Sev Fluss - Academia.edu (original) (raw)
Papers by Sev Fluss
AIDS & public policy journal
Revue médicale de la Suisse romande, 1992
Revue médicale de la Suisse romande, 1992
Organ Replacement Therapy: Ethics, Justice Commerce, 1991
The World Health Organization (WHO) has had a long and continuing interest in organ transplantati... more The World Health Organization (WHO) has had a long and continuing interest in organ transplantation legislation since 1948 (the year WHO’s Constitution came into force), when a brief summary of what may well have been the first item of national legislation on the subject, a French Decree of 20 October 1947, was reported in the first issue of the International Digest of Health Legislation 1. In 1969, WHO published a survey of legislation on the subject [2] which noted, inter alia, that the Italian Law of 26 June 1967 appeared to be the first statute to address the issue of commerce (it prohibited any form of reward or compensation for living kidney donors). Since then, WHO’s Health Legislation unit, and its counterparts in WHO’s six regional offices, have monitored both national and related international developments. Thus, at the 1989 Ottawa Congress (cited elsewhere in this volume) Fuenzalida-Puelma provided a comprehensive overview of key aspects of the legislation in this area in Latin America [3]. Noting that “the key to organ shortage does not lie in commercialization”, he pointed to legal difficulties that may not be limited to that subcontinent. A particularly apposite comment by Gerson is cited: Ultimately, the potential for organ transplantation will depend not only on advanced medical technology, but also on progress in the legal technology of organ donation [4].
Recueil International De Legislation Sanitaire, 1998
Ethics and the Pharmaceutical Industry, 2005
Advances in medicine depend on innovative and bold clinical research. Much of the progress we hav... more Advances in medicine depend on innovative and bold clinical research. Much of the progress we have seen in the effectiveness and safety of disease treatment, diagnosis, and prevention is the result of intensive research involving human subjects. The pharmaceutical industry has a leading role as a sponsor of clinical research and clinical trials aimed at development of new therapies. There is a consensus that clinical research conducted anywhere in the world should be ethically acceptable as well as scientifically sound. A number of national, regional, interregional, and international ethical documents and norms have been developed during the last five to six years to guide investigators, ethical committees, the pharmaceutical industry, and other sponsors in the ethical conduct of clinical trials. Some of these documents, such as the World Medical Association's Declaration of Helsinki, the World Health Organization's Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects developed by the Council for International Organizations of Medical Sciences (CIOMS), are sets of ethical principles and recommendations, but may become norms if they are included in national regulations and legislation. Others, such as the GCP Guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the EU (European Union) Directive on Clinical Trials, are binding because they have been or will be implemented through national legislation.
Entre nous (Copenhagen, Denmark), 1994
In this article WHO reports on certain laws promulgated in different central and eastern European... more In this article WHO reports on certain laws promulgated in different central and eastern European countries in the early 1990s. Russia has passed a law creating a Coordinating Committee on Problems of the Family Motherhood and Childhood. It brings together governmental agencies public organizations and citizens to identify ways to improve womens status and protection of maternal and child health. Russia has also adopted Legislative Orientations of the Russian Federation concerning the Sanitary Protection of Citizens. For example this law guarantees pregnant women the right to work under conditions adapted to their physiological and sanitary state. A whole chapter is dedicated to family planning and regulation of human procreation. Only women have the right to decide whether to terminate or continue their pregnancy. A law in Kyrgyzstan states that every woman has the right to make her own decisions concerning motherhood. With their consent women also have the right to modern contraceptive methods. Sterilization can only be done with the consent of the woman or for medical reasons. The Counsel of Ministers in the Ukraine adopted a program aiming to improve the condition of women and the family and to protect mothers and children. A Hungarian law does not consider abortion to be a family planning method or a means of fertility control. At the same time it considers family planning to be a right and a duty of parents. It calls for considerable education on the value of health and life the healthy life responsibilities accompanying relations between partners a family life compatible with human dignity and contraceptive methods. Albania first approved family planning activities in May 1992. Romania approved technical norms relative to hormonal contraceptives and to IUDs. In January 1993 Poland passed a law restricting abortion to cases of medical indications fetal death a grave abnormality and illicit acts.
AIDS & public policy journal, 1990
Maryland law review (Baltimore, Md. : 1936), 1989
at Baltimore, commented on the need to examine the "total societal response" to the acquired immu... more at Baltimore, commented on the need to examine the "total societal response" to the acquired immune deficiency syndrome (AIDS) epidemic.' Almost at the same time, the staff of the World Health Organization's (WHO's) Health Legislation Unit in Geneva recognized the need to create and maintain a clearinghouse of significant international, national, and subnational legislative texts dealing with all aspects of AIDS and infection by the human immunodeficiency virus (HIV). Sweden was the first country to introduce legislation on AIDS. Promulgated on March 8, 1983, these regulations made mandatory the reporting of confirmed and suspected AIDS cases to the National Bacteriological Laboratory. 2 Sweden also adopted the first legal instruments dealing with protection against HIV transmission in the health care environment. In March 1985 Sweden's National Board of Occupational Safety and Health (the Board) issued general recommendations "concerning protection against AIDS in the course of the care and administration of patients" along with highly detailed recommendations which laid out "measures to be taken in work entailing a risk of infection with HTLV-III." 3 The Board ad
Journal of Commercial Biotechnology, 2003
Public acceptance of the products of biotechnology is an important issue for the industry. This p... more Public acceptance of the products of biotechnology is an important issue for the industry. This paper looks at relevant academic and policy developments in the field of public understanding of science, which considers the role of science in the public sphere. It traces the interaction of scientists, social scientists and the public in the move from early 'deficit' conceptions of public understanding to more recent positions in which the public are seen as active participants in a variety of contexts for science. These newer conceptualisations could usefully contribute to the biotechnology industry's ongoing task of establishing constructive relations with its various publics.
Science and Engineering Ethics, 2004
The Journal of Law, Medicine & Ethics, 2004
propose in this essay to briefly describe some of the main current stakeholders who issue guidanc... more propose in this essay to briefly describe some of the main current stakeholders who issue guidance on I the ethics of human subjects research. This will be preceded by a very brief historical introduction. Prior to World War 11, as far as I have been able to ascertain, there were no international efforts to regulate human experimentation. National activities were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian Minister of Religious, Educational and Medical Mairs. This was followed by a Circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People's Commissariat for Health of the Russian Socialist Federated Soviet Republic (RSFSR), the main constituent Republic of the then Union of Soviet Socialist Republics, issued an Advisory Resolution on the procedures for testing new medicinal substances and methods which may present a hazard for the health and life of patients. And that is, I believe, the sum total of prewar efforts to regulate human experimentation. As you may well imagine, much has been written about the origins and impact of these early activities. These are no less crucial to the history of human experimentation than the nineteenth century Codes of Thomas Percival in England, William Beaumont in the USA, and Claude Bernard in France. And no less so than the well-known Nuremberg Code of 1947. The best source for material on the Code and its origins remains the 1992 book edited by George Annas and Michael Grodin, The N w ' Doctors and the Nuremberg Code: Human Rights in Human Experimentation. For those of you who do not know the details of this Code, I would remind you that it was promulgated by a U.S. Military Rbunal as part of the final judgement in the so-called "Doctors' Ral" (the "Medical Case") held in Nuremberg in 1946-1947. The Code has been the subject of much scholarly attention, notably at a series of Conferences convened to mark its 50th Anniversary in 1997, e.g. in Nuremberg and Freiburg-im-Breisgau. It is noteworthy that in 1946 the American Medical Association published its first principles of human experimentation, while in 1953 the US Department of Defence issued its then "top-secret" Memorandum on Sev S. Fluss, M.S., is a Senior Adviser at the Council for International Organizations ofMedical Sciences, a nongovernmental organization based at WTlO in Geneva. He was formerly Chief of WHO'S Health Legislation Unit, and is the author of numerous publications in thefields of health legislation and bioethics.
European Journal of Health Law, 1995
AIDS & public policy journal
Revue médicale de la Suisse romande, 1992
Revue médicale de la Suisse romande, 1992
Organ Replacement Therapy: Ethics, Justice Commerce, 1991
The World Health Organization (WHO) has had a long and continuing interest in organ transplantati... more The World Health Organization (WHO) has had a long and continuing interest in organ transplantation legislation since 1948 (the year WHO’s Constitution came into force), when a brief summary of what may well have been the first item of national legislation on the subject, a French Decree of 20 October 1947, was reported in the first issue of the International Digest of Health Legislation 1. In 1969, WHO published a survey of legislation on the subject [2] which noted, inter alia, that the Italian Law of 26 June 1967 appeared to be the first statute to address the issue of commerce (it prohibited any form of reward or compensation for living kidney donors). Since then, WHO’s Health Legislation unit, and its counterparts in WHO’s six regional offices, have monitored both national and related international developments. Thus, at the 1989 Ottawa Congress (cited elsewhere in this volume) Fuenzalida-Puelma provided a comprehensive overview of key aspects of the legislation in this area in Latin America [3]. Noting that “the key to organ shortage does not lie in commercialization”, he pointed to legal difficulties that may not be limited to that subcontinent. A particularly apposite comment by Gerson is cited: Ultimately, the potential for organ transplantation will depend not only on advanced medical technology, but also on progress in the legal technology of organ donation [4].
Recueil International De Legislation Sanitaire, 1998
Ethics and the Pharmaceutical Industry, 2005
Advances in medicine depend on innovative and bold clinical research. Much of the progress we hav... more Advances in medicine depend on innovative and bold clinical research. Much of the progress we have seen in the effectiveness and safety of disease treatment, diagnosis, and prevention is the result of intensive research involving human subjects. The pharmaceutical industry has a leading role as a sponsor of clinical research and clinical trials aimed at development of new therapies. There is a consensus that clinical research conducted anywhere in the world should be ethically acceptable as well as scientifically sound. A number of national, regional, interregional, and international ethical documents and norms have been developed during the last five to six years to guide investigators, ethical committees, the pharmaceutical industry, and other sponsors in the ethical conduct of clinical trials. Some of these documents, such as the World Medical Association's Declaration of Helsinki, the World Health Organization's Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects developed by the Council for International Organizations of Medical Sciences (CIOMS), are sets of ethical principles and recommendations, but may become norms if they are included in national regulations and legislation. Others, such as the GCP Guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the EU (European Union) Directive on Clinical Trials, are binding because they have been or will be implemented through national legislation.
Entre nous (Copenhagen, Denmark), 1994
In this article WHO reports on certain laws promulgated in different central and eastern European... more In this article WHO reports on certain laws promulgated in different central and eastern European countries in the early 1990s. Russia has passed a law creating a Coordinating Committee on Problems of the Family Motherhood and Childhood. It brings together governmental agencies public organizations and citizens to identify ways to improve womens status and protection of maternal and child health. Russia has also adopted Legislative Orientations of the Russian Federation concerning the Sanitary Protection of Citizens. For example this law guarantees pregnant women the right to work under conditions adapted to their physiological and sanitary state. A whole chapter is dedicated to family planning and regulation of human procreation. Only women have the right to decide whether to terminate or continue their pregnancy. A law in Kyrgyzstan states that every woman has the right to make her own decisions concerning motherhood. With their consent women also have the right to modern contraceptive methods. Sterilization can only be done with the consent of the woman or for medical reasons. The Counsel of Ministers in the Ukraine adopted a program aiming to improve the condition of women and the family and to protect mothers and children. A Hungarian law does not consider abortion to be a family planning method or a means of fertility control. At the same time it considers family planning to be a right and a duty of parents. It calls for considerable education on the value of health and life the healthy life responsibilities accompanying relations between partners a family life compatible with human dignity and contraceptive methods. Albania first approved family planning activities in May 1992. Romania approved technical norms relative to hormonal contraceptives and to IUDs. In January 1993 Poland passed a law restricting abortion to cases of medical indications fetal death a grave abnormality and illicit acts.
AIDS & public policy journal, 1990
Maryland law review (Baltimore, Md. : 1936), 1989
at Baltimore, commented on the need to examine the "total societal response" to the acquired immu... more at Baltimore, commented on the need to examine the "total societal response" to the acquired immune deficiency syndrome (AIDS) epidemic.' Almost at the same time, the staff of the World Health Organization's (WHO's) Health Legislation Unit in Geneva recognized the need to create and maintain a clearinghouse of significant international, national, and subnational legislative texts dealing with all aspects of AIDS and infection by the human immunodeficiency virus (HIV). Sweden was the first country to introduce legislation on AIDS. Promulgated on March 8, 1983, these regulations made mandatory the reporting of confirmed and suspected AIDS cases to the National Bacteriological Laboratory. 2 Sweden also adopted the first legal instruments dealing with protection against HIV transmission in the health care environment. In March 1985 Sweden's National Board of Occupational Safety and Health (the Board) issued general recommendations "concerning protection against AIDS in the course of the care and administration of patients" along with highly detailed recommendations which laid out "measures to be taken in work entailing a risk of infection with HTLV-III." 3 The Board ad
Journal of Commercial Biotechnology, 2003
Public acceptance of the products of biotechnology is an important issue for the industry. This p... more Public acceptance of the products of biotechnology is an important issue for the industry. This paper looks at relevant academic and policy developments in the field of public understanding of science, which considers the role of science in the public sphere. It traces the interaction of scientists, social scientists and the public in the move from early 'deficit' conceptions of public understanding to more recent positions in which the public are seen as active participants in a variety of contexts for science. These newer conceptualisations could usefully contribute to the biotechnology industry's ongoing task of establishing constructive relations with its various publics.
Science and Engineering Ethics, 2004
The Journal of Law, Medicine & Ethics, 2004
propose in this essay to briefly describe some of the main current stakeholders who issue guidanc... more propose in this essay to briefly describe some of the main current stakeholders who issue guidance on I the ethics of human subjects research. This will be preceded by a very brief historical introduction. Prior to World War 11, as far as I have been able to ascertain, there were no international efforts to regulate human experimentation. National activities were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian Minister of Religious, Educational and Medical Mairs. This was followed by a Circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People's Commissariat for Health of the Russian Socialist Federated Soviet Republic (RSFSR), the main constituent Republic of the then Union of Soviet Socialist Republics, issued an Advisory Resolution on the procedures for testing new medicinal substances and methods which may present a hazard for the health and life of patients. And that is, I believe, the sum total of prewar efforts to regulate human experimentation. As you may well imagine, much has been written about the origins and impact of these early activities. These are no less crucial to the history of human experimentation than the nineteenth century Codes of Thomas Percival in England, William Beaumont in the USA, and Claude Bernard in France. And no less so than the well-known Nuremberg Code of 1947. The best source for material on the Code and its origins remains the 1992 book edited by George Annas and Michael Grodin, The N w ' Doctors and the Nuremberg Code: Human Rights in Human Experimentation. For those of you who do not know the details of this Code, I would remind you that it was promulgated by a U.S. Military Rbunal as part of the final judgement in the so-called "Doctors' Ral" (the "Medical Case") held in Nuremberg in 1946-1947. The Code has been the subject of much scholarly attention, notably at a series of Conferences convened to mark its 50th Anniversary in 1997, e.g. in Nuremberg and Freiburg-im-Breisgau. It is noteworthy that in 1946 the American Medical Association published its first principles of human experimentation, while in 1953 the US Department of Defence issued its then "top-secret" Memorandum on Sev S. Fluss, M.S., is a Senior Adviser at the Council for International Organizations ofMedical Sciences, a nongovernmental organization based at WTlO in Geneva. He was formerly Chief of WHO'S Health Legislation Unit, and is the author of numerous publications in thefields of health legislation and bioethics.
European Journal of Health Law, 1995