, is always unjust. (shrink)

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by extending brand (...) exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017. (shrink)

The current debate on recreational drug policy is roughly a contest between prohibition advocates and legalization advocates. This paper offers a third alternative that is a compromise between those two. The centralized-use compromise can secure the autonomy interests that are important to defenders of legalization, and it can prevent harms to others that are the focus of prohibition arguments. The centralized-use compromise also offers a possible way to reduce the black market while also reducing the rate of addiction (...) and the associated debasing harms to self. (shrink)

The target of my discussion is intuitions lay people have about justice in the context of drug policy—intuitions that take on a more or less moral-desert-based shape. I argue that even if we think desert is the right measure of how we ought to treat people, we ought still be in favour of Harm Reduction measures for people who use drugs. Harm Reduction measures are controversial with members of the public, and much of the opposition seems to come (...) from something like an appeal to a desert conception of justice—the notion that a just state of affairs is one in which everybody gets what they deserve, no more, no less. A recent study, for example, found that ‘moral outrage’ predicts a preference for prevalence reduction over Harm Reduction. The thinking seems to be that, since drug use is wrong, letting people who use drugs suffer and/or die as a consequence of their use is just. Aiding their health and safety, while perhaps compassionate, is unjust. I argue that there is a bad desert fit between using drugs and suffering avoidable harm even if using drugs is morally wrong. Many of the possible harms of drug use are socially/policy driven, and much problematic drug use is context dependent, not cleanly attributable to the decisions of the person who uses drugs. This means that even if drug use is wrong, people who use drugs deserve Harm Reduction policies, at minimum. (shrink)

Mark Kleiman, Against Excess: Drug Policy for Results New York: Basic Books, 1992. 474 pp. + xvi.

For all its problems, the microeconomic theory had the appeal of making clear predictions about the effects of various drug policies. The emerging picture of the and of addiction is far more complex. Addiction scientists might help bridge the sciencewhomwhen” of addiction.

One of harm reduction’s most salient features is its pragmatism. Harm reduction purports to distinguish itself from dominant prohibitionist and abstinence-based policy paradigms by being grounded in what is realistic, in contrast with the moralism or puritanism of prohibition and abstention. This is reflected in the meme “harm reduction works”, popular both in institutional and grassroots settings. The idea that harm reduction is realistic and effective has meant different things among the main actors who seek to shape harm reduction (...) policy. Drawing on scholarly literature about harm reduction, as well as examples from recent harm reduction advocacy efforts in relation to drug policy in Canada, this paper argues that harm reduction distinguishes itself through a unique “way of knowing”. Grassroots harm reduction advocates, particularly as they argue through human rights frameworks, do more than simply make claims for the provision of particular services—like needle exchange, safe consumption sites, safe supply and the like—on the basis that these are realistic paths toward the health and well-being of people who use drugs. Rather, as they marshal lived experience in support of these policy changes through peer-driven initiatives in contexts of prohibition, they make particular claims about what constitute valid, methodologically rigorous evidence bases for action in contexts where policies to date have been driven by ideology and have developed in ways that have excluded and marginalized those most affected from policymaking. In doing so, they advocate for the centrality of people who use drugs not only in policy-making processes, but in evidence production itself. (shrink)

The Müller & Schumann (M&S) view of drug use is courageous and compelling, with radical implications for drug policy and research. It implies that most nations prohibit most drugs that could promote happiness, social capital, and economic growth; that most individuals underuse rather than overuse drugs; and that behavioral scientists could use drugs more effectively in generating hypotheses and collaborating empathically.

Earp, Lewis, and Hart make a comprehensive and compelling argument for ending the “war on drugs,” highlighting the importance of both ending the criminalization of people who use drugs, and...

Tieu, Matthew The main results of the reports published on the efficacy and achievements of the Medically Supervised Injecting Centre in Kings Cross over the last decade of its operations are discussed. The reports do not provide any substantive evidence that the MSIC has achieved its objectives.

“Female sexual dysfunction” is the type of contested disease that has sparked concern about the role of the pharmaceutical industry in medical science. Many policies have been proposed to manage industry influence without carefully evaluating whether the proposed policies would be successful. We consider a proposal for incorporating citizen stakeholders into scientific research and show, via a detailed case study of the pharmaceutical regulation of flibanserin, that such programs can be co-opted. In closing, we use Holman’s asymmetric arms race framework (...) as a tool for evaluating policies in industry-funded science. (shrink)

. Foreign policy by indictment: Using legal tools against foreign officials involved in drug trafficking. Criminal Justice Ethics: Vol. 8, No. 2, pp. 3-31.

This article investigates the distribution of power in Poland’s drug reimbursement policy in the early 2000s. We examine competing theoretical expectations suggested by neopluralism, historical institutionalism, corporate domination, and clique theory of the post-communist state, using data from a purposive sample of 109 semi-structured interviews and documentary sources. We have four concrete findings. First, we uncovered rapid growth in budgetary spending on expensive drugs for narrow groups of patients. Second, to achieve these favorable policy outcomes drug (...) companies employed two prevalent methods of lobbying: informal persuasion of key members of local cliques and endorsements expressed by patient organizations acting as seemingly independent “third parties.” Third, medical experts were co-opted by multinational drug companies because they relied on these firms for scientific and financial resources that were crucial for their professional success. Finally, there was one-way social mobility from the state to the pharmaceutical sector, not the “revolving door” pattern familiar from advanced capitalist countries, with deleterious consequences for state capacity. Overall, the data best supported a combination of corporate domination and clique theory: drug reimbursement in Poland was dominated by Western multinationals in collaboration with domestically based cliques. (shrink)

This article proposes a model for regulating use of cognition enhancement drugs for nontherapeutic purposes. Using the method of reflective equilibrium, the author starts from the considered judgment of many citizens that treatments are obligatory and permissible while enhancements are not, and with the application of general principles of justice explains why this is the case. The author further analyzes and refutes three reasons that some influential authors in the field of neuroethics might have for downplaying the importance of justice: (...) (1) Justice applies only to public funds and state action—not to individual choice or corporate actors. (2) “Performance enhancement” does imply questions of justice, while “performance maintenance” does not. (3) There is no sufficient difference between cognition-enhancement drugs and other technologies to warrant the importance of justice for the debate. The challenges are refuted by taking into account the difference between consumption and tool use, and the influence of socioeconomic pressure for widespread use that existing drugs could have on the basic structure of society and equal autonomy of citizens. The analysis of requirements of justice points to a conclusion that introducing economic disincentives for the use of cognition-enhancement drugs would be the most legitimate public policy. With the imposition of taxes, fees, and requirements of additional insurance, the use and indirect coercion to use would be less profitable and less widespread, while additional funds thus created could be allocated to meet basic medical needs and/or education. (shrink)

Genetically engineered animals that are meant for release in the wild could significantly impact ecosystems given the interwoven or entangled existence of species. Therefore, among other things, it is all too important that regulatory agencies conduct entity appropriate, rigorous risk assessments that can be used for informed decision-making at the local, national and global levels about the release of those animals in the wild. In the United States, certain GE animals that are intended for release in the wild may be (...) regulated as new animal drugs by the Food and Drug Administration. This paper argues that the decision to treat them as new animal drugs is attributable to the influence of neoliberalism on the US biotechnology regulatory policy framework. The case is made that there should be public democratic deliberations and decision-making about the values and concerns that should guide the nation’s biotechnology regulatory policy paradigm, including the risk assessment process for GE animals meant for release in the wild. -/- . (shrink)

In public health and the social sciences, there is growing recognition of the role that social context plays in determining health. Frequently, social relations of inequality are among the most important features of social context identified in this work, and emphasis is placed on identifying and addressing these inequalities in order to improve health. Within the field of HIV/AIDS prevention as well, researchers have begun to look beyond individuals for an understanding of the structural causes of HIV-related risk. This research (...) demands that greater attention be paid to the social mechanisms and contextual factors that lead to HIV risk. Among these factors are law and social policy, which form a part of the context in which risk-taking occurs and which can promote both HIV transmission and prevention. On the one hand, laws limiting access to sterile injection equipment have contributed to HIV-related risk behavioxs among injection drug users. (shrink)

In public health and the social sciences, there is growing recognition of the role that social context plays in determining health. Frequently, social relations of inequality are among the most important features of social context identified in this work, and emphasis is placed on identifying and addressing these inequalities in order to improve health. Within the field of HIV/AIDS prevention as well, researchers have begun to look beyond individuals for an understanding of the structural causes of HIV-related risk. This research (...) demands that greater attention be paid to the social mechanisms and contextual factors that lead to HIV risk. Among these factors are law and social policy, which form a part of the context in which risk-taking occurs and which can promote both HIV transmission and prevention. On the one hand, laws limiting access to sterile injection equipment have contributed to HIV-related risk behavioxs among injection drug users. (shrink)

Most literature about vaccine hesitancy has been focused on parental attitudes. Less attention has been devoted to both scientists and experts who raise criticism about immunization policies and intervene in the public debate. This consideration aims to balance the current emphasis in the literature on parents’ attitudes about vaccination, offering a complementary angle to reframe and widen the controversy. Focusing on scientists and experts, an unattended complex picture of multiple attitudes towards vaccines and vaccinations has been discovered through a qualitative (...) content analysis of texts related to the harsh public debate, held between March 2017 and November 2018, triggered by the legislative proposal of making ten vaccinations mandatory for children. Unlike oversemplications that misleading dichotomies reproduce, the analysis reveals nine different positions along the continuum of immunisation attitudes, ranging from radical acceptance of vaccinations to radical rejection, which constitute a fuzzy set. Consequently, a twofold reality emerges: on the surface, the conflict seems between pro-vaxxers versus hesitant, pro-choice and anti-vaxxers; beneath it is amid standardized versus a varieties of contextual and personalised approaches to health. (shrink)

The genetic component of variations in human responses to pharmacological agents is called pharmacogenetics while the molecular basis for these variations are most often identified as pharmacogenomics. Pharmacogenomics as a field of scientific endeavor is so new that in the scientific literature the two terms are often used interchangeably. In fact, the search for new drugs at the molecular level start with the identification of variations in DNA sequences whose products produce alterations in the amino acid structure of the active (...) portion of a protein which are then identified with the clinical disorder in question. This process is just the reverse of standard pharmaceutical approaches which begin with exploration of the physiological and potentially the biochemical basis of the specific disorder under study. The completion of the first draft of the human genome in the first months of the new millenium has increased expectations that molecular genetic approaches to drug disovery and development will significantly shorten the time-frame of new drug testing, significantly reduce the level of adverse events and anable the design of drugs to treat those with unique disorders.Based on such rosy expectations and the potential economic opportunities afforded by those who obtain such patents, there has been a rush of patent applications both in the United States and in Europe by private industry and university laboratories conducting genomic research to secure the rights to specific DNA sequences and federal agencies attempting to place the control of such information in the public domaine. This paper will document and discuss from a historic prospective the public policy and bioethical issues associated with the availability of patents for drug development. (shrink)

There is strong evidence suggesting that harm reduction policies are able to reduce the adverse health and social consequences of drug use. However, in this article I will compare two different countries to demonstrate that some social aspects lead to the adoption or rejection of harm reduction policies. In this case, countries where drugs are seen as a security concern are less likely to adopt these harm reduction policies. For that purpose, I will compare Colombia and Uruguay’s political, normative, (...) and social aspects, which are considered drivers in the adoption of harm reduction policies, as well as how those factors influence the treatments available for substance abuse disorders. (shrink)

The genetic component of variations in human responses to pharmacological agents is called pharmacogenetics while the molecular basis for these variations are most often identified as pharmacogenomics. Pharmacogenomics as a field of scientific endeavor is so new that in the scientific literature the two terms are often used interchangeably. In fact, the search for new drugs at the molecular level start with the identification of variations in DNA sequences whose products produce alterations in the amino acid structure of the active (...) portion of a protein which are then identified with the clinical disorder in question. This process is just the reverse of standard pharmaceutical approaches which begin with exploration of the physiological and potentially the biochemical basis of the specific disorder under study. The completion of the first draft of the human genome in the first months of the new millenium has increased expectations that molecular genetic approaches to drug disovery and development will significantly shorten the time-frame of new drug testing, significantly reduce the level of adverse events and anable the design of drugs to treat those with unique disorders.Based on such rosy expectations and the potential economic opportunities afforded by those who obtain such patents, there has been a rush of patent applications both in the United States and in Europe by private industry and university laboratories conducting genomic research to secure the rights to specific DNA sequences and federal agencies attempting to place the control of such information in the public domaine. This paper will document and discuss from a historic prospective the public policy and bioethical issues associated with the availability of patents for drug development. (shrink)

Organized religion has played a key role in shaping national and international policy for millennia. This paper discusses the parts some Christian churches have played in creating and supporting drug control policies stipulated inunmultilateral treaties. Mainstream churches have largely ignored the harms these policies inflict on vulnerable populations, including both people who use drugs, and those who are terminally ill and cannot access controlled medicines for pain relief. Mainstream – especially theologically “conservative” – churches reject people who use (...) drugs, an approach that damages individuals, families, and communities both inside and outside the church, along multiple dimensions. This damage has, dialectically, produced a counter-theology and praxis that prioritizes compassionate ministry and insists on metanoia, a scriptural ethic of hospitality and evidence based care. Churches must play a prophetic role according to scripture, contemporary theologians, and Christians engaged in social justice praxis, in ministering to individuals who are marginalized and criminalized for using prohibited substances. (shrink)

Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios—series of trials that are interrelated (...) by a common set of objectives—is crucial. the ethical acceptability and evidentiary probity of individual trials can change depending on the characteristics of the portfolios in which they are embedded. Second, how trial portfolios are composed, how well they are coordinated, and how efficiently they use information determines the balance of risks and benefits they present as well as their different prospects for generating socially valuable information; these three factors also raise distinct questions of justice. (shrink)

Our drug policy has been widely deemed a failure because the criminalization of drug use has not succeeded in reducing prevalence rates. I contend that the most promising basis to defend the justifiability of drug offenses is to construe them as proxy crimes: offenses designed to prevent the commission of other, more serious crimes. I make a case that many law enforcement officials use drug proscriptions for this purpose in the real world. When construed as (...) proxy crimes, drug prohibitions are less vulnerable to some of the familiar objections brought against their legitimacy. Nonetheless, the justification for punishing those who violate drug proscriptions remains unpersuasive. (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)

Public policy tries to promote appropriate drug use by allowing firms to market drugs in interstate commerce only for uses that the Food and Drug Administration has found to be safe and effective. Because of their medical knowledge, physicians are authorized to prescribe drugs even for uses unapproved by the FDA. Nevertheless, physicians have relied on drug firms for information on appropriate prescribing despite the inherent tension between drug firm dissemination of information to promote sales (...) and rational prescribing. In the past, physicians often relied particularly on drug firm advertising for information on drug use. Today, physicians rely on drug firms to finance continuing medical education. A historical review reveals connections between these two different ways commercial interests have influenced the information that physicians receive and points the way to needed reforms. (shrink)

This article explores morality and credibility struggles in connection to two officially sanctioned public Swedish experiments launched in the late 1960s to investigate the (ab)use of alcohol and illicit drugs, especially in relation to young people, and the subsequent decisions to terminate the experiments and research. We argue that these 1960s struggles on how to analyze the effects of increased availability of psychoactive substances must be understood in the light of a simultaneous development of modern (social) science studies. The public (...) display of conflicting expert views on how to investigate and interpret questions of alcohol and drugs in modern society played out in concordance with the growth of social science alcohol and drug research and expertise. The article focuses on the 1960s, a decade that was characterized by profound transformations in Swedish society. In so doing, the article contributes from the perspective of history to debates on the nexus between knowledge production and policy in modern societies. (shrink)

This article examines how the EU gender mainstreaming approach has addressed work and family reconciliation across Southern Italian regions, to foster a more egalitarian and socially inclusive development. Drawing upon a survey of women of different socioeconomic backgrounds and in-depth interviewing of regional policy-makers, this article assesses what gender equality policies do and don’t do for work–family reconciliation within the Italian Mezzogiorno. Findings show that while poor women may be stigmatized as inadequate mothers, middle-class women are pushed (...) to join men in employment and civic sphere at the expense of caring. As both public and private caring supply is underdeveloped and unevenly guaranteed between protected and unprotected workers, women may be constrained to reduce their participation in the labour market. Traditional gendered family roles and power relations within the household may further discourage women to work, form and maintain a family. (shrink)

Historically, laws and policies to criminalize drug use or possession were rooted in explicit racism, and they continue to wreak havoc on certain racialized communities. We are a group of bioethicists, drug experts, legal scholars, criminal justice researchers, sociologists, psychologists, and other allied professionals who have come together in support of a policy proposal that is evidence-based and ethically recommended. We call for the immediate decriminalization of all so-called recreational drugs and, ultimately, for their timely and appropriate (...) legal regulation. We also call for criminal convictions for nonviolent offenses pertaining to the use or possession of small quantities of such drugs to be expunged, and for those currently serving time for these offenses to be released. In effect, we call for an end to the “war on drugs.”. (shrink)

The prelims comprise: Introduction 1 Should I Use Drugs? Is the State Justified in Punishing Drug Users? Conclusion References Further Reading.