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Background: Nazi Germany surrendered to the Allies on May 8, 1945. Six months later, the Allies tried the surviving leaders of Nazi Germany at the first Nuremberg trial. Later, the United States conducted 12 additional trials. The first one, The Unites States of America versus Karl Brandt et al., has been dubbed the Doctors' Trial. During the trial, the prosecution relied on the testimony of Dr. Andrew Ivy and Dr. Leo Alexander. At the end of the trial, Judge Sebring enunciated 10 principles needed to conduct human subject research-the Nuremberg Code. Authorship of the Code has been the subject of dispute, with both Ivy and Alexander claiming sole authorship., Methods: In the summer of 2017, I visited Duke University Medical Center's Archives and surveyed the contents of boxes labeled "Alexander's papers." I also explored online databases with information on the Doctors' Trial. Pertinent documents were compared across collections, and against scholarly works on the topic., Results: Box 3 of Alexander's papers at Duke University Medical Center's Archives contains a three-page document with six principles that, nearly word for word, were included in what is known as the Nuremberg Code. Alexander's name and appointment are typed at the end of the document., Conclusions: Although the Nuremberg Code is likely to have been an unplanned collaboration among members of the prosecuting team and the judges, I present evidence suggesting that Alexander drafted the blueprint and was the main contributor to the final version of the Code., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation., Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020., Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry., Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products., Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

When stillbirth registration became mandatory in England and Wales in 1926, it was not to amass statistics in the service of public health. Instead, it was part of broader anxieties that victims of infanticide were being disposed of under the guise of having been stillborn. But because it necessitated distinguishing between the living and the dead, the legislation that introduced stillbirth registration generated debate about the definition of life itself. This focused both on what counted as a sign of life and on questions about the viability of preterm infants. These contentious disputes had serious repercussions for the treatment of premature births well into the twentieth century. Significantly, they also underscore that what classifies a person as dead or alive is never self-evident. Instead, the state's authorized definition of life is under permanent negotiation as it is always mobilized in the service of particular regimes of power.

This paper explores the role of medicine in the regulation of legal gender recognition for trans and gender diverse people in France and Italy. I focus on the processes that led the two countries to establish for the first time a procedure for legal gender change in the 1980s/1990s. Despite the differences, both in France and in Italy medical knowledge and technologies were embedded in the procedures for legal gender change and health professionals took a role as gatekeepers to gender recognition. The medicalization of legal gender recognition, I argue, was part of the deploying of a bio-political apparatus that aimed at regulating and controlling "gender transitions" through regulation and normalization rather then through repression., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Prenatal diagnosis (PND) was introduced in France in the 1970s on the initiative of medical researchers and clinicians. For many years the regulation of practices was self-imposed, decentralised and idiosyncratic. The advent of 'therapeutic modernity' in the 1990s gave rise to an ethical, legal and scientific framework designed to homogenise PND at a national level, with the creation of multidisciplinary centres (CPDPN) and the Agence de la biomédecine. This article first recovers the history of PND in France. It then compares the activities of two CPDPNs, using ethnographic fieldwork and by analysing national quantitative data compiled by the Agence. It argues that the official policy of nationally homogeneous practices is not born out in practice, at the local level. This lack of homogeneity is most apparent in the number of authorisations for pregnancy termination due to foetal malformation, which varies considerably from one centre to another. Rooted in local culture, this variation relates to organisational methods, decision-making processes and variable levels of tolerance towards the risk of disability. Foetal medicine practitioners, thus, maintain a certain amount of autonomy that is collective rather than individual and that is reflected in the particular 'identity' of a given centre.

In 1920 in France, a law was passed prohibiting abortion, the sale of contraceptives and 'anti-conception propaganda'. While contraception was legalised in 1967 and abortion in 1975, 'anti-natalist propaganda' remained forbidden. This article takes seriously the aim of the French state to prevent the circulation of information for demographic reasons. Drawing from government archives, social movement archives and media coverage, the article focuses on the way the propaganda ban contributed to shaping the public debate on contraception as well as lastingly impacting the ability of the state to communicate on the subject. It first shows how birth control activists challenged the legal interdiction against communicating about contraception (1956-67) without questioning the natalist obligation. It then shows how, after 1968, communication on contraception became a power struggle carried out by various actors (sexologists and feminist and leftist activists) and how the dissemination of information about contraception was thought of as a way to challenge moral and social values. Finally, the article describes the change of state communication policies in the mid-1970s, leading to the first national campaign on contraception launched in 1981, which defined information as a task that women should take on.

On January 31, 2018, advance directives law has come into effect in Italy. It is a law that grants the right to any individual of full age to express his or her preferences regarding treatment in anticipation of the days when he or she might be unable to do so. In France, however, two years after its entry into effect, the Claeys-Leonetti law is increasingly under attack. Some are even calling for a new end-of-life legislation altogether. A discussion of the Italian case, focused on the debates that led to the approval of this new legislation, can help us re-contextualize the French case. While there are many similarities between the two laws, their differences in terms of practices and intellectual frameworks may suggest additional avenues of thinking and help improve end-of-life conditions., (© 2019 médecine/sciences – Inserm.)

The article deals with the regulatory and jurisprudential evolution of medical criminal responsibility from the 70s to the Gelli-Bianco law of 2017. Subsequently it winds through the contribution of the last important judgments of the subject up to the decisions of the Supreme Court with United Sections of 2018, finally to conclude with an economic analysis on the increasement of the legal disputes registered in recent years., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

In 1928 members of the South Dakota State Medical Association (SDSMA or the Association) held a special meeting in Huron to consider a basic science bill that conformed "…in its entirety to the conditions existing in our state." Their draft bill proposed a standardized examination for all practitioners of the healing arts. A legislative committee, with its attorney, "…was in Pierre during the early part of the 1929 legislative session to make sure the bill was properly launched and in effective channels." Shortly after its introduction, the bill was withdrawn due to opposition from one SDSMA district whose legislative representatives were among the most influential in the legislature. A similar bill promoted by the SDSMA in 1933 also failed. It would be another six years before a basic science bill was enacted by the legislature. Eighty-nine years later, a bill governing the practice of certified nurse practitioners (NP) and certified nurse midwives (NM), including a board independent of the South Dakota Board of Medical and Osteopathic Examiners, was considered (Senate Bill 61). Introduced by a senator who characterized herself as representing the "House of Nursing," the bill challenged "…the overarching role that medicine thinks and perceives that they may have regarding advanced practice nursing practice." SB 61 passed in the senate and house and was signed by the governor. For this legislation in the 1930s and in 2017, the SDSMA's interest was defining and maintaining control of medical practice under the twin rubrics of quality and patient welfare. In both circumstances, legislators and other health care professional organizations contested not only the SDSMA's motivations, but also the evidence supporting their efforts. Our research explored (1) whether the collective viewpoints and conduct of the legislature, the SDSMA, and non-physician medical professionals are comparable in the two circumstances; and (2) if the circumstances are comparable, can we derive a useful concept or theme that could help guide the SDSMA in the future?, (Copyright© South Dakota State Medical Association.)

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management., (Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

In May 1892, Belgium adopted a law on the exercise of hypnotism. The signing of the law constituted a temporary endpoint to six years of debate on the dangers and promises of hypnotism, a process of negotiation between medical doctors, members of parliament, legal professionals and lay practitioners. The terms of the debate were not very different from what happened elsewhere in Europe, where, since the mid 1880s, hypnotism had become an object of public concern. The Belgian law was nevertheless unique in its combined effort to regulate the use of hypnosis in public and private, for purposes of entertainment, research and therapy. My analysis shows how the making of the law was a process of negotiation in which local, national and transnational networks and allegiances each played a part. While the transnational atmosphere of moral panic had created a seedbed for the law, its eventual outlook owed much to the powerful lobby work of an essentially local network of lay magnetizers, and to the renown of Joseph Delbœuf, professor at the University of Liège, whose work in the field of hypnotism stimulated several liberal doctors and members of Parliament from the Liège region to defend a more lenient law.

Since the establishment of People's Republic of China in 1949, the Chinese government has encountered several catastrophes related to transfusion transmitted diseases. The government's increasing attention to blood safety has prompted the initiation of a series of policies and measures that have enhanced the level of safety for the blood supply and met the basic clinical demands of blood for 1.3 billion people in the country. Blood donation screening strategies in China predominantly comprise donor screening and donor testing. Donor screening includes selection of low-risk blood donors by the use of a donor history questionnaire, predonation physical examination, and initial rapid donor testing. Donor testing includes direct pathogen detection and serology tests. The year 1998 marked the most transformative change in blood donor selection and screening policies in China. Before 1998, paid donation was the predominant mode of blood donation. Donor screening and donor testing were conducted before donation, and only those who were eligible were allowed to donate. To ensure the safety of blood, donor testing was performed again after donation. After the implementation of the Blood Donation Law in 1998, to promote voluntary and unpaid donation, predonation donor testing was eliminated to reduce the amount of waiting time and to provide a more convenient donation experience for blood donors. However, it is the national requirement that donated blood should undergo 2 rounds of testing using different equipment or reagents, conducted by different personnel. Donor selection has transitioned from paid donation and obligatory donation to voluntary donation with fixed volunteer groups, as the latter mode of donation provides the lowest risks. Donations are currently screened for syphilis, hepatitis C virus, HIV, and hepatitis B virus (HBV). Units, previously typed only for ABO, are now routinely tested for both ABO and Rh(D). Innovations in testing technologies and methods have also brought changes to screening parameters. For instance, screening for HBV pathogens evolved from the early use of hemagglutination method to the later use of radioimmunoassay, independent enzyme-linked immunosorbent assay, and now the widespread application of nucleic acid test (NAT). Since 2010, the Chinese government has established NAT capacity in several blood centers; and in 2015, the government invested 900 million RMB on the nationwide expansion of NAT. Although the Chinese government has worked to enhance blood safety, many challenges remain. Concern exists for rising rates of HIV infection. The existence of occult HBV infection and the transmission of emerging blood-borne diseases continue to challenge the safety of the blood supply., (Copyright © 2017 Elsevier Inc. All rights reserved.)

This paper explores the settlement process of one of the most common home diagnostic tools currently in use, the home pregnancy test. The controversial new device appeared to threaten the jurisdiction of both doctors and Food and Drug Administration regulations, while it aligned with the women's health movement's goals. But this study finds a more nuanced narrative: one of boundaries and positions that at once were blurry, later shifted, and were ultimately aligned without compromising the credibility of doctors or the legal system. To understand this process, the roles of court decisions and regulations are explained by stages of juris-technical accordance. In this case, rather than restricting technological innovation, legal innovation provided pathways for widespread acceptance of the home pregnancy test by various groups. As more tools move from expert users to layperson users, this paper demonstrates the utility of examining existing juris-technical assemblages as we consider the future of self-monitoring and self-diagnosis.

This article traces the genealogy of the category of 'abnormals' in psychiatry. It focuses on the French alienist Felix Voisin (1794-1872) who played a decisive role in the creation of alienist knowledge and institutions for problem children, criminals, idiots and lunatics. After a presentation of the category of 'abnormals' as understood at the end of the nineteenth century, I identify in the works of Voisin a key moment in the concept's evolution. I show how, based on concepts borrowed from phrenology and applied first to idiocy, Voisin allows alienism to establish links between the medico-legal (including penitentiary) and medical-educational fields (including difficult childhood). I stress the extent to which this enterprise is related to Voisin's humanism, which claimed to remodel pedagogy and the right to punish on the anthropological particularities of individuals, in order to improve them., (© The Author(s) 2015.)

In regulating the voluntary interruption of pregnancy, English law has accorded particular significance to two biological events. First, 'viability', the moment when a fetus is said to acquire the capacity for independent life, plays an important role in grounding restrictions on access to legal abortion later in pregnancy. Second, equally significantly but far less frequently discussed, 'implantation' marks the point in pregnancy from which abortion laws apply. This paper focuses on this earlier biological event. It suggests that an unquestioning reliance on implantation as marking an appropriate moment of transition between two radically different legal frameworks is deeply problematic and is rendered still less sustainable in the light of the development of new technologies that potentially operate shortly after the moment of implantation., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Introduction: Charles Lucas, apothecary, physician and MP, was instrumental in facilitating legislation in Ireland in 1765 that established a nationwide network of hospitals in Ireland. This legislation was unique in contemporary Europe, and by the end of the century, there was a hospital in every county in the country., Materials and Methods: His work as an apothecary provided him with the knowledge to attempt to address the problems in the apothecaries' trade, and his 1741 pamphlet, Pharmacomastix, provided the framework for the 1761 Irish Apothecaries Act, which attempted to address these issues. It was, however, 1791 before nationwide regulation of the Irish apothecaries' trade was implemented following the establishment of the Apothecaries Hall, and this was 24 years before similar regulatory legislation was passed in Britain. Lucas sought enhanced regulation of the apothecaries' trade to provide better quality drugs and medicines for the general public, and he tried to ensure that untrained quacks did not practise as apothecaries, unbeknownst to their patients. He was aware that his proposals would meet with opposition, but he had the courage to pursue these without any element of personal gain., Conclusion: In medical terms, Charles Lucas was man ahead of his time.

The article describes laws and regulations concerning the Russian army and navy, and accordingly its medical services accepted during the reign of Paul I. During this period different decrees aimed to improve medical personnel training in order to admit students to medical and surgical schools, reorganization of educational medical institutions, improving of professional skills of medical workers. Other decrees, aimed to improvement of recruitment of medical personnel of troops: the best students of <> had to be sent to troops instead physician assistant, medical staff increase and additional funding, countering the reduce of physicians' social welfare due to the inhumane attitude of the authorities, to regulate of the military medical service rotation order as well as assessment of their professional, moral, and psychological qualities.

When Napoleon the 3d's government turned to its liberal phase, dissatisfactions felt free to become visible, among which the problems engendered by the law of 1838 about the situation of mental patients; during the 60s, a novelist, Hector Malot; a doctor, Léopold Turck; a jurist, Théophile Huc, tried to amend it.

The article describes the considerations that were carried out by Polish psychiatrists and neurologists in the thirties of the twentieth century, due to the sterilization of persons with mental disorders. The paper presents a short history of sterilization laws in the world. The reaction to the German Law for the Prevention of Hereditary Diseased Offspring (1933) among Polish psychiatrists was presented. The views of psychiatrists and neurologists to the proposed sterilization law in Poland were also outlined. Two projects of eugenic laws in Poland came from psychiatrists. Sterilization Law in Poland ultimately was enacted.

The Emergency Medical Treatment and Active Labor Act (EMTALA) is a seminal law that imposes screening, stabilization, and transfer duties on all Medicare-participating hospitals that have emergency departments. More than twenty-five years after its enactment, EMTALA continues to generate controversy over the scope and depth of its obligations on issues ranging from the nature of the screening obligation and rules regarding on-call specialists to whether EMTALA's stabilization protections exclude emergency inpatients. Despite ongoing questions that flow from its detailed provisions, EMTALA is an enduring testament to society's evolving views that hospitals must provide emergency care not only to their established patients but to the broader communities they serve.

This Article examines Americans' enduring demand for freedom of therapeutic choice as a popular constitutional movement originating in the United States' early years. In exploring extrajudicial advocacy for therapeutic choice between the American Revolution and the Civil War, this piece illustrates how multiple concepts of freedom in addition to bodily freedom bolstered the concept of a constitutional right to medical liberty. There is a deep current of belief in the United States that people have a right to choose their preferred treatments without government interference. Modern American history has given rise to movements for access to abortion, life-ending drugs, unapproved cancer treatments, and medical marijuana. Recently, cries of "Death Panels" have routinely been directed against health care reform proposals that citizens believe would limit the products and procedures covered by government health insurance. Some of the most prominent contemporary struggles for health freedom have been waged in court. But other important recent battles for freedom of therapeutic choice have taken place in other forums, from legislative hearings to Food and Drug Administration advisory committee meetings to public demonstrations. This attitude of therapeutic libertarianism is not new. Drawing mainly on primary historical sources, this Article examines arguments in favor of freedom of therapeutic choice voiced in antebellum America in the context of battles against state licensing regimes. After considering some anti-licensing arguments made before independence, it discusses the views and statements of Benjamin Rush, an influential founding father who was also the most prominent American physician of the early national period. The Article then analyzes the Jacksonian-era battle against medical licensing laws waged by the practitioners and supporters of a school of botanical medicine known as Thomsonianism. This triumphant struggle was waged in explicitly constitutional terms, even though it occurred entirely outside of the courts. The Thomsonian campaign thus offers one of the most striking examples of a successful popular constitutional movement in American history. This article shows that, at its origin, the American commitment to freedom of therapeutic choice was based on notions of not only bodily freedom, but also economic freedom, freedom of conscience, and freedom of injury. Finally, this Article considers ways in which this early history helps illuminate the nature of current struggles for freedom of therapeutic choice.

The Liberal government in 1911 was determined to improve the health care of the poor and working class in Britain. The Chancellor of the Exchequer, Lloyd George, introduced a National Insurance Bill before Parliament without consulting the medical profession. The doctors were furious but Horsley, a progressive liberal, was firmly in favour of a national health service and vociferously supported the bill. This led to a series of acrimonious meetings that did not enhance the reputation of the profession and alienated Horsley from his colleagues.

In its initial years, the nascent Turkish republic established the Ministry of Health and Social Assistance in order to promote public health. Beyond simply facilitating its modernizing agenda for the emergent nation-state as it sought to define itself against an Ottoman past, this institution was also geared toward remedying a self-defined population crisis by prioritizing and confronting particular diseases and health conditions. One of the maladies of utmost concern was syphilis. Based upon an analysis of official primary sources, this article engages with how the developing republic distinguished and consequently politically constructed-or framed-the syphilis problem from the vantage of its new forward capital, Ankara. Integral to this project of confronting this sexually transmitted disease, public health officials projected upon both this ailment and their understanding of the suitable means for its treatment their own views of what constituted appropriate sexual practices and relations. In doing so, certain subgroups of the population, especially prostitutes, were particularized as targets for surveillance and policing through regimes of licensing and compulsory medical examinations. Stemming from the state's framing of the disease-and its definition of appropriate sexual practices-this article also examines the subsequent legislative and public health education projects that followed.

The Code of Šibenik dates back to the 13th century and is impressive inasmuch as it pays a lot of attention to health culture issues. It brings a number of hygienic and sanitary measures such as the ban to keep pigs in the town, to throw "filth and decay" on public roads, to unload and sell fish in places not intended for selling, to display and sell meat outside butcheries, to skin animals outside butcheries, to sell carrion meat, and the order to bakers to bake bread thoroughly. It pays particular attention to public bodies of water such as ponds and to watersupply, and the town subsidised half the welling costs. In respect to general health protection, the Code banned corpse kissing to prevent infections, and graves were removed from the town centre for the same reason (because they "stank"). The "insane" and "simple minded" could not close legal deals. The fact that the town employed a trained physician - medicus - (in addition to a barber) suggests that it was the physician's job to decide who of the townspeople belonged to the category of the mentally challenged.

Aim:   This paper provides a historical overview of licensing law in Scotland. It seeks to put important contemporary policy developments into their historical context and to draw attention to key themes in licensing policy debates across the United Kingdom., Design:   Based on a survey of statutes, commissions of enquiry and consumption and retail data, this paper draws together historical evidence to present a synopsis of Scottish licensing history., Settings:   The article focuses on Scotland, but also discusses UK-wide licensing policy over a 250-year period., Findings:   Scottish licensing has diverged from licensing in England and Wales and has addressed some historical licensing weaknesses, including problems of accountability, overprovision and systemic oversight regarding off-sales. Distinctive features of current Scottish legislation include public health protection as a statutory licensing objective; local Licensing Forums and Licensing Standards Officers; a requirement for explicit policies on the 'overprovision' of licensed premises; mandatory restrictions on price promotions in the on- and off-trades; and limitations on opening hours for off-licences., Conclusion:   Scotland has developed alcohol policies several times addressing long-standing licensing weaknesses throughout the United Kingdom. Some Scottish alcohol policies have later become the norm in England and Wales., (© 2012 The Author, Addiction © 2012 Society for the Study of Addiction.)