Michael Fuchs National ethics councils - Deutscher Ethikrat

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Michael Fuchs National ethics councils - Deutscher Ethikrat

Nationaler Ethikrat

Michael Fuchs

National

ethics councils

Their backgrounds, functions

and modes of operation compared


National ethics councils

Their backgrounds, functions

and modes of operation compared


Nationaler Ethikrat

Michael Fuchs

National

ethics councils

Their backgrounds, functions

and modes of operation compared


Published by the German National Ethics Council

Chair: Kristiane Weber-Hassemer

Jägerstraße 22/23 · D-10117 Berlin

Telephone: +49/30/203 70-242 · Fax: +49/30/203 70-252

Email: kontakt@ethikrat.org

www.ethikrat.org

German National Ethics Council

National ethics councils. Their backgrounds, functions and modes of operation compared

© 2005 Nationaler Ethikrat, Berlin

All rights reserved

English translation by: Philip Slotkin MA Cantab. MITI

Permission to reprint will be granted on request

Design and production: Bartos Kersten Printmediendesign, Hamburg

Printed and bound by Druckhaus Berlin Mitte, Berlin 2005

CONTENTS

>> Preface 9

>> Introduction 11

>> I. Europe 13

>> 1. France and the Benelux States 13

>> 2. Scandinavia and the British Isles 23

>> 3. Southern Europe 35

>> 4. Germany, Switzerland and Austria 41

>> 5. Central and eastern Europe 48

>> II. North America 63

>> III. South and central America 68

>> IV. Middle East and north Africa 71

>> V. Asia 76

>> VI. Australia and New Zealand 83

>> VII. The ethical debate on modern medicine and state responses to it 85

>> 1. Establishment of national ethics bodies: background situations 85

>> 2. Institutional framework models

and assignment to agencies of the state 86

>> 3. Size and composition 86

>> 4. Assigned fields of competence and main issues addressed 89

>> 5. Right of referral 91i

>> 6. Advisory mandate 91i

>> 7. Influence on legislative procedures 91i

>> 8. Procedures for involvement of the public

and influencing public debate 92

>> 9. Funding, facilities and internal structure 93

>> VIII. The Role of national ethics councils in the inter-state

and international bioethics 94

>> 1. COMETH 94

>> 2. Global Summit 95

>> 3. Bilateral Cooperation 96

>> General Bibliography 99

7


PREFACE

National ethics councils. Their backgrounds, functions and modes of operation compared

This study was compiled on behalf of the German National Ethics Council. It follows

an initial survey of national ethics bodies which the Konrad Adenauer Foundation

commissioned at the beginning of 2001 and published (in German) in the

series Arbeitspapiere. Since then a large number of new national ethics councils have

been established, while many existing ones have been restructured, and the tendency

for such bodies to be created has continued not only in central Europe but also,

for example, in Spain, eastern Europe and the Far East. Interest in these matters has

increased and the need for reflection on their consequences for democracy and society

has grown. The rapid pace of these developments calls for constant updating

of this conspectus.

I have conducted the necessary research in collaboration with members of the

staff of the Institut für Wissenschaft und Ethik. I am indebted to Dr. Ana Borovečki,

Dr. Chang-Tze Hu and Professors Vilhjamur Arnason, Shinitz Kang, Judit Sándor, Jirˇi

Sˇimek, Jun Matsuda and Carlos María Romeo-Casabona for information supplied.

Particular thanks are due to Nils Fischer for his critical perusal of the manuscript.

Bonn, June 2005

9


INTRODUCTION

National ethics councils. Their backgrounds, functions and modes of operation compared

Over the past two decades, ethics committees, advisory groups or ethics commissions

have come into being at national level in all parts of the world. Their function is to

contribute to opinion formation and to advise state decision-making bodies on moral

issues raised by science and its applications, in particular in the biosciences and

medicine. The background to the creation of advisory groups on ethics as central national

institutions is stated to be scientific progress. The present study attempts to

identify the particularities and common features of these national ethics bodies.

Although the main focus of the study is on Europe, examples from all continents will

be given, together with details of the experience gained with the models concerned,

where this information has been published or is otherwise available. The survey begins

with a number of individual examples, grouped geographically. There follows a crosssectional

comparison of certain important aspects, such as the issues for which the

bodies are competent, their composition and transparency, involvement of the public,

and their legal and institutional framework. Contacts between national ethics bodies

are discussed in a separate, systematic section, given that such contacts are considered

to be increasingly significant for opinion formation in individual countries. Bilateral

and international meetings are a further important element in the worldwide attempt

to arrive at a consensus on ethical issues in the field of biomedicine.

11


I. Europe

1. France and the Benelux States

France

National ethics councils. Their backgrounds, functions and modes of operation compared

The French Comité Consultatif National d’Ethique pour les Sciences de la Vie et de

la Santé (CCNE) is surely a paradigmatic national ethics body. Notwithstanding repeated

changes of government and president in France, it has displayed remarkable

continuity in the two decades of its activity. It is thus one of the oldest permanent

ethics bodies in the field of biomedicine, and as such the oldest of all committees

with the clearly defined status of an advisory organ to the legislature. The CCNE

stands out from the large number of such bodies that have since been established

by virtue of its exceptional productivity, having now published some 80 Opinions

(Avis). That is why the Committee is described here first and in particular detail.

When François Mitterrand established the Committee, he made it clear that he

saw it as a response to the challenges of the modern biosciences. It was intended to

stimulate reflection on the ethics of research. Responsibility was not to be left to the

researchers alone, but to be approached by a wide-ranging and thorough debate in

which dogmatism and laissez-faire were equally to be avoided. Under the terms of the

founding decree of 1983, issues can be referred to the CCNE by the President of the

National Assembly or of the Senate, by members of the Government, by public or

non-profit organizations and by universities. While the Committee is bound to draw

up Opinions on matters referred to it by these institutions, it may also take up referrals

from other parties and itself propose subjects for its consideration. Referrals by

individual members of parliament, for example, fall into this group. In practice, a

large number of referrals stem from members of the Government – in particular, the

Minister of Health and the Minister of Research. However, the CCNE also responds

to minor requests and letters from doctors, research workers, associations, students

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

and secondary school pupils. Local ethics commissions in France have the right to

draw the attention of the national committee to new problems. This sometimes results

in suggestions for reports and Opinions. The provisions of the decree were given

statutory force by the two “Bioethics Laws” of 1994.

Composition

The founding decree provided for a membership of 37. This number was increased

in 1997, so that, in addition to the Chair and two honorary chairs, the Committee

now has 39 members. The Chair is appointed by decree of the President of the Republic.

Another five members belonging to the five principal faiths and philosophies

(Roman Catholicism, Protestantism, Judaism, Islam and Marxism) are also Presidential

appointments. Then come a group of 19 individuals qualified by their competence

and interest in ethical problems, and 15 persons from the research sector.

Those 19 (formerly 16) members are selected by the relevant ministries and the

Prime Minister or appointed from among the members of the National Assembly

and the Senate, the Conseil d’Etat and the Court of Cassation by the presidents of

these bodies. As a result two of the Committee’s 42 members are politicians in the

strict sense of the word. The 15 persons from the world of science are members of the

Academies and the major national collèges, research institutes and universities, or are

appointed by them. These statutory requirements have not led to the formation of

blocs. The competence for appointments is not divided among different scientific

cultures or based on a dichotomy between experts and lay persons.

Issues

The formation of the CCNE introduced a form of political advisory activity in

France that had previously been quite unusual (see Byk/Mémeteau 1996). The

founding decree had raised questions of demarcation in relation to the functions of

existing institutions. President Mitterrand’s emphasis on the implications of research

and of novel medical techniques resulted in an attempt to leave the treatment of traditional

issues of medical and professional ethics within the field of competence of

the doctors’ professional organizations. However, such a division between matters of

bioethics and research ethics on the one hand and professional medical ethics on the

other can by no means be regarded as beyond dispute. Furthermore, the CCNE’s repeated

consideration of euthanasia shows how changes in medical technology also

have repercussions on long-established questions of medical ethics.

Overall, the tasking of the individual bodies has proved to be a complex process

involving the founding decree and its interpretation, referrals by the competent institutions

of state, the CCNE’s conception of its own role as it has emerged from its

work, and additional legal instruments. Chief among these instruments is the Law on

the Protection of Human Subjects of Medical Research, the Loi Huriet of 1988, which

14

deals comprehensively – that is to say, with a wider field of application than the German

Medicinal Products and Medical Devices Laws – with the functions and status

of ethics commissions in such research projects. In addition, this Law put an end to

the debate on whether the existing CCNE ought also to serve as a central commission

for research projects involving human subjects, either as a body to which appeals

could be directed or in order to rule on particularly important or complex cases. The

decision that the regional commissions have sole responsibility for these matters

means that the CCNE must concentrate on general issues. Consideration of the

Opinions hitherto published, however, reveals a broad spectrum, from the very first

Avis, on the sampling of dead human embryonic and fetal tissue, to the eightieth, on

the role of occupational medicine. It extends from the major international issues

such as embryo research or cloning, via psychological research and oncological studies,

to the ethical aspects of neurosurgery, which have hitherto not, or not systematically,

been addressed in bioethics, let alone by advisory bodies.

Mode of Operation

The Committee appoints rapporteurs for the subject-matter under consideration,

who are responsible for the scientific question, the research problem or the ethical issue

concerned. A working party made up of members of the Committee and external

specialists is formed, and begins by determining whether the issue in hand is a

genuine scientific problem and whether it has not already been examined by the

Committee or is not covered by existing law. The working party then approaches the

documentation centre (Centre de Documentation en Ethique) of the INSERM (Institut

National de la Santé et de la Recherche Médicale); the founding decree provides

that the CCNE shall receive administrative and technical support from this body. In

particular, the INSERM is required to provide the Ethics Committee with a documentation

and information centre on the ethics of the life and health sciences. Next

comes the ethical debate, which may extend over several months. Its outcome is a scientific

report, an ethical report and a draft Opinion (Avis) which are published and

forwarded to the Committee’s Technical Department and to a 14-member subcommittee.

The latter submits the text, after examination and discussion, to the Plenary

Committee, which meets at approximately six-weekly intervals to consider and discuss

the drafts. It then returns the text to the working party for revision. In most cases,

the Committee finally adopts the report together with the Opinion unanimously.

However, dissenting positions are allowed for and have in some cases been expressed,

attached to the report and published with it. In some cases, areas of consensus and

dissent are recorded, but not the results of a vote on dissenting positions.

In addition to the working parties assembled for the purpose of compiling an

Avis, there is a permanent working group on molecular biology and reproductive

techniques and another on the neurosciences.

15


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Status as a consultative body

The French Ethics Committee sets a great deal of store by the distinction between an

ethics committee and elected legislative bodies. Although two members are parliamentarians

and further politicians are not excluded from membership, the CCNE as

a national ethics committee has deliberately distanced itself from political institutions.

It has also been concerned since its foundation to preserve a clear distinction

between itself and the organizations representing the medical profession, especially

as regards their self-regulatory activity in regard to professional codes and ethics.

The CCNE sees itself as an advisory body on ethics that also serves the legislature.

In many cases it has concluded that existing French law was ethically inadequate or

incomplete. Its second Opinion, dating from 1984, on the testing of new drugs on

human subjects, already revealed a need for specific regulation, and the 1988 law was

partly based on it. In some cases, however, the conclusions of the Ethics Committee

have not been reflected in subsequent legislation. Although the Committee has accepted

its task of commenting on the existing legal position, it has always taken care

not to draw up draft laws itself, although some of its members would certainly have

possessed sufficient competence in legal dogma and systematization to do so. In November

2000, the Committee was requested by the Prime Minister to comment for

the second time on the revision of the bioethics laws. The Opinion of 18 January

2001 on the preliminary draft revision of the bioethics laws calls for detailed clarifications

and corrections. With regard to therapeutic cloning, one of the thorniest ethical

aspects of the proposed reform, the CCNE confessed that it was itself split. It

analysed the problems, drew attention to the dissenting positions, and recommended

a cautious approach to such research. It urged a further intensification of the debate,

extending beyond Parliament to society as a whole. Thereafter, the legislative

revision was postponed several times. However, both the Minister of Health and the

legislature kept the CCNE’s proposals in mind (see Le Quotidien du Médecin, 4 June

2003). In December 2003, the revision was adopted by the National Assembly on its

second reading and submitted to the Senate.

Approaches to scientific evaluation

Whereas the European Commission has in the past subsidized a study comparing the

effects of citizen participation processes in the appraisal of the consequences of technology

for certain European states, there is at present no corresponding project on

the impact of national ethics commissions’ recommendations on legislation. France

is currently the only country in which preliminary scientific work at national level

has been undertaken. A dissertation on this subject was recently submitted at the

University of Aix-Marseilles.

16

Transparency and public participation

The CCNE’s Avis are published at press conferences, which are held four or five times

a year. Furthermore, as required by the founding decree, a conference, for which the

Committee is responsible, is held annually. Several different types of events providing

for public participation have been developed.

In addition to wide-ranging documentation on the Internet, the Committee publishes

a quarterly journal (Les Cahiers du Comité Consultatif National d’Ethique).

Under the heading Rubrique internationale it regularly presents reports and news of

international and European meetings of national ethics committees and of the activities

of other national ethics bodies. Although no claim is made to completeness, information

that would otherwise be relatively inaccessible can be found here, for

instance on the work of the Algerian or Tunisian committees or on that of Luxembourg.

Website

CCNE: http://www.ccne-ethique.fr

Bibliography

Ambroselli, C. (1988). Les journées annuelles d’éthique 1987. Présentation. In: Comités d’éthique à travers le

monde. 2, recherches en cours 1987. Paris: 83.

Byk, Chr.; Mémeteau, G. (1996). Le droit des comités d’éthique (Collection “Médecine et droit”). Paris.

Changeux, J.-P. (1994). The Role and Functioning of the National Consultative Ethics Committee in France.

In: Council of Europe (ed.). Standing Conference of European Ethics Committees. Proceedings, Stockholm

8 – 9 April 1994: 100 – 106.

Chirac, J. (2003). Discours de Monsieur Jacques Chirac, Président de la République, à l’occasion du 20e

anniversaire du Comité consultatif national d’éthique pour les sciences de la vie et de la santé. Les cahiers

du Comité consultatif national d’éthique pour les sciences de la vie et de la santé 35: 27 – 30.

CCNE (1984). Avis sur les prélèvements de tissus d’embryons et de foetus humains morts, à des fins

thérapeutiques, diagnostiques et scientifiques (Avis n° 1 – 22 mai 1984).

CCNE (1987). Décret de création, n° 83 – 132, 23 février 1983. In: Comités d’éthique à travers le monde.

1, recherches en cours 1986. Paris: 79 – 84.

CCNE (1989). Avis sur les greffes de cellules nerveuses dans le traitement de la maladie de Parkinson

(Avis n° 16 – 16 octobre 1989).

CCNE (1990). Avis sur la non-commercialisation du corps humain (Avis n° 21 – 13 décembre 1990).

CCNE (1991). Avis sur la transfusion sanguine au regard de la non-commercialisation du corps humain

(Avis n° 28 – 28 décembre 1991).

CCNE (1997). Avis sur la constitution des collections tissus et organes embryonnaires humaines et leur

utilisation à des fins scientifiques (Avis n° 52 – 11 mars 1997).

CCNE (2001). Avis sur l’avant-projet de révision des lois de bioéthique (Avis n° 67 – 18 janvier 2001).

Décret n° 97 – 555 du 29 mai 1997 relatif au Comité consultatif national d’éthique pour les sciences de la vie et

17


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

de la santé. Journal officiel de la République française n° 124 du 30 mai 1997: 8287 – 8288.

Fagot-Largeault, A. (1987). Le Comité consultatif national d’éthique et les comités locaux. In: Comités d’éthique

à travers le monde. 1, recherches en cours 1986. Paris: 129 – 132.

Fuchs, M. (2001). Wer den Schlusspunkt setzt – Frankreich debattiert über die Sterbehilfe. Frankfurter

Allgemeine Zeitung Nr. 10 vom 12. Januar 2001 (Feuilleton): 46.

Holderegger, A. (2001). Embryonenforschung, Stammzellengewinnung, therapeutisches Klonen – zur politischethischen

Diskussion in Frankreich. Zeitschrift für medizinische Ethik 47/3: 292 – 298.

Loi n° 94 – 653 du 29 juillet 1994 relative au respect du corps humain. Journal officiel de la République française

n° 175 du 30 juillet 1994: 11056 – 11059.

Loi n° 94 – 654 du 29 juillet 1994 relative au don et à l’utilisation des éléments et produits du corps humain,

à l’assistance médicale, à la procréation et au diagnostic prénatal. Journal officiel de la République française

n° 175 du 30 juillet 1994: 11060 – 11068.

Maio, G. (1994). Forschung am Menschen. Eine französische Debatte. Ethik in der Medizin 6: 143 – 156.

Maio, G. (1995). Die französische nationale Ethikkommission. Entstehungsgeschichte, Arbeitsweise und

Bedeutung am Beispiel ihrer Empfehlungen zur Embryonenforschung. Zeitschrift für medizinische Ethik 41:

291 – 299.

Mattei, J.-F. (1993). Rapport à Monsieur le Premier Ministre sur l’éthique biomédicale. Available online at:

http://www.inserm.fr/ethique/Ethique.nsf/0/658512614bc9b94cc12567c2004b31e2?OpenDocument

Michaud, J. M. (1990). Die Französische Nationale Ethik-Kommission. In: Füllgraff, G.; Falter, A. (eds).

Wissenschaft in der Verantwortung. Möglichkeiten der institutionellen Steuerung, Frankfurt a. M., New York:

178 – 188.

Michaud, J. M. (1994). Establishing Ethics Committees. In: Council of Europe (ed.). Standing Conference of

European Ethics Committees. Proceedings, Stockholm 8 – 9 April 1994: 14 – 15.

Sève, L. (1998). S’entendre en éthique. Projet 255: 71 – 76.

Sicard, D. (2001). Stellungnahme zum Fragebogen zu Ethikkommissionen. In: Enquete-Kommission “Recht und

Ethik der modernen Medizin” (14. Deutscher Bundestag). Stellungnahmen von Vertreterinnen und Vertretern

europäischer Ethikkommissionen zur Öffentlichen Anhörung “Europäischer Diskurs zu ethischen Fragen der

modernen Medizin” vom 19. November 2001. Available online at:

http://www.bundestag.de/parlament/kommissionen/archiv/medi/medi_di_stell/Sicard_dt.pdf

18

Belgium

The Belgian Advisory Committee on Bioethics (Comité Consultatif de Bioéthique,

CCB) was established on 13 January 1996. Although the Committee had been

planned for some time, it took a total of ten years for agreement to be reached between

the Belgian State, the Flemish, Walloon and German-speaking communities

and the Joint Commission of the Communities, so that work could begin. The Committee

is made up of 35 members chosen for their knowledge and experience of, and

interest in, ethical problems.

Sixteen members are appointed by the Inter-University Council, six by the Belgian

Medical Association, two by the Belgian Law Society, another two by the judiciary and

nine by the King and regional governments. There is intended to be an overall balance

between philosophical and faith groups and the world of science and medicine on the

one hand and members with competence in academic philosophy, law and the humanities

on the other. A balance between male and female members is also supposed

to be struck. Exactly equal numbers of French- and Flemish-speaking members are

required, while one member is to be drawn from the German-speaking community.

The CCB is funded 75% by central government and 25% pro rata by the Regions.

The Committee’s mission is to furnish information and to issue Opinions on matters

of bioethics, both on its own initiative and in response to referrals by government

bodies or universities and research institutions. The CCB is required to maintain a

documentation centre. So far it has published 22 Opinions on bioethical issues, including

two on euthanasia and two on the legal protection of biotechnological inventions,

and one each on embryo research and the handling of cryopreserved embryos,

on genetic tests in the field of employment, and on compulsory medical treatment.

Website

CCB: http://www.health.fgov.be/bioeth

Bibliography

CCB (1999). Avis n° 9 du 22 février 1999 concernant l’arrêt actif de la vie des personnes incapables

d’exprimer leur volonté. Available online at: http://www.health.fgov.be/bioeth/fr/avis/avis-n09.htm

CCB (1999). Avis n° 10 du 14 juin 1999 concernant le clonage humain reproductif. Available online at:

http://www.health.fgov.be/bioeth/fr/avis/avis-n10.htm

CCB. Index. Available online at: http://www.health.fgov.be/bioeth/fr/index-fr.htm

CCB. Liste des membres du Comité consultatif de bioéthique. Available online at:

http://www.health.fgov.be/bioeth/fr/presentation/liste_membres.htm

CCB. Présentation du Comité consultatif de bioéthique. Available online at:

http://www.health.fgov.be/bioeth/fr/presentation/presentation-index.htm

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Luxembourg

Luxembourg’s Commission Consultative Nationale d’Ethique pour les Sciences de la

Vie et de la Santé (CNE) was established as long ago as in 1988. The Government is

responsible both for its foundation and for the appointment of members, who are

drawn from the worlds of politics, philosophy, the religious communities and the

relevant scientific disciplines and professional groups. Their three-year mandates are

renewable. Both on its own initiative and in response to official referrals, the CNE has

drawn up Opinions on the Council of Europe’s Protocol on Transplantation, on the

Convention on Children’s Rights, and on many other bioethical issues.

Address

Commission Consultative Nationale d’Ethique pour les Sciences de la Vie et de la Santé

2, Circuit de la Foire Internationale, 1347 Luxembourg, Luxembourg

Bibliography

CNE (1997). Rapport annuel 1995. Journal international de bioéthique 8/4: 107 – 109.

CNE (1998). Avis concernant l’acharnement thérapeutique (Avis 1/96). Journal international de bioéthique 9/4:

111 – 124.

CNE (1999). Avis 2/96 sur les comités d’éthique hospitaliers. Journal international de bioéthique 10/5: 71 – 72.

CNE (2001). Recommandations de la CNE. Journal international de bioéthique 12/1: 125 – 128.

CNE (2001). Avis 1/2000 concernant les problèmes éthiques et juridiques soulevés par la reconnaissance d’un

droit de l’enfant à connaître ses parents biologiques. Journal international de bioéthique 12/4: 89 – 92.

CNE (2002). Avis No. 1/2000: Autour de la convention relative aux droits de l’enfant. Le droit de l’enfant à

connaître ses parents biologiques. Journal international de bioéthique 13/2: 111 – 113.

20

Netherlands

The Netherlands lacks a body with comparable status to the French CCNE. Important

bioethical questions arising have been dealt with by ad hoc bodies working on behalf

of the state, and performing an important function in the moulding of legislation

and in the field of public information and opinion formation. For instance, the report

of the Remmelink Commission (1990) substantially determined the subsequent regulation

of euthanasia, while that of the Dunning Commission (1991) laid down guidelines

for the setting of healthcare priorities.

However, like other countries the Netherlands has permanent national-level

bioethics or health-ethics bodies. Their relative fields of competence are not precisely

distinguished from each other. In addition to an ethical committee established by the

Royal Medical Association, there is a National Platform for the Ethical Aspects of the

Sciences and an advisory committee on moral and religious issues in the hospital sector.

In particular, however, the Health Council of the Netherlands (Gezondheidsraad,

GR) has established a Standing Committee on Medical Ethics and Health Law, and,

finally, the Centrale Commissie Mengsgebonden Onderzoek performs a central coordinating

function for the local ethics commissions responsible for examining research

projects involving human subjects. The Standing Committee on Medical

Ethics and Health Law was established by a specific law. It is accommodated within

the Health Council, which was formed in 1902 and keeps ministers abreast of relevant

developments in the health sciences. Like the reports of other committees of the

Health Council, all of whose members are high-ranking specialists, those of the

ethics and law committee offer guidance rather than final judgements. However, they

provide an initial brief analysis of ethical problems and reveal any need for clarification

of the law or for regulation. The Standing Committee on Medical Ethics and

Health Law is composed not only of members of the Health Council but also of other

specialists. One third of its members are doctors, one third ethicists and one third

legal experts. Although none of the permanent councils directly influences legislation,

all these bodies have a voice in the process of political opinion formation.

The function of stimulating social debate in the Netherlands is performed first

and foremost by the Rathenau Institute, which operates on behalf of the Government

and uses modified Danish models of citizen participation in the processes of opinion

formation, for which it develops approaches of its own.

For this reason, most of the tasks performed in other countries by central national

bodies are undertaken in the Netherlands by a number of separate institutions,

which also constitute an additional potential source of plurality. However, the

Netherlands Government considered that an early warning system for ethical problems

raised by new technological challenges might be lacking. For this reason, it also

established the Centrum voor Ethiek en Gezondheid (CEG). The annual monitoring

21


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

exercise of the Health Council and of the Council for Public Health and Health Care

(Raad voor de Volksgezondheid en Zorg, RVZ), the results of which were presented for

the first time in May 2003, is intended to provide further early warning of ethical issues.

The advantages and disadvantages of the Dutch approach have been discussed

in the past at Council of Europe meetings and, most recently, in the hearing of the

Commission of Inquiry of the 14th Electoral Term of the Lower House of the German

Parliament (Deutscher Bundestag) on the Law and Ethics of Modern Medicine held

on 19 November 2001.

Website

Gezondheidsraad: http://www.gr.nl

Bibliography

Borst-Eilers, E. (1994). Collaboration Between Local (Hospital) Committees and a National Committee.

In: Council of Europe (ed.). Standing Conference of European Ethics Committees. Proceedings, Stockholm

8 – 9 April 1994: 66 – 70.

Ministry of Welfare, Health and Cultural Affairs (1991). Medical Practice with Regard to Euthanasia and

Related Medical Decisions in the Netherlands: Results of an Inquiry and the Government View [Remmelink

Commission Report].

Ter Meulen, R. (2001). Nationale Ethik-Kommissionen und Ethik-Beiräte in den Niederlanden. In: Enquete-

Kommission “Recht und Ethik der modernen Medizin“ (14. Deutscher Bundestag). Stellungnahmen von

Vertreterinnen und Vertretern europäischer Ethikkommissionen zur Öffentlichen Anhörung “Europäischer

Diskurs zu ethischen Fragen der modernen Medizin” vom 19. November 2001. Available online at:

http://www.bundestag.de/parlament/kommissionen/archiv/medi/medi_di_stell/Meulen_dt.pdf

Van Eijndhoven, J.; van Est, R. (2000). The Choice of Participatory TA Methods. In: European Participatory

Technology Assessment (EUROPTA). Participatory Methods in Technology Assessment and Technology

Decision-Making: 112 – 134. Available online at: http://www.tekno.dk/pdf/projekter/europta_Report.pdf

22

2. Scandinavia and the British Isles

Sweden

The Swedish National Council on Medical Ethics (Statens Medicinsk-Etiska Råd,

SMER) was established in 1985, and is thus one of the oldest bodies of its kind. It

differs from equivalent institutions in other countries by the inclusion of a large

number of politicians. Of its 19 members, seven represent the political parties in Parliament,

while 12 experts are drawn from the fields of philosophy, the Church, the

arts, law, organizations of the disabled, the Swedish Medical Association, the nurses’

association and other groups.

It is common in Swedish parliamentary life for expert commissions to be consulted

in the legislative process. During the 1980s, commissions were appointed to

consider ethical matters such as the criterion of brain death, genetic integrity, reproductive

technologies and the rights of unborn children. The SMER has now been assigned

the function of subjecting the proposals and drafts of the relevant expert

commissions to ethical review as a part of the process of legislative preparation. This

includes the expression of opinions by social groups and other interests. The role of

the Council is considered to be to act as an interface between the world of science and

the political decision-makers.

The Swedish Council, too, was one of the first bodies of its kind in the world to

have taken up the subject of priorities in healthcare. This issue was raised by the

politician members of the Council. In the last two years, the principal motivations for

its published Opinions have been the transposition of European directives into

national law and the forthcoming ratification of Council of Europe protocols.

Website

SMER: http://www.smer.gov.se

Bibliography

Frank, M. (1994). The Role of the Parliamentarian in Ethics Committees. In: Council of Europe (ed.). Standing

Conference of European Ethics Committees. Proceedings, Stockholm 8 – 9 April 1994: 37 – 39.

Könberg, B. (1994). Introduction. In: Council of Europe (ed.). Standing Conference of European Ethics

Committees. Proceedings, Stockholm 8 – 9 April 1994: 7 – 8.

SMER (2002). Statement of Opinion on Embryonic Stem Cell Research (17.01.2002).

Available online at: http://www.smer.gov.se/index.htm?lang=en&index=0&url=intro.html

SMER (2002). Draft Additional Protocol to the Convention on Human Rights and Biomedicine, on Biomedical

Research (25.03.2002).

Available online at: http://www.smer.gov.se/index.htm?lang=en&index=0&url=intro.html

23


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Denmark

The Danish Council of Ethics (Det Etiske Råd) has attracted international attention

and, in particular, great praise for its proximity to the public (see Heubel, Kennedy

and Wikler), so that it can be seen as a third paradigm alongside the Swedish and

French models.

The Council was established by a law passed in 1987 and commenced work in

1988. It owed its foundation to a report entitled The Price of Progress presented by a

government commission after six months’ work in October 1984. The commission’s

terms of reference were to examine the ethical problems raised by gene technology,

artificial fertilization and prenatal diagnosis, and to determine whether there was a

need for political action. Particular features of the founding law are that it not only

lays down relatively specific issues for consideration by the Council but also includes

statements of values extending beyond a general espousal of principles of human

dignity and the freedom of the individual. It provides that the work of the Council

must “be based on the assumption that human life begins at the moment of fertilization”.

The Christian Democrats (the former Christian People’s Party) succeeded in

gaining acceptance for this provision in spite of a parliamentary and social controversy.

However, the formulation has neither led to a restrictive policy on the protection

of life, nor, apparently, had any effect on the actual work of the Council.

The very first considerations on the establishment of a council address the question

of its composition. The report The Price of Progress proposes a balance between

biomedical expertise and lay representation. The present composition is the result of

a struggle between different detailed approaches. A proposal by the Minister of the

Interior and Health was in competition with another put forward by a group of Social

Democratic members of the Danish Parliament (Folketinget). Whereas the former

was intended to provide a counterweight to the power of research, the latter

extended the expertise to be involved beyond biomedicine to the realms of philosophy,

law, the social sciences and nursing science. The lay component was represented

by members of adoption, women’s and youth organizations. The chair was required

to be impartial. In the eventual compromise enshrined in the relevant law, both sides

substantially refrain from detailed stipulation of the required competences. The responsibility

for appointments is specified as follows: the Minister of the Interior and

Health appoints eight members who must represent the non-biomedical world or

corresponding areas of expertise, while the Folketing is free to select the other nine

members according to its discretion – although they should include biomedical experts

so as to ensure an appropriate balance. The law also provides for the establishment

of a parliamentary commission for the Council of Ethics, which is responsible

not only for the selection and appointment of the nine members of the Council,

but also monitors the activity of the Council and acts as a link between it and the

24

Parliament (Folketinget). In terms of organization, the Council of Ethics falls within

the purview of the Ministry of Health, which provides the necessary resources and is

also responsible for staffing the Secretariat. However, the Minister does not have the

right to instruct the Council.

In the first few years of its activity, the Council worked through the subjects

already specified in the Law and drew up relevant reports – on the protection of

fertilized human ova; on the treatment of human gametes, fertilized ova, embryos

and fetuses by gene technology; and on prefertilization diagnosis, preimplantation

genetic diagnosis and prenatal diagnosis. Most of the subsequent issues covered have

been selected by the Council itself. These include priorities in healthcare, the treatment

and care of psychiatric patients, euthanasia, and organ transplantation. The

Council is not responsible for examining individual medical research projects in

accordance with the Helsinki Declaration. Nor does it act as a coordinating body for

such examinations. The only body with that responsibility is the Danish National

Committee on Biomedical Research Ethics (Den Centrale Videnskabsetiske Komité,

CVK), to which appeals against decisions of the regional research ethics commissions

may be directed.

Consideration of the reports issued so far does not suggest that the Council has

had any lasting influence on legislation. This is attributed to the fact that a large

group on the Council – in particular, the members without a biomedical background

– are more critical of biomedical developments than the political majority in

the Folketing (Koch/Zahle). The main influence of the Council is thus exercised

through its activity in the field of information and education. The principal vehicle

of this activity, in addition to the reports on individual ethical issues, is the annual report.

Both kinds of publications are intended to be widely disseminated free of

charge. The Council’s information and education function is also evident in its provision

of teaching material for schools and other educational institutions. The various

publications produced by the Council account for an appreciable portion of its

total budget. The Council also holds conferences and hearings. Through its activity

in the fields of publication and education, the Council has succeeded in defining the

main issues for public debate in Denmark.

Like other ethics bodies, in the last few years the Danish Council of Ethics has increasingly

found itself unable to arrive at a unanimous position, not only on the issue

of embryo research, which has arisen in a new form, but also on other matters.

The approach adopted in such cases – for instance, with regard to therapeutic cloning

and the practice of organ removal for donation purposes – is to publish the names of

the individual members of the Council who espouse the various positions.

Website

Det Etiske Råd: http://www.etiskraad.dk

25


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Bibliography

Andersen, S. (1996). Expertenurteil und gesellschaftlicher Konsens: Ethischer Rat und Konsensuskommissionen

in Dänemark. Jahrbuch für Wissenschaft und Ethik 1: 201 – 208.

The Danish Council of Ethics (1992). 4th Annual Report of the Danish Council of Ethics 1991. Copenhagen.

The Danish Council of Ethics (1992). Public Discussion about Bioethics. Copenhagen.

The Danish Council of Ethics (1993). Ethics and Mapping of the Human Genome: Protection of Sensitive

Personal Information; Genetic Screening; Genetic Testing in Appointments etc. Copenhagen.

The Danish Council of Ethics (1993). The Danish Council of Ethics Fifth Annual Report. Copenhagen.

The Danish Council of Ethics (1995). Assisted Reproduction – A Report. Copenhagen.

The Danish Council of Ethics (1998). Annual Report 1997. Copenhagen.

The Danish Council of Ethics (1999). Humans and Genetic Engineering in the New Millennium: How Are We

Going to Get “Gen-Ethics” Just in Time? Conference Paper. Copenhagen.

The Danish Council of Ethics (2003). The Perfect Person? – Statement on the Biotechnological Transformation

of People. Ethical Forum of Young People 2003. Available online at:

http://etisk.inforce.dk/graphics/03_udgivelser/engelske_publikationer/EthicalForum/index.htm

Heubel, F. (1997). Stellungnahme. In: Friedrich-Ebert-Stiftung (ed.). Braucht Deutschland eine Bundes-Ethik-

Kommission? – Dokumentation des Expertengesprächs Gentechnik am 11. März in Bonn. Bonn: 45 – 46.

Kemp, P. (1987). Les comités d’éthique et la politique. In: Comités d’éthique à travers le monde. 1, recherches

en cours 1986. Paris: 63 – 70.

Kennedy, I. (1994). Influence of Ethics Committees on Legislation. In: Council of Europe (ed.). Standing

Conference of European Ethics Committees. Proceedings, Stockholm 8 – 9 April 1994: 23 – 27.

Koch, L.; Zahle, H. (2000). Ethik für das Volk. Dänemarks Ethischer Rat und sein Ort in der Bürgergesellschaft.

In: Kettner, M. (ed.). Angewandte Ethik als Politikum. Frankfurt a. M.: 117 – 139.

Nielsen, L. N. (1994). Establishing Ethics Committees. In: Council of Europe (ed.). Standing Conference of

European Ethics Committees. Proceedings, Stockholm 8 – 9 April 1994: 17 – 20.

Nielsen, L. N. (2001). Hintergrundinformationen zur Errichtung von Ethikkommissionen. In: Enquete-

Kommission “Recht und Ethik der modernen Medizin” (14. Deutscher Bundestag). Stellungnahmen von

Vertreterinnen und Vertretern europäischer Ethikkommissionen zur Öffentlichen Anhörung “Europäischer

Diskurs zu ethischen Fragen der modernen Medizin“ vom 19. November 2001. Available online at:

http://www.bundestag.de/parlament/kommissionen/archiv/medi/medi_di_stell/Nielsen_dt.pdf

Wikler, D. (1996). Statement of Daniel Wikler. In: National Bioethics Advisory Commission (NBAC); National

Institutes of Health (NIH) (ed.). The International Summit of National Bioethics Advisory Bodies […]

San Francisco, California […] Thursday, November 21, 1996 […]: 196 – 212. Available online at:

http://www.georgetown.edu/research/nrcbl/nbac/transcripts/1996/11-21-96.pdf

26

Norway

Norway considers its model of the national organization of research ethics to be

unique in so far as it not only extends to biomedicine and biotechnology but also

seeks to cover all fields of research. In 1988/89, the Government proposed the establishment

of three national committees for research ethics. Following parliamentary

approval in 1990, the Ministry of Education, Research and Church Affairs defined

their mandates in detail. The members are nominated by the Research Council of

Norway and appointed by the Minister. They are not representatives of interest

groups, but are selected on the basis of personal qualification. Each committee is to

comprise at least nine members, of whom two in each case must be not specialists but

lay persons. The other members are specialists in ethics and law and specialists in the

disciplines for which the relevant committee is competent. In the case of the National

Committee for Medical Research Ethics (Den Nasjonale Forskningsetiske Komité

for Medisin, NEM), at least clinical practice and genetics must be represented. Important

issues considered have been the communication of fundamental and clinical

research, problems of resource allocation, and also the interests of sport. In

September 2001, the Committee published guidelines on the inclusion of women in

clinical studies. During the current term (2003 – 2005), guidelines for clinical research

on persons with limited mental competence are in preparation.

In the case of the National Committee for Research Ethics in Science and Technology

(Den Nasjonale Forskningsetiske Komité for Naturvitenskap og Teknologi,

NENT), the natural sciences, industry, technology, agricultural and fisheries research

must be represented, and there is explicit provision for representation of the disciplines

of ecology and modern biotechnology. The Committee has worked on problems

of gene technology in agriculture and on fisheries issues, and has taken part in

research projects for the European Commission.

Finally, with the NESH (Den Nasjonale Forskningsetiske Komité for Samfunnsvitenskap

og Humaniora), Norway also possesses an equivalent committee for

research ethics in the social sciences and the humanities. The specialists represented

on this committee are required to possess expertise in the fields of history, government,

sociology, psychology and ethnology. Its competence extends from the ethical

aspects of social-science research on children and of migration research to ethical issues

in literary studies.

In each of the fields covered by the three committees, research ethics is supposed not

to be defined narrowly but to be understood in the wider sense of a scientific ethics that

takes account of the responsibility of the sciences for social issues. Coordination and

the ability to take advantage of synergies are intended to be facilitated by institutional

and physical proximity. The committees share a single press and information office.

Website

De Nasjonale Forskningsetiske Komiteer: http://www.etikkom.no

27


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Finland

A number of bodies responsible for dealing with ethical issues of research and science

were established in Finland by specific laws and government regulations in the 1990s;

these are accommodated in the Ministry of Education, in the Ministry of Social Affairs

and Health, or in the provincial offices of the Ministry of Agriculture. The Ministry

of Agriculture’s Animal Experiments Committees are intended to guarantee the

protection of animals in research, while the Cooperation Group for Laboratory Animal

Sciences (Koe-eläintutkimuksen yhteistyöryhmä, KYTÖ) to promote the consideration

of ethical issues in teaching and the provision of information was set up

in the Ministry of Education in 2001.

Both the Board for Gene Technology (Geenitekniikan lautakunta, GTLK) and the

National Advisory Board for Biotechnology (Biotekniikan neuvottelukunta, BTNK)

were established by decree in 1995. Whereas the GTLK issues Opinions on and evaluations

of genetically modified organisms and is the competent authority for European

Community purposes, the BTNK is tasked with the promotion of research and

cooperation in the field of biotechnology, as well as with assessing the consequences

of technology. The decree also explicitly calls for stimulation of the consideration of

ethical aspects. The Board is appointed by the Council of State. The National Institute

of Health provides the chair and the Ministry of Education his or her deputy.

The Board includes in addition 18 members from the field of research, relevant bodies

and non-governmental organizations.

The National Advisory Board on Research Ethics (Tutkimuseettinen neuvottelukunta,

TENK), whose members are appointed by the Minister of Education and

which was established as long ago as in 1991, is also not an ethics council along the

lines of the French or Danish model, but has a different task. In view of the great importance

of research to Finnish society, great store has been set by scientific integrity

in order to guarantee the social standing of, and trust in, science. The TENK is thus

responsible for formulating standards of scientific activity and for preventing dishonesty

and deceit. For this reason, the Board is constantly working on recommendations

of the kind formulated in Germany by, for example, the Deutsche Forschungsgemeinschaft

(German Research Foundation) or the Max Planck Society, to be applied

by the ombudsmen at the universities.

Hence the only Finnish equivalent to the European ethics councils discussed so

far is the ETENE (Valtakunnallinen terveydenhuollon eettinen neuvottelukunta), the

National Advisory Board on Health Care Ethics. The ETENE was established in 1998

as a body of experts within the Ministry of Social Affairs and Health and is required

to draw up Opinions on all ethical issues arising in the healthcare system, in particular

with a view to legislation. Another function is the collection and forwarding

of information in this field. The chair, the deputy chair and the other 18 members

28

represent patients, healthcare service providers, the health professions, law, the health

sciences and ethics. The membership is completed by four Members of Parliament.

The Board is appointed by the Council of State.

A particular feature of the Advisory Board is that it possesses a permanent Sub-

Committee on Medical Research Ethics (Lääketieteellinen tutkimuseettinen jaosto,

TUKIJA), which assists the regional research ethics boards mainly by offering training

for their members. It is also responsible for arriving at a single national position

on multi-centre international clinical trials. For this purpose it usually consults the

regional boards.

Websites

ETENE: http://www.etene.org

KYTÖ: http://www.helsinki.fi/koe-elaintoiminta

GTLK: http://www.geenitekniikanlautakunta.fi

BTNK: http://www.biotekniikanneuvottelukunta.fi

TENK: http://www.pro.tsv.fi/tenk

Bibliography

Halila, R. (2003). The Role of National Ethics Commissions in Finland. Bioethics 17/4: 357 – 368.

Lötjönen, S. (1999). Ethics Committees in Finland. Available online at:

http://pro.tsv.fi/tenk/ETHICS%20COMMITTEES%20IN%20FINLAND.pdf

29


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Iceland

Iceland too has a national bioethics committee (Vísindasidanefnd). However, this is

not a commission that focuses on general bioethical issues and their possible political

consequences, but a central committee for examining research projects involving

human subjects. The use of human biological material for research purposes also falls

within the competence of this supervisory body. In the context of the implementation

of the 1998 Law Establishing a Database for the Health Sector, the Committee,

through its examination of specific research projects, addressed the fundamental issues

of consent posed by the establishment of biobanks and medical databases.

Website

Visindasidanefnd: http://www.visindasidanefnd.is

30

United Kingdom

The function of a national bioethics committee is performed in the United Kingdom

by an independent, non-governmental body, the Nuffield Council on Bioethics.

There are also state bodies whose responsibilities correspond to those of national

ethics commissions in other countries. In view of their relatively long history, they

will be described first.

Human Fertilisation and Embryology Authority (HFEA)

The foundation of this standing statutory body was preceded by the British Government’s

appointment of an ad hoc advisory group on the problems of artificial fertilization

and embryo research. Like its somewhat later counterpart in Germany, the

Benda Commission, it was named after its chair, the philosopher Dame Mary

Warnock (now Baroness Warnock). Its concluding report of 1994 laid the foundations

of the subsequent legislation.

The Authority was established in 1991 to ensure that clinics offering medically

assisted reproductive procedures did so with appropriately high medical and professional

standards and were regularly inspected. All research on human embryos must

be approved by the HFEA. The 21 members of the Authority are appointed by UK

Health Ministers. More than half of their number must have backgrounds in disciplines

other than medicine and embryo research.

Human Genetics Commission (HGC)

In May 1999, the British Government also established the HGC, to advise it on human

genetics issues, and not only to consider economic prospects but also to draw

attention to the ethical, legal and social implications. The HGC is required to be impartial

and to provide for a degree of transparency. Personal interests must be disclosed.

In addition to the Chair of the HFEA, leading clinicians, research workers,

ethicists, legal experts, patients, consumers and lay persons are represented on the

Commission. Membership is based on personal merit rather than representation of

a group or association. The Commission combines the tasks of a number of earlier

bodies that have since been wound up. Members are appointed by the science and

health ministers on the basis of nominations by a Department of Health committee,

to which anyone is free to volunteer for this work.

An instrument often used by the HGC in the past was to consult external experts

and the public. This procedure was also adopted in the preparation of the report on

the supply of genetic tests direct to the public, published in April 2003. The function

of maintaining contacts with other national ethics bodies in the United Kingdom is

performed mainly by the HGC.

31


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Nuffield Council on Bioethics

The Nuffield Council on Bioethics was established by the Nuffield Foundation in 1991.

It is independent and is funded jointly by the Nuffield Foundation, the Wellcome

Trust and the Medical Research Council. Its mission is to select important issues in

the field of bioethics and to set up working parties to consider them. The working

parties draw up lengthy reports and issue brief recommendations. So far they have

produced reports on genetic screening, the use of human tissues, xenotransplantation,

mental disorders and genetics, genetically modified crops, medical research in developing

countries, the ethics of patenting DNA, and genetics and human behaviour. In

addition, discussion papers are sometimes compiled. The discussion paper Stem Cell

Therapy: Ethical Issues of 6 April 2000 substantially anticipated current British legislation

on therapeutic cloning and its regulation.

The Council does not claim to be representative. It has only 14 members, chosen

for their outstanding knowledge and experience. Its reports are particularly valued by

international expert groups. Invitations to apply for membership are issued at intervals

when a vacancy arises. They are directed in particular to medical practitioners,

natural scientists, teachers, legal experts, persons with media and health management

experience, and individuals with philosophical and ethical backgrounds. The

Nuffield Council has often sent delegates to the Global Summit of Bioethics Advisory

Bodies, and has sometimes supplied members of its planning bureau.

Websites

HFEA: http://www.hfea.gov.uk

HGC: http://www.hgc.gov.uk

Nuffield Council: http://www.nuffieldbioethics.org

Bibliography

Gelder, M. G. (1990). A National Committee for the Ethics of Research. Journal of Medical Ethics 16/3: 146 – 147.

McCall Smith, A. (2001). Fragenbeantwortung. In: Enquete-Kommission “Recht und Ethik der modernen

Medizin” (14. Deutscher Bundestag). Stellungnahmen von Vertreterinnen und Vertretern europäischer

Ethikkommissionen zur Öffentlichen Anhörung “Europäischer Diskurs zu ethischen Fragen der modernen

Medizin” vom 19. November 2001. Available online at:

http://www.bundestag.de/parlament/kommissionen/archiv/medi/medi_di_stell/McCall_dt.pdf

Nuffield Council (1992). Annual Report 1991/92. London.

Nuffield Council (1992). Press Release: Working Party on Genetic Screening. London.

Nuffield Council (1995). Human Tissue: Ethical and Legal Issues. London.

Nuffield Council (1996). Animal-to-Human Transplants: The Ethics of Xenotransplantation. London.

Nuffield Council (1999). Genetically Modified Crops: The Ethical and Social Issues. London.

Nuffield Council (2000). Nuffield Council on Bioethics 1992 – 99. London.

32

Nuffield Council (2000). Stem Cell Therapy: The Ethical Issues; a Discussion Paper. London.

Nuffield Council (2002). The Ethics of Research Related to Health Care in Developing Countries.

Available online at: http://www.nuffieldbioethics.org/fileLibrary/pdf/errhdc_fullreport001.pdf

Shapiro, D. (1995). Nuffield Council on Bioethics. Politics and Life Sciences 14/2: 263 – 266.

Turner-Warwick, M. (1994). Ways and Means of Ethics Committees: Counselling Authorities, Health System.

In: Council of Europe (ed.). Standing Conference of European Ethics Committees. Proceedings, Stockholm

8 – 9 April 1994: 35 – 37.

33


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Ireland

The Royal Irish Academy set up the Irish Council for Bioethics (Comhairle Bitheitice

na hÉireann) in May 2002, in response to the recommendation of an interministerial

working party on modern biotechnology dating from October 2000.

The 21 members appointed by the Academy are legal experts, philosophers, ethicists,

physicians, geneticists, food scientists, biologists, microbiologists, biochemists

and journalists. Although they are drawn from important institutions, they are not

their representatives but are chosen on the basis of personal expertise and authority.

Their independence from the Academy is stressed.

The Council is required to identify and consider ethical issues raised by biological

and medical research. The aim of its deliberations and reports is to improve public

understanding and to make for informed discussion and education. In addition to

encouraging debate, another function is to propose guidelines where appropriate.

There are at present three working groups. The group on the use of human biological

material is engaged on drawing up recommendations for research (now published).

The working group on genetically modified organisms deals with ethical

issues in the spheres of medicine, industry and agriculture with particular reference

to their Irish specificities. Finally, the group on ethics committees is initially intended

to review their actual modes of operation, with a view to compiling a guide to the

composition, structure and mode of operation of ethics committees in Ireland. All

working groups may co-opt external expertise.

Website

The Irish Council for Bioethics: http://www.bioethics.ie

34

3. Southern Europe

Italy

The initiative for establishing the Italian National Bioethics Committee came from

Parliament. The outcome of a debate on “problems of life” on 5 July 1988 was that

the Assembly of the Chamber of Deputies committed the Government to initiate a

debate, at both national and international level, on the status of biomedical research

and gene technology with a view to the preservation of human dignity and freedom,

and for this purpose proposed that a committee be set up.

The Comitato Nazionale per la Bioetica (CNB) was established by decree of the

President of the Council of Ministers of 28 March 1990. An organ of the Presidency

of the Council of Ministers, it is tasked with advising the Government, Parliament

and other institutions. The Committee can be requested to furnish information in

the field of bioethics by the bodies mentioned, research centres, local ethics committees,

scientists and individual citizens. It also has the function of liaising with similar

bodies in other states, the European Union and the Council of Europe.

The Committee is explicitly called upon to furnish both information and advice.

It is required to provide information mainly on new research projects in the biosciences.

Its advisory activity includes assessing and reporting on ethical and legal issues

and is intended to lead to legislation, the establishment of monitoring and

supervisory mechanisms, and consciousness raising and opinion formation among

the public and representatives of various interests. In this way it is hoped not only to

arrive at solutions in the field of law and professional codes but also to establish

moral rules. To this end the Committee has considered a broad spectrum of ethical

issues in the field of biomedicine as well as some in ecology. In a small number of cases,

its influence on legislation is clearly evident. For instance, the Law on the Definition

and Determination of Death substantially conforms to the Committee’s

documents. However, such influence is by no means the rule.

The President of the Council of Ministers appoints the members, who are selected

from the fields of law, research and healthcare or on the basis of their competence

in the sphere of ethics or as representatives of society (the family, education, and so

on). The Committee at present comprises 43 members in addition to the President,

four honorary presidents and three vice-presidents. Representatives of national research

institutions and of the nurses’ association belong ex officio to the Committee.

Unlike the situation in France, whose committee exhibits a relative degree of continuity,

or in Belgium, where the same is true despite the difficulties experienced at the

time of establishment and those of arriving at a consensus between the individual

communities, the subordination to the Council of Ministers and to Italy’s democratic

35


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

institutions has manifestly resulted in discontinuity, even if this does not emerge

from the official documents. Observers report that the beginning of Silvio Berlusconi’s

first term in government represented a caesura in the Bioethics Committee as

elsewhere in Italy (Lenoir, 20).

Since its foundation, the National Committee has on a number of occasions considered

the situation of the local ethics commissions. It has also discussed the Convention

presented by the Council of Europe and its additional protocols. Its recent

deliberations on embryo research and therapeutic cloning compete with those of

other bodies. The fundamental consensus that early human life deserves particular

protection, which unites the Committee notwithstanding major differences, led to

the adoption of cautious recommendations in relation to health policy, which met

with criticism in the Ministry of Health. For this reason, in September 2000, the Ministry

appointed the Commissione Cellule Staminali, chaired by the Nobel Laureate

Renato Dulbecco, to examine some important aspects of this issue. The question of

the status of the embryo was subordinated to scientific expectations and therapeutic

hopes. The 25-member commission, made up of scientists and ethicists, took a much

more positive view, and adopted a much more liberal attitude, than the National

Bioethics Committee. The Committee has recently considered the subject of nicotine

addiction. It calls for the abandonment of tobacco cultivation in favour of other agricultural

products.

Website

CNB: http://www.governo.it/bioetica

Bibliography

Lenoir, N. (1997). Nationale Ethikkommissionen in Europa – Möglichkeiten und Grenzen. In: Friedrich-Ebert-

Stiftung (ed.). Braucht Deutschland eine Bundes-Ethik-Kommission? – Dokumentation des Expertengesprächs

Gentechnik am 11. März in Bonn. Bonn: 5 – 27.

Maio, G. (2001). Die ethische Diskussion um embryonale Stammzellen aus internationaler Sicht – das Beispiel

Italien. Zeitschrift für medizinische Ethik 47/3: 299 – 309.

Wray, E. (2000). Ethics Committees in Italy – A Time for Change? Bulletin of Medical Ethics & EACME

News 160: 13 – 16.

36

Portugal

The Conselho Nacional de Etica para as Ciências da Vida (CNECV) was established

by a law of 9 June 1990. Although an independent body, it is linked to the office of

the President of the Council of Ministers. Its function is systematic analysis of the

moral problems posed by scientific progress in the field of biology, medicine and

general healthcare. It is required to furnish an annual report to the President of the

Council of Ministers on the status of new technologies and their application to human

subjects, as well as the associated ethical and social problems, and to draw up

recommendations on these problems.

The Council’s President is appointed by the President of Council of Ministers. Article

3 of the Law provides that the Council shall have another 20 members, of whom

seven must be distinguished in the humanities and social sciences and have shown

particular interest in ethical problems, while seven others must be experienced in

medicine or biology, including the ethical implications of these disciplines. Finally,

six members representing the principal faiths and ethical philosophies are appointed

by the National Assembly. Of the seven representatives of the humanities, four are appointed

by Ministers (of Planning, Justice, Education and Youth) and the others by

the Conference of University Rectors, the Law Society and the Council for Women’s

Issues. Responsibility for appointing the medical experts and biologists rests with the

Minister of Health, the Conference of University Rectors, the Academy of Sciences,

the Medical Association, the National Institute of Scientific Research, the National

Commission on Scientific and Technological Research and the Higher Council on

Forensic Medicine. As in France, the Council appoints a ten-member coordinating

committee from among its members and may establish working parties.

The right of referral is not confined to the institutions of state but extends far beyond

them. Article 11 of the founding law already provides for regular conferences to

ensure ongoing dialogue with the public. Even so, the Council itself admits to difficulties

precisely in communication with the media, at least in the initial phase. The

Council is dependent for administrative and financial resources on the Office of the

President of the Council of Ministers, to which it is institutionally subordinated and

whose premises it shares. The Law provides for the establishment of a documentation

centre to support the Council in its work. However, the centre is appreciably

smaller than its counterpart in Paris at INSERM.

Over the last 13 years, the Council has compiled reports and adopted positions on

almost all issues of biomedical ethics. It meets once a month in plenary session, and

a number of working parties also hold meetings. The Council is in addition free to

comment on issues that are already regulated by law. For this reason, it also considers

itself responsible for monitoring ethical standards (National Council, 8). Despite

the relatively small scale of biomedical research in Portugal, the CNECV has issued a

37


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

very large number of reports and greatly boosted the development of bioethics in

Portugal. The country has hosted meetings of the European Conference of National

Ethics Committees (Oporto 1998), the European Association of Centres of Medical

Ethics (Coimbra 1997, Lisbon 2003) and many other international conferences.

Website

CNECV: http://www.cnecv.gov.pt

Bibliography

National Council of Ethics for the Life Sciences (1999). Aims, Structures & Functions. Lisbon.

Malta

The Maltese Bioethics Consultative Committee was set up within the Ministry of

Health in 1991. Its members are appointed directly by the Minister of Health or his

or her deputy and are required to include medical and scientific experts, psychologists,

social workers, representatives of the legal profession, of professional ethics and

of the non-medical health professions, as well as lay people. The 12 members currently

include one representative of the media and one Member of Parliament.

The members of the Committee regard it as their responsibility to promote the

consideration of bioethical issues in research and teaching and to stimulate public information

and debate. The Maltese Committee is consistently represented at meetings

of the Council of Europe’s Conferences of National Ethics Committees and at

the Global Summit by its chair, the pathologist Professor M. N. Cauchi. All its documentation

on its own role strongly emphasizes the aspect of education. The Committee

does not claim to possess an independent political advisory function.

Website

Bioethics Consultative Committee: http://www.health.gov.mt/statutory_bodies/bcc.htm

38

Greece

A law dating from 1998 established both a National Commission on Human Rights

and the National Bioethics Commission in Greece. The latter is tasked with examining

the ethical, social and legal consequences of advances in biology, biotechnology,

medicine and genetics. It is required to present Opinions, to inform society on ethical

issues, and to coordinate the various governmental advisory bodies in this field.

The nine members of the Commission are appointed by the Prime Minister for

five-year terms. They are professors and emeritus professors of the Universities of

Athens, Thessaloniki and Patras from the disciplines of civil and criminal law, genetics,

pathology, philosophy, sociology and theology.

The Commission has so far issued reports and recommendations on genetically

modified plants, the application of genetic fingerprinting, and the use of stem cells

in biomedical research and clinical medicine. Following its meetings of January and

February 2003, the Commission published a recommendation on human reproductive

cloning. An Opinion on patents in biotechnology followed in the second half of

the same year. Future subjects to be considered include transplant medicine.

Website

National Bioethics Commission: http://www.bioethics.gr

Bibliography

National Bioethics Commission. Recommendations. Available online at:

http://www.bioethics.gr/category.php?category_id=55

39


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Spain

Although Spain has had a national ethics commission for only three years, it has already

greatly influenced legislation. The Commission commenced work in July 2002,

after the Council of Ministers had established the Foundation for Science and Technology

(Fundación Española de Ciencia y Tecnología, FECYT), which includes an

advisory committee on ethics (Comité Asesor de Etica) in addition to other committees.

As a national ethics body, it deals not only with bioethical issues but also with

other matters involving the ethics of science and technology. Besides the chair, it has

eleven members, of whom four are drawn from the life sciences, five from the world

of medicine and one each from the disciplines of law and philosophy. The President

of the Council of Ministers officially received the first report of the new Commission

in the spring of 2005. The proposed amendment of the Spanish law on reproductive

medicine espouses some of its conclusions.

Considering that Spain is a country in which bioethical themes such as reproductive

or transplant medicine are the subject of vigorous debate both in society and in

cultural life, and where particular individuals have played a major part in the process

of arriving at a European and international consensus, the fact that the Commission

was established so late may be found surprising. The first conference of national

ethics councils of member states of the Council of Europe was held in Madrid as long

ago as in 1992 – that is, ten years before Spain itself formed such a body. The reasons

for this delay cannot be examined here (see, for example, Byk/Mémeteau 1996, 269).

As in every other country where the process of opinion formation had to get under

way without an ethics council, Spain had other bodies which performed this function

in part. These included, in particular, the Comisión Nacional de Reproducción

Humana Asistida (CNRHA), which was set up by Royal Decree in 1997.

Like Germany and Canada, Spain has regional advisory bodies, in this case in the

comunidades autónomas (autonomous regions). Particular mention should be made

in this respect of Catalonia, which has not only a long-established major research institute

but also, since 1991, a regional ethics commission, known since 2001 as the

Comitè de Bioètica de Catalunya. Catalonia was represented at the national ethics

committee summits in London and Brasilia, whereas Spain itself failed to send a

representative.

Websites

Comité Asesor de Ética: http://www.fecyt.es/default.cfm?id_seccion=1919&id_sec=1918&nivel=1

Comitè de Bioètica de Catalunya: http://www.gencat.es/sanitat/portal/cat/spbioe00.htm

Bibliography

Byk, Chr.; Mémeteau, G. (1996). Le droit des comités d’éthique (Collection “Médecine et droit”). Paris.

40

4. Germany, Switzerland and Austria

Germany

As long ago as the mid 1980s, the bioethical debate in Germany led to the establishment

of important advisory bodies by institutions of state. For instance, two committees

met for the first time in 1984, and subsequently held simultaneous meetings –

namely, the working party on genome analysis and gene therapy appointed jointly by

the Federal Minister of Justice and the Federal Minister of Research and Technology

(the Benda Commission, named after its chair, Professor Ernst Benda) and the Ad

Hoc Commission of Inquiry on the Prospects and Risks of Gene Technology, set up

by the Bundestag (the Lower House of the German Parliament). The composition of

the Benda Commission was based on the principle of interdisciplinarity, with certain

important organizations and associations also being represented: it included scientists

and medical experts from various learned societies and research foundations,

representatives of the major churches, a philosopher, representatives of a variety of

legal disciplines, of the Bundesärztekammer (German Medical Association), of the

Federal Employers’ Association and of the German Trades Union Congress. In accordance

with the Bundestag’s usual principles, the Ad Hoc Commission of Inquiry

included both parliamentarians and experts selected by the parliamentary parties

from various disciplines and interest groups. After some two years’ work, the two bodies

submitted their concluding reports and recommendations to the legislature.

The first permanent national-level ethics commission in Germany was established

not by an institution of state but by the German Medical Association. It was

formed on 13 March 1994 as the Association’s Central Ethics Commission. Although

it does not constitute a high-level body to which the regional medical associations’

medical ethics commissions on research involving human subjects can appeal, it is

nevertheless required to express a view on specific projects involving issues of particular

importance, and thus to act as an advisory body for the local ethics commissions.

Another of its functions is to comment, independently of the German Medical

Association, on fundamental issues arising in the bioethical debate and on ethical

questions posed by the healthcare system. The first governmental body to follow the

example of the German Medical Association was the Federal Ministry of Health in

1995. It appointed an advisory committee on ethics to advise and inform the Federal

Minister of Health on ethical aspects of health policy. After the change of government,

a new body with a similar mandate was established by decree, appointed and

convened by the Federal Minister of Health on 15 November 1999.

In the following year, the Bundestag voted to set up an Ad Hoc Commission of Inquiry

on the Law and Ethics of Modern Medicine (Enquete-Kommission Recht und

41


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Ethik der modernen Medizin). Whereas the Commission’s terms of reference mention

future issues of modern medicine, the Commisison, while still adopting a wide-ranging

approach, focused on a narrower range of subjects – namely, reproductive medicine,

prenatal diagnosis, preimplantation genetic diagnosis, the handling of genetic

data and tests, stem cell research, and general aspects of the bioethical debate and

social participation.

Having regard to institutional developments in Europe – in particular, in France

and Denmark – a vigorous discussion began in the mid-1990s on whether Germany

should establish an ethics commission at Federal level. At the instigation of the Bundestag

deputies Wolf-Michael Catenhusen and Gudrun Schaich-Walch, a meeting of

experts was convened at the Friedrich Ebert Foundation in Bonn in March 1997 on

the subject “Does Germany need a Federal Ethics Commission?” Noëlle Lenoir reported

on and assessed the experience of other countries. The draft on which the two

initiators based the debate assumed that when a German commission was formed it

would be responsible to Parliament. This institutional framework was the main point

of contention in the debate. While Professor Dr. Richard Toellner (theory and history

of medicine, University of Münster) took the view that the commission should be assigned

to the Federal President, other experts – Professor Dr. Günter Altner and Professor

Dr. Klaus Michael Meyer-Abich – favoured an association with the Bundestag

(Meyer-Abich) or close proximity to Parliament (Altner). Finally, the deputy Sigrun

Löwisch advocated an arrangement similar to the Swiss model then in operation, in

which the commission would come under the auspices of an academy of sciences, in

which case a German Academy of Sciences would first have to be established.

It was not until May 2001, when the Federal Government decided to establish the

National Ethics Council (Nationaler Ethikrat), that the project for a Federal ethics

commission became a reality. The Council’s members are nominated and appointed

by the Federal Chancellor. The Secretariat is accommodated within the Berlin-Brandenburg

Academy of Sciences. According to the founding decree, the Council constitutes

“a national forum for dialogue on ethical issues in the life sciences”. It is

intended to serve as the central organ for interdisciplinary discourse between the natural

sciences, medicine, theology and philosophy, and the social and legal sciences; to

organize the social and political debate and ensure that all the relevant groups are involved;

and to provide citizens with information and material for discussion, for example

by holding public conferences. Not until the second paragraph of the relevant

section of the founding decree (Section 2(2)) is the Council assigned the task of

drawing up Opinions at the request of the Federal Government or of the Bundestag.

The decree itself already provides for collaboration with other national ethics committees

(Section 2(4)). The Council is to be composed of up to 25 members “who

shall be prominent representatives of the scientific, medical, theological, philosophical,

social, legal, ecological and economic worlds”. The chair is elected from among

42

the Council’s members. How and to what extent the various aspects are to be represented

is not laid down in writing. Almost immediately after its formation, the Council

was confronted with a request for an Opinion on the import of human embryonic

stem cells, which was presented in December 2001. A further, very long Opinion on

genetic diagnosis before and during pregnancy followed in January 2003. The subjects

of biobanks and cloning are currently being discussed by a number of working

parties (the relevant Opinions have now been published). The requirement of exchanges

with other national ethics committees on specific matters is amply satisfied

both by the chair and individual members and by the Ethics Council as a whole.

Every year the National Ethics Council holds several public conferences, while its

monthly meetings have been open to the public since January 2003.

Websites

Nationaler Ethikrat: http://www.ethikrat.org

Enquete-Kommission “Ethik und Recht der modernen Medizin”:

http://www.bundestag.de/parlament/kommissionen/ethik_med

Bibliography

Catenhusen, W.-M. (1997). Vorstellung des Projekts Bundesethikkommission vor dem Hintergrund der

deutschen Ethikdiskussion. In: Friedrich-Ebert-Stiftung (ed.). Braucht Deutschland eine Bundes-Ethik-

Kommission? – Dokumentation des Expertengesprächs Gentechnik am 11. März in Bonn. Bonn: 1 – 4.

Enquete-Kommission “Recht und Ethik der modernen Medizin” (2002). Schlussbericht der Enquete-

Kommission “Recht und Ethik der modernen Medizin” (Drucksache / Deutscher Bundestag, 14,9020).

Available online at: http://dip.bundestag.de/btd/14/090/1409020.pdf

Florian, U. (2003). Neue Mitglieder in den Nationalen Ethikrat berufen. Available online at:

http://idw-online.de/pages/de/news64562

Kuhlmann, A. (2002). Kommissionsethik. Zur neuen Institutionalisierung der Moral. Merkur. Deutsche

Zeitschrift für europäisches Denken 56/1: 26 – 37.

Löwisch, S. (1997). Politische Bewertungen aus Sicht der Bundestagsfraktionen. In: Friedrich-Ebert-Stiftung (ed.).

Braucht Deutschland eine Bundes-Ethik-Kommission? – Dokumentation des Expertengesprächs Gentechnik am

11. März in Bonn. Bonn: 52 – 55.

Staeck, F.; Renn, O. (2001). “Die Ethikdebatte kann man nicht an ein Gremium delegieren”. Ärzte Zeitung 85

vom 09.05.2001. Available online at: http://www.aerztezeitung.de/docs/2001/05/09/085a0501.asp

Toellner, R.; Altner, G.; Meyer-Abich, K.-M. (1997). Eine Bundesethikkommission in Deutschland?

Stellungnahmen und Kommentare. In: Friedrich-Ebert-Stiftung (ed.). Braucht Deutschland eine Bundes-Ethik-

Kommission? – Dokumentation des Expertengesprächs Gentechnik am 11. März in Bonn. Bonn: 28 – 51.

Weber-Hassemer, K. (2002). Politische Entscheidung und Politikberatung in der “konsensualen Demokratie” am

Beispiel des Nationalen Ethikrates. Referat der Tagung “Genetik und die Zukunft des Menschen – Positionen

aus dem Nationalen Ethikrat” 19. – 21. Juli 2002. Available online at:

http://www.ethikrat.org/texte/pdf/elmau_referate/Referat_Weber-Hassemer.pdf

43


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Switzerland

Switzerland too has established a national ethics body in addition to other existing

commissions: in the spring of 2001, the Swiss National Advisory Commission on Biomedical

Ethics (Nationale Ethikkommission im Bereich Humanmedizin - Commission

Nationale d’Ethique pour la Médecine Humaine, NEK-CNE) was appointed by

order of the Federal Council, in accordance with a relevant provision of the Federal Law

on Medically Assisted Reproduction (the Reproductive Medicine Law) as last revised

in December 2000 (Article 28). The function of the new Commission is to inform the

public and to promote debate on ethical issues in society, to prepare recommendations

for medical practice, to draw attention to lacunae and problems of enforcement

in the national and cantonal legal codes, to advise the Federal Assembly, the Federal

Council and the Cantons and to draw up reports on behalf of the Federal Council.

The Commission has 18 to 25 members, who are appointed for a four-year term

by the Federal Council and are required to perform their functions personally and independently.

The Commission is currently made up of experts from the healthcare sector,

patients’ representatives, natural scientists, legal specialists, social scientists,

economists, ethicists and “lay persons with a particular understanding of ethical issues”.

The 21 appointed members have so far presented Opinions on the import of embryonic

stem cells, on time limits for the termination of pregnancy, on embryonic

stem cell research, on the ethical aspects of the Swiss Embryo Research Law and on

human reproductive cloning. A number of Opinions issued in 2003 are concerned

with problems of living donation in transplant medicine.

The Swiss Confederation’s first initiative for the establishment of a national ethics

commission dates from 1998. On 27 April 1998 the Federal Council decreed the establishment

of the Swiss Ethics Committee on Non-Human Gene Technology (Eidgenössische

Ethikkommission für die Biotechnologie im Ausserhumanbereich,

EKAH), which it charged with advising the Federal Council and its subordinate bodies

on ethical issues in the preparation of legislation, by the provision of Opinions on

draft laws and proposals for future legislation. The Commission is also required

to express its views on applications for the approval of exemplary projects involving

genetically modified organisms, to inform the public and to promote dialogue on

biotechnology. The 12 members of the EKAH comprise four natural scientists, one

politician, one legal expert, two philosophers and four theologians (one of whom

is the chair). The Secretariat is accommodated within the Federal Agency for the

Environment, Forests and Landscapes. The chair of the EKAH is also a member of

the NEK-CNE.

In May 2000 the Commission issued an Opinion on regulation of the release of

genetically modified organisms, in which it advocated a moratorium on commercial

releases of genetically modified organisms (GMO) and on trials directed towards

44

their marketing. In the context of the ethical debate on the patenting of animals and

plants, the Commission in March 2001 presented a discussion paper that in principle

favours the protection of intellectual achievements in biotechnology as in other

fields, but proposes the model of an “invention privilege” to take account of misgivings

and ethical objections. A brochure entitled Gene Technology for Food was published

in March 2003.

Prior to the State’s initiatives, the Swiss Academy of Medical Sciences (Schweizerische

Akademie der Medizinischen Wissenschaften, SAMW) had established some

important bodies that performed some of the functions of a national ethics council.

The Supraregional Ethics Commission on Clinical Research appointed by the Senate

in 1992 was tasked for some years with the assessment of multi-centre studies. It was

made up not only of representatives of the medical profession but also of legal experts,

ethicists, researchers in the field of nursing care, theologians and representatives

of the churches. There is also an ethics commission specifically devoted to animal

experiments. Another pluralistic body, the Central Ethics Commission, was formed

as long ago as in 1979 with the aim of setting new standards for the protection of patients

and society. Given its function of drafting “medical-ethics guidelines” on problems

in various fields, its activity was quite comparable with that of national ethics

councils. Since the formation of the NEK-CNE, this body has sought to work together

with the National Advisory Commission. Its work has always extended far beyond

the representation of research and the interests of research workers.

Websites

NEK-CNE: http://www.nek-cne.ch

EKAH: http://www.umwelt-schweiz.ch/buwal/de/fachgebiete/fg_ekah

Bibliography

Bundesversammlung der Schweizerischen Eidgenossenschaften (2000). Bundesgesetz über medizinisch

unterstützte Fortpflanzung (Fortpflanzungsmedizingesetz, FmedG). Nr. 814.90.

EKAH (1998). Vorläufige Stellungnahme zur Gen-Lex-Vorlage.

Available online at: http://www.umwelt-schweiz.ch/imperia/md/content/ekah/3.pdf

EKAH (2001). Schutz intellektueller Leistungen im Bereich der Biotechnologie: Ethische Überlegungen zur

“Patentierung” von Tieren und Pflanzen. Ein Diskussionsbeitrag.

Available online at: http://www.umwelt-schweiz.ch/imperia/md/content/ekah/7.pdf

EKAH (2001). Stellungnahme der EKAH zur Regelung von Freisetzungen gentechnisch veränderter Organismen.

Available online at: http://www.umwelt-schweiz.ch/imperia/md/content/ekah/4.pdf

Guillod, O. (1997). Le rôle des comités nationaux d’éthique. In: Bioéthique: de l’éthique au droit, du droit à

l’éthique. Colloque international, Lausanne, 17 – 18 octobre 1996 (Publications de l’Institut suisse de droit

comparé, 30). Zurich: 257 – 274.

NEK-CNE (2002). Zur Forschung an embryonalen Stammzellen (Stellungnahme 3/2002). Bern.

Available online at: http://www.nek-cne.ch/de/pdf/sn3_stammz_de.pdf

45


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

NEK-CNE. Einleitung. Available online at: http://www.nek-cne.ch/de

NEK-CNE. Internes. Mitglieder. Die Mitglieder der Nationalen Ethikkommission im Bereich der Humanmedizin.

Available online at: http://www.nek-cne.ch/de

Schweizerische Akademie der Medizinischen Wissenschaften (2001). Positionspapier der Zentralen

Ethikkommission zur Gewinnung von und Forschung an menschliche Stammzellen. Available online at:

http://www.samw.ch

Vallotton, M. (2001). Antworten zum Katalog der Enquete-Kommission “Recht und Ethik der modernen

Medizin”. In: Enquete-Kommission “Recht und Ethik der modernen Medizin” (14. Deutscher Bundestag).

Stellungnahmen von Vertreterinnen und Vertretern europäischer Ethikkommissionen zur Öffentlichen

Anhörung “Europäischer Diskurs zu ethischen Fragen der modernen Medizin” vom 19. November 2001.

Available online at:

http://www.bundestag.de/parlament/kommissionen/archiv/medi/medi_di_stell/Vallotton_dt.pdf

Austria

A Bioethics Commission (Bioethikkommission beim Bundeskanzleramt) was established

in Austria by order of the Federal Chancellor of 29 June 2001. Its mission is “to

advise the Office of the Federal Chancellor on the ethical aspects of all social, scientific

and legal issues arising in connection with the development of the sciences of

human medicine and biology” (cf. Section 2, Bundesgesetzblatt I No. 141/2000). In

particular, in addition to practical recommendations, proposals for necessary legislative

measures and reports on specific issues, the order emphasizes first and foremost

the furnishing of information and the promotion of debate on important discoveries

in human medicine and biology and on the associated ethical issues in society.

The order provides that the Commission shall have between 15 and 25 members. The

disciplines to be represented are medicine, molecular biology and genetics, law, sociology,

philosophy and theology. Within the field of medicine, specific mention is

made of reproductive medicine, gynaecology, psychiatry, oncology and pathology.

Members are appointed by the Federal Chancellor, who also chooses the chair and

deputy chair from among their number. The Chancellor also has the right to convene

meetings. Besides the Federal Chancellor, other members of the Cabinet may take

part in meetings of the Commission. The meetings are not open to the public. The

secretariat that assists the work of the Bioethics Commission is accommodated within

the Office of the Federal Chancellor.

Developments at Council of Europe and European Union level were particularly

important in the first phase of the Bioethics Commission’s activity. A recommendation

that Austria accede to the Council of Europe’s Convention on Human Rights

and Biomedicine was presented in February 2002. The Commission has also expressed

its views on the transposition of the European Union’s biotechnology directive

into national law and on issues of stem cell research in the context of the EU’s

46

Sixth Framework Programme for Research and Technological Development. In February

2003, the Commission submitted an interim report on reproductive cloning.

The intention is to present a comprehensive Opinion on the application of cloning

to human beings, on embryo protection and research involving embryos, on preimplantation

genetic diagnosis and on other aspects of reproductive medicine in connection

with a planned revision of the Reproductive Medicine Law. The Commission

can itself choose subjects for consideration. In many cases, however, it acts in response

to a specific request by the Federal Chancellor or members of the Cabinet.

For instance, the Opinion on the transposition of the biotechnology directive into

national law, dated 6 March 2002, was drawn up in response to a request by the Federal

Minister of Transport, Innovation and Technology made in October 2001, while

the Opinion on issues of stem cell research in the context of the EU’s Sixth Framework

Programme resulted from a referral by the competent Federal Minister.

The Commission currently comprises 19 members, of whom 16 are men and

three women. The majority are professors from the Universities of Vienna, Graz,

Innsbruck and Salzburg. One member is Professor of Public Law at the University of

Bonn in Germany.

Website

Bioethikkommission: http://www.bundeskanzleramt.at/DesktopDefault.aspx?TabID=3456&Alias=bka

Bibliography

Gmeiner, R.; Körtner, U. H. J. (2002). Bioethikkommission: Aufgaben, Arbeitsweise, Bedeutung. Recht der

Medizin 65: 164 – 173.

Schüssel, W. (2001). Verordnung des Bundeskanzlers über die Einsetzung einer Bioethikkommission.

Bundesgesetzblatt für die Republik Österreich, 29. Juni 2001, Teil 2, 226. Verordnung.

47


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

5. Central and eastern Europe

Slovenia

Slovenia is occasionally said by representatives of central and eastern European

bioethics to be the state with the oldest national ethics body. The National Medical

Ethics Committee was established as long ago as in 1977. Unlike the decision of the

French President in 1983 to create a bioethics forum and a legislative advisory body

for ethical issues in the life sciences and healthcare, the Slovenian decision of 1977 was

the state’s response to developments in research involving human subjects and in

pharmaceutical research, and was intended to confer state authority on the ethical examination

of the relevant projects. The Committee was able to follow in the footsteps

of a predecessor in the medical faculty of the University of Ljubljana that had existed

since the mid-1960s. In addition to examining research projects, the Committee began

early on to concern itself with medical ethics education for medical students.

The Committee’s tasks and the basis of appointment of its members were redefined

in 1995. It is therefore only in that year that Slovenia’s National Medical Ethics

Committee can be said to have become an ethics council comparable in its functions

and mode of operation with the French or Danish model. It is an advisory body established

to examine ethical problems in medicine, which can issue Opinions at the

request of Parliament, the Minister of Health, the National Health Council and the

Medical Association, various healthcare institutions, and citizens. In addition, the

Committee can draw up Opinions on its own initiative.

The Committee has 13 members. Candidates are proposed by the University, the

National Health Council and the Slovenian Medical Association from the spheres of

medicine, psychology, law and social sciences, the humanities and ethics, and appointed

by the Minister of Health. At present, the majority of the members are doctors,

the others being a clinical psychologist, a legal expert, an ethicist, a Roman

Catholic priest, a sociologist and a lay person. In addition to their activity as university

professors, three of the members also belong to the Academy of Sciences and

Arts. In the view of the prominent Committee member Jozˇe Trontelj, the composition

is balanced, in terms of disciplines and professional backgrounds as well as of

philosophies of life.

Since the redefinition of its role, the Committee has intervened decisively in the

legislative process, both by drawing up draft laws (on organ transplants, medically assisted

reproduction and gene technology) and by commenting on proposed legislation

drafted by Parliament. The Committee’s chair was for many years also a member of

the Council of Europe’s Steering Committee on Bioethics (CDBI). As a result, the international-law

deliberations of the CDBI have strongly influenced the parliamentary

48

debate and opinion formation in Slovenia. To date, the Committee has prepared

Opinions and reports on the following subjects: euthanasia, medically assisted suicide,

the status of non-medical therapies, the refusal of blood transfusions for children

of Jehovah’s Witnesses, the Convention for the Protection of Human Rights and

Dignity of the Human Being with Regard to the Application of Biology and Medicine,

therapeutic cloning, patients’ rights in terminal illness and palliative care, the

use of placebos in studies of psychiatric drugs, and limitation of the treatment of patients

in a permanent vegetative state.

In addition, the Committee remains the central body responsible for the examination

of research projects involving human subjects. In this field, the National Committee’s

consent is required for all state-funded research projects for doctoral theses

and also for clinical studies. The consent of a local ethics committee suffices only for

Phase 4 clinical studies.

Address

National Medical Ethics Committee

Institute of Clinical Neurophysiology, University Medical Center

Zaloska 7, 1525 Ljubljana, Slovenia

Bibliography

CDBI (2001). Addendum to Developments in the Field of Bioethics in Member States, other States and

International Organisations: Slovenia. Recent Developments in the Field of Bioethics in Slovenia

(CDBI/INF 2001/4). Strasbourg, June 2001: 4.

Trontelj, J. (1996). Statement of Jo_e V. Trontelj. In: National Bioethics Advisory Commission (NBAC); National

Institutes of Health (NIH) (ed.). The International Summit of National Bioethics Advisory Bodies […]

San Francisco, California […] Thursday, November 21, 1996 […]: 68 – 72. Available online at:

http://www.georgetown.edu/research/nrcbl/nbac/transcripts/1996/11-21-96.pdf

Trontelj, J. (2000). Ethics Committees in Slovenia. In: Glasa, J.; Council of Europe (ed.). Ethics Committees in

Central & Eastern Europe. Bratislava: 239 – 249.

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Czech Republic

Both the Czech Republic and Slovakia have had central ethics committees since the

early 1990s. A particular aspect of their history is that, at the time of their foundation,

Czechoslovakia was still a single state. With the decision to split the country into two

states, which was taken in 1992 and took effect at the beginning of 1993, the central

committees of the individual republics became central national ethics committees.

Even before the Velvet Revolution and the fall of communism in 1989, extensive

civil-society debate was taking place in the Czechoslovak Republic in small groups

and clubs that met unofficially and in some cases underground. The foundations of

bioethical initiatives also date from this period, and were laid by meetings of doctors,

psychologists, social workers and nurses of different faiths and outlooks. As early as

the spring of 1990, the newly founded Prague Club of Catholic Doctors forwarded a

draft text for the establishment of an Ethical Committee in Prague to the Minister of

Health, Professor Pavel Klener. His successor, Martin Bojar, accepted the draft, no alternatives

to which were discussed, in autumn 1990. A decree by the Minister became

the basis for the institution of the Central Ethics Committee (Centralni Etička

Komise Pri Ministerstvu Zdravotnictvi Česke Rebubliky). It provides that the Committee

shall be the Minister’s advisory body. The Committee was placed under the

auspices of the Ministry of Health’s Department of Education and Science.

The members of the Committee are appointed by the Minister. Appointments

were originally based on recommendations by the medical faculties, learned societies

and churches. This nomination system was reorganized in October 2001. The Committee

is made up of specialists and lay individuals. Due consideration is given, in its

composition, to an appropriate balance of regions and disciplines, to proportionate

representation of men and women, and to a plurality of philosophies and faiths.

Since October 2001 patients’ associations have also been officially represented.

The Committee’s main task is the assessment of draft laws and the preparation of

reports on specific ethical problems. Following the establishment of regional ethics

commissions to examine research projects involving human subjects, which also began

in October 2001, the Central Ethics Committee has retained responsibility for research

projects that cannot be assigned to another commission.

The Committee responds to requests by the Ministry and the world of politics,

and can choose other subjects of its own accord. The recommendations and reports

submitted to the Minister of Health are based as far as possible on consensus rather

than on majority votes. Owing to limited resources, as well as, perhaps, to the absence

of official instructions to that effect, the Committee’s relations with the public are

confined to the activities of individual members in the form of lectures and the like.

At conferences, the Committee endeavours to work together with the societies representing

the various medical specialties. Individual members of the Committee are

50

occasionally invited to take part in meetings of parliamentary committees. However,

there is at present no ongoing collaboration with Parliament.

The involvement of its members in the Czech delegation of the CDBI seems to

have greatly influenced the work of the Ethics Committee. Their collaboration in the

drafting of the Council of Europe’s protocols on organ transplantation and on the

ethics of biomedical research has led to the preparation of corresponding draft laws

at national level.

The subordination of the Committee to the Ministry of Health has resulted in a

limitation of the subjects of its deliberations. On the other hand, a bioethics committee

of the Czech Government’s Science and Research Council has addressed issues

of non-human gene technology, genetically modified foods and also ecology. Under

a law of 1992, an ethics committee of the Medical Association exists in addition to the

Central Ethics Committee. So far there has been no coordinated collaboration between

it, the Science and Research Council’s bioethics committee and the Central

Ethics Committee.

Address

Central Ethics Committee of the Czech Republic

2nd dept. of medicine, 3rd medical school of Charles University

Srobarova 50, 10034 Praha 10, Czech Republic.

Bibliography

Bratinka, P. (2000). Statuts de la Commission de bioéthique du Conseil de gouvernement tchèque pour la

recherche et le développement. Journal international de bioéthique 11/1: 68 – 70.

Les commissions d’éthique au sens de la Loi sur les médicaments no 1997-91 du RdL. Journal international de

bioéthique 11/1 (2000): 70.

Haderka, J. F. (1999). Commission centrale d’éthique. Journal international de bioéthique 10/3: 57.

Haderka, J. F. (2000). Les Commissions de bioéthique en République tchèque. Mot d’introduction. Journal

international de bioéthique 11/1: 65.

Kment, M. (1994). Establishing Ethics Committees. In: Council of Europe. Standing Conference of European

Ethics Committees. Proceedings, Stockholm 8 – 9 April 1994: 15 – 17.

Pohunková, D. (2001). Stellungnahme zum Fragebogen. In: Enquete-Kommission “Recht und Ethik der modernen

Medizin” (14. Deutscher Bundestag). Stellungnahmen von Vertreterinnen und Vertretern europäischer

Ethikkommissionen zur Öffentlichen Anhörung “Europäischer Diskurs zu ethischen Fragen der modernen

Medizin” vom 19. November 2001. Available online at:

http://www.bundestag.de/parlament/kommissionen/archiv/medi/medi_di_stell/Pohunkova_dt.pdf

Roithová, Z. (2000). Les statuts de la Commission centrale d’éthique auprès du Ministère de la santé de la

République tchèque. Journal international de bioéthique 11/1: 65 – 68.

51


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Slovak Republic

As in the Czech Republic, the establishment of a National Commission on Medical

Ethics preceded the foundation of the nation state of Slovakia. The central ethical

commission set up by the Ministry of Health in Bratislava in the autumn of 1990 has

thus since 1993 assumed the role of a national ethics council. One of its first and most

important tasks was advice on and control of the formation of local ethics commissions

both in the field of clinical ethics and for the examination of research projects,

as well as ethics commissions engaged in both kinds of advisory activity and examination.

The guidelines on the establishment and work of ethics committees in healthcare

institutions and in biomedical research institutions drawn up by the central

ethics commission were submitted to the Ministry of Health as a recommendation in

June 1992. The Commission now regards its main function as the assessment of legislative

proposals affecting the health sector. The Commission has in addition played

an important part in the foundation of institutions directed towards the establishment

of medical ethics and bioethics as a scientific discipline. The issues considered

by the Commission are referred to it by the Ministry of Health and other state institutions

and authorities, but it is also free to choose topics itself. The composition of

the Commission is interdisciplinary: its members possess a variety of professional, religious,

philosophical and ethical backgrounds.

The role the National Commission on Medical Ethics has since played in the politics

of the Slovak Republic has greatly depended on the value assigned to it by successive

Ministers of Health. Both the support given to the Commission and the number

of issues referred to it have differed substantially from one incumbent to the next.

Address

Slovak National Commission on Medical Ethics

Department of Medical Ethics

Institute for Continuing Medical Education

Limbova 14, 83303 Bratislava, Slovak Republic

Bibliography

Glasa, J.; Bielik, J.; Dacok, J.; Glasova, M.; Porubsky, J. (2000). Ethics Committees in the Slovak Republic.

In: Glasa, J.; Council of Europe (ed.). Ethics Committees in Central & Eastern Europe. Bratislava: 229 – 238.

52

Croatia

In 2001 the Government of the Republic of Croatia resolved to establish a National

Bioethics Committee for Medicine (Nacionalno bioetičko povjerenstvo za medicinu

vlade Republike Hrvatske) and published its decision in the country’s official gazette

(No. 35/2001). The Committee’s function is to examine the legal and ethical aspects

of the development and application of biomedical science involving human beings.

It is required to issue recommendations for both new laws and the revision of existing

ones. For this purpose, the Government has appointed 20 independent experts

drawn from the natural and social sciences. The experts were nominated by the Minister

of Health, whose department is also responsible for the Committee’s administrative

support. The Government’s decision on the establishment of the Committee

mentions the following specific subjects: biomedical research on human beings,

medical and professional ethics, family planning and the termination of pregnancy,

the regulation of medically assisted fertilization, gene technology, human genome

research, protection of the human embryo, cloning, the transplantation of human

tissues and organs, xenotransplantation, compulsory treatment, the treatment of terminally

ill patients, euthanasia, and occupational training in the field of bioethics.

The Government’s National Bioethics Committee has now commenced work. Six

of its 20 members are women. The chair and deputy chair are elected by the Committee

itself. In addition to representatives of various medical disciplines, the members

include a moral theologian, a philosopher, a historian of medicine, two

biologists and a veterinarian. Another member represents the Ministry of Science.

Address

National Bioethics Committee for Medicine

Ministry of Health and Social Welfare

Ksaver 200a, 10000 Zagreb, Croatia

Bibliography

CDBI (2001). Addendum bis to Developments in the Field of Bioethics in Member States, other States and

International Organisations: Croatia (CDBI/INF 2001/4), Strasbourg, June 2001: 2 – 3.

Croatian Medical Chamber. Statute. Article 38. Committee for Medical Ethics and Deontology.

53


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Poland

Unlike its southern and north-eastern neighbours, Poland does not have a national

bioethics committee. However, there has been an ongoing debate for some years on

whether such a body should be established and, if so, what form it should take. The

Medical Ethics Committee of the Polish Chamber of Physicians and Dentists was one

of the instigators of a draft law directed towards the formation of a national bioethics

committee in Poland, but the initiative was rejected by the Sejm on 21 August 2001.

There is no central coordinating body for the ethics commissions responsible for

research on human subjects – unlike the situation with regard to the protection of

animals in research, where a central ethics committee coordinates the work of the individual

commissions. Following the Law on the Chamber of Physicians agreed in

round-table discussions as early as in 1989, a Medical Ethics Committee was set up

within the Polish Chamber of Physicians and Dentists in the context of the statutory

self-governing organization of the medical profession. This Committee assumes the

role of a national ethics body in some respects. Through the Higher Medical Council,

it submits proposals for legislation to Parliament, and also represents Poland on

the Council of Europe’s Standing Conference of European Ethics Committees. However,

the Committee sees itself as an organ of the medical profession, and as representing

its interests. Although its meetings are not open to the public, the public are

informed about its work and recommendations in a number of different ways. Any

dissenting opinions are also documented.

The Committee on Ethics in the Sciences established by the Polish Academy of

Sciences and the Committee on Ethics in Medicine formed by the Polish Academy of

Arts and Sciences are assigned different tasks. As with comparable initiatives of the

Deutsche Forschungsgemeinschaft (German Research Foundation) and the Max

Planck Society at the end of the 1990s, these committees are concerned with the observance

of ethical principles in the practice of science – that is, with scientific and

personal integrity.

The difficulties in the establishment of a national ethics committee to interface

between science and politics are an indication of the persistence of anxieties about

contact between these two spheres, following decades of political totalitarianism. The

main fear is of procedural decisions being dictated from above on important issues

of social development, in case this results in a relapse into an autocratic system. Other

concerns have to do with the boundaries between the various religious and philosophical

camps.

Address

Polish Chamber of Physicians and Dentists, Ethics Committee

Ul. Sobieskiego 110, 00-764 Warsaw, Poland

54

Bibliography

Chlap, Z. (1994). The Work of Ethics Committees in Poland. In: Council of Europe (ed.). Standing Conference of

European Ethics Committees. Proceedings, Stockholm 8 – 9 April 1994: 107 – 109.

Gorski, A.; Zalewski, Z. (2000). Recent Developments in Bioethics in Polish Science and Medicine. In: Galsa, J.;

Council of Europe (ed.). Ethics Committees in Central & Eastern Europe. Bratislava: 209 – 215.

Umiastowski, J. (2001). Antworten zur Arbeit der Kommission für ärztliche Ethik der Polnischen Ärzte- und

Zahnärztekammer. In: Enquete-Kommission “Recht und Ethik der modernen Medizin” (14. Deutscher

Bundestag). Stellungnahmen von Vertreterinnen und Vertretern europäischer Ethikkommissionen zur Öffentlichen

Anhörung “Europäischer Diskurs zu ethischen Fragen der modernen Medizin” vom 19. November 2001.

Available online at:

http://www.bundestag.de/parlament/kommissionen/archiv/medi/medi_di_stell/Umiastowski_dt.pdf

55


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Hungary

The history of the Medical Research Council (Egészségügyi Tudományos Tanács,

ETT) dates back to the 1950s. At the instigation of the Communist Party, committees

were formed during this period to combat the practice of accepting illegal fees by

medical practitioners. After the fall of communism, the Commission was given a new

function and assigned a new position as a council on health sciences. In an order by

the Minister of Welfare of 1997, its status is defined as an advisory and preparatory

body in the field of health policy, medicine, pharmacology and the health sciences.

The ETT is responsible to the Ministry of Health. It comprises a chair, a general assembly

and commissions. The commissions are responsible for the ethics of science

and research (Scientific and Research Ethics Committee, Tudományos és Kutatásetikai

Bizottsága, TUKEB), the ethics of clinical pharmacology, forensic medicine,

human reproduction, and research and development. Their specific tasks were

laid down recently in a decree of June 2003.

Specialists from the relevant disciplines are represented on the ETT and its commissions.

They work together with the competent agencies of the Hungarian Academy

of Sciences and the Ministry of Culture and Education. Whereas the TUKEB’s main

function is the central ethical evaluation of research projects involving human subjects,

the ETT as a whole can be regarded as a national council for the health sector.

It was only in 2003 that the Prime Minister also established a national commission

that includes not only natural scientists and medical experts but also representatives

of the churches, the various legal disciplines and the ministries. Its field of

competence is human genetics.

Address

National Bioethics Commission of Hungary

Institute of Experimental Medicine

Hungarian Academy of Sciences

P. O. Box 67, 1083 Szigony u. 43, 1450 Budapest, Hungary

Bibliography

Blasszauer, B; Kismodi, E. (2000). Ethics Committees in Hungary. In: Glasa, J.; Council of Europe (ed.). Ethics

Committees in Central & Eastern Europe. Bratislava: 191 – 195.

Ferencz, A. (1994). Ways and Means of Ethics Committees. In: Council of Europe. Standing Conference of

European Ethics Committees. Proceedings, Stockholm 8 – 9 April 1994: 74.

Negrutiu, F. (2000). Ethics Committees in Hungary. In: Glasa, J.; Council of Europe (ed.). Ethics Committees in

Central & Eastern Europe. Bratislava: 217 – 223.

Sándor, J. (2003). Hungary (International Encyclopedia of Laws: Medical Law; Suppl. 31). The Hague.

56

Romania

Initial work on the institutionalization of bioethics was undertaken by the Bucharest

Academy of Medical Sciences. As early as in 1991, the Academy established a

Bioethics Commission devoted both to the creation of study programmes for medical

students and to general issues of bioethics and the ethics of medical research. In

the ensuing years there were Council of Europe and UNESCO initiatives directed towards

the formation of a large-scale National Bioethics Council for Romania. These

led to the formation of a body with 40 members drawn from the fields of medicine,

law, economics, sociology, theology, biology and other disciplines. However, the fact

that this body proved not to be viable, so that these initiatives were abandoned, is attributed

to poor organization and the excessive scale of the planned projects. The

Council ceased to operate after holding just a few meetings.

For this reason, the role of a national ethics council has been assumed by the Bioethics

Commission (Comisiei de Bioeticâ a Ministerului Sǎnǎtǎt,ii s,i Familiei), which

is accommodated within the Ministry of Health. The Bioethics Commission is one of

the Ministry’s 52 presidial commissions. It comprises 12 physicians, a legal expert, a

priest and a biologist. Its task is defined as advising on legislative initiatives in the

field of bioethics and biomedicine, as well as in healthcare in general. The Commission

is also required to monitor the activities of local hospital ethics committees, and

to represent Romania on international bodies and in exchanges with other national

ethics commissions.

Address

Ministry of Health

Comisia de Bioeticâ

Str. Cristian Popisteanu, nr. 1 – 3,

sector 1, cod 010024 Bucharest, Romania

Bibliography

Comisia de Bioeticâ. Membri. Available online at: http://www.ms.ro/ms/infosan4/anexa3.htm

57


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Russia

As in other eastern European countries, after the fall of communism in Russia a

group of scientists from various disciplines who saw themselves as a bioethical avantgarde

came together. Besides medicine, philosophy was represented in this movement

to a greater extent than in other eastern European nations. A National

Committee on Bioethics was formed as early as in 1992 within the Russian Academy

of Sciences. The protagonists sought exchanges with Western bioethics centres, in

particular in the United States and western Europe. An important part has been

played in this respect by the Eastern Europe Program of the Hastings Center in New

York State. The Russian National Committee on Bioethics has concerned itself primarily

with the monitoring of biological, psychological and medical research and the

protection of experimental animals. Although ethics committees have subsequently

been established at the Russian Academy of Medical Sciences as well as at other institutions,

there is no national-level ethics commission to advise on the process of

legislation in the field of biomedicine and healthcare.

Address

Russian National Committee on Bioethics

Academy of Sciences of Russia

14 Volkhonka Street, Moscow 119842, Russia

Bibliography

Moral Status of Fetuses in Russia. Journal international de bioéthique 10/4 (1999): 73 – 74.

Russian Medical Association (2000). The National Ethics Committee. Journal international de bioéthique 11/1:

71 – 73.

Tischenko, P.; Yudin, B. (2000). Ethics Committees in the Russian Federation. In: Glasa, J.;

Council of Europe (ed.). Ethics Committees in Central & Eastern Europe. Bratislava: 225 – 227.

Yudin, B. (1992). Bioethics for the New Russia. Hastings Center Report 22/3: 5 – 6.

Yudin, B. (1996). [Self-Introductions of Delegates] Mr. Yudin. In: National Bioethics Advisory Commission

(NBAC); National Institutes of Health (NIH) (ed.). The International Summit of National Bioethics Advisory

Bodies […] San Francisco, California […] Thursday, November 21, 1996 […]: 31. Available online at:

http://www.georgetown.edu/research/nrcbl/nbac/transcripts/1996/11-21-96.pdf

58

Georgia

Georgia is one of the countries in which, as a part of the process of democratic renewal

after 1990, the reorganization of the health system was considered to be a particularly

urgent and essential task. The Georgian Healthcare Law of 1997 provides for

the establishment both of ethics commissions for research on human subjects and of

clinical ethics committees. A central national ethics council was founded in Georgia

in accordance with Decree No. 15 of 12 January 1998 and Order 57M of the Minister

of Health and Social Affairs. The Regulation of 5 July 2000 of the Ministry of

Labour, Health and Social Affairs (Department of Health Law and Bioethics) lays

down the conditions for membership of the Council and its statutes.

The Council’s task is to examine ethical issues in biomedicine and to prepare recommendations

for the solution of relevant problems. Although it is responsible to

the Minister of Labour, Health and Social Affairs, it may also be charged by other executive

organs of the State with the furnishing of advice. According to its statutes, the

Council’s priority is to promote the protection of the rights, dignity and autonomy

of persons in the process of medical care and biomedical research. Once all the legal

provisions on the establishment of ethics commissions for research and clinical practice

have been implemented, the Council will be able to confine itself permanently to

an advisory function for the executive and the legislature. At the same time, however,

it is required to act in a coordinating capacity and to ensure that bioethics can develop

as a discipline in its own right in Georgia. The first issue to be addressed by the

Council is that of blood transfusions for Jehovah’s Witnesses.

Address

Ministry of Labour, Health and Social Affairs

National Health Management Centre

National Bioethics Council

51 Javahishvili st., 380002 Tbilisi, Georgia

Bibliography

Javashvili, G.; Kiknadze, G. (2000). Ethics Committees in Georgia. In: Glasa, J.; Council of Europe (ed.).

Ethics Committees in Central & Eastern Europe. Bratislava: 179 – 185.

59


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Estonia

The initiative for a concern with bioethics in research and education in Estonia

stemmed from the University of Tartu, where a commission on ethical issues of research

on human subjects was formed as long ago as in 1990. A similar commission

was established three years later at the Institute of Experimental and Clinical Medicine

in Tallinn. Both commissions currently perform the function of monitoring research

projects involving human subjects, as provided by the Helsinki-Tokyo Declaration.

Most (80%) of the research applications are addressed to the Tartu University commission.

In addition, in 1995 the Estonian Medical Society established an ethics committee

whose main task was to revise the old Estonian Codex Deontologicus.

A national ethics council proper has existed in Estonia only since 1998. The Estonian

Council on Bioethics was established by the country’s Ministry of Social Affairs.

Arvo Tikk, Professor of Neurology and Neurosurgery at the University of Tartu

and founding President of the Council, describes its task as that of a coordination

centre. The work undertaken at Tartu was directed primarily towards making

bioethics a compulsory subject for medical students.

The Estonian Council can justifiably be seen as a coordinating body, as its eleven

members include not only representatives of the Committee on the Ethics of Research

on Human Subjects and of the Committee on Clinical Ethics, but also specialists

from the fields of paediatrics, organ transplantation, genetics, artificial

fertilization and law. One member is also a deputy in the Estonian Parliament. The

task of the Council is to make recommendations to Parliament and to the Minister

of Social Affairs on current problems of medicine and bioethics, in particular with a

view to legislation. The Council also considers itself responsible for training and

postgraduate training functions. Finally, the members of the Estonian Council regard

participation in the work of international bodies, within both the Council of Europe

and the Nordic Committee on Bioethics, as an important part of their work.

The Estonian debate on bioethics has attracted worldwide attention owing to the

Estonian Genome Project, which involves the creation of a database that will contain

health and genetic data for the Estonian population. The project is to be implemented

over a five-year period and will cover about a million persons. The project was given

a statutory basis in 2000 when the Human Genome Research Law was adopted by

the Estonian Parliament. Section 29(1) of this Law provides that the ethical aspects

of work undertaken in the context of the project shall be examined by an ethics committee.

This committee was formed on 21 December 2001, when it held its first meeting.

It has seven members, who are appointed by the Supervisory Board of the Chief

Processor of the Gene Bank. The committee is also responsible for liaison with the

Estonian population, for whom it acts as a source of information.

60

Website

Estonian Council on Bioethics (Ethics Committee for the Genome Project): http://www.geenivaramu.ee

Bibliography

Storm, L. (2001). Die wichtigste Entscheidung ist in Estland schon gefallen. Frankfurter Allgemeine Zeitung vom

30. April 2001 (Politik): 5.

Tikk, A.; Parve, V. (2000). Ethic Committees in Estonia. In: Glasa, J.; Council of Europe (ed.). Ethics Committees

in Central & Eastern Europe. Bratislava: 173 – 178.

Lithuania

Lithuania has had a national bioethics committee (Lietuvos bioetikos komitetas,

LBEK) since 1995. It was established by a decree of the Minister of Health of 27 December

1995 after the Law on the Lithuanian Health System took effect. All its members

are also appointed by the Minister of Health. There are 17 members, equally

divided between medical and non-medical specialists (the latter being legal experts,

ethicists, philosophers, psychologists, theologians, etc.). Members are appointed on

the basis of experience and expertise in the field of biomedical ethics. The chair was

elected by majority vote at the constituent meeting. He is Eugenijus Gefenas, who is

also a member of the CDBI and of the IBC (UNESCO). Since 1997 he has been Professor

of Biomedical Ethics at the University of Vilnius. The institution and competence

of the Lithuanian Bioethics Committee are governed by the Law of 11 May

2000 on the Ethics of Biomedical Research. The Lithuanian Committee has the status

of a legal entity whose activities are funded from the state budget.

The Committee’s specific tasks, under Article 13(2) of the founding decree, are to

analyse bioethical problems and to advise central and local authorities and organizations

on these matters, to submit proposals and conclusions in relation to laws and

other legal instruments for the regulation of bioethical problems, to prepare Opinions

and ethical reports on biomedical research and to monitor the work of regional

biomedical research ethics committees. Once a year it is required to submit a report

of activities to the Minister of Health and to make proposals on how biomedical

problems should be addressed. The Committee must assess the extent to which

individual and public healthcare conforms to the requirements of medical ethics and

monitor legal entities’ observance of bioethical principles. Other tasks are the provision

of methodological support and advice to medical ethics committees in healthcare

institutions, as well as representing Lithuania in international organizations

concerned with issues falling within the Committee’s field of competence.

The enumeration of these tasks illustrates the intense concentration of responsibilities

for bioethical debate and advice in Lithuania. For the practical operation of

61


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

the Committee, however, it is important to note that it also performs the function of

a local and central research ethics committee. This is of course very time-consuming.

The Committee’s members are involved in many international bioethics bodies.

They are therefore aware that their committee is unusual in its combination of so

many different functions, which are divided among a number of bodies in Western

countries. The Committee itself describes its primary task as the provision of information

to the biomedical community and the public at large on moral dilemmas

posed by the modern healthcare system, together with relevant education. The

Lithuanian Committee is the first national ethics council in an eastern European

country to have a website of its own.

Website

LBEK: http://www.bioetika.sam.lt

Bibliography

Gefenas, E. (2000). A Short Information on Lithuanian National Committee on Biomedical Ethics. Journal international

de bioéthique 11/1:63.

62

II. North America

Canada

Canada at present has a number of ethics commissions and advisory bodies working

in the fields of medicine and biotechnology. The Canadian Biotechnology Advisory

Committee (CABC)/Comité Consultatif Canadien de la Biotechnologie (CCCB) advises

not only on the ethical, legal and sociological aspects of long-term political programmes

for the promotion of biotechnology but also on their scientific and

economic implications. The Committee, which is composed of external experts, was

established by the Government in 1999 and has since concentrated on issues of genetically

modified organisms and the patenting of higher forms of life.

The National Council on Ethics in Human Research (NCEHR)/Conseil National

d’Ethique en Recherche chez l’Humain (CNERH) is more a central coordinating

body for local ethics committees than a national ethics council. Originally appointed

by the medical association itself, it now operates under the auspices of the Coordinating

Committee formed in 1995 jointly by the Canadian Department of Health,

the Royal College of Physicians and Surgeons of Canada and the Natural Sciences

and Engineering Research Council of Canada. The NCEHR now also has members

representing the principal clinical research institutions and the public. Its most important

function, however, remains that of assisting local ethics committees in the

examination of research applications.

Thirdly, there is the Commission de l’Ethique de la Science et de la Technologie

(CEST), which is a Subcommittee of the Government of Quebec’s Science and Technology

Council, established by the Quebec Government in 2001. Its composition is

based on the principle of social diversity and it sees its main task as consulting the

public on current issues of science and the utilization of technology.

Websites

CBAC/CCCB: http://www.cbac-cccb.ca

CEST: http://www.ethique.gouv.qc.ca

NCEHR/CNERH: http://www.ncehr-cnerh.org

Bibliography

Rivet, M. (1989). La place de l’éthique dans les travaux de la Commission de réforme du droit du Canada. In:

Comités d’Ethique à travers le Monde. 3, recherches en cours 1988. Paris: 23 – 26.

63


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

United States of America

By Executive Order 13237 of 28 November 2001, George W. Bush established the President’s

Council on Bioethics (PCBE), which met for the first time in January 2002. The

President had first wound up the National Bioethics Advisory Commission (NBAC),

formed by Executive Order of his predecessor Bill Clinton in October 1995. The United

States thus at present has its second ethics council intended as a permanent body.

President’s Council on Bioethics

Under the terms of the constituent Order, the Council is required to advise the President

on bioethical issues that might emerge as a consequence of advances in biomedical

science and technology. For this purpose it is required to undertake studies

of the anthropological and moral significance of these developments and to examine

the associated ethical and political issues, to provide a forum for national debate on

these issues, to facilitate a greater understanding of bioethical questions and to explore

possibilities for useful international collaboration on them.

The issues specified by the President are embryo and stem cell research, assisted

reproduction, cloning, uses of knowledge and techniques derived from human genetics

or the neurosciences, and end-of-life issues, as well as “broader” ethical and social

questions such as the protection of human subjects in research, the appropriate

uses of biomedical technologies and their moral implications, and the consequences

of limiting scientific research. Other Government authorities must be able to refer issues

and subjects to the Council for consideration. The Council receives technical

and administrative support from the Department of Health and Human Services,

which also appoints an Executive Director to head its staff.

As already provided by the Executive Order, the Council is composed of 18 members,

drawn from the fields of science and medicine, law and government, philosophy

and theology, and other areas of the humanities and social sciences. The Chair,

Leo Kass, a bioethicist from the University of Chicago, was appointed to that office in

advance by the President. The other members too are prominent academics, except

for Charles Krauthammer, who is a columnist of the Washington Post, winner of the

Pulitzer Prize and a trained psychiatrist. The White House press release prior to the

inaugural meeting emphasizes the wide range of viewpoints to be covered and the

importance of thoughtfulness and devotion to serious ethical inquiry in addition to

specialized knowledge.

With an academic staff of 16, the Council can call on a wide range of expertise.

The founding Executive Order already provides for sufficient funding for the holding

of hearings and the publication of reports; the Order also allows the payment of

per diems and compensation to the members.

64

National Bioethics Advisory Commission

In view of the substantial documentary legacy of the National Bioethics Advisory

Commission, a consideration of this body remains relevant today. It presents structural

parallels with its present-day counterpart, while also differing from it in significant

respects. Considering that the United States was already a long-established

leader in bioethics research and teaching, it is surprising that it was not until 1995 –

i.e. later than in France, Sweden, Denmark, Portugal or the Czech Republic – that Bill

Clinton took the step of establishing a permanent ethics body.

The newly established Commission faced its first major challenge with the birth

of Dolly the sheep, when President Clinton charged it with examining the ethical implications.

However, by 1995 there was already a long tradition of presidents seeking

expert advice in ethical crisis situations. The formation of the National Commission

for the Protection of Human Subjects of Biomedical and Behavioral Research

(NCPHS) dated back to the 1970s. This body had succeeded in overcoming differences

between different schools of moral philosophy and faiths and arriving at an

ethical consensus, which was embodied in the Belmont Report of 1978. The resulting

guidelines were given the force of law not only in the United States but also in other

countries. In the 1990s, another Presidential Commission was still investigating misconduct

in research involving experiments with radioactivity.

However, the mandate of the Advisory Commission set up in 1995 covered a

wider range from the beginning. The NBAC was required to furnish advice and recommendations

to the National Science and Technology Council and other appropriate

government entities. It was supposed to express views on the bioethical aspects of

Government programmes and on regulations and guidelines concerning research in

human biology and behaviour and the clinical application of such research. It was to

lay down the broad principles intended to govern the ethical conduct of research, addressing

specific projects only in order to illustrate principles. Congress, the public

and the Commission itself could submit issues for consideration. Priorities mentioned

in the founding Executive Order were the protection of human research subjects

and the handling of genetic information; the Order also sets out four formal

criteria for further priorities: the public-health or public-policy urgency of the

bioethical issue; the relation of the issue to goals for Federal investment in research;

subsidiarity in relation to other possible advisory entities; and the extent of interest

in the issue within the Federal Government.

The 18 members of the NBAC (only 15 until 1999) were appointed by the President.

An Amendment of 1999 stipulated that at least one member shall have expertise

in each of the following disciplines: philosophy/theology, social science, law, medicine/allied

health professions, and biological research. At least three members were to

be selected from the general public. As far as possible, there was to be a numerical balance

between scientists and non-scientists. Close attention was to be given to equitable

65


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

geographic distribution and to ethnic and gender representation. Although its mission

was restricted to successive periods of a few years, after which it had to be renewed,

the NBAC, compared with equivalent bodies in other countries, had the largest

budget (some $3 million per year), the largest administrative and scientific staff and

the best resources for conducting hearings, consulting external experts, and so on.

After 1997, the Commission presented extensive reports and recommendations

on human cloning, on the handling of human biological materials in research, on research

involving persons with mental disorders and on human embryonic stem cell

research. The Commission’s last publications were two long studies on clinical trials

in developing countries (April 2001) and on research involving human participants

(August 2001) respectively. All documents are still available via the National Reference

Center for Bioethics Literature at the Kennedy Institute in Washington.

The President’s Council: choice of issues for consideration

A significant element of the Executive Order establishing the new Council and of the

press release mentioned above is the desire to develop a profound understanding of

the problems to be solved. In addition to immediate decisions on practical action, the

Council itself repeatedly mentions fundamental anthropological aspects. Whereas

the NBAC had analysed scenarios of social consequences and again and again sought

the views of different population groups and faiths, the present Council seems to put

forward and discuss all-embracing moral concepts of its own, while at the same time

attempting to arrive at an anthropological consensus on most of them.

The first subject of the Council’s deliberations, based on this new approach, was

cloning, on which the NBAC had already issued an Opinion. The second was enhancement

– that is, the extent to which interventions aimed at enhancing human

beings were desirable and legitimate. The relevant report, Beyond Therapy: Biotechnology

and the Pursuit of Happiness, was published in October 2003. These were of

course issues and problems likely to become significant in the future, which had hitherto

been systematically addressed only by relatively small research groups in various

parts of the world and were not yet on the political agenda. The aim of the report is

less to facilitate the preparation of political initiatives than to stimulate a wide-ranging

debate among the public, with a view to subjecting the various possible kinds of

biotechnological interventions on human beings to comprehensive consideration.

Websites

PCBE: http://www.bioethics.gov

NBAC: http://www.georgetown.edu/research/nrcbl/nbac

Bibliography

Advisory Committee on Human Radiation Experiments (ACHRE) (1995). Final Report of the Advisory

Committee on Human Radiation Experiments. Washington, DC. [Reissued: New York, NY 1996]

Available online at: http://www.eh.doe.gov/ohre/roadmap/achre/report.html

66

Bush, G. W. (2001). Creation of the President’s Council on Bioethics: Executive Order 13237 of November 28,

2001. Federal Register 66/231 (November 30, 2001): 59851 – 59853.

Capron, A. M. (1997). An Egg Takes Flight: The Once and Future Life of the National Bioethics Advisory

Commission. Kennedy Institute of Ethics Journal 7/1: 63 – 80.

Clinton, W. J. (1995). Protection of Human Research Subjects and Creation of National Bioethics Advisory

Commission: Executive Order 12975 of October 3, 1995. Federal Register 60/193 (October 5, 1995): 52063 – 52065.

Clinton, W. J. (1996). Amending Executive Order No. 12975: Executive Order 13018 of September 16, 1996.

Federal Register 61/182 (September 18, 1996): 49045.

Clinton, W. J. (1997). Further Amendment to Executive Order 12975 of May 16, 1997, Extension of the National

Bioethics Advisory Commission: Executive Order 13046 of May 16, 1997. Federal Register 62/97 (May 20, 1997):

27685.

Clinton, W. J. (1999). Amendment to Executive Order 12975, as Amended, National Bioethics Advisory

Commission: Executive Order 13137 of September 15, 1999. Federal Register 64/181 (September 20, 1999): 50733.

Gutman, A. (1996). Deliberating About Ethics in a Democracy: Some Reflections for Commissions. In: National

Bioethics Advisory Commission (NBAC); National Institutes of Health (NIH) (ed.). The International Summit of

National Bioethics Advisory Bodies […] San Francisco, California […] Thursday, November 21, 1996 […]: 170 – 193.

Available online at: http://www.georgetown.edu/research/nrcbl/nbac/transcripts/1996/11-21-96.pdf

NBAC (1998). 1996 – 1997 Annual Report. Rockville, MD. Available online at:

http://www.georgetown.edu/research/nrcbl/nbac/pubs/ann_rept.pdf

NBAC (1999). 1998 – 1999 Biennial Report. Bathesda, MD. Available online at:

http://www.georgetown.edu/research/nrcbl/nbac/pubs/Biennial98-99.pdf

NBAC (1999). Ethical Issues in Human Stem Cell Research. Executive Summary. Rockville, MD. Available online

at: http://www.georgetown.edu/research/nrcbl/nbac/pubs.html

NBAC (1999). National Bioethics Advisory Commission Charter. Available online at:

http://www.georgetown.edu/research/nrcbl/nbac/about/nbaccharter.pdf

NBAC (2000). Ethical and Policy Issues in International Research. Bethesda, MD. Available online at:

http://www.georgetown.edu/research/nrcbl/nbac/pubs.html

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1975).

The Commission Report: Deliberations and Conclusions. Hastings Center Report 5/3 (June): 41 – 46.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978).

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research.

Washington, DC. Available online at: http://www.nihtraining.com/ohsrsite/guidelines/belmont.html

Palca, J. (1996). A New National Bioethics Commission – Maybe. Hastings Center Report 26/1: 5 – 6

President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral

Research (1981). Protecting Human Subjects. Washington, DC. Available online at:

http://www.gwu.edu/~nsarchiv/radiation/dir/mstreet/commeet/meet16/brief16/tab_b/br16b1f.txt

PCBE (2002). Human Cloning and Human Dignity. New York, NY.

PCBE (2003). Beyond Therapy: Biotechnology and the Pursuit of Happiness: A Report by the President’s Council

on Bioethics. Washington, DC.

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

III. South and central America

Argentina

Argentina was the first Latin American country to make a commitment to bioethics.

A National Reference Centre for Bioethics was formed as long ago as in 1986. In 1992,

the Minister of Health and Social Action issued a decree establishing the first national

bioethics commission in Latin America. The Comisión Nacional de Etica Biomédica

is chaired by the State Secretary of Health, the other 25 members being selected on a

multidisciplinary basis.

The Commission’s main function is to advise the Executive on issues of medical

ethics and bioethics, in particular with regard to the quality and humanity of healthcare,

justice and solidarity in health systems, aspects of scientific progress and new

medical techniques with implications in the fields of anthropology, professional

ethics and general ethics. One of its first initiatives was to call for the establishment

of ethics committees at hospitals.

Address

Argentina National Bioethics Advisory Commission

Ministry of Health and Social Welfare, Defensa 120, 1345 Capital Federal, Argentina

Bibliography

Luna, F. (1995). Bioethics and the Development of Ethics Committees in Argentina. Journal international de

bioéthique 6/4: 304 – 305.

Mainetti, J. A. (1992). Academic and Mundane Bioethics in Argentina. In: Pellegrino, E.; Mazzarella, P.;

Corsi, P. (eds). Transcultural Dimensions in Medical Ethics. Frederick, MD: 43 – 55.

Ministerio de Salud y Accion Social (1998). Decreto 426/98 del 16/04/98 – Poder Ejecutivo Nacional, creación

de la Comisión Nacional de Ética Biomédica. Available online at:

http://www.msal.gov.ar/htm/site/Digesto_Rec_Hum_Salud/decretos/decreto_%20426-98.html

National Bioethics Commission. Journal international de bioéthique 6/4 (1995): 304.

68

Mexico

In the same year as in Argentina, a national ethics council was established in Mexico –

namely, the Comisión Nacional de Bioética (CNB). It was formed by decree of the

President of the United States of Mexico as a working party of the National Health

Council. It is chaired by the Secretary for Health, who appoints its members. These

are men and women drawn from the field of medical research, the health sector and

its State Administration. An important part in the work of the Commission is played

by its Executive Secretary, Dr. Manuel Velasco, an emeritus professor of neurology

and neurosurgery.

The Commission’s field of competence covers a wide range, from ethical issues of

research on human subjects and the monitoring of such research, via the furnishing

of information on bioethical matters to the public, to the provision of advice to government

entities. Bioethics is deemed not to be limited to biomedical issues but to

extend also to ecological problems.

Website

CNB: http://www.bioetica.salud.gob.mx

Bibliography

Consejo Nacional de Bioetica. Journal international de bioéthique 6/4 (1995): 313 – 314.

National Bioethics Commission. Journal international de bioéthique 6/4 (1995): 314.

Dominican Republic

A few years later (in 1994/95), the Dominican Republic followed these examples by

setting up the Comisión Nacional de Bioética de la República Dominicana. The

Commission is intended to promote the establishment of ethics committees in faculties

of medicine and private and public hospitals, to draw up information documents,

to organize postgraduate and continuing training, and to participate in

bioethical research projects.

Address

Comisión Nacional de Bioética

c/o Comisión Nacional Dominicana de la UNESCO, SEEC

Avenida Máximo Gómez, Santo Domingo, Dominican Republic

Bibliography

Byk, Chr.; Mémeteau, G. (1996). Le droit des comités d’éthique (Collection “Médecine et droit”). Paris: 274.

Comisión Nacional de Bioética de la República Dominicana. Journal international de bioéthique 6/4 (1995): 306.

69


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Uruguay

In September 2001 the House of Representatives of the Republic of Uruguay voted to

establish a national ethics council, the Comisión Nacional de Bioética Humana, in

the context of a law providing for state responsibility for scientific research and its

application to human subjects and prohibiting human cloning. Of its five members,

the chair is appointed by the Executive and one member each by the University of the

Republic, the Ministry of Public Health, the National Academy of Medicine and the

Clemente Estable National Institute of Biological Research.

Uruguay had already influenced the international bioethical debate through the

figure of Héctor Gros Espiell. As Uruguay’s ambassador to France and a permanent

delegate to UNESCO, he became Vice-President of UNESCO’s International

Bioethics Committee. The description of the genome as “the heritage of humanity”

included in the Universal Declaration on the Human Genome and Human Rights is

largely attributable to him.

An appreciably older body than the House of Representatives’ National Ethics

Commission is the Comisión de Bioética del Sindicato Médico del Uruguay (SMU),

which celebrated its eleventh anniversary at the 2002 Bioethics Days in Montevideo.

Websites

Comisión Nacional de Bioética Humana:

http://www.parlamento.gub.uy/Repartidos/Camara/D2001090723-00.htm

Comisión de Bioética del SMU: http://www.smu.org.uy/elsmu/institucion/comisiones/bioetica

70

IV. Middle East and north Africa

Israel

A discussion on bioethical issues in the development and application of new technologies

has been under way in Israel for many years, involving not only the predominant

international topics and approaches but also the expression and

interpretation of rabbinical tradition. However, it is only in the last few years that attempts

have been made, in the framework of the Israel Academy of Sciences and Humanities,

to gather representatives of the majority of interpretations and schools

around a single table in a permanent body. The Bioethics Advisory Committee of the

Israel Academy of Sciences and Humanities has since published two important Opinions.

August 2001 saw the publication of the report The Use of Embryonic Stem Cells

for Therapeutic Research, which adopts an approach related to the present British position

and also discusses therapeutic cloning. This was followed in December 2002 by

another report, on biobanks Population-Based Large-Scale Collections of DNA Samples

and Databases of Genetic Information.

The Committee’s members are representatives of the judicial authorities and the

judiciary, academic lawyers, geneticists, philosophers and biochemists; there is one

representative of the Ministry of Health.

The activity of the 12-member Committee is based on the general provisions on

the functions and structure of the Academy laid down by the Law of 1961, according

to which it is required not only to promote science and international scientific exchanges,

but also to advise the Government within its field of competence.

Website

Israel Academy of Sciences and Humanities: http://www.academy.ac.il

Bibliography

Israel Academy of Sciences and Humanities (2001). The Use of Embryonic Stem Cells for Therapeutic Research.

Available online at: http://www.academy.ac.il/bioethics/english/report1/Report1-e.html

Israel Academy of Sciences and Humanities (2002). Population-Based Large-Scale Collections of DNA Samples

and Databases of Genetic Information.

Available online at: http://www.academy.ac.il/bioethics/english/report2/Report2-e.html

71


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Lebanon

The Lebanese Medical Association established a bioethics committee in 1996. The

Comité de Bioéthique de l’Ordre des Médecins du Liban is required to provide the

Council of the Medical Association with Opinions on moral problems posed by research

and its application in the fields of biology, medicine and health, as well as issues

raised by the public.

As an advisory body, it has the function of creating an awareness of the relevant

issues, furnishing information, and facilitating and improving dialogue. The Committee’s

members must be drawn not only from the health professions but also from

the worlds of law, theology and education. Issues hitherto addressed are transsexualism,

genetic tests, clinical research on schizophrenia and cloning.

Since May 2001, Lebanon has also had a body possessing state authority, the

Comité Consultatif National Libanais d’Ethique pour les Sciences de la Vie et de la

Santé (CCNLE), which was established by order of the President of the Council of

Ministers on 15 May 2001 and is chaired by the former Health Minister Marwan

Hamadé. Like the chair, the 18 members of the Committee were appointed in the

founding decree. This instrument requires the Committee to respect human rights and

to take due account of the various religious faiths represented in Lebanese society.

Address

Comité Consultatif National Libanais d’Ethique pour les Sciences de la Vie et de la Santé

c/o Chronic Care Center

P. O. Box 213 Hazmieh, Beirut, Lebanon

Bibliography

Comité de bioéthique de l’ordre des médecins du Liban. Journal international de bioéthique 9/1 – 2 (1998):

139 – 140.

Ducruet, J. (2001). La bioéthique institutionnalisée. Travaux et jours 68/3: 73 – 101.

Membres du Comité consultatif national libanais d’éthique pour les sciences de la vie et de la santé (CCNLE).

Journal international de bioéthique 13/2 (2002): 109 – 110.

72

Tunisia

Tunisia created the Comité National d’Ethique Médicale (CNEM) by the Law of 29

July 1991. Its mandate and the enumeration of the issues for which it is competent

are modelled on the French example, whose wording is sometimes reproduced verbatim.

The Committee comprises a chair and 18 members, each of whom are appointed

for a three-year term. The first issue addressed by the Committee was assisted

reproduction (Avis No. 1, 1996), followed by aspects of the establishment of local

ethics committees and cloning (Avis No. 3, 1997). In its fourth Opinion, it considered

questions of allocation (Ethique – progrès technologiques et dépenses de santé, 1999).

Address

Comité National d’Ethique Médicale

B. P. 74

Institut Pasteur de Tunis

1002 Tunis Belvédère, Tunisia

Bibliography

Ben Ali, Z. E. (2001). Loi n° 2001-93 du 7 août 2001, relative à la médecine de la reproduction. Journal international

de bioéthique 12/4 (2001): 93 – 99.

CNEM (1998). Première conférence annuelle du Comité national d’éthique médicale. Amphithéâtre – Institut

Pasteur de Tunis, 25 avril 1996. Thèmes: La formation en bioéthique, Bioéthique: recherches et applications.

Journal international de bioéthique 9/1 – 2: 149.

CNEM (1998). Rapport sur les comités d’éthique locaux (1997). Journal international de bioéthique 9/1 – 2: 151 – 156.

CNEM (2000). Nominations. Par arrêté du Ministre de la Santé publique de 27 avril 1998. Journal international

de bioéthique 11/2: 86.

CNEM (2002). Avis n° 3 du 22 mai 1997: Le clonage. Journal international de bioéthique 13/2: 115 – 119.

CNEM (2002). Avis n° 4 du 26 janvier 1999: Éthique, progrès technologiques, dépenses de santé. Journal international

de bioéthique 13/1: 97 – 106.

Ministère de la Santé Publique (2001). Décret n° 2001 – 2133 du 10 septembre 2001, modifiant et complétant le

Décret n° 94 – 1939 du 19 septembre 1994, fixant les attributions, la composition et les modalités de fonctionnement

du Comité national d’éthique médicale. Journal international de bioéthique 12/4: 101 – 103.

Ministre de la Santé Publique (2002). Arrêté du Ministre de la Santé publique du 10 août 2001 portant

nomination des membres et du Président du Comité national d’éthique médicale. Journal international de

bioéthique 13/1: 107 – 108.

Tunisie. Comité national d’éthique médicale. Cahiers du Comité consultatif national d’éthique pour les

sciences de la vie et de la santé 26 (2001): 52 – 53.

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Algeria

The Algerian Conseil National de l’Ethique des Sciences de la Santé was established

by the Government Decree of 10 April 1996 and is accommodated within the Ministry

of Health in Algiers. The decree does not explicitly specify the subjects for which

the Council is competent. The laws referred to in the decree suggest that its competence

extends to the entire field of health policy and its moral aspects. Anyone may

refer an issue to it.

The Council includes as its members one representative each of the Ministries of

National Defence, Justice, Health, Labour and Social Affairs, as well as two representatives

of the Ministry of Research and Higher Education. Nine professors of medicine

and three health practitioners are appointed by the Minister of Health. Finally,

the Council includes one representative of the National Council of Medical Professional

Ethics and one of the Higher Islamic Council.

It emerged from the debate on the role of the Council that, apart from classical Islamic

law, there is no adequate legal framework for the subject-matter of the Council’s

Opinions, that its composition is adversely affected by the dominance of the

medical professions, and that the failure to spell out its mission in detail results in a

lack of clarity (Ossoukine).

Address

Conseil National de l’Ethique des Sciences de la Santé

Ministère de la Santé, de la Population et de la Réforme Hospitalière

125, Boulevard Abderrahmane Laala, El-Madania

16075 Algiers, Algeria

Bibliography

Ossoukine, A. (1998). Un conseil d’éthique ou de déontologie (bis). Commentaires sur le Conseil national

algérien de l’éthique des sciences de la santé. Journal international de bioéthique 9/1 – 2: 133 – 135.

Ouyahia, A. (1998). Décret exécutif n° 96-122 du 18 Dhou El Kaada 1426 correspondant au 6 avril 1996 portant

composition, organisation et fonctionnement du Conseil national de l’éthique des sciences de la santé. Journal

officiel de la République algérienne n° 22. Journal international de bioéthique 9/1 – 2: 131 – 132.

Rapport final du Conseil national de l’éthique des sciences de la santé sur les transplantations et greffes

d’organes (1997). Journal international de bioéthique 9/1 – 2 (1998): 137 – 138.

74

Egypt

The present National Committee for Bioethics was established by order of the Minister

of Education of 25 November 1996. It includes representatives both of the scientific

community and of society, such as former ministers and representatives of the

religious schools. The chair is elected from among the Committee members. Annual

meetings are required to be held for the purposes of public information.

Address

Egyptian National Committee for Bioethics

c/o Egyptian National Commission for UNESCO

17 Kuwait Street, Dokki

Guizeh P. O. Box 12311, Cairo, Egypt

Bibliography

Egypte. Un arrêté du 25 novembre 1996 du ministère de l’Education a établi un Comité national de

bioéthique. Journal international de bioéthique 9/1 – 2 (1998): 138.

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

V. Asia

People’s Republic of China

The debate about reproductive cloning and rumours of the therapeutic use of nonhuman

stem cells in human medicine are just two recent examples that have made

the treatment of bioethical problems in the People’s Republic of China a subject of

worldwide interest. Attention had already been aroused by state directives on family

planning and selection. Sinologists emphasize that China’s adoption of market economy

principles in the last few years has resulted in tendencies of the type defined by

Jürgen Habermas as liberal eugenics – that is to say, action that is not state-controlled,

but motivated by parents’ expectations of their children’s social success.

The response of the Chinese state to the new challenges of medical technology

and biotechnology has by no means been one of laissez-faire. Chinese authors have

contributed to WHO and UNESCO ethical guidelines since the end of the 1990s. In

1998, a law on blood donation including provisions to protect patients and donors

was passed. In the same year, the Ministry of Health published a five-point declaration

banning human cloning and all experiments directed to that end, not excepting

therapeutic cloning. The family planning policy and the one-child rule received a

statutory foundation in 2002.

Opinion formation and legislation are partly facilitated and paralleled by the debate

in the major scientific centres of the People’s Republic. Bioethics centres have

been established in Beijing and Shanghai, as well as in Sichuan and at the Academy

of Sciences in Beijing. The members of the two national ethics bodies formed in the

People’s Republic are also drawn from these centres. They are philosophers and research

workers from various medical and scientific disciplines (e.g. Qui Renzong).

Detailed information on recruitment procedures has not been published.

Both bodies presented important documents in 2001. The Medical Ethics Committee

of the Ministry of Health in Beijing formulated ethical principles on the use

of human embryonic stem cells (English abstracts can be found in Döring 2003 and

Cho 2002). The general principle of respect for human life at all stages of its development

is invoked, as well as those of informed consent, safety and value for biomedical

research; a ban on the trade in gametes, embryos and fetuses is also

demanded. Institutions wishing to conduct research on human embryonic stem cells

are required to be licensed by the Government, to provide ethical training for their

staff and to submit their projects to a competent ethics committee. In accordance

with the British model, the Government is recommended to establish an authority

for the licensing procedure and to formulate general standards.

76

Another bioethical advisory body of national significance is the ELSI (Ethical Legal

and Social Issues) Committee of the South Chinese Human Genome Research

Centre in Shanghai. It proposed guidelines on the above issues at the same time, opting

for an approach that took more account of the ethics of research and the associated

risks. It too does not in principle rule out research in the first 14 days of embryo

development. In addition, in its view cross-species recombination experiments (hybridization),

as planned by research workers in Shanghai, should be permissible in

the context of fundamental research (Article 13.4). In all outstanding issues, it is clear

that the ethical debate and the advice given are based on greater respect for the autonomy

of patients and experimental subjects; the first phase of human life benefits

from fairly minimal protection, while the concept of the dignity of the species seems

to be unknown.

Address

Ministry of Health

1, Xi Xhi Men Wai Nan Lu

Beijing 100044, PR China

Bibliography

Cho, Ph. (2002). Human Embryonic Stem Cell Research in China.

Döring, O. (2002). Ein Kind, eineinhalb Abtreibungen. Regelmäßige Unregelmäßigkeiten: Dubiose Quellen der

Stammzellen in China. Frankfurter Allgemeine Zeitung Nr. 22 vom 26. Januar 2002 (Feuilleton): 45.

Döring, O. (2003). China’s Struggle for Practical Regulations in Medical Ethics. Nature Reviews Genetics 4:

233 – 239. Available online at: http://www.ruhr-uni-bochum.de/kbe/DoeringNRG.pdf

77


Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Taiwan

In 1997 the Taiwanese National Science Council (NSC) embarked on priority programmes

for science and technology with the aim of enhancing Taiwan’s position in the

development of technology research having major social and economic implications

for the future. This was the context of the National Research Program for Genomic

Medicine (NRPGM), initiated in 2002, one of whose four parts involves “Ethical, Legal

and Social Issues” (ELSI) and is accommodated at the Center for ELSI Studies.

The Center is responsible for monitoring ongoing research projects, establishing

and maintaining a database, and deriving specific policy recommendations from the

results of ELSI projects. It also facilitates the holding of workshops and conferences,

thus creating forums for dialogue. Crash courses given by prominent scientists from

abroad are also planned. As a part of the requirement to provide public information on

the ethical aspects of genome research, a website is to be set up and academic journals

are to be founded. The Center maintains contacts with international bioethics institutions

via the overseas science and technology divisions of the National Science Council.

The Center is at present the only institution in Taipei that performs an advisory

function for bioethical issues. Information is available not only from the overseas divisions

but also from the National Science Council’s Department of Humanities and

Social Sciences.

Website

NSC: http://www.nsc.gov.tw

78

Japan

Bioethical issues were addressed by Japanese politics for the first time at the beginning

of the 1990s. The problems of brain death and the permissibility of organ removal

became a major concern of the Japanese population, as a result of which the

Prime Minister formed an ad hoc commission. Its deliberations, which were not

open to the public, resulted in its accepting the definition of brain death as the condition

for organ removal. The criterion of brain death and its definition were disputed

in dissenting minority positions. In addition, resources for studies and conferences

on the ethical, legal and social implications of genetic research were provided in the

context of the Japanese genome project and a 20-member working party was formed.

However, there has to date been no broad debate on bioethical issues in Japan, either

in the scientific community or among the public. As a part of the 2002 joint

strategic plan for biotechnology policy, the Ministry of Education and Research and

the Ministry of Economics and Industry are seeking to initiate a discussion in which

the population is not only a recipient of information but also assumes a new role as

an opinion former in its own right.

The function of a national ethics council is currently performed by the Bioethics

Committee of the Council for Science and Technology. The Committee undertakes

research projects and advises the Prime Minister. The 17-member body put forward

fundamental principles for research on the human genome in June 2000. The subsequent

report on research on human embryonic stem cells was published on 6 March

2001 after two years of deliberation and 14 meetings. In the same year the Government

adopted legislation conforming to the recommendations of the report.

Website

Council for Science and Technology, Bioethics Committee:

http://www.mext.go.jp/english/org/councils/69b.htm

Bibliography

Japon. Bioethics Committee. Cahiers du Comité consultatif national d’éthique pour les sciences de la vie et de

la santé 22 (2000): 18.

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Korea

South Korea plans to establish a permanent national ethics council. The preliminary

work on this project is one of the tasks currently assigned to an ad hoc bioethics advisory

commission appointed by the Minister of Science and Technology. The

group’s overall mandate is to arrive at a consensus and to draw up guidelines on the

handling of bioethics issues arising in Korea as a result of the rapid development of

the life sciences. In particular, the commission is required to prepare a proposed

framework for legislation, to sketch out the functions and mode of formation of the

national ethics committee, to define limits for research on human embryos, cloning

and the use of genetic transformation, and to specify the permissible scope of genetic

intervention and enhancement, the use of human genetic information and the

patenting of the results of genetic research.

According to information supplied by the Korean Bioethics Association, the KBA

itself plays a significant part in this aspect of the commission’s work. The KBA, established

in 1998, has 150 members drawn from the disciplines of philosophy, medicine,

law, sociology and biology, as well as representatives of non-governmental

organizations (NGOs).

The Korean National Commission for UNESCO has already held two consensus

conferences in the country. Along the lines of the Danish Technology Council, citizens’

groups were set up in 1998 to discuss the safety and ethics of genetically modified

foods. A second consensus process, on the application of cloning in humans and

animals, followed from March to September 1999.

Website

KBA: http://www.koreabioethics.net

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Singapore

One of the world’s most astonishing national ethics bodies is Singapore’s Bioethics

Advisory Committee (BAC). Its foundation was closely bound up with the Government’s

declared aspiration to make Singapore a leading centre of research in the biosciences.

Under the Government’s programme, research and development are

supposed to cover the entire range from clinical trials to the production and dissemination

of healthcare services and drugs. In December 2000 the Committee was initially

appointed for a two-year period to address the potential ethical, legal and social

issues arising out of the intensification of biomedical sciences research. The Committee

will submit its recommendations to the Life Sciences Ministerial Committee.

In June 2002, the Committee published its first report: Ethical, Legal and Social Issues

in Human Stem Cell Research, Reproductive and Therapeutic Cloning. Subject to

certain conditions, the Committee considers research involving human embryonic

stem cells to be legitimate. In particular, it calls for the establishment of a supervisory

authority in accordance with the British model. The Committee’s second report –

Human Tissue Research – which was devoted to tissue banks, followed in November of

the same year. It too stresses the importance of a clear licensing procedure, and insists

on the principle of informed consent.

The Committee has a website of its own, on which the complete text of its reports

can be accessed. Its electronic newsletter is also available for subscription. Published

for the first time in April 2003, it reports on the work of the Committee and its Secretariat,

on conferences and the like organized by the Committee and on visits from

international bioethics experts.

Another Singaporean body is the Health Ministry’s National Medical Ethics

Committee (NMEC). This has existed since 1994 and includes experts in medical disciplines

and health policy, lay individuals and representatives of the ethnic minorities.

It has published guidelines on organ and tissue transplantation, on the

termination of pregnancy in the event of lethal malformations of the fetus, on the

medical treatment of high-risk infants, on research on human subjects, on psychiatry,

on ethical issues of gene technology (2/2001) and on financial issues in medical

practice (1/2000).

Website

BAC: http://www.bioethics-singapore.org

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

India

The Indian Council of Medical Research (ICMR) is one of the world’s oldest state institutions

for the promotion and coordination of medical research. In 1996 the

ICMR appointed a Central Ethical Committee to consider a number of bioethical issues.

In addition to epidemiological research and clinical trials of products for human

use, the field of competence of the Committee extends from organ

transplantation to human genetics. In 2000, the ICMR published ethical guidelines

for biomedical research on human subjects.

The Committee is also responsible for bilateral exchanges with foreign delegations.

In March 2002 it organized the first German-Indian workshop on bioethics at

Lonavalle, near Mumbai. In January 2003 a course on the political implications of

genome research was held in Kumarakom, Kerala, attended by scientists not only

from India but also from the University of Toronto.

Website

ICMR: http://www.icmr.nic.in

Bibliography

Fuchs, M. (2001). Bioethik in Indien. IWE-Informationsbrief 1: 1 – 2.

ICMR (2000). Ethical Guidelines for Biomedical Research on Human Subjects. New Delhi.

Available online at: http://icmr.nic.in/ethical.pdf

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VI. Australia and New Zealand

Australia

The Australian Health Ethics Committee (AHEC) was founded in 1992. It is one of

the committees of the National Health and Medical Research Council (NHMRC).

The composition and mission of the Committee are laid down in the NHMRC Act

of 1992. It is required to include experts in philosophy, the ethics of medical research,

public health and social science research, clinical medical practice and nursing, disability,

law, religion and health consumer issues. An important function is the discussion

of general ethical issues arising from medical research on human subjects.

The Council is also required to stimulate the general debate on ethical issues in healthcare.

The AHEC has drawn up guidelines not only on ethical considerations in research

involving human subjects but also on cloning, human genetics and animal ethics.

Independently of the Research Council, a multidisciplinary, 12-member National

Bioethics Consultative Committee was formed as long ago as in 1988. Its brief was to

act as an autonomous advisory body for the Conference of Health Ministers, and it

concerned itself mainly with issues of medically assisted reproduction. Byk/Mémeteau

(1996, 275) report that, according to the Australian press, this body was superseded by

the Research Council’s Committee because its position was felt to be too liberal.

Website

AHEC: http://www.nhmrc.gov.au/ethics/human/ahec

Bibliography

Byk, Chr.; Mémeteau, G. (1996). Le droit des comités d’éthique (Collection “Médecine et droit”). Paris.

Chalmers, D. (1996). Statement of Donald Chalmers. In: National Bioethics Advisory Commission (NBAC);

National Institutes of Health (NIH) (ed.). The International Summit of National Bioethics Advisory Bodies […]

San Francisco, California […] Thursday, November 21, 1996 […]: 50 – 56. Available online at:

http://www.georgetown.edu/research/nrcbl/nbac/transcripts/1996/11-21-96.pdf

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

New Zealand

Under New Zealand law (1993 and 2000), applications involving particular measures

of medically assisted reproduction must be submitted to a committee for examination

of their ethical aspects. The national-level body with the competence to issue relevant

guidelines is the National Ethics Committee on Assisted Human Reproduction

(NECAHR), which is mainly concerned with the conditions for the licensing of

sperm donation and surrogate motherhood.

In 1999 the Minister of Research, Science and Technology established the Independent

Biotechnology Advisory Council (IBAC), to give advice and at the same time

to facilitate an informed public debate on biotechnology, as well as to improve the

standard of that debate. The Council had seven members: a professor of bioethics, an

Anglican archbishop, an ecologist, a clinical geneticist and a plant geneticist, a farmer

and a retired headmistress (who was its chair). The IBAC often worked with focus

groups of external participants. It was wound up in August 2002.

In accordance with a recommendation by the Environment Minister’s Royal

Commission on Genetic Modification, the Government established Toi te Taiao: the

Bioethics Council in December 2002. The Council is responsible for providing the

Government with high-level advice, taking due account of overarching ethical, cultural

and spiritual aspects. In the Maori language, “Toi te Taiao” denotes the sphere

of the spiritual and natural worlds. Some of the 12 members are former members of

the IBAC, while others are experts in and connoisseurs of Maori culture. Toi te Taiao

has already prepared an Opinion on a bill on assisted reproduction and drawn up reports

on nanotechnology and the use of human genes in other organisms.

Websites

NECAHR: http://www.necahr.govt.nz

IBAC: http://www.ibac.org.nz

Toi te Taiao: http://www.bioethics.org.nz

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VII. The ethical debate on modern

medicine and state responses to it

1. Establishment of national ethics bodies:

background situations

For all the diversity of structure, composition, institutional framework and mission,

comparison of the founding documents reveals a common thread invoking the rapid

development of research, especially in the life sciences, and the presumed moral

implications of its medical application. The challenge of these new situations is supposed

to be met by assembled expertise and the formation of an ethical consensus.

However, each state was affected differently by these challenges at the time of foundation

of its permanent ethics body. In a number of states, the new permanent body

can look back over a history of activity of ad hoc predecessors. In some cases it is dependent

on the work of earlier commissions appointed for a limited time and with

limited terms of reference, whose work it continues. In other cases, by contrast – for

example, in France or Denmark – the early decision to establish a permanent body is

accompanied by the prospect of its breaking new ground. In either case, the permanent

committee is expected in some instances to initiate the tasks of examination and

information of its own accord, and in addition to be prepared to address promptly

new issues referred to it.

Specific problems arise in parts of the world that are in the throes of radical

change independently of the challenges of bioethics. Here, interesting parallels can be

drawn between certain Latin American states and the post-communist states of eastern

Europe. In these countries, the restructuring of the healthcare system and the

testing of social debate on bioethical topics assume an exemplary character for the

process of democratization as a whole, at least for some social and scientific groups.

In this way, national ethics bodies can form the institutional framework for the activity

of civil-society avant-gardes.

The situation in the so-called threshold countries is different again. Here the new

technologies are expected to boost the national economy. In these states, unlike those

in the process of democratization, bioethics appears less as a part of a movement of

renewal emanating from society and taken up by politics than as the result of insights

by the political establishment. The model here is that of the states of north America

and Europe, with which a research and economic partnership exists or is sought.

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

2. Institutional framework models and assignment

to agencies of the state

All national ethics bodies were established as independent entities. Their orientation

is admittedly influenced by both the body competent to appoint members and the

initiative for their foundation. For this reason, the competence for appointments is

often shared, especially in the various European models. The institutional framework

and physical location call for separate consideration. Here again, a consistent situation

is not observed. In the instances where the power of appointment and the institutional

framework coincide wholly or partially, as in Portugal or Italy, this has at

least strong symbolic significance. In the case of Italy, political crises seem at times also

to have entailed a crisis of the ethics committee, or at least a discontinuity in its activity.

For both variants of the United States Presidential model, specific intentions

can be discerned behind their establishment, although these are not binding on the

bodies and do not preclude their independent operation. Again, the varying degree

of interest on the part of the government entities to which the ethics committees are

assigned, as in some central European countries, does not by itself fundamentally call

into question the independence of the advisory body and its members.

A factor of particular importance for the practical working of the committees in

this respect is that, regardless of the detailed technical provisions, there is no evidence

of influence being exerted over budgets. However, the conferment of a statutory basis

on many ethics bodies has contributed substantially to their independence (Kennedy).

This ensures that these bodies have a solid democratic foundation even where the initiative

for their establishment stemmed from a specific institution of state.

3. Size and Composition

The number of members ranges from five (Uruguay) to over 40 (France 42; Italy 51).

In most cases the figure is somewhere in the middle of this range, between 15 and 25.

The main consideration here is to ensure the representation of a multiplicity of viewpoints

while at the same time permitting face-to-face debate.

The transition from an ad hoc body to a permanent entity calls for different

arrangements as regards expertise and a systematic response to the problem of social

plurality and representativeness. Two main strategies are deployed for this purpose,

in different combinations. One is to describe the required competences in concrete,

detailed terms, while the other involves an attempt to achieve the desired result by detailed

stipulation of the competence to make appointments. Whereas Norway, for instance,

opts for the first approach, Denmark can be regarded as an example of the

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second. In a few cases, the initial choice of members seems to have preceded the description

of competences and the groups to be represented. This is true, say, of the

NBAC in the United States (Capron, 66), whose exact composition was not described

until its mandate was extended. A common feature of all models is that the membership,

even if deliberately chosen from specific disciplines or backgrounds, is supposed

to comprise independent individuals rather than representatives of a lobby.

Occasionally, as in Norway or Ireland, there are explicit provisions to that effect.

Subject expertise

Unlike commissions with specific, narrowly defined terms of reference, the permanent

bodies must possess a reasonably wide range of competences. In most cases, a

spectrum extending from fundamental research to clinical application is required for

the life sciences and medicine. In view of the breadth of the subject-matter to be covered,

external experts are co-opted for individual deliberations. So are representatives

of patients and other research subjects. Since it is not possible to appoint patients’

representatives as members for all diseases covered by a committee’s deliberations,

the relevant aspects from the point of view of the persons concerned must be addressed

by means of hearings. This principle is departed from only in a very small

number of instances (e.g. the ETENE in Finland).

Ethical expertise

Specific ethical expertise within the committee itself is not demanded in all cases. In

France, for example, where such expertise is provided only indirectly through the

representatives of the various faiths and philosophies, it is reported that a competence

to analyse ethical problems develops in all members precisely during the course of the

committee’s work. Often (for example in some of the central and eastern European

committees), an interest in ethical issues is an explicit criterion for the selection of

scientific and medical experts. Not only prior evidence of an interest in ethical problems

but also relevant professional competence is required by a number of models (see

Hermerén), as is indicated by the demand for philosophically or theologically based

ethical expertise. The requirement that legal experts and social scientists be involved

appears to have the same origins. Whether the ethicists appointed are expected to

stand for particular values or instead to possess scientific and philosophical competence

(see Hermerén) is not clear from the founding documents, nor can the balance

between these requirements readily be discerned from the committees’ practice.

Plurality of faiths and philosophies of life

Many of the bodies discussed here insist on the representation not only of a multiplicity

of disciplines but also of a plurality of philosophies and creeds. This requirement

is satisfied on the one hand by stipulations on their overall composition and on

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

the other by the representation of specific philosophical tendencies and faith groups

by individual members. As to overall composition, there are a number of examples

that seek a balance between scientific cultures or, alternatively, between the scientific

and the non-scientific spheres. However, the plurality of outlooks is expressed only

by a small number of members who are known to espouse them. They are nominated

not by the groups themselves but by the competent institutions of state (the President

in France, or the National Assembly in Portugal). The specific philosophies and

creeds to be represented are specifically defined only in France – namely, Roman

Catholicism, Protestantism, Judaism, Islam and Marxism. Allowance is not made for

individual sects within these groups, either in France or elsewhere.

Representation

Representativeness is not achieved in any of the examples considered here through

democratic election of committee members. Many of the models provide for a lay

component, although to different degrees. While the non-specialist in Sweden is a

politician, some models attempt to include specific social groups when appointing

members. In individual cases, it is difficult to say whether a plurality of philosophies

and faiths is aimed for and whether specific personalities are then demanded, and if

so, whether they are able to free themselves from dependence on their lobby. This difficulty

also sets limits to the transparency of the committees’ work. Where certain social

groups or associations are nevertheless required to be represented, these are

confined to a small number. This situation is compensated for by hearings and the

commissioning of reports from the relevant associations.

In a very small number of cases, the composition requirements stipulate not only

lay membership and the appointment of individual experts, but also specific quotas.

Only Denmark lays down specific quotas for men and women (in Section 2(2) of

the Law of 3 June 1987). The representation of the sexes required by the NBAC in the

United States, as well as the requirements of geographical and ethnic representation,

did not precisely reflect the ratios existing in society. Belgium demands an appropriate

division of mandates between the sexes, but actual quotas are specified only for

the representation of the regions and language communities. The majority of language

communities are represented in the Swiss committees, but quotas are neither

formulated nor evident from their composition. None of the bodies described provides

for quotas, or appropriate proportions, of different age groups. Since members

can often be reappointed, as well as for other reasons, it is quite common for the average

age of the membership to be conspicuously high.

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4. Assigned fields of competence and main issues addressed

The rapid advances in science and research in the life and health sciences that underlie

the institutionalization of ethics bodies, according to the texts of the founding

decrees and laws, are observed or expected mainly in genetics, reproductive medicine

and biotechnology. This is reflected not only in the assignment of specific topics for

examination, sometimes already provided for in the relevant laws, but also in the issues

on which the committees subsequently concentrate their activity. For instance,

a committee may attempt to confine its work to the assessment of new areas of research

– that is, of actual innovations. This intention is explicit in certain statements

by members of the French Committee (e.g. Jean Michaud), who consider that ethical

monitoring and the adoption of positions should be left to the established medical

practice of professional ethics – that is to say, to the medical profession itself and

its codes of practice. However, the boundary is not sharply defined and cannot necessarily

always be respected. In its latest publications on euthanasia, the French Committee

has certainly expressed a view on one of the classical issues of medical ethics,

which thus also falls within the sphere of professional ethics. The report on the role

of occupational physicians (December 2003), too, addresses questions of doctors’

conception of themselves that have traditionally been answered by professional

ethics. Particular controversy has been aroused, at European conferences of ethics

committees, by the question of how far the setting of healthcare priorities could be

deemed a legitimate subject for the deliberations of an ethics council. It is mainly the

committees of countries with centralized state health systems (Sweden, Norway and

Denmark) that have placed this subject on their agenda. Outside Scandinavia, the

Tunisian committee, for example, has addressed this issue.

However, competence for research issues gives rise to further demarcation difficulties.

The Norwegian model, involving a separation between the major scientific

sectors and cultures, is the only one to include quite clearly defined boundaries. A

similar division obtains in Switzerland. In other countries, it is not always clear

whether bioscience applications with no implications for human medicine should be

covered. For instance, the Nuffield Council published a study on genetically modified

crops in 1999, and the Greek and Irish councils have also addressed the subject of genetically

modified organisms; the Italian committee presented a study on bioethics

and the environment in 1995 and another on childhood and the environment in

1997. Bioethics is here defined more broadly, as covering not only biomedical ethics

but also extending to ethical fields associated with living organisms in general or with

the effect of the environment on living organisms. The same is true, in terms of its

programme, of Toi te Taiao, New Zealand’s Bioethics Council. The French Committee,

too, in its 38th Avis (October 1993), overstepped the boundaries of the narrow

field of medical ethics by considering ethical issues of experimental psychology.

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

However, the main emphasis falls unequivocally on the medical application of

certain procedures to human beings. Particular attention has been devoted in this

connection to reproductive medicine and genetics and their significance for diagnosis

and therapy. A major part has also been played by issues of research ethics as more

strictly defined (e.g. research on subjects incapable of giving consent). In addition,

ethical issues in psychiatry have been considered on a number of occasions in Italy.

Not only the issues themselves are important, but also when they are addressed.

For instance, the Nuffield Council turned its attention to xenotransplantation early

on, while the French Committee considered the treatment of embryonic stem cells

even before human examples had been cultured for the first time. Such possibilities

exist only where the bodies concerned are partially free to make their own choice of

issues to address. The majority of ethics bodies seem to set their own priorities. In a

few cases, the issues to be addressed were fixed temporarily by the founding legislation.

Even in countries where referrals from institutions of state and from third parties

are relatively frequent, such as France in particular, committees have evidently

retained sufficient independence to work, even in the relatively long term, on important

issues of their own choosing, and thereby prospectively to address ethical topics

of the future. Other essential elements in this respect are contact with research institutes

and communication with local ethics committees.

Precisely in view of the diversity of these bodies from country to country, it is emphasized,

finally, that the term “ethics commission” or “ethics committee” actually denotes

three or four quite different types of bodies and missions. In addition to

advisory bodies at European, national or provincial level, there are commissions with

regional or institutional competence for the examination of research projects involving

human subjects, as well as locally or institutionally competent commissions intended

to advise on clinical decisions. Finally, the term can also be applied to bodies

devoted to good scientific practice and the avoidance of misconduct. However, it can

certainly not be taken for granted that these various tasks will be reflected in the establishment

of a corresponding number of institutions. The examples from the Baltic

countries, central Europe and, in some cases, other continents show that this differentiation

has not been implemented universally, nor, presumably, is it everywhere

deemed necessary. In countries with a two-tier system of examination of research

projects involving human subjects, in particular, a distinction can be drawn between

the Danish model (establishment of a central commission alongside the Council of

Ethics) and the Lithuanian paradigm (in which all functions are integrated).

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5. Right of referral

Although nearly all the founding instruments specifically mention the institutions of

state as enjoying the right of referral, a liberal approach to access to ethics bodies

seems to be the rule internationally. In this respect, the ad hoc commissions are

sharply distinguished from the permanent bodies discussed here. However, a wide

variety of tendencies are observed in referral practice. Overall, referrals by governments

and ministries appear to predominate, but this situation may be offset in some

countries by large numbers of minor referrals from individual research workers or

members of the public – although minor referrals of this kind do not give rise to

large-scale reports and fundamental analyses.

6. Advisory mandate

None of the bodies described here as paradigms has legally binding decision-making

powers. In some cases, the central coordinating body for local ethics commissions

operating in accordance with the Helsinki Declaration constitutes a separately functioning

part of the national ethics council. Where this is case, as for example in

Lithuania or Slovenia, positions adopted by the national ethics body may have direct

legal effects. In most cases, on the other hand, the functions of examining research

projects and of general bioethical advice are clearly divided among different institutions,

as in France and Denmark. A restriction to advisory and consultative activity

is also often expressed in the body’s name. Depending on its mission, institutional

framework and specific historical development, the proximity of an advisory body to

the executive and the legislature may vary.

7. Influence on legislative procedures

In continental European jurisdictions at least, identification of a need for legislation

appears to be a central task of national ethics committees.Yet there are institutions such

as the Danish Council that are internationally regarded as successful although they

have not manifestly influenced actual political decisions. Conversely, others, such as the

Nuffield Council in the United Kingdom or the Italian Committee, have occasionally

exerted a substantial influence. In eastern Europe, where many countries lacked specific

laws on bioethical issues before the national councils were established, these bodies

have sometimes even taken the initiative for the formulation of such instruments.

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

Representatives of states whose legal systems are based on English law stress the

importance of furnishing advice for political action even in fields where legislation is

not considered necessary (Kennedy, Turner-Warwick). In addition to advising the executive,

the committee may offer guidance to the courts (e.g. the CCNE’s Avis No. 63).

In France, where the Committee has often exerted a decisive influence on legislation,

the members emphasize the difference between the ethical and macropolitical perspectives.

Even where the Committee adopts an unequivocal position, other considerations

may contribute to the political decision. For this reason, the CCNE has

always declined to compile draft laws of its own or to present detailed proposals for

legislation. It is interesting to note that none of the bodies discussed here, in its own

self-descriptions, substantially measures its own success by its influence on legislation

– if only because a high degree of correspondence with subsequent legislation

might, in the view of the committee itself, cast doubt on its independence, as the influence

could also be interpreted as having been exerted in the opposite direction.

8. Procedures for involvement of the public and

influencing public debate

It is considered important to influence not only legislation and guidelines but also the

public debate. This influence seems to be a fact both for the social sectors of science and

health and for society as a whole. For instance, the Danish Council has manifestly succeeded

in defining the main topics for public debate (Koch/Zahle). The ethics councils

of every country seem to have acquired great authority by virtue of their competence

for the issues and for ethics, for the thoroughness and seriousness of their problem

analyses, and for the impartial, free and independent manner in which they arrive at

their conclusions. They appear as bodies whose internal discussions initiate or appreciably

enhance the debate between science, the world of politics and the public.

Since non-public deliberations are at least conducive to members’ independence,

specific procedures must be developed to allow public participation. In a survey conducted

by the Council of Europe, the majority of responding states, or their national

ethics committees, emphasized the importance of taking account of public opinion

on new biotechnologies. At the same time, however, in this survey at any rate, no instruments

for determining this opinion, whether now or in the future, were mentioned

(Le Bris, 25). Some committees have since made strenuous efforts to involve

the public in their work. The principal instruments here are the regular hearings and

public conferences held in many countries. In France, where this practice has been established

for some years, schoolchildren and students are given an opportunity of

putting their views publicly and to the members of the National Committee and

92

Government representatives – and, what is more, a genuine discourse can come into

being because such interventions are thoroughly prepared for with the support of the

Committee and teachers. The German National Ethics Council, too, besides its annual

public meeting, every year holds a number of public meetings and evening lectures

(Forum Bioethik). In addition, since the beginning of 2003, the public have been

admitted to plenary meetings of the Council as observers.

Other approaches to promoting citizen participation, such as consensus conferences

and similar citizens’ forums, are the responsibility of institutions other than the

national councils in most countries (e.g. Denmark or Switzerland; for a comparison

of ethics councils and citizens’ conference initiatives, see Fuchs 2001b).

9. Funding, facilities and internal structure

Except for the Nuffield Council, which is privately resourced and receives supplementary

funding from the European Commission, the committees operate wholly or

substantially with public funds. In some cases the committee or its secretariat is free

to decide on the appropriation of resources, while in others funds must be obtained

from the institution of state or authority to which the committee is answerable. The

situation is similar for bodies under the auspices of academies of sciences or quasigovernmental

research councils. Budget allocations are thus made in some cases in

advance and in others on a post hoc basis. All committees reimburse members with

their travelling expenses. In some instances funds are available for other expenses, per

diems and meeting allowances. Further expenditure may be occasioned by hearings

and the commissioning of external experts’ reports.

Most bodies have a secretariat, which sometimes includes scientific staff. The scientific

staff of the President’s Council is particularly worthy of mention because it is

so numerous. An appreciable proportion of the costs of some ethics bodies is accounted

for by the production and dissemination of publications and teaching material,

as well as the holding of conferences and discussion forums. A particularity of

the French Committee is the establishment of a large on-site documentation centre;

other committees, such as those of Portugal and Belgium, have established smaller libraries

or collections of essential reference works.

The committees are very similar in their internal structures. In addition to their

plenary meetings, which take place at four- to six-week intervals, they hold working

and coordinating committee meetings. Additional expertise is often co-opted. The

chair is sometimes elected by the body itself (as in the NBAC in the United States or

the National Ethics Council in Germany) and in other cases appointed externally

(e.g. in the French CCNE or the US President’s Council).

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Michael Fuchs National ethics councils. Their backgrounds, functions and modes of operation compared

VIII. The role of national ethics councils in

the inter-state and international bioethics

debate

The statutory mandate of the Italian commission includes maintaining links with

similar bodies in other states, in the European Union and in the Council of Europe.

The German National Ethics Council is charged with the same task by decision of the

Cabinet. This function is also performed by most other national committees.

1. COMETH

A framework for international discourse between representatives of national ethics

councils was first established by the Council of Europe. Commencing with a conference

in Madrid in 1992, it was decided to hold biennial meetings. In accordance

with the first resolution of the Conférence Européenne des Comités Nationaux

d’Ethique (Standing Conference of European Ethics Committees) in 1999, an annual

frequency was adopted. In addition to official national councils, “similar bodies”

are admitted.

Although some of the initiators at first aspired to create a Europe-wide body, the

more modest role of cooperation and exchanges was already agreed in Madrid. The

Council of Europe wished at the same time to assume the function of gathering information

on the work of the committees. Sonia Le Bris’s study Les instances nationales

d’éthique was published as long ago as in 1993. In spite of the decision to

continue this work, it was not until 2000 that the consolidated results of a more recent

survey of member states were presented, in the form of a brief report by Sandrine

Sabatier. The reliability of the published data depends on that of the organizations

approached in the member states. For this reason, some member states have undertaken

initiatives of their own to compile a comparative review. A report covering seven

states was commissioned in France by the Senate and published in April 2001. The

regular reports in the Rubrique internationale of the Cahiers du CCNE and the Journal

international de bioéthique are even more important. In Germany, the Commission

on the Law and Ethics of Modern Medicine of the 14th Electoral Term of the Lower

House of the German Parliament held a hearing with seven representatives of national

ethics bodies in other European countries and commissioned comparative reports

on the treatment of dissenting positions within these bodies.

94

At European level, there have been initiatives not only from the Council of Europe

but also from the European Commission. The Secretariat of the European Group on

Ethics in Science and New Technologies issued its first newsletter in February 2003,

on the activities of national ethics councils. A second newsletter was published in December

2003. Göran Hermerén draws attention in his editorial to the importance of

exchanging information in view of the enlargement of the EU. The Commission

plans to promote exchanges between national ethics councils in the future.

Website

COMETH: http://www.coe.int/T/E/Legal_Affairs/Legal_co-operation/Bioethics/COMETH

2. Global Summit

The first international summit was held as late as in 1996. Organizations were invited

to San Francisco by the NBAC. Further meetings then took place in Tokyo, London,

Brasília and Canberra. They took the form of satellite conferences of the World

Congress of the International Association of Bioethics and received organizational

support from the WHO in Tokyo and London. Like the Council of Europe, the Global

Summit decided to admit bodies which did not unequivocally possess the status of

a national committee or which belonged to states with more than one relevant body.

Like the second COMETH meeting in Stockholm, the San Francisco Conference

chose the work of ethics committees itself as its topic. Usually, however, the main focus

of the Summit’s exchanges is on specific current bioethical issues. In addition to

providing information about the debate in other countries, representation at international

meetings results in better visibility of national debates and positions abroad.

This means that smaller countries such as Portugal or Belgium can also play a part in

the international discussion. In some cases, the national debate and the institutional

framework adopted in individual countries constitute paradigms for newly participating

states. That is why the number of states represented has grown constantly.

Website

Global Summit: http://www.who.int/ethics/globalsummit

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Michael Fuchs

3. Bilateral cooperation

In addition to multinational conferences, bilateral contacts have recently been initiated.

The approach of the German National Ethics Council has played an important

part in this development. A few months after its formation, it held a meeting with the

French Committee in Paris in November 2001 (Cahiers du CCNE No. 30, 2002, 81).

The purpose was to obtain information on the CCNE’s strategic experience and to

exchange details of positions on current bioethical issues and their justification. A

meeting with the Greek Committee followed, as well as an invitation to the Chair

from the President’s Council in the United States. At a second joint meeting of the

German and French bodies in Berlin in June 2002, permanent close collaboration

was decided upon (Cahiers du CCNE No. 33, 2002, 22; German National Ethics

Council press release of 28 June 2002). The institutionalized cooperation was intended

to result in the publication of joint Opinions. The first topic chosen for such

an Opinion was biobanks. Supplementing the recommendations made to national

legislatures, which differed in minor respects from each other, a joint declaration by

the two advisory bodies was published in October 2003.

This cooperation results from the realization that issues that must first be addressed

nationally can be resolved only if the boundaries of the national perspective

are borne in mind (as stated in the inaugural address by Professor Spiros Simitis at

the first annual meeting of the German National Ethics Council on 24 November

2002). This raises important issues concerning not only the work of ethics bodies and

their conceptions of themselves but also their cooperation.

What is the origin of the common aspects and the differences in the agendas of the

national debates on research ethics? How are cultural traditions and historical experience

to find a legitimate place in the formation of ethical judgements? How far must the

existing national legal system be taken into account in the provision of ethical advice to

government entities? What simplifications are justified in the comparison of national

viewpoints, and what limits are encountered by ethics committees in the “administration

of the public ethical agenda” (Koch/Zahle, 130), in the “structuring of the debate”

(Catenhusen, 3) and in international communication of this agenda and structure?

The success of national ethics bodies both in stimulating public debate and in

their function of assisting government decision-makers is largely attributable to their

having created an “agora” (Le Bris, 23) for bioethical debate without claiming sole

rights to pronounce on these matters. Since subject expertise is so strongly represented

in national ethics bodies, bioethical issues must be addressed not by them

alone but also in the context of public debate; some issues in addition call for consensual

processes in order to resolve differences between interest groups. National

councils will in the future continue to play an important, if not exclusive, part in the

international debate on bioethics.

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