This article evaluates New Zealand’s Medicines Amendment Bill 2011. This Bill is currently before Parliament and will amend the Medicines Act 1981. On June 20, 2011, the Australian and New Zealand governments announced their decision to proceed with a joint scheme for the regulation of therapeutic products such as medicines, medical devices, and new medical interventions. Eventually, the joint arrangements will be administered by a single regulatory agency: the Australia New Zealand Therapeutic Products Agency. The medicines (...) regulations in Australia and New Zealand will be updated as part of this process. The Medicines Amendment Bill addresses some of the well-recognised deficiencies in the Medicines Act 1981. However, a comprehensive overhaul of the Act is not being undertaken. I argue that repealing and replacing the Medicines Act 1981 would be preferable and advisable, given the number of legal difficulties with the Act and, in particular, where it does not align with equivalent current international law. (shrink)

Educational Legislation and Administration of the Colonial Governments is an unchanged, high-quality reprint of the original edition of 1899. Hansebooks is editor of the literature on different topic areas such as research and science, travel and expeditions, cooking and nutrition, medicine, and other genres. As a publisher we focus on the preservation of historical literature. Many works of historical writers and scientists are available today as antiques only. Hansebooks newly publishes these books and contributes to the preservation of literature (...) which has become rare and historical knowledge for the future. (shrink)

Governments are increasingly inviting patient organizations to participate in healthcare policymaking. By inviting POs that claim to represent patients, representation comes into being. However, little is known about the circumstances under which governments accept POs as patient representatives. Based on the analysis of relevant legislation, this article investigates the criteria that self-help organizations, a special type of PO, must fulfil in order to be accepted as patient representatives by governments in Austria and Germany. Thereby, it aims to contribute to (...) the discussion on the role of governments in steering SHOs. There are different degrees of regulation. Governments in both countries not only formulate explicit criteria for SHOs with respect to patient representation but also guide SHOs representing patients through implicit criteria for associations. We discuss the findings against concepts of responsiveness, authorization, and accountability. Our findings indicate that governmental steering is not negative per se as indicated by previous research but—depending on legislative criteria—can promote transparency and democratic quality in patient representation. (shrink)

Governments are increasingly inviting patient organizations to participate in healthcare policymaking. By inviting POs that claim to represent patients, representation comes into being. However, little is known about the circumstances under which governments accept POs as patient representatives. Based on the analysis of relevant legislation, this article investigates the criteria that self-help organizations, a special type of PO, must fulfil in order to be accepted as patient representatives by governments in Austria and Germany. Thereby, it aims to contribute to (...) the discussion on the role of governments in steering SHOs. There are different degrees of regulation. Governments in both countries not only formulate explicit criteria for SHOs with respect to patient representation but also guide SHOs representing patients through implicit criteria for associations. We discuss the findings against concepts of responsiveness, authorization, and accountability. Our findings indicate that governmental steering is not negative per se as indicated by previous research but—depending on legislative criteria—can promote transparency and democratic quality in patient representation. (shrink)

An anthology of original and reprinted articles expressing views on all aspects of the subject of abortion.

Written by one of Ireland's leading medical law academics, this practical book comprehensively covers case law and regulations regarding the healthcare system, the law relating to human reproduction, and the key issues of consent and treatment. Designed to be used by lawyers and healthcare professionals, Medicine, Ethics and the Law in Ireland provides an invaluable reference tool for anybody who requires accurate information and guidance on this area of Irish law. This new edition includes: Medical research and clinical trials; Organ (...) donation and transportation; Patient safety and QA; and Biobanking. (shrink)

Medicine, Power, and the Law demonstrates that criminal and civil justice interact with medicine and public health more than is presently understood. The book focuses on the role of healthcare practitioners and an array of other professionals across industries in identifying wrongdoers, reporting behavior, and testifying on behalf of the state or government agencies. It also covers circumstances in which law enforcement relies on medicine for evidence or support in ways that compromise medical ethics. By reporting or testifying as experts, (...) a range of people, from specialist pediatricians to flight attendants, can have a life-changing impact on individuals in the name of public health or medicine. People who work in hospitals, social work settings, and even airlines, often contribute to wrongful and aggressive criminal and civil actions against society's most vulnerable people, including parents, older adults, and people living with poverty. The book explores a number of examples, including police use of medicine as a restraint or the collection of blood as evidence and the risks of opting out of certain scientific discoveries, such as pharmaceuticals. It describes the harms that may come to those who engage in suboptimal but generally heretofore legal child-raising behaviors, and people opting to live independently as older adults. These can lead to civil and criminal charges when noticed by those in a position of power. Medicine, Power, and the Law is an important contribution for researchers and practitioners in medicine, the law, and the expanding field of bioethics. (shrink)

This book examines the relationship between law and scientific advancement, with a particular focus on the theory of evolution and medical innovation. Historically, the law has struggled to keep pace with modern medical advances. The authors demonstrate that the laws that govern human behaviour must evolve in response to such advances."--Provided by publisher.

This is the second of the annual series on medical law and ethics, based on lectures given at the Centre for Medical Law and Ethics at King's College, London. The contributors, who come from a wide range of disciplines and represent diverse interests, review important issues in the forefront of recent controversy.

Until approximately twenty years ago, advances in the study of human genetics had little influence on the practice of medicine. In the 1980s, this changed dramatically with the mapping of the altered genes that cause cystic fibrosis and Huntington disease. In just a few years, these discoveries led to DNA-based tests that enabled clinicians to determine whether prospective parents were carriers of CF or whether an individual carried the Huntington gene and, as a result, would almost certainly develop the disease.Observers (...) interested in the social and economic implications of genetic technology realized that such genetic tests could be used by insurance companies to predict which insurance applicants were likely to become ill or even die from these diseases. (shrink)

Until approximately twenty years ago, advances in the study of human genetics had little influence on the practice of medicine. In the 1980s, this changed dramatically with the mapping of the altered genes that cause cystic fibrosis and Huntington disease. In just a few years, these discoveries led to DNA-based tests that enabled clinicians to determine whether prospective parents were carriers of CF or whether an individual carried the Huntington gene and, as a result, would almost certainly develop the disease.Observers (...) interested in the social and economic implications of genetic technology realized that such genetic tests could be used by insurance companies to predict which insurance applicants were likely to become ill or even die from these diseases. (shrink)

Serious concerns about pervasive, persistent, and unjustified social inequalities have prompted a small—but growing—number of academic commentators to raise some hard and troubling questions for those who would like to legalize physician-assisted suicide. In various ways, these commentators have asked: In light of existing social inequalities—inequalities that operate, for example, along sometimes intersecting lines of race, class, age, sex, and disability—how persuasive are autonomy-based arguments in favor of legalization of assisted suicide when those arguments depend on a conception of autonomy (...) that either presupposes social equality or does not expressly account for its absence? How compelling are arguments that we ought to legalize assisted suicide out of feelings of mercy for the sick and dying, when such affective expressions may actually be the socially acceptable manifestation of private ambivalence that includes merciless discrimination? (shrink)

Serious concerns about pervasive, persistent, and unjustified social inequalities have prompted a small—but growing—number of academic commentators to raise some hard and troubling questions for those who would like to legalize physician-assisted suicide. In various ways, these commentators have asked: In light of existing social inequalities—inequalities that operate, for example, along sometimes intersecting lines of race, class, age, sex, and disability—how persuasive are autonomy-based arguments in favor of legalization of assisted suicide when those arguments depend on a conception of autonomy (...) that either presupposes social equality or does not expressly account for its absence? How compelling are arguments that we ought to legalize assisted suicide out of feelings of mercy for the sick and dying, when such affective expressions may actually be the socially acceptable manifestation of private ambivalence that includes merciless discrimination? (shrink)

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

Assisted reproduction (ART), particularly that performed using donated gametes, increases the prospect of healthy babies being delivered to increasing numbers of people striving for parenthood. The psychosocial, ethical and legislative issues related both to the donation and receipt of gametes are perceived as extraordinarily complicated. In 2009, a research project aimed at mapping the issues was drawn up and implemented in the Czech Republic. The project should have provided material for consultation purposes, for the work of ethical and legislative bodies, (...) and for better interdisciplinary and international communication in reproductive medicine. Work on the project was affected by several unforeseen events, particularly by the drafting and adoption of a new law on ART (to which the project was initially to have contributed material once concluded). The article describes the dynamic and structural changes occurring within the project due to drafting of the bill as well as the changes and consequences resulting from other circumstances related to the topic researched. (shrink)

SummaryThis article analyses the viewpoints of doctors, patients and the state of the phenomenon of unconventional methods of treatment/alternative medicine in Slovenia. The doctors’ viewpoints are taken from the official documents of the Medical Chamber of Slovenia and the Slovene Medical Association. The patients’ viewpoints are established on the basis of public opinion and epidemiological research, carried out in 1994 and 1996 on two representative samples of the Slovene population from the Celje area. The estimation of the attitude of the (...) state is based on legislation and other regulations connected with alternative medicine. The findings of our analysis show a strongly negative attitude of doctors to any form of alternative medicine. In contrast, as many as half the patients express a favourable opinion on alternative methods of treatment, and more than a third of them actually make use of them. From existing laws it is evident that the state in general does not deal with alternative medicine, except for possibilities in such cases when a doctor or some other healthcare professional uses alternative methods of treatment. Alternative medicine is, from the point of view of social medicine, a phenomenon that should be followed, analysed and controlled. Dangerous as well as protective factors which accompany the exceution of alternative methods should be recognised so as to be able to inform the public of the results in a timely and accurate manner. Because of the need for the legal and healthcare security of Slovene citizens, the state should regulate existing unconventional treatments. (shrink)

Genetic-specific nondiscrimination laws have been enacted in most states, but the laws are ineffective and increase the stigma of genetic conditions. Whether these laws are better than no new legislation depends on their consequences and a recognition of their limitations.

One of the most important and contentious policy issues surrounding genetics is whether genetic information should be treated separately from other medical information. The view that genetics raises distinct issues is what Thomas Murray labeled “genetic exceptionalism,” borrowing from the earlier term “HIV exceptional-ism.” The issue of whether the use of genetic information should be addressed separately from other health information is not merely an academic concern, however. Since the Human Genome Project began in 1990, nearly every state has enacted (...) legislation prohibiting genetic discrimination in health insurance; two-thirds of the states have enacted laws prohibiting genetic discrimination in employment, and other state laws have been enacted dealing with genetic discrimination in life insurance, genetic privacy, and genetic testing. Bills in Congress also would prohibit genetic discrimination in health insurance and employment. (shrink)

Some time ago an article was published in this journal relating the difficulties of legislating for InVitro Fertilization in a Catholic country and the issues and side issues which had to be faced. Since then one has approached closer to having a law which regulates this technology. However several issues continue to challenge the country. The main concern, other than IVF not being a natural method of having children is the status of the embryo. The normative values of the country (...) in fact induces politicians to discuss an ‘embryology act’ rather than a ‘reproductive medicine’ act. At the eleventh hour Bishops continue to launch concerns which raises queries on how the debate moved forward over the past two decades. This paper tackles these issues and other more recent concerns and suggestions and takes a look at how such processes can be improved through a more rigorous understanding and logistic of dialogue, as certainly such debates should have implications for bioethics in general. Although the Church’s document Donum Vitae’s instructions for politicians where legislation for this technology has to occur has been vindicated, I seems that whilst many disputes have been resolved, the main conflict—that of the value of the conjugal act—has not. (shrink)

This project tested a two-way model of communication between lay groups and experts about genetic medicine in Perth, Western Australia. Focus group discussion with community group participants was followed by a communication workshop between community group participants and experts. Four groups of concerns or themes emerged from discussion: clinical considerations; legislative concerns; research priorities, and ethical and wider considerations. Community group concerns are not always met by the actions of "experts". This is, in part, because of the differing life-worlds of (...) each group. However, the communication workshop showed the potential of two-way communication for both lay and expert members in understanding the others' viewpoint. Further, the approach developed here offers one possible way for community groups to participate in a substantial way in policy formulation processes. (shrink)

This Major Reference series brings together a wide range of key international articles in law and legal theory. Many of these essays are not readily accessible, and their presentation in these volumes will provide a vital new resource for both research and teaching. Each volume is edited by leading international authorities who explain the significance and context of articles in an informative and complete introduction.

Regulation of Regenerative Medicines: A Global Perspective covers regenerative medicine regulations globally where frameworks have been or are being established. Chapters by discipline include manufacturing, supply chain, pharmacology, pharmacokinetics, toxicology, and combination product.

Kentucky and West Virginia are among the states most severely affected by opioid poisonings and deaths. The legislatures of both states have enacted a broad range of bills intended to address related issues. We present an overview of legislation enacted in 2017 and 2018, along with an approach to analysis of practitioner response to one type of legislation.

Malta traditionally enjoys a Roman Catholic Society, with the official religion of the country being cited in the second article of the constitution. Recently the government proposed to legislate to regulate human reproductive technology, in particular In Vitro Fertilization, which has been practiced for over two decades without controlling legislation. A Parliamentary Committee for social affairs was set up to study the situation inviting most stakeholders. The arguments gravitated mostly on issues of the status of the embryo and the (...) media played a considerable role. At the end of the discussion the Archbishop made a statement which pointed out that IVF involves destruction of embryos and the process stopped. This article examines what caused the deterioration of the process and points favourably towards a way forward within the context of a Catholic Country. (shrink)

Topics discussed in this work are abortion, euthanasia, medical negligence and human experimentation.

PREFACE Ubi bene, ibi patria. The proverb expresses an important feature of this book. 'Being somewhere' necessarily implies an orientation towards ...

This is the first in an annual series of volumes of medical law and ethics based on lectures given at the Centre of Medical Law and Ethics, King's College, London. The contributors, who come from a wide range of disciplines and represent diverse interests, review important issues in the forefront of recent controversy, relating particularly to artificially assisted reproduction and to the Gillick judgement. It is hoped that their essays will stimulate reflection and debate on the ethical and legal issues (...) that surround contemporary medical practice and will inaugurate a series that will come to be viewed as an important source of comment. (shrink)

Government’s responsibility to safeguard the public’s health through law has been part of the social contract since ancient times. Cicero declared salus populi suprema lex esto - “the safety of the people is the supreme law”. Disraeli proclaimed that protecting the public’s health is the first duty of the statesman. Of the ten most important public health achievements of the 20th century in the US., seven are directly related to legal interventions, including legislative interventions. As new and existing risks to (...) health risks emerge internationally, governments have consistently used the law as a tool to define the goals of public health, direct public health authorities to accomplish these goals, and equip them with the power and resources to do so.Tobacco control represents a salient example of how law can be used to ensure health. Like other public health laws, tobacco control laws have historic grounds. Government and other policymakers have enacted laws to control tobacco use for hundreds of years. The Russian church forbade tobacco use as an “abomination.”. (shrink)

Government’s responsibility to safeguard the public’s health through law has been part of the social contract since ancient times. Cicero declared salus populi suprema lex esto - “the safety of the people is the supreme law”. Disraeli proclaimed that protecting the public’s health is the first duty of the statesman. Of the ten most important public health achievements of the 20th century in the US., seven are directly related to legal interventions, including legislative interventions. As new and existing risks to (...) health risks emerge internationally, governments have consistently used the law as a tool to define the goals of public health, direct public health authorities to accomplish these goals, and equip them with the power and resources to do so.Tobacco control represents a salient example of how law can be used to ensure health. Like other public health laws, tobacco control laws have historic grounds. Government and other policymakers have enacted laws to control tobacco use for hundreds of years. The Russian church forbade tobacco use as an “abomination.”. (shrink)

Human and veterinary medicine have many commonalities. The split into distinct disciplines occurred at different times in different places. In Europe, the establishment of the first veterinary universities towards the end of the 18th century was triggered by ravaging rinderpest epidemics and the increasing importance of livestock for draft, food supply, and war fare. Given this background, would it make sense to combine human, animal, traditional and modern medicine in healthcare provision, especially in less developed countries? Such a “one-medicine” approach (...) could enhance biomedical progress, improve the outreach of medical and veterinary services especially in remote areas, offer greater choices to patients, and make healthcare more culturally appropriate. On the other hand, it would require generalists rather than specialists and rare diseases may go unrecognized. The commonalities of human and veterinary medicine and the financial constraints many governments are presently facing are arguments in favor of a “one-medicine” approach, while status thinking, education systems, administrative structures, and legislations hinder its implementation. There are no instant recommendations for the application of one medicine but governments and development professionals need to generate fine-tuned, location-specific healthcare solutions. Advocacy, changes in education and training, the creation of institutional linkages, and the removal of legal barriers could help overcome obstacles. (shrink)