In this article we will present an overview of important events in medical ethics in the three Scandinavian countries, Denmark, Norway and Sweden. We have, unfortunately, not been able to report on the activities in Finland and Iceland, but will do so in the next edition of this yearbook.
This report is divided into four main sections. In the first section we give an overview of the ethics committee systems in the three countries. Although some of these committees were established before 1989, they have issued various reports during the period covered by this yearbook which will be discussed below. In the second section, we will introduce the Scandinavian debate related to the issues of abortion, prenatal diagnosis and fetal research. Then follows a presentation of the Danish and Swedish developments with regard to criteria of death and transplantation. The fourth section deals with a number of issues which involve patients: treatment of patients in a persistent vegetative state, genetic testing, and HIV/AIDS.
In all of the section we will give extensive reviews of the various government reports. We have chosen to deal with each country separately. There will then necessarily be some overlap in the presentations of the reports, but because they are in languages which are not understood by most people, we have decided to give a fairly detailed summary of the official documents. We will also refer to some of the discussion in the professional journals.
In a report such as this one it is of course not possible to review all the material that has been published. We have mainly concentrated on the official documents, and the discussion which has followed their publication. We have therefore not reviewed many excellent articles on medical ethics published in Scandinavian language journals. The material covered has been published in 1989, 1990 and the first half of 1991, with a few exceptions, such as the Danish report on death criteria which was published at the end of 1988. The discussion, however, took place in the period covered by this report. We have also chosen not to report on a very important document published in June 1991 (Norges Offentlige Utredninger, 1991b) on protection of the rights of people with mental disabilities. The report also contains an important and extensive overview of Norwegian thinking concerning informed consent. The document will be discussed in the coming year in Norway and we will be covered by our next report.
In all countries there have been certain institutional developments with regard to Medical Ethics. Medical Ethics has been introduced in the teaching of medical students at the Universities of Copenhagen and Oslo, a Center for Medical Ethics has been established in Oslo, and a national professorship in Medical Ethics has been established in Sweden (professor Göran Hermerén).
All three Scandinavian countries have a system of research ethics committees which review all research on human beings. We will not here report on any details concerning how these committees function. In addition to these review committees, there are national committees in all three countries. These may have a connection to the review committees, or they may be independent of them. All national committees function as advisory bodies to their respective governments with regard to policy issues in medical ethics. During 1989-1991 they have issued several policy reports, which will be discussed below. First, however, we will give a brief overview of how the organization of these committees.
Det Etiske Råd (The Danish Council of Ethics) was established by law in 1987. The Council consists of 17 members - 8 chosen by the Minister of Health - 9 by the Danish Parliament (Folketinget). The members are elected for three years and might be re-elected but one time. The members must have publicly documented credentials concerning ethical, cultural, and social questions and may not be members of the Folketing or the municipal or county councils.
The Council's two main assignments are to promote public debate and to submit proposals for new legislation within the field of medical research and development. The Council is also advised to build upon the fact that human life starts at the moment of conception. This is interpreted thus: from the moment of conception a situation occurs, where the freedom of action must be submitted to ethical and judicial considerations, and maybe limited. It is not the purpose to give a definition of human life and its beginning.
The Council is supposed to make suggestions - concerning laws to protect fertilized human eggs, living embryos and foetuses, as well as genetic experimentation on human gametes.
- concerning the admissability of undertaking genetic treatment of human gametes used for fertilization, human fertilized eggs, embryos, and foetuses.
- concerning the admissability of using new technology for detecting congenital defects or diseases in human gametes, human fertilized eggs, embryos, and foetuses.
- concerning rules for freezing human gametes, intended for future fertilization, and fertilized human eggs.
Beyond these specified tasks, the Council can give advice to the research ethics committees about general ethical problems concerning experimentation on human beings, advise the authorities of the health organizations in questions concerning their domain, as well as to national authorities in about judgements concerning questions of registration, dissemination and application of information on diseases and characteristics due to heredity.
Within its field, the Council might take up subjects on its own initiative.
The Council shall inform the public about the progress of its work, and initiate public debate over ethical problems which may occur.
Denmark has a system of seven Regional Research Ethics Committees, which review all biomedical research. In addition there is a Central Research Ethics Committee, which functions as a body of appeal for the seven regional commiittees. The seven regional committee as well as the Cenral Committee have a semi official status. No specific legislation covers the field at present. In November, 1988, however, the Minister of health set up a committee to consider the need for legislation on certain areas of biomedical research involving human subjects. This committee finished its work in 1989 proposing a statutory two-tier system of ethics committes very similar to the existing system. This proposal has so far not led to any changes in legislation. The two independent central bodies, the Danish Council of Ethics and the Central Research Ethics Committee, are supposed to cooperate, although they should remain independent, autonomous councils.
Norway has a system of five regional research ethics committees. They review all biomedical research involving human subjects within their region, and are fully autonomous. There is no possibility of appeal, as there is in the Danish system. In June 1989 the Norwegian Parliament (Stortinget) endorsed the recommendation of a 1988 White Paper from the Ministry of Education and Research for the establishment of National Research Ethics Committees within the following three subject areas of research and development:
- medicine in a broad sense (health and life sciences)
- normative academic disciplines, i.e. the social sciences and the humanities, including law and theology
- natural sciences and technology including those parts of biotechnology which do not fall under medicine.
Great importance is placed on securing representation in the national committees from the fields of ethics and law, and all of them have lay members as well.
An important function of the committees is to provide information to politicians, civil servants and the general public. They will also issue policy recommendations concerning research ethics.
The National Committee of Medical Research Ethics has 12 members: Three physicians, three members trained in ethics, two lay members and four from relevant disciplines such as biotechnology, the social sciences, personal data registers and law.
According to the mandate laid down by the Ministry of Education and Research May 16, 1990 the main assignments of this National Committee are the following:
1) to keep itself continuously informed of current and potential questions of research ethics in the field of medicine;
2) to be the coordination and advisory body for the five regional ethics committees;
3) to inform researchers, the administration and the public of current and potential questions of research ethics in the field of medicine;
4) to submit reports on matters of principle relating to medical research ethics, and comment on specific matters of special significance relating to research ethics;
5) to report on its activities during an open meeting at least once a year, and in whatever way it finds suitable promote informed discussions in society of ethical questions relating to medical science and knowledge;
6) to keep other national and international research ethics committeees informed of its activities, and in cooperation with them seek to establish a platform of principles of research ethics which extends beyond the boundaries of the respective research subjects.
Sweden has a system of six regional ethics committees. These committees review all biomedical research involving human beings in their region. The Swedish Council on Medical Ethics was established by Parliament (the Riksdag) and given the status of National Council in March 1984. The National Council on Medical Ethics comprises of seven politicians and eleven expert members representing medical science, philosophy and the arts, law, the Catholic and Protestant churches in addition to one member from the organisations of the disabled. The Council's principal assignment is to maintain a continuous interchange of information and opinions concerning research and medical treatment of critical consequence to human integrity or capable of influencing respect for human dignity. The Council is to act as an advisory body to the Government and the Riksdag on questions of medical ethics. Its proceedings are to be made public and aimed at encouraging debate, with particular emphasis on human equality and the right to physical and psychological integrity. The Council should also act as an intermediary between the scientific community, politicians and the general public. There is no formalised cooperation between the National Council and the system of regional ethics review committees.
The Swedish government issued two reports concerning the research ethics committees in 1989 (Sveriges Offentlige Utredninger, 1989c, d). The report recommends that the composition of the committees should change so that one fourth of the committee members are lay members. A lawyer should also be on the committee. The committees should continue to be advisory bodies, but in reality it should be impossible to conduct research without approval from a research ethics committee. The report also recommends that courses in research ethics should be made compulsory in the education of researchers.
Informed consent and research ethics
There have been a number of developments with regard to informed consent in the three countries. In Denmark a report was published which claimed that research subjects were poorly informed about the proposed research (Scocozza 1990). The report was based on participant observation of 15 patients taking part in six different research protocols. In Norway, the regional ethics committees decided, after much debate, that consent to research should be written. The revised Declaration of Helsinki recommends that a written consent be given, but both in Norway and in Denmark it has been argued that a written consent would make the research subjects more reluctant to withdraw from the project should they so desire. This argument has not been regarded as convincing by the ethics committees. They now require that patients be given written information, where it is among other things made clear that the subjects can withdraw at any time, and they also require written consent (Bergsjø, 1991).
During the last part of 1991 a discussion has started in Norway concerning ethical guidelines for epidemiological research. We will not report on that discussion here, but only mention that a working group has issued recommendations in Sweden in 1989. One of the recommendations is that informed consent need not be sought for the use of already existing data about patients. Researchers should, however, inform the public through the newsmedia about proposed research using such data (Allebeck and Westrin, 1989).
II. ABORTION, PRENATAL DIAGNOSIS, FETAL RESEARCH
There are a number of interrelated issues which have dominated the medical ethics debate in the Scandinavian countries in the period 1989-1991: the abortion question in terms of late abortions after diagnosis of an abnormality in the fetus, the ethics of fetal research, and new reproductive technologies. In addition there has been a debate about the ethics of organ donation and transplantation, which in Denmark has been coupled with a discussion of the definition and criteria of death.
There are many similarities in the way the three Scandinavian countries have dealt with these issues, but there are also important differences. In the following exposition, we will treat each country separately, concentrating on the various government reports which have been issued. We will also refer to some of the discussion in the professional journals.
ABORTION AND PRENATAL DIAGNOSIS
All three Scandinavian countries have abortion laws which were passed during the mid 1970s granting a pregnant woman the right to freely choose an abortion until the end of the 12th week of pregnancy. There have not been any serious attempts to repeal these laws. There has, however, been a concern over late abortions. With new diagnostic tools such as amniocentesis and ultrasound, it has become possible to diagnose diseases and abnormalities in the fetus. Such a diagnosis may lead to an abortion. During the last few years there has been a fierce debate in the Scandinavian countries over the justification for abortions based on such diagnoses.
In all three countries working groups have issued recommendations to their respective governments concerning regulation of such practices. There are marked similarities between these reports. All stress that the abortion decision should be made by the woman herself in consultation with her physician. The decision should be based on an individual evaluation of the hardships expected by having to raise a child with severe disabilities. The use of diagnostic tests should never be mandatory, but should be a voluntary offer in cases of high risk pregnancies. There has been a marked resistance to drawing up lists of indications for the use of diagnostic tests, as well lists of conditions which would qualify for abortions. It has been felt that such lists would imply that society has decided that some human lives are not worth living.
There has been a debate in all three countries about whether one should introduce a time during pregnancy after which no abortions should be permitted. The reason for this has been the ability to keep ever younger newborns alive. It has been felt that it is morally problematic to abort a fetus which could live outside the body of the mother. Although the Norwegian abortion law includes a clause which forbids an abortion in cases where the fetus is 'viable', only Sweden has introduced a specific length of pregnancy after which no abortions can take place (22 weeks).
In the current Norwegian abortion law, a woman can freely choose to have an abortion until the 12th week of pregancy. After the 12th week of pregnancy abortion can only be performed if there is a great danger that the foetus may have a serious genetic disease or develop a disease during pregnancy. After the 18th week abortion can only be performed if the reasons are especially serious ("tungtveiende"). Decisions to terminate a pregnancy after the 12th week have to be approved by a committee of at least two physicians.
One troubling issue in Norway has been on what basis abortion decisions after the 12th week, and particularly after the 18th week, should be made. In particular, there has been a debate about the justification for terminating pregnancy if the foetus suffers from a genetic condition or a chromosome abnormality, after such a diagnosis is made by procedures such as amniocentesis or ultrasound.
There has been no legal regulation of prenatal diagnosis in Norway up until now. The use of such diagnostic tests have been limited to pregnancies where there is an increased risk of certain genetic diseases. This includes pregnancies in women over the age of 38, or pregnancies where the parents earlier have had a child with a chromosome abnormality. In a discussion in the Norwegian Parliament in 1982 it was felt that such a list of indications, and an automatic offer of diagnostic tests based on them, would imply that society accepted the notion that some human lifes were not worth living. Members of Parliament therefore urged that the use of these tests and subsequent abortion should be an individualized decision in cases where the care of a disabled child would be a severe burden on the family and/or the woman. It was also stressed that the final decision about whether one should perform an abortion or not should rest with the woman herself or with her family.
Despite this debate in the Norwegian Parliament a list of indications for prenatal diagnosis has been used in Norway, in part because of limited capacity to perform such diagnostic tests, and consequently a need to give priorities to women with increased risk. Nevertheless, there has continued to be a certain uneasiness among members of Parliament about the practice of aborting foetuses with certain genetic diseases. In a question to the Minister of Social Affairs November 15, 1989, a member of Parliament wanted to know how many of the abortions performed after the 12th week of pregnancy were due to a genetic condition of the foetus. Another representative asked the same Minister on February 7, 1990 whether abortion as a result of diagnosis of Down's syndrome in a foetus was in accordance with the law. In her answer the Minister pointed out among other things that it was the woman and the family who made these decisions after they had evaluated their ability to care for a disabled child, and that such a practice therefore was in accordance with the law. For an overview of this debate, see Helsedirektoratets utredningsserie, 1990.
The use of ultrasound as a diagnostic tool during pregnancy has accentuated the ethical debate. In a consensus conference in 1986 it was recommended that all pregnant women should be offered one ultrasound investigation during pregnancy. It was stressed that taking the test should be voluntary. On the basis of an ultrasound investigation one may suspect a chromosome abnormality in the foetus and consequently desire amniocentesis. This has led to an increase in the number of diagnosed abnormalities and consequently to an increase in the number of abortions performed for this reason. There has also been a concern that there is little documentation concerning the psychological effects on the mother after receiving information from ultrasound investigation, and that the use of this diagnostic tool may lead to the abortion of healthy fetuses, based on misdagnosis (see Schei 1991).
As a result of this uneasiness concerning abortions after the 18th week of pregnancy two working groups have been charged with the task of providing guidelines. One group issued its report to the Norwegian Directorate of Health in July 1990 (Helsedirektoratets utredningsserie, 1990).
The group has offered the following recommendations:
1) As before, abortion after the 18th week should only be performed if the reasons for the abortion are especially serious. After the end of the 21st week permission for an abortion can not be granted unless the committee finds that it is clear that the foetus has a condition which is incompatible with life.
2) A special committee should review all applications for an abortion which in whole or in part are desired because of serious disease or abnormality in the foetus.
3) A "second opinion" should be sought in cases where an abnormality is diagnosed by ultrasound.
4) The committee reviewing the applications shall establish that there has been a full review of the seriousness of the disease or abnormality, including possible treatments prenatally or postnatally and the prognosis with regard to survival and the possibility of disabilities.
The second working group was appointed for the purpose of drawing up guidelines to cover the aspects of research and development in biotechnology and gene technology relating to human beings. A substantial portion of its report, issued in november 1990 (Norges Offentlige Utredninger, 1991a) is devoted to the issues raised by prenatal diagnosis. The Committee points out that within the next few years a technique using a combination of tests of the mother's blood will be able to reveal 60 per cent of fetuses with Down's Syndrome in the 16th week of pregnancy. Combined with ultrasound investigation an even greater percentage of such fetuses will be diagnosed. A majority of the committee would want to prohibit the use of such tests for women who are not at risk. A majority of the committee would, however, permit abortions on the basis of a diagnosis of Down's syndrome. They argue, however, that this does not involve a denigration of the human worth of a fetus with such a diagnosis, because the reason for the abortion is the intolerable burden such a child may represent for the family as a whole. A minority of the committee would like an amendment to the current abortion law providing that non-fatal developmental abnormalities should not in themselves be an indication for abortion. Abortion should only be permitted if there is a risk that the child itself will have to live with a great deal of pain and suffering.
In 1989 the Swedish government issued a report concerning abortion and prenatal diagnosis (Sveriges Offentlige Utredninger, 1989).
With regard to abortion, this report upholds the Swedish abortion law from 1975, which allows a woman to have an abortion without interference in any way before the 12th week of pregnancy. Between the 12th and 18th week a so-called pastoral investigation will be made. After the 18th week, a permission of the National Board of Health and Welfare is required.
The report proposes that in addition an obligatory offer of counselling is made after an abortion, as well as pastoral counselling before the intervention.
The main ethical standpoint is that the foetus and the woman are two different individuals, although the first depends on the latter. The potential conflict of interest between these two individuals start at the very beginning of the pregnancy, and the interests of the foetus gain weight during the course of pregnancy.
The report has led to an extensive debate in the professional journals, because of its insistence that the fetus is a separate individual with at least some moral standing. Torbjörn Tännsjö (1989) praises the elaborate work which is done, but critizises the justification for the conclusions reached by the Committee's. He finds that the philosophy of the report is based upon natural rights and the sanctity of life, and therefore on this basis the foetus is wrongly considered a moral subject. Thus, it has rights on the same level as the mother, and the conclusion should be that every abortion is an intolerable infringement of the foetus' rights. However, the report does not draw this conclusion, but Tännsjö indicates that its motives nevertheless imposes guilt upon a woman seeking an abortion.
In a reply the catholic theologian Erwin Bischofberger argues for the position that the fetus indeed does have an inherent right to existence (Bischofberger 1989), but interestingly enough does not draw the conclusion that this entails that one should not perform abortions. In certain cases, such in a case of a severe defect in the fetus, the rights of the fetus should be weighed against the rights of the mother and the family to a life of integrity.
As in Norway, the new diagnostic tools used during pregnancy have raised new dilemmas of ethical, psychological, and legal character in Sweden, which is discussed by the Swedish report. The dilemma arises because prenatal diagnosis, carried out routinely at the maternal clinics, designed to create the best condition for the growth of the foetus, sometimes can discover diseases or malformations which cannot be treated. Some see few problems with these techniques, and emphasise that they prevent human suffering (Brody 1989). Others, while agreeing that they should be used to diagnose severe defects, point out that they are already used to abort fetuses with less severe conditions, and can lead to devaluation of the life of disabled human beings (Grunewald 1989).
The Swedish report published in 1989 suggests that prior to the prenatal diagnosis, the woman should be informed of the available diagnostic options, what they can achieve and their limitations and risks. The pregnant woman, together with the treating physician, should then determine which examinations she would want carried out. It is crucial that correct and detailed information is given. There is a limitation, however, to what procedures can be offered. There must be some reason for carrying out the diagnostic test, compatible with science and experience. Worries without any substance do not justify an examination, as long as the worries do not affect the woman's general state of health.
The Committee recommends that these examinations should not be used as general screening tools. One reason for this view is that such use could be regarded as a "hunt" for deviations, and thus degrade the value of human life. Another aspect is the limited value of prenatal diagnosis with regard to the discovery of foetal damage. The permission for screening examinations should be made on case by case basis.
Prenatal diagnosis should only be permitted either to check the progress of the pregnancy or in order to determine the possible presence of any serious injuries or diseases. It should not be used in order to determine the sex of the foetus.
The woman herself is the one who should decide whether to have an examination, and the current indications for examinations should consequently be abolished.
Women who do not belong to any risk group, and who are below the age of 35, should not automatically, but only on request, be given detailed information concerning prenatal diagnostis. Women above the age of 35, or who belong to a risk group, should always be offered information.
Moreover, when examined, the woman is entitled to receive all possible information concerning the health of the foetus. Information about abnormalities should be given in the presence of the responsible gynaecologist and representative of the Womens Clinic, and if possible, a geneticist and a represenative of the disabled should be available.
These recommendations of the SOU 1989:51 have not yet resulted in any alterations in Swedish law.
In 1990 the health authorities issued new guidelines governing cremation and burial of aborted fetuses (Socialstyrelsen, 1990). It recommended that fetuses aborted after the 12th week should be routinely cremated or buried. It should also be possible to do this for fetuses aborted before the 12th week. Earlier, only viable fetuses could be buried (fetuses after the 28th week, or those born alive). These guidelines have been criticised bye some who have pointed out that such a practice is a symbolic criminalisation and stigmatisation of those women who seek abortions (Löfgren et al., 1991a, b). These arguments have been countered by the health authorities who do not think that there is any inconsistency between the current abortion law and the new recommendations (Larsson and Thorén, 1991).
To stimulate the debate over prenatal diagnostics, prenatal screening, and genetic counselling the Etiske Råd issued the booklet Prænatal diagnostik, Prænatal screening, Genetisk rådgivning (Det Etiske Råd, 1989b, 1990). It gives a survey of the different types of diagnostic tools available. It also covers the practical organisation of testing, and legislative aspects.
A preliminary conclusion is drawn from the discussion of diagnostics and the subsequent possible abortion. The conclusion considers two opposing principles.
The first maintains that the human embryo is a human life from the moment of conception. Given this status it has the same right to protection as born human beings. This principle does not, however exclude the possibility of an abortion under circumstances where the embryo is judged to be like a serious and terminally ill patient. The criterion is then that if the child is born, it will only manage to live for a short period, purposelessly, and under extreme suffering. This criterion, however, excludes abortion based on the interests, economic or otherwise, of the parents or society. This principle might be used to describe the defects and diseases which allow abortion, or the precise criteria by which these are to be judged.
The second principle is based on the wish to avoid suffering. Again, this would include the desire to avoid a purposeless and suffering life for the individual itself, but it would also consider the situation of the family which the child is born into. For instance, if the diagnosis indicates that the child will suffer a severe handicap, and the family obviously cannot cope with it, without problems for the child and the family, abortion might be an alternative.
In a later publication, the Council of Ethics gives its recommendations (Etisk Råd, 1989c). The goal of prenatal diagnosis is to identify serious diseases in order to prevent serious disease in the expected child and thereby for the mother and her family. It is therefore unacceptable to perform prenatal diagnosis of sex and normal traits. Eugenic or cost-benefit considerations should also not be the main reasons for introducing prenatal diagnosis. In cases where the child can be expected to be born with extreme suffering or disabiliteis, abortion is an acceptable alternative. Other disabilities are of such a character that ethically one cannot justify an abortion. This should, however, not lead one to withhold information, or lead one to think that the right to abortion should be taken away. The woman's right to decide for herself should be the most important consideration.
In an article in the Danish Medical Journal, the Minister of Health affirms the principles which should govern the use of these tests (Larsen, 1991). The tests should be voluntary, should not be used for screening purposes, and the decision to use them and decisions to perform abortions should be made by the mother/parents, within the limits of the law.
NEW REPRODUCTIVE TECHNOLOGIES AND FETAL RESEARCH
All three countries have accepted the various new reproductive technologies, and in particular have accepted in vitro fertilization. These techniques are governed by legislation in the three countries. In Norway and Sweden, for example, it is forbidden by law to combine the technique of in vitro fertilization with donated sperm or donated eggs. In Norway the same law forbids research on fertilized eggs and fetuses. In Sweden a new law was proposed in November 1990 and passed in March, 1991 which would allow research during the first 14 days after conception. Fertilized eggs which have been used for research can not be reintroduced into the woman's body, and can only be used for research if the woman has given her permission. Denmark passed a preliminary injunction against fetal research in 1987 until the Etiske Råd (Danish Council of Ethics) had issued its report and the issue could be debated in the Danish Parliament.
During the Fall of 1989 the report from the Council of Ethics was issued (Etisk Råd, 1989a). The majority of the Council would allow for some research on fertilized eggs and fetuses. Before such research can be carried out it has to be approved by a committee. Only if certain conditions are fulfilled can such research be carried out. The research must not incur any unnecessary harm on the fetus, and there must be a justified hope that one can achieve results which will be of significant importance for future prevention and treatment of diseases. The research must also not harm the health of the mother. Informed consent to such research must be given by the mother and her husband or partner. The minority of the Council felt that any research on fertilized eggs or fetuses should continue to be forbidden.
As a result of this disagreement, the Minister of Health decided in February 1990 to continue the preliminary injunction against fetal research for one year. In April of 1991 a bill was introduced in the Danish Parliament on research on human subjects, which also included the possibility of performing research on fertilized eggs during the first 14 days after conception.
As mentioned any fetal research, including research on fertilized eggs, is currently forbidden by Norwegian law. The National Medical Research Ethics Committee in Norway issued a policy recommendation in 1990 . Fetal research is defined as all research involving unborn fetuses from the moment of conception until birth. Although it allows some research on fetuses, it is still quite restrictive. It would only allow research which in one way or another is of possible benefit to the research subject (the fetus) itself. Some of its specific recommendations are:
1) The same ethical principles governing research on born human beings should apply to research on fetuses:
2) Fetuses as research subjects should be protected in the same way as other groups of research subjects which cannot give their informed consent to research:
3) Research on fetuses which leads to the death of the research subject or irreversible damage in the fetus is unacceptable. It is also ethically unacceptable to produce fetuses in order to do research on them.
4) Non-therapeutic research which involves short or long term risk or discomfort for the fetus or the mother is ethically unacceptable;
5) Risk-free, nontherapeutic research on fetuses which cannot be done in another way can be ethically acceptable. For example systematic monitoring of the heart beat.
6) Therapeutic research on fetuses can be ethically acceptable if this research directly or indirectly is of value for the fetus itself, and knowledge is available concerning the possible short or longterm risks of the research, and there is no risk of irreversible damage to the fetus or the mother.
7) Therapeutic research on fetuses where there is not yet any knowledge concerning the possible risks is ethically unacceptable. This includes gene therapy on germ cells, and gene therapy on somatic cells from fetuses.
The ethics committee of the Norwegian Ministry of Health and Social Affairs (Norwegian Ministry of Health and Social Affairs 1991) also recommended that the current ban on research on fertilized eggs should continue in Norway. The Committee acknowledges that information and methods based on research on fertilized eggs can lead to significant improvements in the methodology of in vitro fertilization, and that this treatment is currently accepted in Norway. It also recognizes a possible inconsistency here, but it still does not feel that the ban should be lifted. According to the committee, "Norwegian society will simply have to live with this inconsistency". The committee does, however, allow changes in the procedures used during extractions and fertilizations of eggs in order to improve the method, when the egss are returned to the woman's uterus. It upoholds the Norwegian ban on using donor sperm and donor eggs in conjunction with in vitro fertilization. Eggs which are not implanted must be destroyed or can be frozen for up to three years for later implantation. The committee would not allow selective reduction of fetuses in order that the remaining fetuses may continue to develop.
Research on spontaneously aborted fetuses should be permitted after normal review by the regional research ethics committees. The committeee recommends that research on fetuses before an intended abortion should be prohibited. Cells and tissue from aborted fetuses can be used for diagnostic purpuses of viral diseases in approved medical laboratories as is the practice today, and can also be used for research. The majority of the committee did not want to commit itself to av view regarding transplantation of organs from aborted fetuses, because such procedures are still, according to the committee, in a research stage. A minority would prohibit all such use of organs from aborted fetuses. With regard to the use of organs from born anencephalic children, the comittee recommended that this question be reviewed at a later date in conjunction with a possible revision of the death criteria.
A working group within the Church of Norway has reached the same conclusions against fetal research, although a minority of this group would accept such research if it could result in alleviation of human suffering (Kirkerådet 1989; see also the comment by Heriksen and Aarre 1989).
The disagreement within the Danish Council of Ethics, the delay in the revision of the Danish law, and the restrictive policies recommended in Norway, is reflective of a deep disagreement among professionals and the public in all three Scandinavian countries concerning these issues. During the past few years there has been a debate both in the professional journals and in the newsmedia concerning the ethical issues raised by in vitro fertilization and research on fertlized eggs. Many have pointed out certain inconsistencies in the official attitudes to these issues. Abortion without any restrictions is allowed before the 12th week of pregnancy, but no research on fertilized eggs is allowed. The technique of in vitro fertilization is accepted, even given high priority in Norway, yet no research is allowed which may improve the methodology of this treatment (see Kjessler, 1989a and 1989b). Some have, however, pointed to other problems with techniques such as in vitro fertilizations: the low success rate, the uncertainty concerning possible negative effects, and the unrealistic high expectations which are fostered (Hagenfeldt, 1989; Dahlquist, 1989). In Denmark the proposed changes in the law concerning fetal research have led some to complain that the whole issue of assisted fertilization has not been properly discussed (Møller and Nielsen 1991, Nilsen and Møller 1991). There have also been attempts to discuss whether it makes sense to speak of the right to have children, or about the rights of the unborn (Tranøy, 1989). One person has rejected an ethics based on rights as relevant, and instead proposed that one an 'ethics of care' is more appropriate (Frost, 1989). Hellum et al. (1990) contains a number of articles on various aspects of new reproductive techniques and reflects the viewpoints in the Norwegian debate.
III. BRAIN DEATH, ORGAN DONATION AND TRANSPLANTATION
Brain death, Denmark
In 1988 Denmark was the only country in Western Europe which had not yet adopted brain death criteria. Kidney transplantation was performed in Denmark, but organs were only removed after the heart had stopped beating. When brain death was diagnosed, it was also a general practice to withdraw therapy such as the use of respirators. The lack of brain death criteria, however, made it impossible to perform heart and liver transplantations.
The law in effect in 1988 (passed in 1976) allowed death to be immediately recognised after the heart had stopped in a person with irreversible loss of whole brain function if one wanted to transplant organs from the deceased person. The law in effect before 1976 had demanded a period of observation after the heart had stopped before organs could be removed.
In a government report submitted in 1985 it was recommended that brain death be introuced as a parallel criterion of death in addition to the cessation of heart function. This inititated a fierce debate over whether Denmark should adopt brain death criteria.
In 1988 The Danish Council of Ethics issued a report on this topic (Dødskriteriet). For a presentation of the report in English see Rix (1990), and for a criticism see Evans (1990).
The report discusses the ethical aspects concerning an introduction of the concept of braindeath. The common experiences of death are seen in relation to a biomedical concept of death, and the report also considers the ethical problems in relation to various medical definitions and their legal meaning.
The report argues that death should be seen as a process, rather than as an event. This is in accord with both common usage and scientific knowledge. This process is not over until neither of the following three functions can be traced nor resurrected: i) heart-function/blood-circulation ii) breathfunction, iii) brainfunction. The total loss of brain function may be the start of the process of death, which means that at that moment one should not do anything further to prolong that process. The process is, however, not over until all of the above three mentioned functions have ceased.
Even if death should be regarded as a process, it may be necessary to introduce certain criteria of death which is associated with a moment of death. Both of the terms are neccesary, because the fact that a person is dead, and a fixation of time of this event, is of crucial significance for the person himself, his next of kin, and the interests of other persons. The report considers what kind of criteria one should introduce based on the interests of these three groups.
One could argue that if one considers the dying or dead person's interests, one would want to introduce criteria based on some variants of brain death. If there is no possibility of experience, one has passed the border between life and death. The committee argues, however, that one's attitude to one's own death also involves an interpersonal aspect. For one's relatives it is not the case that death coincides with the absence of brain function. For them it is important that all stages of the process of death have passed. Therefore the only reason for wanting to introduce brain death criteria involves third party interests, specifically the potential recipients of organs.
If one regards death as occurring at a specific moment, one will arrive at the ethical dilemma of having to choose between the interests of the dying person and his or her relatives on the one hand and potential recipients of organs on the other hand. If, however, death is regarded as a process one can argue that total brain death indicates that this process has irreversibly started, and cessation of breathing and heart function indicates that the process has ended. Lack of brainfunction indicates that a person is within the process of death. When within the process of death, all efforts to sustain life artificially should come to an end. This is not to cause death, but bring about the end of the process. The moment of death is that particular moment, when the process is finished. It is the moment when heart- and breath-function is irrevocably stopped.
Despite this, the committee argues that the process may, under special circumstances, be prolonged artificially in order to remove organs for transplantation, if the person (or the next of kin) has given consent (registered as donor). This intervention causes the the end of the process of death, but it is not what causes the death of the person.
Under no circumstances should one think of a potential organ recipient has having a right to receive organs from others, even if this person is dead or is dying. Society can therefore not decide that it can use the organs of dead or dying people as it pleases.
The Committee consequently rejected the earlier proposal that brain death criteria should be used in parallel with cessation of heart function. It argued that it is important to have one concept of death, and that this concept should protect the interests of the dying person and his or her relatives. Such a concept should, however, not prevent dying persons from donating their organs if they so desire, or prevent the removal of respirator therapy. The committe therefore proposed that after two physicians have diagnosed irreversible cessation of brain function, all measures which prolong the dying process should be withdrawn. This action can, however, be postponed for a maximum of 48 hours.
The Committee proposed further that a directory containing information about donors should be created and adminstered by the Ministry of Health. Anybody who has reached the age of 15/18 is allowed to register. The permission can, however, be withdrawn by the donor at any stage. All information to the general public concerning the directory should be taken care of by the Minister of Health in co-operation with Det etiske Råd. Any payment involved in registration or donation should be criminalized.
The report by the Danish Council of Ethics has been criticised. The criticism has been focussed on the report's insistence that death is a process, rather than an event (Lübcke and Norum 1989; Wiingaard 1990). Others have pointed out that the Council does not want to introduce brain death criteria at the same time that it wants to permit transplantation to take place. Since, according to the Council, a person is not dead at the time of irreversible cessation of brain function, but it is the case that the dying process has started, one would remove organs from living persons (Gjerris 1989).
Denmark adopted a new law concerning death criteria in 1990 (Law no. 402, June 13, 1990). According to this law death can be established either by the cessation of breathing and heartbeat or the irreversible loss of all brain function. This is in accord with the earlier government proposal and goes against the recommendations of the Council of Ethics. The same law also regulates transplantation. Organs may be removed from deceased persons who have given their permission, or, if there is nothing to indicate that the deceased person would object to organ donation, if the relatives have given their permission. Organs can not be removed if the relatives can not be consulted, thus establishing a presumption against organ donation. This particularly issue has been debated in Sweden (see below).
The Swedish Law dealing with transplantations dates back to 1975. Since then, the criterion of death has been changed (Cfr. Law 1987:269, Jan 1,1988), and toghether with new technology, this has led to a wide range of possibilities in this branch of medicine. These changes have also caused various kinds of problems. The report SOU 1989:98 "Transplantation - etiska, medicinska och rättslige aspekter" (Sveriges Offentlige Utredninger, 1989b) elucidates the new problems and suggests some changes that should be made in the law of 1975. The report especially discusses guidelines concerning consent.
The dead body as a donor
The Transplantation Law of 1975 states as a guiding principle that the deceased should have given a written consent if organ removal can take place. If such a document does not exist, the organ removal can only be executed if the deceased has expressed an opinion consistent with such an act. If there is disagreement over the view of the deceased, his or her next of kin can make the decision. If no next of kins are available, or if they disagree, consent to organ removal is presumed. After the introduction of the new definition of death, as of January 1, 1988, the transplantation law was changed and it is now the case that under the these circumstances, refusal to organ donation should be presumed.
According to this committee report, the first principle which should govern our relationship to dead bodies is that we should show piety towards it. This is not a question of the integrity of the dead body, but of the psychological integrity of the living. The Committee's aim has not been to increase the number of organs provided, but to find the conditions under which these interventions should to take place. The superior rule is the right to decide over one's own body - none should have the power to overrule the decision whether to be a donor or not. A written document of intention is therefore to be preferred, but as very few people document their opinion in this manner, it cannot count as an absolute criterion. Such a praxis would in many cases lead to a conflict with the will of the deceased. The general standpoint of the donor should be searched for, and if this can not be ascertained, the next of kins should have the opportunity to refuse transplantation, in order to protect themselves against psychological reactions. However, as this decisionmaking normally takes place under grief, it must be voluntary, not obligatory. This means that in case of uncertainty, transplantations can take place if the close relations do not refuse it. They should, of course, be informed of the planned transplantation, and offered an absolute right to veto. A reasonable time for decisionmaking must also be provided.
If the next of kins are impossible to reach, or the deceased did not have any, the Committee suggests that no organs should be removed.
The living person as a donor
The taking of organs and tissue which do not regenerate, should be limited as much as possible. If a transplantion involves any risk of serious damage for life or health, it should not be carried out. The current lack of kidneys, however, indicates that an absolute prohibition against organ doantiaon by adults would be unreasonable.
With regard to tissue such as bonemarrow, skin, or blood, permission should be granted as long as the donator is an adult. If the person somehow, due to age (under 18) or mental capability, lack the ability of giving consent, no action should be prompted. Under special circumstances, for instance when it is crucial that the tissue comes from a brother or sister of the deceased, even if underaged or mentally incompetent, a transplantation can take place, if the consent is given from the parents and the child itself. The neccesity of the transplantation should in such cases be controlled by Socialstyrelsens rättsliga råd.
Within the present legislation, small surgical interventions such as the taking of blood, skin, and cornea, are discussed apart from other kinds of transplantations. The report proposes that this arrangement comes to an end. A written consent must be produced from a living donor. Concerning deceased donors, the general rules of consent should be followed.
Information and registration
Information is the keyword if the right of self-determination is to be maintained. This is considered a national task by the Committee. Information should be widely spread, and especially to targetgroups such as students, drafted, etc. The costs of a directory containing all the available information would not be in proportion to the benefit. (The report claims that hardly more than 30% of the population would be willing to register) An arrangement with donation cards is therefore the choice of the Committee, and they suggest that an official system is introduced.
The Committee also suggests that after death has occured, the relatives of the deceased should routinely be asked for the attitude of the deceased towards transplantations, regardless of whether a transplantation is due or not. This would, however, not be a part of any legislation.
As for buying and selling organs, the Committee states that an organ is not a product. No profit should be made neither for donating, nor for any other activities around the biological material designed to be used for transplanation.
The Report finally suggest that the law concerning secrecy (1980:100) should be altered, so that it explicitly mentions transplantation as an areas covered by the law.
So far, this report has not led to any changes in the legislation.
The report proposes that in the absence of explicit consent one should presume refusal to organ donation. This has been the topic of some debate in Sweden. The Swedish Medical Association issued guidelines in 1989 which are different from the committe's report (Svenska läkaresällskapet 1989). These guidelines also affirm that respect for the deceased wishes is central, and that no organ donation should take place in the presence of an explicit refusal. If, however, there is no explicit refusal from the deceased or from the next of kin, one should presume consent to organ donation. They give the following reasons for this point of view:
1) Population surveys have shown that a majority of people are in favour of organ donation;
2) Taking into consideration the need for organs it would seem worse not to use an organ from a person who would have wanted to donate an organ if given a chance, then to use an organ from a person who would have refused.
3) It is often difficult for relatives to consider questions of organ donation in the period after the death of a loved one. Sometimes it may be hard to reach relatives, or they may have different opinions.
This reasoning has been criticised by some (Ifvarsson et al. 1989) and supported by others (Persson 1989).
The population survey referred to by the Swedish Medical Association is quite interesting (Gäbel and Lindskoug 1989). 68% of those surveyed would not have any objections to organ donation after death, and 45% would give permission for organs to be used from a deceased relative in cases where the opinion of the deceased concerning organ donation is unknown. As many as 31% were not able to answer this question. 11% were against organ donation. 68% felt that it would be more difficult to give consent to donation of a heart, than to donation of a kidney or liver.
There has also been a similar debate concerning autopsy in Sewden, where the issues of consent and a weighing of the interests of the deceased vs. the interests of others have been brought in (see Nilstun, 1991)
As is evident from the above, there has been a lively discussion in Denmark and Sweden concerning brain death and organ transplantation. A similar discussion has not taken place in Norway. Brain death criteria has been widely accepted in Norway. The Norwegian law concerning brain death and transplantation dates from 1973. The transplantation activity and results at the Norwegian National Hospital in Oslo are comparable to those of the main international transplantation centers. Organs can be removed from deceased persons in hospitals if they or their next of kin have not explicitly refused, or if one has reason to believe that it would be against the religious views or the values of the deceased person. While there has not been any discussion in Norway about the ethical issues raised by organ donation and transplantation, questions have been raised whether this is an effective use of scarce resources (Rasmussen, 1991).
Human Genome, Denmark
In 1990 the Danish Council of Ethics issued a working paper on the mapping of the human genome (Etisk Råd, 1990). Large projects has already commenced in the USA and Japan, and in the summer of 1990, the European Community (EC), of which Denmark is a member, initiated a program called Human Genome Analysis. The working paper Kortlægningen av menneskets arvemasse aims at describing international progress, the organizing of the present projects, and perspectives on and areas for application of the knowledge the mapping has produced so far. A judicial evaluation of the use of genetic tests in the workplace, for insurance purposes, and the legal situation in Denmark is also included in this paper.
A predecessor of the EC project Human Genome Analysis was called Predictive Medicine. It stated that diseases common in the Western world, such as diabetes, cancer, and heart-diseases might be a result of an interaction between a number of genes, making them difficult to predict by considering heredity. The diseases occur when genetically sensitive individuals are exposed to a specific environmental influence. The project considers the environmental component difficult to cope with. Predictive Medicide is therefore to be understood as a means for protecting the individuals from their genetic predispositions, and possibly - if possible - to prevent the passing of genetic sensitivity to the next generation.
A screening of the population might make it possible for an early intervention of certain illnesses, but genetic information might also be misused by employers and insurance-companies. Further, the program states that with the increased ability to diagnose fetuses, it might be possible to satisfy parents' wish for certain qualities for their children. It was stressed that it is crucial how society balances the right of the individual to decide regarding information about himself or herself, and the health benefits for the society as a whole.
The program was hevily critizised, especially by the Danish and the West-Germans. The latter described the project as a neo-eugenics. Det Etiske Råd felt that the program really should concentrate on diagnosis and treatment of serious diseases due to heredity. Furthermore, that the program should consider legal, social, and ethical issues to a larger extent. The Ministry of Health directed an official critique of the project on this basis.
A revision of the proposed program was made, and the new project was called Human Genome Analysis. The purpose of this program is to apply and develop biotechnology in the mapping of the human genome, with regard to prevention and and treatment of diseases. All research concerning gene-theraphy on gametes and embryos, leading to hereditary changes, is abolished. The development of gene-theraphy on somatic cells is also not included in the program.
It is maintained that the individual rights must be protected and respected, while the program is executed. All genetic data should be considered a part of the individual's integrity, and treated anonymously. A parallel investigation on ethical, social, and juridical issues should take place. A committee of lawyers, geneticists, philosophers, ethicists, must be constituted.
Gene technology and ethics in Norway
Related issues have been discussed by the committee appointed by the Minister of Social Affairs which issued its report in 1990 (Norges Offentlige Utredninger, 1991a). Some of the content of this report has been discussed in relation to the ethics of prenatal diagnosis and fetal research.
The committee takes a strict view with regard to the use of genetic data by anyone except the person himself or herself. Nobody, including the authorities, present and future employers, educational institutions, medical institutions, pension funds, life insurance companeis and other institutions, may request, possess, receive or make use of such information, or attempt to find out whether such tests have been carried out.
The committee is in general critical of the use of screening methods to register the prevalence of genetic disease, or individual predispositions towards disease. Tests which may detect risks of developing future disease, should not be introduced unless there is a specific medical objective, there is adequate evidence of the efficiency of preventive measures, and issues of privacy have been dealt with. It discusses screening for cystic fibrosis in particular, and argues that a general testing of the population to establish carriers of the gene for cystic fibrosis should not be introduced in Norway. It argues that such screening methods would lead to stigmatization of persons with cystic fibrosis, and persons who are carriers for the disease, it would require large resources, the number of false positive test results would create problems, and a testing program would lead to unnecessary fear and worry among many people. A Swedish expert group is also sceptical to general screening for cystic fibrosis, but recommends that diagnostic methods based on gene technology should be introduced, that close relatives of sick individuals should be tested after informed consent, and that prenatal diagnosis should be offered carriers after informed consent (Wahlström et al., 1990).
The committee also considers the use of predictive testing for Huntington's disease. In early 1990 the Ministry of Social Affairs have introduced testing on audults at risk at their request. Detailed guidelines have been published as an appendix to this report. This issue is also discussed in Sweden (Andersson, 1990). Only six out of ten persons at risk for the disease were positive to a test for Huntington's disease (Mattson and Almqvist, 1990). The authors conducted intensive interviews with these ten people. Those who were mostly interested in taking a test were those who had not had much contact with people who had the disease in the family, or who had passed normal age of disease manifestation.
The Norwegian committee would allow somatic gene therapy, but not germ cell therapy because of the risk of man-mediated changes in the genetic makeup of the human species.
In Sweden a law was passed in March 1991 which demands permission from the health authorities (Socialstyrelsen) before genetic tests are used in addition to the consent of the individuals tested.
Ethics, HIV and AIDS
The three Scandinavian countries differ markedly in their legal response to the aids epidemic. Sweden has adopted some of the most restrive measures in the Western world, whereas there is no laws which specifically apply to hiv/aids in Denmark. Norway has not yet adopted any legislation. We will first discuss the situation in Sweden and Denmark, and then the proposed infectious disease law in Norway.
HIV in Sweden is covered as a venereal disease by the Infectious Disease Act. An overview of the Swedish response to HIV/AIDS is given in Henriksson and Ytterberg, 1991. According to the provisions in this law infected people must be registered (although not by name), copntact tracing must be carried out, and they can be quarantined in a hospital if a physicians feels that this is important in order to prevent disease transmission. Any individual who believes that he or she has been exposed to an infectious disease must report to a physician to be examined. The physician must determine the identities of those who may be exposed by the infected person. These individuals can be subject to compulsory testing.
When individuals test HIV-positive they must seek regular medical examination, give information concerning their HIV-status to all potential sexual partners and to physicians or dentists when undergoing treatment. If it is suspected that a person will not adhere to these rules, the local Infectious Disease Officer must be informed, who will determine whether the person has failed to follow the rules. If that is the case, the police and the social work authorities will be notified. They will have to report back to the Infectious Disease Officer if such behavior is observed. The Infectious Disease Officer may ask a county administrative court to impose a quarantine for an indefinite period of time on a person who is suspected of spreading disease. This measure has in fact been used on a number of occasions.
The health authorities have wanted to have a psychiatrist in charge of HIV-positive individuals who are isolated according to this law, arguing that since they do not have any physical conditions, psychiatry is the proper specialty. This has met with marked resistance among psychiatrists. The chair of the Swedish Psychiatric Association has argued that psychiatrists cannot take part in such measures of social control because it would go against the Hawaii declaration (Åsberg, 1990). The only legitimate purpose for treatment against a person's wishes is the presence of a psychiatric disorder. It is not enough that an individual does not know what is in his or her own interests, or has a different opinion concerning what is in his or her own interests compared with the majority of people. Åsberg also rejects the view of the health authorities that the fact that these individuals are suspected of engaging in behaviour which may endanger others in itself is a sign of the presence of a psychiatric disorder. She sees the desire by the health authorities to use psychiatrists as no different in principle from the misuse of psychiatry in the Soviet Union and the misuse of physicians in Nazi Germany. Some have defended the use of psychiatrists, arguing that many of the patients show signs of personality disorders (Lassenius, 1990)
Infectious disease physicians have also been reluctant to use the law. It has also been pointed out that the law is counterproductive in that people will be reluctant to get tested if they fear quarantine and that the law should not allow such infringements of individual freedom merely on the suspicion that somebody may endanger others (Stiernsted, 1990). The Government has recently proposed that it is not necessary for a physician to be in charge of the involuntary isolation.
Denmark has taken quite a different approach to the AIDS epidemic. An overview of the Danish response to HIV/AIDS is given in Albaek, 1991. As in Sweden, issues concerning infectious diseases are governed by an Infectious Disease Act. This Act distinguishes between infectious which are 'generally dangerous' and those which are not. 'Generally dangerous' infectious diseases include diseases such as the plague and smallpox. Diseases such as HIV/AIDS or tuberculosis are not included in this category. Restrictive measures may only be carried out with regard to infectious diseases in this category.
The most recent Danish Venereal Disease Act was adopted in 1973. After the start of the AIDS epidemic there was a heated debate about whether HIV/AIDS should be covered by this act. The Act allowed for such measures as contact tracing and prison terms for people who exposed others to a venereal disease. The Act was repealed by the Danish Parliament in 1988 (see Lovforslag 1988). Several arguments were used by those who wanted the law repealed. They pointed out that there was no relationship between the number of sexually transmitted diseases and changes in legislation. They also argued that other measures than legal regulation would be effective in combatting infectious diseases, and even that legal regulation may give one a false sense of security. Finally, they pointed to experience from abroad which indicated that the use of force, isolation, and punishment with regard to AIDS are counterproductive. Even if such measures are aimed at the 'totally irresponsible' person, the fact that such measures are associated with the disease would weaken the possibilities of effective public health measures.
The Danish health authorities have been very reluctant to suggest that the principle of confidentiality should be set aside with regard to HIV/AIDS. In a case discussed in the Danish Medical Journal in 1985 the health authorities (Sundhedsstyrelsen) recommended that a physician should not break confidentiality in a case where an HIV-positive man refused to tell his pregnant wife of his HIV-status. One of the arguments used was that, although the recommendation may have detrimental consequences in this individual case, breaking confidentiality would result in other patients losing trust in the health care system, and thereby ultimately to an increase in the number of people infected. Recently, however, the Minister of Health has recommended that physician should tell the partners of HIV-positive patients when they refuse to do so, referring to the general exception to the legal requirement of confidentiality in cases when one needs to protect the interests of others (Jungersen, 1991).
Norway has not yet adopted any specific legal regulation with regard to HIV/AIDS, but a proposal for an Infectious Disease Act was submitted to the Department of Social Affairs by the Directorate of Health in 1990 (Norges Offentlige Utredninger, 1990). As is the case in the Danish Act, this proposal is also a general law, covering all infectious diseases.
Some of the more restrictive measures will only be applicable to what the law defines as "generally dangerous" infectious diseases. In the Norwegian proposal this class is much broader than in Denmark and includes, among others: Plague, Tuberculosis, HIV/AIDS, meningococcal disease, viral hepatitis B, gonorrhea, herpes genitalis, genital chlamydia infection, syphilis. For this class of diseases, the following measures can be used:
a) A physician may, against the wishes of a patient, give information about the infectiousness of the patient to another person when there is a reason to believe that there is a danger that the disease may be transmitted to this person.
b) a physician has a duty to inform another person of an obvious and immediate danger that the person may become infected by the patient.
c) A health care institution can test a person for an infectious disease as a condition of diagnosis and treatment, if the presence of disease would necessitate extraordinary measures to protect other patients or personell from infection. Examples of the kind of situations where one may demand a test include: surgical interventions, use of respirator, dialysis.
d) An infected person has a duty to inform the physician about the person who may be source of the infection, and about whom he or she may have infected. There are no sanctions attached to this part of the proposed law.
e) Contact tracing is made obligatory for infectious diseases.
f) Infected persons may be isolated in hospitals if it is very likely that they may transmit the disease to others and if there are no other means of preventing the disease from being transmitted to others.
g) An infected person may be prohibited from certain kinds of work if he or she poses a significant threat of infecting others.
h) Testing of health care workers for infectious diseases is not mentioned in the proposed law.
i) No attempts are made to introduce legislation which would explicitly protect the rights of infected people in terms of insurance or work.
The proposal has not yet been submitted to the Norwegian Parliament.
All pregnant women are offered screening tests for HIV in Norway. As of July 1990, 244.608 women have been tested. 19 HIV-positive cases have been identified. All except one of these women had already tested positive or belonged to a clear risk group. It is estimated that 100 women tested false positive (Lindemann et al. 1991).
Blood transfusion to members of Jehova's Witnesses
It may seem surprising to some North-American readers, but the issue of how one should deal with requests from members of Jehova's witnesses not to have bloodtransfusion has been the topic of some debate in the Scandinavian countries. The legal situation is somewhat unclear. On the one hand, it is clearly against the law to impose a treatment on another person against her or his will. On the other hand, physicians have a clear legal duty to do what they can to save a human life. There are no court decisions which would give guidance about what to do in cases where these two principles conflict, such as in a case of a Jehova's witness who before an elective surgical procedure has expressed a wish not to have a blood transfusion, but which unexpectedely needs one during the operation. The legal situation is similar in all three Scandinavian countries. In Denmark, there is a proposal that would give advance directives legal status, but this has not yet led to any changes in the law (see Knudsen and Guldager, 1991).
The Swedish and Danish health authorities have issued guidelines concerning how physicians should deal with such cases. The Swedish health authorities and the ethics committee of the Swedish Medical association issued guidelines in 1989 (Socialstyrelsen, 1989). According to these guidelines, the wishes of the patient should be the basis for the decision. Competent patient who refuse blood transfusions should not receive any blood products. However, if there is the slightest uncertainty about what the patient really wants, blood should be given in life-threatening situations.
The Danish Directorate of Health ("Sundhedsstyrelsen") issued an announcement in 1991 concerning this issue (Sundhedsstyrelsen, 1991).
If a competent adult does not want a blood transfusion under any circumstances, the physicians have to decide whether they want to treat a patient under these conditions. If the physicians accept the conditions, they cannot give the patient any blood products. If, however, significant new developments have taken place after the patient gave his or her directive, and the patient no longer is competent, the physicians have to decide whether these new conditions would have influenced the patient's decisions concerning blood transfusion. In patients who are temporarily unconscious, who have not clearly and unambiguously said anything about blood transfusions, and who are in a life threatening situation, transfusion must be given if this is necessary to save these patient's lives. This must be done irrespective of whether relatives do not give their consent to blood transfusion on behalf of the patient.
These directives have been criticised by members of Jehova's witnesses as not giving enough protection to the rights of temporarily incompetent patients (Bølling, 1991). It should also be clear that the announcement by the health authorities in Denmark really do not resolve the tricky legal issue concerning what to do with an a temporarily incompetent patient who has previously expressed a desire not to have a blood tranfusion.
Treatment of patients in a persistent vegetative state and terminally ill patients
A case in 1987 sparked a debate in Sweden concerning treatment of patients in persistent vegetative state. The case was a three year old boy who was brought into the hospital after a drowning accident. The physicians decided that there were no possibilities of meaningful life and consequently withdrew artificial feeding. The health authorities criticised the three physicians involved.
One Swedish lawyer has argued that according to Swedish law, such withdrawal of feeding would be classified as murder (Wennergren, 1989 and 1990). Wennergren argued that from the legal standpoint, to let a patient starve to death would be the same as to kill a patient by giving a lethal injection. Against this position, others have pointed out that a physician would not be charged with murder if he or she followed standard medical practice, that is if treatment was in accord with science and confirmed experience (Vängby, 1990; Karlsson, 1991). This means that if there is consensus in the medical community that treatment should be withdrawn for a particular condition, this would not be murder.
Since Sweden's highest court has not reviewed any such cases, it is still uncertain how the law would be interpreted. Interestingly enough, however, the issue in the Swedish debate has not been what the patient himself or herself would decide, as has been the case in the USA. In the last half of 1991 the Swedish health authorities have issued new guidelines. The Danish Council of Ethics has also issued a report on active euthanasia. Both of these will be discussed in the next volume.
A survey of Swedish internists regarding do not resuscitate orders revealed that the interpretation of such orders varies considerably, and that the orders were often associated with witdrawal and witholding of other life-sustaining treatments other than cardiopulmonary resuscitation. It was also found that the physicians rarely discussed DNR orders with their patients or the relatives (Asplund and Britton, 1990).
Husabø (1990) discusses the changes that have taken place in the Netherlands with regard to active euthanasia. Although there has not been any changes in the law, the courts have found arguments in terms of a person's freedom of choice and in terms of compassion persuasive. Husabø argues that this would not be possible in Norway, because the law explicitly forbids killing a terminal ill person out of compassion for this person. Such a special law does not exist in the Netherlands. Norwegian law also explicitly forbids killing people who consent. These particular laws give Norwegian courts much less room for interpretation than the courts have in the Netherlands.
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Hellum, A. et al. (ed.): 1990, Menneske, natur og fødselteknologi. Verdivalg og rettslig regulering, Ad Notam Forlag, Oslo
Helsedirektoratets utredningsserie: 1990, Abort etter 18. svangerskapsuke på grunn av fosterskade, Helsedirektoratet, Oslo.
Henriksen, J-O. and Aarre, T.F.: 1989, 'Mer enn gener - men mer enn et menneske', Tidsskrift for den norske lægeforening 109, 3621-3624.
Henriksson, B., and Ytterberg, H.: 1991, 'Swedish AIDS policy: a question of contradictions', In R. Bayer and D. Kirp (eds.), Passion, politics and policy: AIDS in eleven democratic nations. Rutgers University Press, New Brunscwick, N.J.
Husabø, E.J.: 1990, 'Legalisering av aktiv dødshjelp i Nederland', Tidsskrift for rettsvitenskap 4, 672-707.
Ifvarsson, C.-A. et al.: 1989, 'Läkaresällskapets delegation för medicinsk etik rekommenderar brott mot transplantationslagen!', Läkartidningen 86, 1681.
Jungersen, D.: 1991, 'Ikke belæg for brud på lægers tavshedspligt i HIV-sager', Information, July 26.
Karlsson, Y.: 1991, 'Medicinsk kontrovers om avbrytande av behandling. Riskerar läkaren att bli åtalad för dråp? Endast om han avviker från kårens konsensus', Läkartidningen 88, 1417-1420.
Kirkerådet: 1989, Mer enn gener, Oslo.
Kjessler, B.: 1989a, 'Skall osäkerhet inför det nya och okända behöva tvinga oss avstå från viktig forskning?', Läkartidningen 86, 1063.
Kjessler, B.: 1989b, 'Embryonalforskning - en etisk styggelse eller en chans för mänskligheten?', Läkartidningen 86, 1610-1613
Knudsen, F. and Guldager, H.: 1991, 'Blodtransfusion og Jehovas Vidner. Etiske og medikolegale aspekter', Ugeskrift for læger 153, 632-636.
Larsen, E.: 1991, 'Fosterdiagnostik i Danmark', Ugeskrift for læger 153, 2247-2248.
Larsson, Y. and Thorén, M.: 1991, 'Abortlagen ifrågasätts inte i almänna råden om foster!', 88, 384.
Lassenius, B.: 1990, 'Tvångsisolering av HIV-smittade. Psykiatrerna måste ta sitt ansvar', Läkartidningen 87, 1556.
Lindemann, R. et al.: 1991, 'Perinatal HIV-smitte. Epidemiologiske, sosiale og etiske aspekter', Tidsskrift for den norske lægeforening 111, 434-436.
Lovforslag: 1988, 'Forslag til Lov om ophævelse af lov om bekæmpelse af kønssygdomme', Lovforslag. Folketingsåret 1987-88, København, pp. 3151-3160.
Löfgren, M. et al.: 1991a, 'Abortlagen ifrågasätts genom nya rutiner för omhändertagande av foster efter abort', Läkartidningen 88, 12-13
Löfgren, M. et al.: 1991b, 'Aborterade foster - etik eller etikett?' Läkartidningen 88, 1265.
Lübcke, P. and Norup, M.: 1989, 'Døden som process?', Ugeskrift for læger 151, 2816-1818.
Mattson, B. and Almqvist, E.W.: 1990, 'Prediktivt test för Huntingtons sjukdom - djupintervjuer med personer i riskzonen', Läkartidningen 87, 3204-3206.
Møller, J. and Nielsen, B. H.: 1991, 'Tiden er inde til eksperimenter med menneskelige æg', Information July 29.
Nielsen, B. H., and Møller, J.: 1991, 'Lov om humane æg', Information October 2.
Nilstun, T.: 1991, 'Svensk förening för medicinsk etik. Samhällsnyttan av obduktion måste vägas mot respekten för den avlidnes integritet', Läkartidningen 88, 1603-1604.
Norges Offentlige Utredninger: 1990, Lov om vern mot smittsomme sykdommer, NOU 1990:2, Oslo.
Norges Offentlige Utredninger: 1991a, Mennesker og bioteknologi, NOU 1991:6, Oslo.
Norges Offentlige Utredninger: 1991b, Rettssikkerhet for mennesker med psykisk utviklingshemming, NOU 1991:20, Oslo.
Persson, I.: 1989, 'Förutsätt samtycke till organtagande i oklara fall. Den modellen är bäst ur allas perspektiv', Läkartidningen 86, 1394-1395.
Rasmussen, K.: 1991, 'Transplantasjoner, prioriteringer og etikk', Tidsskrift for den norske lægeforening 111, 295-296.
Rix, B.A.: 1990, 'Danish ethics council rejects brain death as the criterion of death', Journal of Medical Ethics 16, 5-7.
Schei, B.: 1991, 'Mellom mor og barn - tidlig fosterdiagnostikk som rutine innen svangerskapsomsorgen', Tidsskrift for den norske lægeforening 111, 2118-2121.
Scocozza, L.: 1990, 'Forsøgspatienter informeres dårligt', Sygeplejersken 3, 8-14
Socialstyrelsen: 1989, 'Nej till blodtransfusion bör respekteras om patienten är klar över följderna', Läkartidningen 86, 450-451.
Stiernstedt, G.: 1990, 'Avskaffa tvångsvårde enligt smittskyddslagen. Ett hot mot rättssäkerheten', Läkartidningen 87, 2405-2406.
Sundhedsstyrelsen: 1991, 'Meddelse om patienter der afviser at modtage blodtransfusion', Ugeskrift for læger 153, 2583-2584.
Svenska läkaresällskapet: 1989, 'Självbestämmandet avgör om organ får tas. Samtycke bör förutsättas i de oklare fallen', Läkartidningen 86, 980-981.
Sveriges Offentlige Utredninger: 1989a, Den Gravida kvinnan och fosteret - två individar, SOU 1989:51, Stockholm.
Sveriges Offentlige Utredninger: 1989b, Transplantation / etiske, medicinska och rättsliga apsektar, SOU 1989:98, Stockholm.
Sveriges Offentlige Utredninger: 1989c, Forskningsetisk prøvning. Organisasjon, information och utbildning, SOU 1989:74, Stocholm.
Sveriges Offentlige Utredninger: 1989d, Etisk granskning av medicinsk forskning. De forskningsetiska komitteernas versamhet, SOU 1989:75, Stockholm.
Tännsjö, T.: 1989, 'Utredningen om det ofödda barnet - bra förslag men illa motiverade', Läkartidningen 86, 3437 - 3440.
Tranøy, K.E.: 1989, 'Den nye fruktbarhetsteknologien - nye og gamle rettigheter', Tidsskrift for rettsvitenskap 2, 112-126.
Vängby, S.: 1990, 'Förkortande av liv under adekvat vård inte en fråga som lämpar sig for lagstifning', Läkartidningen 87, 641-642.
Wahlström, J. et al.: 1990, 'Diagnostik av cystisk fibros med hjälp av genteknik -- riktlinjer från expertmöte', Läkartidningen 87, 3429-3430.
Wennergren, B.: 1989, 'Diskrepans mellan samhällets och medicinens etik i synen på olika former av eutanasi?' Läkartidningen 86, 1708 - 1709.
Wennergren, B.: 1990, 'Förkortande av liv under adekvat vård - lagstifta för att undanröja oklarheter!', Läkartidningen 87, 640-641.
Wiingaard, P.: 1990, 'Det forvredne dødsbegrep', Ugeskrift for læger 152, 247.
Åsberg, M.: 1990, 'Psykiatrerna, HIV-smittade och tvång -- håll isär medicinsk terapi och social kontroll!', Läkartidningen 87, 1383-4, 1387-8.