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Ethics and the Law in Medicine – in Research and Healthcare

by Joanna Długosz (Volume editor) Jan C. Joerden (Volume editor) Elżbieta Paszyńska (Volume editor) Florian Steger (Volume editor)
©2020 Edited Collection 256 Pages

Summary

This volume contains contributions from the international and interdisciplinary scientific conference "Ethics and the Law in Medicine – in Research and Healthcare", which took place at the Faculty of Law and Administration of the Adam Mickiewicz University in Poznań and at the Poznan University of Medical Sciences. The contributions to these proceedings encompass a broad spectrum of current medico-ethical questions that arise in particular disciplines. Compared to monographic works, interdisciplinary anthologies have the advantage of bringing together scientists from different disciplines into conversation on controversial issues from different scientific perspectives. The aim is an interdisciplinary discussion on challenging questions in medicine – conducted from different viewpoints. The volume's contributions also highlight differences in the analysis and assessment of medico-ethical dilemmas due to socio-cultural differences.

Table Of Contents

  • Cover
  • Title
  • Copyright
  • About the editors
  • About the book
  • This eBook can be cited
  • Contents
  • Foreword
  • Section 1. Research Ethics in Germany and Poland – Ethical and Legal Aspects
  • Internationally Binding Bioethical Standards – a Utopian Idea? (Florian Steger)
  • The Bioethical Commission of Poznan University of Medical Science - Background, Legal Restrictions, and Current Activities (Andrzej Marszałek and Matthew Ibbs)
  • Rechtliche Fragen der Zusammensetzung von Bioethik-Kommissionen (Jerzy W. Ochmański)
  • Section 2. Clinical Ethics in Germany and Poland – Legal Aspects
  • On Taking into Account the “Natural Will” When Dealing with Consent to Medical Treatment1 (Jan C. Joerden)
  • Zur Rechtswidrigkeit der Einwilligung in medizinische Eingriffe bei unterschiedlichen kulturellen Wertvorstellungen in Deutschland und Polen (Joanna Długosz)
  • The GP’s Criminal and Disciplinary Liability for a Wrong Diagnosis from the Polish Perspective – a Case Study (Jerzy Lachowski)
  • Section 3. Clinical Ethics in Germany and Poland – Ethical Aspects
  • Responsibility for Health – a Brief Outline (Tomasz Maksymiuk, Jacek Putz, and Jędrzej Skrzypczak)
  • Genes, Freedom, Suicide. Some Ethical Dilemmas in Biological Psychiatry (Joanna M. Pawlak and Weronika Herbet)
  • Is a Foetus a Patient? Some Ethical Aspects of Compelled Obstetric Interventions (Joanna Miksa)
  • What Does It Mean That Human Enhancement Is a Bioethical Problem? (Bartosz Pokorski)
  • Telemedicine and Teledermatology (Dorota Jenerowicz and Aleksandra Wnuk-Kłosińska)
  • Futile Therapy in Clinical Practice – the Challenge of Contemporary Medicine (Anna Lewandowska-Graduszewska and Szczepan Cofta)
  • A Bioethic Light on Dental Materials Used in the Root Canal Treatment in Dentistry (Elżbieta Paszyńska, Małgorzata Pawińska, Grzegorz Szczurko, Justyna Otulakowska-Skrzyńska, Szymon Rzątowski, Anna Pawłowska-Lis, and Maria Gawriołek)
  • List of Figures
  • List of Tables
  • Notes on the Editors and Contributors
  • Series Index

←8 | 9→

Foreword

Doctors are often accompanied by lawyers in difficult questions arising in the context of medical research and clinical care. These questions can become quite complex if they also address, in addition to medical and legal issues, social or medico-ethical aspects. Ethics of medicine, as an independent science, focuses on normative issues within medicine. In doing so, it keeps its focus on medicine as a practical science and on the respective legal framework. Human dignity as a universal category and the four middle-range principles of Beauchamp and Childress – autonomy, beneficence, non-maleficence, and social justice – provide clear points of reference. Globalization, increasing pluralism of societal values, and progressing developments in medical science lead to a number of challenges that require normative accompaniment through ethics and law. Among others, central topics that emerge in this area are: the safety of experimental treatment methods, the application of the state-of-the-art technologies, and data security. Legal responsibility resulting from use of innovative techniques is a particular challenge.

This volume contains contributions from the international and interdisciplinary scientific conference “Ethics and the Law in Medicine – in Research and Healthcare”, which took place on June 27 and 28, 2018 at the Faculty of Law and Administration of the Adam Mickiewicz University in Poznań and at the Poznan University of Medical Sciences. The organizers also include Professor Jan C. Joerden, representing the Interdisciplinary Center for Ethics at the European University Viadrina Frankfurt (Oder), and Professor Florian Steger with the Institute of the History, Philosophy and Ethics of Medicine at the Ulm University.

The contributions to these proceedings encompass a broad spectrum of current medico-ethical questions that arise in particular disciplines. Compared to monographic works, interdisciplinary anthologies have the advantage of bringing together scientists from different disciplines into conversation on controversial issues from different scientific perspectives. The aim is an interdisciplinary discussion on challenging questions in medicine – conducted from different viewpoints. The volume’s contributions also highlight differences in the analysis and assessment of medico-ethical dilemmas due to socio-cultural differences.

We thank the authors of this volume for their contributions covering various disciplines. We are grateful to many institutions and individuals for support during the organization of the abovementioned conference and for giving ←9 | 10→us the opportunity to present its proceedings in the series “Studien zur Ethik in Ostmitteleuropa”. The Faculty of Law and Administration of the Adam Mickiewicz University in Poznań, Poznan University of Medical Sciences, the Interdisciplinary Center for Ethics of the European University Viadrina Frankfurt (Oder) and the Institute of History, Theory and Ethics of Medicine of the Ulm University all contributed to this publication. We are grateful to Prof. Dr. Renata Langfort, from Department of Pathology at the National Institute of Tuberculosis and Lung Disease in Warsaw, for writing a review of this volume. We thank Benjamin Kloss for the support of this publication from the side of the publisher. Finally, we thank Iwona Grenda and Marcin Orzechowski for their help in organization of the conference and for the review and translation.

Florian Steger

Internationally Binding Bioethical Standards – a Utopian Idea?

Zusammenfassung

In Zeiten der Globalisierung und der fortschreitenden technologischen Entwicklung in der Biowissenschaft und der Medizin wird immer wieder die Forderung laut, international verbindliche bioethische Standards festzulegen. Fokussiert man auf konkrete ethischen Fragen wird einem rasch klar, wie schwierig es ist, einen solchen ethischen Minimalkonsens zu bestimmen. Allerdings lässt sich ein grundlegendes Verständnis für ethische Dilemmata in den gemeinsamen kulturellen Wurzeln Europas finden, die bis in die Antike zurückreichen. Hier ist zuerst der Hippokratische Eid zu nennen, welchen den Auftakt der ethischen Kodifizierung macht und ein zentraler Bezugspunkt ethisch reflektierten Handelns darstellt. Besinnt man sich auf den Eid, werden grundlegende Prinzipien sichtbar, die auch heute noch eine Orientierung für eine Ethik in der modernen Biowissenschaft geben können.

Streszczenie

W czasach globalizacji i postępu technologicznego w naukach przyrodniczych i medycynie istnieje ciągłe zapotrzebowanie na określenie międzynarodowych standardów bioetycznych. Jeśli skoncentrujemy się na konkretnych kwestiach etycznych, szybko uświadomimy sobie jednak, jak trudno jest ustalić minimalny konsens etyczny. Możliwość podstawowego zrozumienia współczesnych etycznych dylematów leży we wspólnych kulturowych korzeniach Europy, sięgających czasów starożytnych. Przede wszystkim należy wskazać na przysięgę Hipokratesa, która stanowi początek kodyfikacji etycznej oraz centralny punkt odniesienia działania odzwierciedlającego etyczne zasady. Analiza przysięgi Hipokratesa umożliwia dostrzeżenie fundamentalny zasad, które nadal mogą wyznaczać kierunek w etyce we współczesnej medycynie i w naukach przyrodniczych.

Introduction

Discussion on moral questions of the modern bioethics gains new importance these days.1 Starting with the debates on allocation of public ←13 | 14→resources,2 through the issues of prenatal diagnostics,3 abortion, end of life questions, artificial intelligence, robotics, big data, gene technology and changing compositions of our societies, the issues of ethical contention are numerous. As we look at the state of this discussion, we can observe the increasing concern with which these problems occupy modern societies.

However, contemplating the developments which take place in the resolution of the modern bioethical conflicts, one dares to ask: Are the answers to these problems identical for all societies, everywhere and at all times? Is there a possibility of creation of an international “code of rules” for bioethical conflicts? And last but not least: Are there any normative points that could offer a basis for individual ethical decisions in the modern world?

It is very difficult, maybe impossible, to find an ethical minimal consensus that could be applicable to all societies, everywhere and at all times. Rather, historical viewpoints could provide us with, at least partial, answers to several modern debates that allow making decisions on individual basis. More than a few of the abovementioned problems are modern in their manifestation but they are not new. Some of these conflicts – at least in their essential core – reach back to Antiquity and refer to the central normative points of the ethical competence. Historical context can offer a universal ethical background on which modern bioethical conflicts can individually be resolved or at least a common standpoint on the issues can be proposed.4

Bioethical Standards in a Globalized World – Reality or a Wishful Thinking?

Globalization is a phenomenon that became for all of us a normal point of life. Younger generations of students cannot even imagine a world in which they are ←14 | 15→bound by borders; in which they cannot freely choose an international university to study or it is impossible for them to read scientific literature from around the world. Scientists publish their research internationally and their results have impact all over the globe. Pharmacological companies conduct drug studies abroad and sell their medicaments worldwide. That is why, more and more visible are postulates for common international bioethical standards that would comply with the globalized perception of the modern world.5

For several years now, common international guidelines in bioethics were advocated by representatives of several communities: doctors, researchers and politicians. It has been often argued that when faced with advancing globalization of the world, such common guidelines could offer a joint set of rules for research and practice. These, for example, could prevent excellent scientists from moving abroad. In Germany, we are often confronted with concern that because of strict regulations in our country, other states – which have much more liberal regulations – provide a tempting alternative for scientific work. For that reason, it is argued that bioethics needs universal norms, and some voices in the debate call for an intercultural agreement, which could be expressed as an ethical minimum.

Binding rules certainly respond to our deep anthropological desire for axioms: for stability, foundations and focus as well in private life as in professional career. In medicine and in research, such need results from frequent, daily decisions that have to be taken often under pressure of time and circumstances. Bioethical guidelines could provide us with relatively straightforward answers on how should we behave in situations of moral conflict. However, the important questions remain: How can we formulate the “ethical minimum” that some people so much wish to reach? What should be the foundation for these guidelines? What are the constant and norm–determining factors that could define this “ethical minimum”? A hypothetic answer, provided by some, would be: religion and faith. Yet, in times of open borders, mass migrations and changing life-values, achieving unity in respect to beliefs, even within the framework of one society, would be very difficult. Achieving it in the international setting verges almost on impossibility.6

←15 | 16→

Is introduction of international bioethical standards even conceivable? Evidence from the recent history provides rather pessimistic picture in this respect. On April 4th 1997, within the framework of the Council of Europe, “The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine” (so-called “The Oviedo Convention”) was signed. This Convention was notably the first multilateral instrument entirely devoted to biolaw. Its aim is to protect human dignity and to prohibit the misuse of innovations in biomedicine.7 It was precisely the basic premise of this document that minimum common bioethical standards for international (in this case European) community can be created. Yet, even twenty years after the Convention was signed, several states still have not ratified the document. Among these are: Germany, Poland, Italy, the Netherlands, Sweden and United Kingdom. Furthermore, six of the ratifying states have called for reservations limiting the extent to which they are bound to certain provisions. The challenge in finding the common international position can be expressed by the fact that whereas Germany withheld ratification on the ground that the Convention is too permissive, in Belgium or in the United Kingdom the Convention was considered too restrictive. Similar reservations as in Germany forestalled ratification of the Convention in Poland. It has been argued that the Convention propagates only a certain ethical view and consequently weakens the protection of the unborn children. Moreover, several particular directives of the Convention are still regulated by the national laws. For example, in Germany the regulation of research on embryos is provided by the “Act for Protection of Embryos” of 1991 (with changes introduced through “Preimplantation Diagnostics Act” of 2011) or in the “Stem Cell Act” of 2002. In this perspective, a fundamental question that comes to mind is: Is it really desirable that so many ethical approaches are brought together in very general statements, suggesting some kind of European consensus?8

←16 | 17→

Ethical Conflicts at the Beginning of Life

To further illustrate the difficulty in introducing common bioethical standards, let us look into a few ethical conflicts that make an impact on societies in just two countries: Germany and Poland. One of the most controversial issues in both countries is the question of the beginning of life and abortion.9 At the very core of this problem stands the ethical debate whether a fetus is – and when it becomes – a human being. It is very clear that the answer is deeply embedded in social and historical contexts and cannot be identical for both societies. Various positions, from the Christian or Catholic point of view, through the argument of women’s autonomy, to the liberal positions on the issue provide highly polarized perspectives. Proponents of an “indication” policy argue for legal abortion only under certain medical (for example, threat to mother’s life) or legal (pregnancy as a result of rape) conditions. Supporters of a “time period” policy postulate free access to abortion up to a certain time point during the pregnancy. In Germany, the abortion law from 1995 incorporates both positions. Under its provisions, abortion is a criminal offence; however, several “deadline regulations” („Fristenregelungen“) provide exemptions. Abortion is not punishable during the first twelve weeks if the pregnant women took part in a so-called “pregnancy conflict consultation”. In this, woman’s life circumstances, physical and mental or emotional health should be taken under special consideration. In result, up to a certain deadline, abortion can be conducted on request of the woman. This regulation was the result of a compromise between the proponents and opponents of liberalization of the abortion law; yet, for several decades, it deeply polarized German society. Now, it is interesting to see that the often-used phrase “abortion compromise” has a quite different meaning in the Polish context. In Poland, abortion can be conducted only on grounds of medical indication (threat to health or life of the mother), if pregnancy is a result of a criminal act or if prenatal diagnostics indicates severe and irreversible malformation of the fetus. The social and economic factors are excluded as a legitimation for the procedure. This abortion law results from tightening legal regulations from the communist period, during which abortion was nearly free ←17 | 18→accessible on grounds of difficult living conditions of the woman.10 We clearly see that the dominant position of the Catholic Church in Poland after 1989 and increased pressure from the pro-life groups brought about quite different kind of compromise than in Germany. Moreover, changing political situation during the last 25 years led to repeated attempts to change this law – in both more liberal and more conservative directions. Several thousands of women protested on Polish streets in 2017 and 2018 against tightening of the current law.11 Social and political contexts, next to more stable contexts of values, religion and history, play a significant, although a very volatile, role in shaping prevailing ethical norms.

Similar conflicts emerge on the issues of the beginning of life, in-vitro fertilization and embryonal stem cell research. Currently, the possibility of the therapeutic use of human stem cell still requires creation and possible elimination of human embryos.12 However, the principles of the human dignity and the human right to live forbid – without exception – intentional killing of people. Insofar, the question of admissibility of the embryonal stem cell research is conditioned by our understanding of an embryo, from the moment of fertilization, as a human being provided with human rights and dignity. Possibility of acquiring stem cells from tissues and organs of adults – so called induced pluripotent stem cells – could provide a potential alternative in this respect. However, in the last years, differences in gene expression between embryonal stem cells and induced pluripotent stem cells have been discovered. These differences indicate that induced pluripotent stem cells are less efficient in differentiation into goal-cells that build up tissues and organs. Moreover, it has been observed that induced pluripotent stem cells potentially age faster than the embryonal stem cells. Because of that, it is still not clear whether they could constitute a viable alternative for the embryonal stem cells in research and therapy.13

←18 | 19→

Similarly as in the question of abortion, irreconcilable philosophical, religious and biological positions stand in opposition on this issue. Possible compromise could be achieved through binding legal national or international rules. The state, as the highest lawmaking organ in this issue right now, is obligated to certain “ideological neutrality”. Yet, how such neutrality can be realized? Is it even possible to have a neutral standpoint on the issue of life and death? German legislature in the “Stem Cell Act” from 2002 tried to provide a compromising regulation.14 The core point of this regulation was that stem cells for research in Germany could be imported from abroad only if they were obtained before a certain cutoff date. Through this, the German lawmakers tried to reach a compromise satisfying all interested parties. The law granted the possibility for research in this important and vital area but the provision of the cutoff date, which was set before the law came into effect, has been seen as a tool to eliminate any incentive for production of new embryos for export to Germany. Yet, transmission of such regulation onto the international stage brings out multiple problems. From where the embryos should be obtained if all states participate in similar regulation? Should we deem one country as an “embryo factory”? If already available embryos run out, shall we stop any further research in this area? The imperfection of this regulation was already highlighted when the German Parliament in 2008 moved the cutoff date from 2002 to 2007. Through this, a clear signal was send to producers of embryos abroad that the seemingly fixed cutoff date could be moved depending on state of current research and needs of the research community. It became visible that through this action, the ideological neutrality of the German state on the issue has been compromised.

In Poland, on the other hand, stem cell research still has to be clearly regulated. Several regulations provide only indirect guidelines. For example, article 26 of the “Law on Profession of Doctor and Dentist” from 2006 states that: “Children, from the moment of conception, (…) cannot take part in research experiments”.15 This regulation clearly shows the current position in Poland on stem cell research. Fetus, from the moment of conception, is regarded as a human being and therefore any research with use of stem cells is forbidden. These regulations are further reinforced by the “Law on the Ombudsman for Children” from the year 2000, which states that the child is every human being from the moment ←19 | 20→of conception until the legal age. However, as already mentioned, there are no specific rules in Polish law that would regulate the legal position of embryos or the question of research on human embryos. For more than 20 years, the public debate failed to provide a clear position or even a compromise on this issue. The recent attempt to regulate this area, in March 2017, could still not arrange for binding rules.

Life’s End – a Further Field of Ethico-medical Contention

It becomes clear there are multiple ethical conflicts connected to the question of the beginning of the life. Let us now look at the moment of life’s end. Dying and death are the border situations of the doctor’s profession. A physician has in her or his responsibility both to aid in providing a good life for patient (ars vivendi) as well as to attend to patient’s good and dignified death (ars moriendi). However, how these principles relate to the issue of euthanasia and assisted suicide? For several years now, this question stirs up many controversies and debates.16 German Medical Association stands firmly on the position that euthanasia is not reconcilable with the principles of physician’s ethos. Nevertheless, the controversy on the issue is stipulated by the fact that within German medical profession there are factions with opposite opinion. According to them, doctors should help patients with advanced incurable illness to commit suicide. This argument rests on the presumption of the autonomy of the patient and her or his right to determine the time of their own death. Moreover, physicians are in high degree suited to provide such aid to their patients – mostly through easing the unnecessary pain in the process. An opinion poll among the German doctors form 2009 showed that the majority of them oppose a legal norm regulating physician–assisted suicide; yet, most of the respondents could understand the wish for assisted suicide and comprehend the need for it. About one-third of the doctors could imagine the situation in which they would provide help in patient’s death. The ambiguity of the situation and the differences in opinions required provision of clear-cut rules. German law right now distinguishes between assisted suicide, that is, action conducted by patient with aid of physician, and killing on request, that is, action conducted by physician on demand ←20 | 21→of patient. According to changes in the German criminal code from the year 2015, assistance in suicide is punishable only if it is offered in a businesslike manner. Businesslike in this context means that the action is repeated and provides financial profit. If the action is conducted not in a businesslike manner or the relatives of the patient help in suicide, the assistance is not a criminal act. Contrary to this, killing on request is always a criminal action punishable by German law.

As we see, no simple answers can be given in this highly complex topic. In addition, another layer of the complexity is provided by the German history.17 The German past, especially the practice of euthanasia, forced sterilization and human experiments during the time of National Socialism, are the central reasons for the absolute prohibition of killing of patients. From 1939 to 1941, in the course of so-called “Action T4”, mentally ill and disabled persons were systematically deported and killed. Some of the victims were children. Although “Action T4” was conducted in secrecy, this organized killing could not be concealed from the public. Increasing resistance of the German society led to the stop of the centralized action. Yet, still after 1941, in several psychiatric institutions, decentralized killing of the patients with other methods – through misuse of medicaments or negligence – continued. From 1944 onwards, many patients that were deemed unfit to work were starved to death. Under the ideological cover of “cleaning the healthy national body out of unwanted, ill limbs”, physicians trusted with organization of this operation decided which patients were to be exterminated. Besides “Action T4”, during the time of the Third Reich doctors conducted medical experiments on the prisoners of the concentration camps and forcibly sterilized physically and mentally ill or alcoholics. It has been estimated that in the course of this operation, about 400.000 people were rendered infertile. And it is important to mention that the practice of euthanasia took place without legal legitimation – the “eradication of unworthy life” was a criminal act until 1945; however, it had no legal consequences for the perpetrators during this time. Doctors accused of the abovementioned crimes were put to trial in 1946 during so-called “doctors’ trial” in Nuremberg. This dark chapter in the German and human history led to creation of the Nuremberg Code in 1947 and the Declaration of Geneva in 1948.18 Another aspect of disregard for ethical ←21 | 22→principles in medicine in German history provide examples of “politicized medicine” during the period of German Democratic Republic (1949–1990).19

Details

Pages
256
Year
2020
ISBN (PDF)
9783631812969
ISBN (ePUB)
9783631812976
ISBN (MOBI)
9783631812983
ISBN (Hardcover)
9783631801161
DOI
10.3726/b16580
Language
English
Publication date
2020 (March)
Published
Berlin, Bern, Bruxelles, New York, Oxford, Warszawa, Wien, 2020. 256 pp., 2 fig. b/w, 6 tables.

Biographical notes

Joanna Długosz (Volume editor) Jan C. Joerden (Volume editor) Elżbieta Paszyńska (Volume editor) Florian Steger (Volume editor)

Prof. Dr. Joanna Długosz, Adam Mickiewicz University in Poznań, Faculty of Law and Administration, Chair of Criminal Law Prof. Dr. Jan C. Joerden, European University Viadrina in Frankfurt (Oder), Chair of Criminal Law, especially International Criminal Law and Comparative Criminal Law, Philosophy of Law Assoc. Prof. Dr. Elżbieta Paszyńska, Poznan University of Medical Sciences , Department of Integrated Dentistry and Community Dentistry Section Prof. Dr. Florian Steger, Ulm University, Institute of the History, Philosophy and Ethics of Medicine

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