Annual Report 2011 Published by the German Ethics Council

Deutscher Ethikrat

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

Report compiled by: Ulrike Florian English translation: Margaret Marks Ph.D., MITI, Fürth Layout: Torsten Kulick Cover design: BartosKersten Printmediendesign, Hamburg

April 2012 Annual Report 2011

Contents

Introduction ...... 5 Topics ...... 7 Medical benefits and costs in healthcare ...... 7 Preimplantation genetic diagnosis ...... 10 Human–animal mixtures in research ...... 15 Intersexuality ...... 19 Dementia and self-determination ...... 22 Genetic diagnosis ...... 23 Public meetings and promotion of social discourse ...... 24 Annual meeting: Feeding the world ...... 24 Public meeting: Synthetic biology ...... 28 Bioethics Forum: The controversial case of baby drops ...... 33 Bioethics Forum: Research on medicines in children ...... 36 Dialogue of experts: Need for legislation on research with human biobanks? ...... 40 Online discourse on intersexuality ...... 42 Panel discussions with students ...... 42 Collaboration with the German Bundestag ...... 44 Parliamentary Evening on 23 March 2011 ...... 44 Parliamentary Evening on 26 October 2011 ...... 45 International initiatives and contacts ...... 47 Meetings of the national ethics councils of the European Union ...... 47 Trilateral meeting of the ethics councils of Germany, France and the United Kingdom ...... 48 Publications ...... 50 Opinions ...... 50 Proceedings ...... 50 Infobrief ...... 50 Evolution of the social debate ...... 51 Outlook ...... 55 The members of the German Ethics Council ...... 56 Appendix ...... 58

Annual Report 2011

Introduction

The year 2011 was an exceptionally crea- In order to encourage direct exchange tive one for the German Ethics Coun- of opinions between the Ethics Council cil. This is shown not only by the large and the members of the German Bunde- number of meetings of the plenum and stag, two Parliamentary Evenings were the working groups, but also by the num- held, in the course of each of which the ber of Opinions presented and of public Council’s latest Opinions were presented events and further initiatives of public and discussed. The Bundestag members discourse. find these events extremely interesting, as With regard to providing information was shown in particular by the fact that to politicians and the public, the Opinions more than forty members attended the and public events are the cornerstones of Parliamentary Evening on 23 March 2011 the Council’s work. In this connection, on the Bundestag premises. The President pride of place goes to the three Opin- of the German Bundestag, Professor Dr. ions which the Ethics Council presented Norbert Lammert, welcomed the Ethics in 2011: “Medical benefits and costs in Council members and expressly thanked healthcare: The normative role of their the Ethics Council for the Opinion on evaluation” (January 2011), “Preimplanta- preimplantation genetic diagnosis. He tion genetic diagnosis” (March 2011) and praised this as an extremely important “Human–animal mixtures in research” document in which the Bundestag mem- (September 2011). In addition to the in- bers could find all the relevant informa- tensive consultations on the Opinions, the tion including an objective weighting and Ethics Council held six public events and evaluation of the arguments. He said that introduced a new style of public debate in this was the kind of consultation which the form of an online discourse. he hoped to see in the work of the Ethics

Parliamentary Evening of the German Ethics Council at the Paul-Löbe-Haus of the German Bundestag

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Council and which all members could use in the field of life sciences and their ap- in order to form their own opinion on plication to humans. Its duties include ethically problematical questions. informing the public and promoting so- The second Parliamentary Evening cial discourse involving the various social on 26 October 2011, in which Eduard groups, preparing Opinions and recom- Oswald, the Vice-President of the Ger- mendations for political and legislative man Bundestag, welcomed the Council action and working together with national members, was also well received by the ethics councils and similar institutions members, who used it to inform them- of other countries and of international selves on the Opinion on human–animal organizations. The present report docu- mixtures and to discuss the topic. ments, in compliance with section 2(4) of The year 2011 was dominated by the the Ethikratgesetz (Ethics Council Act, see work on the Opinion on intersexuality, appendix) in what way and to what extent which the Federal Government instructed the Council fulfilled this requirement in the Ethics Council to prepare in Decem- the time from January to December 2011. ber 2010. The Ethics Council found that the state of scientific data on this topic was insufficient, and therefore it commissioned a survey of persons affected and experts, arranged a public hearing and initiated an online discourse, in which the internet was first used as a forum for public debate. At the end of October 2011, the Federal Government commissioned the Ethics Council to prepare an Opinion, for the second time since the Council was consti- tuted in April 2008. In a joint letter from Professor Dr. Annette Schavan, the Fed- eral Minister of Education and Research, and Daniel Bahr, the Federal Minister of Health, the Ethics Council was requested in the name of the Federal Government to prepare an Opinion on the topic of “The future of genetic diagnosis from genetic research to clinical practice – social challenges of new methods of genetic diagnosis, taking particular account of predictive and prenatal methods”. The German Ethics Council is required by law to follow the ethical, social, scientific, medical and legal questions and the expected consequences for the individual and society which arise in connection with research and developments, in particular

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Topics

With a view to the publication of an Opin- of deterioration of quality arising from ion, the German Ethics Council consid- relative scarcity of resources in areas of ered the following topics in 2011: healthcare and of outpatient and inpatient care. Against this background, the Ethics • medical benefits and costs in health- Council regards it as essential to discuss care, limits that will be placed on solidarity- • preimplantation genetic diagnosis, based (collective) financing of healthcare • human–animal mixtures in research, treatments in the future. If it transpires • intersexuality, that it is no longer possible to finance • dementia and self-determination, a comprehensive system of healthcare • genetic diagnosis. in which every citizen may obtain every medically advisable benefit, there must These and other topics were addressed be a discussion of legitimate entitlements by the Ethics Council in specific work- and fair distribution, that is, ultimately of ing groups and also in public plenary social justice in questions of healthcare. meetings and other public events (see The debate must concern the extent of the p. 24 ff.). entitlements required on moral grounds and of those guaranteed as fundamental rights. Medical benefits and costs in healthcare Evaluation of costs and benefits Attempts are often made to address situ- On 27 January 2011, the German Ethics ations of scarce resources by the instru- Council published its third Opinion. On ment of efficiency savings. It is a matter the occasion of the legislative debate in the of experience that innovative medicinal context of the Gesetz zur Neuordnung des products are very expensive. For this rea- Arzneimittelmarktes (Act on the Reform of son, a particular aim, internationally as the Market for Medicinal Products) and well as in Germany, is to identify poten- of the planned Gesetz zur Verbesserung der tial savings in this field and mechanisms Versorgungsstrukturen in der gesetzlichen for their achievement. One instrument German Ethics Council (ed.): Krankenversicherung (Act to Improve the is the evaluation of the medical bene- Medical benefits and costs in Health Care Structure), the Ethics Coun- fit and cost-effectiveness of medicinal healthcare: The cil’s Opinion was intended to help bring products. International health econom- normative role of their evaluation. the difficult questions of the equitable ics has developed instruments of cost- Berlin, 2011 (ISBN allocation of resources to the attention of effectiveness analysis, which, however, 978-3-941957-20-6) the public and the political world, using are not uncontroversial. In Germany, the the example of ethically disputed methods Institut für Qualität und Wirtschaftlichkeit of evaluation in health economics. im Gesundheitswesen (Institute for Quality Germany has one of the most compre- and Efficiency in Health Care) has since hensive healthcare systems in the world. 2007 been required by statute to establish Nevertheless, there are increasing signs cost-effectiveness analyses on the basis of

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Eckhard Nagel, spokesperson of the working group, and Christiane Woopen, Vice-Chair of the Ethics Council, during the presentation of the Opinion “Medical benefits and costs in healthcare: The normative role of their evaluation”

“internationally recognized standards”. of the medical benefit of a measure is the These analyses are intended to serve as ultimate criterion for the provision or recommendations for the Gemeinsamer otherwise of that measure in the statu- Bundesausschuss (Federal Joint Commit- tory health insurance scheme, particular tee), which is responsible for determining importance attaches to the measurement the extent of treatments provided under of quality of life. The Act on the Reform the statutory health insurance scheme. of the Market for Medicinal Products in- However, whether and how such analyses troduced a systematic evaluation of the should be conducted and implemented in medical benefits of all medicinal products. health policy is not a value-free econom- Although this is a significant advance, ic decision, but has significant legal and it does not go far enough, owing to the ethical implications, particularly since limitation to early evaluation of medi- the outcome may also entail restrictions cal benefits. For the actual benefit of a on medically necessary treatments. While medicinal product often emerges only the analyses are based on economic con- years after licensing from evidence-based siderations, their calculations and models data accruing from scientific studies. This are by no means politically or ethically may result in the application of therapies neutral. The implementation raises far- which, while deemed effective, offer no reaching questions of justice which call medical benefits, or only minor benefits for careful reflection. in comparison with other therapies, to the patient group concerned. In addition, Benefit to the patient the patients may thereby be exposed to a In the determination of benefit to the pa- high risk of harm, the patient’s trust in * In the following, tient, the measurement of quality of life his* doctor may be undermined, and lastly for convenience, the masculine form is presents a particular challenge, because there may be a quite considerable waste of used for both sexes. this parameter is qualitative and not, as in resources. In the view of the Ethics Coun- the case of longevity, purely quantitative. cil, reduction of the instrument of benefit In addition, there is no uniform standard assessment to the status of a pricing aid for assessing quality of life. Since analysis is unacceptable from the point of view of

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quality assurance and protection of the aimed at raising the level of collective patient and incompatible with economi- medical benefits. Again, the calculated cally efficient utilization of solidarity- or presumed socioeconomic “value” of based resources. individuals or groups must not be the basis of distributional decisions. Equitable distribution of resources Establishing criteria for an equitable Recommendations distribution of healthcare resources is a On this basis, the German Ethics Coun- political task with medical, economic, cil formulates twelve recommendations ethical and legal aspects. In view of the which should be followed by decision- complex issues involved, however, it is im- makers in the healthcare system when possible to arrive at a consensus between they draft statutory provisions, in order all interested parties. Nevertheless, the to achieve the best possible and at the German Ethics Council is of the opinion same time equitable use of the funds for that principles can be formulated against the healthcare system. which existing structures and processes If scarce care resources are to be used must be measured. responsibly, they must be employed for The Ethics Council regards it as ur- measures that really do yield medical ben- gently necessary for prioritization, ra- efits under field conditions. In addition tionalization and rationing in the health to early evaluation of medical benefits care system to be openly discussed. Every for pricing purposes, it must remain pos- form of “concealed rationing” of medical sible for the Federal Joint Committee and treatments and benefits must be rejected. the Institute for Quality and Efficiency in Necessary decisions on rationing must Health Care to conduct a comprehensive not be delegated to an individual medi- evaluation of medical benefits at any time cal practitioner or nurse. Acknowledge- irrespective of cost considerations, in par- ment of the existence of the problem of ticular in relation to the patient-focused how scarce healthcare resources should end points of mortality, morbidity and be distributed does not imply the espousal quality of life. In the case of important of an “economization” of decisions. An groups of indications, a systematic sec- objective debate in fact calls for the in- ond stage of evaluation of benefits should volvement of medical, economic, ethical follow as a matter of course after an ap- and legal expertise in a transparent pro- propriate interval, not only for medicinal cess. Decisions on the extent of solidarity- products, but also for non-pharmacologi- financed treatments are ultimately ethical cal treatments. It must always be possible decisions, which must be taken on the to exclude a given treatment from the basis of social discourse and through the range of treatments provided on grounds political process. of lack of medical benefits where neces- All decisions must proceed from the sary for reasons of patient protection. starting point of the principle of human The Ethics Council recommends that dignity and fundamental rights, which transfer- and care-provision-related re- call for every citizen to have access to search should be expanded, as well as appropriate healthcare, this access being manufacturer-independent subvention guaranteed by rights. These rights must of clinical studies in the practical treat- not be subordinated to any considerations ment situation after a medicinal product

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or medical device has been licensed. This entitlement to the provision of all medi- should be linked to the systematic iden- cally necessary care is legally unchanged. tification of research topics of particular These requirements currently serve not relevance to the provision of medical care, as an instrument for the distribution of for instance by the Federal Joint Commit- scarce resources, but for pricing purposes. tee. An appropriate statutory framework However, the likely future need of ration- should be established for this purpose. ing decisions will compel the legislature An eventual aim should be the compul- to clarify the extent to which entitlements sory publication of all studies, regardless to treatments under section 27 and sec- of their findings, and not only of con- tion 12 SGB V may be influenced by a firmatory studies conducted for licensing cost-effectiveness analysis, and to spell purposes, as well as of post-licensing clini- out the relative roles of this analysis and cal trials. This is the only way to guarantee of the criterion of medical need. access to all data relevant to the assessment of medical benefits. In the context of the cost-effectiveness Preimplantation genetic analysis of medical treatments, there are diagnosis important ethical and equity-related reasons not to apply the principle of maximi- In July 2010, the Bundesgerichtshof (Fed- zation of medical benefits across patient eral Court of Justice) acquitted a doc- groups. The legislature should therefore tor who had filed a criminal complaint clarify Section 35b of Book V of the Sozi- against himself for conducting genetic algesetzbuch (SGB – Social Code) (evalua- tests on embryos, and following this, in tion of the cost-effectiveness of medicinal August 2010, the German Ethics Council products) accordingly. Yet calculations of established a working group with the pur- German Ethics cost-effectiveness based on an efficiency pose of preparing an Opinion on preim- Council (ed.): Preim- plantation genetic frontier approach can also not be deemed plantation genetic diagnosis (PGD). The diagnosis. Berlin, [in print] (ISBN 978-3- ethically “neutral” when applied as a crite- Opinion was presented at an early date, on 941957-34-3) rion for the appropriateness of decisions 8 March 2011. In the Opinion, the Coun- on reimbursement for innovations. This cil set out the arguments for and against is because the cost-effectiveness of the PGD in detail and provided a variety of particular established therapy that offers proposals for legislation on PGD. the greatest level of medical benefit in Against the background of current the relevant field of indications – i.e. the scientific, technological and legal devel- status quo – is based on a variety of factors opments, which raise a large variety of which are not always coordinated with ethical and social questions with regard each other. In referring to taking account to the need for legislation on PGD, the of the international standards of health Opinion describes current practice and economics (section 35b(1) sentence 5 the new possibilities of genetic diagnosis SGB V), the legislature has failed to lay of embryos, sets out differing positions down sufficiently clear requirements. and arguments on the status and protec- The effects of the current requirements tion of the embryo, and lists the most concerning cost-effectiveness analysis in important socio-ethical aspects, which are Germany are at present essentially not subject to considerable controversy in the harmful, because an insured person’s current debate.

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From the left: Wolfgang Huber, Christiane Woopen, Edzard Schmidt- Jortzig, Wolf-Michael Catenhusen, Ulrike Riedel and Jochen Taupitz during the presentation of the Opinion “Preimplantation genetic diagnosis”

Clinical practice specific genetically based diseases and In order to obtain an impression of the chromosome abnormalities can be carried current and probable future clinical prac- out even on older embryos, that is, on the tice with regard to PGD and the law gov- fifth day after fertilization (blastocyst bi- erning it, in December 2010 the Ethics opsy). At this time, the embryo’s cells are Council invited representatives from Eu- no longer totipotent, and therefore even ropean countries in which PGD is already in Germany their examination would not practised to attend an exchange of views. be ruled out at the outset. However, for In the case of blastomere biopsy, which is PGD to be carried out successfully, nor- the PGD procedure most widely used at mally more embryos are needed than the present, one to two totipotent cells are re- three which, according to prevailing opin- moved from the embryo on the third day ion, the Embryo Protection Act permits. after fertilization, that is, in approximately the eight-cell stage; this is prohibited in Status of the embryo Germany by the Embryonenschutzgesetz The question as to how far the produc- (Embryo Protection Act). At least with tion of such superfluous embryos can be regard to establishing aneuploidy, it has justified depends decisively on how the as yet not been shown that this method status of the embryo is assessed. In this improves the prospect of a healthy child, connection, the German Ethics Council among other things because at this stage states clearly that this question cannot be the embryo’s cells often have genetic dif- unequivocally answered either legally or ferences which mean that the number of ethically. This follows from an analysis of chromosomes of an examined cell is not the constitutional framework and of vary- very informative. ing positions on the moral status and pro- But currently, improvements in the tection of the embryo. Advocates of one speed and reliability of the diagnostic test- position are of the view that after fertiliza- ing methods used, in particular in the area tion is completed a graduated protection of DNA chip technology, are increasing of life cannot be justified and also refer the probability that meaningful tests for to a special responsibility to the embryo

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created in vitro. Advocates of the other Those in favour of the restricted per- position, however, argue that parental mission of PGD proceed on the basis of responsibility only begins to grow when six principles, for which they give detailed pregnancy is established and continues, reasons in the Opinion: and that in the first days of its development the embryo may and can very well 1. The way should be open for a couple be differently assessed and protected than to fulfil their desire for children, even prenatal life in its later stages of develop- if they know that they may pass on a ment, in particular after the embryo has serious genetic disease to the child. embedded itself in the uterus. 2. The rights and the claims to protection of the mother must be weighed against Socio-ethical aspects those of the embryo; however, those The Opinion also shows contrasting of the mother may not be unilaterally perspectives with regard to socio-ethical pushed aside. questions. There are different assessments 3. The use of PGD should be restricted. here as to whether the permission of PGD 4. The use of PGD may be restricted. might mean fundamental social accept- 5. The decision of a couple in this situa- ance of the selection of genetically con- tion does not constitute discrimination spicuous embryos and how far this might against persons with disabilities. lead to discrimination against persons 6. The concept of protection of a restrict- with a disability or put pressure on future ed permission of PGD avoids a conflict parents to have such tests carried out at with the existing concept of protection all or to decide against a life with affected of unborn life in our legal system. children. Proceeding from these scientific, legal Against this background, these Coun- and ethical considerations, the Council cil members devise a number of recom- members next develop two opposing ar- mendations for legislation governing a guments for and against the permission restricted permission of PGD. of PGD in Germany. According to these, a high degree of medical risk is necessary for genetic tests Position statement in favour of to be conducted on embryos. This exists restricted permission A group of thirteen members of the Ger- a) if evidence shows that the parents have man Ethics Council regard PGD, subject a hereditary disposition which if it were to particular restrictions, as ethically justi- passed on to the child would result in fied, because PGD creates the possibility a serious illness or disability and if it of avoiding a lawful termination of preg- were established by prenatal diagnosis nancy following prenatal diagnosis and on would constitute a medical indication the basis of medical indication, and also for termination of pregnancy by reason offers an opportunity of assistance to cou- of an endangerment of the physical or ples who for genetic reasons have experi- psychological health of the woman in enced repeated miscarriages or stillbirths. question, In both cases, the permission of PGD is b) if there is evidence that the parents supported by good reasons relating to the have a high degree of risk of passing protection of the woman’s health. on a chromosome disorder or other

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mutation which excludes extrauterine the genetic risk and counselling from a viability of the embryo or human geneticist, after medical advice c) if, after repeated miscarriages or unsuc- from a specialist in reproductive medi- cessful attempts at treatment by assist- cine and after psychosocial advice by ed reproduction after thorough medi- an advice centre recognised under the cal clarification, the parents have a high Schwangerschaftskonfliktgesetz (Conflicted degree of risk of germ cell maturation Pregnancy Act), the diagnosis should be disorders, with the result that a large made jointly by the experts involved in proportion of the embryos created are the counselling and a representative of not viable outside the womb. In these the IVF commission of the State Chamber cases, PGD should be carried out only of Physicians. in clinical studies, in order to establish In addition, the position in favour scientifically that it is effective in this contains suggestions on the treatment area, which has not as yet been shown. of superfluous genetic information in the course of PGD, on avoiding super- On the other hand, in the opinion of these fluous embryos and on the organization Council members, PGD is impermissible and documentation of the conduct of the and must be prohibited by statute PGD. a) to determine the sex of an embryo, un- Position statement supporting less this is done in order to prevent prohibition the birth of a child with a very serious, A group of eleven members of the Ethics sex-linked congenital genetic anomaly, Council is of the opinion that permission b) if it is to be carried out with the objec- of PGD is ethically indefensible, since it tive of selecting an embryo to donate would call into question the protection of cells, tissues or organs for another per- embryos created in vitro as a form of hu- son, man life which deserves respect in itself. c) if, without any of the indications set They accept that great weight attaches out above, it is, for example, to be car- to the hopes and wishes of couples carry- ried out to prevent a risk of chromo- ing genetic risks who wish to realize their some disorders in the embryo which desire for healthy children with the help of is assumed solely on the basis of the PGD. But they argue that careful ethical woman’s age, and examination of PGD and the development d) in the case of late-onset illnesses. it may be expected to take nevertheless leads to the conclusion that the procedure The supporters of a restricted permission should be expressly prohibited. of PGD recommend that the legislature The opponents of permission cite the should lay down these criteria but should following reasons for this: not create a catalogue of individual illnesses or disabilities in the case of which 1. The embryo created in vitro, because PGD may be considered. it was artificially created, is subject to In addition, they suggest that there a particular and novel responsibility, should be rules of procedure for con- since there are no comparable possi- ducting PGD, which should be uniform bilities of intervention in the case of nationwide. After the determination of natural conception in the first days of

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embryonic development. This particu- 6. The technological development of chip- lar responsibility forbids creating em- assisted diagnosis techniques makes it bryos in vitro in order to discard them probable that in the foreseeable future in the case of undesired characteristics. PGD will be used more broadly for the 2. PGD is associated with selective con- diagnosis at the same time of a large sideration which is aimed at selecting number of genetic deviations or dispo- some of the embryos created in vitro sitions to illness. For the embryos ex- and discarding the others. This funda- amined, these techniques will provide mentally differentiates PGD from the results which were not even sought. situation of termination of pregnancy This “superfluous information” will by reason of medical indication after result in a selection of embryos over prenatal diagnosis. For this reason, and above a selection for “narrowly PGD cannot be justified by a compari- defined” reasons. son with prenatal diagnosis in which 7. With such developments, the pressure prenatal diagnosis – let it be noted that on parents carrying genetic risks who this is in contradiction to the current do not wish to undergo PGD, and on statutory provisions – is interpreted persons with disabilities, in particu- as a means to achieve “pregnancy on lar with genetically caused disabilities, approval”. would increase. Such a development 3. But such a comparison shows that PGD would be contrary to the efforts on be- would reintroduce an embryopathic half of integration and inclusion of the indication, that is, the permission to disabled. discard human life by reason of undesired characteristics. But this em- In the opinion of the signatories to this bryopathic indication was expressly position, the anxieties and wishes of cou- removed from the law on conflicted ples carrying genetic risks must be taken pregnancy in 1995. seriously, But they do not justify the in- 4. Permitting PGD would result in grave troduction of PGD. Instead, it must be consequences for the protection of ensured that there is better counselling embryos. The “rule of three”, which and support for affected couples or fami- is intended to ensure that human em- lies; it must also be determined whether bryos may only be created in vitro for their genetic problems can be alleviated the purpose of human procreation, by means of other procedures. could not be maintained. Instead, a large number of “superfluous” embryos Dissenting position statement would be created whose fate would be In a dissenting position statement, one uncertain. Council member advocates permitting 5. A restriction to a few groups of cases PGD to identify embryos that are capa- or to serious diseases could not be ad- ble of development. For those situations hered to. On the contrary, it can be in which genetic malfunctions are not anticipated that the indications and compatible with life, it is argued, PGD is occasions for the use of PGD will be capable of forestalling pregnancies which increased, and this has already hap- are biologically hopeless and which would pened in other countries which have only result in a danger to the mother or to permitted PGD. the parents. This applies, for example, to

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most aneuploidies and many other chro- introduction of disease-specific human mosome abnormalities, but also to some genes into the mouse genome has been illnesses which are untreatable and which commonplace since as long ago as the result in death shortly after birth. In order 1980s. Researchers are now working on to enable a clear definition of the possi- the transfer not only of genes, but also of bilities of application of PGD under such entire chromosomes. In addition, nerve aspects, however, there must be a binding precursor cells derived for instance from catalogue of indications. human stem cells have been transferred into the brains of experimental animals, including primates, for the investigation Human–animal mixtures in and possible eventual treatment of disor- research ders such as Alzheimer’s and Parkinson’s disease. The Ethics Council began to con- How do we understand the distinction cern itself with the topic when the Human between humans and animals? What is Fertilisation and Embryology Act in the the significance for humans’ self-image United Kingdom expressly legalized the of a research development which increas- creation of cytoplasmic hybrids (cybrids), ingly calls into question the biological de- formed by the insertion of a human so- marcation between humans and animals? matic cell into an enucleated animal egg, Where is there already a need for action in order in this way to be able to create by scholarship, society or the political embryonic stem cells without resorting to German Ethics Council (ed.): world? The German Ethics Council pre- human oocytes. The topic attracted great Human–animal mixtures in sented an Opinion on these questions on interest in Germany too, in view of the research. Berlin, [in 27 September 2011. fact that the Embryo Protection Act does print] (ISBN 978-3- 941957-46-6) The self-image of humans is charac- not prohibit the creation of such cybrids terized by a strict distinction between in Germany. humans and animals. Even though from Such experiments increasingly call into a biological point of view humans are question the biological species boundary also part of the animal world, ethics and between humans and animals. For this law are based on a strict differentiation, reason, the Ethics Council considers it and this also plays a fundamental role in necessary to identify the ethical challenges religion and culture. However, despite that may be presented by the creation being conscious of a clear distinction, in of human–animal mixtures and to de- their imagination humans do cross the termine where it may be appropriate to boundary they have created themselves. set binding limits. With this in view, the Thus, for example, mythological tradi- Ethics Council concentrated its attention is replete with reports and images tion on the transfer of human material to of mixtures of animals and humans, the animals, which it examines on the basis Sphinx, Pegasus, the Chimera, centaurs of three examples: cytoplasmic hybrids and mermaids. (cybrids), transgenic animals with hu- In biomedical research too, humans man genetic material, and the transfer have long since begun to cross the bound- of human cells into the brains of fetal or ary between humans and animals. The adult animals (brain chimeras). The Eth- breeding of mice as “model organisms” ics Council presented recommendations for research on human disorders by the on these examples, which are as follows:

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Joachim Vetter, Head of Office, and the Ethics Council members Jochen Taupitz, Wolf- Michael Catenhusen and Jens Reich during the presentation of the Opinion “Human–animal mixtures in research”

I. General recommendations These restrictions should be supplement- I.1 The German Ethics Council is of the ed by including the following bans: opinion that no human–animal mixtures should be permitted to be transferred to a • a ban on the transfer of animal embryos uterus when it is clear in advance that it into humans, will not be sufficiently possible to allocate • a ban on the introduction of animal them to animals or humans (“genuine material into the human germline, human–animal mixtures”). This applies • a ban on procedures that could result in irrespective of the dispute as to whether the formation of human egg or sperm it is regarded as permissible to experi- cells in an animal. mentally create such entities or use them in vitro. I.3 Under Article 49 of Directive 2010/63/ I.2 The German Ethics Council en- EU, a national committee for the protec- dorses the prohibitions laid down in the tion of animals used for scientific pur- German Embryo Protection Act (Sec- poses is to be established in Germany. tion 7): It is possible that the Animal Welfare Commission under section 16b of the • no transfer of human embryos into an Tierschutzgesetz (Animal Welfare Act) is animal, to be entrusted with this committee’s du- • no creation of interspecific chimeras or ties. This committee should make one of hybrids , that is, of living beings the main emphases of its work the field –– by fertilization using human and of research into human–animal mixtures, animal gametes, and in this connection it should have par- –– by fusion of a human and an animal ticular regard to the following topics: embryo; or –– by the joining of a human embryo • the creation of transgenic animals by with an animal cell that is capable the insertion of a considerable propor- of further differentiation with that tion of human genetic material and the embryo. incorporation of regulatory genes,

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• the creation of human–primate brain II. Specific recommendations on the chimeras, creation of cybrids • projects resulting in drastic changes A cytoplasmic hybrid, or cybrid, is de- in the appearance and capabilities of fined as a living cell formed by the fusion an animal. (hybridization) of an enucleated egg (for instance of a cow) with the nucleus of The national committee should pos- another, somatic cell (in the present case sess the wide-ranging interdisciplinary a human somatic cell). competence necessary for the purpose; it II.1 Irrespective of the question of a should draw up guidelines for the work possible ban on the creation of human– of the regional animal welfare commis- animal cybrids, the German Ethics Coun- sions in this field; it should be involved cil unanimously recommends prohibition in relevant decisions of principle in this of the implantation of human–animal cy- field; and it should perform its functions brids into a human or animal uterus. An with due regard for the status of social explicit prohibition to that effect should discourse. be incorporated in the Embryo Protec- I.4 More transparency is called for tion Act. with regard to research involving the II.2a The members of the German Eth- creation of human–animal mixtures, for ics Council who consider the creation and instance by the inclusion of detailed infor- use of cybrids to be ethically acceptable mation on “human–animal mixtures” in take the view that a statutory prohibition the Federal Government’s animal welfare is inappropriate. reports. [Stefanie Dimmeler, Frank Emmrich, I.5 Experiments involving a high de- Volker Gerhardt, Hildegund Holzheid, gree of manipulation, in particular the Weyma Lübbe, Eckhard Nagel, Jens insertion of genes or the injection of cells Reich, Edzard Schmidt-Jortzig, Jürgen during embryonic development, should Schmude, Jochen Taupitz, Kristiane We- be permissible only if of overriding im- ber-Hassemer, Christiane Woopen] portance in terms of their scientific objec- II.2b The members of the German tives, especially as regards the anticipated Ethics Council who hold that the creation medical benefits for humanity, and there and use of cybrids is ethically unaccepta- should be an evaluation of their possible ble call for the incorporation of a statutory repercussions on the moral status of the prohibition in the Embryo Protection Act. mixed entity. [Axel W. Bauer, Alfons Bora, Wolf- I.6 In biological and interdisciplinary Michael Catenhusen, Wolfgang Huber, research on the effects of the incorpora- Christoph Kähler, Anton Losinger, Peter tion of human genes, chromosomes, cells Radtke, Ulrike Riedel, Eberhard Schock- and tissues in an animal organism, more enhoff, Erwin Teufel, Michael Wunder] attention must be devoted to ethical issues, including also the effects on behav- III. Specific recommendations on the iour and capabilities, as well as on pheno- creation of transgenic animals with typic changes. The results of such research human genetic material should be made public to a greater extent An organism is considered to be transgen- than hitherto. ic if its genetic material has been modified by technical manipulation involving

17 German Ethics Council

the integration of foreign or synthetically other than primates is ethically acceptable derived genetic material into the cell nu- if, first, the objective of the research is of cleus. The genes are transferred by various overriding importance especially in terms methods at a very early stage of individual of the expected medical benefit to hu- development. All cells of the transgenic manity; second, the generally applicable animal always carry the genetic modi- ethical requirements of animal welfare are fication, which is also passed on in the satisfied; and, third, chimerization does germline. However, the expression of the not take place prior to the development genetic modification may be confined to of organ primordia. To ensure that the specific tissues, such as brain or blood conditions under which the animal is kept cells. An animal is said to be transgenic are appropriate to its species, the degree if genes from other species have been in- of cell integration and the behaviour of serted into it. the animal after birth should preferably III.1 The incorporation of human be monitored. genes into the germline of mammals (oth- IV.2 In view of the possible degree of er than primates) is ethically acceptable if manipulation involved in the implanta- the objective of the research is of overrid- tion of brain-specific human cells into ing importance in terms of the expected primate brains, of the vital importance of benefit to humanity and provided that the the brain and nervous system for species- generally applicable ethical requirements specific capabilities, and of our provision- of animal welfare are satisfied. al and limited knowledge of the possible III.2 Owing to our provisional and effects on physiognomy and cognitive limited knowledge of the possible effects capacity, the insertion of brain-specific on appearance, behaviour and capabili- human cells into primate brains should be ties, the insertion of human genetic mate- permissible only after an interdisciplinary rial (genes or chromosomes) into the ger- evaluation process involving the national mline of primates should be permissible committee as stated in Recommendation only after an interdisciplinary evaluation III.2. process involving the national committee. IV.3 The insertion of brain-specific Such experiments should be carried out human cells into the brains of great apes only if the expected medical benefit is of in particular should be prohibited in ac- overriding importance and there is no cordance with Recommendation III.3. alternative. Opinions differ on the defini- Council member Regine Kollek ex- tion of overriding importance and the ab- plains in a dissenting position statement sence of alternatives to be observed with why she is unable to agree with the version regard to animal experiments in general. of the Opinion as presented. In her state- III.3 The creation of transgenic hu- ment she also notes that she considers man–animal mixtures involving great the creation of human–animal cybrids apes should be banned. to be ethically acceptable because there are good reasons for assuming that such IV. Specific recommendations on entities do not constitute viable human the creation of human–animal brain embryos. chimeras IV.1 The creation of brain chimeras by the transfer of human cells to mammals

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Intersexuality and experts from various disciplines as to how intersex persons live and what The term intersexuality refers to a large responsibility society bears in this con- number of different phenomena relat- nection. Following this, at the end of the ing to persons whose gender identity is year 2010, the Federal Government com- ambiguous, with varying causes. Data as missioned the Ethics Council to continue to how many people are affected diverge the dialogue and to prepare a report on widely, depending on which definition is the situation of intersex persons in Ger- taken as the basis. The terminology used many. In January 2011 a working group itself implies a variety of definitions and was appointed; it prepared and structured evaluations in each case. Thus, for exam- the discussions in the plenary meeting. ple, after the 2005 Chicago Consensus In view of the complexity of the topic Conference the term intersexuality was and with the aim of finding a method of replaced in medicine by “disorders of formation of opinions that was as dis- sex development”, abbreviated as DSD; cursive, transparent and participative this term also includes medical diagnoses as possible and which would contribute which are not part of the concept of in- to freeing the topic of taboos, the Ethics tersexuality. Since 2008, the abbreviation Council conducted a discourse proce- DSD – introduced by the Arbeitsgruppe dure in three stages. At the beginning of Ethik im Netzwerk Intersexualität (Ethics May 2011, a written questionnaire which Working Group within the Network In- could also be answered online was sent tersexuality) has also been referred to as to intersex persons and also to experts “differences of sex development”. The ex- and practitioners who are concerned pression “differences of sex development” with intersexuality within their specific represents a move away from viewing fields. Following this, on 8 June 2011 there the phenomenon as a deficiency and to- was a public hearing in Berlin of intersex wards respecting the variety of bodies and persons, parents, doctors, psychologists sexes. The underlying understanding in and lawyers, in order over and above the each case is particularly important when written questionnaire to gather expert answering the question as to whether knowledge to create a solid foundation for children born intersex may be surgically the Opinion to be prepared. On the day aligned to the male or female sex. of the hearing, the Ethics Council started Socially, intersex persons are in an an online discourse as the third stage of area regarded as taboo. The public ob- the proceedings. In this low-threshold tain scarcely any information as to how and up-to-date manner it intended to they live or what their experiences and facilitate a debate on a broad social scale, needs are. At most, the public receives a to obtain further important information sense of the topic when intersex athletes and to trigger a mutual exchange between come to the attention of the media follow- intersex persons, experts, practitioners ing problematic and hurtful treatment of and interested persons. them by sports associations. In this discourse procedure and in par- Online: As early as June 2010, in its Bioeth- ticular in the online discourse, the Ethics www.ethikrat.org /veranstaltungen ics Forum “Intersexuality – life between Council incorporated a new format for /forum-bioethik the sexes”, the German Ethics Council social debate in its range of activities. The /intersexualitaet -leben-zwischen held discussions with intersex individuals digital discourse platform was set up in -den-geschlechtern

19 German Ethics Council

particular so that intersex persons who 8 June 2011. The experts invited included are not organized in networks were given doctors, psychologists, lawyers and repre- a low-threshold opportunity to enter the sentatives of parents’ initiatives, organi- debate. zations of intersex persons and self-help groups. Questionnaire The hearing was conducted in two con- Questioning intersex persons, experts and secutive parts, in order not only to obtain practitioners was the first of three steps the varying points of view of the persons towards the creation of a solid base for heard but also to emphasize a variety of the Opinion on the situation of intersex aspects of the topic. The first part deals persons on which the Ethics Council is with the topic “Medical treatment, in- currently working. The main focus of the dication, consent”, and the second with questionnaire is on medical intervention, “Quality of life, social situation and pros- information and consent, quality of life, pects of intersex persons”. integration and discrimination, network- In a first appraisal, the Council mem- ing between persons affected and the law bers who participated in the hearing of civil status. stated that the central point in the debate Questions for experts and practitioners was the right to physical integrity of those were directed to persons who are con- involved. In this connection there ap- cerned with intersexuality in their occu- pears to be a consensus that irreversible pations. They were requested to submit a medical intervention for the purpose of written expert’s report on the questions gender assignment must be deferred for formulated by the Ethics Council. At the as long as possible. Opinions differed as same time the Ethics Council was con- to whether this should be achieved by cerned to reach and question as many statute or by a medical code of practice. intersex persons as possible by way of However, attention was also drawn to the contact with the organizations and self- fact that there may be individual cases in help groups of intersex persons. These which irreversible intervention is neces- organizations passed the questionnaire sary for urgent health reasons at an early on through their distribution lists and date, when the child is not yet capable of informed users on their websites and at consent, and this must then be possible in their events of the possibility of taking exceptional cases. All this makes it neces- part in the survey. Persons affected could sary for the boundaries to be defined as also fill in the questionnaire online from clearly as possible in the Opinion to be 2 May to 19 June 2011. The answers re- prepared. This is difficult and requires ceived from doctors, therapists, social careful consideration. scientists, philosophers and lawyers can An element seen as important in con- be accessed on the website of the German nection with medical intervention was Ethics Council; the intersex persons were the fundamental right of parents to de- questioned anonymously. cide on medical intervention in the best interests of the child as long as the child Hearing and dialogue itself is incapable of deciding. Since medi- Online: www.ethikrat.org The second step in the discourse proce- cal intervention for gender assignment /veranstaltungen dure was the public hearing on the situ- affects the core of every person’s right /anhoerungen /intersexualitaet ation of intersex persons in Germany on of personality, his sexual identity, sexual

20 Annual Report 2011

sensation and fertility, the parental right not to be forced to assign themselves to finds its limits here. This too suggests that the binary categories male or female. such medical intervention should be car- In the hearing, the persons concerned ried out as late as possible, in order that demanded compensation for suffering the intersex persons affected may make resulting from medical intervention. In their own decisions. In this connection response, it was pointed out that it is dif- it was suggested that there should be a ficult to provide evidence of the culpable moratorium on medical inventions in violation of medical standards at a date order to delay a decision on treatment and which in most cases was long ago, particu- to allow the parents to get to know their larly since at an earlier date there were no intersex child. There was also a call for medical standards which could be proved the child to be involved as far as possible. to have been violated. But some partici- The child should be directly involved by pants thought that a state fund might be way of ongoing information appropriate used to provide compensation. Others, to age, interdisciplinary consultation and however, doubted that a state fund could involving the child in all decisions, irre- be implemented, for reasons of law and spective of considerations as to its ability fiscal policy. to decide for itself. The experts agreed that medical and A further topic which was identified for psychological counselling and treatment the Ethics Council’s discussions was the of intersex persons must be provided in law of civil status, although in the course centres with an interdisciplinary composi- of the hearing some of the intersex per- tion and with specially trained specialists. sons described it as secondary, albeit not In addition, the Ethics Council ob- unimportant. There was a call for the law tained the impression that the areas of of civil status to be amended to make it standard medical care and appropriate possible to defer gender assignment until consideration of intersex persons in social the person was capable of consent or of insurance are extremely important. full age. Section 47 of the Personenstands- Overall, most of the participants at the gesetz (Civil Status Act) makes it possible hearing requested more information and to amend an incorrect gender entry; this advice, and state support of the existing was not seen as sufficient. assistance, in order to improve the situa- The question as to how to determine tion of intersex persons in Germany. ability to consent is a difficult one. For a variety of reasons, puberty, for example, Online discourse may be a problematic time for an autono- The third component of the discourse Online: diskurs.ethikrat.org mous decision, since this is a period when procedure carried out by the Ethics Coun- fundamental processes of finding one’s cil was an internet-based participation identity are under way. It is also unde- platform; in providing this platform, the cided how the question can be answered Ethics Council for the first time used a for those persons who are intersexed and digital and freely accessible means of even as adults either cannot or do not transparent and participative commu- wish to be assigned either to the female or nication with a low access threshold in the male gender. By reason of the prohi- order in particular to extend the debate bition of discrimination and the right of to persons affected who are not organized self-determination, these persons ought in networks.

21 German Ethics Council

From 8 June to 7 August 2011 inter- status. The comments contain varying sex persons, experts and practitioners of and extremely nuanced suggestions for a variety of disciplines and members of legislation; these were taken into account the German Ethics Council had the opin the Ethics Council’s deliberations. portunity to discuss various questions in The results of the questionnaire, of the the context of intersexuality from their public hearing and of the online discourse respective positions and to come to an were included in the deliberations of the agreement among themselves. Ethics Council and the Opinion and were In order to conduct a discourse with published separately. a wide range of topics and to repeatedly give new stimulus, throughout the duration of the online discourse contributions Dementia and self- from named authors were uploaded twice determination a week; the participants in the discussion could post comments on these. The first At present about one million persons with contribution was provided by the Council dementia live in Germany and by 2030, members involved in the hearing, who according to projections, up to 1.7 million provided a first assessment. In addition, could be affected. Dementia is a challenge first impressions from the hearing and not only for family members, carers and short video interviews with the experts the medical profession, but for the whole at the hearing were made available on- of society. As early as in February 2010, line. There followed contributions from the Ethics Council established a working persons concerned, Council members, group on the topic of dementia; it is the experts and practitioners from the fields aim of this group to prepare an Opinion. of law, medicine, psychology, philosophy In connection with the topic of de- and gender studies on six different areas: mentia, which is already being widely discussed by a variety of social actors, • medical intervention, the working group directs its specifically • information and consent, ethical focus to the question of self-deter- • quality of life, mination in dementia. Self-determination • the law of civil status, is an essential component of human self- • integration and discrimination and image and is a central point of reference in • networking and assistance. ethical discourse. For a long time, attention was focused only on the deficiencies In fifty specialist reports and over 700 associated with dementia, with the result comments, the discourse participants that many persons with dementia felt ex- discussed a wide range of questions in posed to disproportionate patronization the context of intersexuality. The great after diagnosis. Many people talked about importance which attached to the topic them, and few with them. However, it is an “Medical intervention”, which in the ethical imperative to seek communication hearing too was determined to be the with the persons concerned themselves most important question, is shown by and to respect their self-determination the large number of comments on this even if it is restricted. Thus, for example, topic in the discourse. The greatest dis- for a long period of their illness persons putes arose in questions of the law of civil with dementia should be permitted to a

22 Annual Report 2011

considerable extent to determine their the name of the Federal Government to own lifestyle, which gives them a sense prepare an Opinion on the topic of “The of wellbeing which also makes it easier to future of genetic diagnosis from genetic support and care for them. research to clinical practice – social chal- There are now increasing attempts to lenges of new methods of genetic diagno- direct attention to considering what ca- sis, taking particular account of predictive pabilities people with dementia have. The and prenatal methods”, if possible before possibilities are being investigated of more the end of the year 2012. easily understanding what they want and The context of this assignment is that of supporting them and respecting them although the Gendiagnostik-Kommission in their self-determination and ability to (Genetic Diagnostic Commission) was express themselves. In this connection instructed to evaluate the development the question arises as to how much self- of genetic diagnosis, the development of determination is possible in dementia, such procedures, with regard to the han- as does the question as to what is neces- dling of the results of examination and sary to obtain a better understanding of possible repercussions for society, raises the ability of persons with dementia to a number of ethically relevant questions have self-determination and what forms which go beyond the statutory mandate of care support those concerned in their of this commission. self-determination. The Ethics Council has established a The introductory presentation of working group, which met for its first ses- Online: www.ethikrat.org Council member Michael Wunder on the sion on 14 December 2011. The Opinion /sitzungen/2010 /dokumente subject of “Self-determined to the end? is to be completed, if possible, by the end -plenarsitzung Dignity in dementia” and the following of the year 2012. -24-06-2010 discussion of the Council of June 2010 laid the foundation for the consultations on the Opinion. A further important step was marked by a one-day public event on 24 November 2010 in Hamburg entitled “Dementia – the end of self-determination?”, in which the members of the Ethics Council were able to have an exchange of views with persons concerned and experts and to give more depth to their reflections on this topic. The results of the conference were incorporated into the deliberations on the Opinion.

Genetic diagnosis

Online: Prof. Dr. Annette Schavan, the Federal www.ethikrat.org /veranstaltungen Minister of Education and Research, /weitere and Daniel Bahr, the Federal Minister of -veranstaltungen /demenz-ende-der Health, instructed the Ethics Council in -selbstbestimmung

23 German Ethics Council

Public meetings and promotion of social discourse

Informing the public and encouraging Annual meeting: Feeding the discussion in society, involving the vari- world ous social groups, is part of the range of duties specified by the Ethikratgesetz (Eth- On 26 May 2011, over 400 attendees ac- ics Council Act). cepted the invitation of the German Ethics In its public meetings – the Annual Council to attend its third Annual Meet- Meeting, a second day-long meeting, two ing, which presented courses of action on evening meetings in the Bioethics Fo- questions of world food and concentrated rum series and a dialogue of experts held in particular on the ethical implications. jointly with the TMF (Technology, Meth- In the keynote speech, Hans Rudolf ods, and Infrastructure for Networked Herren, President of the Millennium In- Online: Medical Research) – the Ethics Council stitute in Arlington, Virginia, discussed www.ethikrat.org /veranstaltungen seeks a public exchange of ideas with ex- the question of food security in a world /jahrestagungen /die-ernaehrung-der perts, academics in the life sciences and suffering stress. He emphasized that in -weltbevoelkerung bioethics research, and with representa- recent years there have been several cri- tives of organizations and associations. ses, in particular with regard to climate, These events are designed to enable an environment, biodiversity, food and fi- interested, wider and not necessarily ex- nances, which are all interconnected. A pert public to engage in dialogue with the holistic approach was therefore needed speakers, most of whom are external, and to solve the problems. He emphasized the members of the Ethics Council. the importance of a multi-functional and In addition to this, in its online dis- ecological agriculture, with sustained course on the topic of intersexuality, the treatment of problems and causes instead Ethics Council for the first time included of short-term solutions. The three aspects a new format for social debate in its range of social questions, the environment and of activities. the economy must be brought into har- Another platform for discourse con- mony and thus determine agriculture. In sisted of information and discussion addition, it was important for agriculture meetings with students and schoolchil- to return to its culture and tradition and dren; these were largely organized by the to place more weight on the knowledge administrative office. of farmers. This was also of particular To enable the hearing-impaired to take importance because industrialized food- part in the public meetings and events, stuff production had led to a gulf be- real-time transcriptions are made; like the tween agriculture and the environment audio recordings, these are made available and between farmers and consumers, and to a wider public online. politicians did not pay enough attention to the consequences of their decisions. Herren emphasized that the amount of food produced was fully adequate to feed the world. Nevertheless, many people had to starve because a large proportion of

24 Annual Report 2011

agriculture produce was unsuitable for Thomas Pogge, Professor of Philosophy human food and in addition large quanti- and International Affairs at Yale Univer- ties were lost in the course of processing sity, discussed the question of food secu- and as a result of unjust distribution. In rity and food safety from an ethical point order to change this, it was necessary to of view. Pogge criticized the fact that the take new paths in agriculture. These in- situation of the poor had dramatically cluded supporting family operations for deteriorated and the number of chroni- sustained agriculture, improved access cally undernourished persons was at pre- to production capital and possibilities of sent growing again. He said that a central paid work, investment in the creation of reason for this development is the process wealth and an improvement of market of globalization. In this process, rules are access, infrastructures and institutions. In laid down on a supranational level and addition, there should be encouragement undemocratically which benefit large en- of responsible governments on global, terprises but harm the poor. It is therefore national and regional levels and of fair important to make globalization processes trade. In order to solve the problems, more transparent and democratic, and to therefore, it was necessary to rethink the create better rules to successfully combat situation and above all to consider ethi- poverty and hunger. Bernhard Emunds cal aspects. focused on the human right to food as part of the right to subsistence. In his Food security as an ethical challenge view, there is an urgent duty to ensure In a panel discussion chaired by Christi- that this human right is realized for eve- ane Grefe, a journalist for Die Zeit, Bern- ryone. In order to attain this goal, it is of hard Emunds, Professor of Christian So- primary importance that the creation of cial Ethics and Social Philosophy at Sankt wealth in developing countries increases, Georgen Graduate School of Philosophy as must the share of a broad proportion of and Theology, Kurt Gerhardt, journal- the population in this creation of wealth. ist and co-initiator of the Bonn appeal The duty of people in the north which “A different development policy!” and corresponds to the human right to food is

Panel discussion with Bernhard Emunds, Kurt Gerhardt, Christiane Grefe and Thomas Pogge (from the left)

25 German Ethics Council

the duty to ensure that their own govern- Bishops’ Organization for Development ments engage in development coopera- Cooperation, clarified this concept of tion and world trade policy to this end. poverty orientation by the example of a Kurt Gerhardt emphasized that it is the project in India in which diversified agri- task of development aid, maintaining the culture and self-determined food culture subsidiarity principle, to make people in are being encouraged. He emphasized the developing countries independent of that it is important for the success of de- aid, and that it is unethical if development velopment work to focus on people, to aid creates permanent dependency. In recognize their potential and to give them addition, in development aid it is impor- a voice. tant always to ensure that the recipients remain subjects and are not degraded to The role of women in agriculture and objects. nutrition The next speaker was Christa Randzio- Poverty orientation Plath, the President of the Marie Schlei In the second part of the Annual Meet- Association, on the role of women in ing, practical approaches to overcoming combating hunger and poverty. She said the problem of hunger and poverty were that globally, women farm the majority presented in the light of the aspects of of smallholdings, but only rarely do they poverty orientation, the role of women own their own land. It is therefore cru- in agriculture and nutrition and sustain- cially important to give women access to ability. land, technical knowledge and resources, First, Cornelia Füllkrug-Weitzel, the in order to achieve agricultural develop- director of Brot für die Welt (Bread for ment and food security. the World), presented the concept of pov- Vandana Shiva, the founder of the or- erty orientation as an important key in ganization Navdanya, emphasized that a combating hunger. She said that it was large part of the world’s food is produced necessary to orientate oneself towards by women and that women do not regard the needs, rights and potential of the poor food as a commodity. She said that this is for three reasons: firstly, from the point a decisive aspect, for if food is seen as a of view of social science it was crucial to commodity, it is irrelevant whether food take action against the legal, social and is used to produce biofuels and to feed economic marginalization of small farm- animals for meat production or if it is ers and to increase their political involve- available to feed people. It is also impor- ment. Taking a human rights approach, tant to preserve food sovereignty; this the starving should be seen as the subjects is endangered by globalization and free of rights and not as the recipients of alms. trade. Food sovereignty should primarily In addition, from an ethical point of view, lie in the hands of women, who should be the dignity of every individual took pri- well informed as to efficient and diversi- ority. Humans must remain the subjects fied agriculture. of their actions and may not become the objects of pity or of exploitation. Sustainability Martin Bröckelmann-Simon, Manag- The third complex dealt with the concept ing Director for International Coopera- of sustainability in overcoming the prob- tion at Misereor, the German Catholic lem of hunger and poverty.

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Panel discussion with Hans Rudolf Herren, Vandana Shiva, Wolfgang Huber, Robin Roth and Hans-Jürgen Beerfeltz (from the left)

Franz Heidhues, Professor of Agricul- the rural population for the regularly re- tural Economics in Developing Countries curring periods of drought and the im- at the University of Hohenheim, empha- provement of drinking water hygiene. In sized participation and local knowledge emergency relief operations during times as fundamental elements to make projects of drought, it ensures acute provision of sustainable. He said that the central mes- water, but it addition the programme is sage of sustainability consists in ensuring directed towards a long-term and sustain- that decisions made by the present gen- able safeguarding of water provision. It eration do not limit the possibilities of is particularly important here to involve future generations to maintain or improve the local communities in the planning their conditions of life. With reference to and implementation, in order to achieve processes of development, he said, there sustainability. are three dimensions of sustainability: the ecological, the economic and the socio- Local action cultural. In order to realize sustainability The final stage of the meeting was a panel in all three dimensions, it is essential to discussion chaired by Council member integrate both the local population and Wolfgang Huber between Hans-Jürgen local knowledge. This can be achieved Beerfeltz, State Secretary in the Federal by knowledge partnerships which bring Ministry for Economic Cooperation and together farmers, local institutions, non- Development, Hans Rudolf Herren Robin governmental organizations, consultancy Roth, Manager of the Gesellschaft zur För- and research. derung der Partnerschaft mit der Dritten Following this, Jörg Heinrich, Desk Welt (GEPA – Society for the Promotion Officer at Welthungerhilfe, explained the of Partnership with the Third World), and concept of sustainability using the ex- Vandana Shiva. The main emphasis of the ample of a project on storing water for discussion was on the challenges present- times of drought. The aims of this Welt- ed by the world food situation and how hungerhilfe project from Kenya are to these can be transferred into local action supply the poor with water, to prepare by every individual. The repercussions of

27 German Ethics Council

these challenges for responsible political making the populations of the countries action were discussed. affected by poverty independent of for- Hans-Jürgen Beerfeltz conceded that eign aid. Offers of help should therefore the Europeans, including Germany, have be directed towards giving people access not merely interfered with but actively to natural resources, to production capital obstructed development policy with their and to the market, but also to education agricultural export subsidies. These sub- and research, and in this way enabling sidies, he said, must therefore be phased them to share in economic growth and out, and all development policy actions thus in the value chain. must be based on sustainability and responsibility. Vandana Shiva criticized international trade regulations, in particular Public meeting: Synthetic those of the World Trade Organization, biology saying they had a detrimental effect on developing countries and in particular on On 23 November 2011, some three hun- the production of food by small farmers. dred attendees accepted the invitation She said that the citizens of all countries of the German Ethics Council to join its were called upon to support fair trade members in the Great Hall of the Univer- conditions and to demand them in the sity of Mannheim for a whole-day public exercise of their democratic rights. Robin meeting with German and international Roth also emphasized the importance of experts on the significance of synthetic international fair trade standards, which biology for science and society. Online: must be complied with in order that as The new research field with the pos- www.ethikrat.org /veranstaltungen much money as possible goes direct to the sibilities it promises of engineering forms /weitere -veranstaltungen farmers. Hans Rudolf Herren called on of life independently of existing forms /werkstatt-leben governments to take increased responsi- represents a new stage in the nature and bility in the field of agricultural research implications of our approach to life. In his and not merely to leave the monitoring of opening address, Wolf-Michael Caten- this research to the private sector. husen described the aim of the meeting One question recurred in all panel dis- as informing the public on the current cussions: what could the individual and state of synthetic biology, taking social in particular young people do not only to perception as a theme, putting the ethical think globally but also to act locally? The challenges in the public view and discuss- unanimous answer was that civic commit- ing prospective approaches. With the aim ment and informed consumer behaviour of stimulating further debate in society by every individual can contribute to es- as a whole, the Ethics Council organized tablishing fair trade partnerships. this event in order to enter into discussion The papers and discussion contribu- with representatives of science, industry tions made it clear that poverty and mal- and organizations and with the public. nutrition cannot easily be overcome by increasing the flow of funds from north Old wine in new wineskins to south and thus creating and maintain- Petra Schwille from the Biotechnology ing dependency. Instead, it is necessary to Centre of the Technische Universität Dres- stimulate local economic development by den (Dresden University of Technology) way of helping people to help themselves, first gave an introduction to synthetic

28 Annual Report 2011

biology, its current development and its interest groups exchanged views. First, potential. She pointed out that the aims of Nils-Christian Lübke, a doctoral student synthetic biology are the same as those of at Bielefeld University, reported on the traditional biotechnology, attempting to iGEM competition in which he took part obtain new active pharmacological sub- in the year 2010. This competition is or- stances, materials or natural substances to ganized by the Massachusetts Institute supply energy. The new element, she said, of Technology in Cambridge, USA, and was that synthetic biology takes a modular is open to students all over the world. It engineering approach and thus can model involves carrying out a research project the necessary processes in abstract terms, in the field of synthetic biology with the control them in a targeted manner and aim of using standardized biological com- thus shape them far more efficiently, and ponents (BioBricks) to develop models in this way guarantee that the desired for biological systems. In addition, the products are produced as far as possible project always requires participants to on an industrial scale. A central require- discuss the safety aspects and the ethical ment for such efficient production was considerations. The competitors develop the construction of a minimal organism. a creative and interdisciplinary approach Schwille presented main areas of her work and engage in active discussion with the by way of illustrative examples. She said public on questions in particular on the that her aim was to understand a self- possibilities and potential of synthetic organizing dynamic system as the first biology. This idea was taken up by Rüdi- step in the direction of constructing a self- ger Stegemann of Bund für Umwelt und organizing and self-dividing mini-system. Naturschutz Deutschland (Union for the In this connection, Schwille referred to Environment and Nature Conservation the work of Craig Venter as an enormous Germany). He forcefully advocated not technical achievement, but at the same deferring social discourse until research time not the creation of artificial life. had already created a fait accompli. The In the following stakeholder discus- main question in his view related to the re- sion, the representatives of various social sponsibility of society and how this should

Stakeholder discussion with Oskar Zelder, Rüdiger Stegemann, Wolf-Michael Catenhusen, Nils- Christian Lübke and Petra Schwille (from the left)

29 German Ethics Council

be exercised. Who decides on the develop- during the Bio:Fiction festival, take a more ment and application of new forms of life? straightforward approach in the direction Is there an ethically responsibly assess- of infotainment, which lacks a critical ment of the consequences of technology? interaction with science. Lehmkuhl, Markus: Stegemann called for transparency in the The interest of the German print media Die Repräsentation der synthetischen handling of research findings, an open in synthetic biology, as the media analysis Biologie in der deutschen Presse. discussion of the risks, equal treatment in prepared by Markus Lehmkuhl on behalf Abschlussbericht the promotion of alternative technologies of the Ethics Council showed, appeared einer Inhaltsanalyse von 23 deutschen and a moratorium on public promotion relatively small in contrast to reporting on Pressetiteln. Online: www.ethikrat.org and implementation of synthetic biology. other new technologies. Published opin- /dateien/pdf Oskar Zelder of BASF’s biotechnology ion, he said, was divided into three parts. /lehmkuhl-studie -synthetische research department stated that he was Sometimes it conveyed a positivist be- -biologie.pdf convinced that molecular biotechnology lieve in progress and sometimes sceptical holds great potential. At the same time he reserve, but it was also open to science’s warned against equating synthetic biology self-promotion. as it is conducted at present with the creation of synthetic life and thus endangering Between breakthrough and hype promising developments. In his opinion, The attraction of new technological devel- the concept of metabolic engineering al- opments, according to Armin Grunwald, ready covers everything which falls into the head of the Institute for Technology synthetic biology in the current state of Assessment and Systems Analysis and the research. Office of Technology Assessment at the German Bundestag, had a tendency to Presentation in art and the media be accorded high to exaggeratedly high New technologies have always exercised expectations. However, this assessment a fascination which invites artists to deal gives way to disillusion at the latest when with them creatively. In the case of syn- it transpires that the expectations were thetic biology, a number of artists have inflated or when negative aspects come to handled this topic from an epistemo- attention. This development can also be logical and aesthetic viewpoint. Markus seen in connection with synthetic biology. Schmidt, a director of Biofaction and a In real life, the time from a scientific board member of the Organisation für breakthrough to application in practice Internationalen Dialog und Konfliktma- is usually very much longer than at first nagement (Organization for International expected. Against this background, hype Dialogue and Conflict Management), in- results in speculative bubbles without a troduced presentations of synthetic biol- real basis, and the fascination which pro- ogy, in particular in art and in the media. ceeds from new technologies in general Taking examples from the exhibition is used in the positive and the negative synth-ethic he showed in what different sense to influence not only our conscious- ways artists approach the subject. In this ness, but also the scientific agenda. But process, synthetic biology – like modern hypes do not last long, Grunwald contin- biotechnology in general – is unmasked ued, because people soon become tired or embedded in new contexts. In contrast, of them. In contrast, the long path from theatre and film performances, which breakthrough to application has the ad- were among the productions displayed vantage that one can approach the new

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possibilities step by step, evaluate the new according to Rehmann-Sutter. Life is not a technologies in social discourse and if strictly scientific concept, but a term refer- necessary control them. ring to a phenomenon with its own spon- In the case of synthetic biology, all taneity and meaningfulness. But what is the criteria necessary for an imminent more important than the question as to hype are present. This is manifested in artificial life is the question as to how the number of publications, the networks synthetic cells are used. The potential for coming into existence, the reports and endangerment does not result from the opinions on the topic both in Germany new technologies themselves, but from and internationally, and also the accom- the socialization of these technologies. panying research. But Grunwald warned In this connection, Pühler regarded it against treating the speculations on which as possible to assess the consequences of the high exceptions and fears rest as the technology, because to date it has always yardstick of an ethical assessment. been possible to find organisms comparable to changed organisms. In his view, Life – a question of definition synthetic biology as currently practised Since synthetic biology is both a technol- does not create artificial life. But he did ogy and a science that deals with life, the not exclude the possibility that this may question arises as to the concept of life need to be assessed differently in future and how far it is possible to speak of the projects. creation of artificial life in synthetic biology. This topic was discussed by Alfred Creation or plagiarism? Pühler from the Centre for Biotechnol- In the following discussion, Joachim ogy of Bielefeld University and Christoph Boldt of the Institute for the Ethics and Rehmann-Sutter from the Institute for the History of Medicine of the Albert Ludwig History of Medicine and Science Studies University of Freiburg and Peter Dabrock of the University of Lübeck. Artificial life of the Department of Theology of the cannot be defined before there is agree- Friedrich-Alexander University of Erlan- ment as to what it may be compared to, gen-Nuremberg considered the question

Open discussion with Joachim Boldt, Jochen Taupitz and Peter Dabrock (from the left)

31 German Ethics Council

as to whether mankind uses synthetic bi- decisive point is that people must become ology to create new forms of life and thus aware of what consequences “creation” sets himself up as homo creator. Boldt would have and what could really be con- compared the current development in trolled. synthetic biology with the transition from analytical chemistry to synthetic chemis- The control of new technologies try. With the help of synthetic chemistry, The future of synthetic biology was the not only can nature be reproduced, but topic of the last session. Pat Roy Mooney new materials and classes of materials of the ETC Group in Canada spoke on can be created. It is true that at present the arguments for and against and the synthetic biology does not create life that necessary control mechanisms in the de- is really new, but sooner or later it will velopment and application of new tech- no longer be a question of analysis and nologies. The crucial issue, he said, was manipulation, but also synthesis and thus who steered and monitored it and what creation. Dabrock, in contrast, doubted consequences it had for our everyday life. whether it was desirable to use the theo- There must be a public debate on this. Al- logical metaphor of “creation” in this though synthetic biology has great poten- context, since science was only drama- tial, it can nevertheless have detrimental tizing itself in this way. Mankind did not effects on the subsistence of millions of create from nothing, but was merely in people who have previously produced the position to intervene in the process of one of these materials in the natural way. preservation of creation. From a theologi- In addition there must be a discussion as cal point of view, therefore, man could to how far patents should be awarded in not be a homo creator, but at best homo this area. Mooney said that the control of plagiator. But for Boldt, the concept of new technologies must not be permitted “creation” has a less religious connota- to lie in the hands of a few companies. In tion. Instead, in this context “creation” summary, he said that a moratorium on must be understood as the summit of the synthetic biology would not be of much ability of technological production. The use in solving these problems.

Panel discussion with Bernd Müller-Röber, Klaus Peter Rippe, Wolf- Michael Catenhusen, Pat Roy Mooney and Ralf Wagner (from the left)

32 Annual Report 2011

The future prospects of synthetic biol- biofuels and the reduction of pollutants ogy were also the subject of the final panel will only be publicly accepted if the new discussion, in which the participants were knowledge also reaches the population. Pat Roy Mooney, Bernd Müller-Röber of This can only be guaranteed by transpar- German National Academy of Science ency in research. It is also essential to and Engineering, Klaus Peter Rippe of the address the questions of biosafety (the Swiss Federal Ethics Committee on Non- protection of humans and the environ- Human Biotechnology and Ralf Wagner, ment in working with synthetic biology) Chief Scientific Officer of GeneArt. and biosecurity (measures against abuse) 95 per cent of synthetic biology is the at university level and to establish control continuation of molecular biology, ac- mechanisms in companies. cording to Bernd Müller-Röber. Admit- In the course of the day, the public had tedly, its constructive element opens a new several opportunities to take part in the viewpoint. One of the recommendations various discussions. The centre of general for action of the joint opinion of the Na- interest was focussed on questions as to tional Academy of Science and Engineer- the definition of artificial life, the long- ing, the German Research Foundation term prospects of synthetic biology, social and the Germany Academy of Sciences transparency and patenting. In addition, Leopoldina on synthetic biology was to questions were asked on the safety risks, be aware of this constructive element. In above all on the dangers that might be addition, Müller-Röber advocated moni- caused by a deliberate or accidental use toring and interdisciplinary cooperation of synthetic organisms. between chemistry, physics, engineering Wolf Michael Catenhusen was pleased and bioinformatics. Müller-Röber also with the results of the meeting. He sum- said that patents are needed, since they marized the expectations of synthetic bi- are necessary for the work of industry, ology and the recommendations on how but they must be very carefully granted. to deal with it which had been expressed Klaus Peter Rippe also advocated this. in the course of the day: transparent inter- He said that the ethical questions which disciplinary research, scientific and ethical arose in the field of synthetic biology were concomitant research and monitoring not fundamentally new, but related to all by society in order to identify as soon new technologies in the field of the life as possible potential dangers to humans, sciences. One should therefore rather ask animals and the environment and to rec- what is really new about synthetic biol- ognize where lines have to be drawn in ogy, and continue the monitoring process application. which has already been established. In Germany, the Zentrale Kommission für die Biologische Sicherheit (Central Commis- Bioethics Forum: The sion for Biological Safety) has already been controversial case of commissioned to carry out such a moni- baby drops toring process on synthetic biology with the main emphasis on safety questions. The Bioethics Forum is a two-and-a-half Online: www.ethikrat.org According to Ralf Wagner, the poten- hour evening event in Berlin which takes /veranstaltungen /forum-bioethik tial of synthetic biology with regard to up topics which are currently subject /streitfall-babyklappe the development of medicinal products, to considerable ethical controversy. On

33 German Ethics Council

24 February 2011, the German Ethics their lives. It is therefore not a question Council held a discussion with repre- of a conflict of values between the right sentatives from practice, the media and to life and the right to knowledge of one’s politics on what developments there have parentage, but of additional assistance been since the publication of its Opin- for women who do not make use of the ion on the anonymous relinquishment existing help on offer. of infants. In November 2009, the Ethics Council Nationwide study recommended that the statutory basis In 2009, the Federal Ministry for Fam- should be created for relinquishment of ily Affairs, Senior Citizens, Women and infants on a confidential basis and that Youth commissioned from the Deutsches the possibilities of anonymous birth and Jugendinstitut (German Youth Institute) baby drops, which are unlawful but which the first nationwide study on numbers till now have been tolerated, should be of cases, facilities and contexts of anony- German Ethics discontinued. Parallel to this, the avail- mous child relinquishment. The objective, Council (ed.): Anonymous ability of public information on the ex- method and first findings of this study relinquishment of infants: tackling the isting comprehensive legally sanctioned were presented by Joelle Coutinho, the problem. Berlin, assistance facilities for pregnant women research officer for this project. This study 2009 (ISBN 978-3- 941957-06-0) and mothers in situations of distress or contains a survey of the numbers of cases conflict should be expanded. and of the procedures by means of writ- Christiane Woopen, Vice-Chair of the ten questionnaires sent nationwide to Ethics Council, introduced the Coun- 591 youth welfare offices and 343 agen- cil’s deliberations: She said that although cies offering facilities for the anonymous possibilities of relinquishing infants relinquishment of children, and also anonymously were established in order qualitative interviews, and in addition it to prevent babies from being killed and examines the psychosocial situation and abandoned, it is improbable that this aim motivation of women affected. Coutinho is actually achieved, in the light of statis- reported great differences in the motives tics and research findings from forensic and the degree of professionalization of psychiatry. In addition, the relinquish- the organizations and in the cooperation ment of the child does not in itself solve and procedures following the anonymous the women’s emergency or conflict situ- relinquishment of a child. ation. It is necessary to proceed on the assumption that in many cases the women The position of the suppliers who have taken advantage of the possibil- Maria Elisabeth Thoma, Federal Chair ity of anonymous relinquishment without of Sozialdienst katholischer Frauen (SkF being involved in counselling suffer even – Catholic Women’s Social Service), re- more at a later date. The facilities have ported on the discussion on the Opin- serious consequences both for the psy- ion, which she said had been perceived chological development of the children, in different ways in the individual SkF who may suffer all their lives from the organizations. The SkF’s federal associa- anonymity of their parentage, and in ad- tion had expressly welcomed it. However, dition for mothers, and sometimes also the local associations wished to main- for fathers, who are excluded from contact tain the existing baby drops, at all events to their biological children for the rest of as long as there was no good, tried and

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tested alternative. The Ethics Council’s own parentage. But the reporting in the proposal for a statutory arrangement for media had placed this alleged conflict in confidential birth was welcomed, because the centre. this would mean that there was at last a reliable legal framework for confidential Discussion facilities. The final item on the programme was a panel discussion with Ingrid Fischbach, Media analysis the Vice-Chair of the CDU/CSU parlia- The science journalist Volker Stollorz mentary group, Ulrike Herpich-Behrens Lehmkuhl, Markus: Babyklappen und presented a media analysis of the press of the Senate Department for Education, sonstige Angebote Science and Research of the State of Ber- zur anonymen reporting on the Ethics Council’s Opin- Geburt in der ion, co-authored with the communication lin, Maria Geiss-Wittmann, Chair of Do- deutschen Presse. Die Stellungnahme scientist Markus Lehmkuhl. He stated num Vitae in Bavaria, and Volker Stollorz des Deutschen Ethikrates und ihre that in its position the Ethics Council had and Council member Weyma Lübbe. Resonanz in den attempted to remove the empirical ba- Ingrid Fischbach reported that all at- Massenmedien. Online: sis from an intuitively plausible but only tempts in the last years to make anony- www.ethikrat.org /dateien/pdf speculatively founded assumption that mous relinquishment of infants legal had /lehmkuhl-studie -babyklappen baby drops could save lives. However, the ended without results. Before an initia- -anonyme-geburt.pdf analysis showed that a balanced discus- tive for a statutory arrangement for the sion in the media had not been achieved. confidential relinquishment of infants, The only subject that had been taken up in it had been decided to wait for the Ger- substance was the majority recommenda- man Youth Institute study. It needed tion of closing baby drops, in which the to be determined in particular for what Ethics Council had not succeeded in con- reasons women rejected the legal facili- vincing the public. It had not been made ties and wished to remain anonymous clear that this recommendation was made and how they could best be helped in against the background of the conviction this situation. It was urgently necessary that there is no conflict between the right for there to be a statutory arrangement to life and the right to knowledge of one’s following this, for the current facilities

Panel discussion with Ulrike Herpich-Behrens, Ingrid Fischbach, Maria Geiss-Wittmann, Christiane Woopen, Weyma Lübbe and Volker Stollorz (from the left)

35 German Ethics Council

for anonymous relinquishment of infants unlawful facilities were addressed. Em- were unlawful. phasis was also placed on the necessity Ulrike Herpich-Behrens stated that to continue considering how women in the youth welfare offices and the Senate emergency or conflict situations can be Department had found the opinion very reached. A practitioner asked whether it helpful for their work, since it made an was not necessary to preserve the baby discussion of the problems of the facilities drop as a possibility despite its problems. possible. She reported particularly prob- A confidential birth, such as the Ethics lematic cases in Berlin known to her and Council proposed, required the mother the difficulties which arise as the result of to act rationally at a time when she was the lack of statutory provisions. unable to manage this. Doubts were also Maria Geiss-Wittmann emphasized expressed as to whether legislation was that in order to protect life one must above actually necessary. Fischbach empha- all reach women. The more successfully sized that the legislature had a duty to this was done, the more successfully the create clearcut provisions. It was also to children were protected. Her association be anticipated that children relinquished agreed with the specific proposals of the anonymously would later place the blame Council for a solution; its own model was for their fate in not knowing their own largely similar to these. The association parentage on the state. therefore favoured anonymous birth and anonymous relinquishment of infants. It rejected the baby drop. Bioethics Forum: Research on Weyma Lübbe challenged the much- medicines in children quoted argument “if only one life is saved, Online: it is worthwhile”. She stated that in its On 21 September 2011, the German Eth- www.ethikrat.org /veranstaltungen main position, the Ethics Council had not ics Council held a discussion with experts /forum-bioethik /arzneimittelforschung set out clearly enough that in its view baby from the fields of medicine and ethics on -mit-kindern drops were not justified even if the claim how far research on medicines in children that they protected lives could actually is ethically necessary or questionable. be proved in very rare individual cases. A Jochen Taupitz, German Ethics Coun- very small reduction in the risk of children cil member, introduced the controversial being killed, which baby drops offer at subject and summarized the problems best, could be weighed against other inter- involved. On the one hand there is the ests and rights such as the right to know large percentage of medicinal products one’s own parentage. She said that such which are not approved for paediatric a weighing of interests was constantly use and therefore are used on children carried out in other social areas. But the without confirmed knowledge on the ef- proposal of “confidential relinquishment fective and safe dose, and the child’s right of infants with temporarily anonymous to appropriate medical care. On the other registration” was presumably unrealistic hand, when children who are not them- as an alternative for the same category of selves able to give valid legal consent are persons, since these were persons without involved in research, some regard this as sufficient trust in personal contact. the instrumentalization of the defenceless. In the discussion with the public, In order to evaluate the subject objec- questions on continued toleration of the tively, it is necessary to distinguish three

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areas: standard medical treatment carried possible to intervene in the process in out exclusively with the intention of help- good time. ing a specific patient; therapeutic research using new medicinal products which is Off-label use in paediatric oncology directed at the same time to the benefit Following this, Angelika Eggert, Director for the patient and the further develop- of the West German Tumour Centre at ment of science; and scientific experiment Essen University Hospital, reported on intended for a specific group, which does her experience of the clinical treatment of not benefit a specific patient, but may in children with cancer. She emphasized that future benefit other patients who have the cancer, after accidents, is the second most same illness. common cause of death of children in Europe and that the molecular character- Harm to children istics are very different from those of adult Wolfgang Rascher, Chair of the Commis- cancers. For this reason, it is urgently nec- sion on Medicinal Products for Children essary for specific medicinal products to and Young People at the Federal Institute be developed. However, she said, it is one for Drugs and Medical Devices, next re- of the great success stories of medicine ported on the provision of medicinal that the cure rate in paediatric oncology products to children in Germany and has risen from less than 20 per cent in the Europe. He emphasized that no other 1950s to a current figure of 80 per cent. population group is so disadvantaged by This success is based on the cooperation untested medicinal products as children. of paediatric oncologists on a national, He noted that the new EU Regulation European and international level with the on medicinal products for paediatric aim of carrying out joint clinical studies. use , which entered into force in Janu- A further improvement can be achieved ary 2007 and which requires a detailed only by further research and better use of paediatric development plan for every medicinal products. Thus, for example, 95 medicinal product which must be newly per cent of children with cancer in Europe licensed, and the twelfth reenactment of are treated in what are known as therapy the Arzneimittelgesetz (Medicinal Prod- optimization studies, which examine al- ucts Act) of the year 2004, which pro- ready known medicinal products in both vides that benefit for a group is sufficient, the on-label and off-label areas in order had the effect that in recent years the to obtain new findings on possibilities of number of clinical studies in Germany diagnosis and therapy. The consolidation has slightly increased. Although this is of the pan-European multicentre data not a resounding success, it is a move in makes it possible to obtain comprehen- the right direction. A large number of sive findings. In this connection, Eggert clinical studies involving children have emphasized the very high proportion of currently been deferred, since the data off-label use in paediatric oncology, which for adults are not yet available. Although can be as much as 87 per cent. She said studies are always planned to entail mini- that the problem is that on the one hand mum risk and minimum stress, Rascher off-label use results in twice as high a risk pointed out that there are also undesired of undesired side effects and is often not events and harm. But a good monitor- reimbursed by the health insurance funds; ing system within the studies makes it but on the other hand, if we do not rely on

37 German Ethics Council

off-label use, we deprive children of me- a direct use for the same group of patients dicinal products with proven or potential must be apparent. In this connection, the effectiveness. In addition, Eggert referred associated risks and burdens should be as to the problem of the lack of incentives small as possible. In summary, Taupitz for the pharmaceutical industry to invest said that there are a number of strict pro- more effort in the development of medici- visions in the Medicinal Products Act and nal products for children. A further aspect therefore children enjoy a high level of is that the current financing of the therapy protection in Germany. optimization studies by way of donations will no longer be possible under the new Protecting children through research conditions of the Medicinal Products Act. Georg Marckmann, Director of the In- Eggert therefore recommended that these stitute of Ethics, History and Theory of studies should be treated separately from Medicine at Munich Ludwig Maximilian those of the pharmaceutical industry and University, presented an introduction that bureaucratic hurdles and additional to the ethical aspects of the subject. In fees should be dispensed with. She also his view, it would be a violation of the favoured more incentives for the pharma- ethical principles of not doing harm and ceutical industry, public funding and Eu- of doing good if one were to dispense ropean translational medicine networks with studies with children and in this at the interface of preclinical and clinical way expose children to increased risks research, and also a paediatric review of from untested medicinal products, and the effects of medicinal products, in order in this way withhold beneficial therapies that children obtain the best possible sup- from them. Marckmann discussed the ply of medicinal products. protective criteria presented earlier and emphasized the ethical problems of re- Minimizing risk and burden search with children, since their capacity Jochen Taupitz next set out the legal situ- to consent is either limited or non-exist- ation. He spoke of the capacity to consent ent. According to Marckmann, research and the duty to provide information as on medicinal products with children is the central requirement for research, and ethically required and at the same time of the conditions for the clinical review questionable – a fundamental ethical of medicinal products. In this connec- dilemma which cannot be resolved but tion, he discussed a number of protec- only legislated on. He said that it was tive criteria, such as risk-benefit analysis, an ethical challenge on the one hand to procedural safeguarding by means of a protect children with a view to the risk- review by competent authorities, and the benefit relationship, informed consent individual right of self-determination of and research which benefits groups or is the person affected or of the patient. He altruistic, and on the other hand to make explained that clinical research involving ethically responsible paediatric research healthy children is permitted for diag- possible. In this connection, the public nostic agents and preventive medication, sector was called upon to create appro- but not for other products unless there is priate regulatory, financial and personal no alternative method available. On the conditions for research and correspond- basis of data from research on adults, a ing structures, such as paediatric studies prospective individual benefit or at least centres.

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More information needed on that the study should be associated with off-label use positive experiences. Following this, Claudia Wiesemann, She called for accompanying research Director of the Department of Medical on the attitudes of children and young Ethics and History of Medicine at Georg people to research, and appropriate clari- August University Göttingen, presented, fication of off-label use, because knowl- exemplified by a number of studies, the edge that a product might conceivably be point of view of parents who permit their used strengthened parents’ readiness to children to take part in research projects. allow their child to take part in a study. She said that these studies showed that the parents of healthy children were gen- Against a prohibition of medicinal erally more reserved in this respect than product research with children the parents of sick children, who often The event closed with a panel discussion felt that they had no choice, regarded the in which the evening’s speakers and also benefit for their children as greater than Siegfried Throm, Managing Director of the risk, and had a better idea of how the Verband Forschender Arzneimittelher- important well-tested medicinal products steller (Association of Research-Based are. Altruistic motives and the consid- Pharmaceutical Companies) and Dietrich eration that in this way they could have Niethammer of the Stiftung für kranke access to free treatment might also be Kinder Tübingen – Dietrich-Niethammer- the main reason for the decision to take Stiftung (Charitable Foundation for Sick part in research projects. In addition, the Children) took part. studies had shown that parents are ca- Throm presented current figures on pable of consent and themselves want to newly licensed medicinal products for give consent even in stressful conditions. children and their areas of application. Wiesemann showed that when studies He welcomed the goals of the European are conducted, attention must be given to Regulation on medicinal products for pae- ensuring that children are not burdened diatric use of 2006 and provided informa- more than is appropriate for their age and tion on the procedure for the licensing of

Panel discussion with Jochen Taupitz, Dietrich Niethammer, Georg Marckmann, Siegfried Throm, Claudia Wiesemann, Angelika Eggert and Wolfgang Rascher (from the left)

39 German Ethics Council

paediatric development plans. In conclu- discussion. The topics which attracted sion, Throm said that the question facing most general interest were questions as pharmaceutical companies is not whether to ethics commissions of this type in studies with children are permitted, but hospitals, the criteria for competence to how they can best be realized. consent, the problems and consequences Niethammer too regarded research into of patent protection, the risk of being medicinal products with children as nec- harmed by studies, and the monitoring of essary. He said that it would be unethical studies. Another problem mentioned was to hinder research with children by means that under the Medicinal Products Act of financial or bureaucratic obstacles, as only a pharmaceutical enterprise may ap- happens in the case of therapeutic studies. ply for a medicinal product to be licensed, Niethammer referred to the high degree instead of a doctor who has experience of of responsibility of ethics commissions, it and would like to take the initiative in the right of parents to have a say and the having it reviewed and licensed on this necessity for the children to consent. On basis. In addition, great lack of under- the basis of his positive experience, he standing was expressed for the fact that advocated an ethics commission of spe- the European Union has discontinued cialists, which was to advise not only the further funding of paediatric studies for doctor but also the parents. 2012. In the course of the discussion, reference was again made to the importance that children should be capable of con- Dialogue of experts: Need for senting and possibly have a right of veto. legislation on research with Eggert was of the opinion that the dis- human biobanks? cussion between parents and child and information appropriate to the child’s age On 7 April 2011, in a dialogue of experts were of enormous importance. in Berlin, the German Ethics Council and Taupitz addressed the problems of pla- the TMF (Technology, Methods and In- cebo-controlled studies, in the course of frastructure for Networked Medical Re- which children in the control group were search) discussed the recommendations given a placebo without foreseeable ben- of the Ethics Council on putting research efit. Rascher replied that such an imbal- using human biobanks on a statutory Online: ance could be avoided by very good design basis. www.ethikrat.org /veranstaltungen of studies. Thus, for example, the children Human biobanks are collections of /weitere -veranstaltungen could alternately be given different quanti- samples of human body substances (for /regelungsbedarf ties of the medicinal product at random. example tissue, blood, DNA) which are -fuer-forschung-mit -humanbiobanken The panel experts agreed that purely electronically linked to personal data and altruistic research may not be carried out health-related information on the donors. on children, because it is not ethically They play a central role in research on the defensible. If a study merely benefited a causes and mechanisms of a large num- group, this was acceptable, but the main ber of diseases and their treatment and interest must consist in achieving a thera- are an essential resource for biomedical peutic effect for the specific patient. research. New trends in biobank research, Following this panel discussion, the including quantitative and qualitative public had the opportunity to join in the expansion; increased networking and

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internationalization; and privatization dispute as to how far collections whose and commercialization, present legal and contents or duration were limited, for ethical challenges. example those created in connection with In its Opinion “Human biobanks for doctoral theses, should be treated in the research”, published in June 2010, the same way as large biobanks. It was said Ethics Council proposed a concept based that some of the recommendations were on five pillars for legislation on biobanks. already customary in practice, and there- The recommendations include the intro- fore a special statute was not required. duction of biobank secrecy; laying down permissible use; involving ethics commis- Biobank secrecy sions; quality assurance; and transparen- There was intensive discussion on the cy. These recommendations are intended question as to whether a statutory duty of on the one hand to provide a sufficient biobank secrecy was necessary in order to legal framework for the interests and per- ensure an objective balance between the sonality rights of the donors and on the interests of donors and research. other hand to create more legal certainty Biobank secrecy as recommended by for biobank research and at the same time the Ethics Council in its Opinion con- to facilitate research. sists of a multi-dimensional duty of con- In the course of the expert dialogue, fidentiality: Firstly, persons who handle scientists, lawyers, data protection spe- biobank materials may not transmit sam- cialists and ethicists shed light on the ples and data to agencies outside science, many aspects of research on the basis of and secondly, they may not make efforts human biobanks. They sounded out the to identify the donors if they work with German Ethics Council (ed.): consequences of legislative measures gov- pseudonymized samples. Thirdly, the in- Human biobanks for research. Berlin, erning research practice and discussed formation from biobank research may not 2010 (ISBN 978-3- with politicians, patients’ representatives be used by external agencies, neither by 941957-10-7) and other interested persons whether a insurance companies nor by employers. biobank statute is necessary. Fourthly, the persons named should be able to rely on a right to refuse to give Stronger protection of donors evidence which is comparable to the pro- The speakers and the participants in the fessional discretion of doctors. This is in- discussion broadly agreed on the central tended to guarantee that researchers can- recommendation of the Ethics Council not be forced by state agencies to reveal that donors should be protected more information which they have obtained in strongly than previously against the risks connection with their work with biobank of a misuse of their data and public confi- samples. This is an important aspect to dence in the operation of biobanks should strengthen confidence in biobanks. Fifth- be maintained, while at the same time the ly, there should be a prohibition of access limitation of the use of samples was re- to individual samples or information by laxed and thus it was made easier to carry state agencies. In addition, there should out medical research with biobanks. The be no possibility of matching data as part recommendations on permissible use, on of electronic profile searching. the involvement of ethics commissions, In contrast, practitioners in particular on quality assurance and on transparency expressed reservations in that biobank were also welcomed. However, there was secrecy would give greater protection to

41 German Ethics Council

Panel discussion with Andreas Reimann, Wolfgang Hoffmann, Andreas Edelmann, René Röspel, Volkart Wildermuth, Sabine Riewenherm, Thomas Feist, Markus Nöthen and Jochen Taupitz (from the left)

both donors and scientists, but at the same Online discourse on time it might result in greater administra- intersexuality tive expenses for research projects and projects involving international coopera- In its online discourse as the third com- tion might pass Germany by. A possible ponents of its discourse procedure on alternative to biobank secrecy would be the topic of intersexuality, the Ethics guidelines which could be given effective Council included a new format for so- sanctions by the refusal or removal of cial debate in its range of activities. This financial promotion. digital discourse platform was established during the preparation of the Opinion Lively discussion on intersexuality in order to facilitate a In the following discussion, there was dialogue between intersex persons and no agreement as to whether legislation parents of intersex children, and also ex- is necessary or whether self-regulation perts and practitioners, and in order to within the research community on the make the complex topic accessible to a basis of the existing statutory situation, broad public. Almost 35 000 page views as supported by the TMF with its data from Germany and other countries such protection ideas and recommendations, as Switzerland, Austria, the Netherlands is sufficient. and the USA, fifty articles, and 727 com- It also remained open whether a uni- ments in 64 days show that the Ethics form federal biobank statute is possible Council’s invitation to join the discourse or whether the Länder are competent for was well received (see p. 19 ff.). some of the provisions, which would lead to considerable fragmentation of law. Panel discussions with students

In the period covered by this report, the German Ethics Council received two

42 Annual Report 2011

student groups, from Germany and the USA, in the administrative office. On 16 June 2010 students of politics from Greifswald University visited the administrative office of the German Eth- ics Council. Joachim Vetter, the Head of Office, informed the students on the Council’s work. As in the previous years, in 2011 a group of students from the USA who were taking part in Bonn University’s Sum- mer School on Life Sciences and Culture again visited the German Ethics Council. Council member Jens Reich presented the work of the Ethics Council and answered the students’ questions. In addition, the Head of Office, presented the work of the Council at the up- per secondary level Lise Meitner School of Science in Berlin and held a discussion with the students on the previous Opinions and on fundamental questions of political advice by bodies such as the German Ethics Council.

43 German Ethics Council

Collaboration with the German Bundestag

With its first Parliamentary Evening In his welcoming address, Professor Dr. in the year 2010, the German Ethics Norbert Lammert, the President of the Council established a practice which it Bundestag, thanked the Ethics Council intensified in the year 2011: both the for its work. With regard to the current Council members and the members of Council Opinion on preimplantation ge- the Bundestag found the exchange of netic diagnosis (PGD), he emphasized opinions with the members of the Ger- that “in case of doubt, I prefer Opinions man Bundestag on current Opinions of which relate to matters that are currently the Ethics Council very informative and on the parliamentary agenda or are likely instructive, in particular since it gave the to be, even if they are not unanimous, to Bundestag members the opportunity to unanimous Opinions which are produced scrutinize the recommendations and to after such an endlessly long process of give the Ethics Council suggestions for deliberation and then possibly with their its future work. edges so worn down that they no longer have any real operative significance for the parliamentary process”. He emphasized Parliamentary Evening on that above all in questions of ethics there is 23 March 2011 “no single conclusive answer that is plainly free of doubt”, but that it is necessary to On 23 March 2011, the German Eth- evaluate conflicting points of view. He said ics Council held its first Parliamentary that credit should be given to the German Evening in the year 2011 and discussed Ethics Council for having done this in its the Opinion on preimplantation genetic PGD Opinion. Lammert hoped that some diagnosis with members of the German of the Council members would still be Bundestag. available for discussion on the dates when

Wolfgang Huber, Wolf- Michael Catenhusen, Norbert Lammert, Edzard Schmidt-Jortzig and Christiane Woopen (from the left) during the Parliamentary Evening on 23 March 2011

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it would be necessary to deal with the mat- Parliamentary Evening of the year in Ber- ter in more depth in the Bundestag. lin, in order to present its latest Opinion, Against the background of the ongoing “Human–animal mixtures in research” consultations of the German Bundestag and to discuss with the members of the on the subject of preimplantation genetic German Bundestag the subjects currently diagnosis, Council members Wolf-Mi- on the Council’s agenda: intersexuality, chael Catenhusen, Christiane Woopen and dementia and self-determination. and Wolfgang Huber presented the Coun- In his welcoming address, Edzard cil’s Opinion with its two main positions. Schmidt-Jortzig, Chair of the German Wolf-Michael Catenhusen reported on Ethics Council, stated that in this way the the general section of the Opinion, which German Ethics Council wishes to satisfy comprises an up-to-date status report on the intensely felt need for exchanges and the medical basis, on the constitutional communication between the Council and context and on the foundations of the the Bundestag. He also reminded those at- ethical evaluation of PGD. Christiane tending that the term of office of the first Woopen presented the principles of those members of the German Ethics Council Council members who are in favour of a is ending in April 2012 and new appoint- restricted permission of PGD. Wolfgang ments will need to be made. Huber then set out the arguments of the In his opening address, Eduard Oswald, Council members who regard the permis- the Vice-President of the German Bun- sion of PGD as ethically untenable. destag, said that the Ethics Council’s in- Central issues in the following discus- dependent and sound advice helped the sion with the members of the German Bundestag members to get to the heart of Bundestag included the possible restric- relevant issues more quickly and hence tion of the use of PGD, the accuracy of to make a decision. Quoting the English the term “a slippery slope” when applied philosopher and mathematician Bertrand to the permission of PGD, and the pass- Russell’s adage “Even when all the ex- ing on of what is known as superfluous perts agree, they may well be mistaken”, genetic information. The question was Oswald encouraged the Ethics Council to also raised as to how far the Ethics Coun- continue its wide-ranging and critical ad- cil has taken account of social reality in vice to the members of parliament and its its deliberations and whether the social expression of divergent views in its Opin- climate has changed in countries which ions. He expressed thanks in the name of permit PGD. all members of the German Bundestag In the course of the evening, Council for the work done by the Ethics Council. Chair Edzard Schmidt-Jortzig also pre- Next, Wolf-Michael Catenhusen, as sented the 2010 Annual Report to Bun- spokesperson for the Council’s internal destag President Lammert. working group, presented key elements of the Opinion and the Ethics Council’s recommendations on approaches to hu- Parliamentary Evening on man–animal mixtures and their treat- 26 October 2011 ment. The ensuing discussion centred on issues including the actual need for On 26 October 2011 the German Ethics statutory regulation in connection with Council issued invitations to its second mixtures and the criteria that should be

45 German Ethics Council

Members of the German Ethics Council during the Parliamentary Evening on 26 October 2011

applied in the evaluation of research pro- Opinion was to establish the potential ca- jects involving human–animal mixtures. pabilities of persons with dementia and to Michael Wunder, the spokesperson reinforce such self-determination as was for the working group on intersexual- still possible even at advanced stages of ity, reported on the current status of the the disorder. Again, it was appropriate not deliberations. With regard to the Federal only to consider dementia as a disease, but Government’s request for an Opinion to also to take account of the psychosocial be prepared and the dialogue with those situation of persons with dementia and concerned and their self-help organiza- their families. tions to be continued, he said that the The ensuing questions put by the mem- Ethics Council had already done this in bers of the Bundestag addressed possible that it had carried out a survey of intersex points of contact with the statutory provi- persons and of scientists and practition- sions on advance directives, the funding ers, had held a public hearing and had of residential care communities and pay- conducted a highly appreciated online ment for care by family members. discourse. In the following panel discussion, the members of the Bundestag were particularly interested in the principle of equal treatment and the prohibition of discrimination, in involving the parents of intersex individuals in the process of dialogue and in the question as to how far the recommendations of the Ethics Council also extended to the field of sport. Michael Wunder reported in addition on the status of the Council’s deliberations on the issue of dementia and self-determination. A particular aim of the planned

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International initiatives and contacts

As in earlier years, the Ethics Council in difficult to make recommendations in 2011 again took part in exchanges with this area, since there were constantly national ethics councils and organizations new developments. The EGE’s Opinion at international level, in accordance with would deal with the various applications, its mandate as laid down in the Ethics for example the internet and the use of Council Act. electronic media in medical care. In a second Opinion, the EGE would deal with the ethical repercussions of security Meetings of the national technologies. ethics councils of the European Union Health services on the internet After a discussion on the challenges pre- On 21 and 22 September 2011 the rep- sented by the use of information and resentatives of the national ethics coun- communication technologies, Hugh cils of the EU Member States met for the Whittall, the Director of the British Nuf- 17th NEC Forum in Brussels. Kristiane field Council on Bioethics, presented the Weber-Hassemer attended the meeting Nuffield Council’s report entitled “Medi- as the representative of the German Eth- cal profiling and online medicine: the ics Council. ethics of ‘personalised healthcare’ in a At the beginning of the two-day meet- consumer age”. The report considers new ing, there was a joint session with the developments in the fields of personal- European Group on Ethics in Science ized healthcare and the health services and New Technologies (EGE), in the offered on the internet, and analyses the course of which the ethical implications ethical effects of these developments. The of information and communications Nuffield Council recommends that the technologies were discussed. On the government should provide better moni- instructions of the European Commis- toring of the services offered and ensure sion, the EGE is currently preparing an that well-founded and independent infor- Opinion on this subject. In an introduc- mation on these services is available. For tory talk, Julian Kinderlerer, the Chair this reason, doctors in particular should of the EGE, examined the ethical and be given special training to enable them legal questions. The information and to advise patients who look for health communication technologies include information or order medicinal products computers, mobile phones and the in- on the internet. ternet. Kinderlerer emphasized that these Next, Christiane Druml, the Chair of technologies were associated with cen- the Austrian Bioethics Commission, in- tral questions of data protection and of troduced the report published in May intellectual property. He said that there 2010 “Genetic and Genome-Wide Test- needed to be a discussion as to how users ing on Internet”. In this report, the Aus- could be protected and their fundamen- trian Bioethics Commission deals with tal rights preserved. It was particularly genetic tests offered on the internet for

47 German Ethics Council

healthcare and the associated ethical Trilateral meeting of the ethics challenges. The tests offered on the inter- councils of Germany, France net, she said, circumvent legal standards and the United Kingdom with regard to data protection, advice and self-determination of the patient. On 1 December 2011 members of the The Austrian Bioethics Commission German Ethics Council, the British Nuf- therefore recommends that before re- field Council on Bioethics and the French course to such a test, patients should have Comité Consultatif National d’Éthique a consultation with a specially trained (National Consultative Ethics Commit- doctor and should inform themselves of tee) met for a joint meeting in London. the precise business purpose of the test. The German Ethics Council was repre- If a monogenic disorder is suspected, the sented by Wolf-Michael Catenhusen, Eck- Bioethics Commission advises that the hard Nagel, Eberhard Schockenhoff and patient should consult a medical spe- Kristiane Weber-Hassemer. cialist in order to obtain comprehensive At the beginning of the trilateral meet- advice. ing, the representatives of the three ethics councils exchanged information on Responsible research and innovation their current programmes of work. The The central topic of the following meet- agenda of the French ethics council at ing of the European ethics councils present contains the topics of neuro- was responsible research and innova- sciences, biodiversity, drugs and genetic tion. René von Schomberg, from the tests, and ethical questions with regard Directorate General for Research and to cord blood banks. The council is also Innovation, introduced the activities of considering the subject of sexuality and the European Commission in research disability. The Nuffield Council in Brit- and innovation policy. He particularly ain is considering mitochondrial disor- emphasized the importance of ethical ders, new developments in the fields of aspects in the development and evalu- biotechnology and neurotechnology, and ation of research projects. He said the the subject of genes and education. In fu- a project could only be endorsed from ture, the topics of research into medicinal an ethical viewpoint if it conformed to products with children, genome databas- the European Charter of Fundamental es, data protection and global inequali- Rights, in particular to the right to re- ties in healthcare may be included in the spect for private life and to the protection programme. The German Ethics Council of personal data. is at present preparing Opinions on the Building on this, the representatives issues of intersexuality and “Dementia of the European ethics councils formed and self-determination”. In addition, in smaller groups in which they discussed response to a commission by the Federal the role of ethics for responsible research Government, it is establishing a work- and innovation and exchanged details of ing group which will consider the future their own experience in evaluating re- of genetic diagnosis. Council member search projects. In conclusion, there was Wolf-Michael Catenhusen reported on a discussion as to what measures should the Opinion “Human–animal mixtures be taken on a national level in order to in research”, which the German Ethics promote responsible research. Council published in September.

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Organ and tissue donation and whatever the genome they have thir- A report of the Nuffield Council on the do- teen genes in the cell nucleus. By reason of nation of bodily material for medicine and the central role of these genes in metabo- research was published in October. In the lism, mutations in them can result in dis- United Kingdom it is possible for organs eases affecting virtually every organ and ex- to be donated after death if the person con- press themselves in a variety of symptoms cerned was registered in his lifetime in the such as muscle weakness, blindness, liver organ donation register or if the next of kin disease or diabetes. Since mitochondria are give their consent. Donations from living only ever inherited through the mother, donors are also possible if there has been it would be possible to prevent these dis- detailed information and the donor has eases being passed on to the children if, consented. Marilyn Strathern, the Chair in the course of artificial fertilization, the of the Nuffield Council working group, mitochondria were removed from the egg presented the core points of the report, of a carrier and replaced by the mitochon- which inter alia suggests financial incen- dria from the egg of a healthy woman. tives for organ donors. Thus, for example, However, such a procedure would also be the funeral costs for organ donors could an intervention in the germline, since the be paid or compensation could be paid change would be permanently passed on to women who donate eggs for research. to the next generation. In addition to an In April, the French ethics council also ethical consideration of these treatments, published a report on ethical questions therefore, it is also an aim of the report to of organ donation; this was introduced encourage public debate as to whether such by Bertrand Weil. In France, everyone is a procedure is even desired by society. regarded as a potential organ donor unless he has expressly objected to organ dona- International cooperation tion. The foundation for this is a “pre- The participants agreed that the exchange sumed consent” of all citizens to organ and the discussion with the representatives donation. Donations from living persons of other ethics councils were very valuable are also possible, but in this case the neces- and helpful, especially in view of the fact sary procedure requires express consent of that there are a large number of topics of the potential donor given before a judge. joint interest. International exchange is Following this, Eckhard Nagel, member of particularly important in the areas where the German Ethics Council, spoke on the research touches on ethical and legal ques- current debate on transplantation medi- tions, as for example in the case of human cine in Germany. He set out possibilities biobanks for research, where the legisla- to reduce the lack of organs and explained tion varies in each country, with the re- the model which is currently under discus- sult that there has to be consultation and sion, in which persons have to declare their agreement as to how the different arrange- wishes as to donorship. ments should be treated. For this reason, the close cooperation of the ethics coun- Mitochondrial disorders cils of Germany, France and the United The Nuffield Council is currently prepar- Kingdom should therefore continue in the ing a report on the ethical aspects of a pos- future. The German Ethics Council invited sible treatment of mitochondrial disorders. its British and French counterparts to a tri- Mitochondria generate energy in the cell lateral meeting in Berlin in the year 2012.

49 German Ethics Council

Publications

Online: The Ethics Council makes its Opinions the dialogue of experts held jointly with www.ethikrat.org /publikationen and activities known to the public in a the TMF on the subject of biobanks will number of series of publications. The be collected in volumes and published. All printed versions of these publications may three collections will shortly be available be ordered free of charge from the office in print and for download on the Ethics of the Ethics Council and are also acces- Council’s website (in German only). sible on the internet as PDF files.

Infobrief Opinions The Infobrief (newsletter, available in Ger- The Opinions are the cornerstones of the man only) was introduced to offer a wider Ethics Council’s publications. They are the interested public a condensed and read- result of intensive discussions in the in- ily comprehensible version of the topics ternal Council working groups and in the discussed by the German Ethics Council. plenary meetings. In this way, the Ethics Contributions are prepared in the Ethics Council pursues the goal of collecting the Council’s office on the basis of the Coun- opinions and convictions held in society cil’s published documents – audio record- and also in the Ethics Council, deriving ings and real-time transcriptions of the lines of argument from them and develop- public meetings and other events, as well ing options for courses of action. as Opinions. The compilations of news In the year 2011 the Ethics Council from the Ethics Council have appeared presented three Opinions: on 27 Janu- three times a year since December 2008 in ary 2011, it published its opinion “Medi- a print run of approximately 3000 copies. cal benefits and costs in healthcare: The normative role of their evaluation”. On 8 March 2011 there followed the Opinion “Preimplantation genetic diagnosis”, and finally on 27 September 2011 the Opinion “Human–animal mixtures in research”. Each of these Opinions was printed in an edition of 3500 copies. English and French translations of these Opinions are either already available or currently in press.

Proceedings

The papers presented at the Annual Meet- ing, the Synthetic Biology workshop and

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Evolution of the social debate

The office of the German Ethics Council of debates, above all on future financing Online: www.ethikrat.org keeps track of press reports and prepares of long-term care insurance, Daniel Bahr /presse/pressespiegel daily compilations of reports on bioeth- (FDP), the Federal Minister of Health, in ics topics. These compilations are made November presented the key points of the available to the Council members and planned care reform, which had previous- can also be accessed by the public on its ly been agreed on by the Federal Cabinet: website via an online calendar. A com- more services for people with dementia plete set of the monthly or annual evalu- and the disabled, support for family mem- ations of these reports therefore gives an ber carers, promotion of outpatient forms impression of the public debate on bio- of accommodation, creation of a private ethics topics, which is not complete but form of supplementary insurance and an is at least evidence-based. In the course increase of contribution rates in long-term of 2011, the following ten topics were care insurance by 0.1 percentage points. represented most frequently in the na- A draft bill is to be completed in the first tionwide German print media (Financi- half of 2012. al Times Deutschland, Focus, Frankfurter In October 2011 the Bundestag passed Allgemeine Sonntagszeitung, Frankfurter the Familienpflegezeitgesetz (Family Long- Allgemeine Zeitung, Frankfurter Rund- Term Care Leave Act) initiated by Kristina schau, Handelsblatt, Der Spiegel, Stern, Schröder (CDU), the Federal Minister Süddeutsche Zeitung, Der Tagesspiegel, taz, of Family Affairs, which is intended to Die Welt, Welt am Sonntag, Die Zeit). improve the reconciliation of occupation and family care. Care for elderly and disabled people In June, the Federal Cabinet resolved In the year 2010, the topic of care for on a National Action Plan to implement elderly and disabled people was still in the United Nations Convention on the fourth place in press reports, but in 2011 Rights of Persons with Disabilities. The it was the top subject, at least the one most frequently named. The reason for this Care for elderly and disabled people 357 was probably that 2011 was the “Year of Care”. Improved quality of life and medi- Reproductive medicine 266 cal progress result in an increase in life Transplants/organ donation 219 expectancy and in connection with this an World food 203 increasing number of people in Germany Agro-genetic engineering 141 who are old and in need of help. In order Allokation im Gesundheitswesen 97 to cope with the challenges presented by Assisted suicide/terminal care/advance directives 84 this demographic change, there is need for a coordinated and socially accepted pro- Dementia 68 cedure. As part of this process, the Federal Brain research 60

Government declared 2011 the Year of Biopatenting 50 Care, and in particular put care reform on the political agenda. After many months

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measures presented by Ursula von der judges dismissed an action from Austria Leyen (CDU), the Federal Minister of La- which was directed against the current bour and Social Affairs, are in particular prohibition of egg and sperm donation. intended to facilitate occupational and This means that the prohibition of egg social integration of persons with disabili- donation applicable in Germany does not ties. However, disabled persons’ associa- contravene current EU law either. tions and social organizations criticized the plans as inadequate. Transplants/organ donation Since Frank-Walter Steinmeier, the leader Reproductive medicine of the SPD parliamentary group, donated As in the previous year, in 2011 too the a kidney to his sick wife in August 2010, field of reproductive medicine was in organ donation has been the subject of second place in the list of frequency of intense public discussion. After months reports. In July 2010, a judgment by the of political struggle, in November 2011 Federal Court of Justice on the permissi- all the parliamentary parties in the Bun- bility of preimplantation genetic diagnosis destag agreed on an initiative to amend triggered proceedings for the reenactment the procedure. The plan was that Ger- of the Embryo Protection Act; these ended man citizens should in future be regularly in July 2011 with a resolution of the Bun- asked whether they wish to be donors. The destag providing a limited permissibil- “declaration solution” is to replace the ity of genetic tests on artificially created “expanded consent solution” currently embryos. There was a free vote, and a laid down in the Transplantationsgesetz clear majority of the Bundestag members (Transplantation Act); the latter provides voted for use of preimplantation genetic that organs may only be removed if the diagnosis. It is true that it remains pro- deceased consented before his death or hibited in principle under the Embryo his next of kin consent to a transplanta- Protection Act, but it is permissible in tion. The amended procedure, which had cases in which one of the parents has a not yet been passed by the Bundestag at genetic disposition for a serious genetic the end of the year 2011, is intended to disease or where a miscarriage or still increase the number of organ donors in birth is to be expected. Couples affected Germany. According to estimates of the may use this method in licensed centres Deutsche Stiftung Organtransplantation after prior expert advice and the consent (German Organ Transplantation Foun- of an ethics commission. The decision was dation), approximately 1000 people die preceded by many months of intensive every year for lack of donor organs. debate among politicians and in society; the German Ethics Council also took part World food in this debate in its Opinion published in Last year, a large number of reports on a March. famine in East Africa drew public atten- In November the European Court of tion once again to a global problem with Human Rights confirmed national prohi- which the German Ethics Council also bitions of egg and sperm donation. Under concerned itself at its Annual Meeting this judgment, the EU Member States and which in 2011 it included in the focus have a duty to legislate on limits to artifi- of its press watching for the first time: cial fertilization. At second instance, the feeding the world population and the

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associated ethical challenges. Through- responsible for permitting certain species. out the world, about a billion people are In November, a judgment of the European starving, and every day thousands die of Court of Justice caused a stir: In the opin- the consequences of malnutrition. And ion of the judges in Luxembourg, honey yet approximately one-third of all food which contains pollen from genetically produced lands on the rubbish dump or modified plants may only be marketed is lost in transport, as is shown by a study if the plants in question are permitted in of the United Nations Food and Agricul- Europe. Environmentalists and ecologists ture Organization presented in May. The regarded the judgment, which applies not calls for a responsible treatment of food only to honey but to all foodstuffs with and land resources are becoming louder. the smallest traces of genetically modified But global food security is also threatened plants, as a great success, which may have by the constantly rising cost of food. In far-reaching effects on genetic cultivation order to ensure more transparency on throughout Europe. the international markets and to prevent the manipulation of raw material prices, Allocation in the healthcare system in June the agriculture ministers of the After the Act on the Reform of the Mar- twenty most important industrialized ket for Medicinal Products entered into countries and emerging economies passed force at the beginning of 2011, the re- an action plan against price fluctuations ports on this topic markedly decreased in agricultural raw materials. in number in the course of the year. For the first time in many years it has been Agro-genetic engineering possible to reduce expenditure for me- In 2011, the debate on the application of dicinal products. The statutory health procedures of what is known as “green insurance funds profited above all from genetic engineering” was also one of the the Federal Government’s savings pack- main focal points of public reporting. In age, which reduced the expenditure on this connection, some decisions on Eu- medicinal products by approximately six ropean level in particular stood in the per cent in comparison to the previous foreground. In February, the EU Member year. However, a new initiative of Frank States agreed to relax the complete ban on Ulrich Montgomery, the President of the the import of genetically modified plants, Bundesärztekammer (German Medical As- which are prohibited in the European sociation), gave rise to more outrage: in Union. The competent agriculture com- view of the limited financial resources in mittee in Brussels permitted insignificant the healthcare system, he regard it as nec- residues (0.1 per cent) of genetically mod- essary to have a list of medical treatments ified plants in foodstuff imports, provided graded by importance. In this, he takes up there was an application in the European demands made by his now deceased pre- Union for the admission of the plants. In decessor, Jörg-Dietrich Hoppe. The Ethics July, the European Parliament adopted a Council too, in its Opinion published in proposal of the EU Commission that in January 2011, “Medical benefits and costs future the Member States themselves were in healthcare: The normative role of their permitted to decide on prohibitions of evaluation”, pointed out that “prioritiza- cultivation for genetically modified plants. tion” in healthcare may be necessary in However, the Commission remained the future.

53 German Ethics Council

Assisted suicide/terminal care/ appear to confirm this. In the centre of the advance directives ethical debate is again and again the ques- The current legislation on advance dition as to humans’ free will and whether rectives, which has been in place since this can still be seen as really “free” on September 2009, has calmed the social the basis of scientific findings and not debate, but the question of euthanasia as unavoidably laid down as a result of continues to be controversial in Germany. biophysical conditions. The call for medical assistance for suicide is also intensively discussed in society. In Biopatenting June, the German Medical Association, In October, the European Court of Justice, at its 114th Ärztetag (German Medical in a leading decision, held that procedures Assembly) in Kiel adopted a new version which benefit human embryonic stem of its professional code, providing that cells may not be patented. The court held doctors may not render assistance in sui- that because fertilized eggs are destroyed cide. Doctors who help patients commit in order to obtain such cells, patenting suicide must therefore in future expect to violates the protection of human dignity. lose their practising certificates. In the view of the judges, this is against public policy, since legally fertilized eggs Dementia are also embryos. In addition to the pa- Approximately 1.2 million people with tentability of embryonic stem cells, bi- dementia live in Germany. In an aging opatenting also relates to the fundamental society, this condition is becoming a question as to the extent to which human widespread disease, which presents family genetic sequences should be permitted members, carers and the medical profes- to be patented at all. While on the one sion with great challenges. Consequently, hand researchers fear that research may public attention is increasingly directed to be blockaded by patents, on the other interaction with persons with dementia, hand industry points to the significance of their care and custodianship, and also patents for safeguarding its claims against their possibilities of self-determination. third parties and the high costs in connec- The German Ethics Council is rising to tion with developments in the biomedical this challenge and is currently preparing field. an Opinion.

Brain research The brain is becoming more and more accessible for medicine and research. Im- aging procedures give deeper and deeper understanding of its structures and locate the regions which are active in thinking, feeling and acting. The findings of neuro- logical research may have repercussions for social practice. Reports on the use of brain scans in predicting the success of giving up smoking, recognizing catchy tunes and determining sexual inclinations

54 Annual Report 2011

Outlook

At the end of the year 2011, in contrast to previous years, the German Ethics Council did not lay down the topics of its future Opinions. In view of the fact that the first term of office of twenty-four of the twenty-six Council members ends in April 2012 – Mrs Walles and Mr Huber were appointed on 30 June 2010 – the Council members did not want to make firm decisions on topics in advance for the new Council. By reason of the Federal Government’s instructions to prepare an Opinion on the subject of genetic diagnosis, it is merely confirmed that irrespective of the changes in membership of the Eth- ics Council this subject will be dealt with and the Council is expected to present an Opinion on it at the end of the year 2012. The Council scheduled only the topic for the Annual Meeting in May, since extensive organization and time planning are necessary to prepare it. The subject of personalized medicine will therefore be the focus of the German Ethics Council’s 2012 Annual Meeting. In its Annual Meet- ing, the German Ethics Council wishes to consider ethical and social questions of personalized medicine, focussing on the patient. Against the background of the present state of research, urgent questions of future medical care will be discussed with doctors, academics in the sciences and the arts, representatives of patients and industry and the public.

55 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, Bishop Bavarian Consti- (retired) tutional Court and 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 Bishop (retired) rer. pol. Anton Losinger

56 Annual Report 2011

Prof. Dr. med. habil. Dr. phil. Peter Prof. Dr. med. Jens Ulrike Riedel, Dr. phil. Dr. theol. Radtke Reich lawyer, former h. c. 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

Prof. Dr. rer. nat. Kristiane Weber- Dipl.-Psych. Dr. Heike Walles Hassemer, former phil. Michael State Secretary in Wunder the State of Hesse

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Appendix

Working groups 2011 Synthetic biology Spokesperson: Catenhusen The working groups of the German Ethics Members: Bora, Reich, Taupitz Council form the basis of its substantive External experts: Prof. Dr. Peter Dabrock, work. The groups mentioned below met Prof. Dr. Alfred Pühler for more than fifty sessions in the year 2011. 2011 Annual Meeting Spokesperson: Schockenhoff Research on chimeras and hybrids Members: Huber, Kollek, Teufel, Weber- Spokesperson: Catenhusen Hassemer Members: Dimmeler, Emmrich, Kollek, Reich, Schockenhoff, Taupitz, Weber- Public meeting: Synthetic biology Hassemer, Woopen workshop Spokesperson: Catenhusen Dementia and self-determination Members: Bora, Reich, Taupitz Spokesperson: Wunder Members: Gerhardt, Kähler, Radtke, Bioethics Forum: The controversial Reich, Riedel, Schmude, Schockenhoff, case of baby drops Teufel, Woopen Spokesperson: Riedel Members: Gerhardt, Schockenhoff, Genetic diagnosis Schmude, Woopen Spokesperson: Kollek Members: Bora, Catenhusen, Dimme- Bioethics Forum: Research on ler, Emmrich, Losinger, Reich, Riedel, medicines in children Schockenhoff, Schmidt-Jortzig, Taupitz, Spokesperson: Taupitz Weber-Hassemer, Woopen Members: Catenhusen, Dimmeler, Em- mrich, Kollek, Walles Intersexuality Spokesperson: Wunder Members: Bora, Gerhardt, Kähler, Kollek, Procedure Reich, Riedel, Schockenhoff, Taupitz, We- ber-Hassemer The German Ethics Council is independent in its work and bound only by the Preimplantation genetic diagnosis mandate given to it by the Ethikratgesetz Spokesperson: Catenhusen (Ethics Council Act). Under section 6(2) Members: Bora, Dimmeler, Emmrich, of the Ethics Council Act, the Ethics Holzheid, Kollek, Losinger, Reich, Rie- Council has adopted rules of procedure del, Schmidt-Jortzig, Schmude, Schocken- governing its procedure in specific terms. hoff, Taupitz, Weber-Hassemer, Woopen, The Ethics Council prepares its Opin- Wunder ions on its own volition, but it may also be instructed to prepare an Opinion by the

58 Annual Report 2011

German Bundestag or the Federal Gov- In 2011, the staff of the office comprised ernment. In addition, the German Ethics the following persons: Council is required to report in writing to the German Bundestag and the Federal • Dr. Joachim Vetter (Head of Office) Government at the end of each calendar • Dr. Katrin Bentele (Research Officer) year on its activities and the current state • Dr. Nora Schultz (Research Officer) of the social debate. • Dr. Jana Wolf (Research Officer, pa- The Ethics Council meets once a month rental leave replacement for Dr. Nora in Berlin for a plenary session which is Schultz) usually open to the public. To address • Ulrike Florian (Press and Public Rela- individual topics or entire fields of related tions Officer) topics, the Council establishes working • Torsten Kulick (Scientific Documenta- groups of members which coordinate the tion) preparation of draft texts of its Opinions • Carola Böhm (National Affairs and Or- and which meet as necessary separately ganisation of Meetings) from the regular plenary debates. In ad- • Theresia Sunadi (International Affairs) dition, the Ethics Council may arrange • Petra Hohmann (Secretariat) for investigations to be carried out and • Pia Becker (Student Assistant) for expert reports to be made and may enlist the services of experts in its work, in particular to assist the working groups. Funding The German Ethics Council is assisted in the performance of its duties by The costs of the German Ethics Council an office, which was established by the and its office are borne by the Federa- President of the German Bundestag under tion. The sum of 1.695 million euro was section 8 of the Ethics Council Act and ac- allocated to the funding of its work in the commodated at the Berlin-Brandenburg year 2011 in the Bundestag’s budget (De- Academy of Sciences and Humanities. partmental Budget 02, Title 52603-011). The general conditions governing the ac- tivity of the office are determined by an agreement between the Bundestag admin- istration and the academy. The office is responsible for locating, preparing and evaluating scientific documents relating to the topics addressed by the Council, for the compilation of material for publication, for the planning and conduct of meetings and public events and for the publication of Opinions and other documents. The principal duties of the office also include managing contacts with the media, responding to enquiries from the public, maintaining the Coun- cil’s presence on the internet and looking after the Council’s international contacts.

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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, science, 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 Bun- Government. It shall forward its Opinions destag shall appoint the members of the

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