|The Impact of Technology on Human Rights: Global Case-studies (UNU, 1993, 322 pages)|
|6. Western European case-study: The impact of advanced methods of medical treatment on human rights|
AART HENDRIKS and MANFRED NOWAK
Progress in medical sciences and advanced treatment methods involves new challenges to humanity and the traditional regulation of societies. With the biomedical development, new opportunities and life perspectives have been created for those with previously intractable complications or health problems. Not only have the boundaries of life and handicaps been removed but, at the same time, new forms of procreation have been developed which have an enormous impact on our definitions of parenthood, family, descent, heredity, titles, and other concepts.
Since the Second World War rapid developments have taken place, particularly in the fields of medicine, biology, microbiology, and chemistry. Nevertheless, or maybe as a consequence, states face unprecedented problems in their endeavours to guarantee the fullest possible enjoyment of rights and fundamental freedoms to all their citizens and to regulate, and eventually to adjust, interhuman relations within their jurisdictions.
The experiences of the Second World War have also resulted in an important impulse to formulate and give legal protection to the inherent rights of human beings, on both a national and an international level. The tragic developments caused by the rise of totalitarian regimes in Europe left no doubt that the departure from democracy not only leads to a continuous destruction of the rule of law and human rights, but also endangers international peace and security. For the first time in history the international community fully realized the interdependence of peace, democracy, the rule of law and human rights. In the Preamble to the Universal Declaration of Human Rights, the United Nations recognized that "disregard and contempt for human rights have resulted in barbarous acts which have outraged the conscience of mankind" and that human rights are "the foundation of freedom, justice and peace in the world." Although Article 21 of the Universal Declaration proclaimed the right of every one to take part in the government of his country, democracy was not considered a requirement for membership of the United Nations.
Such a link between democracy and human rights has, however, been established by the Council of Europe. Article 3 of its Statute defines the principles of human rights, the rule of law, and a pluralist democracy as indispensable conditions for membership. These three principles have become the pillars on which the new identity of Western European societies rests. Authoritarian regimes such as Spain under Franco and Portugal under Salazar had no place in Western Europe as defined by the Council of Europe. When it became obvious that the Greek military regime under Papadopoulos in the late 1960s had seriously violated these principles, Greece was forced to leave the Council. Until the removal of the Iron Curtain Eastern European states were prevented from joining the Council, but as soon as they comply fully with certain minimum standards of a pluralist democracy, human rights, and the rule of law, they will be invited by the Committee of Ministers to become members. Hungary was the first former Communist state to join the Council of Europe on 6 November 1990, followed by Czechoslovakia on 21 February 1991. As of April 1991, Poland, Bulgaria, Romania, and Yugoslavia have consultative status with the Council of Europe, Poland probably being the next state to be offered full membership. By this policy the Council underscores its role as the major driving force for an all-European unification process based on the common cultural heritage of the "old continents." 1
The Council of Europe's human rights concept is defined by the European Convention on Human Rights2 and a number of other treaties, such as the European Social Charter and the European Convention for the Prevention of Torture. This concept is a traditional Western one with a major emphasis on civil and political rights, the rule of law and judicial safeguards for the domestic and international implementation of human rights.
Since the Second World War many Western European States, such as the Federal Republic of Germany, Italy, Spain, Portugal, Greece, Turkey, and the Netherlands, have adopted new constitutions in which domestic bills of rights and their protection by constitutional courts or similar organs play a very important role. In addition, the vast majority of the present 24 member states of the Council of Europe have incorporated the European Convention on Human Rights into their domestic legal order.3 Austria has accorded the rights enshrined in the Convention a directly applicable constitutional status equal to that of the traditional bill of rights.4 In the Netherlands the European Convention enjoys an even higher legal status than the comprehensive catalogue of human rights defined in the new Constitution of 1983.5 But even in the United Kingdom, which still adheres to a strict dualist system, the European Convention is regularly invoked before and by British courts.6 One may, therefore, conclude that the Convention and its dynamic implementation by the European Commission and the Court of Human Rights have established a common European order for the relationship between governments and the individual.7
There have been impressive developments in knowledge about the human body and mind, and the methods to be employed to adjust or change congenital qualities and disorders, since the Second World War. At the same time both the scope and content of some human rights have been evaluated, while new categories of rights have been conceptualized.
Changing moral and social values always have a considerable impact on the formulation, interpretation and - not least - the application of the rules of laws.8 In the framework of this study it is important to refer to the changing ideas on the state-citizen relationship as well as to modifications of the notion of the freedom of contract. Particularly since the late 1960s, there has been an impressive global process of citizens claiming better sabeguards for the protection of their rights and freedoms, in relation both to public authorities ("vertical relations") and to fellow-citizens ("horizontal relations"). In the vertical relationship there was the important development of citizens claiming the right to popular participation in the decision-making process in all sectors of social, economic, cultural, and political life. As a result of this "emancipatory process," the right to freedom of contract became restricted. Discrimination in social life, thus impeding access to social goods or services for human beings with certain traits, convictions, or characteristics, came to be considered unjustified and was made illegal. Policies were developed to guarantee equal access to goods and services to all citizens. Misusing power through defining the contents of an agreement to the disadvantage of a weaker party would make the contract void, as a legal basis was lacking. This process also had enormous repercussions for the health-care sector and in particular the physician-patient relationship.9
The right to health care is one of the rights that became internationally recognized as a fundamental human right after the Second World War. In this respect, both for physicians and patients, rights and duties were formulated, towards each other and towards third parties.10 It is important to note that, although sometimes erroneously referred to as such, there never has been formulated a right to health. A "right to health" can never be obtained, as it implies a right to a given good which cannot be formulated objectively and which thus cannot be protected.11
The right to health care can be defined as the right to share the benefits of health care and health services available in society. The right to health care is primarily an obligation imposed on states to provide sufficient means to guarantee its citizens a certain standard of health, as well as equal access to health services. The latter also follows from the anti-discrimination provisions, as contained in all major human rights instruments (see below). At the same time there rests an obligation on states to make the necessary (financial) investments in primary health promotion, health and professional education, modernization of equipment, etc.
So far the term "right to health care" has not been used in any of the major international human rights instruments. However, the right to health care can be derived from different formulations, such as: "a right to a standard relevant to health" (Article 25 of the Universal Declaration of Human Rights, UDHR); "a right to the enjoyment of the highest attainable standard of health" (Article 12 of the International Covenant on Economic, Social, and Cultural Rights, CESCR, and the Preamble to the Constitution of the World Health Organization, WHO); "a right to enjoy the best attainable state of physical and mental health" (Article 16 of the African Charter on Human and Peoples' Rights, ACHPR); "a right to the preservation of health" (Article 11 of the American Declaration of the Rights and Duties of Man, ADRDM); "a right to health protection" (Article 11 of the European Social Charter, ESC) and "a state of complete physical, mental and social well-being, and not only the absence of disease or infirmity, is a fundamental human right and ... the attainment of the highest possible level of health is a most important social goal" (Article 1 of the Declaration of Alma Ata). As a corollary to the obligations of states, individuals can invoke several rights and freedoms, which are inherent in the right to health care.
Three universally recognized human rights are particularly relevant for the protection of an individual's health and well-being against impairments by others:
1. The right to life (Article 3 of the Universal Declaration of Human Rights, UDHR; Article 6 of the International Covenant on Civil and Political Rights, CCPR; Article 4 of the American Convention on Human Rights, ACHR; Article 4 of the African Charter on Human and Peoples' Rights, ACHPR; Article 2 of the European Convention for the Protection of Human Rights and Fundamental freedoms, ECHR).
2. The prohibition of torture, maltreatment and medical experimentation (Article 5 of the Universal Declaration of Human Rights, UDHR; Article 7 of the Internation Covenant on Civil and Political Rights, CCPR; Article 2 of the UN Convention against Torture and other Cruel, Inhuman, and Degrading Treatment, CAT; Article 5 of the American Convention on Human Rights, ACHR; Article 6 of the Inter-American Convention to Prevent and Punish Torture, IACPPT; Article 5 of the African Charter on Human and People's Rights, ACHPR; Article 3 of the European Convention for the Protection of Human Rights and Fundamental freedoms, ECHR; and the Preamble to the European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment, ECPT).
3. The right to equality and non-discrimination (Article 2 of the Universal Declaration of Human Rights, UDHR; Articles 2, 3, 23, 24, and 26 of the International Covenant on Civil and Political Rights, CCPR; Articles. 2 and 3 of the International Covenant on Economic, Social, and Cultural Rights, CESCR; Preamble to the Constitution of the World Health Organization, WHO; Articles 2 and 18 of the African Charter on Human and Peoples' Rights, ACHPR; Article 1 of the American Convention on Human Rights, ACHR; Article 14 of the European Convention for the Protection of Human
Rights and Fundamental freedoms, ECHR; and the Preamble to the European Social Charter, ESC). National legislators and public health authorities should not restrict themselves to pursuing an active health-promotion and disease-prevention policy. As stated at the conference at Alma Ata (1978), health is more than the absence of disease or infirmity. Several other aspects are inherent in the right to share the benefits of health care. Health services should be geographically well distributed and accessible as well as affordable to all persons. The work of health-care providers and institutions must be of a high professional standard and based on practical, scientifically sound, and socially acceptable methods and technologies. Health education for the entire population and special educational and training facilities for health-care providers are essential to promote individual and community self-reliance. Health-care providers should work according to codes of professional medical ethics that can be assessed and judged by a competent administrative body, particularly in the event of a complaint by a patient. Special services and measures of prevention should be created for people who are sick or in need, such as pregnant women, children, handicapped persons, and other such groups.
As a general proposition it should be stated that the provision of health care must never be a means to curtail patients' rights, but should be aimed at the promotion of the autonomy and well-being of all persons.
While after the Second World War the establishment of health-care services, the development of new remedies, and the introduction of advanced treatment methods were in full swing, attention was also drawn to the rights and freedoms, of patients. The inherent tensions between these two developments were acknowledged and studies on the dilemmas for human rights that might arise from further developments in science and technology were recommended.12 It was obvious that any new methods of treatment or drugs could only be introduced after being carefully pre-tested, and this could well be on human beings. Thus, experimentation with treatment methods and drugs is a conditional stage in achieving higher standards of health.
There was a great impact caused by court opinions concerning the trial of persons accused of "war crimes and crimes against humanity," including "experiments with human beings." The statement by the Nuremberg court represents the most complete and authoritative statement of the law of informed consent to human experiments.13 In 1953 the very first declaration on patients' rights was prepared by Professor Dr A. Querido and Professor G. Kraus at a WHO seminar in Amsterdam. This clearly reflected the spirit of the post-war period of protecting patients against unsound medical interventions.14
In the 1960s the emancipation, participation, and democratization movements, together with the twentieth anniversary of the UDHR, provided important incentives for the discussion of patients' rights. At the 1968 International Conference on Human Rights in Tehran, it was slated that future efforts should be directed towards the implementation of the established human rights norms. In other words, the main focus changed, and from now on was aimed at human rights protection rather than their promotion. At the same time, the question of the impact of scientific and technological developments on human rights was raised. The Proclamation of Tehran stated that "while recent scientific discoveries and technological advances have opened vast prospects for economic, social, and cultural progress, such developments may nevertheless endanger the rights and freedoms of individuals and will require continuing attention." 15
Since the 1970s the rights of patients have been formulated on different occasions, on both the national and the international level.16 The American Hospitals Association promulgated a patients' bill of rights. WHO has set up various committees to make studies and recommendations in this area. Declarations and codes from the World Medical Association (WMA)17 and their national branches had (and have) an important standard-setting function. As a result of national discussions, rules defining the rights of the consumers of the health-care sector became further elaborated and embodied in enforceable rules of law.18
The rights of patients are based on two fundamental human rights: the right to health care and the right to privacy.
The right to privacy, as guaranteed in Article 17 CCPR, Article 8 ECHR, and Article 11 ACHR, reflects the old liberal idea that the individual should be protected against any undue interference with his or her private space and autonomy.19 In addition to the protection of one's family life, home, and correspondence, the right to privacy also protects the individual's particular identity, integrity, intimacy, autonomy, private communication, and sexuality.20
Autonomy means that an individual is completely free to arrange his/her private life in accordance with his/her own ideas and is responsible for his/her own life, as long as he/she does not interfere with the rights and freedoms of others.21 There is no consensus concerning the question of to what extent autonomy is fully covered by the right to privacy, or if this right has its own legal basis. Particularly in health law literature, autonomy, sometimes called "individual self-determination," is often referred to as a separate and inalienable right of individuals.22 The right to individual autonomy is not explicitly enshrined in any of the major international human rights instruments but can, at least partially, be derived from the right to privacy.23 Some scholars consider this right as one of the pillars of the internationally recognized human rights law.24
Apart from this discussion, there is agreement that autonomy ensures the right over one's own body, which even includes the right to suicide and to inflict physical harm on oneself. Consequently, every medical treatment, examination, or experimentation constitutes an interference with the autonomy of the individual. In the absence of any legitimate restriction of the right to privacy, medical treatment, examination, and experimentation may only be performed with the voluntarily given and informed consent of the person concerned.
Medical treatments also touch upon another aspect of the right to privacy, the protection of an individual's integrity. As against the absolute prohibition of torture and inhuman or degrading treatment or punishment contained in the CAT and the ECPT, Article 7 CCPR, Article 3 ECHR, and Article 5 ACHR only protect comparatively serious interferences with a person's physical or mental integrity.25 In addition, Article 7 CCPR contains a specific right not to be subjected to medical or scientific experimentation without a person's free consent. This particular right, which was inserted as a reaction to the medical experimentation performed in the Nazi concentration camps, only applies to medical experiments (and thus not to examinations and treatments) which amount to torture or cruel, inhuman, or degrading treatment. Whereas these serious interferences with a person's personal integrity are prohibited under international law without exception (even in times of a public emergency), even less serious medical treatments, examinations, or experimentations, such as compulsory testing against poliomyelitis or a compulsory blood test after an accident, constitute interferences with the right to personal integrity deriving from the protection of one's privacy. Consequently, these and similar interferences are only permitted if they can be justified under the limitation clauses contained in the relevant provisions of international human rights treaties.
While Article 17(1)CCPR prohibits any arbitrary or unlawful interference with one's privacy, Article 8(2)ECHR is much more specific. According to the ECHR an interference is only permitted if it is in accordance with the law and if it is "necessary in a democratic society in the interests of national security, public safety, or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others."
In the context of advanced forms of medical treatment and examinations, the protection of health and of the rights and freedoms of others seems to be the most relevant objective which could justify a particular interference with the right to privacy. A deeper analysis of the legal texts, the drafting history of the relevant treaties and clauses, and the jurisprudences of the competent organs shows what conditions eventually need to be fulfilled before a restriction of the right to privacy can be said to be justifiable.
A look into the travaux préparatoires of Article 17 CCPR26 shows that the limitation grounds listed in Article 8(2)ECHR are roughly what the drafters of Article 17 CCPR had in mind when they decided to prohibit any "arbitrary interference." Consequently, under both treaties restrictions of the right to privacy are only permissible if they
- are provided by and carried out in accordance with the law (i.e. a statute enacted by a legitimate parliamentary body or a similar common law norm),
- are in the interests of a legitimate objective such as the protection of public health or of the rights and freedoms of others,
- are strictly necessary in a democratic society to achieve such an objective, that is to say proportional to the goal, and
- are not imposed arbitrarily, i.e. in an unreasonable, discriminatory , or unproportional manner.
Since international human rights treaties are concluded by states, only states parties are directly bound by their provisions. Consequently, the obligations contained in such treaties, in particular the obligation to respect and ensure to all individuals the human rights enlisted therein, are obligations of states. In principle these obligations have an effect on the vertical relations between the individual and the state only. If, for example, a police officer is found guilty of having tortured a detainee, the state concerned has violated the right of the victim to physical integrity. If, on the other hand, a man is sexually abusing his wife and children, he commits a crime, but the state where this occurs cannot be held responsible for such crimes of private individuals. Only in exceptional circumstances, e.g. if the legal order does not at all prohibit and/or prevent the ill treatment of children or where a state incites hatred and encourages the use of force against certain population groups, the state concerned may be held responsible for a violation of the prohibition of torture on the horizontal level. This comparatively limited duty of states to protect human rights between private individuals (horizontal effects) derives from the obligation under international treaties, e.g. Article 2(1) CCPR and Article I ECHR, to "ensure" or to "secure" to all individuals the rights contained in the international instrument conceived. In addition to this general obligation, certain human rights provisions emphasize the duty of states parties to protect such a right by law. The International Covenant on Civil and Political Rights, for example, contains such a clause with respect to the rights to life, privacy, and equality and the rights of children and minorities.27 The explicit "right to the protection of the law against such interference" with one's privacy in Article 17(2) CCHR28 clearly shows the particular obligation of states parties to protect the right to privacy against interferences on the horizontal level.29 Although Article 8 ECHR does not contain a similar provision, the Strasbourg organs decided in a number of cases that states parties had not afforded sufficient protection to the right to privacy against interferences from private individuals.30
Since the physician-patient relationship is normally one between two private individuals, the horizontal effect of the right to privacy is of major importance for the evaluation of state obligations to prevent, inter alia, certain practices relating to mandatory medical examinations or genetic engineering. Thus, although in most countries the physician-patient relationship is covered by private law provisions, parties are not completely free to determine the contents of their contractual agreements. Following the positive obligations imposed upon states by the above-mentioned human rights treaties, there is a clear duty for states to protect individuals, particularly the "weaker contractual parties" (the patients) from inhuman and degrading treatment, medical experimentation, etc.
As regards advanced treatment methods and developments in the medical sciences to improve health-care provisions, we meet with a certain paradox. While the health-care system is built up to assist human beings in the preservation and promotion of their health, at the same time this system may threaten the privacy and integrity of individuals. Medical research may be conducted both in the general interest (scientific research) and in the individual interest (diagnostic research), and these need, not necessarily overlap.31 Human rights law has been structured to prevent human beings being used as "study and experimental objects" for health-care providers, instead of being the primary beneficiaries of the newest treatment methods. However, (bio-)medical sciences are developing very fast and are taking forms unforeseen by the drafters of most human rights treaties in force today. It may already be necessary to review and adopt legal safeguards to ensure that they will provide sufficient legal protection for the individual right to privacy under these changed circumstances. Health care, in the first place, should always be aimed at preserving and restoring a person's health, as this is considered a condition for the enjoyment of individual autonomy. However, it is debatable if an individual can be forced to undergo all kinds of medical treatment considered to be for the benefit of his/her own life. Here we come to the key question of to what extent an individual's will, in the form of "informed consent," is to be the basis of any form of interference with an individual's privacy and integrity, and under what situations others are permitted to make decisions on behalf of an individual.
It is important to note that in principle illness does not change the legal status of a person,32 although hospitalization, as well as the provision of a sickness benefit, may create new forms of dependency . In addition we should be aware that illness, like health, cannot be formulated objectively. The definition of illness, particularly mental illness, will always depend on cultural settings. Following the emancipatory process of the 1960s and 1970s, and the changed notions on the role of law, new Iegislation has been promulgated to protect the "weaker" and "more vulnerable" contracting party. Following two United Nations declarations at the beginning of the 1970s - the Declaration on the Rights of the Mentally Retarded Persons (1971)33 and the Declaration on the Rights of Disabled Persons (1975)34- it has notably been in Western Europe where rights of patients have been formulated, both on a national and on a European level.35
In this respect the institutions of the Council of Europe took a leading role by establishing different working groups and special committees of health experts, as well as by passing several recommendations and resolutions. One could mention the Recommendation on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, and commercial purposes (1976), the Recommendation on the participations of the sick in their own treatment (1980), the Recommendation on automated medical data banks (1981), the Recommendation on the legal protection of persons suffering from mental disorders placed as involuntary patients (1983), the Recommendation on the legal status of physicians vis-à-vis their patients (1985), the Resolution of the Committee of Ministers of the Council of Europe on sterilization (1975), and the Resolution on removal, grafting, and transplantation of human substances (1978).36 With regard to the patient's right to privacy, special reference should be made to the Council of Europe's Convention for the protection of individuals with regard to automatic processing of personal data (1981).37
The World Health Organization, WHO (with its Headquarters in Geneva and its Regional Office for Europe based in Copenhagen) has made (and makes) efforts to bridge the differences between the various nations and groups of nations by collaborating with all states. WHO has been particularly successful in the coordination of AIDS control and HIV prevention programmes.38 With the support of public health experts from many countries, WHO tries to design a common strategy to fight AIDS/HIV infection, while respecting the rights and freedoms, as well as the human dignity, of people with AIDS and persons found to be infected with HIV, the agent causing AIDS. In times of epidemics, like AIDS, states may easily feel obliged to announce far-reaching and restrictive measures to control the disease and the behaviour of people infected.39 Thanks to the efforts of WHO and its regional offices, respect for human rights and dignity is now considered to be crucial and to be a condition for the success of any efficient AIDS strategy.40
The European Parliament, the parliamentary forum connected with the European Communities (EC), has also taken some major initiatives, such as the Resolution in which it requested the drafting of a charter of patients' rights (1984) and its Resolution on the elaboration of a European Charter on children treated in hospital (1986).41 The European Commission, the executive and policy-initiating body of the EC, has also shown a deep concern with health issues during the last decade, although less with patients' rights. Most attention has been paid to cancer, smoking, and AIDS.42 Within the Council of Ministers, the EC decision-making body, the Ministers of Health have emphasized the right to equal treatment and freedom of movement, as laid down in the EEC treaties on several occasions.43
In general it could be said that there is a major trend towards transforming obligations for physicians into rights of patients.44 On a national level the rights of patients have been incorporated into civil law, administrative law, and special regulations. Patients have also been provided with remedies to enforce their rights before courts or to submit complaints before special tribunals. These remedies, however, are not always comparable to remedies available through ordinary civil and administrative procedures, and may even give rise to questions regarding the principles of effective remedy, and the independence and impartiality of tribunals (Article 8, 10 UDHR).45 Special provisions have been made with regard to the composition of the judicial bodies and conditions to be fulfilled before lodging a complaint or suing a physician, which may imply important restrictions on a patient in obtaining a legal verdict.
While discussing patients' rights we should also be aware of the limitations on these rights and the possible counterbalancing duties of patients. In many countries, not only those restricted to the European region, the authorities have en forced regulations such as those relating to the mandatory notification of certain diseases, tracing of contacts, partner/contact notification, restrictions on the rights to freedom of movement, to found a family, or to work, and schemes for compulsory screening for certain diseases and physical disabilities.
In this paper we will focus on the major implications of advanced medical treatment methods on the rights and freedoms of the individual recipients of health care and all those who are confronted with the results of changes in the (bio-)medical sector as a result of ongoing technological and scientific developments. We will pay due attention to both positive and negative effects and assess their impacts. In some cases the introduction of new treatment methods may cause new contradictions in society. There will be groups that will benefit from the advanced therapeutic resources, while the rights of the members of other groups may become impaired. Though sometimes difficult to resolve, we shall seek a reasonable balance between conflicting rights on the basis of current international human rights law and the interpretation of the provisions by the relevant organs.
Our point of reference will be internationally recognized human rights law i.e. rights recognized by law46 - particularly as laid down and elaborated in the national and supranational legislative systems in our region, that is to say Western Europe. Although the discussion 011 justice, ethics, and health care takes place on the frontiers of disciplines such as social sciences, law, medicine, biology, microbiology, and chemistry, we will restrict ourselves to monitoring the situation from a human rights perspective. We are aware that scientific and technological developments can be used for the promotion of human rights and to ensure better protection of recognized rights and freedoms, although at the same time they may imply threats to the enjoyment of some of these rights. As the impacts of the rapid (bio-)medical developments and experiments have still far from crystallized, we will operate with a certain degree of caution. It has been our main objective to outline the direct implications of the introduction or expected introduction of advanced treatment and testing methods and techniques on the enjoyment of human rights. Consequently we will indicate the most fundamental legal dilemmas we encounter, as well as the areas where legal regulations are missing or insufficient to provide clear guidelines for judging (bio-)medical practices or to protect the rights and fundamental freedoms of individuals/patients in the new situation. We will also make suggestions and recommendations when considered appropriate.
Since 1987, when the first child conceived by the technique of in vitro fertilization was born in the United Kingdom, the hopes and fears caused by modern reproductive techniques have been the subject of increased medical, ethical, political, and legal debates.47 In the past, couples who were unable to have children had to accept their childless state or adopt a child. Since adoption did not always satisfy the desire of parents to have their own child, medical science for centuries has aimed at identifying the causes of infertility and at providing remedies. Already in the late eighteenth century the first recorded artificial insemination using semen from the husband took place, and from the nineteenth century we have been told about cases of artificial insemination with semen from donors.48 Other forms of artificial procreation such as in vitro fertilization, egg donation, embryo donation, and surrogacy are, however, truly modern reproductive techniques and create a wide range of legal and ethical problems.
Artificial insemination (Al) is a solution where the reason for the childlessness is the man's infertility or his inability to deposit semen into the vagina. The latter problem can be solved by assisted fertilization using the semen from the husband or the male partner of a cohabiting couple (AIH). Since no extraneous element is introduced into the couple's relationship, this technique does not raise serious ethical or legal problems. It is only if the semen is frozen and inseminated after the husband's death that the status of the child (legitimate or illegitimate) may give rise to problems.49
Similar problems arise if Al uses semen from a donor (AID) because of the husband's or male partner's infertility. In the absence of specific laws the child would be illegitimate and AID would have to be considered (at least if it was carried out without the husband's/partner's consent) as adultery with all legal consequences (if still existing), such as, for example, criminal sanctions and a ground for divorce.50 The legal regulations generally seem to be inappropriate to deal with the situation of a single woman or a lesbian couple applying for AID. Although in many Western European countries, thanks to AID, single women and lesbian couples have succeeded in giving birth to a child and raising it, the parenthood rules seem to be very diverse, if existing at all. Further problems related to AID arise in case of anonymous semen banks.
Egg donation is a solution in a case where the woman is unable to ovulate or would be advised on medical grounds not to have a child. Although it is the counterpart of AID it raises more serious legal problems. The old Roman law principle mater semper certa est cannot any longer be applied because the child has both a genetic (biological) and a carrying/nurturing (natural) mother. In order to solve this problem the Australian state of Victoria, for example, introduced a presumption that the woman who actually gives birth to the child is the mother of the child and that the egg donor is not the mother.51
In vitro fertilization (IVF) is a technique by which an egg is fertilized under laboratory conditions.52 After the resulting embryo has developed for a short while it is then placed into the uterus of the woman who produced the egg. If it is implanted into another woman, we speak of embryo donation or embryo transfer. Before fertilization can take place an egg has to be removed from the ovary. In order to increase the chances of a pregnancy, in practice a number of eggs (normally three) are produced with the help of drugs and removed, fertilized, and reimplanted at the same time. This technique, however, creates the possibility of more embryos being produced than are needed for reimplantation. These "surplus embryos" may be frozen and stored and/or used for research purposes including genetic engineering. The problems arising in this context are dealt with in the next section of this paper. It has to be noted that even if all embryos are reimplanted a number of difficult ethical and legal problems concerning the status and protection of the embryo, etc., remain.
Surrogacy is an arrangement whereby one woman carries a child for another woman with the intention that it should be handed over after birth.53 Surrogacy is used more and more by gay couples and single men who cannot otherwise have their own offspring. Surrogacy agreements may involve different methods of procreation such as natural or artificial insemination, egg or embryo donation. Usually it is a married couple that enters into the arrangement with a surrogate mother who will be either artificially inseminated with the husband's semen or who will receive the embryo after IVF. In most cases the surrogate mother agrees to do this only for a fee but there are also agreements without financial implications. Surrogacy agreements intend that the genetic mother (who produced the egg) will also be the nurturing mother after the child's birth, and that the surrogate mother will only function as carrying mother and surrender the child immediately after birth to the nurturing mother. In practice, however, the genetic mother or parents might change their minds during pregnancy, the surrogate mother might wish to keep the child after birth, or both mothers might wish to abandon the child and the nurturing mother would then be a third woman. Consequently, the ethical and legal problems arising from surrogacy agreements are extremely complicated and have become aggravated by the increasing involvement of commercial agencies.
Human Rights Aspects
Much has been written about the shortcomings of traditional civil and criminal law vis-à-vis these modern techniques of human reproduction. Frequently governments are requested to enact criminal legislation in order to prohibit methods such as genetic engineering or commercial surrogacy agreements In our opinion there is, however, more demand for amendments in the area of family law, contract law, and other fields of civil law. Courts are no longer in a position to provide justice on the basis of existing principles such as mater semper certa est. Many of the issues involved are so controversial and so highly emotional that even ethical commissions find it very difficult to arrive at proper solutions. In the absence of any generally accepted moral or religious standards, human rights have been frequently referred to as the major contemporary guidelines for legislators, courts, ethical commissions, and other competent authorities.
At the first European Ministerial Conference on Human Rights organized by the Council of Europe in Vienna from 19 to 20 March 1985, the French delegation submitted a report on "The Challenge to Human Rights Posed by the Development of Science and Technology," which dealt primarily with the protection of human beings in the context of the progress being made in the fields of biology, medicine, and biochemistry.54 The discussion of this and subsequent attempts to deduce from the European Convention for the Protection of Human Rights and Fundamental freedoms, (ECHR), and from other international treaties such as the CCPR, clearly defined standards for the solution of the manifold problems arising from artificial procreation turned out, however, to be less conclusive than one might hope. There are a number of human rights at stake which have to be balanced, but a definite prohibition of certain techniques or a definite obligation of states to permit certain practices may only in extreme cases be derived from existing human rights law.55
In principle, all methods of artificial procreation developed by modern science aim at creating life and founding a family. Articles 12 ECHR and 23(2) CCPR guarantee the right of men and women of marriageable age to marry and to found a family. Having children is the major means of founding a family. If a couple is prevented from having children by natural procreation, artificial techniques of human reproduction provide an alternative which is protected by the human right to found a family. Similarly, the right of respect for one's privacy and family life (Articles 8 ECHR and 17 CCPR) prevent arbitrary and unlawful interferences with private family planning. In addition, Article 23(1) CCPR, Article 10 of the UN Covenant on Economic, Social, and Cultural Rights and Article 16 of the European Social Charter afford explicit protection by society and the state to the family, which is conceived as the "natural and fundamental group unit of society." Furthermore, freedom of science and research which evolved in the context of freedom of expression56 and which is enshrined in a number of domestic bills of rights57 provides some protection against undue state interference with the further development of research in the fields of biology, medicine, biochemistry, etc.
It should be noted here that the traditional Western European concept of a nuclear family, that is to say husband, wife, and their possible offspring, has become a major point of discussion during the last decade. There is increasing opposition to reserving a number of privileges, such as access to artificial methods of procreation, only to married couples. Although family law as such is rather rigid, in many Western European countries the legislator has to some extent changed over to recognizing unmarried couples as families, including in some countries couples of the same sex,58 thereby conferring the same rights and duties upon them.59
None of these human rights is, however, absolute. Scientists must surrender some freedom of research to society in the public interest,60 the privacy of parents may be restricted for the protection of health or morals, and the desire to have a child cannot justify the exploitation of surrogate mothers or any form of inhuman treatment of children or human foetuses. In other words, all human rights cited above have to be balanced against legitimate public interests, as enumerated, for example, in Article 8(2) ECHR, and against other human rights of the child and other persons involved.
The first right which is usually relied upon as argument against the dangers involved in modern reproductive techniques is the inviolability of human dignity. Article 1 of the German Basic Law of 1949 is, for example, regularly invoked by German courts, lawyers, and scholars in this respect.61 Although respect for human dignity seems to be the foundation of human rights in general, international law does not provide an explicit right to the inviolability of human dignity. In the context of the protection of mental and physical integrity (e.g. Article 3 ECHR, Article 7 CCPR, UN Convention against Torture), not only torture, but also other cruel, inhuman or degrading treatment is prohibited by international law under any circumstances. Furthermore, Article 10 CCPR guarantees to all persons deprived of their liberty an explicit right to be "treated with humanity and with respect for the inherent dignity of the human person." Although it would go too far to understand human embryos as "persons deprived of their liberty, " this provision shows that, according to the drafters of the UN Covenants, human beings have an inherent dignity. To the extent that modern techniques of human reproduction or genetic engineering. amount to inhuman treatment of any person involved, states seem to be under an obligation to protect this inherent dignity. The same applies if these techniques would endanger the right to life (Articles 2 ECHR and 6 CCPR) or would amount, as possibly in the case of exploitative surrogacy arrangements,62 to a slavery-like practice as prohibited in Articles 4(1) ECHR and 8(1) CCPR.
How Far May States Restrict Reproductive Techniques?
The right to found a family is independent of the right to marry and includes the right of married or unmarried couples as well as single persons to have children by procreation or adoption.63 The scientific progress achieved in this field undoubtedly demands a dynamic interpretation which includes not only natural, but artificial procreation as well.64 The right to found a family is, however, guaranteed in Article 12 ECHR only "according to the national laws governing the exercise of this right." Since this provision does not speak of restrictions and taking into account that Article 23(2) CCPR does not contain any limitation clause, only certain generally accepted impediments to or requirements for marriage, adoption, and procreation will be admissible. With respect to modern reproductive techniques, legal restrictions on commercial surrogacy arrangements, on experiments with human embryos in vitro and in utero, and on all forms of genetic manipulations might be compatible with the right to found a family. General probibitions of artificial insemination, egg donation, or IVF would, however, violate the right to human reproduction as much as governmental measures of compulsory sterilization, compulsory abortion, or the prohibition on having more than one child.
The protection of privacy and family life includes the rights to individual autonomy, communication (in particular in the emotional sphere), intimacy, and sexuality.65 One may assume, therefore, that artificial means of procreation fall under the scope of privacy. Not every interference with one's privacy is, however, prohibited under international law. Article 17 CCPR only prohibits arbitrary or unlawful interferences, and Article 8(2) ECHR permits any interference which is in accordance with domestic law and "is necessary in a democratic society in the interests of national security, public safety or the economic wellbeing of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others." It follows from this broad limitation clause that restrictions of the rights to privacy may go further than regulations governing the exercise of the right to found a family. With respect to modern reproductive techniques, the protection of health or morals, the prevention of crime, or the protection of rights and freedoms of others (in particular the child) might be legitimate objectives for states to restrict the right to privacy. Those restrictions must, however, be provided for by law and be necessary in a democratic society, i.e. proportional to the objective aimed at and acceptable in an open, free, tolerant, and pluralistic society. Although the right to privacy seems to afford less protection than the right to found a family, broad restrictions of artificial insemination and IVF could probably not be justified on the grounds of protecting morals or the rights of others.66 From present practice it is obvious that there is an urgent need to define under which circumstances access to a form of artificial procreation can justifiably be refused, or when the woman/couple is entitled to such treatment.
Article 14 ECHR and Articles 2, 3, and 26 CCPR contain anti-discrimination clauses which have to be taken into account by gavernments in their efforts to regulate artificial procreation. In particular, distinctions on the basis of sex would only be admissible if they are beyond doubt "reasonable and objective." 67 In addition, new distinctions between legitimate an d illegitimate children arising from AID, egg donation, IVF, etc., might constitute discrimination on the grounds of birth.68
Do States Have an Obligation to Restrict Reproductive Techniques?
According to the traditional Western concept of human rights, it is the primary function of civil and political rights to protect the individual against undue state interference. Only in exceptional circumstances do these rights oblige states to protect individuals by positive legislative or other action against interferences by private individuals or entities. Since modern reproductive techniques are normally not carried out by public authorities (apart from doctors or researchers employed in state clinics), human rights provide guidelines for legislative measures rather than strict obligations under international law. This is, however, a very controversial issue among international lawyers. In general, the Strasbourg organs (the European Commission and Court of Human Rights) are more re luctant than, for example, the Human Rights Committee of the United Nations to recognize binding legal obligations to positive state action. Furthermore, such obligations also depend on the rights concerned. If provisions stipulate that a given right "shall be protected by law" - as, for example, in the case of the right to life, Articles 2(1) ECHR and 6(1) CCPR, as well as the protection of privacy, the family, and children under Articles 17(2), 23(1), and 24(1) CCPR - this is an indication of a duty of positive state action on the horizontal level.69
Since artificial methods of procreation in principle aim at creating life it would be difficult to deduce prohibitive state measures from the obligation to protect the right to life. Such measures would only be required if certain reproductive techniques constituted an imminent danger to the life of the woman concerned. Under present medical conditions this is, however, not the case.
Similarly, since artificial procreating contributes to the founding of families, no prohibitive state action can be derived from the duty to protect the family under Article 23(1) CCPR. According to Article 24(1) CCPR, every child shall have the right to such measures of protection "as are required by his status as a minor." This formulation, the context of the provision, and the travaux préparatoires lead to the conclusion that the unborn child is not protected.70 Only if certain reproductive techniques would have proven harmful effects on the mental or physical well-being of children after birth would the question of a positive state duty arise. The fact that the drafters of the Convention on the Rights of the Child adopted by the United Nations General Assembly on 20 November 1989 did not include any specific provision on artificial procreation shows that such negative effects have not been suspected.
With respect to the state obligation under Article 17(2) CCPR to protect individuals by law against arbitrary interferences with their privacy, problems could arise from the anonymity of donors of semen, eggs, or embryos. The right to privacy includes the right to communicate with other human beings and to develop emotional relations such as those between a pregnant woman and her unborn child.71 One might conclude, therefore, that the right of children to obtain knowledge of their genetic parents is also protected by the right to privacy.72 Consequently, anonymous semen or egg banks would violate the child's right to privacy and would also render respect for the prohibition of incest under civil and criminal law impossible, particularly from the second generation onwards.73 If one agrees with this interpretation, states would not only be prevented from legally guaranteeing the anonymity of semen, egg, or embryo donors, but would also have a positive obligation to prohibit such anonymity by law. This has been achieved, as for example in para. 4 of the Swedish law on artificial insemination of 1984.74 In Germany, the Constitutional Court in 1989 deduced the constitutional right of children to obtain knowledge of their parents from the protection of human dignity and the right freely to develop one's personality in Articles 1(1) and 2(1) of the German Basic Law of 1949.75
Most controversial is the question of whether the prohibition of inhuman and degrading treatment in Article 3 ECHR and Article 7 CCPR contains any obligation of state parties to enact laws restricting modern reproductive techniques.76 Even if one assumes that the unborn child is in principle protected by these provisions, the question of when such protection starts is extremely difficult to answer. Is a human embryo already protected as from the day of conception (thus also in case of IVF?),77 or only after day 14 as suggested in the "Warnock Report," or after day 17, the point at which early neural development beings, or after day 30 when the brain begins to develop, or only after the first trimester of pregnancy, as in the case of several abortion laws?78 Some persons would argue that any method of Al or IVF as such constitutes inhuman treatment; others would only consider the commercial exploitation of human embryos or surrogate mothers as degrading, while yet others do not even regard methods of genetic therapy for aesthetic reasons as infringements of human dignity. Furthermore, even supposing there was a consensus on certain measures as inhuman, the question would remain as to whether states were under an obligation in international law to prohibit them.
We, therefore, arrive at the conclusion that civil and political rights enshrined in present international law oblige states only under extreme circumstances to adopt legislative or other positive measures in order to restrict certain reproductive techniques. This, however, does not take away the responsibility of democratically elected parliaments and governments to enact laws for the regulation of these techniques. The balancing of different human rights will, of course, provide valuable guidance for the objectives of such laws. One matter which is directly related to IVF and embryo donation and which involves far-reaching consequences for the human rights of future generations, the question of medical genetics, will be dealt with in the following section.
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.
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).
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.
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.
Patients request their physicians to carry out medical examinations in order to acquire information on their susceptibility to certain diseases or to obtain general or specific knowledge on their health status. In other cases physicians take the initiative for such examinations if they have had certain objective suspicions or doubts about the patient's health and consider that more detailed diagnosis could be helpful. Depending on the nature of the "complaints" or other criteria, some physicians carry out medical examinations on a routine basis. the latter procedures also depend on national health practices and the rules governing the patient-physician relationship.
In exceptional cases, specific health-related examinations are carried out on a mandatory or on a compulsory basis.127 Health authorities used to state that they needed precise epidemiological data on certain prevailing diseases to design accurate and appropriate health intervention policies. There have been cases in which the results of a medical examination have been used as a basis for ostracizing or isolating "contagious" citizens or denying entrance to the country to aliens with specific diseases. The latter policy in particular has been applied in cases of epidemic diseases. , such as bubonic plague, typhoid, poliomyelitis, cholera, etc.128 It is obvious that such testing policies jeopardize the right to the protection of private life and a person's physical integrity. In this section we will analyse the circumstances under which human rights law justifies the carrying out of compulsory or mandatory medical examinations, and which entities are authorized to do so.
With regard to medical examinations, we have first to give a more precise definition of such an examination. Within the framework of this study we understand by a medical examination all methods used to obtain information on an individual's physical health status in the broadest sense. Such examinations include health status questionnaires, tests of a predictive nature such as those to measure a person's medical biology or susceptibilities to diseases, and tests to measure a person's consumption pattern, such as for alcohol or drugs. Owing to their impact, the definition also includes tests carried out in relation to human procreation and prenatal diagnostics. Following this definition, medical examinations are not always bodily invasive- and thus do not automatically interfere with a person's physical integrity.
Testing methods have developed in a revolutionary manner in the past decades. This has gone hand in hand with the technological innovations that have radically changed our societies. To an important extent, the development of more sophisticated testing methods has been made possible through better insight into and understanding of the human being's inherited substances (see section on "medical genetics").
Since these advanced diagnostic techniques are available, medical examinations are frequently carried out in both medical and non-medical settings. In the latter situation the examination is often prescribed by non-state entities. While for employers medical examinations have become a means of selection, for insurance companies they are an instrument to assess their financial risks in accepting an individual. Medical examinations can also be used as legal evidence in civil and criminal proceedings (e.g. to measure the level of alcohol in a person's blood or to identify sexual offenders). Here several human rights questions arise, notably those concerning the legitimacy and proportionality of the interference with an individual's privacy as well as with his/her physical integrity.
Taking into consideration the risks involved and the possible far-reaching consequences of a particular test result, there are clear requirements concerning the persons authorized to carry out a medical examination and the way in which to do so. As a general rule only persons with an acceptable medical background and who are licensed as a "physician" are entitled to do so.129 Their educational background should be a guarantee of their skill in making the most accurate diagnosis of an individual case, without exposing the person concerned to unnecessary risks or causing avoidable injuries. At the same time professional codes oblige physicians to exercise the greatest possible care within the physician-patient relationship, particularly with regard to confidentiality and the storage of personal information.130 Some of these provisions are also incorporated in legal codes, which give patients a remedy in case they feel that their physician has infringed his/her duties.
It is important to note that medical examinations are primarily a means by which medical sciences are used to assist an individual by providing him/her with personal health information, eventually enabling him/her to ask for medical intervention or to take appropriate precautionary measures to prevent the outbreak of disease. Since more advanced genetic examination methods have been developed, personal-health-related information can be obtained and used as an aid for procreative decisions or to calculate a person's life expectations. Medical examinations traditionally belong within the framework of the physician patient relationship and therefore the rights and duties of both parties fully apply in the examination situation.
The results of a medical examination and other information concerning a person's health status can be defined as "privacy-related data" and consequently enjoy the protection of the right to privacy (see Introduction). The unauthorized disclosure of health information is considered to be a "breach of confidentiality," and is regarded as an interference with the right to privacy. This may also hold true for passing health-related information to a spouse/partner and relatives.131 In this section we will analyse the circumstances under which such interferences with a person's privacy can be justified and what conditions have to be fulfilled.
Owing to its sensitive nature, in Western Europe health information may not be processed automatically, "unless domestic law provides appropriate safeguards" 132 The implications for threats to privacy are clear. Although the importance of this issue can hardly be overestimated, we have decided not to elaborate on it and to confine ourselves to the legitimacy and legality of mandatory and compulsory medical examinations as such.133
The Principle of "Informed Consent"
As a medical examination is a far-reaching intervention in an individual's private life and often also his/her physical integrity, the usual procedure requires that the person, or institution, prescribing such an intrusion into a person's privacy obtain the testee's freely given consent to carry out the examination. Within medical settings, as in health legislation and medical ethics, the term "informed consent" is commonly used to express the patient's willingness to under-go an examination (or other medical treatment) and thus accept a breach of his/ her privacy and physical integrity.134 It is important to note here that a person can only agree to undergo a medical examination after having acquired sufficient knowledge and understanding of all elements and implications of the examination so as to enable him/her to make a carefully considered decision. The person concerned can only give his/her voluntary consent when he/she can exercise free power of choice without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion. Moreover, the individual should also have the legal capacity to give consent.
If all these conditions have been fulfilled and if the individual gives his/her "informed consent," then we can speak of a voluntary medical examination. Such an examination does not constitute an unlawful restriction of a human right, as the individual concerned has voluntarily accepted such an interference with his/her privacy and physical integrity. Freedom of contract is part of one's individual autonomy. An individual is free to give up one or more assured rights or freedoms when this is for the best for that individual (e.g. to obtain a diagnosis in order to improve one's health perspectives).
The "informed consent" principle, which directly derives from the right to privacy, can only be overruled in exceptional cases. Under human rights law, forced intervention with an individual's privacy is only justifiable when the measure is founded on a legal provision, serves a legitimate aim, is proportional, and fulfils a pressing social need.135 It is even argued that a state should approve of such a measure only on the basis that there is no alternative, less intrusive, means available to get a comparable result.136
The protection of public health is mentioned in Article 8 ECHR as one of the grounds that can be invoked to restrict the individual's right to privacy. However, this does not automatically justify the restriction. We will further elaborate on this below. It is crucial to know, however, that generally a person's "informed consent" is required to carry out a medical examination. In exceptional and narrowly described cases, the "informed consent" rule can be omitted.
The "informed consent" principle is not only the leading principle for carrying out a medical examination: it is also a necessary condition for confronting him/her (or third parties) with the test results. One should realize that the "informed consent" principle in the case of a medical examination is many-sided. First of all, the testee should agree to be treated by a particular health-care provider (freedom of contract). Secondly, the testee should consent to all the medical treatments he/she will be subjected to and indicate what the health-care provider is allowed to do with the test results (the follow-up stage). Both parties to the contract should have a clear and similar understanding of the contents of the freely reached agreement.137
With regard to the disclosure of the results of a medical examination, the parties should determine to whom, if anybody, the test results will be passed. There are, for example, testing programmes that take place within the context of epidemiological research, for example to measure the prevalence of certain traits in a sample population. In these situations it is not uncommon for the trial subject not to be informed about the results of the individual examination.338 On the other hand, in the case of a medical examination carried out on the initiative of a patient, it is most unusual for the test result to be withheld from the patient.139
For the purpose of this study it is important to note that personal health information is considered to be a personal good.140 Therefore it is up to the testee to determine who can have access to this information. In the case of a medical examination, a testee is justified in determining that he/she does not want to know the test result himself/herself (the right not to know). A physician is only authorized to disclose the test result to the testee after the testee has voluntarily agreed ("consented after having received all information") to receive these results. A physician who nevertheless decides to pass the test result to the testee may be found guilty of violating the privacy of the testee.141
Closely related are the situations in which a physician by coincidence discovers some important facts concerning the health status of a patient during a medical examination. The "informed consent" rule states that this information can only be passed to the individual if he/she has previously indicated willingness to receive such information. In these kinds of situations, the "informed consent" rule should not be interpreted too rigidly. The physician should weigh up the testee's psychological make-up and consider all foreseeable advantages and disadvantages before deciding whether to confront the testee with the information or not. In the event of the discovery of a disease or disability, an important factor will be if there is or is not a cure or therapy for the diagnosed disease or disability. After having carefully considered all these questions, interference with the testee's privacy may be declared justifiable, despite the fact that the testee's "informed consent" was missing.
Compulsory Medical Examinations by the State
Within the context of human rights laws, states are authorized to take certain measures entailing compulsion even if these interfere with one or more recognized rights or fundamental freedoms. The grounds for promulgating such measures are generally embodied in a general or specific legal provision. For a number of human rights this is even explicitly prescribed, as if to guarantee the fullest possible enjoyment of these rights. 142
As stated above, a medical examination as such interferes with the testee's privacy, and often also with his/her physical integrity.143 The international human rights treaties in which the right to privacy is contained permit states to restrict this right under a number of circumstances. Although the conditions in which this can be done are usually quite clear, the grounds on which a state should make its decision are of an uneven nature and not always very evident, and are thus difficult for an outsider to weigh. States often have to balance the interests of individuals against the interests of the community - sometimes a very difficult task.144 Here it should be noted that states have a responsibility to protect general interests, among them "national security, public safety," as well as "health. . . and the rights and freedoms, of others," and thus are justified in promulgating appropriate measures, even if they thereby restrict an individual right, such as the right to privacy. Though, according to the general principles of public action, these measures should be relevant, proportional, effective, feasible, and ethically acceptable, and should balance conflicting values, states possess rather broad discretionary powers to weigh these different interests.145 The Strasbourg organs have adopted the margin of appreciation doctrine, with reference to the "responsibilities of Government for maintaining law and order. . ." 146 Therefore it cannot always be said that these organs "ensure the observance of the engagements undertaken by the High Contracting Parties in the present Convention" (Article 19 ECHR).147 Nevertheless, in the course of years the contents of the several "justifiable aims" have crystallized, if not directly by way of judicial decisions then at least indirectly by statements made by legal experts and authoritative international bodies and in the literature.
In order to avert threats to public health or for any of the other policy goals which may be invoked as a legitimate reason for restricting human rights, states have repeatedly imposed far-reaching restrictions on individuals with diseases that might give rise to quarantine.148 The danger that another person may be exposed to the risk of acquiring a serious - and maybe fatal - disease which might easily have been avoided is a serious threat to his/her right to life and a breach of the prohibition of inhuman or degrading treatment.149
Compulsory testing, however, was, and can only be considered, a justifiable interference with the individual's privacy when it is considered the most efficient means of halting an infectious disease. In other words, the infringement of the individual's privacy (and physical integrity) may be considered necessary when thereby the spread of a contagious - and dangerous - disease can be prevented. This particularly holds true for diseases. in which infection may take place through simple physical proximity or casual human contact, such as plague or tuberculosis.
Compulsory testing can also be considered if there is evidence that a person is wilfully spreading a disease, thus threatening the rights and freedoms, of others. Here a medical examination may be considered in an individual case, generally in the context of a criminal charge against the person concerned. Penal law may prescribe the subjection of the suspected person to a number of examinations essential to determine the rightness of the claim.150 The European Commission of Human Rights has repeatedly stated that medical (and psychological) examinations may be an essential component of the preliminary investigation and justify the interference with the rights and freedoms of the suspected person.151
In Western European countries, contagious diseases are generally dealt with in the infections (or epidemic) diseases. laws, or an appendix thereto. The harm and human suffering these diseases may cause to others were considered of such importance as to justify a systematic policy of trying to identify persons who may be infected. In the first place this includes the group of persons to whom, there are objective reasons to believe, transmission of the disease (or virus) has taken place. These contact-tracing policies almost automatically include compulsory testing of these contacts in order to be able to contain the disease. Here the rights and freedoms of others are considered to outweigh the right to privacy of the individual.
With regard to these restrictive measures, it should be noted that there is a general trend to use legislation in a supportive way in the field of protection of public health. Legislation should first and foremost enable the implementation of efficient and humane prevention and information policies. This was reflected by the list of recommendations accepted at a European consultation on "Health Legislation and Ethics in the Field of AIDS and HIV Infection" (Oslo, 26-29 April 1988). Some of the recommendations read as follows:
2. Existing laws for the prevention and control of infectious diseases should be reexamined to ensure that they are up-to-date to deal with this epidemic and to protect the rights of the individual and the community [emphasis added];
3. Traditional legislative measures in the field of public health should be re-evaluated to assess their effectiveness and the ethical acceptability in relation to this epidemic;
4. Health legislation should be used in a positive way to promote and support health education and the distribution of information that can be provided by the public with the means for voluntary behavioural change [emphasis added];
5. The importance of certain long-standing legal provisions, particularly those for confidentiality, must be re-emphasized. Clearly, the maintenance of confidentiality is too often threatened by administrative, technological and other developments.152
Although a state can still decide to pursue a policy of compulsory medical examinations, from a human rights and public health perspective there are two other factors that should always be weighed before a decision is actually taken. Discrimination and stigmatization of persons with the disease (or infection) concerned and all those perceived to be "at risk" is a frequently reported human reaction, particularly in case of a fatal disease. It is now acknowledged that discrimination and stigmatization can undermine the overall objectives of public health policy. The people concerned may actively avoid any contact with the health-care services out of fear of becoming further marginalized. With regard to AIDS this was stated at a UN/WHO consultation as follows:
5.9 To prevent HIV infection actively, persons whose behaviours place them at risk of exposure to HIV must be informed, educated and provided with health and social support. Persons suspected or known to be HlV-infected should remain integrated with society to the maximum possible extent and be helped to assume responsibility for preventing HIV transmission to others. Exclusion of these persons would be unjustified in public health terms and would undermine the public health programme to prevent HIV.
5.10 For these reasons, discrimination endangers public health; stigmatization itself represents a threat to public health. In summary, protecting human rights and dignity of HlV-infected people, including people with AIDS, and members of population groups, is not a luxury- it is a necessity...153
The conclusion is that states may engage in a policy of compulsory examinations, although for public health reasons this is only justified as an appropriate measure to contain a disease in a very restricted number of situations. The rights of the individual should be carefully weighed against the rights of the community, notably the right to health care and the rights and freedoms of others. Moreover, the principle involved points to the duty to study the possibility of achieving the desired results by less restrictive measures, e.g. policies aimed at promoting particular health styles and informing people how to avoid risky contacts.
Mandatory Examinations by Private Individuals, Companies, and States
As briefly indicated above, there is an undeniable trend to apply medical examinations in a wider and particularly in a non-medical context. Although a person's health status is in the first place of relevance to the person concerned, it is obvious that it has various implications for others as well. An employee who becomes unfit to perform his/her work generally claims alternative work, thus affecting the labour process, or may even apply for a disability benefit, thus placing a financial burden on the employer and/or insurance company. Early death increases the chances that the spouse/partner will claim a benefit, etc. These and other reasons explain why many private individuals (in their personal capacity or as representatives of a private company or state institution) have a strong interest in obtaining personal health information from private citizens. particularly since some of the life inconveniences can be calculated by subjecting individuals to a predictive medical examination. The interest in obtaining such information is particularly strong in cases where a party takes a financial risk by entering into a contractual relationship with another individual. Therefore the question arises to what extent private individuals, companies, or states are allowed to make access to a service or social good conditional on the results of a medical examination.
If the state provides for mandatory examinations, such an interference with the right to privacy is only permissible if it is imposed in accordance with the law, is in the interest of a legitimate objective as laid down in Article 8(2) ECHR, and is necessary in a democratic society, i.e. proportional to the objective aimed at. If a Traffic Road Act provides, for example, for a mandatory medical examination as a precondition to obtaining a driver's licence, such a regulation may be considered to be necessary in the interests of public safety, the protection of health and the rights of others. In order to fulfil the principle of proportionality the testing must, however, be restricted to medical requirements for driving a motor vehicle, such as an eye test. The medical examination of an aircraft pilot may obviously be much more demanding.
Much more difficult to answer is the question of where the limits for mandatory examinations by private employers, insurance companies, schools, etc., should be drawn. As has been explained in the introduction, both Article 17(2) CCPR and Article 8 ECHR provide individuals with the protection of the law against arbitrary and unlawful interferences with a person's privacy by another private person. In the exercise of their obligations to protect privacy against interferences on the horizontal level, states, however, enjoy a fairly broad margin of discretion. If a private company selects its personnel by means of a psychological test, or if a life insurance company makes its services subject to a medical certificate, certainly no duty of the state arises to prohibit such practices. Moreover, it would even be questionable whether such a legal prohibition would not unduly interfere with the freedom of contract (derived from the right to privacy) and the right to property of the company concerned. On the other hand, if a state were to enact, for example, a law prohibiting mandatory HIV tests of school pupils, such a law could certainly be considered as a legitimate protection against interferences by private or public schools. Whether a state is, however, obliged by virtue of Article 17(2) CCPR to enact such a law if negative HIV tests were made an admission requirement for private schools is doubtful. If only black, Jewish, Muslim, or female children were required by private schools to undergo a medical examination, this would constitute an arbitrary interference with their privacy, which a state would be under a legal obligation to prohibit. Otherwise it would violate its duty under Articles 2(1) and 17(2) CCPR to ensure to all individuals, without distinction on the grounds of race, colour, sex, or religion, the right to the protection of the law against arbitrary interference with their privacy. In the General Comment 16/32 of 23 March 1988, the Human Rights Committee has explicitly stressed the duties of states parties to the CCPR "to provide the legislative framework prohibiting such acts154 by natural or legal persons.'' 155
These examples show that the right to privacy affords a rather limited protection against mandatory examinations required by private persons or entities. Only in extreme cases do states have an obligation legally to prohibit interference with another person's privacy on the horizontal level. It is thus primarily in their discretionary power which cases of mandatory examinations they permit and which they prohibit in the interest of the right to privacy.
Another question is to what extent and in which cases it is permissible to make a selection on the basis of a person's health status. Making access to services and social goods, such as employment, social insurance, and education, conditional on a good health status might contradict the non-discrimination principle. It also creates problems concerning the duty of states to guarantee the right to work (Articles 6 and 7 CESCR and Articles 1 and 2 ESC), the right to social security (Articles 9 CESCR and 12 ESC), and the right to education (Article 13 CESCR and Article 2 of the First Additional Protocol to the ECHR). While, on the one hand, it can be argued that the duty to treat people equally only applies to situations in which people are really equal, it is clear that we are dealing with slightly different situations that may, however, be comparable. The key question is thus under what circumstances a person's health status is a justifiable selection criterion.
Article 26 CCPR entitles all persons to the "equal protection of the law. The law shall guarantee to all persons equal and effective protection against discrimination on any ground such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status." A person's health status is not included in this list. It could only be subsumed under the criterion of "other status." From this it follows that even a legal distinction based on a person's health status must be extremely unreasonable or arbitrary to constitute discrimination in violation of Article 26 CCPR.156 Consequently, the obligation of states to protect individuals against selection criteria by private companies based on a person's health status must be considered as minimal.157
The case may be different, however, if the enjoyment of human rights such as the right to work, social security, and education is made subject to a particular health status. According to Article 9 CESCR, states parties recognize the right of everyone to social security, including social insurance. If in a given state health insurance were only offered by private insurance companies, and if all of them refused to accept a person who had acquired a certain disease, this person would be denied a right to social insurance on the ground of his or her health status. Consequently, the state concerned would violate Article 9 in connection with the anti-discrimination clause in Article 2(2) CESCR. It would be under an obligation either to offer public health insurance without any distinction or to force private insurance companies by law to refrain from making their services dependent on the customer's health status.
The same argument holds true for the right to education and in principle also for other economic, social, and cultural rights, such as the right to work. If a private school owner, for example, refused admission to a child on the ground that he/she had a contagious disease such decision would not amount to discrimination as long as it could be justified as necessary to protect the right to health of other schoolchildren and/or the school's employees. Even the most contagious disease must, however, not deprive a child of its right to education under Article 13 CESCR. It is a duty of states parties under Article 2(2) CESCR to guarantee that all rights enumerated in this Covenant will be exercised without discrimination. In practice, however, there exists very little legislation regulating the selection procedures for employment,158 insurance,159 and education.
Passing of Medical Information to "Third Parties"
Confidentiality is the expression used to describe the special nature of the physician-patient relationship. According to the International Code of Medical Ethics of the World Medical Association, "A physican shall preserve absolute confidentiality on all he knows about his patient even after the patient has died." Passing personal health-related information to a third party without the patient's prior consent thereto is considered as an interference with the patient's right to privacy.160 A treating physician also has to respect secrecy in his relationships with physician colleagues.161 Although the physician's duty to respect confidentiality is not absolute,162 the legal dilemma is obvious. Deviations from these rules are only possible if all conditions to restrict the right to privacy are fulfilled (see above)163 or in the exceptional situation of conflicting duties164 for the physician.
Confidentiality is crucial to the patient-physician relationship. As long as a patient knows that all the efforts his/her physician makes are in the interest of his/her health, normally he/she will be willing to cooperate. Moreover, a patient who has confidence in his/her physician and knows that the information he/she gives will not be passed on to third parties is more likely to reveal all the facts and tell the absolute truth, so that the physician can make an optimal diagnosis of his/her case.
According to the rules of the physician-paticnt relationship, the physician primarily has a duty and responsibility to inform his/her patient on his/her health status. In the second stage the physician and patient should decide jointly whether to pass the information obtained to a third party or not. It is only in a very narrowly defined number of cases that a physician is allowed to inform a third party without first asking the patient concerned for his/her permission.
It follows from the above that a physician who works as an intermediary between a patient and, for example, an employer in case of a pre-employment examination has primarily a responsibility towards his/her patient. As soon as there is an (implicit) treatment agreement between the physician and the patient, the employer will become the third party. The rules of confidentiality derived from the right to privacy prescribe that the physician should first of all inform the patient about the results of the examination. Unless agreement is reached to act differently, the patient remains entitled to refuse to permit the passing on of the test results to the employer, who is the third party.
States have a general duty to secure respect for these rules in vertical relations. It is unacceptable that the use of advanced medical examination techniques, particularly in a non-medical setting, should become a new selection criterion to exclude large numbers of people.
We have discussed the relationship between advanced methods of medical treatment and human rights with respect to three particular fields: medical examinations, artificial procreation, and medical genetics. There exist, of course, a number of further topics, such as organ transplantation and similar methods of advanced medical treatment, which have a direct impact on human rights. All of them reveal, however, certain common characteristics which can be summarized as follows:
1. As in other fields of modern technology (industry, agriculture, electronics, etc.) new developments cause a number of serious dangers to human rights. Above all, the individual's right to privacy is infringed upon if, for example, states introduce arbitrary compulsory medical examinations for the prevention of contagious diseases such as AIDS, if private employers or insurance companies make their jobs or services subject to mandatory medical tests and pass medical information on to other institutions, if semen, egg, and embryo banks do not disclose the identity of their donors, or if human embryos created by in vitro fertilization are subjected to experiments against the will of their parents. the right to physical integrity and human dignity might be violated by certain methods of compulsory medical examination and genetic engineering. Economic, social, and cultural rights such as the right to work, housing, and social security are frequently restricted as a direct result of modern screening techniques. Since these methods are not infrequently applied in a discriminatory manner, the right to equality is also at stake. Finally, methods of gene therapy and manipulation have irreversible effects and interfere with the human rights of future generations. States have, therefore, an obligation under international law to respect these human rights and to protect them against any undue interference.
2. More than in other technological fields, however, the advanced methods of medical treatment also have also a very positive impact on human rights. As a general rule, medical research, experimentation, and treatment are directed at improving health services and are, therefore, a necessary requirement for ensuring the individual's right to health care. A satisfactory health status is an essential element of the human right to an adequate standard of living and contributes to the enjoyment of the most fundamental human right, the right to life. All methods of artificial procreation aim at improving the right of men and women to found a family. Consequently, these and other human rights such as freedom of research oblige states in principle to respect and to encourage the further development of medical research and treatment.
3. In order to comply in an appropriate manner with these diverse international obligations and to solve the rapidly increasing problems caused by new technological developments in the fields of medicine, biology, and genetics, we observe that there is an urgent need for parliaments, governments, and international organizations to take adequate legislative and other measures. One of the first questions to deal with concerns the meaning of the non-discrimination principle, notably on the grounds of health status, and its applicability both in horizontal and vertical relations. These and other decisions by democratically elected political bodies should be the result of carefully balancing all human rights involved.
4. A careful legal analysis of the existing international human rights law shows, however, that these human rights standards only in exceptional cases provide clear and legally binding obligations for states either to refrain from certain actions or to take particular positive measures with the purpose of preventing private individuals and entities from acting in contravention of human rights.
5. In most cases international human rights must, therefore, be considered as guidelines rather than as binding obligations. There might, however, be a need to draw up new and more specific human rights, for instance a catalogue of patients' rights and rights of future generations, including binding obligations of states to regulate horizontal relations between private individuals and entities in the spirit of human rights.
African Charter on Human and Peoples' Rights
American Convention on Human Rights
American Declaration of the Rights and Duties of
Artificial insemination using semen from donor
Acquired immune deficiency syndrome
Artificial insemination using semen from husband
Covenant against Torture and Other Cruel, Inhuman, and Degrading
International Covenant on Civil and Political
Council of Europe
International Convention on the Elimination of All Forms of Racial
International Covenent on Economic, Social, and Cultural
Conference on Security and Cooperation in Europe
Decisions and Reports of the European Commission of Human
European Convention for the Protection of Human Rights and
European Convention for the Prevention of Torture and Inhuman or
Degrading Treatment or Punishment
European Social Charter
Human immunodeficiency virus
Inter-American Convention to Prevent and Punish
In vitro fertilization
Universal Declaration of Human Rights
World Health Assembly
World Health Organization
1. Cf. Z. Kedzia, "Accession of Non-Member States to the European Convention on Human Rights," Expert Study for the Committee on Legal Affairs and Human Rights of the Parliamentary Assembly of the Council of Europe (Strasbourg, 1990), (Council of Europe Document AS/Jur (42) 4).
2. Cf. P. van Dijk and G.J.H. van Hoof, De Europese Conventie in theorie en prattijk (Ars Aequi Libri, Nijmegen, 1990);J.A. Frowein and W. Peukert, Europäische Menschenrechtshonvention - EMRK - Kommentar (Engel, Kehl/Strasbourg/Arlington, 1985).
3. Cf. Andrew Drzemczewski, European Human Rights Convention in Domestic Law (Clarendon Press, Oxford, 1983).
4. Cf. M. Nowak, "The Implementation of the European Convention on Human Rights in Austria," in N. Mikkelsen, ed., The Implementation in National Law of the European Convention on Human Rights (Danish Centre of Human Rights, Copenhagen, 1989); F. Ermacora, M. Nowak, and H. Tretter, eds., Die Europäische Menschenrechtshonvention in der Rechtsprechung der österreichischen Höchstgerichte (Braumüller, Vienna, 1983).
5. Cf. P. van Dijk, "Domestic Status of Human Rights Treaties and the Attitude of the Judiciary - The Dutch Case," in M. Nowak, D. Steurer, and H. l retter, eds., Progress in the Spirit of Human Rights - Festschrift fur Felix Ermacora (Engel, Kehl am Rhein/Strasbourg/Arlington, 1988), p. 631; L. Zwaak, "The Implementation of International Human Rights Treaties in the Dutch Legal Order," in Mikkelsen (note 4 above), p. 40.
6. Cf. A. Lester, "The Prospects for Incorporation of the European Convention on Human Rights into United Kingdom Law," in Mikkelsen (note 4 above), p. 72.
7. Cf. M. Nowak, "Adhesion of Non-Member States to the European Convention on Human Rights," Expert Study for the Committee on Legal Affairs and Human Rights of the Parliamentary Assembly of the Council of Europe (Strasbourg, 1990), p. 10 (Council of Europe Document AS/Jur (42) 3).
8. See, for example, case 5935/72, X v. Federal Republic of Germany, Yearbook XIX (1976), pp. 284-286. In this case, concerning the legitimation of a restriction on the right to private life (Article 8 ECHR), the European Commission of Human Rights clearly stated that to make a decision on the admissibility of such a restriction it takes into account the latest developments within the country as well as outside the national context.
9. In this contribution the words "physician" and "patient" are used as general terms to refer to the providers and recipients of health care. Although we are aware that the words can be inappropriate in some situations - particularly in the cases of predictive medicine, pregnancy, artificial procreation, voluntary sterilization, blood and organ donation, etc. - for the ease of survey and the reader's convenience we decided to use these words as umbrella expressions .
10. Cf. KNMG/LCPC, Modelregeling arts-patiënt (Het Centrum, Utrecht, 1990).
11. H.D.C. Roscam Abbing, International Organizations in Europe and the Right to Health Care (Kluwer, Deventer, 1979), p. 105; and H.JJ. Leenen, Handboek gerondbeidsrecht -rechten van mensen in de gezondbeidszorg, 2nd ed. (Samsom Uirgeverij, Alphen aan den Rijn, 1988), p. 23.
12. Notably UN General Assembly Resolution 2450(XV111) of 19 December 1968.
13. The so-called Nuremberg rules are considered to be an important sour<e of international customary law.
14. Cf. Leenen (note 11 above), p. 151.
15. Final Act of the International Conference on Human Rights, Tehran, 22 April to 13 May 1968, p.5.
16. Cf. Recommendations of the Dutch Board of Health between 1979 and 1982 ("Adviezen van de Centrale Raad voor de Volksgezondheid").
17. Cf. Declaration of Lisbon "The Rights of the Patient," adopted by the Thirty-fourth World Medical Assembly, September/October 1981.
18. P.T. Smit, Patiëntenparticipatie - patiëntenrecht (Bohn, Scheltema, & Holkema, Utrecht/Antwerp, 1984).
19. Cf. European Court of Human Rights, Belgium Linguistical Case, 23 July 1968 (Series A, no. 6 (1968), pp. 24-25), and the report of I March 1979 in the Van Oostermijck Case (Series B. no. 36 (1983), p. 24). See also Resolution 428 (1970) of the Consultative Assembly of the Council of Europe, stating that the right to privacy "consists esentially in the right to live one's own life with a minimum of interference. "
20. Cf. M. Nowak, UNO-Pakt über bürgerliche und politische Rechte und Fahultativprotokoll - CCPR-Kommentar (Kehl/Strasbourg/Arlington, 1989), pp. 302 ff.
21 . See Recommendation (note 16 above), Article 10.
22. According to medical professional codes, a physician has to respect the patient's right to autonomy. Cf. Article 9, "Rules for the Relation with Patients," in Koninklijke Nederlandsche Maatschappij tot bevordering van de Geneeskunst (KNMG), Gedragsregels voor artsen, 2nd ed. (Utrecht, 1984).
23. Cf. Council of Europe, Cons. Ass. Twenty-first Ordinary Session (Third Part), Texts Adopted (1970), and Council of Europe, Collected Texts (Strasbourg 1979), p. 911.
24. According to Pieter van Dijk, some principles have such a fundamental character that they are the basis for the overall legal system and as such automatically incorporated in the legal order, regardless of whether they are embodied in rules or not. P. van Dijk, "Het internationale recht inzake de rechten van de mens," in Rechten van de mens in mundiaal en Europees perspectief (Ars Aequi Libri, Nijmegen, 1978), p. 22.
25. Cf. Nowak (note 20 above), pp. 133 ff.
26. Cf. Nowak (note 20 above), pp. 306 ff.; M.J. Bossuyt, Guide to the "Travaux Préparatoires" of the International Covenant on Civil and Political Rights (Kluwer, Dordrecht, 1987), p. 346 ff.
27. Articles 6(1), 17(2), 23, 24, 26, and 27 CCPR. Cf. Nowak (note 20 above), pp. 40 ff.
28. Similarly Article 11(3) ACHR.
29. Cf. Nowak (note 20 above), pp. 304 ff.
30. Cf. van Dijk and van Hoof (note 2 above), pp. 417-418; and Frowein and Peukert, (note 2 above), pp. 198 ff. See also the judgments of the European Court of Human Rights in the cases of Raes (Series A, no. 106 (1987), pp. 24-26), X and Y v. the Netherlands (Series A, no. 91 (1985), pp. 22-23), and Airey v. Ireland (Series A, no. 32 (1980), pp. 11-16), as well as the report of the European Commission of Human Rights in the case of Van Oosterwijck v. Belgium (Report of I March 1979, Series B. no. 36 (1983), p. 26).
31. E. Jacobs, ed., De bio-maatschappij- een humanistische visie op de ethiek van het biomedisch handelen (Acco, Enschede, 1990), pp. 56 ff.
32. Cf. Leenen (note 11 above), pp. 29 and 174. Compare also Article I of the Declaration of Mentally Retarded Persons (proclaimed by the United Nations General Assembly Resolution 2856 (XXVI) of 20 December 1971): "The mentally retarded person has, to the maximum degree of feasibility, the same rights as other human beings. "
33. Human Rights - A Compilation of International Instruments (Centre for Human Rights, United Nations, New York, 1988), p. 391.
34. See note 33 above, pp. 400-401.
35. See also: World Health Organization Regional Office for Europe, Health Legislation in Europe, WHO ICP/HLE 101 (Copenhagen, 1985), and H.J.J. Leenen, G. Pinet and A.V. Prims, Trends in Health Legislation in Europe (Masson, Paris, 1986).
36. Cf. Leenen (note 11 above), p. 155.
37. This Convention came into force on I October 1985 after France, the Federal Republic of Germany, Norway, Spain, and Sweden ratified the treaty.
38. As of I June 1990, 179 of 185 countries and areas collaborate with the Global Programme on AIDS (GPA), a special unit within the WHO, based in Geneva. See Global AIDS Factfile -Case Review, June 1990. Collaboration may vary from the technical evaluation of the national HIV/AIDS situation to the formulation of national programmes, setting up of adequate health-care facilities, etc.
39. Cf. A. Hendriks, "The Right to Freedom of Movement and the (Un)lawfuluess of AIDS/HIV Specific Travel Restrictions from a European Perspective," in The Nordic Journal of International Law (1990), and R. Frankenberg, The Other Who is Also the Same: Epidemics in Space and Time: Youth and AIDS (Berkeley/Keele, 198/89).
40. Cf. "London Declaration on AIDS Prevention," World Summit of Ministers of Health, London, 28 January 1988. "Health Legislation and Ethics in the Field of AIDS and HIV Infection," report on an international consultation, Oslo, 26-29 April 1988; V. Boltho-Massarelli, "Incidences éthiques du SIDA (dans le cadre sanitaire et social," in D. Borillo and A. Masseran, eds., SIDA et droits de l'homme (GERSULP, Strasbourg, 1990), pp. 19-28; and K. Tomasevski, "Equality and Non-discrimination: Action by the International Community against AlDS-related Discrimination," written communication presented at the seventh International Colloquy on the European Convention on Human Rights (Council of Europe H/Coll (90) 14).
41. Cf. Leenen (note 11 above), pp. 155-156.
42. In early 1990 the Directorate-General V (Employment, Industrial Relations, and Social Affairs) of the Commission commissioned several studies to be carried out to research problems of access to health-care services for particular persons/patients in the EC Member States and discrimination against people on the basis of their health status.
43. Cf. conclusions of the Council and the Representatives of the Governments of the Member States meeting within the Council of 31 May 1988 concerning AIDS (88/C 197/05).
44. H.J.J. Leenen, "Patiëntenrechten in internationaal perspectief," in Tijdschrift voor gezondheidsrecht, no. I (1987): 2-6; and Leenen, Pinet, and Prims (note 35 above), pp. 1-36.
45. For an analysis of the Dutch system, see D. Zeegers, "Het medisch tuchtcollege en openbaarheid" (final thesis) (Rijksuniversiteit Groningen, Groningen, 1987).
46. See P. Sieghart, The International Law of Human Rights (Clarendon Press, Oxford, 1983); van Dijk and van Hoof (note 2 above); Frowein and Peukert (note 2 above); Nowak (note 20 above); T. Buergenthal, R. Norris and D. Shelton, Protecting Human Rights in the Americas: Selected Problems (Engel, Strasbourg, 1982); P. Sieghart, AIDS and Human Rights - A UK Perspective (British Medical Association Foundation for AIDS, London, 1989).
47. The legal literature on artificial procreation in Western Europe and other industrialized countries has developed rapidly in recent years. Our considerations are based, above all, on the following studies which all contain a number of further references: C.G. Weeramantry, The Slumbering Sentinels, Law and Human Rights in the Wake of Technology (Penguin Books Australia, 1983); Douglas J. Cusine, New Reproductive Techniques: A Legal Perspective (Gower, Aldershot, 1988); Sheila A.M. McLean, ed., Legal Issues in Human Reproduction (Gower, Aldershot, 1989); Theo Öhlinger/ Manfred Nowak, "Grandrechtsfragen künstlicher Fortpflanzung," in Bundesministerium für Familie, Jugend, und Konsümentenschutz, ed., Familienpolitik und kunstliche Fortpftanzung (Vienna, 1986); Richard Frank, Die künstliche Fortpflanzung beim Menschen im geltenden und im künftigen Recht (Schuithess, Zurich, 1989); Meinhard Knoche, ed., Wege zur europaischen Rechtsgemeinschaft (Göres, Koblenz, 1988), pp. 52-167.
48. Cf. Cusine (note 47 above), pp. 11 ff.
49. Cf. Douglas Cusine, "Legal Issues in Human Reproduction", in McLcan (note 47 above), pp. 17, 20 ff.
50. Cf. Cusine (note 47 above), pp. 36 ff.
51. Cf. Cusine (note 49 above), p. 29; see also para. 6.8 of the famous British "Warnock Report": Report of the Committee of Enquiry into Human Fertilisation and Embryology, Cmnd. 9314, 1984.
52. Cf. Cusine (note 47 above), pp. 130 ff.
53. Cf. Cusine (note 47 above), pp. 143 ff.; Cusine (note 49 above), note 2, pp. 30 ff.; Michael Freeman, "Is Surrogacy Exploitative?", in McLean (note 47 above), pp. 164 ff.
54. See CE-Doc. MDH (85)3 (Strasbourg, 1985).
55. Cf. for the following Öhlinger/Nomak (note 47 above), pp. 32 ff.
56. Cf. Weeramantry (note 47 above), p. 201.
57. See e. g. Article 1 7 of the Austrian Basic Law on Fundamental Rights of the Citizens 1867 (RGBI 1867/142).
58. On 25 May 1989, the Danish Parliament passed a law enabling gay and lesbian couples to register their relationship at a civil registration, which gave them almost the same rights and duties as married couples. It is believed that more countries are to follow, notably Sweden, the Netherlands, and France.
59. On the other hand, European states seem to be very reluctant to allow, for example, legally residing immigrants to have more than one spouse from the country of origin coming to the European country concerned on the basis of family reunion.
60. Cf. Weeramantry (note 47 above), pp. 201 ff.
61. Cf. e.g. Wolfgang Graf Vitzthum, "Die Menschenwürde als Verfassungsbegriff"," in Juristeuzeifung (JZ) (1985), p. 201; Heribert Ostendorf, "Juristische Aspekte der extrakorporalen Befruchtung und des Embryotransfers beim Menschen," in Ulrich Jüdes, ed., In-vitro-Fertilisation und Embryotransfer (Retortenhaby) (Wissenschaftliche Verlagsgesellschaft, Stuttgart, 1983), p. 177; Ernst Benda, "Humangenetik und Recht - eine Zwischenbilanz," Nene Juristische Wochenschrift (1985), p. 1730; Günter Jerouschek, "Vom Wert und Unwert der pränatalen Menschenwürde," JZ (1989), p. 279; und Dieter Giesen, "Genetische Abstammung und Recht", JZ (1989), p. 364.
62. Cf. however, Freeman (note 53 above), p. 177, who arrives at the conclusion "that the principal objection to surrogacy - that it exploits or dehumanizes women - does not stand up to critical examination."
63. Cf. Öhlinger/Nowak (note 47 above), pp. 34 ff.; Manfred Nowak, UNO-Pakt über bürgerliche und politische Rechte und Fahultativprotokoll, CCPR-Kommentar (Engel, Kehl am Rhein/Strassburg/Arlington, 1989), pp. 441 ff.
64. Cf. also Thilo Ramm, "Die Fortpflanzung - ein Freibeitsrecht?," Juristenzeitung (1989), pp. 861 ff., who alleges a new positive freedom to artificial procreation in German law.
65. Cf. Nowak (note 63 above), pp. 310 ff.
66. Cf. case 1990/88 "Vordering tot ondergaan van IVF behandeling in K.G. afgewezen" (K.G. 1990/286), in Tijdschrift voor gezondheidsrecht, no. 7 (1990). In this case a childless couple who had been trying to get access to IVF treatment for several years addressed the President of The Hague District Court, Netherlands, after they were finally denied treatment by a medical team after two years of interdisciplinary research. Though there were no specific medical objections, the specialists concerned alleged that the relationship of confidence with the couple was insufficient to carry out such a treatment. The President of the District Court agreed with the defendants that the refusal of the spouse to pass personal information about his temporary detention had indeed undermined the relationship of confidence and justified the defendants' refusal to provide the IVF treatment.
67. Cf. Jochen A. Frowein/Wolfgang Peukert, Europäische Mensrbenrechtshonvention, EMRK-Kommentar (Engel, Kehl am Rhein/Strassburg/Arlington, 1985), pp. 314 ff; Nowak (note 63 above), pp. 503 ff.
68. Cf. Nowak (note 63 above), p. 56.
69. Nowak (note 63 above), pp. 40 ff.
70. Nowak (note 63 above), p. 459. See also A.J.M. Delissen, "De rechten van het kind: na 10 jaar voorbereidingen nu bij verdrag vastgelegd," in NJCM Bulletin, no. 15-5, August 1990.
71. See e.g. para. 57 of the report of the European Commission on Human Rights in the case of Brüggemann and Stheuten v. Germany (Application no. 6959/75, D. R. 10, p. 116): "the concept of private life in Article 8. . . also comprises. . . the right to establish and to develop relationships with other human beings, especially in the emotional field for the development and fulfilment of one's own personality." See also the case of X v. Ireland (Application no. 6825/75, L).R. 5, p. 86).
72. Cf. Nowak (note 63 above), p. 315.
73. See the Memorandum of the Austrian delegation to the European Ministerial Conference on Human Rights 1985, p. 2 (Council of Europe Document MDH (85)8); Öhlinger/Nowak (note 47 above), p. 40.
74. Lag om Insemination of 20 December 1984, SFS (1984), p. 1140.
75. Judgement of 31 January 1989, 1 BvL 17/87: cf. Dieter Giesen, "Genetische Abstammung und Recht", Juristeuzeitung (1989), pp. 364 ff.
76. Cf. Öhlinger/Nowak (note 47 above), pp. 37 ff.
77. R. Frank (note 47 above), pp. 13 ff., refers in general to the date of procreation and assumes in the case of IVF that procreation was only achieved with the successful implantation of the embryo. One might doubt this reasoning.
78. Cf. Cusine (note 49 above), p. 24.
79. In the non-industrialized countries this percentage is lower owing to the direct and indirect effects of poverty, such as starvation, lack of health education, scanty health facilities, lower hygienic standards, more limited access to programmes to control infectious diseases, financial restrictions in carrying out vaccination programmes, etc.
80. Other terms used to refer to the manipulation and recombining of genetic materials of (living) organisms are genetic engineering and gene splicing. See Recommendation 934 (1982) of the Parliamentary Assembly of the Council of Europe.
81. See Palacios (Rapporteur), "Report on Scientific Research relating to the Human Embryo and Foetus," Parliamentary Assembly of the Council of Europe, 13 September 1988, p. 54 (Doc. 5943).
82. This is, for instance, the case when there is a disorder in the replication process of cells, and the overproduction of new cells causes tumours ("cancer"). Through radiation treatment or by administering a cell-killing remedy ("cytostatica") under favourable circumstances the harmful cells can be destroyed and the cancer process stopped.
83. E. Jacobs, ed., De biomaatschappij - een humanistische visie op de ethiek van het biomedisch handelen (Acco, Enschede, 1990), p. 72.
84. The term "carrier" is used here to indicate an individual who possesses a recessive gene together with its normal allele. Although the recessive gene is not expressed, the individual can transmit the gene to his/her offspring, where the trait can manifest itself if another recessive gene at the same site is inherited from the other parent. If the recessive gene embodies a defect or susceptibility to a disease this can have far-reaching consequences.
85. S. L. Mansour, K. R. Thomas, and M. R. Capecchi, "I)isruption of the Protooncogene Int-2 in Mouse Embryo-derived Stem Cells: A General Strategy for Targeting Mutations to Non-selectable Genes," Nature, no. 336 (1988): 348-352.
86. In the literature a differentiation is sometimes made between genetic monitoring and genetic testing. Genetic monitoring should be understood as measuring the changes of, and particularly injurious influences on, the human genome during a particular period. Against this, genetic testing is a means of predicting a person's medical biology by examining his/her genome.
87. G. Anders, "De erfelijkheidsvocrlichting," Metamedica (1981), p. 166; and B. ter Haar and M. Niermeyer, "Erfelijkheidsadvies," Nederlands tijdschrift voor gezondheidszorg, no. 49 (1982): 2245-225t.
88 This moratorium lasted, however, for less than a year.
89. During the Second World War experimentations with human beings were carried out by German physicians, particularly on prisoners kept in the so-called concentration camps. Cf. "Experimente an Häftingen", in K. Smolen, Auschmitz- ein Gang durch das Museum (Panstwowe Muzeum w Oswiecimiu, Oswiecim, 1974), p. 73; and Wspomnienia Rudolfa Hoessa kamendanta obozu Oswiecimskiego (Memories of Rudolf Höss, commandant at Auschwitz camp) (Warsaw, 1960), pp. 349-351.
90. J. Klaassen, "Gentechnologie in West-Duitsland stuit op heftig verzet," De Vokskrant, 21 October 1989.
91. NRC Handelshlad, 9 November 1989.
92. These organisms are considered to be harmless and the risk of an accident with serious consequences is consequently minimal.
93. Recommendation of the European Medical Research Councils, "Gene Therapy in Man," Lancet, no. 1 (1988): 1271-1272.
94. On a European level, reference should be made to the Council of Europe's Convention for the Protection of Individuals with regard to Automatic Processing of Data (1981), which came into force on I October 1985.
95. H.J.J. Leenen, Handboek gezondbeidsrecht - rechten van mensen in de gezondheidszorg, (Samsom Uitgeverij, Alphen aan den Rijn, 1988), p. 94.
96. Article 3 ECHR and Article 7 CCPR.
97. Cf. e. g. Article 8(2) ECHR: "There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of a country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others. "
98. Gezondheidsraad, Erfelijkheid: maatschappij en wetenschap, Advies No. 31/89, The Hague, 29 December 1989, p. 7.
99. Cf. note 89 above. See also R. Plant, De roze driehoek - Nazivervoiging van homoseksuelen (Veen, Utrecht/Antwerp, 1987), p. 153 ff.
100. See Article 5 of the draft recommendation of the report on scientific research relating to the human embryo and foetus, prepared by Mr Palacios, Rapporteur, for the Committee on Science and Technology of the Parliamentary Assembly of the Council of Europe, 13 September 1988 (Doc. 5943).
101. R. Green, "Justice and the Claim of Future Generations," in E. Shelp, ed., Justice and Health Care (Reidel Publishing Company, 1981).
102. In some respects this is less the case for persons who lack competence (e.g. minors) or the capacity (e.g. persons under tutelage) to make legally binding decisions. In these cases there are usually one or more legal guardians, who are authorized to decide instead of the incompetent or incapable person. The legal guardian is under a duty in so far as his/her decisions should best meet the interests of the person he/she represents. See also F.C.B. van Wijmen, Dtiehoeksverhoudingen - Gezondheidsrechtelijke beschouwingen over vertegen-woording van merrderjarige oubekwamen, Preadvies uitgebracht voor de jaarvergadering van de Vereniging van Gezondheidsrecht op 27 april 1990.
103. Cf. case 8307/78, De Klerck v. Belgium (1:) & R 21 (1981)), pp. 116 ff. See also case 8962/80, X and Y v. Belgium (D & R 28 (1982)), pp. 112 ff. and case 6959/75, Brüggemann and Scheuten v. Federal Republic of Germany (Yearbook XIX (1976)), pp. 382 ff.
104. Cf. Leenen (note 95 above), p. 144. See also van Dijk and van Hoof, De Europese conventie in theorie en in praktijk (Ars Aequi Libri, Nijmegen, 1990), p. 444.
105. In the view of some Dutch religious communities, blood transfusions or the administration of other blood products, for example after an accident, are unacceptable, as the accident is considered to reflect God's will. The Council for the Protection of Children has decided that, while respecting the parents'/guardians' religious convictions, the life and well-being of the minor should take precedence: Leenen (note 95 above), pp. 148- 149.
106. According to the Lima Declaration on Academic Freedom and Autonomy of Institutions of Higher Education, adopted by the International General Assembly of World University Service (WUS) in September 1988, research is one of the essential activities members of the academic community should be able to engage in.
107. Declaration on the Use of Scientific and Technological Progress in the Interest of Peace and the Benefit of Mankind, United Nations General Assembly resolution 3384 (XXX) of 10 November 1975.
108. Cf. H.J.J. Leenen, "Geen vrijheid zonder wetten," in S. Dresden and D. van der Kaa, eds., Wetenschap ten goede en ten kwade (Koninklijke Nederlandse Akademie van Wetenschappen, Noord-Zuid Hollandsche Uitgevers Maatschappij, 1984). See also C.G. Weeramantry, The Slumbering Sentinels - Law and Human Rights in the Wake of Technology (Penguin Books Australia, 1983), pp. 201 ff.
109. See Article 5 UDHR, Article 3 ECHR, Article 7 CCPR, the Nuremberg Code, and the Declaration of Helsinki (Biomedical Research in Man) by the World Medical Association. The latter three explicitly contain a prohibition of medical and scientific experimentation with human beings.
110. Cf. L. Offerhaus, "Clinical trials: regels en regelgeving," in Tijdschrift voor gezondheidsrecht, no. 6 (1990): 362-370.
111. Offerhaus (note 110 above), pp. 368-369. See also E.F. Hvidberg, "Good Clinical Practice - A Way to Better Drugs," Editorial, British Medical Journal, no. 299 (1989): 580-581.
112. Cf. W. French Anders, "Human Gene Therapy,"Journal of Medicine and Philosophy, no. 3 (1985): 275-291.
113. Cf. Jacobs (note 83 above), p. 72.
114. See Article 2 (1) CERD and the anti-discrimination clauses embodied in Article 2, UDHR; Articles 2, 3, 23, 24, 26 CCPR; Articles 2, 3 CSECR; Preamble to the Constitution of the WHO; Articles 2, 18 ACHPR; Article 1 ACHR: Article 14 ECHR; and the Preamble to the ESC.
115. No clear human rights standards have been defined for future generations yet.
116. Recommendation 934 (1982) on Genetic Engineering, Parliamentary Assembly of the Council of Europe, 33rd ordinary session, adopted on 26 January 1982.
117. See Article 1: "the right to a genetic inheritance [ . . . ] should not be interfered with except for therapeutic purposes."
118. Cf. Eindrapport van de Commissie ter bestudering van de maatschappelijke en ethische aspecten van werkzaamheden met erfelijk materiaal (Staatsuitgeverij, The Hague, 1983).
119. I.e. bodies in which citizens directly participate or in which they at least represent the electorate.
120. As was proposed for the Netherlands, cf. Recombinant DNA, Eindrapport van de commissie ter bestudering van de maatschappelijke en ethische aspecten van werkzaamheden met erfelijkheidsmateriaul (Staatsuitgeverij, The Hague, 1983). Also J.K.M. Gevers, "Rechtsvragen rond medische toepassingen van recombinant-DNA-techniek: het rapport van de brede DNA commissie," Tijdschrift voor gezondheidsrecht, no. 2 (1985): 65-78. For a case-study on Dutch psychiatric hospitals, F.J. Roos, "Toetsing van experimenteel onderzoek in psychiatrische zickenhuizen, " Tijdschrft voor gezondheidsrecht, no. 4 (1987): 249-255.
121. In the case of"ordinary" medical interventions physicians have more freedom to act, as there are several situations where consent can be assumed or where physicians have a certain discretion to carry out urgent interventions if the patient does not have the competency or the legal capacity to give voluntary consent. See Leenen (note 95 above), pp. 175- 183.
122. Notably within the context of the CSCE negotiations, where there is a special "basket" on disarmament.
123. Cf. the Declaration of Helsinki Recommendations Guiding Doctors in Clinical Research (WMA, 1964/197511983).
124. See Article 13 of Recommendation 1046 (1986) on the Use of Embryos and Foetuses for Diagnostic, Therapeutic, Scientific, Industrial and Commercial Purposes by the Parliamentary Assembly of the Council of Europe.
125. Cf. N. Gilmore and M. A. Somerville, Physicians, Ethics and AIDS - A Discussion Paper (Canadian Medical Association, Ottawa, 1989), p. 21; and K. Tomasevski, "Equality and Non-discrimination: Action by the International Community against AlDS-related Discrimination," written communication to the seventh International Colloquy on the European Convention on Human Rights, Council of Europe, Strasbourg, 1990 (H/Coll (90)14).
126. H.D.C. Roscam Abbing, "Anonieme screening op HIV: alles nog eens op een rij," Medisch contact, no. 47 (1989): 1548.
127. In this text a medical examination is mandatory if undergoing such an examination is a prerequisite to obtain, or to avoid losing, a benefit or status or to be allowed to participate in some activity. Like a voluntary examination, a mandatory medical examination requires the person's informed consent. Consequently a person can refuse an examination. A medical examination is compulsory when the person cannot avoid being examined or has no way of avoiding an undertaking which requires undergoing a medical examination.
128. Cf. A. Hendriks, "The Right to Freedom of Movement and the (Un)lawfuluess of AIDS/HIV Specific Travel Restrictions from a European perspective,'´ Nordic Journal of International Law (1990); R. Frankenberg, The Other Who is the Same: Epidemics in Space and Time; Youth and AIDS (Berkeley/Keele, 1988/89); J. P. Baud, "Histoire institutionelle des maladies exotiques," SIDA et droits de l'homme - I'epidémie dans un Etat de droit (GERSULP, Strasbourg, 1990), pp. 65-76; and G. Grau, AIDS - Krankheit oder Katastrophe? (Verlag Neues Leben, Berlin, 1990).
129. "Physician" is the general term used in this text for a health-care provider who at least has passed a medical examination at a recognized medical school or university, and who is entitled to practise his/her profession according to standard provisions and national regulations; see also the Tokyo Declaration of the WMA "containing Guidelines for Medical Doctors concerning Torture and other Cruel, Inhuman or Degrading Treatment or Punishment in relation to Detention and Imprisonment" (1975). This rule, however, is not always respected. In 1982 the General Assembly of the United Nations Organization stated "that throughout the world significant medical activities are being performed by health personnel not licensed or trained as physicians, such as physician-assistants, paramedics, physical therapists, and nurse practitioners," Resolution 37/194 of 18 December 1982, "Principles of Medical Ethics Relevant to the Role of Health Personnel, particularly Physicians, in the Protection of Prisoners and Detainees against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment."
130. Cf. the universal Oath of Hippocrates for physicians and the Declaration of Geneva of the World Medical Association, 1948/1968/1983.
131. "Richtlijnen inzake het geven van inlichtingen aan de pers, politie, familie, etc. over patiënten die in zickenhuisinrichtingen opgenomen zijn danwel zich om medische hulp tot deze inrichten wenden c.q. hebben gewend," Medisch contact, no. 36 (1980): 1110.
132. Article 6 of the Convention on the Protection of Individuals with regard to Automatic Processing of Personal Data (Council of Europe Convention)
133. For further information see L. F. Markenstein and T.A.M. te Braake, De patiënt en zijn medishe gegevens - een analyze van jurisprudentie (Vakgroep Gezondheidsrecht, Rijksuniversiteit Limburg, Maastricht, 1985); J.K.M. Gevers, "Rechtsvragen rond medische toepassing van recombinant-DNA-techniek," Tijdschrift voor gezondheidsrecht, no. 2 (1985): 65-78; H.J.J. Leenen, G. Pinet, and A.V. Prirns, Trends in Health Legislation in Europe (Masson, Paris, 1986), pp 13-18; H.D.C. Roscam Abbing, Privacy bescherming, medische (persoons) gegevens en wetenschappelijk onderzock (Vakgroep Gezondheidsrecht, Rijksuniversiteit Limburg, Maastricht, 1988).
134. Cf. W. Wachsmuth and H. Schreiber, "Grenzen der ärztlichen Aufklärungspflicht im Westeuropäischen Vergleich," Deutsches Medizinisches Wocheuzeitschrift, no. 4 (1984): 153-155; H.M. Dupuis, "Informed Consent," Handboek gezondheidsethick (van Gorcum, Assen, 1988), pp. 217-225; H.D.C. Roscam Abbing, "Het toestemmingsbeginsel en het onderzoek op HlV-infecties," Nederlands tijdschrift voor geneeskunde, no. 131 (1987): 1420-1422.
135. The legitimate restrictions on the right to privacy are exhaustively enumerated in Article 8(2) ECHR. Article 17 CCPR is less detailed than Article 8 ECHR, although it prohibits arbitrary and unlawful interferences. In practice the restrictions permitted by Article 8 ECHR will also be permissible by Article 17 CCPR. See P. Sieghart, The International Law of Human Rights (Clarendon Press, Oxford, 1983); van Dijk and Hoof (note 2 above); Frowein and Peukert (note 2 above); Nowak (note 20 above); Buergenthal, Norris, and Shelton (note 46 above); P. Sieghart, AIDS and Human Rights - A UK Perspective (British Medical Association Foundation for AIDS, London, 1989).
136. L.F. Markenstein and R. Gocthart, Gezondbeidsrechtelijke aspecten van AIDS - testen op HIV (Vakgroep Gezondheidsrecht, Rijksuniversiteit Limburg, Maastricht, 1989), p. 18.
137. If this is not the case, one cannot speak about a legally binding agreement - cf. the national regulations of contract law in civil law provisions and jurisprudence.
138. It is usually required that research manuscripts describe the way test results will be stored and how the processed data will be presented, taking into consideration the "privacy" aspects of the subjects of the sample.
139. Cf. E. Deutch, "Das therapeutische Privileg des Arztes: Nichtanfklärung zugunsten des Patienten," Neue Juristische Wocheuzeitschrift, no. 24 (1980): 1305-1309; and L. Moutsopoulos, "Truth-telling to patients," Journal of Medicine and Law, no. 3 (1984): 239-251.
140. Roscam Abbing (note 126 above).
141. Cf. Medisch Tuchtcollege Amsterdam, case 1988/25 and case 1988/26, of 14 September 1987 (published in Tijdschrift voor gezondheldsrecht, May 1988). In both cases patients were told the result of an HIV antibodies test, although they had explicitly made clear that they did not want to receive such information independent of the test result. The Medical Disciplinary Court decided that the right to privacy had been violated. CF. Siegbart (note 135 above), and 1. Ravenslag, "HIV, een dilemma voor een arts?", Medisch contact, no. 2 (1989): 56.
142. Cf. Articles 2(1), 5(1), 7(1), 8(2), 9(2), 10(2) and 11(2) ECHR and Articles 6(2), 9(1), 12(3), 14(1), 14(2), 15(1), 17(1), 18(3), 19(3), 21 and 22(2) CCPR.
143. The right to privacy, as laid down in Article 17 CCPR, Article 8 ECHR, and Article 11 ACHR, embraces, among other things, an individual's particular identity, integrity, intimacy, autonomy, private communication, and sexuality (cf. Introduction).
144. W.E. Parmet, "Legal Rights and Communicable Discases: AIDS, the Police Power, and Individual Liberty," Journal of Health Politics, Policy and Law, vol. 14, no. 4 (1989): 741-771.
145. Cf. J. Martin, "Health Policy and the AlDS Epidemic: The Call for Public Health Intervention: The Use of Legislation for Prevention, Its Tasks and Limits," International Journal of Medicine and Law, vol. 8, no. 3 (1989): 234 ff.
146. Cf. The Lawless case, report of 19 December 1959, B.1 (1960/61), p. 408.
147. See also van Dijk and van Hoof (note 2 above), pp. 644 ff.
148. Cf. International Health Regulations (1969), 3rd. annotated ed. (WHO, Geneva, 1983).
149. Cf. H.J. Simon, "Onmenselijke behandeling en asiel," Nederlands Juristenblad (forthcoming, 1990).
150. Though these methods are not unrestricted and cannot be arbitrarily imposed, see Article 10 CCPR and Article 6 ECHR. See also the judgement of the Dutch Supreme Court, 2 July 1990, 1990/83 in Tijdsthrift woor gezondheidsrecht, no. 7 (1990), concerning the permissibility of certain invasive examination methods to measure the level of alcohol consumption as well as to determine if the suspect was implicated in a case of sexual abuse or not.
151. Cf. Case 986/61, Xv. Federal Republic of Germany, Yearbook V (1962), pp. 192 ff.
152. "Health Legislation and Ethics in the Field of AIDS and HIV Infection," report of an international consultation, Oslo, 26-29 April 1988 (World Health Organization Regional Office for Europe and the Directorate of Health, Norway), p. 17.
153. "AIDS and Human Rights," background document, International Consultation on AIDS and Human Rights, Geneva, 26-28 July 1989 (United Nations Centre for Human Rights and World Health Organization), p. 7 (HR/AIDS/1989/1).
154. "Such acts" means interferences inconsistent with Article 17.
155. For the full text of this General Comment see Nowak (note 20 above), pp. 892 ff.
156. For the "reasonable and objective criteria" test applied by the Human Rights Committee, cf. Nowak (note 20 above), pp. 503 ff.
157. Cf. G. Pinet, 15 the Law Fair to the Disabled?, WHO Regional Publications, European Series no. 29 (WHO, Copenhagen, 1990).
158. Cf. "Goed gekeurd?", rapport voorbereid door de Interdepartementale Werkgroep Aanstellingskeuringen (Den Haag/Rijswijk/Voorburg, 1990), pp. 4 ff.; "Le depistage du SIDA dans les professions à haute responsabilité," Le Monde, 4 February 1988, p. 12; and Wim Willems, De AIDS test bij annstellingskeuringen en verzekeringen (COMT, Leiden, 1990).
159. Cf. AIDS en particuliere verzekeringen (NCAB, Amsterdam, 1990) and Willems (note 158 above).
160. Depending on the legal system, such breaches of confidentiality can be considered as a breach of contract under civil law provisions, or a criminal offence under penal law provisions.
161. H.J.J. Leenen, Gezondheidsrecht, 2nd ed. (Samsom Uitgeverij, Alphen aan den Rijn/ Brussels, 1986), p. 44. However, in case of replacement of the treating physician, his/her licensed substitute is allowed to have access to the patient's files.
162. Cf. Gezondheidsraad, "Erfelijkheid: maatschappij en wetenschap," advies uitgebracht aan de Minister en Staatssecretaris van Welzijn, Volksgezondheid en Cultuur, no. 31/89, The Hague, 29 December 1989, pp. 99-100
163. Such breaches of privacy are offen foreseen by epidemiological laws which prescribe that physicians report cases of specific diseases to a central administrative organ.
164. Cf. Leenen (note 161 above), pp. 170-175.