Bioethics, a public issue: present and future of International and National Bioethics Committees
Gonzalo Herranz, departmentof Bioethics, University of Navarra.
lectureDelivered at the congressInternational Bioethics Conference.
Universidad de La Sabana, Campus Universitario de Chía, 16 July 1997.
A Brief History of National Bioethics Councils
An uncertain future. The cloning crisis
No one could have imagined thirty, even twenty years ago, the extent to which today's man in the street would take an interest in bioethical issues. What was then topica matter of reflection for only a few, has now entered the media, it is topicpart of people's conversation, it is part of everyday life.
Nor would anyone have imagined, at the end of the 1960s, that the interest of a few small academic circles in the nascent bioethics of transplants, biomedical research, assisted reproduction, all in their early stages of development, and the increasingly problematic doctor/patient relationship, would become, beyond the private discussion, a matter of public policy. It took little more than a decade for bioethical issues to leap from university circles to the diaryof councils of ministers, to parliamentary debates, to the decisions of constitutional courts, or to the agendaof ecclesiastical synods in the 1980s.
The two fields of relations between general politics and bioethics
In the intervening years, bioethics and politics have become closely intertwined. And they have done so, according to Dan W. Brock1 , in two broad areas.
One of these, which is of little interest to us today, is the activity - of parliaments, ministries of health, high courts of law or government agencies - of producing and applying laws, administrative rules, guidelines or protocols, which constitute the great mass of medical law.
The other field in which general policy and bioethics come together, and which is the subject of this intervention of mine, is that occupied by certain consultative bodies, created by some public authority or institution, dedicated to reflection and discussionon bioethical and biolegal issues, of which national or international bioethics committees are typical representatives. Their function is not to set standards, but to define and clarify problems, to explore them in depth, to refine data, to propose criteria and formulate recommendations, and thus to educate the public, to inform politicians and governments and, through them, to lay the foundations for standards and protocols.
As we shall have the opportunity to see, Bioethics Committees have achieved, despite their not always effective and sometimes tormented existence, a very wide acceptance and a solid prestige. Their issuehas grown, to such an extent that those who seriously dedicate themselves to Bioethics are almost inevitably forced to join, sooner or later, a Bioethics committee. Because today, in Bioethics, in order to pose problems and seek solutions to them, it seems impossible to do without workat committee.
Preliminary issues: necessity, typology, history, procedure
The body of my speech will consist of describing and characterising what, in my opinion, are the most outstanding international or national Bioethics Committees. But first, it is worth stopping briefly to consider the previous question of the why and wherefore of the Committees.
I will begin by saying that, in Bioethics, the Committees are a response to the very human need we all feel to consult with each other on serious issues. And, in particular, consulting on subjectethics is a sign of moral maturity. The trainingof judgement and decision-making in bioethics, because of what is new and important about subject, is something that invites, already at the level of staff, to seek the conversation and the committeeof others. In this way, doubts and data, perplexities and solutions are shared horizontally. In this way, one manages to protect oneself from the vertigo of diving alone into new problems. In particular, enquirywith others frees us from biases and myopias: it makes us hear different voices and opens us to unsuspected perspectives.
This impulse to confer with others is reinforced when, going beyond the private level, thinking or deciding in bioethics is applied to questions of public scope, on which it is useful to listen to many, scrutinise reasons and discover, through dialogue, new or different ways of considering and seeking solutions to problems. This explains why, in recent times, it has been increasingly common for those who, being in positions of power and responsibility, and therefore having to legislate or guide social or professional conduct, have opted to create Committees to help them carry out their responsibilities.
The history of Bioethics Committees is complex, as is their structure and function. They are a recent phenomenon, although, as we shall see, there have been medical ethics committees for 50 years - such as the Ethics Commission of the associationWorld Medical Association and also the committeeof International Organisations of Medical Sciences (CIOMS) - which were set up to rebuild the ethics of doctors, so badly damaged during the Second World War.
But it was later, a little less than 25 years ago now, that the movement of large bioethics committees began to gain momentum, when in the United States, in 1974, the statusof biomedical research, of its ethics, had become a matter of concern. A lot of public money was being poured into research, and politicians and human rights advocates alike wanted to be sure that it was being well spent, as there was no lack of evidence that some doctors, unfortunately more than a few, were subjecting human beings to incredible abuses in the course of their research. The US congresschose to create a committeeof experts to assist it in the task of reviewing the ethics of federally funded projects, which was called the National Commission for the Protection of Human Subjects in Biomedical and Behavioural research. That committeedid very well: its final report, the famous reportde Belmont, definitively accredited the workat committee. Since then, Bioethics Committees have never ceased to be set up. And perhaps we will have them with us forever.
In the general history of committees, as in the history of everything human, effectiveness and futility, magnanimity and opportunism, intermingle. Depending on its leaders and members, a committeemay acquire unquestioned authority or it may vegetate in triviality. We cannot forget that public committees, including Bioethics Committees, are the work of some authority. Depending on the attitude, respectful or domineering, that it manifests towards committee, it can be a vigorous, original and independent body, or a servile and manipulated puppet. The authority that creates it can hold it in its grip and subject it to powerful influences that limit its freedom. It can also weaken it through slow economic suffocation and prevent it from exercising its primary function of being an ethical conscience.
The typology and character of committees is extremely varied. Walters2 has made an inventory of the types and roles that sociologists have assigned to committees, according to their dependence-independence, which I shall summarise here, taking wide liberties. At one extreme, there are the decorative committees, created to play a purely ornamental role: made up of straw men, they serve to give an appearance of dignity or impartiality to the rules of official policy that have already been decided. Not far from them are the kamikaze committees, which are appointed to save, by their sacrifice, the political erosion of the authority that erects them: they are there to delay a compromising decision or to recommend unpopular decisions. Platform committees have a nobler mission: they are created to serve as a forum for ethical pluralism, to constitute themselves as an inventory of social diversity and thus to act as a showcase for different and conflicting ideas and interests. Fortunately, there are also effective, competent committees which seek and systematise information, design and evaluate the various solutions to be applied, and offer instructionson which decisions can be taken. These are committees, in short, which carry out an effective task of Educationof the public, and which are capable of gaining the intelligent support of society for the suggestions and recommendations they propose.
The greatness and weakness of bioethics committees lies precisely in their advisory nature. They can acquire moral authority ad extra through the rationality and tempering of their statements and programs of study. But they can never impose their decisions or in any way impose them as binding. On the contrary, they must often see them forgotten or disregarded. This demands of its members a total intellectual and moral humility test, an extensive capacity for understanding and apology, an unlimited patience to suffer the decisions of politicians and administrators. And the members of committeeneed, for workad intra, an extraordinary capacity for tolerance and flexibility, for skillnegotiation, for conviction of the value of dialogue and a proportionate sense of the role that ethical diversity and cultural pluralism play in today's society.
This is not the place to address the thorny problem of the ethical diversity of the members of committeeand the meaning of moral consensus3. Suffice it to say that there are issues so fraught with moral tension - such as, for example, the status of the human embryo, abortion, medically assisted reproduction or the suspension of terminal patient care - for which there is no prospect of a future of agreementand concord. This is precisely the time for the Committees themselves to raise certificateof the hard and enduring fact of ethical diversity in society. A purely majority solution should not be imposed as a final pact: it is then obligatory to accept dissenting votes, respect ethical minorities and live peacefully together in polite disagreement, creating the conditions of respect for each person's freedom.
But the problems that come to a committeeare more often than not problems open to a negotiated solution, where the art of compromise, the compromise of accepting a less than ideal solution, the benevolent condescension to human limitations play a very important role. This is not to say that Committee members should be ethically invertebrate. They must be people of firm and solid convictions, for only in this way can they act as genuine representatives of the diversity of values, convictions and priorities present in society.
trainingCultural pluralism, that is, the coexistence and cooperation, within committees, of people from different academic backgrounds, from different geographical and social origins, from different political, philosophical or religious affiliations, is an undeniable enrichment. knowledge I believe that one of the greatest dangers facing bioethics today is not so much legitimate ethical pluralism, but rather operational reductionism, the unilateral vision that reduces reality to the abstract, the purely scientistic vision as a totalitarian ideology, which proclaims that science is the only reliable and universal source, that reality is reduced to the positive and objective interpretation that science gives of the world and of man. To counterbalance the enormous attractive force of scientism as an ideology, people not dominated by the technological-manipulative paradigm are needed in the Committees. Without them, the truly human component of the conflicts posed by progress would be lost, and there would be a risk of reducing bioethical man to a mere diagnostic label, a constellation of genes, or molecular complexes. In the same way, a committeemade up of moral cynics would not be acceptable, nor would a committeewith a single-colour ideology.
If for nothing else, the Committees of national and international standing must exist to be platforms on which the voices of men of goodwill can be heard. The voice of Christian ethics with its formidable life-giving force should never be absent from them. Their sectarian exclusion would mean an irreparable impoverishment of the value of these Committees.
discussion paperLet's move on to subject. First I will talk about the International Committees. Then it will be the turn of the National Bioethics Committees.
International Committees 
For reasons of time, I will limit myself to describing only four of them. I exclude a few, such as the Pontifical Academy for Life, a universal Catholic bioethics body which, I hope, is destined to exert great influence.
The four I am going to discuss - the Medical Ethics Commission of the World Medical Association association, the committeeof International Organisations of Medical Sciences, the committeeInternational Bioethics of UNESCO, and the committeeBioethics Steering Committee of committeeof Europe - are very diverse. Each occupies its own niche - professional, political, cultural - in the bioethical universe. The addressees of their analyses and declarations, their resolutions or their programs of study, are the governments or professional associations of the whole world or of a continent. BTheir strength and moral authority depends, to a large extent, on the dissemination policies of their resolutions (there is a whole marketing of prestige) or on the support of the sponsoring political entity. But, fortunately and above all, on the intrinsic quality of their statements.
The associationWorld Medical Association and its Ethics Commission
The associationWorld Medical Association (WMA) is the oldest bioethics institution. Next September it will be 50 years old. In its already long history, it has not been without its ups and downs and crises4. It defines itself as an apolitical, free and open world forum for the discussion of ethical and social issues in medicine. Its voice does not lack moral authority: it represents the expert opinion of physicians from 70 national associations5 from all regions of the world, associations which are required to be independent of political power and to have a democratic internal structure. The WMA has adopted a system of slow operation, immune to haste, learned from long experience, but not free of friction, since decision-making power is concentrated in the national associations that contribute most to the support of the WMA.
Statutory issues aside, Bioethics must recognise the WMA as having a first-rate record of service class. Some of its Declarations enjoy a singular prestige and universal recognition. The Declaration of Geneva, the now classic modern, secular and universalist version of the Hippocratic Oath, is the cornerstone of medical ethics today. The Declaration of Helsinki on biomedical researchon human beings, despite its late arrival (its first version dates back to 1964), has played a decisive role in introducing and spreading the ethics of respect for man as the subject of research. It is worth noting in passing that the doctrine of the Nuremberg Code remained totally forgotten until the Helsinki Declaration rescued it from oblivion6.
The WMA has been the launching pad for the interweaving of medical ethics and human rights. It has done so with the 1956 Regulations for Time of Armed Conflict and the 1975 Tokyo Declaration on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment; with the 1981 Lisbon Declaration on the Rights of the Patient, recently expanded in Bali; with the Declaration on Human Rights and Individual Freedoms of Physicians (Brussels, 1985); with the Standards of Behaviour for Prison Doctors (Budapest, 1993) and with the 1991 Malta Declaration on Medical Care for Prisoners on Hunger Strike.
The protection of vulnerable groups has been the subject of important documents: on Child Health (Madrid 1987), adolescent suicide (Malta, 1991), condemnation of female genital mutilation (Budapest, 1993), withdrawaland child abuse (Singapore, 1987), abuse of the elderly (Hong Kong, 1989). partner The economic aspects of medicine have been addressed in the Twelve Principles for the Provision of Health Care in any National Health System (1963), and in the Declarations on Health Care in Rural Areas (Helsinki, 1975), on Universal Access to Health Care (Vienna, 1988), on Health Promotion (Bali, 1995).
The WMA has not shied away from dealing with the burning issues of bioethics. This is attested by its Declarations on the diagnosis of death (Sydney, 1968) and organ transplantation (Brussels, 1985 and Madrid, 1987); on terminal illness (Venice, 1983), Euthanasia (Madrid, 1987) and suicide by medical financial aid(Marbella, 1992); on Therapeutic Abortion (Oslo, 1970), in vitro fertilisation (Madrid, 1987), embryo reduction (Bali), or foetal tissue transplantation (Hong Kong, 1989); on the care of AIDS patients (Madrid, 1987, Vienna, 1988 and Marbella, 1982); on gene diagnosis and therapy (Madrid, 1987) and the projectHuman Genome (Marbella, 1992).
Institutional aspects of the professional practice of physicians have been addressed in several declarations: on Professional Autonomy and Self-Regulation (Madrid, 1987), Rancho Mirage (1986) on physician independence and professional freedom, and Marbella (1992) on Medical Malpractice.
The WMA has not turned its back on ecological problems, which it has addressed in the Declarations on Pollution (São Paulo, 1976) and on the Role of Physicians in Environmental Problems (Vienna, 1988).
More than 80 Declarations have now been promulgated by the WMA. Their quality and timeliness are uneven: some could fairly be described as trivial or baroque. But together they form a formidable body of work. Sometimes dismissed as corporatist or ultra-conservative by bioethicists of philosophical persuasion, the WMA's body of standards could, if they were to find an echo in the Codes and in the disciplinary internshipof national medical associations, have an elevating effect on the ethical sensitivity of physicians.
The committeeof International Organisations of Medical Sciences (CIOMS)
CIOMS is an international body, created in 1949 jointly by WHO and UNESCO, to bring together international organisations involved in biomedical science. Throughout its history, CIOMS has concentrated its activity in the fields of ethics and human values, Education, policy and Economicsof medicine.
As resultof its annual Conferences, it has been accumulating a more than Bcollection of monographs of medical-ethical content, many of them of considerable importance: the International Guidelines for biomedical researchon animals7, for the ethical assessmentof epidemiological programs of study, and for biomedical researchon human subjects9, the Inuyama Declaration on the projectHuman Genome, genetic diagnosis and gene therapy10 and the Itxapa Declaration, on the ethics and equity of health promotion11. The 1993 Declaration for Biomedical researchon Human Subjects, together with the commentaries illustrating it, is one of the most mature and comprehensive documents of its kind.
True to its universal vocation, CIOMS has a particular concern for developing countries developmentand their cultural peculiarities and has consequently sought to take them into account in the preparation of its declarations. CIOMS must be acknowledged for its unique leadership in recognising and respecting ethnic particularity, which is an essential feature of authentic universalism.
The committeeBioethics Steering Committee of the committeeof Europe
Bioethics has been one of the major concerns and occupations of Europe's committee, the guardian and promoter of human rights in the 40 European countries of which it is a member. Its intervention in the bioethical arena is a logical consequence of the close relationship between human and social rights, on the one hand, and the protection of individuals in relation to biomedicine, on the other. It is not surprising, therefore, that once the European Convention on Human Rights was promulgated and signed in the early 1950s and the European Social Charter a decade later, both the committeeof Ministers and the Parliamentary Assembly of the committeeof Europe were intensively engaged in developing the ethical dimensions of the right to health.
The list of bioethical documents on Europe's committee, although not very long, is impressive.
The committeeof Ministers is the author of standards to harmonise its member countries' legislation on privacy and security of personal data, on transplantation, on legal protection of persons with mental disorders, on gene manipulation, and on uses and applications of recombinant DNA.
The Parliamentary Assembly has enacted a resolution on the rights of patients and the dying, and has made recommendations on engineering Genetics, use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes, on embryo-fetal science research, psychiatry and biotechnology12.
A major achievement of Europe's committeehas been the creation in 1985 of a Bioethics committeewhich started as committeead hoc Bioethics (CAHBI) and was later renamed committeeDirector for Bioethics (CDBI). Its members are appointed by the governments of the countries that make up the committeeof Europe. Its most significant work has been the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, called the Bioethics Convention13 for short, which was approved by the committeeof Ministers in November 1996 and solemnly offered to the signatureof the member countries in Oviedo (Spain) on 4 April 1997. The Convention can also be signed by countries outside committeeEurope.
The complex history of the Convention on Bioethics paradigmatically reveals the difficult marriage of ethics, law and politics14 . Its successive drafts testify to the difficulties of consensus building. Due to political pressure, the Convention was born with little weight, deliberately reduced to a minimum core, with shocking thematic exclusions. It is expected to grow in the future with the addition of supplementary protocols. Those on embryo testing and medically assisted reproduction, researchbiomedical, human genome and organ and tissue transplantation are being prepared15.
committeeUNESCO International Bioethics Committee (IBC)
The IBC is a very young institution. It was created in 1992 to respond to the major concerns raised by advances in the life sciences. Its role is threefold: to be a forum for confrontation and harmony between different bioethical cultures; to help develop educational actions for the general public and recommendations to raise governments' awareness of the choices they have to make; and finally, to identify and protect the human values that are the basis of the equal dignity of all men and women on the planet16.
Its 53 members represent all disciplines, civilisations and cultures. The IBC meets annually in plenary sessions, but entrusts much workpreparatory work to its Legal Commission or to ad hoc groups. Plenary debates are open to the public and free.
The Universal Declaration on the Human Genome and Human Rights17 is, for the time being, the fundamental and only venture of the IBC. In its current version, which has not been submitted to a vote by the members of the IBC, it is a very concise document, which requires, in order to be understood, the simultaneous reading of the comments and explanations given at the sessions of the Legal Commission of the IBC itself18 19 . Like the Bioethics Convention of committeeof Europe, it has some serious omissions, which seriously weaken its value: nowhere does the Declaration indicate who are the holders of the rights it confers and protects, nor does it take a position on any of the practical applications or clinical uses that may result from the researchon the human genome. As IBC President Noëlle Lenoir has stated, deliberately refrains from saying anything about embryonic research, specific gene diagnostic tests, or somatic or germline cell gene therapy, as this would be inappropriate and unmanageable in an international context20.
It is distressing that the Declaration on the Human Genome will be born with such serious shortcomings. A recent episode has shown this. On the occasion of the cloning of Dolly the sheep, UNESCO's Director General Mayor Zaragoza strongly condemned the possibility of cloning human beings. Subsequently, he asked IBC members whether, in their view, a ban on human cloning was implicit in the Declaration. Some members of the IBC, gathered by UNESCO in Paris on 14 May last, after having reflected [...] on the reasons that might encourage attempts to create a human clone, acknowledged that this latter application raises, in addition to doubts as to whether it is in fact feasible, considerable ethical problems "21. But the experts have not answered the question: What does the Declaration say about human cloning? Does it approve of it, condemn it?
President Lenoir herself has again insisted that "for the text of the Declaration to retain its timelessness, it must refrain from referring to specific practices and technologies. To proceed by enumeration and prohibition would limit the application of these principles to the situations specifically considered, which would run counter to the universal character of the Declaration". This is disappointing, because it means one of two things: either that the Declaration is a text report, of which the IBC has to act as an oracle interpreting it in the face of emerging situations, or that the Declaration is an ethically agnostic document, made of plastic material, with which everyone can shape his or her own decision.
Perhaps I have gone on too long in these comments, but I believe that the UNESCO Universal Declaration on the Human Genome sampleparadigmatically shows the limits of the ethics of consensus, so marvellously effective in seeking solutions to negotiable problems, but so sterile in the face of profound issues that create substantive disagreement, in the face of which there are two possible attitudes: either persisting in a long and sincere dialogue that slowly clarifies the truth, or a humble confession that one has stumbled upon the harsh reality of insoluble ethical pluralism. It does not seem to be the best solution to decree a grey and spineless ethical minimalism that is imposed on all as a political solution. Ethics Committees can never be political institutions: given the impossibility of a consensual agreement, they should limit themselves to taking stock of irreconcilable attitudes and the reasons behind them.
The IBC is dominated by its Legal Commission and this brings it closer to a political assembly than to a body of reflection and assessmentethics.
National Committees
In 1992, Sonia LeBris prepared an extensive reporton national ethics bodies and committees, summarising their origin and history, their constitution and organisation, their mission statement, activities and authority22. LeBris pointed out that in today's advanced societies there is a strong demand for ethics to which governments have to respond by defining some basic principles in the field of biomedical science and its applications. To achieve this, governments have chosen either to create independent and stable committees or to use short-lived bodies to deal with a specific problem.
The choice of one form of structure or another (committeepermanent national or groupof workad hoc) seems to depend on many circumstances, including, it seems, the unitary or federal character of the state itself. They are mostly set up by the executive (Head of State, committeeof Ministers, Ministries of Health, research, Justice) or by Parliament.
A virtually universal feature is their advisory nature, advisor. It is reasonably argued that as ethics committees they cannot be prescriptive institutions. Since ethics cannot be imposed by force, Committees can never constitute a de facto 'power'. Their strength lies in their authority and moral ascendancy, in the objectivity with which datais presented, the even-handedness with which arguments are summarised, and the consistency and persuasiveness of the conclusions they propose. National committees may make recommendations, but will refrain from drafting new legislation. They do not necessarily have to reach consensus: that must often be left to the pragmatic and inevitably compromise-prone negotiations of politicians23.
An important point concerns the guardianship regime, since the greater or lesser degree of autonomy and independence of the committee depends on it. The authority hosting the committeeshould never subject it to a financial and bureaucratic dependence statusthat could limit its freedom of enquiry or its operational independence. Above all, Committees must be granted the freedom to make their programs of study findings and recommendations known: when they act as the conscience of society, as advocates of dignity and justice within their assigned field, their voice must be heard by all, including those who have created them. To be sure, Ethics Committees are very vulnerable to institutional pressures: the power that has erected them can also destroy them. It can and has happened that committees may follow the fate of the institution or the political groupthat created them, or that they are subject to the vagaries of parliamentary majorities or party politics24.
It is a characteristic feature of any national committeeto aspire to be a place of convergence of the different ideological trends circulating in society and the different approaches which, from the different humanistic or biomedical branches of science, offer complementary versions and solutions to the problems being studied. In other words, by definition, the Committees must be ideologically pluralistic and scientifically multidisciplinary. Their statutes very often establish from which institutions (religious, political, cultural, legal or social) and from which scientific or professional territories the members of the committees are to come. The issueof the committees is variable and depends on many factors.
A Brief History of National Bioethics Councils
France: The committeeNational Advisory Board for Life and Health Sciences
A decree of President Mitterrand created this committeein 1983 to give its opinions on the ethical problems raised by the progress of knowledgein the fields of biology, medicine and health insofar as these problems concern man, social groups and society as a whole and to give them advertising25. The decree established strict rules on the issue, origin and system of renewal of its members and on its mission statementand its technical supervision and management assistant.
In the almost five decades of its operation, the French National committeehas built up a solid reputation. In addition to producing a series of more than 50 opinions, B, it has convened an annual ethics conference, which has served to establish dialogue between society and committeeand to create a public atmosphere of trust towards it. The committeeis popularly known as les sages. It has published its annual reports since 1984. Four years ago, it started publishing its own journal: Les Cahiers du committeeConsultatif.
It has responded to consultations on clinical experimentation, assisted reproduction techniques, medical dataregisters for programs of studyepidemiological and prevention purposes, prenatal and perinatal diagnosis, experimentation on subjects in a chronic vegetative state and in a brain dead state, use of mifepristone, prevention of HIV infection, screening for drug addiction at business, nerve cell grafting to treat Parkinson's disease, identification techniques by DNA analysis, pre-implantation diagnosis in the human embryo, gamete donation and its consequences, non-commercialisation of the human body, gene therapy, human genome, blood transfusion, on various forms of drug dependence, application of anti-androgens in sex offenders, researchof human behaviour, contraception of the incapacitated, or contraception in mentally handicapped women.
As can be seen, the French committeehas not shied away from studying many current and acute bioethical problems. Some of its opinions are modelof prudence. Others yield to pragmatic imperatives or to the minimum ethics set by national legislation. His general attitude has generally been considered. There has been no shortage of harsh criticism, including, paradoxically, that of hijacking the public discussionand solving problems behind closed doors26.
Denmark: The Ethics committee
Det Etiske Råd was established by an Act signed by Queen Margrethe II in 1983. The first task of committeewas to provide recommendations to the government on issues related to assisted reproduction. In addition, the ethical committeewas to advise local committees on the ethics of experimentation; to advise the authorities on ethical aspects of health policy27.
What makes the Danish committeeunique is its endeavour to give public space to its deliberations, the intention to involve the whole population in bioethical debates, the production of educational tools aimed at different social groups, from children to the elderly, and the frequent enquiryof citizens through opinion polls. This willingness to take root in society is the distinguishing feature of the Danish committee. Since 1988, it has published annual reports28 on its activities, which, since 1989, have included the programs of studycommissioned by the founding law and others that the committeehas prepared on criteria for the diagnosis of death, extreme prematurity, patenting of human genes, protection of sensitive personalised information, foetal reduction, etc.
Italy: The National Bioethics committee
It was established in 1990 by a decree of the President of the committeeof Ministers. The committeewas entrusted with a threefold function: to provide a wide-ranging report on what is happening at researchand experimentation in the field of biomedical sciences; to formulate opinions and indicate solutions on ethical-legal issues arising from scientific progress and its clinical applications; to explore solutions to the problems of control and safety in the medical applications of new biological technologies.
There is no doubt that the committeehad already fulfilled this triple function within two years of its existence29. What seems to distinguish the Italian committeefrom all the others is the production of an important series of monographs containing extensive programs of studyand updates, followed by opinions and recommendations. In the spirit of ideological pluralism, it is common for the members of the committeeto publish supplementary statements, apostilles or reserved votes on the most debated topics.
The existence of committee has not always been peaceful, as it has suffered strong internal crises and harsh criticism from outside. Some very prominent members have resigned, to great media acclaim, on the grounds that the balance of ideological representation had been upset, or because of accusations of ineffectiveness and slowness in dealing with certain highly tense issues30 . The Italian National committeehas been heavily involved in some of the storms of recent Italian politics.
The list of topics covered by committeehas reached almost thirty, including, for example, gene therapy, definition and determination of death in humans, attendancefor terminally ill patients, organ donation for transplantation, information and consent to the medical act, prenatal diagnosis and drug testing, projectHuman Genome, electroconvulsive therapy, assisted fertilisation, bioethics and environment, anencephalic neonate and organ donation, and identity and status of the human embryo.
Sweden: committeeNational Board of Medical Ethics
Its mission statementis mainly focused on the inspiration and ethical control of the biomedical research31. It was set up by the government in 1995. Its composition is very original. In addition to the President, elected by the members of the committee, it has seven members appointed by the political parties represented in parliament and eleven experts each appointed by the representative bodies of doctors, the Lutheran and Catholic churches, philosophers, artists, lawyers, the disabled, the Ministries of Health and Social Affairs, the National Health and Welfare committeeand the Federation of Municipalities.
The Swedish committeeis a study forum and discussion, which meets monthly, does not pass judgement on issues, but offers a great deal of information, both informative and informative. It has published, among others, monographs on the concept of death, the ethical conflicts of AIDS, the principles of Bioethics, the bibliographyethical-medical. He is the only committeewho has dared to study the concept of human dignity.
Belgium: the committeeBioethics Advisory Board
Belgium, because of its internal complexity (political, religious, ideological, linguistic) has needed more than 10 years of discussion to create its committee. In January 1996 the committeewas set up by decree of the Ministers of Justice and Public Health. Its composition is complex. There are members appointed by the Crown at proposalfrom the Universities and Medical Colleges; representatives of the judiciary and the legal profession; members appointed by the central government and by the Flemish, Walloon, Brussels and German-speaking Communities.
The role of committeeis primarily to advise on a wide range of medical and biological problems. It must respond to queries from the national parliament, central or regional governments, or from any scientific institution, hospital or university. The committeeis obliged to respond to queries within a period of six months deadline. Its opinions are not subject to a vote, but must either receive unanimous consensus or the full range of views put forward must be included in the response32 . The committeehas to publish, in its annual report, a assessmentof the activities of the more than 150 medical ethics committees scattered in Belgian universities, institutions of researchand hospitals33.
The United States: a rich and complex experience
The history of the national bioethics committees in the United States is in itself a major topic: it shows how effective committees can be instruments for the Educationof governments and the public, but at the same time how their close dependence on the authority that creates and sustains them can turn them into playthings of political tensions. Capron has very briefly summarised the history of the bodies in the great American nation that were charged with guiding society in the choice of its general bioethical norms34. researchIt could not have started better, when the nation's congresscreated the National Commission for the Protection of Biomedical and Behavioural Subjects in 1974. By 1978, when its mandate expired, the Commission had produced the Belmont reportwhich remains today, two decades later, by virtue of the first formulation of the principles of Bioethics, an obligatory reference letterpoint for all Bioethics and not only for the ethics of biomedical research35. In 1978, the same year, the congresscreated, with a broader mandate, the famous Presidential Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural research, which worked very effectively between 1980 and 1983. The influence of some of its reports (on the definition of death36, on access to health services37, and, above all, on the ethical and legal implications of informed consent in the patient-doctor relationship38 and on the ethical, medical and legal problems in treatment decisions39 ) have not ceased to be present in all subsequent bioethical thinking and discussion.
The Reagan-Bush era was a politically motivated hiatus in the activity of the National Commissions. In 1985 the committeeadvisor on Biomedical Ethics had been created and immediately became the plaything of politicians' manoeuvres, with administrative and budgetary paralysis, which kept it in a vegetative state, with a brief awakening or two, from 1985 until its death in 1990. There were unsuccessful efforts by some politicians to re-establish a public bioethical discussionmechanism, until President Clinton40 issued an executive order in October 1995 creating the National Bioethics Advisory Commission, which, after a rather stormy neonatal period, appears to have been assured of life for at least two years. No doubt the interest of many of us will be focused on the work of the NBAC. Inspiration and guidewill not be lacking: the high schoolof Medicine in the United States has just published a book that every member of a National Commission should read, to get a closer look at the factors that determine the success or failure of these institutions41.
Other national committees
Australia has been a country where the ethical issues surrounding assisted reproduction have been the focus of Ethics Committees at all levels42. In 1988, the Government of Canberra created the National Bioethics Advisory committee, which, from the very beginning, had a strong public role. It has encouraged social discussion and opinion polls on issues such as embryo experimentation, surrogate motherhood and prenatal genetic diagnosis. It has produced Ethical Guidelines on these and other issues and an annual series on Health Developments with Ethical Implications.
Canada has acquired a complex experience, given the simultaneous operation of different national bodies that have intensively and conscientiously debated the issues of the ethics of assisted reproduction, biomedical experimentation and attendancefor the terminally ill patient43.
The possibility of learning about the structure and function of national Bioethics Committees depends, to a large extent, on the willingness of the Committees themselves to publish and disseminate their statutes and reports: in other words, on the "public relations" section of the Committees.
The creation of the Committees often receives a lot of attention advertising: after all, it is both a political and a social event. It is therefore easy to obtain documentation about them: their statutes and the brochures that accompany their presentationin society. But it happens that, once created, a committeemay have a precarious or poorly funded life and lack the resources to generate information or to send it to bioethics publications that disseminate news, or, finally, to create a databaseaccessible on the Internet.
In 1990, the Assembly of the Portuguese Republic approved in its Law 14/90 the creation of a National Ethics committeefor Life Sciences. The issueof its members (twenty) is moderate. They are elected by a complex system involving the National Assembly itself, five Ministries, the committeeof Rectors, the Orders of Doctors and Lawyers, and other entities of researchscientific and social representation44.
I have not been able to obtain more than scant information regarding Latin American countries. In 1992, the committeede Salubridad General created in Mexico a National Bioethics Commission45. No other National committeehas received a package of functions as extensive and varied as the Mexican one: to support ethical values in the governmental policy on public health and social justice; to elaborate programmes of activities suggestive for the protection of nature, environmental sanitation and respect for human rights; promotethe developmentof ethics in health institutions; to analyse reproductive health and sexual ethics programmes; to cooperate with other institutions in the fight against drug addiction, violence and AIDS; to favour the Educationethics in the Schoolsof Medicine and to participate as an organ of enquiryin the elaboration of official norms in subjectof Bioethics. In 1994 it sponsored the celebration of an International Bioethics congress, publishes a bimonthly bulletinof information and collaborations, but so far it has not published any Declarations or Recommendations.
National Bioethics Committees have also started to take root in Eastern European countries. In 1990, Czechoslovakia established a Central Ethics Commission, closely linked to the Ministry of Health46.
The missing
Before concluding, it is worth drawing attention to the fact that some countries, such as Germany, the Netherlands, the United Kingdom and Spain, do not appear on the list of countries that have established a national bioethics committee.
The reasons for these shortcomings are very different. Germany has had a successful experience with the surveyCommissions in Parliament which helped in the preparation of the laws on assisted reproduction47 and biotechnology48 . But there does not seem to be in recent years, neither in the Government nor in Parliament, a state of opinion in favour of creating a permanent advisorbody. The vacuum has been partly filled by the committee, founded in 1994, by the Federal Medical committee49 , which will define the ethical principles related to the most significant medical issues, such as pre-implantation diagnostics and tissue and organ transplantation.
In the UK there has been a national aversion to the establishment of ethical guidebodies outside the realm of biomedical research. Alongside a splendid flourishing of local research committees, there is a total lack of committees to rule or report on general medical ethics issues. Only since 1991, at the initiative of the Nuffield Foundation, has there been an institution that resembles a national bioethics committee. It is the Nuffield Council on Bioethics. It has prepared and published recommendations on genetic diagnosis in 1994, on the use of human tissue in 1995 and on xenotransplantation in 1996. His current topicof workis the ethical problems of the Geneticsof psychiatric disorders50. Although its prestige is very high, its future seems uncertain: it depends on the duration of the agreementbetween the Nuffield Foundation, the Wellcome Trust and the committeeof researchMédica for its financial support.
Spain's statusis somewhat strange. Diego and Teresa Gracia describe it as follows: "In September 1990, the Ministry of Health elaborated a projectlaw that designed the objectives and functions of a National Bioethics committee. In July 1992, the same Ministry of Health issued an Order creating the committeeadvisor of Health, whose main purpose was to advise and inform the Minister of departmenton scientific, ethical, professional and social issues. The committeedeals not only with problems of biomedical researchbut also with those raised by health care. This innovative feature distinguishes it from other committees in the region "51.
An uncertain future. The cloning crisis
What will be the future of the Committees? Nothing could be more difficult than being a prophet or more risky than extrapolating datafrom today to tomorrow. But I have the impression that the Committees have a rough future ahead of them.
Take issuefrom the 22 May issue of Nature magazine. It opens with a publishing housethat comments with unusual energy on the danger of the power that national and international Bioethics Committees have acquired in the regulation of science. Commenting on the decision of the French National Advisory committeeto recommend to the government a ban on human reproductive cloning, the Nature editorialist not only accuses the committeeof vitiating the public discussionby sowing prejudice and setting a dangerous precedent of intolerance, but also expresses serious doubts about the political expediency and democratic legitimacy of the committees. Such committees," he says, "are ultimately a small groupof individuals not elected by the people. They are, moreover, a danger to democracy, for, although such committees lack legislative power, they exert considerable influence on legislators unfamiliar with scientific and ethical issues". The publishing housegoes on to rebuke, in a strong tone, the French committeeand reproaches it for its erroneous view in dealing with the ethical aspects of human cloning. He concludes: "But the essential point is that, in deciding to adopt a moral position on human cloning, the committeehas gone beyond its role, which should be simply to clarify the discussionand promotean informed public discussion "52.
This episode is not an isolated example. In the same Nature issue, the magazine's Paris correspondent pillories UNESCO's committeeInternational Bioethics Committee for having endorsed the declarations of UNESCO's Director General, Mayor Zaragoza, to the effect that the Universal Declaration on the Human Genome leaves human cloning out of the law.
The World Health Organisation receives no better attentionfor having adopted, in mid-May, a resolution stating that "the use of cloning for the replication of human individuals is ethically unacceptable and contrary to human integrity and morality "53 . Politicians, from Clinton to Chirac, who had ordertheir legislatures to enact laws banning cloning, received no better attention.
Is this a passing storm or the beginning of the crisis of the Committee system? I prefer to take the first possibility. The Committees, like any human business, can and have had their failures, and indeed they have had them in abundance. But it is my impression that, as things are turning out, scientists, of the scientistic variety, need to be reminded, intelligently and stubbornly, of what Max Planck said about the ethical limits of scientific enquiry: "To rejoice in what can be investigated and to bow reverently before what should not be investigated".
Today's scientists need someone to remind them that science has ethical limits, that science is not everything, nor, as they claim, does it explain everything. They need someone, very simply, to remind them that scientism is a human heresy that only admits the existence of things like molecules, genes, mechanisms, techniques, diseases, but is blind to some basic human facts and values: That the patient and his disease, his body and his organs are inseparable; that human genes are in people, not in the tubes of essayor in an existential vacuum that denies the anthropological, the staff, the familial, the social and the ethical; that a human embryo, including a cloned human embryo, is not a mere molecular complex or a curious cellular artifice, but a human being, with a human destiny, fully open to the future and replete with human dignity.
What the Bioethics Committees have done so far is, like so many truly human things, a mixture of successes and blunders, of wisdom and weakness, of courageous acts of faith and shrewd political concessions. Their future is uncertain. But they must continue. There will always have to be many voices to remind humanity that, to remain human, science is not enough; it needs wisdom, a wisdom that affirms in the face of the reductionist temptation, in the words of John Paul II in his Encyclical Redemptor hominis "the priority of ethics over technology, the primacy of the person over things, the superiority of the spirit over the subject"54.
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