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Introduction
Not until the nineteenth century was systematic attention paid to the way plant and animal characteristics varied from one generation to the next. Gregor Mendel, the father of modern genetics, spoke about "inherited factors" through which certain characteristics pass. In 1944 studies in the field of microchemistry made a linkage with a chemical substance as the molecular basis of inheritance. In 1953 James Watson and Francis Crick, researchers at the Cambridge Laboratory of Molecular Biology, identified the structure of deoxyribonucleic acid (DNA), the chemical substance in living organisms responsible for passing hereditary factors to new generations. The acid can be found in the nucleus of all living cells and embodies the complete set of inherited attributes (genome). DNA is located in chromosomes, spiral-shaped chains within the cell nucleus. In human beings, each cell nucleus normally contains 46 chromosomes, with 22 pairs of autosomes and 1 pair of sex chromosomes. The latter are responsible for the sex determination of a person and his/her offspring. The basic unit of heredity, which can be found on the chromosome, is called a gene. The word gene in Greek means born or produced. Its position in the chromosome has decisive consequences for the function the gene has.
Within a human being (as in other living species), the heredity determined instructions can be passed through a process of protein synthesis by the DNA. Each gene consists of a small segment of DNA that directs the synthesis of amino acids, which are the building blocks of proteins. Since 1967 we know that a special RNA-molecule (ribonucleic acid) serves as a messenger and brings the hereditary information from the cell nucleus to other parts of the cell. RNA does not change the original DNA structures, as its sole role is the communication and organization of the protein production within a cell.
By the union of male and female germ cells (fertilization), a new DNA structure develops, which implies a unique set of inherited traits. By this process we can understand life's diversity.
Alterations in the DNA of a gene, or changes in its location, sequence, or number of nucleotides in one or more genes, cause - among other things - a variation in the hereditary set of instructions. Such mutations are the basis of evolution and normally are caused by a gene-gene and/or gene-environment interaction. This process is usually called natural evolution to distinguish it from artificial changes. As genetic variations determine- among other things both intelligence and abilities, as well as a person's susceptibility to diseases, fertility, life expectancy, abnormalities, and disabilities, mutations can have far-reaching implications.
In the 1960s the potential contribution of genetics to health and health care became more clear. A new science, called medical genetics, evolved. Progress in biochemical and molecular genetics made screening for hereditary and inborn traits possible and focused attention on genetic diseases and disorders. In industrialized countries most prevailing diseases have a genetic component, which may be of a greater or lesser importance.79 There have been discovered about 4,200 diseases caused by a single gene defect (monofactorial). At least the same number of diseases is caused by multiple gene defects (multifactorial), in which multiple genetic and environmental factors are involved. There is a third category of diseases with a genetic origin, caused by abnormalities of chromosome number and structure. An example of the latter is Down's syndrome (mongolism).
By the end of the 1960s medical genetics took screening one step further by introducing methods to diagnose chromsomal and metabolic disorders before birth. Since then impressive progress has been made in pre-natal screening techniques, which go much further than determining the sex of the unborn child.
In 1972 researchers discovered a technique for cutting and splicing DNA, called recombinant DNA technique.80 Although this term is used to mean a variety of activities, the technique is based on the obtaining by artificial means of recombinant DNA, i.e. DNA which contains molecules from various sources.
Thereafter they also learned how to transfer. functional segments of DNA between cells from different species. By these techniques the foundation was laid for changing human characteristics as well as the possibility of creating new forms of life. As a result of the maturing of this new scientific technique, we note that recombinant techniques are now used:
- for selection and improvement in agriculture, horticulture, and animal husbandry;
- for the production of primary products, raw materials, fuel, chemical products, etc.; and
- to improve the natural environment.81
This technique has also resulted in the development of remedies which contribute to the improvement of human health. In particular we should mention the profitable industrial production of certain substances or products.
Genetic engineering for preventive and therapeutic purposes is aimed at developing appropriate means to prevent or correct pre-symptomatic and pathological defects of the human genome and, where possible, related diseases. In some fields research resulted in successful therapies to restore defective genetic attributes, or eventually to destroy them if that was the only way to prevent more harm.82 These techniques could be said to make a substantial contribution to improving the basic conditions in which to enjoy the right to life, to ensuring for more persons access to a decent and dignified life, and, not least, to obtaining for more persons the benefits of a higher standard of health. These are all positive effects on the enjoyment of human rights, as laid down in the international human rights conventions.
Diagnostic techniques, aimed at the discovery and identification of genetic defects and abnormalities in an early stage, have developed progressively. Testing for genetic disorders (a form of genetic screening) has become a very important tool to predict a patient's medical biology and his/her susceptibility to diseases. The time can be envisioned when virtually all relevant information about an (unborn) person's genotype will be readily accessible. At present, some 10 per cent of frequently prevailing inborn defects are demonstrable through genetic screening methods.83
Most of the currently available tests are based on a technique of comparing small variations in DNA (polymorphism) that can be found on all chromosomes, and using the variables as markers for dysfunctional genes. Up to the present time there have been a limited number of genetic disorders in which the marker technique can be applied. An additional complication is that for each individual a different marker should be identified (the DNA and chromosome structure for each person is different). Important limitations of these indirect testing methods are the inaccessibility of some tissues for testing (e. g. the brain) and the probability that the disease will have manifested itself by the time that the genetic marker is detected. Secondly, there is a necessity for (blood) relatives to participate in such an investigation, as the marker technique presupposes that results can be compared between persons with a similar hereditary structure. This not only has practical implications, but can encounter legal and ethical obstacles as well.
For these reasons microbiologists try to trace the polymorphism that traits and disorders spring from. So far some 400 disorders have been mapped to a particular chromosome. Ten per cent of these disorders have been defined in depth. In each of these cases a DNA test can be used as an instrument for pre-clinical diagnosis of a disease of late onset, as well as for prenatal diagnosis or for detecting if someone is carrying a non-manifest defective gene (carrier).84 Ongoing research is aimed at obtaining a better knowledge of the human genome, including the localization and identification of all genes (gene-mapping), and the development of a wide range of diagnostic testing methods.
DNA research has not solely been aimed at achieving a specific genetic map of the human genome of all individuals and at developing corresponding diagnostic testing methods. DNA researchers have demonstrated a strong incentive to apply their knowledge and to interfere with the hereditary process if genetic disorders are found. Research projects are currently aimed at:
(1) the transformation or destruction of one or more cells that affect in a harmful way an individual person without having injurious effects on his/her offspring (gene transfers of somatic bodily cells); and
(2) the correction of a defective cell by surgical intervention by inserting non-harmful DNA directly into a cell, in case the harmful trait is transmitted to the offspring (gene therapy).
The latter process has far-reaching implications as it also has irreversible effects on future generations. The term "manipulation" has often been used in this context. Under the present state of knowledge gene therapy is not yet possible with human beings. Experiments with animals, however, have shown rather satisfactory results. Particularly experiments with the homologue recombinant method (an exchange of introduced DNA for the defective gene extracted from the cell) are very promising for the enlargement of the scope of application.85 It is therefore not unlikely that progress in recombinant DNA techniques will accelerate the possibility of introducing gene therapy for human beings within a reasonable period of time.
In the meantime new testing methods have been developed which can give far more details on a person's health status, susceptibility to diseases, genetic defects, and the presence of recessive genes, and can predict the effects on procreation, etc., than ever before. Thanks to our current knowledge of the human genome, the scope of the new tests is so much larger that we can speak about a new phase in medical history. In this report we will refer to these advanced testing methods under the common name "genetic" screening.'86
Because of its predictive characteristics, genetic screening may be chosen by an individual as an aid in making personal medical and procreative choices. In this context it would be more appropriate to speak about genetic counselling: to advise and counsel an individual person on the basis of information derived from that person's hereditary and inborn structure through the application of a genetic examination.87
The Impact of Advanced Medical Genetics and Intervention Methods on the Enjoyment of Human Rights
Medical genetics, based on advanced knowledge on the human genome and improved possibilities of predicting a person's health prospects, can thus serve to counsel a person, to assist him/her in taking procreative decisions, and eventually to interfere with certain hereditary traits. The science of medical genetics covers a broad range of subdisciplines, such as immunogenetics, behaviourial genetics, and neurogenetics, but also genetic counselling, genetic screening, and prenatal diagnosis. Always a subject of public concern, at least initially, genetic research and recombinant DNA techniques have been tools particularly dominated by scientists. Public debate included issues involving environ mental health and ethics, risks and dangers, benefits and progress. Scientists have always been divided over potential hazards for humanity and civilization of recombinant DNA techniques. The question as to what extent these techniques can have far-reaching and, particularly, injurious effects on human beings and the human environment has always been hotly debated. This can be illustrated by the voluntary moratorium on recombinant DNA experiments announced by genetic researchers in 1974.88
In the Western European context a strong reluctance and suspicion can be noted towards several forms of recombinant DNA experiments and the introduction of genetic therapeutic methods.
In Germany, where owing to the tragic events of the Second World War89 any form of alteration of human traits has always been treated with distrust, from a very early stage recombinant DNA research was subject to a strict licensing system. In practice this meant an almost insurmountable hindrance for the industry to explore any activities related to gene technology. Despite the relatively mild recommendations of the (FRG) parliamentary investigation commission on "Chancen und Risiken der Gentechnologie" (Opportunities and Risks of Gene Technology) in 1984, the Federal Council (Bundesrat) ruled in May 1988 that the granting of a licence to a company that wished to carry out a project on gene technology would depend on the results of a public hearing.90 More recently, the Kassel administrative court forbade the chemical company Hoechst to produce genetically manipulated human insulin for diabetics. As from the same day the court ordered the company to stop the construction of an experimental station, despite the fact that 60 million Deutschmarks had already been invested in the project.91
In May 1986 Denmark passed a law on genetic engineering, which strictly regulates activities connected with genetic engineering. Denmark has no exemption clauses for work with the so-called well-known microorganisms.92 All production and all experiments in containers larger than 10 litres must be approved before commencement.
And despite the fact that gene therapy in human beings is still impossible, in 1988 the European Medical Research Councils adopted a statement on its applicability and future use.93
In general it could be said that after the initial horror stories and bogeys about the creation of perfect human beings and the elimination of sick and handicapped persons, now, 26 years after DNA was defined for the first time, both the benefits and risks for humanity are more clearly understood with the passing of time. Consequently we are able to give an indication of the impacts of genetic research and its implications for human rights in daily life. The main benefits and risks can be enumerated as follows.
Benefits
1. Enhancement of the possibilities of guaranteeing the right to a maximum of physical health and consequently also the right to life for human beings through:
(a) the slowing down, if not the prevention, of the outbreak of (some) fatal diseases or other breakdowns of the human body;
(b) the identification of infections by new and better instruments at an early stage, which is essential for the pursuance of a health-promotion policy;
(c) the use of the newly developed therapeutic means to combat congenital and inherited diseases. and defects on an individual level;
(d) the outcome of research into and experimentation with the introduction of genes in bacterial cells, which is conditional for future vaccines and remedies to contain genetic defects;
(e) the deeper understanding of the cell replication process directed by DNA, and thus the biology of living organisms, and
(f) the expanded possibilities for improving the production of food and primary goods.
2. Enhancement of the possibilities of guaranteeing the right to a maximum of health for the individual and society as a whole, both in the present and future generations, through the application of new techniques to promote and manipulate a healthy human genome in the long run. The new techniques to improve the natural environment must be seen as an important precondition for the benefits to be gained from the right to health care.
3. Simpler, faster, and less costly methods to test human beings for genetic susceptibilities and defects.
4. A new method of seeking for objective proof, for example, as a means of identifying family ties (the DNA banks in Argentina) or in criminal proceedings (particularly in the case of sexual abuse).
Risks
1. Threats to the right to life, the right to health care, and the rights of posterity by:
(a) the possible creation of hazardous substances, which may cause unknown diseases. and disasters;
(b) the possible transplantation of unknown genetic substances as a result of recombinant DNA techniques with viruses and bacteria. These viruses and bacteria may eventually become pathogenic;
(c) the escape of highly toxic bacteria from laboratories, for example those used in experiments with the implantation of cancer viruses in bacteria;
(d) the resistance microorganisms may build up as a result of recombinant DNA experiments, with all its consequences;
(e) the fact that even experiments with totally purified and identified DNA carry certain risks, as it is not always predictable what reactions DNA recombinant will cause after implantation in the human body; and
(f) the risks relating to the storage of manipulated materials.
2. Threats to the right to human dignity and the rights of posterity, as new forms of life may be developed through genetic manipulation in combination with hybridization.
3. Threats to political rights, as the scientific advances may take directions which impede democratic control.
4. Threats to the right to privacy and the right to mental and physical integrity, as all kinds of medical examinations and interventions with the individual's body may be made compulsory as a result of the advanced knowledge, and newly developed testing and treatment methods (see section on compulsory and mandatory medical examinations).
5. Threats to the right to privacy and the right to human dignity, as knowledge on one's genome may impose heavy psychological burdens, since it may have far-reaching consequences for one's life, health, and parental expectations.
6. Threats to the right to privacy, freedom of movement, and economic and social rights, as third parties may impose restrictions and obligations on individuals on the basis of his/her genome, inter alia in the fields of employment, housing, insurance, travel, etc.
7. Threats to the right to privacy, the right to found a family, the right to education, etc., as, for economic reasons, states may decide to impose conditions and limitations on their citizens. with regard to procreation, access to education, etc., as they may fear that congenital and inherited defects may result in extraordinary or avoidable future expenses.
8. Threat to the right to freedom of movement, the right to seek asylum or refuge and the non-refoulement principle, as for economic reasons (see 7) states may restrict entrance to the national territory of aliens with certain hereditary traits and defects. There is already discussion about a "genetic passport" to be introduced as a travel document for the future.
The latter five points are particularly interesting from the viewpoint of weighing the rights and freedoms of an individual against the interest of other individuals or the community in general. The threat of impairment of the above-mentioned rights as a result of genetic research and its application should be an incentive for states to review their legislation and to adopt, where necessary, laws in order to safeguard respect for human rights within their jurisdiction. States are also confronted with completely new problems, such as the protection of sensitive personal data and the so-called "wrongful life" actions. While most European states already seem to have responded to the threats of undue use of privacy-related information,94 so far little legislation has been promulgated dealing with the inconveniences that human beings might have been saved by having the parents undergo a genetic diagnosis before conception. The improved accuracy in predicting and detecting genetic disorders thus causes new legal problems in the children-parents/guardians relationship, which have already resulted in children suing their parents, and their health-care providers, usually on the ground of negligence, before courts in the USA. Thus, although some of these "wrongful life" actions have already been adjudged in the USA,95 a legal response still needs to be developed in Western Europe. From the American experience it is obvious that legislation is needed to define one's liability towards one's offspring.
Present human rights law already provides us with a structured framework giving clear guidance as to how to interpret different provisions in case of an alleged interference with a recognized right or in the event of a conflict of various rights. States almost always have, however, a certain "margin of discretion" which allows them to balance the interests involved in a proportional way and thus to decide how best to implement the provisions of the treaty. This is particularly true for those rights with a number of "justifiable grounds" for interfering with the embodied guarantees (see Introduction).
The discretionary powers of states to interpret legal provisions differs from right to right. The so-called absolute rights, such as the right not to be subjected to "torture or to inhuman or degrading treatment or punishment"96 may not be restricted or interfered with under any circumstances. Most of the other rights, however, such as the right to privacy, to information, to freedom of movement, to found a family, etc., are less absolute and can be restricted or interfered with depending on the limitation clause as embodied in the provision concerned.97 In order to be able to weigh the conflicting interests in the case of medical genetics, precise knowledge on the effects - both positive and negative - as well as the impacts on social life and psychological well-being is needed.
As stated above, genetic treatment methods can make an important contribution to improve the "quality of life" and thus to achieve the fulfilment of the right to life and the right to enjoy the highest possible standard of health. Here reference should be made to the fact that, for example in the Netherlands, genetic diseases form the major cause of death in infancy.98 Thanks to techniques such as genetic screening and genetic counselling we are now able to assist individuals in making personal medical and procreative decisions, and to design prompt and adequate public health policies to counter the threat of some diseases or infections. Here genetics is revealed as a real aid in achieving the goals underlying human rights law.
As there are many risks involved in the introduction of genetic techniques, and particularly genetic engineering techniques, pleas have been made for an absolute prohibition of manipulations and experimentations with hereditary substances. In the ethical and legal debate that surrounds the question of permissibility of genetics the arguments advanced by the adversaries vary. The opponents often refer to the fact that through the existence of and enhanced access to genetic techniques, a person's genome and information on the person's genome may become misused by others. This can be the result both of genetic screening and of genetic manipulation. In Western Europe there has traditionally been a very strong environmentalist movement, which is very critical towards the application of genetics in the health-care sector. There is concern about the implications of the increased control over nature - including humanity - and the increased possibilities for the human race to influence its own development. Nazi practices during the Second World War with gipsy twins, homosexuals, and Slavs99 account for this resistance against genetics amongst large sectors of Western European society.
In this respect reference should be made to a classic legal adage which says that "all avoidable suffering should be prevented". With our present knowledge of our genetic system, and techniques derived therefrom to make adaptations in case of disorders, new possibilities for combating and preventing the manifestation of diseases are within reach, at both the individual and the community levels. These possibilities will only come to fruition as long as continued research is directed to the development and improvement of gene therapy. At the same time it cannot be denied that we have an important responsibility towards future generations. This responsibility is not restricted to the often-mentioned protection of our physical environment; we should also guarantee and promote the "highest quality of life," for example by guaranteeing the highest standards of physical and mental health.100 We should be aware that the natural resources the present generation is drawing on belong to the generations that follow us as well. For these reasons, some authors have stated that it is the duty of each human being to strive for the improvement of the conditions of life of future generations - or at least to guarantee for future generations the same standards as they themselves enjoy.101 The corresponding duty of states is to ensure that these aims are met. Human rights of posterity have, however, not yet been defined in international law.
Genetic research can contribute to the prevention of specific environmental threats to the human hereditary structure. More knowledge on inherited factors can result in adequate precautionary and preventive measures to strengthen the immune system and to protect individuals from developing some of the prevailing diseases.
Crucial, however, is the question as to the extent to which genetic interventions ("manipulations") are justifiable under the present international human rights law and, moreover, the extent to which they are ethically acceptable.
The right to health care implies that interventions that induce an improvement in the mental or physical life conditions of a person are acceptable in principle. The informed consent of the person concerned, that is, his/her freely given agreement to undergo a particular genetic intervention after having received all relevant information in a comprehensible manner, is a precondition. The informed consent rule in fact is nothing more than the individual's acceptance that his/her privacy (and possibly physical integrity) is interfered with. As a general rule all persons enjoy the freedom to make individual decisions as long as this does not interfere with the rights and freedoms of others.102 The European Commission of Human Rights has explicitly stated that the right of respect for private life secures for the individual a sphere within which he/she can freely pursue the development and fulfilment of his/her personality.103
As regards the right to health care and practices in the health-care sector we should note that phenotypical interventions and measures as a result of a genetic defect are generally accepted. Persons with a number of diseases having serious life implications, such as haemaphilia, diabetes and, in recent years, hypercholesterolaemia, can live a "normal" life through the availability of modern therapeutic treatments and/or drugs. What, however, could be the rationale for objecting to the removal of the main causes of such life inconveniences, while not disapproving of the suppression of their harmful manifestations? Moreover, there is a general tendency for the differentiation between phenotypical and genetic manipulation to become more and more gradual instead of the two opposing each other. This has also repercussions for the legal treatment of such interventions, which now becomes more similar.
With regard to the adage "all avoidable suffering should be prevented," a number of problems may arise in cases where parents or legal guardians refuse to let their children undergo a medical treatment which, according to objective standards, can be considered essential to guarantee the highest possible level of health or the right to life as such (Article 2 ECHR) to the minor lacking legal competence to decide upon a medical intervention. These problems will only increase as there will be more situations in which attending physicians will recommend medical treatments, notably for preventive reasons, owing to their advanced diagnostic as well as clinical skills. Parents and legal guardians who oppose certain medical interventions risk being relieved of parental control/ guardianship, as the essence of parenthood/guardianship is a duty to care (to guide minors towards adulthood), and not a right to impose limitations upon the lives of minors.104 In the Netherlands the treating physician, on his/her own initiative or on being asked to do so by others, can make a request to the Council for the Protection of Children (Raad van Kinderbescherming) to relieve parents/legal guardians of their right to decide on behalf of the child, in order to make possible the necessary therapeutic interventions as well as safeguard the privacy and physical integrity of the minor. Following established jurisprudence, the Council will accede to such a request, even in cases where the parents/guardians have religious objections to the treatment.105
Considerations with Regard to Genetic Research and the Application of Genetic engineering. Techniques
We have seen that modern genetics allow us to have increasing influence on human beings and civilization, both now and in the future. Although the technique of gene therapy is still in its infancy, the formulation of standards could already be of great assistance to both researchers and society at large. Before reviewing advanced therapies we should pay attention to genetic research programmes, as these precede the development of techniques that can be used to manipulate the genetic attributes of human beings.
Genetic research can be considered as a form of scientific research, usually carried out by microbiologists, chemists, and geneticists. In order to perform their work researchers need a certain freedom of research which is a precondition for the development of society and the evolution of sciences.106 Although there is not an internationally recognized right to freedom of research, the fact that the United Nations General Assembly has recognized that "scientific and technological progress is of great importance in accelerating the social and economic development of the developing countries," and that these developments "provide ever increasing opportunities to better the conditions of life of people and nations," 107 implies that researchers should have the possibility of conducting their work within the framework of the protection of conscience, opinion, information, and expression. This, however, provides no carte blanche for conducting any kind of research considered to be of interest. The fact that research as a general requirement should from both a legal and an ethical perspective be acceptable implies that the freedom of research ends where it interferes with the rights and freedoms, of others.108
This implies, inter alia, that genetic research programmes should have justifiable aims and that their hazards should be carefully assessed. A project that, for instance, aims at the elimination of (groups of) human beings with certain social or outward characteristics is by definition unacceptable. As a general rule research programmes must comply with the principles of societal care and fulfil human rights law. Researchers, consequently, should always work in accordance with high ethical norms and practice the necessary self-regulation. Moreover, their societal integrity should be unquestionable.
Owing to the fact that genetics is a relatively new science surrounded by many incertitudes and assumptions, trials, experiments, and further investigations are essential to extend and improve the knowledge obtained so far. Trials and experiments may need the participation of human beings. Besides the already recognized safeguards against experimentation with human beings and the misuse of power,109 scientists engaged in research are bound by certain specific limitations. As experiments can pose a direct threat to humanity or the natural environment, precautionary measures must be taken to prevent avoidable hazards. Therefore experiments should only be allowed after compliance with physical safeguards. Secondly, in experiments where viruses and bacteria are involved, they should, if possible, be manipulated in such a way that the harm they could possibly produce outside laboratory conditions is minimal. Further, there should be sufficient security for the health status of the researchers and other staff members involved in carrying out the experiments. This may imply a policy which calls for researchers to let themselves be tested for their susceptibility to certain diseases. or affections.
Special directives should guarantee the rights and fundamental freedoms of the subjects of experiments. As a general rule, the "informed consent" of those participating is absolutely essential (see section on "compulsory and mandatory medical examinations"). For the carrying out of a trial, e.g. a clinical trial, all Western European countries have introduced legislation which, in varying degrees, describes the procedures to be followed.110 It goes without saying that these should be observed in all genetic trials involving human beings. To demonstrate the importance the EC attaches to these experiments it should be noted that a draft Directive on clinical trials with drugs is being circulated amongst the governments of the member states and this is eventually to be adopted by the Council of Ministers.111
Concerning the use of genetic engineering techniques on human beings, one should differentiate between the various forms these techniques can take.
Within the category of genetic engineering we can distinguish between the altering of the genetic attributes of cells, a technique that only has implications for the person concerned , and alterations which affect a person's offspring as well. The first kind of genetic engineering is sometimes called "enhancement," and the second category of interventions is called "eugenetica." 112 Enhancement with somatic bodily cells can be compared with organ transplantations. The principle of the implantation of a gene in a complex of genes in another cell is not much different from the transfer of an organ.
It is obvious that eugenetica has implications that reach much further. There is evidence that a school of "eugeniticists" was founded in the United States of America around 1900, in order to protect the "Anglo-Saxon northern race" against the supposed injurious effects of migrants from "southern" and other "lower" origin.113 Therefore, eugenetica needs to be dealt with the greatest caution. The modification (and "purification") of races is in clear contradiction with the prohibition of discrimination on the basis of race and ethnic origin, a right underlying a number of human rights treaties and imposing a duty upon states to undertake unequivocal action.114 On the other hand, in situations where fatal diseases can be prevented there seems to be no prima facie contra diction with human rights standards. In cases where the development of these diseases. in future generations can be prevented, the position would be that an important step would have been taken in achieving the highest possible level of health.
On the basis of current human rights law,115 we conclude that therapeutic engineering with irreversible effects on future generations may only be undertaken after strict conditions have been fulfilled. Though it goes without saying that the prevention of diseases is a legitimate goal for health interventions, forms of genetic manipulation must be restricted to the modification of only those human characteristics that are of direct relevance to a person's (and his/her offspring's) present and future health status . In this respect reference should be made to Recommendation 934 (1982) of the Parliamentary Assembly of the Council of Europe,116 in which it was proposed to draw up a list of serious illnesses where genetic manipulation would be permissible. The list could be exhaustive, although it would be altered and updated whenever necessary.
A second distinction we can make between forms of genetic engineering concerns those forms of treatment carried out for therapeutic reasons and those for non-therapeutic reasons.
In cases where genetic engineering is applied for non-therapeutic ends, human rights law urges alertness and the highest degree of objectivity, as a solid legal and ethical basis for the application of these forms of treatment is missing so far. Recommendation 1046 (1986) of the Parliamentary Assembly of the Council of Europe completely rejects the introduction of genetic engineering for nontherapeutic purposes.117 There are, however, several reasons why a person could ask for the manipulation of a genetic trait without any obvious physical or mental health purpose in view. These reasons range from aesthetic needs, with psycho-social impacts, to possible implications for the offspring when two persons with a particular genetic structure mate. As stated above, the more such interventions affect future generations, the more severe should be the conditions that have to be fulfilled. It seems unacceptable that a person's progeny should be determined by our present aesthetic values. Changing outward characteristics has nothing to do with the duties and responsibilities towards future generations mentioned before, i.e. the prevention of the outbreak of diseases and the creation of an environment in which the fullest possible expression of the rights and freedoms, of offspring can be ensured. It is obvious that present ethical standards are opposed to the artificial manipulation of germ cells for non-therapeutic purposes.118 The set of rules covering genetic engineering derived from existing human rights standards, in particular the right of all persons - including the unborn child - to be treated with human dignity, seems to underline this conclusion.
The fact that modern genetics is still in its early stages implies that the norms to be drawn up will need regular readjustments. This holds true both for genetic research and the application of the new genetic techniques in the (para-)medical context.
Last but not least, we should be aware of the implications of the advanced genetic sereening techniques. The implications of these techniques can be very serious, as they can reveal essential information that can completely change a person's life perspectives or life expectancy. There is an undeniable threat to the right to privacy and to the right "not to know," which is part of a person's privacy. The danger of using these techniques for other ends is obvious and may jeopardize human autonomy as well as other human rights (see the section on "compulsory and mandatory medical examinations").
Recommendations for Genetic Experiments, Research, and Manipulation on the Basis of Human Rights Considerations
As indicated above, genetic techniques provide us with new possibilities of banishing diseases and promoting the quality of life by improving the prospects for good health. At the same time, however, they involve some serious threats to the enjoyment of human rights and fundamental freedoms. Advanced techniques will enable us to analyse in detail a person's inherited attributes and consequently his/her predispositions and susceptibilities to diseases. It is expected that we shall also be able to predict the major characteristics of a person's offspring at a later stage. Simultaneously, developments in the field of recombinant DNA research will allow us to interfere with hereditary traits and manipulate them in a desired direction. Both these increased possibilities, to examine and to manipulate, may jeopardize the right to life, the right to mental and physical integrity, the right to privacy, and - as a consequence of genetic knowledge and restrictions imposed upon individuals - the right to found a family, the right to social security, the right to work, etc. It is therefore absolutely essential to discuss these implications and thereafter draw up guidelines and regulations.
Concerning genetic research and related experiments, discussions should take place on an equitable balance between the principle of freedom of research and the societal responsibility of researchers. Research should be aimed at improving the conditions of life of humanity, both of individuals and of the community as a whole. At the same time it should guarantee an optimal enjoyment of human rights and the preservation of the natural environment.
Guiding, monitoring, and evaluating genetic research is not only to the benefit of scientific progress and those who engage in research, but is above all a guarantee that research is in the long run to the advantage of civilization. Guidelines must be defined which indicate the kind of research programmes that are acceptable inasmuch as they fulfil certain prospective needs, and comply with the necessary security standards and the prescribed procedure that should be completed before a programme can be authorized. The guidelines should not only sum up the legitimate research objectives, but should also define the basic conditions that should be fulfilled to allow genetic Research to be carried out. Regulations must be spelled out with regard to the required safeguards, the acceptability of hazards and other risks, the status of the testee, and the respect for his/her rights and freedoms.
As genetics and genetic research will in the long run have implications for all human beings, it is of the utmost importance that not only scientists and politicians but also the general public should have a say in this matter. Democratic bodies119 could be set up to monitor and evaluate genetic research, as well as to inform society, in an accurate and adequate manner, of genetic activities and the research which is being conducted. The permanent provision of information is an essential condition to enable democratic control to be exercised and to remove unfounded fears.
The seats in such bodies could be allocated according to a fixed quota system. In order to give such bodies actual competencies and authority, a licensing system and research notification schemes could be considered. Such measures would not only facilitate the overview and coordination of ongoing research projects but they would also create opportunities for interfering with wrong moves at an early stage.120
International cooperation is necessary for success. Coordination and the exchange of information is needed at the stage of exploring the type of directives which will respect freedom of research in the most suitable way and which will at the same time guarantee the fullest possible enjoyment of human rights and fundamental freedoms. Cooperation is also needed at the stage of supervision and monitoring. One should, of course, avoid a situation in which certain experiments are forbidden in some countries but allowed in others. The protection of the natural environment and human values is a common aim of all people, and should be pursued equally in all countries. To this end an international licensing system should be developed. Such a system could, for instance, be set up on a regional basis, taking into consideration the enormous scientific and technological differences between various regions. In the European region the Council of Europe has already made strong efforts to pave the way for the establishment of such a system.
The same should be said about genetic engineering, particularly in the case of genetic therapy. Because of its far-reaching and often irreversible consequences, obtaining the patient's "informed consent" seems even more urgently called for than in the case of "ordinary" medical interventions.121 On the other hand, these far-reaching consequences for future generations mean that the protection of the right to privacy is no longer sufficient by itself. In principle a person is fully autonomous in his/her decisions as long as these decisions have no direct impact on others. If an activity goes beyond this core of an individual's private sphere, the protection of individual autonomy has to be balanced with other societal values and, in particular, the rights and freedoms, of others, including those of future generations. In other words, the principle of "informed consent" provides a guarantee for the protection of privacy only if the consequences of the medical treatment concerned are clearly restricted to the person giving this consent.
General rules should be formulated on the admissibility and conditions for genetic interventions with human beings This requires that national and/or international mechanisms be set up to guide and direct this process. On the basis of the above outline, we recommend that the charter or guidelines concerned should cover at least the following issues.
The Risk Factors
Hazards may not only threaten our natural environment but will have implications for the right to life and well-being of the present and future generations. This requires that sufficient safeguards be formulated. Recombinant DNA techniques may well be applied to develop new biological weapons. So far only international negotiations122 that have resulted in concrete agreements have succeeded in making states accept self-restrictions.
Genetic manipulations may also be used in the medical and paramedical sectors in an unforeseen way. The professional medical codes for physicians may need to be evaluated and adapted to the new situation.123
As a precautionary measure safeguards need to be adopted to prevent unqualified or incompetent persons from applying genetic techniques within the context of their profession . To avoid the misuse of these techniques within therapeutic settings, an exhaustive list of diseases and disorders should be drawn up to define the situations in which genetic engineering is allowed. This would also improve legal security, both for clients and for geneticists.
Societal Control
Geneticists have undeniable social responsibilities when performing their profession. This implies that there is no absolute freedom concerning the choice of subjects to be studied, the manner of carrying out experiments, and the ways in which geneticists can apply new forms of treatment when dealing with patients. certain forms of control, eventually combined with an international licensing and monitoring system, should be set up.
In the European context, the Council of Europe, the Conference on Security and Cooperation in Europe (CSCE), and the European Community could assume certain tasks in this field. The Parliamentary Assembly of the Council of Europe was the first international organ to call explicitly for such cooperation in the field of genetic engineering. and the use of human embryos and foetuses.124 Probably the Council of Europe would be the proper organization to draw up a specific convention on medical genetics that could attempt to define some minimum human rights of future generations. The implementation of such a new convention should be entrusted to the organs of the European Convention on Human Rights or to a newly created independent European court or expert body on medical genetics.
The harmonization of national directives and genetic research agenda are already urgently needed, as research in general has become increasingly international, while modern forms of information and mobility enable individual citizens to go to a country in which a particular (non-)therapeutic genetic engineering technique, not permitted in the individual's own country, can be requested.
The Right to Privacy, Notably Access to and Protection of Personal Data
As shown above, advanced genetic screening techniques provide the possibility of getting detailed information on a person's present health status, including a person's inherited and congenital defects and susceptibilities. Information on these traits may be requested not only by the person concerned - the right to privacy implies a right to have access to all relevant information concerning one's health status- but also by third parties. Third parties may have various reasons to feel that it is legitimate to have access to personal information concerning others. Methods of achieving this would include having access to data stored elsewhere and subjecting a person to an examination.
To avoid misuse, rules need to be laid down regarding conditions under which a third party can be allowed to restrict a person's privacy (and possibly breach confidentiality). As stated above, interferences with the right to privacy should fulfil the criteria of legitimacy, legality, and proportionality, and, not least, they should be carried out in a non-discriminatory manner.125
Information about a person, such as medical files, the results of medical examinations, etc., enjoys the strict protection of the right to privacy and data protection.126 In the case of a genetic examination, this implies that the treating geneticist has a duty to respect confidentiality. Subjecting individuals to genetic examination, as a condition for obtaining or avoiding the loss of a benefit or status, or being allowed to participate in some activity, is another method of obtaining personal health information and should be judged within the limits allowed under the right to privacy.
The Right to Privacy, Notably the Enjoyment of Autonomy
Genetic experiments, research, screening, counselling, engineering, therapy, and other forms of engineering and manipulation can seriously jeopardize the right of the individual to determine his/her own life, lifestyle, and personality, and can threaten the individual's right to privacy as well as the right to mental and physical integrity. The "informed consent" principle should be applied to any new situation that might arise to secure for the individual the maximum benefit of these new techniques, while at the same time preventing his or her being at the mercy of geneticists and genetic counsellors. On the other hand, directives and regulations have to be drawn up to define to what extent an individual has a right to genetic advice and which forms of genetic (non-)therapeutic treatment can be asked for.
Qualifications for Geneticists and Genetic Counsellors
Codes of conduct for all those with a professional role in the field of genetics should be promulgated and should include the legal rights and duties of geneticists and genetic counsellors, and their obligations towards their clients and third parties. These codes should detail patients' rights as well as emphasize such rights.
Although the benefits and risks of genetic techniques have become better understood, the exact consequences of genetic research and enhanced diagnostic prospects still cannot be fully assessed. Care and caution are essential, as we may provoke irreversible changes. As the genetic sciences advance, the legal framework needs, to be regularly checked and adjustments made. The code of conduct for those engaged in genetics is an essential component of this framework, and in a way is a guarantee that the exploitation of genetic opportunities will be to the advantage of the whole of human civilization.