Katharina Beier

Is the commercialisation of human tissue and body material forbidden in the countries of the European Union

The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called ‘no-property rule’ is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles.

Understanding collective agency in bioethics

Bioethicists tend to focus on the individual as the relevant moral subject. Yet, in highly complex and socially differentiated healthcare systems a number of social groups, each committed to a common cause, are involved in medical decisions and sometimes even try to influence bioethical discourses according to their own agenda. We argue that the significance of these collective actors is unjustifiably neglected in bioethics. The growing influence of collective actors in the fields of biopolitics and bioethics leads us to pursue the question as to how collective moral claims can be characterized and justified. We pay particular attention to elaborating the circumstances under which collective actors can claim ‘collective agency.’ Specifically, we develop four normative-practical criteria for collective agency in order to determine the conditions that must be given to reasonably speak of ‘collective autonomy’. For this purpose, we analyze patient organizations and families, which represent two quite different kinds of groups and can both be conceived as collective actors of high relevance for bioethical practice. Finally, we discuss some practical implications and explain why the existence of a shared practice of trust is of immediate normative relevance in this respect.

A Unified European Approach on Tissue Research and Biobanking? A Comparison

As is by now a well-investigated fact that human tissue research and biobanking is not regulated by a common legal framework in Europe so far, this article aims to step beyond this rather descriptive finding. By focussing on central issues of biobank research, the authors do not only highlight common trends and perspectives in the regulation of human tissue research across the countries of the European Union and Switzerland but also identify the ethical and legal foundations for some of the persisting differences in this field. Their analysis bears on the premise that certain countries hold similar research traditions and are united by common ethical and legal pathways for regulating research. Based on their distinction of seven country groups and their respective regulatory frameworks, the authors finally draw some overall conclusions regarding the future regulation and potential legal harmonization of this field within the European Union.

Why brain banking should be regarded as a special type of biobanking: ethical, practical, and data-management challenges

Biobanking of the brain and other central nervous system materials, ie, brain banking (BB), provides an important research tool for understanding the causes of neurodegenerative and psychiatric diseases. Particularly with aging societies, there is an increasing need for molecular neuropathological research in this field. While there is an extensive debate on biobanking in general, the specific challenges that the procurement, processing, and storage of postmortem human brain tissue, and especially whole brains, raise are hardly ever considered systematically. This paper analyzes the peculiarities that make BB a distinct type of biobanking by combining the perspectives of neuropathology, medical informatics, and medical ethics. While ethical, practical, and data-management issues are often dealt with separately and the focus of such research is on only specific aspects of BB, this paper aims at an integrated analysis of the whole process. Six crucial steps in the BB workflow are analyzed: a) donor recruitment, b) follow-up during the donors lifetime, c) postmortem brain donation, d) neuropathological diagnosis, e) research with brain tissue, and f) the provision of brain material to third parties. A compre- hensive understanding of the challenges that BB raises is vital for making this practice more effective but also to counteract the current decline in brain-donation rates.

Ethical Objections About Surrogacy in German Debates: A Critical Analysis

Surrogacy is prohibited by law in Germany. The chapter aims to provide a better understanding of the ethical objections that feed Germany’s restrictive stance. To this end, it does not only describe ethical objections being explicitly or implicitly raised in the academic discourse from the late 1980s until today but also examines their soundness by highlighting their underlying premises and confronting them with insights from international analyses. Given that concerns about children’s right to get to know their origin and surrogate mother’s instrumentalisation remain as most cogent objections from this analysis, some conditions for surrogacy that would have to be in place in order to mitigate these concerns are outlined.

Familien und Patientenorganisationen als kollektive Akteure in der Bioethik: vernachlässigt und unterschätzt?

Als moralisches Subjekt in der Bioethik wird bisher ublicherweise das Individuum angesehen. Im Mittelpunkt steht das moralische Handeln einzelner Personen, hingegen wird die normative Funktion von Gruppen kaum reflektiert. Doch gerade im hochkomplexen und sozial differenzierten Gesundheitswesen engagieren sich eine Reihe von gesellschaftlich organisierten Gruppen mit dem expliziten oder impliziten Ziel, nicht nur den Wirkungsradius des Einzelnen zu vergrosern, sondern auch die normative Relevanz ihrer gemeinsamen Anliegen zu erhohen.

Biobanking strategies and regulative approaches in the eU: recent perspectives

Biobanks, ie, systematic collections of human biological materials and associated clinical and lifestyle data, provide an indispensable infrastructure for modern research. Although biobank research takes place on a global scale, there is no internationally binding framework for its ethical and legal regulation yet. A better understanding of existing regulative approaches is an important prerequisite for its ethical and legal harmonization and, thus, for improving the interoperability of biobank-based research in the future. This review focuses on biobanking strategies, regulative approaches, and recent developments in Europe. Specifically, we discuss selected ethical and legal issues in research biobanking in the European context by looking at population biobanks, new participation models, the cross-border sharing of samples, the participation of minors, the handling of incidental health findings, whole genome sequencing, and commercialization. We also provide an overview of regulations on biobank research in the EU and member states and highlight commonalities and differences. Although several common trends can be identified across Europe, we acknowledge the importance of national research traditions that cannot easily be set aside. Thus, harmonization, rather than a complete unification, of approach seems to be the most realistic vision for future biobank research in Europe.

Abschlusstagung „Autonomie und Vertrauen in der modernen Medizin“

Welche Bedeutung haben Autonomie und Vertrauen in der modernen Medizin und wie gestaltet sich deren Verhältnis in Theorie und Praxis? Am 22. November 2013 gaben Mitglieder der von der VolkswagenStiftung geförderten Göttinger Forschergruppe „Autonomie und Vertrauen in der modernen Medizin“ Antworten auf diese Fragen. Ihren Fokus richteten sie dabei auf medizinische Institutionen wie das Krankenhaus und verschiedene Akteure des Gesundheitssystems, z. B. Patienten, Ärzte und Patientenorganisationen. Die Ergebnisse aus sieben einander ergänzenden Teilprojekten wurden durch die Ko-Referenten Susanne Brauer, Stefan Etgeton, Rainer Prönneke und Dieter Sturma sowie das Plenum im Hannoveraner Tagungszentrum Schloss Herrenhausen kritisch diskutiert.1 In ihrer Einführung stellte die Projektleiterin Claudia Wiesemann zunächst heraus, dass die Patientenautonomie trotz ihrer rechtlichen Verankerung im Patientengesetz in der Praxis, vor allem in komplexen Krankenhaussystemen und bei schwierigen Entscheidungssituationen, tagtäglich gefährdet ist. Im Mittelpunkt des Forschungsprojekts stand daher die Frage, inwieweit sich das etablierte, auf Individuen fokussierte Autonomieverständnis stärker sozial fassen und durch Alternativkonzepte erweitern lässt. Vertrauen wurde dabei als komplementärer Schlüsselbegriff zu Autonomie untersucht. Das Konzept des Vertrauens als ein noch weitgehend unbekanntes Phänomen in der Medizin der wissenschaftlichen Reflexion zugänglich zu machen und zu verdeutlichen, dass es sich dabei nicht nur um den „kleinen Bruder“ der Patientenautonomie handelt, stellte Wiesemann daher als wesentliches Anliegen der Forschergruppe heraus. Zum Auftakt sprach Heiner Geißler, Bundesminister a. D. über „Selbstbestimmung, Vertrauen und die Grundlagen eines solidarischen Gesundheitswesens“. Auch wenn

Die Dialektik der Elternschaft im Zeitalter der Reprogenetik Ein ethischer Dialog

Human reproduction in the age of reprogenetics raises fundamental ethical and political questions. Critics of so-called liberal eugenics like Jürgen Habermas have sparked an ethical debate on whether selective genetic manipulation might undermine the natural basis of the moral self-conception and autonomy of future generations. Contrary to this perception, the authors of this article argue for a dialectic understanding of the moral challenges arising from human natality: Freedom and dependency, sociality and human embodiment, autonomy and relatedness likewise determine our human existence as moral beings. As an answer to these challenges, the authors develop a dialectic understanding of parenthood in the age of reprogenetics, thereby transcending present debates of modern reproductive medicine. Kerstin Andermann, Undine Eberlein (Hrsg.) Gefühle als Atmosphären Neue Phänomenologie und philosophische

First International Workshop of the Tiss.EU Project: Rights and Entitlements in Human Tissue and Cells

Mit dem Workshop zum Thema „rights and entitlements in human Tissue and cells“ (organisiert von nils hoppe, ag Medizinrecht & bioethik der universitat hannover), wurde am 28. und 29. november 2008 der auftakt zu insgesamt neun internationalen expertentreffen gegeben, die im rahmen des Tiss.eu Projektes (http://www.tisseu.org) bis anfang 2011 stattfinden. Das seit April 2008 im 7. Rahmenprogramm laufende EU-Projekt beschaftigt sich mit Fragen der ethischen und rechtlichen regulierung der Forschung mit menschlichen Geweben und Zellen in den 27 EU-Staaten und der Schweiz. Die Koordination des Projekts liegt bei Dr. Christian Lenk und Prof. Dr. Claudia Wiesemann (Abt. Ethik und Geschichte der Medizin, Universitat Gottingen) in Zusammenarbeit mit Dr. Nils Hoppe. Der Workshop in Hannover widmete sich schwerpunktmasig der Frage nach Rechten und Anspruchen im Umgang mit menschlichen Geweben und Zellen. Dabei waren neben experten aus Wissenschaft und Praxis insbesondere Juristen aus der schweiz, Osterreich und Deutschland geladen, um uber den rechtlichen Rahmen der Gewebeforschung in diesem ausgewahlten Landerkreis zu informieren. In seinem Impulsreferat stellte der Jurist nils hoppe drei zentrale Problemkomplexe der gewebeforschung heraus: