Deutscher Ethikrat

Annual Report 2010 Published by the German Council

Chair: Prof. Dr. Edzard Schmidt-Jortzig Jaegerstrasse 22/23 · D-10117 Phone: +49/30/20370-242 · Fax: +49/30/20370-252 Email: [email protected] www.ethikrat.org

© 2011 Deutscher Ethikrat, Berlin All rights reserved. Permission to reprint is granted upon request.

Report compiled by: Ulrike Florian English translation: Philip Slotkin MA Cantab. MITI, London Layout: Torsten Kulick Cover design: BartosKersten Printmediendesign, Hamburg

March 2011 Annual Report 2010

Contents

Introduction ...... 5 Topics ...... 7 Human biobanks for ...... 7 Allocation of resources in healthcare ...... 10 Issues of and hybrid research ...... 11 Dementia and self-determination ...... 14 Reproductive ...... 16 Public meetings and promotion of social discourse ...... 20 Public Plenary Meetings ...... 20 Annual Meeting ...... 22 External meeting ...... 28 Forum ...... 32 Debates with schoolchildren and students ...... 40 Collaboration with the German ...... 41 International initiatives and contacts ...... 43 Forum of National Ethics Councils of the European Union ...... 43 International Dialogue on Bioethics ...... 44 Global Summit of National Bioethics Advisory Bodies ...... 45 Trilateral meeting of the ethics councils of , and the ...... 46 Publications ...... 48 Evolution of the social debate ...... 49 Outlook ...... 52 The members of the German Ethics Council ...... 54 Appendix ...... 56

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Annual Report 2010

Introduction

By virtue of the large number of meetings ruary a hearing involving international and other events held, 2010 was a year experts on human–animal mixed-species marked by intense activity on the part of entities; and in December a hearing on the the German Ethics Council; it was also a regulation of preimplantation genetic di- year that saw many changes. In accord- agnosis in Belgium, France and the United ance with Section 2(4) of the Ethikratgesetz Kingdom. As is clear from the numbers (Ethics Council Act, see Appendix), the attending, both aroused very considerable present report documents the work of the interest among the public and representa- Council from January to December 2010. tives of the world of alike. With a view to informing both the po- Besides these meetings, the Ethics litical world and the public at large, the Council for the first time held – in ad- publication of Opinions and the holding dition to the Annual Meeting – a fur- of public meetings constitute the Coun- ther whole-day event outside Berlin. The cil’s principal means of communication. meeting on “Dementia and self-deter- In this connection, the publication of the mination” at the Hamburg Chamber of Ethics Council’s second Opinion, “Hu- Crafts in November met with an impres- man biobanks for research”, in June 2010 sive response on the part of the public. takes pride of place. The Annual Meeting This bears out the Ethics Council’s belief in May and the Bioethics Forum meetings that it is both important and appropriate have now also become regular fixtures in not to confine the events it organizes to the Ethics Council’s programme of public Berlin, thus enabling interested members information on topics in the field of bio- of the public in other parts of the Federal ethics. These were complemented by the Republic to attend the German Ethics holding of two public hearings: in Feb- Council’s public meetings.

Plenary meeting of the German Ethics Council

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Until September 2009 the Advisory replace them by the Federal Government Council on Ethics had constituted the and were appointed as members of the link between the Bundestag (German Fed- Council by the President of the German eral ), but because that body Bundestag, Professor , was not reappointed in the 17th Elec- on 30 June 2010. toral Term, the Council adopted a new approach to enhancing communication with the Members of the Bundestag, in the form of a Parliamentary Evening. The first meeting of this kind was held at the German Bundestag on 24 March 2010 and comprised an exchange with the Deputies on the current and future work of the Council and on the ethical issues of the 17th Electoral Term which they regarded as particularly relevant. During the course of this event, the Ethics Council also pre- sented its Opinion on the anonymous relinquishment of infants, published in November 2009, and discussed it with the Deputies. Both sides took an extremely positive view of the evening, and the wish was immediately expressed to hold further such meetings in the future. At the end of 2010, the Federal Govern- ment for the first time made use of the provision in the Ethics Council Act allow- ing it to give an instruction to the Council. In a joint letter from the Federal Minister of Education and Research, Professor An- nette Schavan, and the Federal Minister of Health, Dr. Philipp Rösler, the Ethics Council was charged on behalf of the Fed- eral Government with the preparation of a report on the situation of people in Germany. Changes in the membership of the Ger- man Ethics Council occurred for the first time since the Council’s formation. On 1 March 2010, Professor Bettina Schöne- Seifert and Dr. Hermann Barth stood down at their own request. In accordance with the provisions of the Ethics Council Act, Professor Heike Walles and Profes- sor Wolfgang Huber were nominated to

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Topics

With a view to the publication of an Opin- blood or DNA, linked to personal data The Opinions of the German Ethics ion, the German Ethics Council consid- and, in particular, to health-related infor- Council can be accessed online at ered the following topics in 2010: mation on their donors. They have a dual www.ethikrat.org character, as collections both of samples /publications /opinions • Human biobanks for research and of data. Most current biobanks are • Allocation of resources in healthcare research biobanks – that is, institutions • Issues of chimera and hybrid research that collect samples and data of human • Dementia and self-determination origin and either use them for their own • Reproductive medicine research or make them available to third parties for research purposes. They are These and other topics were addressed frequently designed to be used for a vari- by the Ethics Council by means of spe- ety of research purposes, some of which cific working groups, as well as in public only arise at a later date. plenary meetings and other public events By virtue of the long-term linkage of (see p. 20 ff.). medical data of many different kinds, biobanks play a vital part in the investi- gation of the causes and mechanisms of Human biobanks for research numerous diseases and their treatment, and constitute an indispensable aid to On 15 June 2010 the German Ethics biomedical research. Council issued its second Opinion, in Biobanks raise ethical and legal ques- which it called for clear statutory pro- tions which extend from the protection of visions on research with biobanks. The individual rights to the global regulation salient points of the Opinion are set out of research infrastructures. The Gendiag- below. nostikgesetz (Genetic Diagnosis Act) that Human biobanks are collections of hu- came into force in February 2010 contains man bodily substances, such as tissues, no provisions on these matters. Hence

From the left: Joachim Vetter (Head of Office), Regine Kollek and Jochen Taupitz at the launch of the Opinion “Human biobanks for research”

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only general legal requirements currently legal certainty for biobank research, and apply to research biobanks in Germany. at the same time of facilitating research. Again, developments in this field have The first and most important pillar been particularly dynamic in the last few of this approach is the introduction of years. Not only are new biobanks con- biobank secrecy. This is intended to con- stantly being established, but they are also fine the processing and transfer of samples coming to be used in new ways and on and the associated data to the purposes of larger scales. scientific research throughout their exist- The new developments include quan- ence and to guarantee that they remain titative expansion, greater information inaccessible to all third parties external content, increasing reidentifiability of to the field of research. In accordance donors, more extensive networking, in- with the provisions applicable to medical ternationalization, privatization and com- practitioners, biobank secrecy comprises mercialization, as well as expansion of a requirement to observe professional applications and of third-party access. By confidentiality and a right to refuse to give virtue of these trends, the German Ethics evidence on the part of the operators, staff Council felt it necessary to address this and users of biobanks, as well as a prohibi- subject again, although the former Na- tion of access to samples and data for all tional Ethics Council and the Bundestag’s individuals and institutions external to Study Commission on and Ethics of the field of , including the state. Modern Medicine had expressed their The second pillar of the approach con- views on biobanks in earlier Opinions. cerns the definition of the permissible Having regard to the growing challeng- use of biobank materials and data. As at es, the German Ethics Council considers present, donor consent should constitute that specific regulatory measures for hu- the fundamental precondition for the use man biobanks must be adopted. of samples and data in biobanks. How- Early approaches to the protection of ever, donors should also be enabled to donors’ interests were substantially based make their samples and data available for on the notion of informed donor consent. scientific research without restriction to a However, in view of the structural particu- given research project or a specific field of larities of biobanks, individual consent research and without limitation of time. can offer no more than feeble protection, As the third pillar of the approach, since this consent is inevitably given in the the Ethics Council recommends the in- context of limited information. For this volvement of ethics commissions, firstly reason, the consent aspect should be sup- where it is intended to work with personal plemented by institutional and procedural samples and data or where donors are to provisions laying down objective limits be contacted again, and secondly for the to biobank research while also allowing periodic appraisal of activities of biobanks scope for flexibility. not restricted to a particular field and In its Opinion, the German Ethics whose duration is unlimited. Council proposes a five-pillar approach The fourth pillar concerns quality as- to the statutory regulation of biobanks, surance. The rights of donors should be with the aim of providing an appropriate protected by appropriate organizational legal framework for donors’ interests and structures and procedures, as well as by rights of personality, of offering more evaluation of the systems of all biobanks

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not narrowly restricted to specific fields Although, according to such a broad and whose duration is unlimited. definition, a collection of just a few sam- The fifth pillar of the Ethics Council’s ples used, for example, for the purposes proposed regulatory approach comprises of a thesis limited to a particular topic a number of measures intended to guar- and destroyed immediately afterwards antee the objectives and procedures of would constitute a “biobank”, the Ethics a biobank. These include, in particular, Council decided to adopt it in order to complete documentation and regular avoid a situation in which the applica- publication of biobank activities and the bility of a statutory system of regulation establishment of a publicly accessible for biobanks would depend solely on the biobank register. number of samples collected or on some The Ethics Council in addition recom- other arbitrary criterion. This is because mends working towards the introduction the challenges outlined above with re- of internationally mandatory standards of gard to donor protection are the same protection, and in its Opinion proposes a whether they concern, for instance, the number of measures for the safeguarding international linkage of individual small of biobank secrecy when samples and data collections of material or individual large- are exchanged with cooperating partners scale biobanks. Furthermore, subjective in other countries. These include a con- elements, such as the planned duration of tractual obligation on those partners to use, have only limited applicability for the maintain biobank secrecy and criminal purposes of demarcation, because inten- sanctions for violating the prohibition on tions and plans can change at short notice. the provision of information on the basis The Ethics Council therefore rec- of foreign access to samples and data in ommends that the broad definition of Germany, where such access would have “biobanks” given above be used for the been unlawful in Germany too. In addi- entities subject to statutory provisions, tion, it should not be permissible for the but that, as regards the legal consequenc- reference lists whereby pseudonymized es, a distinction be made – as proposed in biobank samples and data can be associ- the five-pillar approach – according to the ated with their donors to be disclosed specific challenges presented by different outside Germany. biobanks with differing depths of regula- In its Opinion, the German Ethics tion. The question whether a collection Council applies a broad definition of a does or does not constitute a biobank for human biobank for research, covering statutory purposes will not then be the any collection that satisfies the following criterion for deciding whether specific three criteria: biobanks remain totally unregulated. In a supplementary position statement, a) It contains genetic material originating four members of the Council advocate from humans with associated data. that collections strictly limited to a spe- b) Its samples are electronically linked to cific purpose and duration, for which personal data and other – in particular, there are no plans to transfer samples health-related – information. and data for different uses, should not be c) Its samples and data are collected, covered by the proposed system of regu- stored or used for the purposes of sci- lation, because they fear that otherwise entific research. such projects would, notwithstanding the

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recommended differentiation of regula- working group which, on the basis of this tory depth, be subject to substantial ad- controversy and the provisions of social ditional regulatory and administrative welfare law that underlie it, addressed the complication and expense. They regard ethical status of cost-effectiveness analy- the existing provisions on data and donor ses. This was done against the more gen- protection as sufficient when samples are eral background of the issue, increasingly taken for limited collections. also the subject of public discussion in Germany, of acceptable ways of limiting spending on the public healthcare system. Allocation of resources In addition, specifically in the context in healthcare of the current legislative debate following the adoption of the Gesetz zur Neuordnung Audio recordings of At its plenary meeting of 25 September des Arzneimittelmarktes (Act on the Re- the public meetings of the Council held 2008, the German Ethics Council had form of the Market for Medicinal Prod- in 2008 can be accessed online considered the content and limits of the ucts), questions arose in connection with (in German) at normative claims of evaluations based on utility analysis – especially early utility www.ethikrat.org /sitzungen/2008 health for the first time, on analysis – and were taken up by the work- the basis of a paper by Council member ing group. Since an early benefit analy- Weyma Lübbe. sis is based predominantly on surrogate Since 2007 Germany has had an explicit parameters, so that patient-focused end statutory requirement for certain deci- points are relegated to the background, sions concerning the range of treatments the result may be the application of thera- provided by the public healthcare system pies which, while deemed effective, in fact to be supported by cost-utility analyses. present no benefit, or very little additional For this purpose, the Institut für Qualität benefit compared with other therapies, for und Wirtschaftlichkeit im Gesundheitswes- the relevant patient group. en (Institute for Quality and Efficiency in The working group therefore con- ) has developed methodologi- centrated on the normative problems of cal proposals that have attracted criticism. benefit analyses, cost analyses and cost- In particular, German health economists effectiveness analyses, to help draw the at- have complained of departures from the tention of both the political world and the methods of analysis recognized within public to the difficult issues of distributive their discipline. justice based on the example of the ethi- The controversy implicitly involves cally disputed analytical methods used in value judgements of fundamental impor- the field of health economics. The Ethics tance to the public healthcare system’s Council had substantially concluded its conception of its own role. With regard to work on the Opinion by December 2010. such judgements, the specialism of health Since the Opinion was not published until economics cannot lay claim to a monopo- the end of January 2011, an account of its ly of interpretation. The judgements must contents will be held over until the 2011 be rendered transparent, and they call for Annual Report. a broadly based, interdisciplinary and also public debate. For this reason, the Ethics Council re- sponded to this paper by establishing a

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Issues of chimera and States, the United Kingdom and hybrid research to take part in a public hearing on 25 Feb- ruary 2010. Mythical and other descriptions of hu- The proceedings began with an intro- Audio recordings and presentations man–animal mixtures have existed since duction by Council member Jens Reich from the public hearings can be the beginnings of human culture, and are on the scientific fundamentals of the for- accessed online at exemplified by the centaurs of Greek an- mation of mixed-species entities, with www.ethikrat.org /veranstaltungen tiquity or the Egyptian sphinx. to- an explanation of the various forms of /anhoerungen day, however, presupposes a clear distinc- these entities. He said that hybrids were tion between human beings and animals. organisms whose cells contained genes Yet scientists have been experimenting for of two different species and which arose, decades with the mingling of human and for example, from the fusion of eggs and animal genes, cells or tissues, for instance sperm of closely related species such as in research on the replacement of human horses and donkeys. There were also par- tissues or organs by animal material, or in ticular forms of hybrids in which only the creation of animals with human genes a small number of genes from one spe- for the investigation of human diseases cies were transferred to the other. These and developmental processes. included transgenic animals, produced The German Ethics Council’s working in Germany as in other countries, that group on human–animal mixtures has possessed some human genes, as well as been deliberating on the ethical aspects the cybrids mentioned earlier, which still of the formation of such mixed entities contained a few animal genes in their cy- since 2009. The aim is the preparation of toplasm. Chimeras, on the other hand, an Opinion intended to contribute to the were composed of cells from different analysis and evaluation of developments species. Chimeras could be obtained with ethical implications in the produc- by transplanting cells, tissues or organs tion of human–animal mixtures and to into an organism belonging to another answer the question whether, and if so species (before or after birth) or by the where, action is called for on the part of experimental fusion of embryos of dif- science, society or the political world. In ferent species. The fusion of human and other countries, after all, the last few years animal germ cells and embryos and the have already seen vigorous public debates introduction of animal cells into human on the formation of mixed-species entities embryos were prohibited under Section – for example, in the United Kingdom on 7 of the Embryonenschutzgesetz (Embryo the production of “cytoplasmic hybrids”, Protection Act), but not the production or “cybrids”, in which a human nucleus of cybrids. is transplanted into an enucleated animal The theologian, scientist and medical Beck, Matthias: Mensch-Tier-Wesen. egg in order to produce embryonic stem specialist Matthias Beck, of the University Zur ethischen Problematik von cells. of Vienna, Austria, who is also the au- Hybriden, Chimären, To discuss the situation in Germany in thor of a book entitled Mensch-Tier-Wesen Parthenoten. Paderborn et al.: the light of this international experience (Human-Animal Mixed-Species Entities), Schöningh, 2008. and to consult ethicists with a particular gave more details of the production of interest in the subject of human–animal cybrids. Professor Beck considered this mixed-species entities, the German Ethics research, which was currently undertaken Council invited experts from the United internationally but not in Germany, to

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From the left: John Harris, Mark Greene, Matthias Beck and Robert Streiffer at a hearing on human- animal mixtures

be unethical. It was in his view immate- be, first, specific characteristics, such as, rial that research workers doubted that in particular, cognition; second, the mere cybrids were capable of development be- potential to develop such characteristics; yond early embryonic stages and that they or, third, simple membership of the ge- on no account wished to permit them to nus Homo. On the basis of these three mature in the womb. For him, the mere approaches, different aspects would be production of a cybrid with a human nu- assigned more weight in the ethical as- cleus was an abomination, as it gave rise sessment of mixed-species entities. Advo- to “a human being with an expiry date cates of the view that actual or potential and with contamination from animal cognitive characteristics were particularly material” – that is, a human embryo that relevant would have to opt for a point was produced for research purposes only beyond which mixed-species research and was damaged by the cloning process made the humanoid formation of such and by the residual animal genetic mate- characteristics probable. If, on the other rial in the cytoplasm. He stated that the hand, membership of the genus Homo philosophical foundation of the Embryo was the central consideration, it would be Protection Act was Immanuel Kant’s cat- necessary to clarify when this status was egorical imperative, according to which attained in a mixed-species entity. one should “use humanity at all times as It was always difficult to answer such an end and never merely as a means”. The questions because there were very many creation of cybrids gave rise to “beings” possible variations in the quantity and na- that could never set ends for themselves, ture of the mixed genes, cells and tissues, and this contradicted the idea of human- as well as in the time of mixing, which ity. Professor Beck called for an explicit was important for the further develop- ban on their production. ment of the organism. In the case of the Robert Streiffer, a at the experiments currently in hand, however, University of Wisconsin-Madison, United it was very unlikely that the moral sta- States, spoke about the moral status of tus of the experimental animals would animals with human cells. Opinions dif- be altered, regardless of how that status fered on the foundations of moral status. was defined. Yet such alterations were Possible criteria for human might already conceivable both theoretically and

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technically. In Professor Streiffer’s view, we were replaced by better organisms. it would not yet be a fundamental prob- The thesis underlying this statement was lem even if a mixed-species entity were to that the genetic composition and genesis acquire an altered moral status according of a creature were irrelevant as long as to one of the three criteria. Instead, the the creature was accorded the full dig- crucial point was that an animal altered nity appropriate to its specific charac- in this way would then have to be treated teristics. During the course of evolution, with more respect, and that could pre- man had, firstly, undergone a constant sent difficulties in the context of animal process of gradual change and, secondly, experiments. retained many features in common with The philosopher and veterinarian Mark other species. There was no reason not to Greene, of the University of Delaware, remain open to the possibility of future United States, emphasized that the vari- changes, even if these were brought about ation of characteristics whereby the wel- artificially by human action and involved fare or needs of an animal were changed the abrupt mixing of human and animal was also relevant to the ethical appraisal genes and cells. of mixed-species entities. Such variation The decisive factor was not the artifici- could present a challenge in terms of ani- ality of a process, but its effects on the sub- mal ethics regardless of considerations of jects concerned, and in this connection it moral status if it led to a situation in which should not be forgotten that failure to act such creatures had no conspecifics with could also have negative consequences. which they could interact normally. As an Ultimately, the crucial point for a posi- example, Professor Greene mentioned the tive evaluation was whether an artificially hypothetical case of a monkey which, ow- produced creature or one modified by ing to a partially humanized brain, sud- mixing with other species was thereby denly grinned when it was happy and was enabled to have a better life, and whether then misunderstood by other members of we were prepared, where necessary, to its species, which perceived grinning as assign a correspondingly modified moral a gesture of aggression. Such problems status to a mixed-species entity with cor- could best be addressed by improved in- respondingly modified characteristics. vestigation of the normal behaviour of the A characteristic particularly relevant to experimental animals, and this was at the status, according to Professor Harris, same time an important foundation for was the capacity for speech. Where the the development of better methods of production of a mixed-species entity was investigating status-related characteristics unlikely to modify the moral status of the and behaviours in mixed-species entities. experimental animal, decisions should in Professor Greene also stressed the need his opinion be made in accordance with for research to take more account of the the possible medical or social utility of risks of the transmission of alien patho- the research. gens by mixed-species entities. In the ensuing discussion, the members John Harris, of the University of Man- of the German Ethics Council addressed chester, United Kingdom, began his con- in particular the various criteria of dignity tribution by predicting that human beings and possible ways of evaluating relative would no longer exist in the future, but differences in the depth of intervention in said that this did not matter provided that the production of mixed-species entities.

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Wolf-Michael Catenhusen, the spokes- possessed by dementia sufferers. Possi- person for the human–animal mixtures ble ways are being investigated of more working group, summed up the proceed- accurately perceiving their wishes, as well ings by drawing attention to the need to as of supporting them and respecting their reflect on the permissibility of inducing self-determination and capacity to express qualitative changes in an animal’s char- themselves. The question thus arises as to acteristics. how much self-determination is possible under the conditions of dementia, as well as of what is necessary for an improved Dementia and perception of the capacity of sufferers for self-determination self-determination and the forms of care that can best support sufferers in their Audio recordings of There are at present approximately a mil- self-determination. the public meetings of the Council held lion people living with dementia in Ger- At a public meeting held on 24 June in 2010 can be accessed online many, a figure predicted to increase to 2010, Ethics Council member Michael (in German) at perhaps as many as 1.7 million by 2030. Wunder presented the fundamental www.ethikrat.org /sitzungen/2010 Dementia presents a challenge not only considerations on the subject to the full to sufferers’ families, carers and medi- Council in a paper entitled “Self-determi- cine, but also to society as a whole. This nation to the last? Suffering from demen- being the case, when discussing its work tia in dignity”. programme for 2010, the German Ethics In the view of Dr. Wunder, our ap- Council decided to address the topic of proach to dementia would become one of dementia, and commenced its delibera- the greatest future challenges in terms of tions on the subject on 24 February. social and health policy, and would have Since the issue of dementia is already to be confronted not only by family mem- the subject of a very broadly based debate bers, carers and medicine but also by so- on the part of various social actors, the ciety as a whole. A particular concern was working group concentrates its specifi- the care of dementia sufferers: should they cally ethical consideration on the question be cared for in an institution, at home, or, of self-determination under conditions alternatively, in assisted living communi- of dementia. Self-determination is an ties? What was the care objective – curing essential element in man’s understand- their disorder or “mere” support compat- * For convenience, ing of himself * and a central point of ible with human dignity? Who should be the masculine form is used for both reference in any ethical discourse. For a responsible for care – professional carers, sexes throughout this translation. long time, attention was directed solely to family members or civil society volun- the deficiencies associated with demen- teers? What limits should be placed on tia, with the result that, after diagnosis, the funding of this care? What quality of many sufferers felt themselves to be pa- care did we owe our fellow human beings tronized inappropriately. Other people – and what quality of life should be guar- talked about them but seldom to them. anteed? At the same time, dementia pre- However, an ethical approach demands sented a challenge to our understanding contact with sufferers themselves and re- of ourselves as human beings in terms of spect for their self-determination even if it reason and self-determination, confront- is restricted. Efforts are now increasingly ing us as it did with our own limitations. being made to focus on the capacities The question of whether dementia should

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be seen as a disease or as a particular form accordance with the individual stages of of ageing likewise arose in this connec- dementia in the form of a context-related tion. Dr. Wunder stated that the principal self-determination? How binding were challenge for the Ethics Council, how- advance directives, as well as advance ever, was the issue of self-determination. consent to research: was a decision made Self-determination was “the necessary at an earlier time on the basis of self-de- condition for the actualization of human termination always to be assigned greater dignity and for a dignified life even under value than one taken later, when the self- the conditions of dementia”. determination of the person concerned This question was not merely theoreti- was no longer recognized, or should the cal, but had eminently practical implica- later decision take precedence? tions. For instance, research in the last ten In pursuing this conception of self- years had shown that the contentment determination and in particular the is- and well-being of dementia sufferers in- sue of the practical validity of an earlier creased in proportion as their activities expression of a sufferer’s wishes, two op- and living environment provided for self- posing positions were encountered. For determination, self-efficacy and self-actu- advocates of Position A, wishes set forth alization. More detailed investigation was in an advance directive had a binding necessary to determine whether, and if so effect for a later stage in the progress of to what extent, self-determination was the patient’s dementia, even if these were still possible as the capacity for decision opposed by his present wishes, because and consent declined with age and what the wish expressed in a state of full mental practical consequences this had in terms competence was deemed superior to the of rendering the care of sufferers more subsequent preference, which was based difficult or, as the case might be, easier. only on situational or intuitive factors. The psychologically based conception According to Position B, although the of self-determination introduced by Dr. wishes expressed in an advance direc- Wunder later in his paper was based on tive had material legal significance, these three pillars: being capable of acting dif- wishes always had to be balanced, in the ferently; having reasons; and recognizing practical situation, with the patient’s cur- one’s own autonomy. In order to be able to rent wishes and determination of his best determine his own actions, an individual interests, because wishes expressed in the must, even under the conditions of de- present took precedence over earlier ex- mentia, be capable of understanding basic pressions, particularly where the subject’s information, assessing that information in personality had changed. the light of his own values, anticipating Summing up, Dr. Wunder stated that the result, and defending his own deci- dementia sufferers possessed capacities sion to others. of understanding, appraisal and auton- In this situation, however, two fun- omous expression of their will at every damental questions immediately arose. stage of the development of their condi- Was there a threshold below which the tion, albeit on an increasingly constricted capacities mentioned were so exiguous and unstable level. Their capacity for self- that competence for self-determination determination, while decreasing, always no longer existed, or could competence had to be respected, and they could ex- for self-determination be graduated in press what was important for their quality

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of life. The forms in which they expressed termination, such as self-actualization, their wishes were increasingly difficult to self-efficacy, self-realization, self-organi- decipher, but could be discerned given zation, self-assertion or autonomous ac- sufficient sensitivity and practice. A re- tion. Dr. Wunder considered that these sponsible and accountable system of care, points called for further discussion and medicine and psychosocial support would clarification. take precise account of these expressions In the course of a whole-day public at every stage of development and take meeting entitled “Dementia – the end of them as the foundation of best-interests self-determination?”, held in Hamburg decision-making. on 24 November 2010, the members of However, according to Dr. Wunder, it the Ethics Council were able to exchange was essential, in the consideration of all views with sufferers and experts and gain these factors, to determine whether the a more detailed understanding of the sub- reality of care was consistent with these ject (see p. 28 ff.). The results of the meet- desiderata. ing will be incorporated in the Council’s The discussion of Michael Wunder’s continued work on its Opinion. paper by the full complement of members of the Council focused on his conception of self-determination. Volker Gerhardt Reproductive medicine commented that Kant’s notion of auton- omy should be applied to the definition of The Ethics Council had placed the topic of this concept, not only because Kant was reproductive medicine on its agenda for the first to use the concept of self-determi- 2010 as early as in November 2009. The nation, but also because Kant associated process of deliberation was launched in the use of the concepts of autonomy and July 2010 with keynote papers by Coun- self-determination with the term “max- cil members Jochen Taupitz and Regine im”: one needed to “have a conception of Kollek on legal and medical aspects of the importance of that which, with regard recent developments in the field of repro- to a situation whose seriousness one has ductive medicine. A working group with recognized, one actually did on this and Wolf-Michael Catenhusen as its spokes- all subsequent occasions”. person commenced its activity shortly Michael Wunder, however, doubted afterwards, in August. In the context of that the philosophical definition of self- its deliberations on reproductive medi- determination was fully applicable to the cine and having regard to a number of course of a dementia. He had been more fundamental judgements on the subject concerned to address the concept of self- in 2010, such as those of the European determination from a different scientific Court of Human Rights in April, the perspective – namely, “to imbue it with, Rostock Higher Regional Court in May or place it under the tension of, the psy- and the Federal Court of Justice in July, chological approach oriented towards the the German Ethics Council decided in experiential world”, so that it yielded pro- September 2010 to focus on the aspect ductive questions for the continuation of of preimplantation genetic diagnosis in the debate. an initial Opinion on this topic, and to The discussion should, in his view, present this Opinion in the spring of 2011 also address concepts related to self-de- if possible. To obtain information on the

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current practice of preimplantation ge- According to Council member Regine netic diagnosis in neighbouring European Kollek, new developments in the tech- countries, the Ethics Council held a public niques of reproductive medicine, the hearing in December. ethical discourse of the last decade and In his keynote paper on 22 July 2010, recent court decisions necessitated a fresh Council member Jochen Taupitz enquired debate. However, it was not clear how far whether the Embryo Protection Act was the scientific and technical developments still adequate for the current situation. made reform of the Embryo Protection He noted that, notwithstanding numer- Act indispensable. ous innovations in reproductive medi- In her paper, Professor Kollek gave an cine and developmental biology, the Act account of the technical possibilities and had now remained unchanged for twenty limits of in vitro fertilization (IVF), in- years. This was problematic in that the Act tracytoplasmic sperm injection (ICSI), included criminal-law prohibitions that polar body (PB) biopsy, preimplantation needed to be formulated with particular genetic diagnosis (PGD) and other tech- exactitude for constitutional reasons. niques used in reproductive medicine. Professor Taupitz reviewed the aims In view of the comparatively low success of the Embryo Protection Act and drew rate and the relatively high incidence of attention to provisions that had either multiple births with IVF and ICSI, not been restricted by recent case law – such only blastocyst transfer but also PGD, as that of the European Court of Hu- which was frequently used in countries man Rights, the Rostock Higher Regional other than Germany, were now becoming Court and the Federal Court of Justice, or more significant. For diagnostic purposes, could in his view be interpreted differ- PGD was increasingly used to identify ently or were disputed by legal authori- pathological predispositions, as well as for ties. Examples were the prohibition of the avoidance of disease, for sex selection gamete donation, artificial fertilization or for the creation of a “saviour sibling”. with a dead person’s sperm, the produc- In addition, PGD was often applied with a tion and use of embryos for a purpose view to increasing the pregnancy rate after not directed towards their preservation, IVF, although this effect was unproven in surrogate motherhood, and the transfer of practice. more than three embryos to a woman. In In the course of the debates on amend- Professor Taupitz’s view, another relevant ment of the Embryo Protection Act or, as question was whether it was justifiable the case might be, the introduction of a re- to provide for greater protection of an productive medicine act, Professor Kollek embryo in vitro in accordance with the also considered it necessary to reflect on Embryo Protection Act than of a grow- the possible need to set limits to these new ing embryo or fetus under the current developments. For this purpose, account law governing abortion. Although few had to be taken, too, of the possible social disputed that the Embryo Protection Act and environmental causes of undesired needed to be amended, further discussion childlessness that made recourse to arti- was necessary on whether it should be ficial fertilization more likely. supplemented or rendered more precise, In the ensuing discussion, the members or instead be superseded by a wider-rang- of the Council initially expressed interest ing reproductive medicine act. in certain concrete aspects of the topic

17 German Ethics Council

– the statistics on IVF, the pregnancy ter- On the practice of PGD in Belgium, mination rate after IVF and subsequent Paul Devroey, a specialist in reproductive prenatal diagnosis, and inclusion of these medicine, explained that the procedure benefits in the statutory health insurance for securing approval for each diagnosis scheme. The discussion then turned to was difficult but transparent. PGD was the possible consequences of the incor- conducted at seven licensed IVF centres poration of more specific provisions in in cooperation with a human genetics the Embryo Protection Act or of a com- centre. Other requirements were the pro- prehensive regulatory system for the new vision of advice to the couple and posi- in the form of a reproduc- tive evaluation of the case by a specialist tive medicine act, and whether the Ethics in reproductive medicine, a geneticist, Council could assist the in this a psychologist and, where necessary, an connection. ethics committee. There was no official In order to learn about the practice of list of permitted indications. preimplantation genetic diagnosis, on 16 The United Kingdom’s contribution December 2010 the Ethics Council held comprised a report by Emily Jackson, Pro- a public hearing on recent developments fessor of Law and Deputy Chair of the in PGD and its regulation and practice in UK’s Human Fertilisation and Embryol- Belgium, France and the United Kingdom. ogy Authority (HFEA). The Authority First of all, Luca Gianaroli, Chair of was the competent body in the United the European Society of Human Repro- Kingdom for the issue of licences required duction and Embryology (ESHRE), re- by centres in order to provide PGD. It ported on the state of development of also decided which genetic and chromo- PGD as reflected in the register kept by somal disorders constituted permissible the ESHRE over a period of more than grounds for PGD. In the advisory process, ten years. Data from 57 of just over 100 the couple’s situation was taken into ac- centres worldwide were stored and evalu- count and the opinions of various experts, ated in the register. Between 1999 and the such as medical practitioners and patient latest reporting period (treatment year groups, were obtained. In the case of par- 2007), some 28 000 treatment cycles were ticularly controversial types of diagnosis conducted and 4047 children were born – e.g. testing for genes carrying the risk after examination at the embryo stage. of breast cancer – the public too were The cells to be tested were taken on the increasingly involved in the deliberative third day in approximately 99.5% of all process. However, once a test was recog- cases. Because these cells were assumed nized, any licensed centre could apply to have the potential to develop into an it without requiring HFEA approval for independent embryo, this procedure was each individual case. prohibited in Germany. Overall, however, Patrick Gaudray, a geneticist and mem- increasing interest was being shown in ber of the French bioethics committee, the examination of blastocysts – that is, the Comité Consultatif National d’Ethique embryos on about the fifth day of their (CCNE), described the French model, development. By then it was possible to which set strict limits to PGD that could obtain more cells which, moreover, were be changed only by way of amendments destined only for the eventual formation to the country’s reproductive medicine of the placenta. act. At present, PGD could be carried out

18 Annual Report 2010

From the left: Luca Gianaroli, Paul Devroey, Emily Jackson and Patrick Gaudray at a hearing on preimplantation diagnosis only at three licensed centres and only sent at the hearing put further questions for families already affected by a serious, to the experts. Particular interest was ex- incurable genetic condition. There was no pressed in the number of embryos needed list of specific pathological dispositions for a PGD. In most cases, this was sig- for which PGD was permissible; instead, nificantly greater than the maximum of each individual case was reviewed by a three embryos per IVF cycle considered fixed procedure. by most authorities to be permissible to Unlike France, Belgium and the United achieve pregnancy. Other questions con- Kingdom also permit testing for chro- cerned the details of the procedure for mosomal disorders that are not already deciding for or against testing for spe- present in the parental genome, but arise cific genetic pathology. In the view of the only during gametogenesis or fertiliza- experts, given the differing approaches tion. According to the latest ESHRE data to preimplantation genetic diagnosis set presented by Dr. Gianaroli, from 2007, and its evaluation, it was important for screening for this purpose is undertaken a democratically legitimized procedure in just under 64% of cases of PGD, and to be applied in order to reach a decision is therefore much more frequent than consistent with the society of the relevant diagnoses of specifically inherited patho- country and the differing positions held logical dispositions. However, Professor within it. Devroey, Professor Jackson and Dr. Gian- The Ethics Council continued its de- aroli pointed out that recent research had liberations immediately after the hearing shown that, contrary to earlier expecta- with the aim of bringing them to a con- tions, the birth rate was not improved by clusion by the beginning of March 2011, screening. For this reason, this approach so that the Opinion could be delivered to could still only be regarded as experimen- the members of the German Bundestag if tal, even if there were indications that possible before the commencement of the more recent techniques might yield better parliamentary debate. results in the future. Following these contributions, mem- bers of the Ethics Council and the many members of the German Bundestag pre-

19 German Ethics Council

Public meetings and promotion of social discourse

The German Ethics Council has a man- Belgium, France and the United Kingdom date to inform the public and to encour- to a hearing in Berlin, to ask them about age discussion in society, engaging the the regulation and practice of PGD and various social groups. the latest developments in the genetic Proven platforms are the public meet- testing of embryos. ings and other Council events held at in- In addition, the Ethics Council held tervals throughout the year. In this way, two whole-day public meetings in Ber- the Ethics Council reaches different parts lin and Hamburg respectively and three of the public. For example, at the Annual public evening meetings in Berlin. An- Meeting, the German Ethics Council en- other platform for discourse consisted of gages in a public exchange of views with information and discussion meetings with experts, with academics engaged in re- students and schoolchildren. search on the life and bioethics, To enable the hearing-impaired to take with representatives of organizations and part in the public meetings and events, associations, and with interested citizens. real-time transcriptions are made; like the The events in the Bioethics Forum series audio recordings, these are made available enable an interested, wider and not neces- to a wider public online. sarily expert public to engage in a dialogue with mostly external contributors and the members of the Ethics Council. Public plenary meetings During the period under review, five Audio recordings of plenary meetings (in February, June, July, The topics addressed at the public plenary the public meetings of the Council held October and December) were partially meetings were discussed in the previous in 2010 can be accessed online open to the public – that is to say, inter- section if also considered by the Council’s (in German) at ested persons could attend the meetings internal working groups. The only excep- www.ethikrat.org /sitzungen/2010 and gain an insight into the work of the tion was tissue engineering, which was de- Council on the various topics and into bated in October, and is discussed below. its discussion culture. The February pro- gramme included a public hearing on the Tissue engineering – making tissues subject of human–animal mixed-species in the laboratory entities. This was followed in June by a pa- At the public plenary meeting held on 28 per by Council member Michael Wunder October 2010, Heike Walles, a member on self-determination and dementia, with of the German Ethics Council since July an ensuing discussion. In July, the Coun- 2010, reported on her research on the cil learned about the legal, scientific and artificial production of human tissue. medical aspects of recent developments Professor Walles explained in her in- in reproductive medicine; while in Octo- troduction that the aims of tissue engi- ber Council member Heike Walles gave neering were, first, to establish the fun- an introduction to the subject of tissue damental mechanisms and functions of engineering. For its December meeting, healthy and diseased tissue and, second, the Ethics Council invited experts from to develop biological replacement tissue

20 Annual Report 2010

from the body’s own cells to support or could be stimulated with growth factors, replace damaged or failed tissue or organ on the one hand this took a very long functions. time and, on the other, it worked only for Although it would be some time before very small blood vessels. Even if artificial complex therapeutically usable replace- microvascular networks were used instead ment tissue could be produced syntheti- and these were then colonized with living cally, promising initial results had already endothelial cells, the current upper limit been obtained with the transplanting of for such vessels was a diameter of only 3 artificially produced skin, cartilage and millimetres. tracheas. Again, in the field of research, laboratory-cultured tissues could replace a large number of animal experiments and thereby yield more reliable results, since the material used came from human cells and was more likely to behave like cells and tissues in eventual patients than ma- terial from remotely related experimental animals. The culturing of tissue basically com- prised three steps: first, body cells were isolated; then they were grown and propa- gated in the laboratory; and, lastly, they Heike Walles reports on tissue were made to grow into the desired form Even so, Professor Walles was able to engineering and structure with the aid of bioreactors report successful results in the culturing of and three-dimensional scaffolds. more complex tissues. Using the BioVaSc To make, say, artificial skin, Professor (biological vascularized scaffold) tech- Walles and her team first grew the type nique developed by her group, she and of cells predominant in the deeper layers her team had produced a liver testing sys- of the skin, known as fibroblasts, in a col- tem “of about finger size” with structures lagen gel, adding on the second day a layer similar to those of a functioning bile duct, of keratinocytes – the cells of which the a trachea test system that simulated condi- outermost layer of the skin was composed. tions within the respiratory system, and After two weeks, the cells had formed a a bowel test system allowing investiga- tissue that was similar enough to natural tion of the absorption of active substances skin to be used in various experiments. via the intestinal mucosa. The artificial These included tests of the skin compat- tracheas successfully used in patients in ibility and effectiveness of new medicinal initial clinical studies were also produced products and other substances, wound- by the BioVaSc technique. healing studies and the investigation of The scaffold used in this technique was infective processes or skin tumours. porcine bowel from which all animal cells In the production of tissue with a more had been removed. The human cells then complex three-dimensional structure, grew on this scaffold in the bioreactor Professor Walles said that a major chal- with the aid of suitable growth factors. lenge was the provision of blood vessels. A further application of tissue engi- Although natural vascular formation neering mentioned by Professor Walles

21 German Ethics Council

was personalized medicine. Methods were Annual Meeting currently being developed that would in the future allow the culturing of a patient- On 20 May 2010, more than 300 persons specific tumour model from the tissue of accepted the German Ethics Council’s in- a cancer sufferer; the model could then vitation to attend its second Annual Meet- be used for further diagnosis and drug ing, on “Migration and health: cultural tests in order to optimize therapy for this diversity as a challenge to medical care”. individual patient. According to data from the Federal Sta- In the ensuing discussion with the tistical Office, some 15.6 million people other members of the German Ethics with a background of migration are cur- Council, Professor Walles stated that in rently living in Germany. Their biogra- her view tissue engineering did not raise phies, cultures and countries of origin are any ethical problems, and she emphasized extremely diverse, so that they can on no its potential to reduce the application of account be regarded as a uniform group. ethically more debatable techniques. This Furthermore, a plurality of cultures exists concerned not only the replacement of within the individual groups. Since each animal experiments by cultured human culture may have a different conception tissue, but, in the future, possibly also of illness and health, which is likely to the field of transplant medicine, should it influence health-related behaviour and prove feasible to replace donor organs and decisions concerning therapy, the doctor- tissues by ones grown in the laboratory. patient relationship, as well as the en- Problems were, however, in her view tire healthcare system, is presented with presented by the current regulatory provi- particular challenges by such patients. In sions on research. Tissue engineering fell addition to language barriers, heterogene- substantially within the purview of the law ous culture-specific values must be ap- relating to medicinal products, which was propriately allowed for. This means that not optimally suited to work with living issues of both medical and social ethics cells. “We have to overcome some crazy immediately arise. For these reasons, the statutory hurdles in order to demonstrate German Ethics Council wished to use the substitutive potential of our tissues,” its Annual Meeting to stimulate reflec- said Professor Walles. tion on the practical form in which these Asked about the longer-term outlook particular challenges could be addressed. for tissue engineering, Professor Walles The aim of the meeting was to highlight stated that it was unlikely that it would various facets of this wide-ranging topic ever be possible to create complete organ- in terms of their ethical implications and isms with a technique of this kind: “That is to discuss them with experts from various too complex. At the moment we can only disciplines and professions, as well as to culture five types of cells together; but present these issues, which used to be in humans there are over 1000 different regarded as falling primarily within the types of cells, which develop in complex realm of social policy, as having an ethical ways over a long period.” dimension. Council member Axel W. Bauer in- troduced the subject to the meeting. He placed it in a historical and demographic context and drew attention to the many

22 Annual Report 2010

possible approaches to it, as reflected in a tion in health and care reporting, which Presentations from the Annual large number of important research pro- remained unsatisfactory, “so as to enable Meetings as well as audio recordings jects. He stated that the Annual Meeting us to proceed more directly towards our (in German) can be could “by no means consider every facet objective, to identify the exact fields where accessed online at www.ethikrat.org of the complex relationship between mi- action is needed, and also to develop solu- /veranstaltungen gration and health”. tions”. The Minister of State said that, in /jahrestagungen In her initial contribution, Minister of a field where many aspects were still at an State Maria Böhmer, the Federal Govern- early stage, advantage should be taken of ment’s Commissioner for Migration, Ref- the opportunity to proceed in the right ugees and Integration, described health as direction from the start. the aim of integration policy. Germany The academic introductory address now saw itself not only as a country of was concerned with the background to destination for immigrants but also as migrant health. Oliver Razum, Professor one characterized by integration; con- of Epidemiology and International Public siderable action was required in the field Health at the University of Bielefeld and of migration and health. She explicitly Chair of the Deutsche Gesellschaft für Epi- thanked the Ethics Council for address- demiologie (German Society for Epidemi- ing the issue, particularly as health and ology), concentrated on three questions: care were a particular focus of the Federal Did the health of migrants differ from that Government’s attention in this Electoral of the majority population? If so, might Term. She laid particular stress on the the differences be predominantly a matter need for an intercultural approach by the of social class? What other factors might healthcare system and for the promotion adversely affect the health of migrants? of intercultural competence in the train- Professor Razum cited studies on infant ing programmes of the health professions. mortality in Germany and on rehabilita- A vital aspect was culture-aware care of tion. According to the data in his first the elderly. However, with a view to pre- example, although migrants shared in the vention, it was equally important to reach overall positive trend of infant mortality, mothers, in order to promote child and mothers who had only recently arrived in adolescent health. It was also necessary Germany had a very much higher risk of to facilitate research on the data situa- losing their child in the first year of its life.

Minister of State Maria Böhmer (in the foreground) at the Annual Meeting, next to her the Chair of the Ethics Council, Edzard Schmidt-Jortzig

23 German Ethics Council

The second study showed that migrants context, discussing in particular patient had an increased need for rehabilitation. autonomy. Since patient autonomy played At the same time, the take-up of medical an important part in the various forms rehabilitation was lower than was to be of ethical discourse, Dr. Ilkilic demon- expected and less than that of the Ger- strated the differences discernible in the man majority population. It was moreo- understanding of this concept and their ver found that the rehabilitation measures implications for decisions in the field of were less successful. This suggested that medical ethics. He also addressed the issue barriers existed in terms of both access of the appropriate conception of patient and efficacy. In Professor Razum’s view, autonomy in a society with a plurality these differences could not be explained of values. On the basis of various exam- solely by sociodemographic factors or, ples, he analysed some specific problems for instance, more physically demanding of ethical decision-making and action in work. Linguistic and cultural differences an intercultural context. Dr. Ilkilic de- also played an important part. Another scribed his proposal for a culture-sensitive pertinent factor, however, was the attitude medical ethics as an approach that was of the institutions concerned. Professor both integrative and particularistic, and Razum mentioned system-related fac- avoided generalizations and consequent tors that probably lay in the structure of misinterpretations. He helped those the rehabilitation centres and which were present to understand the significance likewise among the challenges inherent in of language barriers, a subject that came the relationship between migration and up many times during the meeting. Suc- health. For this reason, he recommended cessful communication was necessary not not only preventive action on the behav- only so that patients could describe their ioural level but also structural changes. symptoms appropriately, but also in order In order to deal with the heterogeneous to permit access to their values and prefer- group of migrants, it was necessary to de- ences. However, successful communica- velop a capacity which Professor Razum tion could often be achieved only with the called diversity management. aid of professional interpreters, who were Ilhan Ilkilic, a medical ethicist at Mainz seldom available. Translation by family University’s Institute for the History, The- members was not always reliable and was ory and Ethics of Medicine, approached furthermore often problematic for rea- the subject from the point of view of sons of authority within the family. For medical ethics. He too referred to the het- example, information might be withheld erogeneity of the group of persons with from patients if the family felt that the a background of migration and stressed difficult diagnosis might be detrimental to the importance of adopting a definition the patient’s prospects of recovery; in ad- of culture that took account of this. He dition, certain aspects might be conveyed began with a description of the possible wrongly because they were not correctly characteristics of a doctor-patient rela- understood. Besides difficulties of this tionship involving intercultural aware- kind, language problems often led to over- ness. This differed from other doctor- diagnosis to compensate for deficiencies patient relationships not in its essence but of communication. in its intensity. Dr. Ilkilic then sought to Theda Borde, Professor of the Medical place ethical questions in an intercultural and Medical-Sociology Foundations of

24 Annual Report 2010

Social Work and Clinical Social Work at institutions for education and informa- the Alice Salomon University of ­Applied tion, sensitive to cultural differences, and Sciences in Berlin, concentrated in her pa- corresponding staff skills. Another re- per on migrant women’s health in terms of quirement was to raise the level of health needs, the reality of care and prospects for competence and self-assertion of migrant the future. The Migration Report of the women by means of social-work projects. Federal Interior Ministry indicated that Alain Di Gallo, senior physician and nearly half the population with a back- deputy medical superintendent at Basle ground of migration was now female and University Clinic’s Child and Adoles- that, as more and more people arrived, cent Psychiatry Unit, reported on expe- this proportion was constantly increasing. rience in his specialty. He complained Professor Borde addressed four issues in of the inadequate data situation on the particular: how to reach patients; patient health of children and adolescents with a expectations and satisfaction; doctor-pa- background of migration in . tient interaction; and patient education. There was, however, no doubt that chil- She considered these with the aid of the dren and adolescents experienced migra- data from two comparative studies by tion differently from adults. He stressed Berlin’s Charité Hospital on the meno- that migration often resulted in changes pause and hormone therapy. In particular, in roles and hierarchies within the family. the results of the patient education sur- For this reason too, child psychiatry was vey were alarming: the level of agreement always also family psychiatry. Children of- between patient knowledge and medical ten faced excessive demands and conflicts diagnosis was very low among female mi- of loyalty within the family, as he showed grants, and actually fell even lower in an with the aid of examples. “Not every child inpatient situation. Particular problems finds it easy to do these cultural splits.” identified by Professor Borde concerned Since much of the communication in his communication and information, the le- discipline in any case took place by way of gal and economic aspects of incorrect, play and drawings, the language barriers insufficient and excessive care and incor- were not quite as difficult to overcome rect, excessive and insufficient take-up as in other fields. Dr. Di Gallo laid stress of available healthcare benefits – as well on the particular value of intercultural as compliance, given that health-related dialogue, from which both sides could information could be used only if it was learn and profit. Migration called for “a understood. Professor Borde considered balance between the alien and the familiar, that the main ethical issues concerned between different emotional, social and the mandate of the care system, equality, cultural needs and demands. The familiar equal treatment, health equity and in- gives us confidence and links us together, formed consent. With regard to migrant but it also ossifies if it is not mixed with women’s own responsibility, Professor the alien and the new.” Borde mentioned that whereas previous The doctor-patient relationship ad- speakers had claimed that patients were dressed at the beginning of the meet- responsible for seeking help, in her view ing was considered from a specifically the care system also needed to be proac- legal perspective in the next paper, by tive. The need was for readily accessi- Andreas Spickhoff, Professor of Private ble arrangements within the healthcare Law, Medical Law, International Law and

25 German Ethics Council

Comparative Law at the University of ation, illness is like a screen on to which Göttingen. “German medical law [is actu- the looming insecurity of their position ally] sufficiently open that it can apply the is suddenly projected in glaringly sharp necessary flexibility to all the problems focus.” Advice and treatment were pro- mentioned in the previous contributions.” vided free of charge and anonymously. Professor Spickhoff considered in particu- A network of clinics and specialists in lar the issue of the appropriate provision private practice offered help for patients of information to patients whose mother in emergencies that could not be dealt tongue was not German and who had with directly at the centre. Dr. Schlem- a non-German cultural background. It mer graphically described some actual was clear from the decisions of the courts cases, drawing attention to the problems that patients had no entitlement to treat- presented by the Asylbewerberleistungsgse- ment in their mother tongue. Several of setz (Asylum Seekers’ Benefits Act) and to the previous contributors had mentioned the social welfare authorities’ obligation the need to use professional interpreters. to furnish data to the Aliens Authority, Minister of State Böhmer had even called a requirement which was dispensed with for the cost to be met as a benefit under only in cases of medical emergency and the statutory health insurance scheme. could lead to deportation and hence to In his view, it was debatable whether a particular psychological stress in a patient. constitutional entitlement to the reim- The benefits provided under the Asylum bursement of interpreting costs from the Seekers’ Benefits Act should in fact guar- statutory health insurance scheme could antee the same rights as in the statutory be established. He himself felt that there health insurance scheme – but the situa- were persuasive legal reasons for explicitly tion in practice was very different. In the including these costs in the list of benefits discussion, Dr. Schlemmer remarked: “If provided by the statutory health insur- you ask what we wish for, the abolition of ance scheme. At present, interpreting the Asylum Seekers’ Benefits Act is our costs were not eligible for reimbursement dearest wish.” The local health authorities because they were deemed to be external should be expanded, legal lines of demar- services that were not prescribed by a cation should be changed, and appropri- doctor and for which the doctor could ate provisions for meeting the relevant not take responsibility. Only recipients costs should be introduced. There was of social welfare benefits could have in- in addition a need for action with regard terpreting costs reimbursed by the social to the care of persons without valid resi- services department. dence status in rural regions. A subject which also constantly fea- In her paper, Ulrike Kostka, head of tured prominently in the media was ad- the Basic Theological Principles Depart- dressed by Bettina Schlemmer, a general ment of the Catholic relief organization practitioner at Munich’s Malteser Migrant- Caritas in Freiburg and Privatdozentin en Medizin. She said that this walk-in cen- at the University of Münster, drew to- tre offered not only medical but also social gether several of the separate threads of and legal advice to persons who lacked the meeting. On the basis of a multidi- valid residence status or had no health mensional ethical analysis, Dr. Kostka insurance owing to a social emergency identified the various actors and levels situation. “For someone in this life situ- of reflection. Her aim was to develop an

26 Annual Report 2010

Panel discussion with Stefanie Vogelsang, Hamit Ince, Eberhard Schockenhoff, Yasemin Yadigaroglu and Axel W. Bauer (from the left) ethical criteriology for the establishment health, which also included higher-level of a healthcare system sensitive to dif- social conditions such as the relationship ferent patient backgrounds and cultures. between health and education, as well as Taking fundamental considerations on work, poverty and social disadvantage, health and illness as her starting point, Dr. Kostka showed that migration and she emphasized that healthcare as a good health was a wide-ranging topic that called for solidarity, but in addition to this embraced many different perspectives, aspect of social ethics had implications on extending beyond the debate about the the level of individual ethics, since “health healthcare system alone. If the discussion [is] closely bound up with my own view of were confined to the aspect of healthcare, my body, with my relationship to myself the problems that lay concealed behind as a subject”. One therefore also had to health difficulties would be medicalized. take responsibility for one’s own self, a Dr. Kostka advocated an overarching en- responsibility she called “self-care” which vironmental-prevention approach falling could not be delegated. However, the care within the fertile area between solidarity system had an obligation to be proactive and self-care. in enabling the individual to undertake The meeting ended with a panel dis- self-care. This requirement to be proactive cussion between Stefanie Vogelsang, a also applied to health professionals, who member of the German Bundestag and of had to be enabled by means of appropri- its Health Committee, and former Head ate training to undertake culture-sensi- of the Department of Health at Berlin- tive care and to practise culture-sensitive Neukölln; Hamit Ince, senior physician medicine. On the level of organizational at the Wahrendorff Clinic and Chair of ethics, benefit and service providers in the the Deutsch-Türkische Medizinergesells- healthcare system ought as far as possible chaft e. V. (the German-Turkish Society to adopt an overall approach in which of Medical Practitioners); Yasemin Yadi- persons with a background of migration garoglu, a social scientist with a particular enjoyed the same access as others to ser- interest in the provision of information vices. This called for close collaboration on consanguineous marriage; and Axel with the various social welfare providers. W. Bauer, a member of the German Eth- On the basis of her conception of social ics Council. The panellists discussed and

27 German Ethics Council

expanded on the various issues raised at valuable contribution of the Council in the meeting on the basis of experience in bringing this severe disorder to the centre their own fields. of public attention and debate. An important conclusion accruing The meeting’s moderator, Council from the Annual Meeting is that the member Michael Wunder, also laid stress phenomenon of migration must be ad- on the current importance of the subject. dressed by a differentiated approach on In his view, a particular requirement was the various levels discussed, thus mak- a change of paradigm whereby the issue ing it possible to perceive people in their of dementia was discussed in terms of individuality rather than in terms solely potentials rather than deficiencies and it of their history of migration, while at the was made clear that sufferers could and same time taking account of the particular should live in the bosom of society. needs of persons with a background of In her contribution, Ursula Lehr, for- migration. It was particularly gratifying to mer Federal Minister and Chair of the note that the contributors consistently re- Bundesarbeitsgemeinschaft der Senioren- sponded in concrete terms to the themes Organisationen e. V. (the Federal Associa- raised by the other speakers; this imparted tion of Senior Citizens’ Organizations), a well-rounded character to the meeting began by describing the context in which and made it easier for the participants to issues of dementia arose: “We have in- make connections between the various creasing longevity – which is gratifying positions represented in this many-sided – but at the same time we see this as a issue. challenge to every individual and to so- ciety! And let us not close our eyes to the fact that the likelihood of dementia External meeting increases with age.” One of the challenges was to safeguard the quality of life even Presentations from On 24 November 2010, over 300 mem- in its final phase – in particular, for de- and audio recordings of external meetings bers of the public came to the Hamburg mentia sufferers too – while making for are accessible online a dignified old age. To this end, particu- (in German) at Chamber of Crafts to attend the meeting www.ethikrat.org on “Dementia – the end of self-determi- lar importance attached to reinforcing /veranstaltungen /weitere nation?” professional help, care and treatment, as -veranstaltungen The German Ethics Council’s inten- well as to early diagnosis and prevention tion in organizing this meeting was to through physical, mental, intellectual and focus on possible ways of improving our social activity. perception of the wishes of dementia suf- According to Andreas Kruse, Director ferers and of supporting and respecting of ’s Department their self-determination and capacity for of Gerontology, three anthropological expression even if these were restricted. indicators facilitated a deeper understand- In her opening address, Angelika ing of a person’s quality of life and ca- Kempfert, State Councillor in Hamburg’s pacity for self-determination – namely, Social Affairs, Family, Health and Con- self-actualization as a means whereby sumer Protection Authority, thanked the the psyche could express itself in the Ethics Council for making the subject various qualities of the personality; the of dementia one of its principal issues exercise of responsibility, in which the of concern. She thus acknowledged the person concerned perceived himself as an

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autonomous actor; and generativity, de- to influence the course of every individual fined as the motivation to do something dementia with any degree of permanence, for other people, or to put oneself in particularly as the causes of and possible someone else’s shoes. Even those in the ad- treatments for the various dementias were vanced stages of dementia retained a de- thought to differ very substantially. For gree of self-determination – albeit limited this reason, research should be directed – and, given appropriate opportunities for to a greater extent towards pathogenesis, communication and a suitable environ- treatment, rehabilitation and prevention. ment, could take responsibility for many Professor Hirsch also advocated an inte- aspects of their lives. In Professor Kruse’s grated biopsychosocial approach in which view, the essential point was to recognize the dementias were seen in their diver- that emotional, social and communica- sity, as well as a research policy involving tive capabilities and the ability to cope all the relevant academic disciplines. At with the practical demands of everyday present, dementias were unfortunately life were resources to be drawn upon in a still regarded, researched and treated too dementia sufferer. Every manifestation of much as purely organic disorders. Initial autonomous activity and empathy should attempts to take more account of the di- be exploited and positively reinforced, versity of individual sufferers, in research thus strengthening and making optimum as elsewhere, were evident in particular use of the capacities of dementia suffer- in geriatric psychiatry and the nursing ers. Using studies by the Department of sciences. Professor Hirsch emphasized Gerontology at Heidelberg, Professor that research involving dementia sufferers Kruse gave examples of possible forms must always allow for the fact that some of rehabilitation and care with the aim of subjects would no longer possess the ca- enhancing quality of life. pacity for consent at a later stage in their In his paper, Rolf-Dieter Hirsch, illness, and therefore required particular Medical Director of the Department of protection. In such cases, he considered Geriatric Psychiatry at the Rheinische that the only acceptable research-related Landesklinik in , addressed the is- interventions were ones whose results sue of research with dementia sufferers. were or could be of direct benefit to the He observed that it was not yet possible subject’s health.

Public meeting “Dementia – the end of self-determination?” at the Hamburg Chamber of Crafts

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The contribution of Margot Lucke, a and geriatric psychiatry. Furthermore, former consultant at the Medizinischer the documentation to be compiled under Dienst der Krankenversicherung Nieder- the care regulations in force took up more sachsen (Medical Service for the Health than 30% of properly trained staff’s work- Insurance Funds in Lower Saxony), was ing time. Dr. Lucke suggested that moti- devoted to home and inpatient care for vated pensioners should be encouraged dementia sufferers. She laid particular to undertake more civil society volunteer stress on the fact that dementia would lead work, that family doctors should receive to the end of self-determination if coordi- more training in the diagnosis, therapy nated measures to satisfy the needs of pa- and care of dementia, and that an element tients and their carers were not adopted. of practical care of the condition should Family members were often unable to form an integral part of the training of cope with the demands of outpatient care, medical practitioners. She pointed out they had only limited knowledge of respite that “perception of the forms of behaviour arrangements, and furthermore often did specific to the disorder, their interpreta- not know how to access these. In this con- tion and classification, and the appropri- nection, Dr. Lucke emphasized the vital ate reactions to them must be learned and role of the nursing care insurance funds, practised – and this applies to doctors, which, in addition to their mandate to professional carers and lay carers alike”. ensure that care was provided, were also Next, people with dementia themselves required to provide comprehensive advice took the floor. The discussion with Peter on care, including advisory home visits Wissmann, head of the dementia support and individual training in the domestic organization Demenz Support Stuttgart environment. and Deputy Chair of Aktion Demenz e. V., As for inpatient care, very few centres dementia sufferer Helga Rohra, a former were capable of fully recognizing the par- translator, and Christian Zimmermann, ticular needs of dementia sufferers and formerly a businessman and now suffer- of adopting an appropriate approach to ing from Alzheimer’s, was entitled “We allow them to exercise self-determina- speak for ourselves!” Unlike most people tion. There was a dearth of suitable staff diagnosed with dementia, who were re- and family doctors versed in geriatrics luctant to talk about their condition in

Discussion “We speak for ourselves!” with Volker Gerhardt, Christian Zimmermann, Peter Wißmann and Helga Rohra (from the left)

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public, Ms Rohra and Mr. Zimmermann stages of the process of learning “how to aggressively confronted the public with grow old in dignity” (Hesse), he proposed their situation, because they saw dementia the three phases of “resigned ageing”, “re- primarily as a social experience. After the flective and integrative ageing” and “crea- shock of diagnosis, they accepted their tive ageing”, and noted that the sequence situation and, by “going public with it”, of the phases need not be linear. On the wished to encourage other sufferers. Mr. question of self-determination in demen- Zimmermann thus declared: “There is tia sufferers, Professor Höffe considered a life after diagnosis.” Helga Rohra, for that, on the one hand, the principle of her part, said that she wished to “step self-determination should not be under- out of the shadows”. Besides care profes- stood in excessively demanding terms, sionals, family members and civil society but preferably on a comparative basis, volunteers, both wished to see sufferers while, on the other hand, documentation themselves integrated, as a fourth group of earlier self-determination – advance of actors, in the process of dealing with directives – should be accepted. the dementias. The meeting ended with a panel discus- The contribution of Otfried Höffe, sion between Ursula Lehr, Otfried Höffe, Head of the Political Philosophy Re- Helga Rohra, Peter Wissmann and Jo- search Unit at Tübingen University and hannes Schröder, Head of the Geriatric President of the Swiss National Advisory Psychiatry Section of Heidelberg’s Uni- Commission on Biomedical Ethics, was versity Clinic. Members of the audience entitled “Ageing in dignity”. Looking at were able to take part in the discussions by views of ageing throughout the course channelling questions through appointed of history, he noted that the problem of spokespersons. Aspects of particular in- ageing itself, reflection on ageing and the terest raised from the floor were utiliza- development of strategies to address the tion of family members’ expertise; coordi- associated challenges were nothing new, nation of the relevant medical specialties; but could already be identified in the pre- training of care professionals; specialist academic exploration the subject in the medical care in care homes; continuing ancient world. Pre-academic research on training of family doctors; and alternative ageing assigned “significant value to the forms of housing. benefits of a consideration that was no An exhibition of photographs by longer couched in functional terms”. This Claudia Thoelen, “Alzheimer’s – another was different from the present-day social world”, accompanied the meeting. Her and political debate, which concentrated photographs display an impressively close on the question of “how to integrate age- approach to dementia sufferers, who may ing and the elderly as effectively as pos- all too readily appear to be living entirely sible, first in the world of work and society in a world of their own. and later in that of old people’s and care The Ethics Council will reflect on all homes”. The disquisitions on ageing and the suggestions made and will take ac- old age to be found in Cicero, Voltaire, count of them in its forthcoming Opinion Jacob Grimm, Ernst Bloch and Hermann on dementia. Hesse showed, in Professor Höffe’s view, that it was possible and indeed essential to learn how to age. As to the successive

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Bioethics Forum organism, whereas, in the second, the re- searchers attempted to remove all non- The Bioethics Forum is a meeting format essential components from natural organ- intended to promote dialogue with the isms and to replace them by tailor-made public. Topics of general interest were substitutes, in order thereby to create ar- vigorously debated on three occasions, in tificial life forms. This implied a change of February, June and October 2010. perspective from manipulation by genetic engineering to the synthetic creation of Synthetic biology – life from a complex gene modules in the laboratory. self-assembly kit? The aim of synthetic biology, according Presentations On 24 February 2010, some 350 guests to Professor Friedrich, was the making from and audio recordings of assembled in the Leibniz Room of the of useful microorganisms which could meetings in the Bioethics Forum Berlin-Brandenburg Academy of Sciences produce, for instance, pharmaceutical ac- series (in German) and Humanities for a joint discussion tive substances, such as the anti-malaria can be accessed online at with the contributors and with members drug Artemisinin, or biofuels reliably and www.ethikrat.org /veranstaltungen of the German Ethics Council for its fifth by clearly defined techniques; examples /forum-bioethik public evening meeting in the Bioeth- were tailor-made yeasts, fungi or bacteria ics Forum series, on issues of synthetic that could convert plant waste into biofuel biology. quickly and at low cost. The still young field of research known The synthesis of large-scale fragments as synthetic biology is increasingly as- of DNA and the production of organ- sociated with headlines such as “living isms without any known relationship to machines”, “bio-building blocks” and nature did not currently impose any addi- “artificial cells”. Using standardized gene tional requirements in terms of biosafety modules and applying engineering prin- in the laboratory or when released into ciples, scientists are attempting to reshape the natural environment, with regard to microorganisms and even to create new unintended interactions between the ar- ones from scratch, the aim being to utilize tificial organisms and that environment. particularly effective microorganisms for In principle, too, no new risks were dis- biotechnological purposes. However, the cernible on the level of deliberate misuse depth of the modifications undertaken to (biosecurity) as compared with genetic simple life forms also gives rise to ethical engineering. For this reason, Professor and philosophical questions: Does syn- Friedrich for the time being considered thetic biology involve the “creation of there to be no need for specific new leg- life”? What is the impact of these new islation or regulations for synthetic biol- possibilities on our image of humanity? ogy. The risks were covered by the Gen- Does genetic engineering present as yet technikgesetz (Genetic Engineering Act); unknown safety risks? What issues of jus- furthermore, safety switches could be in- tice arise in a global context? corporated in the organisms to prevent Bärbel Friedrich, of Berlin’s Humboldt propagation in the wild and to reduce the University, introduced the two principal risk of known pathogens being syntheti- research approaches of synthetic biol- cally reconstructed or modified. However, ogy. In the first, “building blocks of life” since extensive databases of pathogenic were constructed from inanimate materi- organisms and toxins were publicly ac- als with the aim of creating a new living cessible and genetic building blocks could

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Panel discussion with Bärbel Friedrich, Volker Gerhardt, Andreas Brenner, Peter Dabrock, Eberhard Schockenhoff and Wolf-Michael Catenhusen (from the left) be purchased online from synthesis firms, nature, which would become dependent precautionary measures were called for. on its maker, man, according to Dr. Bren- The ensuing panel discussion concen- ner. Hence the need for an ethical and a trated on philosophical and theological cultural debate in society. aspects of the ethical appraisal of syn- Volker Gerhardt, a philosopher at thetic biology. With Council member Humboldt University in Berlin, on the Wolf-Michael Catenhusen as moderator, other hand, emphasized that synthetic the philosopher Andreas Brenner and biology was simply following in the foot- the theologian Peter Dabrock, together steps of other natural sciences, investigat- with Council members Volker Gerhardt ing natural processes by analytic, cause- and Eberhard Schockenhoff, considered and-effect methods, while also seeking whether, by its aspiration to create com- to make the concept of life tangible and pletely novel life, synthetic biology might comprehensible with causal explanations. change our attitude to life itself and lead to Connections could likewise be made with an understanding of man as homo creator. the tradition of philosophy, in which na- Andreas Brenner, Privatdozent at the ture was explored by a unified approach University of Basle, Switzerland, stated based on an interest in its unity. Synthetic that the main challenges facing synthetic biology nevertheless signified a more far- biology were those of risk assessment and reaching intervention in the self-control- global justice. He said that these were “po- ling processes of life. This had the con- litical issues that had to be taken seriously” sequence of increased responsibility not and called for much more discussion. Dr. only on the part of the individual but also, Brenner felt that changes in our concep- in particular, on that of society in this case. tion of “life” were equally important. The However, Professor Gerhardt considered claims made by this new branch of science that the true challenge presented by the were manifestly quite different from those debate about synthetic biology lay not in of traditional biotechnology. If life were to the new possibilities of interfering with be regarded no longer as something that nature, but in the ethical discourse on the had come into being or been created, but concepts of man’s freedom and dignity. instead as something manufactured, this Peter Dabrock, of the University of had major repercussions for the dignity of Marburg, was particularly interested in

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the way the theme of “playing God” fea- thetic biology. Some pointed out that dis- tured in the public debate on synthetic cussion of the notion of human dignity biology – to a greater extent than with was relevant or appropriate in this con- other methods used in contemporary text: as long as the debate did not centre biotechnologies. Many evidently felt that on the synthesis of human cells or gam- the creation of life was uncanny because etes, it was more correct to use the notion it blurred the boundary between life and of the dignity of life than that of human non-life. On this point, Professor Dabrock dignity. Council member Jochen Taupitz considered there to be an urgent need took the view that an ethical debate was for discussion, both on the part of the called for on the question of our respon- sciences on the possibilities and limits sibility to future generations in terms of of synthetic biology, and on that of the possible consequences of both the use public, on the directions of research it and the non-use of new techniques, with regarded as unacceptable. regard not only to the risks, but also to the In the view of Eberhard Schockenhoff, opportunities, for society. a Catholic theologian at the University The moderator, Wolf-Michael Caten- of Freiburg, the metaphor of “playing husen, expressed satisfaction with the God” was a manifest dramatization of outcome of the evening’s discussion. He the debate, because synthetic biology noted in particular that, in the future could assume new dimensions only if too, scientific developments should be used as an extension of natural pro- monitored not only with due sensitivity cesses – that is, with constructive intent. to ethical issues, but also with the neces- Whereas theologians considered crea- sary degree of differentiation. Although tion to be accomplished by God “out of the discourse was still at an early stage, nothing”, in the case of synthetic biology synthetic biology was an increasingly im- man was cast more in the role of an ac- portant field of research, in which ques- tive co-creator. Professor Schockenhoff tions of social consequences and ethical stressed that the organisms that came responsibility arose. In particular, the con- into being were “at any rate not what tributions from the floor, specifically on we usually understand by life or find the definition of life and the safety risks in nature as life, but instead a kind of of the new , had made it clear technical life”. A term commonly used that much still remained to be discussed in the English-speaking countries was with regard to this subject. The German “living machines”. Should it ever become Ethics Council was interested in taking possible to produce living artefacts as a part in this discourse, and would consider higher form of life, they would have to the appropriate steps and formats in the be treated with full respect and rever- ensuing months. ence. In Professor Schockenhoff’s view, “creating life as a mere commodity to Intersexuality – life between serve our needs would impoverish our the sexes natural condition.” On 23 June 2010, more than 300 guests When the discussion was thrown open accepted the Ethics Council’s invitation to to the floor, the main issues raised were join experts from various disciplines and risk research, technology assessment and intersex individuals to debate the topic of possible regulatory mechanisms for syn- intersexuality.

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A variety of genetic and hormonal children by genital surgery, the proce- changes may give rise to very diverse dure being kept secret from the patient. forms of intersexuality, some of which are Professor Richter-Appelt emphasized immediately evident at birth, while others that therapeutic attempts of this kind, are recognized only at puberty. As in the which had often been undertaken with- past, those concerned undergo genital out informing the patient and without surgery in early childhood because the the patient’s consent, were misguided medical profession and parents see inter- and were no longer appropriate today. sexuality as a developmental disorder call- In her opinion, the informed consent of ing for surgical and hormonal treatment those concerned should be sought before for the benefit of the child. However, self- a decision was made, instead of “going help groups of intersexuals increasingly over their heads in assigning a gender oppose such interventions, invoking the to them and then also requiring them to constitutional rights to physical integrity, go through life in a particular role, while self-determination and free development experiencing themselves as men or wom- of the personality. en”. There were a multiplicity of identities Hertha Richter-Appelt, a psychoanalyst as well as a multiplicity of genitalia, and at Universitätsklinikum Hamburg-Eppen- not just two. Furthermore, a genital that dorf, gave an introduction to the medical was not unambiguous need not result fundamentals. She drew attention to the in a disturbance of psychosexual devel- fundamental difficulty of drawing an un- opment. Repeated genital surgery could equivocal distinction between men and have a much greater traumatic effect in women. For instance, individuals with a this connection. Professor Richter-Appelt female chromosome set could neverthe- mentioned the results of her follow-up less have an external male genital and study in Hamburg, the main conclusion vice versa. In the manifestations of inter- of which was that the various diagnoses sexuality, it was often impossible to deter- had to be considered in very great detail mine an unequivocal biological sex. While and treated by a differentiated approach. this was sometimes due to alterations in Konstanze Plett, an academic lawyer the chromosome set, the most common at the University of Bremen, complained causes were changes in the gonads or that it had not yet been realized in her hormonal balance. Apart from the vari- discipline that not everyone was unequiv- ability of physical sexual manifestations, ocally male or female. Although there one often also observed a wide range of were instruments such as the Grundgesetz forms of psychosocial gender, expressed (Basic Law) of the Federal Republic of in gender identity, gender role and sexual Germany, the Council of Europe’s Hu- orientation. man Rights Convention and the United Professor Richter-Appelt took a criti- Nations Convention on the Rights of the cal view of earlier criteria for treatment, Child, which indicated “that people born based in particular on the views of the intersex also have a right to their own American psychologist John Money in sexual identity”, in practice this principle the 1950s. Money had postulated that sex was not followed. Professor Plett consid- could be instilled completely by educa- ered that legal problems lay in the law of tion and that it was therefore possible to civil status, which required assignment assign an unambiguous sex to intersexual to one sex or the other on entry in the

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register of births within one week; in the genital status and drew attention to what law of medicine, as regards the issue of she saw as the incalculable harm done by whether sex assignment surgery should be such interventions and to the associated regarded as therapy or as physical injury; risks. and with regard to the appropriate criteria Whereas there was evidence that for medical intervention. untreated intersex individuals had few Professor Plett drew attention to two problems with their sexual constitution current legal debates. One concerned the and gender, medical interventions often inclusion of the attribute “sex” for the resulted in physical disorders and mental purposes of the Basic Law’s provisions problems extending even to traumatiza- on prohibiting specific groups of persons tion. “The medical interventions deprive from being placed at a disadvantage; the those who undergo them of any possi- other related to the bill proposing that bility of individual physical and mental mutilation of the female genitals be made development, as their physical capacity a criminal offence. Both were being debat- to develop in their own way has been ir- ed in the Bundestag. Although these drafts reversibly destroyed.” also covered intersex individuals, who In the manifest absence of studies on were even mentioned explicitly in regard the impact and long-term effects of these to the ban on placing groups of persons at interventions, they had to be seen as “hu- a disadvantage, they were not mentioned man experiments”. For this reason, the as- in the explanatory memoranda, speeches sociation called for a ban on surgery that of introduction and contributions to the was not necessary for the preservation of debate. Although intersex individuals life or health. were already protected by existing , In the view of Lucie Veith, interven- there was still a situation of “suppressed tions that were not necessary for medical visibility” and “continuation of the ta- reasons were contrary to human rights boo”, because “intersex individuals are and were experienced by the victims not genuinely perceived, even in the bills themselves as torture. Although the state intended to benefit them”. To eliminate had a duty to protect the victims from this undesirable state of affairs, Professor such interventions, it failed to discharge Plett called for more dovetailing of civil that duty. The medical interventions, and criminal law, increased interdisci- which she described as “normalizing by plinary cooperation, and assimilation of violent means”, were in her opinion in- information that already existed by the compatible with the right to physical and political and administrative worlds. She mental integrity. saw that day’s meeting as a step towards She called on the state to comply with the full implementation of human rights its obligation to protect fundamental for all individuals. rights and not to delegate decisions on Claudia Kreuzer and Lucie Veith, of such drastic interventions in the life of a the Verein Intersexuelle Menschen e. V., an child with intersex status to doctors and association of intersex individuals, pre- parents, because this imposed too heavy sented the views of the group concerned. a burden on them. In addition to calling As an example, Claudia Kreuzer described a halt to such surgery, she proposed that feminizing medical interventions in geno- those concerned should be guaranteed typically male individuals with intersexual compensation and rehabilitation.

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The ensuing panel discussion began Wiesemann’s demand for individual-case with an introduction by Claudia Wiese- decisions on surgery. Only a ban on such mann, a medical ethicist at the University interventions in the case of minors would of Göttingen, to the ethical principles and effectively protect their interests. The recommendations of the working group discussion led by Council member Mi- on ethics of the Netzwerk Intersexualität chael Wunder came to focus on possible (Intersex Network), which was assisted practical ways of implementing the right by the Federal Ministry of Education and of minors to be involved in decisions. Research. She stated that the best inter- Professor Plett pointed out that children ests of the child and adult-to-be had to would often formulate, or even perceive, take maximum priority in decisions on the wishes of adult family members as therapy. The child’s best interests were their own. Furthermore, young children represented by physical integrity and free frequently lacked the maturity needed for development of the personality. The in- such decisions. The only point on which terests of the child and of the adult-to- all participants agreed was that cosmetic be could, however, sometimes conflict. interventions resulting from social pres- Professor Wiesemann recommended sure were totally unacceptable. that account be taken of the child’s right When the discussion was thrown open to participation and, depending on the to the floor, contributions were forth- child’s age, self-determination, and thus coming from many intersex individuals, agreed with Professor Richter-Appelt that and the particular point was made that the children concerned had to be involved the individual should not be forced to in the decision. It was very important to conform to the expectations of society, respect and reinforce the parent-child but that society must accept people as relationship, to support parents in deal- they were. If society was to be changed, ing with the situation, and to decide on it was necessary, according to Professor the medical necessity of surgery on an Richter-Apppelt, to begin with parents individual-case basis. and nursery school teachers, as well as In the course of the panel discussion, with medical training. the representatives of the Verein Intersex- One of the criticisms expressed was uelle Menschen e. V. criticized Professor that the discourse was dominated by the

Panel discussion with Hertha Richter-Appelt, Konstanze Plett, Lucie Veith, Claudia Kreuzer, Michael Wunder and Claudia Wiesemann (from the left)

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medical profession, which tended towards organ capable of self-regeneration, older the medicalization and hence the patholo- people too could perfectly well be donors. gization of intersexuality, whereas a much Yet the proportion of post-mortem organ more broadly based debate was demanded donation in Germany was low at under by a problem with such wide social im- 15 per million head of population, put- plications. ting the country in the bottom third of The world of politics was called upon the league table of European nations. To to take cognizance of discrimination address this problem and to encourage against intersex individuals and to adopt scientific advances in transplant medi- urgent measures to end it. In particular, cine, Professor Neuhaus recommended sex assignment surgery on minors should that transplants should be concentrated be halted with immediate effect, since it to a greater extent in major centres, and violated the right to the protection of hu- called upon the politicians to help make man dignity. At the end of the discussion, this a reality. Claudia Kreuzer appealed for concrete Thomas Breidenbach, Managing Phy- action: “Lots and lots of people are af- sician at the Deutsche Stiftung Organ- fected, and lots and lots of children. These transplantation, Region Mitte (German children have no time. [...] We need quick Organ Transplant Foundation, Central decisions, not discussions.” Region), offered a more specific view of the situation from the practical perspec- Opting in or opting out of organ tive of . According to Dr. donation: should the state require Breidenbach, the reasons for the low rate everyone to choose? of consent by family members included At an evening meeting in its Bioethics a concern that doctors might no longer Forum series held on 27 October 2010, do everything in their power to save the the German Ethics Council debated the lives of their loved ones, as well as fear of issue of whether the state could require the trade in organs and differing rational everyone to make a decision about organ and emotional perceptions of . donation. To avoid long-term psychological issues, Peter Neuhaus, Director of the Charité family members needed to be treated Hospital’s General, Visceral and Trans- competently and sympathetically, as “an plant Surgery Clinic in Berlin, began over-hasty yes can be just as wrong as an the proceedings with an introductory over-hasty no”. report on the development of transplant In her contribution, Weyma Lübbe, a medicine to date and the outlook for the member of the German Ethics Council, future. The last few years had shown addressed the ethical implications of man- that organ recipients not only had better datory declarations on organ donation. In prospects of survival, but also enjoyed her personal view, the public debate so “immeasurably improved quality of life, far, which included the former National Opinions issued by physical and mental performance, and Ethics Council’s Opinion “Increasing the the former National Ethics Council can joie de vivre”. Another trend was that the number of organ donations: a pressing is- be accessed online in English at age of organ donors was increasing sig- sue for transplant medicine in Germany”, www.ethikrat.org nificantly. In the case of liver transplants represented “a large-scale moral appeal to /archive/national -ethics-council average donor age had actually doubled the public to declare their consent to post- /opinions in recent years: given that the liver was an mortem organ donation”. This was not

38 Annual Report 2010

readily reconcilable with the simultaneous to be absolutely certain of the deceased’s assertion that a decision not to donate presumed wishes. must also be absolutely respected. The Annette Widmann-Mauz, a Mem- speaker emphasized that a legal obligation ber of the Bundestag and Parliamentary to opt either in or out of organ donation State Secretary to the Federal Minister of could not be imposed without consider- Health, took the view that organ donation ing what was supposed to happen in the was an altruistic gift that could not be au- event of failure to declare. She condemned tomatically expected. There must be “no the thesis that a failure to declare, even obligation to donate and no obligation after state involvement with the issue, to declare”. Instead, other instruments automatically implied consent. Invoking should be deployed to make it easier for the “golden rule” that individuals should people to decide. themselves be prepared to make sacrifices Hans Lilie, holder of the Chair of Crim- that they expected or hoped for from oth- inal Law, Law of Criminal Procedure, ers, she commented: “The reciprocity to Comparative Law and Medical Law at be guaranteed is mutual respect for an the University of Halle-Wittenberg, con- individual’s personal decision, not mutual sidered that the matter at any rate needed willingness to donate.” to be addressed in greater depth, since a The ensuing panel discussion, moder- compulsion to declare could not be de- ated by Council member Eckhard Nagel, duced from constitutional law. Professor was devoted primarily to the issue of how Lilie was convinced that it was immaterial far the individual could be called upon to which model – opt-in or opt-out – was opt either in or out of organ donation. chosen as long as the deficiencies in the As a member of the family of an organ organization of transplant medicine had donor and on the basis of her own experi- not been overcome. ence, Marita Donauer favoured a manda- Jutta Riemer, Chair of the Verein Leber- tory declaration system. She summed up transplantierte Deutschland e. V. (Associa- her conviction in the phrase “I can’t refuse tion of Liver Transplantees in Germany), to give an answer”. This meant that family felt that what mattered most for those members had a duty to declare one way concerned was to know that the organ or the other, even if it was hard for them donation had been voluntary. Everyone

Panel discussion with Weyma Lübbe, Hans Lilie, Annette Widmann- Mauz, Eckhard Nagel, Marita Donauer and Jutta Riemer (from the left)

39 German Ethics Council

agreed on the need for full information to Council on 3 August 2010 in connection be given, and this called for a coordinated with Bonn University’s summer school approach across the board. on “Life Sciences and Culture”. Council When the debate was then thrown open member Jens Reich gave an introduction to the floor, one suggestion was for a for- to the work of the Ethics Council and mal declaration procedure on a voluntary answered the students’ questions. basis, while others advocated an opt-out Another group of students was received system or even a solidarity-based obli- at the Office on 19 November 2010. The gation to donate organs. In addition, a Head of the Office introduced the work wide-ranging public debate that included of the Council to these students from the all positions, however controversial, was University of Halle-Wittenberg. considered necessary. In addition, Dr. Vetter delivered lec- Following this meeting, the Ethics tures on the work of the German Eth- Council decided to establish a working ics Council to two schools. He spoke to group whose brief would be to draw up pupils attending a course on ethics at recommendations on the possible intro- the Gabriele-von-Bülow-Oberschule in duction of a mandatory declaration sys- Berlin-Tegel on 11 January 2010, and in- tem. troduced the work of the Ethics Council to an audience at Berlin’s Hannah-Arendt- Gymnasium on 21 September 2010. On 7 Debates with schoolchildren October 2010, Nora Schultz, a Research and students Officer at the Office, presented the work of the Council and reported on the latest During the period under review the developments in the fields of reproduc- German Ethics Council welcomed four tive medicine and genetic diagnosis at the student groups from Germany and the Oberstufenzentrum Lise Meitner in Berlin United States to its Office. to the participants in the EU seminar on On 9 April 2010, students from the “Genetic Engineering in Training and the Fachhochschule des Bundes für öffentliche Laboratory” (GENIAL). Verwaltung (Federal University of Applied Administrative Sciences) visited the Of- fice of the German Ethics Council. The Head of the Office, Dr. Joachim Vetter, informed them of the activities of the Council. Students from the Freie Universität Ber- lin (Free University of Berlin), who had come to the Office of the German Ethics Council on 18 June 2010 for a seminar on “Applied Ethics: History and Critique”, were particularly interested in the pro- cedure adopted by the Ethics Council for its work. As in earlier years, a group of students from the United States visited the Ethics

40 Annual Report 2010

Collaboration with the German Bundestag

The German Ethics Council held its first status of their deliberations. Regine Kollek Parliamentary Evening in Berlin on 25 reported on the discussion of the Opinion March 2010. The aim of the meeting was “Human biobanks for research”, which to exchange views with the members of was approaching its conclusion; Eckhard the German Bundestag on the current and Nagel mentioned the core issues arising in future work of the Council and on what the discussions of the working group on they saw as the principal ethical issues of allocation in healthcare; Michael Wunder the 17th Electoral Term. gave an introduction to the programme of In his welcoming address, Edzard the working group on dementia, formed Schmidt-Jortzig, the Chair of the Ethics at the beginning of the year; and Wolf- Council, emphasized that it was both the Michael Catenhusen gave an interim ac- task and the desire of the Council to use count of the debate on the topic of hu- its Opinions “in order to approach the man–animal mixed-species entities. The constitutional body as directly as possible, Deputies showed great interest in all these to enable that body where appropriate to topics and took advantage of the oppor- derive generally valid and legally binding tunity to discuss them with the members provisions from the recommendations”. of the Council. The Chair of the Ethics Council took the In the second part of the evening, opportunity to present the Council’s An- Christiane Woopen, Vice-Chair of the nual Report for 2009 to the President of the Ethics Council, presented the Council’s Bundestag, Professor Norbert Lammert. recommendations on the problem of the Professor Lammert stated in his opening anonymous relinquishment of infants. address that the German Bundestag wished She emphasized that full account was not the Ethics Council to furnish “advice that taken of the complexity of the issue by the should be not only as meticulous but also usual formula that “it was already worth- as regular as possible”. However, as regards while even if only one life could be saved” the definition and treatment of relevant and by the simplifying judgement, heard topics, he personally was less concerned even now all too often in public, that the that decisions should where possible be right to life was more important than the arrived at unanimously. Since a consensus right to a knowledge of one’s genetic par- “is almost always decreasingly likely to be entage – which, of course, no one on the forthcoming the more demanding the is- Ethics Council disputed. She also consid- sues”, he thought it preferable in cases of ered it unfortunate that the Ethics Coun- doubt for the Ethics Council to engage in cil’s recommendations on the provision of a vigorous debate and then to present its help to pregnant women and mothers in conclusions “to the Bundestag with a posi- distress had not been taken up sufficiently tion statement to which a greater or lesser in the public debate. The recommended majority of members subscribe”. measures included in particular more ef- Later in the evening, the spokesper- fective publicization and a strengthening sons for the Council’s internal working of trust in the many different kinds of help groups gave an account of the current that were already available.

41 German Ethics Council

Prof. Dr. Norbert Lammert (center), President of the Bundestag, with Council members Eckhard Nagel, Christiane Woopen, Edzard Schmidt- Jortzig and Eberhard Schockenhoff (from the left)

With a view to possible legislation, the This discussion took place in the context Deputies then discussed with the mem- of the debate on the appointment of a new bers of the Ethics Council in particular its Parliamentary Advisory Council on Eth- recommendation that a law be introduced ics. With regard to the appointment of a providing for the confidential relinquish- new Advisory Council on Ethics, Professor ment of children with temporarily anony- Schmidt-Jortzig pointed out that, while he mous notification. was unable to make a recommendation on At the invitation of , the this point, it was important for the Ethics Chair of the Bundestag’s Committee on Council to have an interlocutor in Parlia- Research, Technology and Technology ment. The Ethics Council’s Opinions had Assessment, Professor Schmidt-Jortzig until now already been furnished direct to attended a meeting of the Committee on all Deputies in this way. 1 December 2010. He informed the Depu- Whereas the funding of the Ethics ties of the projects currently in hand at Council was currently adequate, some- the Ethics Council and answered ques- thing of an impasse had been reached tions. The Deputies were manifestly very with regard to the staffing of the Office, impressed with the wide range of topics especially as regards the work of the Re- covered, and unanimously emphasized search Officers, owing to the large num- the important role of the Ethics Council ber of activities involved. For this reason, in advising Parliament and in the bioethi- Professor Schmidt-Jortzig proposed the cal debate as a whole. They asked a large eventual appointment of a third Research number of questions about the topics cur- Officer, particularly as this would be pos- rently being addressed, as well as about sible without any increase in the overall the Opinions already published, and also budget. At the end of the meeting, Profes- learned about the procedure adopted by sor Schmidt-Jortzig announced that the the Ethics Council, its funding, and the Ethics Council’s Opinion on cost-effec- staffing of the Office. Another particular tiveness analysis in the healthcare system object of their interest was the interaction was scheduled for publication in January between the Ethics Council and the Bun- 2011, to be followed by the Opinion on destag’s Parliamentary Advisory Council preimplantation genetic diagnosis by the on Ethics in the previous Electoral Term. beginning of March 2011.

42 Annual Report 2010

International initiatives and contacts

As in earlier years, the Ethics Council in joyed constitutional status in all Member 2010 again took part in exchanges with States. national ethics councils and organiza- The ensuing NEC Forum centred on tions at international level, in accordance the evaluation of clinical trials in an in- with its mandate as provided in the Ethics ternational context; collaboration be- Council Act. tween the public and private sectors in biomedical research and development; and the regulatory foundations applica- Forum of National Ethics ble to the ethical evaluation of clinical Councils of the European trials. Introductory papers on the sub- Union ject were presented by Diego Gracia, of the University of Madrid, John Harris, Under the Spanish Presidency of the of Manchester University, and Carlos Council of the European Union, a joint Alonso, of the Spanish ethics council. meeting of the Forum of National Ethics Stefan Führing, of the European Com- Councils of the European Union (NEC mission, and Daniel Davies, of George- Forum) and the European Group on town University in the United States, Further information can be accessed Ethics in Science and New Technolo- gave an account of the regulatory basis online at ec.europa.eu gies (EGE) was held in Madrid on 3 and for the ethical appraisal of clinical trials /European_group 4 March 2010 to coincide with the 15th in the European Union and the United _ethics NEC Forum. States respectively. The question of the The subject of the joint meeting of approach to be adopted in the composi- the NEC Forum and the EGE was the tion of Opinions involving both consen- institutional role of advisory bodies on sus and dissent was vigorously debated ethics, for instance in advising the world at the full meeting. Notwithstanding of politics. On this point, Michael Fuchs, the differing views expressed, the clear of the Institut für Wissenschaft und Ethik conclusion was that dissenting positions (Institute for Science and Ethics), Bonn, must always remain visible. presented an overview of the various eth- Under Belgium’s Presidency of the ics committees existing in the European Council of the European Union in the Union. Göran Hermerén, the Chair of second half of 2010, the 16th NEC Forum the EGE, Paul Schotmans, Chair of the was hosted by the Comité Consultatif de Belgian Advisory Committee on Bioeth- Bioéthique de Belgique (Belgian Advisory ics, and Kristiane Weber-Hassemer, a Committee on Bioethics) on 28 and 29 member of the German Ethics Council, October. then described the structure and work- At the beginning of the two-day meet- ing of their respective bodies. Professor ing in Brussels, the representatives of the Hermerén pointed out that the work of national ethics councils held a joint ses- the EGE too had been modified by the sion with the EGE to discuss the compar- Lisbon Treaty, since the fundamental ative role of ethics in different European rights enshrined in that treaty now en- countries. The 16th NEC Forum followed

43 German Ethics Council

the joint session with the EGE. Greater and possible abortion in the event that provision was made for participation in the embryo was genetically damaged. the Forum, so as to maximize exchanges The permissibility of using PGD to cre- between the representatives of the various ate a “saviour sibling” as a tissue donor national ethics bodies. For this purpose, for a seriously ill older brother or sister the participants could choose between was another vigorous debated question. three workshops. Some members of the group considered The first workshop, headed by Sigrid that this practice should be prohibited, Sterckx and Ernst Heinen, addressed the on the grounds that it constituted an in- issue of the marketing of the human body. strumentalization of the embryo. Those The discussion centred on the extent to in favour countered that the value of the which the commercialization of human embryo was increased by the fact that it bodily materials should be permissible. was able to save life. Furthermore, there Some participants held that a distinction were many reasons why people had chil- could be made between the “social body” dren, and these often involved a kind of and the “biological body” and that the instrumentalization. donation of materials from the “biologi- The participants agreed that compre- cal body” was less problematic. hensive, skilled advice was necessary in all The second workshop, on the subject cases and that the technique used should of assisted dying/euthanasia, was led by not depend solely on cost. Yvon Englert and Gilles Genicot. The participants discussed the permissibility of assisted dying in the various countries International Dialogue and whether public opinion on the sub- on Bioethics ject had changed. Assisted dying was pro- hibited in most European countries, with Under the Spanish Presidency of the Eu- a few exceptions such as the Netherlands, ropean Council, the second International Belgium, Luxembourg and Switzerland. Dialogue on Bioethics was held on 3 and Its legalization in these countries had 4 March 2010, attended not only by par- greatly influenced the debate and reflec- ticipants in the NEC Forum but also by tion in Europe. Public opinion now took a large number of representatives of na- an increasingly positive view of assisted tional ethics committees throughout the dying, whereas the majority of doctors world. This meeting too focused on the tended to reject it. role of ethics in international biomedical The third working group, led by Inge research. Margaritis Schinas, of the Euro- Liebaers and Geneviève Schamps, dis- pean Commission, noted that the Com- cussed ethical issues of preimplantation mission considered exchanges between genetic diagnosis (PGD), with particular ethics committees at international level reference to the circumstances and cases to be very important and would continue in which it should be permissible. The to support international dialogue. Again, participants expressed differing views on the EU would assist interested countries this subject. Whereas some rejected PGD in the establishment of competence in in order to protect the embryo, others the field of bioethics. Javier Arias Díaz, of emphasized that PGD was less stressful the Spanish bioethics committee, point- for the mother than prenatal diagnosis ed out that, at the initiative of Spain, a

44 Annual Report 2010

declaration on the ethics of biomedical monization and eventual standardiza- research in developing countries was in tion of regulations under an international preparation in the Council of Europe. convention would be possible only on the Professor Sir Michael Marmot, the for- basis of a dialogue on bioethical issues. mer head of the working group on the so- This could be successfully achieved if it cial determinants of health at the World could be agreed that the fundamental Health Organization (WHO), reported universal values could be interpreted dif- on the group’s final report. He stated that ferently according to the relevant cultural life expectancy, both within a country context. and comparatively as between poor and rich countries, showed a direct correla- tion with income or the gross domestic Global Summit of National product of the country concerned. It was Bioethics Advisory Bodies difficult, but not impossible, to change this situation and ultimately to attain a The eighth Global Summit of National consistent level of healthcare for all at Bioethics Advisory Bodies was held in global level too. Singapore on 26 and 27 July 2010 and was Laurence Lwoff (Council of Europe), attended by Kristiane Weber-Hassemer, Dafna Feinholz (UNESCO) and Marie- a member of the German Ethics Council, Charlotte Bouësseau (WHO) reported on and Joachim Vetter, Head of the Office. the activities of their respective interna- The Conference, with delegates from tional organizations in the establishment more than 30 bioethics committees and of bioethical competence in developing representatives of the WHO, the Council countries. For instance, UNESCO had of Europe, the European Commission embarked on a programme (the “ABC and UNESCO, is a biennial event and has Programme”) to facilitate the establish- developed into a permanent fixture for ment of national ethics committees. The international exchanges between national WHO was assisting the establishment ethics councils or comparable structures. and activities of a global network of bio- The secretariat which prepares meetings ethics centres. and deals with exchanges between meet- The members of the bioethics com- ings is accommodated at the WHO in mittees of non-EU states reported, with Geneva. regard to the practice of evaluation of Richard Magnus, the Chairman of the clinical studies with international partici- Organizing Committee, and Kandiah Sat- pation, that all countries had established kunanantham, Director of Medical Ser- national bioethics committees that were vices, Ministry of Health, welcomed the responsible for the evaluation of such delegates at the beginning of the Summit, studies and for the development and im- at which a large number of topics were plementation of guidelines for regional- discussed. These included, for example, level ethics committees. ethical issues in the transplantation of To end the meeting, the participants organs, tissues and cells; research ethics discussed the possibility of developing a committees; ethical issues in tuberculosis uniform ethical framework for the con- control; synthetic biology; biobanks; stem duct of biomedical research throughout cell research and therapy; and bioethical the world. The consensus was that a har- developments in general.

45 German Ethics Council

Since the German Ethics Coun- Trilateral meeting of the cil’s Opinion on research with human ethics councils of Germany, biobanks had just been published, this France and the United topic was particularly interesting for the Kingdom German participants. For this reason, the English version of the Opinion’s rec- In 2010 the German Ethics Council ommendations had been circulated to continued its close collaboration with the participants before the conference. its French and British counterparts, the Although detailed discussion of the rec- Comité Consultatif National d’Ethique ommendations was not possible, the pro- (CCNE) and the Nuffield Council on posal concerning biobank secrecy met Bioethics respectively. This year’s trilat- with considerable interest. eral meeting of the three ethics councils The basis of the discussions on syn- was held in Paris on 3 December 2010 at thetic biology, in addition to papers by the invitation of the CCNE. Amy Gutmann, Chair of the United The principal topics discussed were States Presidential Commission for the medical profiling and global health in- Study of Bioethical Issues, and Julian equalities. The first was the subject of Kinderlerer, of the European Group on a paper by Professor Jonathan Wolff, a Ethics, was a contribution by Dr. Vetter member of the Nuffield Council. He in- on the course of the public debate on the troduced the Council’s consultation pa- subject in Germany so far. per, published in October 2010, entitled At the end of the meeting, the repre- “Medical profiling and online medicine: sentative of the Tunisian ethics commit- the ethics of ‘personalised healthcare’ in a tee invited the delegates to Tunisia for the consumer age”. In it, the Council recom- ninth Global Summit in October 2012. mends improved Government monitor- Following the meeting, the delegates ing of the quality of healthcare services were able to tour a new information and recommended on the internet and sug- exhibition centre accommodated at the gests that doctors should be trained in Singapore Science Centre, whose specific advising patients looking for health in- purpose is to inform the public about formation or purchasing drugs online. bioethical issues. The intention is to en- The members of the French and German able visitors to learn about subjects such councils associated themselves with these as research, genetically modi- recommendations. fied organisms and plants, or the ethical Next, Professor Eckhard Nagel, a aspects of , thereby member of the German Ethics Council, gaining an impression of new develop- reported on the allocation of resources in ments in the life sciences and their pos- the German healthcare system, with par- sible consequences for society. ticular reference to the issue of fair distri- bution in a situation of scarce resources. Professor Nagel also gave an account of the debate within the working group on the allocation of resources, which was preparing the Opinion “Medical benefits and costs in healthcare: the normative role of their evaluation” (the German

46 Annual Report 2010

version of the Opinion was published in January 2011). The ensuing discussion was devoted predominantly to the issue of social justice in the field of healthcare, at both national and international level. Following the joint deliberations, the Chair of the Nuffield Council, Professor Albert Weale, invited his French and Ger- man colleagues to a trilateral meeting in London in 2011.

47 German Ethics Council

Publications

The German Ethics Council uses various Proceedings regular publications to publicize its Opin- ions and activities. The print versions of The papers presented at the Annual Meet- these publications – in German only ex- ing are collated and published in the cept where stated – are available free of proceedings (in German only). An issue charge on request from the Office of the whose title translates as “Migration and Ethics Council and can also be accessed health. Cultural diversity as a challenge to online as PDF files. medical care”, of which 2500 copies were printed, was published in December 2010 (see p. 22 ff.). Opinions Deutscher Ethikrat

Opinions are the Ethics Council’s most important publications. They represent Deutscher Ethikrat the outcome of the in-depth debates conducted both in the Council’s internal und Gesundheit Migration working groups and at its Plenary Meet-

ings. Their aim is to draw together the Tagungsdokumentation Migration und Gesundheit Proceedings ideas voiced both in society and within Kulturelle Vielfalt als Herausforderung für die medizinische Versorgung of the Annual the Ethics Council, to develop lines of Meeting “Migra- Jahrestagung des Deutschen Ethikrates 2010 tion and health” argument, to indicate possible solutions, 2010 Jahrestagung (in German only) and to propose options for action. On 15 June 2010, the German Ethics Council published the German version Infobrief of its Opinion “Human biobanks for re- The Infobrief can be search” (see p. 7 ff.). Some 3500 copies The Infobrief (newsletter, available in accessed online (in German only) at were printed. The Opinion is also avail- German only) was introduced to offer www.ethikrat.org /publikationen able in English and French translation. a wider interested public not necessarily /infobrief in possession of the relevant expertise a Deutscher Ethikrat condensed and readily comprehensible version of the discourse within the Ger- Deutscher Ethikrat Humanbiobanken für die Forschung man Ethics Council. Contributions are Stellungnahme assembled at the Ethics Council’s Office on the basis of the Council’s published Humanbiobanken für die Forschung Humanbiobanken documents – audio recordings and real- time transcriptions of the public meetings and other events, as well as Opinions. Opinion “Human These compilations of news from the biobanks for research” (German edition) Ethics Council have been issued three times a year since December 2008, some 3000 copies being printed.

48 Annual Report 2010

Evolution of the social debate

The Office of the German Ethics Council The Bundestag adopted the Gesetz zur keeps track of press reports and makes Neuordnung des Arzneimittelmarktes (Act daily compilations of articles on bioethi- on the Reform of the Market for Medicinal cal topics. These compilations are made Products) in November 2010, thus putting available to the members of the Council, a provisional end to a debate on health but can also be accessed by the public policy that had dominated press reporting on its website via an online calendar. An throughout the year. The Federal Minister Details of press reports for 2010 can overall consideration of the monthly and of Health, Dr. Philipp Rösler, had publicly be accessed online (in German) at yearly evaluations of these reports thus announced at the beginning of the year www.ethikrat.org conveys an impression of the public de- his intention to break the pharmaceuti- /presse /pressespiegel/2010 bate on bioethical issues which, if not cal companies’ price monopoly. The new complete, is at least evidence-based. In the act established a regulatory framework course of 2010, the following ten topics that addressed such matters as analysis were represented most frequently in the of the utility and cost-utility ratio of new nationwide German print media (Finan- medicinal products. This was intended to cial Times Deutschland, Focus, Frankfurter contain increases in spending on drugs Allgemeine Sonntagszeitung, Frankfurter and the increasing expenditure of the stat- Allgemeine Zeitung, Frankfurter Rund- utory health insurance funds as a whole. schau, Handelsblatt, Rheinischer Merkur, The urgency of the need for savings in Der Spiegel, Stern, Süddeutsche Zeitung, the healthcare sector was also stressed by Der Tagesspiegel, taz, Die Welt, Welt am the President of the Bundesärztekammer Sonntag, Die Zeit): (German Medical Association), Professor Jörg-Dietrich Hoppe, who on a number of oc- casions called for a frank

Allocation of resources in healthcare 451 debate on prioritization

Reproductive medicine 383 and rationing. Reproductive medi- Agro-genetic engineering 330 cine was a focus of at- Care for elderly and disabled people 224 tention in the first half

Assisted suicide/terminal care/advance directives 163 of the year, at first ow- ing to the fate of a young Transplants/organ donation 111 widow. Eggs had been Stem cell research 100 fertilized in vitro while Public health 98 her husband was still

Abortion/prenatal diagnosis 81 alive and she wanted to have these implanted af- Brain research 69 ter his death. She went to court when the clinic refused to release the fertilized eggs. At the

49 German Ethics Council

beginning of May, the Higher Regional provision of information to the public Court of Rostock ordered the clinic to on the cultivation of genetically modi- release them. A spate of reports was then fied plants in a relevant land register to unleashed at the beginning of July by a be constitutional. landmark judgement of the Federal Court Reports by the Federal Statistical Office of Justice (BGH) on the genetic testing of indicated that the increasing ageing of fertilized eggs for the avoidance of severe German society would result in a dramatic genetic disorders. The BGH ruled in its rise in the need for long-term care. In judgement that, in the cases at issue, the 2010, this was sufficient reason for both Embryonenschutzgesetz (Embryo Protec- politicians and the public to take a closer tion Act) had not been infringed by the look at the future of care for elderly and conduct of preimplantation genetic diag- disabled people. Reform of long-term nosis (PGD). The proceedings leading to care insurance, the introduction of a le- this judgement had incidentally been set gal entitlement to family care leave, and in train by the head of a Berlin fertility improvements to the system of care home clinic in spontaneously approaching the supervision are aspects of a many-sided prosecution authorities with his case, and topic that gave rise to a particularly large the ruling immediately gave rise to vigor- number of press reports throughout the ous political arguments for and against year. the practice of PGD, since it had implicitly The group of death-related topics – as- been assumed until the Federal Court of sisted suicide/terminal care/advance di- Justice delivered its judgement that PGD rectives – came fifth in the press statistics was prohibited by the Embryo Protection for 2010. It owed this position mainly to Act. At the end of 2010, therefore, there an event that took place in June. In a land- were indications that the Bundestag would mark judgement, the Federal Court of Jus- be seeking to place PGD on a statutory tice ruled that a life-preserving treatment foundation in 2011. had to be discontinued if that was the pa- Having occupied top position in the tient’s declared wish. The Karlsruhe-based league of press reports in 2009, agro- court therefore acquitted a lawyer of the genetic engineering fell back slightly charge of attempted criminal homicide, to third place in the following year. A thus creating with its judgement more number of events ensured that consider- legal certainty for medical practitioners able attention continued to focus on this and custodians when dealing with co- topic in 2010. For instance, the European matose patients or those suffering from Commission approved the commercial incurable conditions. cultivation of the genetically modified When the Chair of the Social Demo- potato variety “Amflora” at the beginning cratic (SPD) parliamentary party in the of March. In early June, the discovery of Bundestag, Dr. Frank-Walter Steinmeier, seed contaminated with genetically modi- announced in August that he was with- fied maize not licensed in Europe caused drawing from politics for several weeks disquiet in several Federal Länder. Then, to donate a kidney to his sick wife, this in November, the Federal Constitutional rekindled the debate on the substantial Court confirmed the strict provisions of unwillingness of the German popula- the Gentechnikgesetz (Genetic Engineer- tion to donate organs and on statutory ing Act) and, in particular, declared the provisions concerning the harvesting of

50 Annual Report 2010

organs. Vociferous demands were heard for a change in the Transplantationsgesetz (Transplant Act), in particular in favour of the possible introduction of the disput- ed opt-out system. It was Dr. Steinmeier himself who, having recovered from surgery, advocated a mandatory declara- tion on organ donation as an alternative model, which the former National Eth- ics Council had already proposed in an Opinion in 2007. In addition, stem cell research again excited the media in 2010. This was re- flected principally in two events. In Oc- tober, much attention was aroused by an experimental therapy in the United States with human embryonic stem cells, whose use is controversial in Germany. In that experiment, researchers from the Geron Company aimed to develop a new therapeutic approach by replacing the in- jured parts of a paraplegic patient’s spinal cord. However, the use of adult stem cells, which is not normally regarded as unethi- cal, for “individual therapeutic attempts” not subject to clinical trials also generated negative headlines: the Düsseldorf pri- vate clinic XCell-Center attracted criticism from the public when it was learned that a young child had died in August after experimental treatment in which stem cells obtained from bone marrow had been injected into the brain.

51 German Ethics Council

Outlook

At its meeting of 25 November 2010, the Research, Professor Annette Schavan, Ethics Council also discussed the continu- and the Federal Minister of Health, Dr. ation of its work programme in 2011. Philipp Rösler, the Ethics Council was In view of the vigorous social and po- charged on behalf of the Federal Gov- litical debate on a new statutory system ernment with the preparation of a report of regulation of preimplantation genetic on the situation of intersex individuals diagnosis, the Ethics Council decided to in Germany. Notwithstanding the work prioritize this topic over all others and already in progress and the priority as- to complete the relevant Opinion, origi- signed by the Ethics Council to the topic nally planned for issue in mid-2011, by of preimplantation genetic diagnosis, the end of February. This was intended to the Council will therefore set up a work- ensure that the members of the Bundestag ing group by the beginning of 2011 and were in possession of the Ethics Council’s then immediately commence work on Opinion when the subject was debated the subject of the Federal Government’s in Parliament in the spring. The working instruction, with a view to completing it group engaged on this Opinion will then if possible by the end of 2011. continue its work by devoting itself to the Decisions were also taken on the top- wider topic of reproductive medicine as ics for the public meetings to be held in a whole. 2011. For instance, the Bioethics Forum Following its Bioethics Forum meet- on 23 February 2011 will be devoted to the ing on the introduction of a mandatory Ethics Council’s Opinion on the anony- declaration on organ donation, the Ethics mous relinquishment of infants and the Council had already decided, at its plenary resulting activities both in the political meeting in October 2010, to take up the world and in society. At its Annual Meet- proposals made at this meeting and to ing on 26 May 2011, the Ethics Coun- ask some of its members to consider the cil will debate the problems of feeding possibility of drafting a short recommen- the world’s population and discuss these dation offering reliable information on with experts from Germany and abroad organ donation and on a possible manda- at a whole-day meeting. A further whole- tory declaration. On account of the work day meeting is planned for autumn 2011, already in hand on the topics of human– to discuss the ethical and legal aspects animal mixtures and on dementia and and the possible social consequences of self-determination, the Ethics Council synthetic biology with representatives did not make any further decisions on of various social groups. In addition, in addressing new topics. 2011 the Ethics Council will for the first However, at the end of 2010 the Federal time hold a joint meeting with another Government for the first time made use public organization: an expert meeting is of the provision in the Ethics Council planned for 7 April with the Technologie- Act for instructing the Council to con- und Methodenplattform für die vernetzte sider a specific topic. In a joint letter from medizinische Forschung (TMF) e. V. (Tech- the Federal Minister of Education and nology, Methods, and Infrastructure for

52 Annual Report 2010

Networked Medical Research), an organi- zation dedicated to networked medical research and the associated technology and methods, for a joint discussion of the Ethics Council’s Opinion “Human biobanks for research” not only with aca- demics, but also with political actors and other social groups.

53 German Ethics Council

The members of the German Ethics Council

Prof. Dr. iur. Edzard Prof. Dr. med. Prof. Dr. theol. Schmidt-Jortzig, Christiane Woopen Eberhard Former Federal (Vice-Chair) Schockenhoff Minister (Chair) (Vice-Chair)

Prof. Dr. med. Axel Prof. Dr. phil. Wolf-Michael Prof. Dr. rer. nat. W. Bauer Alfons Bora Catenhusen, Stefanie Dimmeler Former State Secretary

Prof. Dr. med. Prof. Dr. phil. Hildegund Prof. Dr. theol. Frank Emmrich Dr. h. c. Volker Holzheid, Former Dr. h. c. Wolfgang Gerhardt President of the Huber, Retired Bavarian Consti­ Bishop (from 30 tutional Court and June 2010) Munich Higher Regional Court

Prof. Dr. theol. Prof. Dr. rer. nat. Auxiliary Bishop Prof. Dr. phil. Christoph Kähler, Regine Kollek Dr. theol. Dr. Weyma Lübbe Retired Bishop rer. pol. Anton Losinger

54 Annual Report 2010

Prof. Dr. med. Dr. Dr. phil. Peter Prof. Dr. med. Jens Ulrike Riedel, phil. Dr. h. c. theol. Radtke Reich Lawyer, Former Eckhard Nagel State Secretary in the State of Saxony-Anhalt

Dr. iur. Dr. h. c. Prof. Dr. iur. Dres. Prof. Dr. iur. Jochen Dr. h. c. Erwin Jürgen Schmude, h. c. Spiros Simitis Taupitz Teufel, Former Former Federal Prime Minister of Minister the State of Baden- Württemberg

The following ceased to be Council members with effect from 1 March 2010: Dr. theol. Hermann Barth, Prof. Dr. med. Bettina Schöne-Seifert

Prof. Dr. rer. nat. Kristiane Weber- Dipl.-Psych. Dr. Heike Walles Hassemer, Former phil. Michael (from 30 June State Secretary in Wunder 2010) the State of Hesse

55 German Ethics Council

Appendix

Working groups 2010 Synthetic biology Spokesperson: Catenhusen The working groups constitute the basis Members: Bora, Reich, Taupitz of the Ethics Council’s substantive work. The groups mentioned below met more Annual Meeting 2011 than 50 times in 2010. Spokesperson: Schockenhoff Members: Huber, Kollek, Teufel, Weber- Biobanks Hassemer Spokesperson: Kollek Members: Bora, Emmrich, Reich, Simitis, Bioethics Forum on intersexuality Taupitz, Weber-Hassemer Spokesperson: Wunder Members: Gerhardt, Riedel, Schockenhoff Research on chimeras and hybrids Spokesperson: Catenhusen Bioethics Forum on organ Members: (Barth), Bauer, Dimmeler, transplantation Emmrich, Kollek, Reich, Schockenhoff, Spokesperson: Nagel (Schöne-Seifert), Taupitz, Weber-Hasse- Members: Lübbe, Riedel, Taupitz mer, Woopen

Dementia Spokesperson: Wunder Members: Gerhardt, Kähler, Radtke, Reich, Riedel, Schmude, Schockenhoff, Teufel, Woopen

Reproductive medicine Spokesperson: Catenhusen Members: Bora, Dimmeler, Emmrich, Holzheid, Kollek, Losinger, Lübbe, Re- ich, Riedel, Schmidt-Jortzig, Schmude, Schockenhoff, Taupitz, Weber-Hassemer, Woopen, Wunder

Allocation of resources in healthcare and social welfare Spokesperson: Nagel Members: Bauer, Kollek, Losinger, Lübbe, Riedel, (Schöne-Seifert), Schockenhoff, Taupitz, Woopen, Wunder

56 Annual Report 2010

Procedure The Office is responsible for locating, preparing and evaluating scientific docu- The German Ethics Council is independ- ments relating to the topics addressed by ent with regard to its activity and is bound the Council, for the compilation of mate- only by the terms of the mandate con- rial for publication, for the planning and ferred on it by the Ethikratgesetz (Ethics conduct of meetings and public events, Council Act). In pursuance of Section and for the publication of Opinions and 6(2), the Ethics Council has provided itself other documents. The principal duties of with rules of procedure governing the the Office also include managing contacts practical aspects of its work. with the media, responding to enquiries The Ethics Council decides itself on from the public, maintaining the Ethics the issues to be addressed in its Opinions, Council’s presence on the World Wide but may also prepare Opinions on the in- Web, and looking after the Council’s structions of the German Bundestag or the international contacts. The staff of the Federal Government. The German Ethics Office in 2010 comprised the following Council is in addition required to report persons: in writing at the end of each calendar year to the Bundestag and the Federal Govern- • Dr. Joachim Vetter (Head of Office) ment on its activities and the current state • Dr. Katrin Bentele (Research Officer) of the social debate. • Dr. Nora Schultz (Research Officer) The members of the Ethics Council • Ulrike Florian (Press and Public Rela- come together once a month for a plenary tions Officer) meeting in Berlin, which is as a rule open • Torsten Kulick (Scientific Documenta- to the public. To address individual topics tion) or entire fields of related topics, the Coun- • Carola Böhm (National Affairs and Or- cil establishes working groups of members ganisation of Meetings) which coordinate the preparation of draft • Theresia Sunadi (International Affairs) texts for its Opinions and meet as neces- • Petra Hohmann (Secretariat) sary, separately from the routine plenary • Pia Becker (Student Assistant) debates. In addition, the Ethics Council may commission investigations or expert reports and call in experts to assist with Funding its work, in particular in support of the working groups. The costs of the German Ethics Council The Ethics Council is assisted in the and its Office are borne by the Federal performance of its duties by an Office, Government. The sum of 1.695 million established by the President of the Bun- euro was allocated in the Bundestag’s destag in accordance with Section 8 of the budget to the funding of the Council’s Ethics Council Act and accommodated work in 2010 (Departmental Budget 02, at the Berlin-Brandenburg Academy of Title 52603-011). Sciences and Humanities. The general conditions governing the activity of the Office are determined by an agreement between the Bundestag Administration and the Academy.

57 German Ethics Council

Ethics Council Act to the German Bundestag and the Federal Government for their information before Act on the Establishment of the publication. German Ethics Council (4) The German Ethics Council shall re- of 16 July 2007 (Federal Law Gazette I port in writing to the German Bundestag p. 1385); entered into force on 1 August 2007 and the Federal Government at the end of each calendar year on its activities and the Section 1 current state of the social debate. Establishment of the German Ethics Council Section 3 An independent council of experts shall Position be formed, bearing the name German The German Ethics Council shall be in- Ethics Council. dependent in its work and bound only by the mandate given to it by this Act. The Section 2 members of the German Ethics Council Duties shall exercise their office in person and (1) The German Ethics Council shall pur- independently. sue the questions of ethics, society, sci- ence, medicine and law that arise and the Section 4 probable consequences for the individual Members and society that result in connection with (1) The German Ethics Council shall be research and development, in particular in composed of twenty-six members special- the field of the life sciences and their ap- izing in scientific, medical, theological, plication to humanity. Its duties shall in- philosophical, ethical, social, economic clude but not be limited to the following: and legal concerns. Its members shall 1. informing the public and encouraging include academics from the above dis- discussion in society, engaging the vari- ciplines, and in addition it shall include ous social groups; persons of repute who are particularly 2. preparing Opinions and recommenda- familiar with ethical questions of life sci- tions for political and legislative action; ences. 3. cooperation with national ethics coun- (2) The German Ethics Council shall con- cils and comparable institutions of tain representatives of a variety of ethical other states and of international or- approaches and a pluralist spectrum of ganizations. opinion. (2) Every year, the German Ethics Coun- (3) The members of the German Ethics cil shall hold at least one public event on Council may not belong either to a leg- questions of ethics, in particular in the islative body of the Federal Republic or a field of the life sciences. In addition, it Land nor to the Federal Government or may hold further public events, hearings a Land government. and public meetings. (3) The German Ethics Council shall pre- Section 5 pare its Opinions on the basis of its own Appointment and term of office of determination, at the request of the Ger- members man Bundestag or the German Federal (1) The President of the German Bundestag Government. It shall forward its Opinions shall appoint the members of the German

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Ethics Council, half on the proposal of the Section 8 German Bundestag and half on the pro- Administrative office posal of the Federal Government. The German Ethics Council shall be sup- (2) The members shall be appointed for a ported in carrying out its duties by an four-year term. They may be re-appointed administrative office. The administrative once. office shall be established by the President (3) The members may at any time declare of the German Bundestag. It shall report to their resignation from the German Eth- the chair of the German Ethics Council. ics Council in writing to the President of the German Bundestag. If a member Section 9 leaves prematurely, a new member shall Duty of confidentiality be appointed for a four-year term. In this The members of the German Ethics Coun- case, the appointment of the new member cil and the members of the administrative shall be on the proposal of the body that office shall observe confidentiality with submitted the proposal of the resigning regard to deliberations in closed session member under paragraph (1). and documents regarded as confidential by the German Ethics Council. The duty Section 6 of confidentiality shall also apply to infor- Working methods mation that is given to the German Ethics (1) The German Ethics Council shall elect Council and described as confidential. a chair and vice-chair or vice-chairs from among its members by secret ballot for a Section 10 four-year term. They may be re-elected Costs once. (1) The members of the German Ethics (2) The German Ethics Council shall Council shall receive a lump-sum expense adopt rules of procedure. allowance and reimbursement of their (3) The German Ethics Council may es- travel costs under the Bundesreisekos- tablish working groups and have reports tengesetz (Federal Travel Expenses Act). prepared by third parties. The expense allowance shall be deter- mined by the President of the German Section 7 Bundestag. Public deliberations (2) The costs of the German Ethics Coun- (1) The deliberations of the German Eth- cil and its administrative office shall be ics Council are public; it may also meet in borne by the . closed session and publish the results of such deliberations. Section 11 (2) The German Ethics Council shall pub- Entry into force lish its Opinions, recommendations and This Act shall enter into force on 1 August reports. 2007. (3) If, in the drafting process, members have a dissenting view, they may express this in the Opinion, the recommendation or the report.

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Rules of Procedure German Ethics Council. The suspension of membership shall end as soon as the mem- Preamble ber in question informs the chair that the Pursuant to Section 6(2) of the Ethics reasons for suspension no longer apply. Council Act (Ethikratgesetz), the German Ethics Council adopts the following Rules Section 2 of Procedure. Resolutions (1) The Council shall constitute a quo- Section 1 rum if more than half of the members Independence of members. Partiality. are present. Unless other majorities are Duty of confidentiality. Suspension of prescribed, the Council shall decide by a membership majority of the members present. (1) The members are not bound by in- (2) Resolutions may be passed in writing structions. They represent their personal or by electronic means, if the Council so convictions and are bound only by their resolves by a majority of the members conscience. present. (2) If, in connection with a particular is- sue, there is concern that there may be a Section 3 conflict of interest, the member in ques- Chair tion shall notify the chair or the vice- (1) The chair and the vice-chairs shall chair of this and discuss the matter with be elected by an absolute majority of the the chair or vice-chair. If this discussion members of the Council. If this majority is does not result in agreement as to whether not attained in a first ballot, there shall be there is a conflict of interest, the Council a second ballot, in which the decision shall shall decide in the absence of the member be by relative majority. In the event of a in question as to whether that member is tie, after a further discussion there shall to take part in the relevant deliberations be a further ballot. If this too results in a and voting. tie, there shall be a decision by drawing (3) The members have a duty of confi- lots. The Council shall decide by simple dentiality with regard to the deliberations majority on the number of deputies. in closed session and the documents de- (2) The chair or a vice-chair shall conduct scribed as confidential. the meetings and be responsible for pre- (4) A member may request the chair to paring the agenda. He or she shall repre- permit his or her membership to be sus- sent the Council. If the chair is prevented, pended. The suspension of membership the vice-chairs shall exercise his or her means that the member will continue to duties in the order determined by the receive all notices from the Office but will Council. With the consent of the Council, no longer attend plenary meetings and he or she may assign individual duties to meetings of the working groups, and that the vice-chairs. the absence of the Council member from these meetings shall be deemed to be ex- Section 4 cused without any further communica- Work programme tion. The suspension of membership also The Council shall adopt a work pro- means that the Council member will no gramme. The programme shall, as a gen- longer appear in public as a member of the eral rule, be updated once a year.

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Section 5 Section 7 Meetings Minutes (1) Meetings shall, as a general rule, be (1) Resolution minutes of the meetings held once a month in Berlin. shall be made. The minutes shall be sent to (2) The date of each meeting shall be set all members within two weeks of a meet- by the Council a considerable time in ad- ing. Any objections must be made within vance. An extraordinary meeting shall be ten days after forwarding. If objections are held within ten days at the request of a not accepted, a decision shall be made on minimum of seven members. them at the next meeting. (3) The agenda of each meeting shall be (2) The minutes or records of the public provisionally decided at the previous meetings and events shall be published on- meeting. The chair and/or the vice-chairs line. The results of deliberations in closed may add further items to the agenda if a session may also be published online. need for this arises subsequently. They shall do this if requested by three mem- Section 8 bers. A final decision on the agenda shall Expert reports, experts and guests be made by resolution at the beginning of The Council may arrange for investiga- the meeting itself. tions to be carried out and expert reports (4) Notices convening meetings, with the made and may enlist the services of ex- agenda and the necessary documentation perts for its work. In addition, representa- attached, shall be sent at the latest ten days tives of the constitutional bodies author- in advance. In the case of extraordinary ized to instruct the Council, of public meetings, the notice period shall be three authorities and institutions, of organiza- days. tions and associations, and other guests may be invited to attend deliberations on Section 6 individual topics. Public nature of meetings (1) Pursuant to Section 7 of the Ethics Section 9 Council Act, the plenary meetings of the Rapporteurs and working groups Council shall, as a general rule, be public. (1) The Council may appoint members, A decision to meet in closed session shall with their consent, as rapporteurs on spe- be passed by the votes of the majority of cific topics. the Council. The meetings of the working (2) In addition, the Council may form groups shall not be public. working groups from among its members (2) Agenda items that pursuant to (1) to prepare specific topics, as well as to above are to be discussed in public shall address entire subject areas. The working be so identified on the agenda. This shall groups shall appoint their spokesperson be published online. and, if necessary, rapporteurs, who shall (3) Admission to the public meetings shall present the results of their work to the be subject to availability of seats. In in- Council. dividual cases, the Council may permit (3) Section 8 shall apply mutatis mutandis sound and image recording. to the working groups.

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Section 10 of day-to-day business are concerned, of Position statements and publications the chair or of the vice-chairs. (1) Opinions, recommendations, reports (2) The Council shall decide on the basis and Annual Reports shall be adopted after of relevant submissions of the chair or an oral discussion of the draft submitted the vice-chairs on the organization of the by the rapporteur or spokesperson of the Office and, where executive-grade posts working group. If this cannot be done are concerned, on filling these, and on the immediately after the deliberation, the appropriation of the total budget funds at passing of a resolution may be postponed its disposal. until the next meeting. For this purpose, (3) The staff of the office shall attend the members must be provided well in meetings as stipulated in detail by the advance with a version of the draft revised Council. by the rapporteur or the spokesperson of the working group on the basis of the Section 13 results of the deliberation. At the request Amendments to the Rules of Procedure of dissenting members, the relevant sup- Amendments to the Rules of Procedure plementary position statements shall be require the consent of a two-thirds major- attached to the resolution. ity of the members of the Council. (2) The Council shall decide in each case on the date and manner of publication of Opinions, recommendations, reports and Annual Reports after they are for- warded to the Federal Government and the Bundestag.

Section 11 Cooperation with the German Bundestag and the Federal Government (1) The Council shall provide the Ger- man Bundestag or a parliamentary body appointed by the German Bundestag and the Federal Government with the agendas of its meetings. (2) The Council may invite members of the Bundestag and the Federal Govern- ment to attend particular deliberations.

Section 12 Office and budget (1) The Council shall be supported in its work by an administrative office. The staff of the office shall be subject to the instructions of the Council in regard to the relevant subjects and, where matters

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