LAW AND DEONTOLOGY IN BIOETHICS:
LOOKING FOR A NECESSARY BALANCE
Dr TAKIS C. VIDALIS *
Introduction
It is more than a quarter of a century that we have started to discuss impressive developments in biomedicine, from the time of the first IVF baby, Louise Brown, to the mapping of human genome and the stem cell research. We have started to express fascinating hopes for our future life, not simply for improving our health but, for some, even for improving our own species. At the same time we point out horrific risks, from the risk of dominance of genetic discrimination among people to the risk of cloned human "copies"' creation or even the risk of reappearance of the Nazi's genetic experiments.
Certainly, "bioethics" is now a trendy word, representing, nonetheless, this contradictory reaction when we face the new technological developments. But, furthermore, bioethics is also a necessary base for thinking about their regulation.
Regulating biomedicine, in particular, is nothing but adapting scientific progress to the ethical standards of a given society in a given time, and thus promoting a socially accepted progress. For some scientists, this aim means, perhaps, a barrier to the freedom of research. To them, scientific research should face only the "naked" nature and its secrets and not merely the society with its usually conservative (if not reactionary) demands. Yet for the most part of scientists and of ordinary people as well, to conform science to social values is the best way for supporting freedom of research, either by strengthening the social acceptance of various research policies, or simply by attracting funds, as far as research meets real social needs.
If we admit this connection between science and society, we have to address a more delicate question. What kind of regulation do we mean? This question is critical in biomedicine. As its object is nothing less than the human life itself, namely a notion rich of moral attributes, deriving from the most different cultures, a coexistence of regulatory demands and, frequently, the conflict between rules of conduct coming from different regulatory orders should not be surprising. The protection and respect of human life is the privileged object not only of the modern law1, but also of ethical rules of conduct, that compose what we call medical deontology; that is to say, medical etiquette.
Moreover, the protection and respect of human life occupies a central position in our personal religious or philosophical beliefs, in our inner moral world.
In this paper, I will try to explore the field of application of law and deontology in biomedicine. First, I distinguish the characteristics of each regulatory order in general (I). I analyze then three different examples, which seem to be illustrative for the mutual impact of both kinds of rules (II). In the end, I propose a new role for the law in biomedicine that takes into account the vital importance of deontology and can guarantee a certain efficacy of regulation in this complex sector (III).
I. Law and deontology: a 'parallel' regulation
1. Biomedicine and law
In the late of 1980's the first laws in biomedicine determined a separate sector of the modern law. Starting from the national legislation on assisted reproduction in various countries (Spain2, UK3, France4, some States in the US) including the strict German Act on the Embryo Protection5, one decade later the two major international documents in that field were adopted. They are the Universal Declaration on Human Rights and Human Genome of UNESCO (1997), an important document of soft-law, and the Council of Europe's Convention on Human Rights and Biomedicine (Oviedo Convention, 1997), a legally binding document in Europe6.
Meanwhile, the elaboration of detailed legal rules and documents on the protection of personal data in Europe7 and elsewhere, due to the rapid progress on informatics, met new regulatory needs in biomedicine. The data-protection emerging issues concern the collection and handling of genetic data, and the last years became more urgent, due to the expected applications of the famous human genome mapping project and the establishment of the first population bio-banks in Iceland, the UK, and Estonia. In the last years, finally, we have legislation initiatives for regulating biomedical research, in the Council of Europe and the E.U. as well, stemming from an increasing interest of scientists and pharmaceutical companies in developing new drugs and therapies on the basis of the genome study8.
The common characteristic of all these laws is that they intend to regulate new biomedical techniques, based mostly on biological discoveries especially in human genetics. However we can suppose that the legal approach in biomedicine is rooted in older laws, already existed in the '80's, concerning the regulation of transplantations or even of abortion. Perhaps, this wider determination of biomedical law is more accurate, since it covers all deliberate medical interventions in the human body, able to modify in a serious manner its physical condition.
As in any other field, the legal regulation in biomedicine imposes coercive patterns of social conduct. Sometimes that requires sanctions provided for those who infringe these patterns. Yet we must consider that, for achieving its scopes, the law uses not only strict orders or prohibitions, but also 'permissive' rules, attributing rights to interested persons. By these rules, the law not only accepts, but moreover promotes, a certain social behavior, while discourages a contrary one, which, thus, is getting socially marginalized. For instance, we have laws permitting IVF under certain conditions, such as the infertility of the couple, or the interested woman's age9. Even if we suppose that there are no sanctions for someone who doesn't want to follow their pattern, it would be difficult for him to proceed alternatively in IVF, that is, to find a clinic, a doctor etc ensuring a safe, though unlawful process.
Even using a variety of means, the law is not always effective. Under certain conditions, the legal regulation cannot achieve what it promises, simply because of its coercive nature. Coercive rules require obedience despite a possible disagreement of their recipient. In a way, such rules 'cover' the variety of personal stances with regard to particular issues, since their scope is, by nature, to ensure uniform behavior in social life. In that context, personal disagreement should be eliminated by legal regulation, which, for that purpose, needs a mechanism of monitoring the implementation of rules.
Yet, for two reasons, this is a problematic solution in biomedicine. First, because the ongoing progress in biomedical research is universal, so any national control is eventually becoming insufficient and, second, because research is developing at the same time rapidly and not in public, so it is practically impossible for any official to prevent its results.
To explain this problem with examples, suppose that a national legislation prohibits reproductive cloning and threatens those violating its rules with strict criminal sanctions. A biologist wanting to proceed in such an experiment might either do that in a foreign country with no such legislation or to risk performing the experiment, "protected" by the privacy of his/hers laboratory. In the first case, obviously, the national law remains unable to stop the experiment, in the second one, if we suppose that the experiment is eventually successful, the baby-clone would be still present, even though the scientist would be arrested and sent to the prison. In both cases the law is proved ineffective.
2. Deontology/Ethics: The ethical dimension of regulation
Long time before the emergence of biomedical law, physicians and medical professionals had elaborated and accepted ethical rules of conduct, governing the exercise of medicine. Beginning with the famous Hippocratic oath, the first known document containing such rules, medical deontology became an inseparable part of medical studies and medical practice. Today we can find international documents on medical deontology, such as the Helsinki Declaration of the W.H.O. or the more recent code of E.S.H.R.E.10 on assisted reproduction, and national codes of medical associations as well.
The rules of medical deontology have a double scope: First, to ensure the social respect of medical profession as collective activity, and second to protect the doctor's personal morality in exercising medical practice. This latter scope is critical. Since exercising medicine means necessarily intervening in the physical condition of human beings, doctors often face difficult ethical problems with respect to the welfare or to the dignity of patients. In fact, the solutions of such problems are lying into the sphere of conscience and of personal moral convictions, in the sense that they can deeply affect the personality and even the future life of the doctor. Therefore, doctors should make such serious choices in conditions of absolute personal freedom: These conditions, precisely, should be guaranteed by rules of medical deontology.
We can use an example for describing this role of deontology. Under conditions of extreme pressure, in particular, when addressing a matter of 'life or death' for the person undergoing medical treatment, and the doctor in charge should make an intervention of a high risk, he/she can invoke the deontological rule providing that 'doctors should make all efforts for preserving human life' as an ultimate argument. This argument, eventually, "legitimate" the doctor's personal opinion about the therapy before the patient's relatives or friends, or even before his/hers colleagues, which may adopt different methods.
Yet, since the rules of deontology should cover every reasonable personal moral stance in particular issues of medical practice, they cannot be detailed. Their content is necessarily quite vague, needing, usually, to be specified in every particular case, in which such a rule is supposed to be relevant. Obviously, this characteristic of rules' vagueness risks to weaken the regulatory force of deontology. Nevertheless, equally to the law, deontology is also a coercive order of rules. Although its sanctions do not restraint 'physically' their recipient, they have unpleasant effects, sometimes worse than those of legal sanctions: In fact, sanctions such as professional defamation or, even more, the conscience remorse are in some cases more painful for most individuals than, for example, an imprisonment or a fine.
3. The crossroad
In most cases legal rules of biomedicine have similar content to those of medical deontology. Many principles, such as the principle of informed consent of persons undergoing medical treatment, the inviolability of medical confidentiality, the prohibition of commercialization of the human body and its parts, the recognition and protection of the patients' rights, the respect of the deceased person's body during the process of transplantation, the right of individuals to refuse information about their personal condition of health (the right 'not to know') are common in both orders. We can find these principles explicitly mentioned in the most of the aforementioned legal or deontological documents.
Certainly, biomedicine is not the only field that we observe such similarities in content. Commercial law, or the law of media, among others, reflect extensively professional ethics governing the relevant social activities. A reasonable explanation for that is that legislators need to repeat rules accepted for a long time by those involved in a particular professional practice, in order to ensure the efficacy of the legal provisions regulating the concrete area. Yet this fact creates a problem: If the legislator just repeats already known and accepted rules of conduct, what is the use of legislating? Is there any added value to consider?
However the more serious problem is an opposite one. How can we deal with cases of conflict between the content of a particular legal rule and the personal beliefs of a doctor, which are based on his/hers freedom, acknowledged by rules of deontology? A plain response on this is that the doctor should obey the law even when that violates dictates of his/hers conscience. But we must remember what it is said before about the question of biomedical law's efficacy, which is not certain, due to the nature of biomedical practice. Given that, the 'plain' response is eventually a false one: Simply because a mode of conduct is described in a legal text, even backed by sanctions, that is not enough to guarantee 'obedience', that is, effective regulation of the concrete social activity. We need here something more, namely an effort to persuade individuals about the necessity of rules, without forcing them. Is deontology an adequate means for achieving that in practice?
II. Complying with what? An analysis of three examples
For dealing with this question, it seems useful to focus on some particular examples, showing typical difficulties in regulation. Such cases are the handling of medical data in relation with the demand of medical confidentiality (1), the problem of confirming death in transplantations (2), and the distinction between therapeutic and reproductive cloning from a researcher's viewpoint (3). In the two first examples, coexisting legal rules and rules of deontology reflect in a characteristic way the different function of each regulatory order. In the last one, hypothetical at present, this coexistence is to be established, for avoiding a "brutal" regulation, threatening important social benefits.
1. Medical data v/s medical confidentiality
According to the article 10 par. 2 of the Oviedo Convention on Biomedicine "Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed". This is the so-called "right not to know" about the personal health condition, protecting the individual's freedom of choices for his/hers future life. It is certainly a legal rule, binding, first of all, the professionals of health.
Let us also remind two other rules, of deontology this time, stating that the doctor should make all efforts for preserving the patient's health, and that all medical information about a person's health are covered by medical confidentiality. These rules are equally binding for a doctor, though at the moral level.
Suppose now that, after performing tests for a particular genetic disease, a doctor finds modifications in the patient's genome that might provoke another such disease in the future, though a serious one, i.e. the Alzheimer's syndrome. Since genetic characteristics are hereditary, it is possible that the same predisposition for Alzheimer's syndrome could be also presented in the genome of the patient's relatives, i.e. children, parents etc.
Our doctor faces a complex dilemma: Should he/she inform the patient about this new information or, by doing that, he/she is violating the right of the patient "not to know" about the personal health condition? For avoiding this, should the doctor inform the relatives who might have also the genetic disease's predisposition, in order to undergo relevant genetic tests and therefore to take preventive measures for their own health, or in that case he/she infringes the medical confidentiality covering the relationship with his/hers patient?
Is there a "third solution", for example not to tell the doctor anything to anybody about the new find? But, in that case, don't we have an infringement of the other deontological rule, providing the doctor's duty to preserve the patient's health?
All these questions are critical for somebody who practices medicine conscientiously, and all are relative not to the concurrence of rules of a different content but rather to the concurrence of rules of a different source. Before explaining that, let us first observe that the "vicious cycle" in which the doctor is involved is due to the presence of all three rules at the same time. We would have a solution, if anyone of them was absent, but this is not the case. Yet if we suppose that all these rules were belonging to the same order, that is, all were legal rules or rules of deontology, we would have also solutions. In fact, in such a case either (in the former assumption) the doctor would ask his lawyer on which legal rule is prevailing in that occasion, without facing any doubts of conscience, or (in the latter one) he would try to weigh up the different rules in accordance with personal moral criteria, without the fear of legal sanctions. But now he faces both regulatory orders, and consequently a conflict of threatening sanctions, legal and moral as well.
2. Transplantations
The second example I would like to present is that of the confirmation of a person's death in transplantations. Today, scientists have no doubt that, when brain operations cease, we have the crucial evidence for confirming the death of a person. "Brain death" is the real death, in the sense that we cannot expect in scientific terms that brain operations will be repaired: In contrast, we can be sure that the operation of all other vital organs will inevitably stop, even if some of them are still active. Based on this evidence, a doctor can remove organs from the body of a deceased person, before they become useless for transplantations.
Yet even if there we have a scientifically accepted identification of death as "brain death", sometimes this is not enough for proceeding to the removal of organs. Scientific conclusions and affirmations are not necessarily those accepted by the moral stance of an individual or by a moral stance shared by many people in a wider social environment. This is reasonable, because, by its nature, science is moving faster than the common sense, its role is to reveal facts often hardly adapted to what ordinary people believes.
Therefore, it is possible that ordinary people, like for instance the relatives of the deceased person, cannot believe that their beloved son, daughter, brother, sister, husband, wife etc is truly dead, since brain's operations have ceased, despite the fact that his/hers heart is still biting.
We cannot exclude from that common way of approaching death even some doctors. Certainly, scientists are more willing to adopt scientific evidences, since not only their formation but also their every day professional practice is based on the rational way of thinking. Yet, even for a scientist, the phenomenon of life is not just a natural fact, but is considered as something "valuable", a fact with the highest moral importance. Thus, although death is naturally unavoidable, morally is perceived as something "bad". That's why everyone believes that we should take every possible measure to postpone its coming, and this is the mission of medical professionals par excellence.
This strong moral importance of life affects some doctors, in the sense that, although they know well the scientific evidence of "brain death", at the same time they suppose that science is able to reveal nature's secrets only partially. Therefore, they prefer to believe that a "miracle" could reverse this tragic condition and the life of a certain person could eventually be saved.
There is no doubt that this complex situation should be regulated. First, because we address a conflict between, on the one hand, the social demand of preserving many people's health, and even life, by using in proper time vital organs of deceased persons, and, on the other, the common sense's difficulties to accept "brain death" as the unquestionable evidence of death. Second, because, if what is mentioned before is correct, the decision of stopping mechanical support of a patient, the brain operations of which have ceased, is depending not only on scientific knowledge, but also on the personal moral beliefs or the psychological reactions of the doctors in charge. Is law or is deontology the best way to guarantee effective regulation in that case? If we force doctors by legal rules to stop mechanical support of patients when confirming brain death, perhaps we can satisfy the social demand for finding organs for transplantations. On the other hand we cannot be certain on whether we respect the personal attitudes of the rules' recipients, in such a fine issue. Some doctors could find in those rules an excuse for "disconnecting the tubes", others could feel humiliated for being forced to comply with, against their strong personal beliefs and their professional dignity, and others could even refuse to comply with those rules, for not being able to suffer an obligation against their own conscience or even the conscience of the patient's relatives or friends. In any case the application of such rules is almost impossible to be controlled. Who will control the accuracy of brain death's checks but the doctors themselves? Is any official of justice able for doing that?
3. Cloning
Our third example is emerging from the widely discussed perspectives of biomedical research. A possible application of cloning in humans is a brilliant idea, that promises no less than a new era in modern medicine, and, at the same time, a highly questionable method, that, if succeed, could create grave problems for our social and moral values.
Cloning in humans is not yet a common research practice, not even an accepted one by the scientific community. Nevertheless the successful attempt of cloning in mammals, few years ago, has provoked not only an intense scientific interest for testing the method in humans, and a considerable bioethical discussion about the social and moral effects of such an experimentation, but also the adoption of specific international or national legal rules, and numerous legal approaches on that issue. It seems that a recent announcement about a successful attempt of human embryos cloning, coming from a Southern Korean research team, will intensify this legal interest.
At present, the bioethical and the legal discussion could be summarized as follows: Cloning of human embryos could be used as a method for therapeutic purposes, by providing us with stem cells, a precious material for developing in vitro tissues or even organs, useful for transplantations. For doing that, we don't have to implant the early embryo into a woman's womb, that is, to start the process of reproduction. However, by removing stem cells, we possibly destroy the embryo at the very first stage of its development (up to 8 - 16 cells).
On the other hand, cloning could be used in the future as a method of reproduction. If we proceed to the implantation of a cloned embryo into a woman's womb, the process of the human organism's development could be normally continued, and eventually we would have a baby - clone. The external characteristics of this new organism would be almost identical to them of the cloned organism, perhaps his/hers mother or father. According to the opinions of the vast majority of scientists, legal scholars, philosophers, sociologists and politicians, this perspective constitutes a new form of eugenics, violating our fundamental social values.
And it is due to that argumentation that reproductive cloning is now prohibited explicitly by special laws in Europe, and in countries like Australia, Canada, and Japan.
If the therapeutic use of cloning is welcomed as a new tool for protecting people's health, though, in contrast, reproductive cloning is considered as threatening our social values, how can we promote the former and avoid the latter? Given that, both perspectives are based on the same method, once again we are facing here a particular problem of effective regulation.
For instance, suppose that there is a strict law prohibiting reproductive cloning, and providing, accordingly, strict sanctions. And suppose that, despite that prohibition, a couple of interested persons along with a scientific team proceed successfully to the application of such a method and create a baby - clone. Even if those people should be punished for their act, the result of it is irreversible: The baby - clone would be still there, and, consequently, the law would be proved ineffective.
For avoiding that, we can think that, perhaps, the best solution is to prohibit every use of cloning, that is, the therapeutic one, as well. Therefore we can be sure that, at least, the scientists willing to proceed would face an additional legal burden that could prevent them from starting the process, before even thinking to implant a cloned embryo into the woman's womb.
Yet, in that case, there is no more need to seek or discuss the benefits of therapeutic cloning. Due to a "brutal" legal prohibition, unable to establish effective regulation in such a fine issue, those benefits are considered also as being "prohibited".
III. A moderate role for legislation
In all these examples we can observe problems of efficacy in legal regulation. The law sole is not able to ensure the desirable social effects in each particular case. In the first two cases, legal rules exert an unaccepted pressure on the conscience of their recipients, and therefore cannot govern the conduct of them. In the cloning case, the legal regulation sacrifices an obvious social benefit for the sake of effective control.
Nonetheless, the law disposes a unique quality in regulating things: It unifies social conducts, regardless the personal beliefs of individuals. In this section, I will argue that we can profit from this quality of law in biomedicine, if we adopt legal rules oriented to moderate aims. These rules should rather promote than impose desirable social conducts (1). Furthermore, they should connect professional deontology with the general legal values of a democratic society, in order to reduce contradictions in regulation. In that sense, they keep rather a "subsidiary" role in regulation, by covering uncertainties occurring when we are trying to understand the concrete meaning of deontological rules in particular cases (2).
1. Avoiding sanctions and offering motives
Legal rules could be effective in biomedicine by inviting individuals to adopt a certain desirable conduct, or even attracting them to do that by offering motives. Traditional orders backed by sanctions, that impose mandatory patterns of conduct to their recipients, are most likely to become ineffective, because, in that field of social activity, we have to deal with extremely sensitive issues of the recipient's conscience.
A medical intervention concerning matters of life and death (as in our second example) or matters affecting deeply the life's quality of a person (as it happens in the first example) is of great importance also for the life and the dignity of a honest professional, since it tests seriously in practice his/hers personal morality.
In ordinary social life such experiences are rather rare. Usually we are willing to obey legal orders backed by sanctions, either because we don't consider the social issues they regulate as critical for our morality (these are, for instance, the issues regulated by the Highway Code), or because these orders correspond to unquestionable moral stances (such as, for example, the orders sanctioning homicide, or fraud etc). It is more than obvious that this is not the case of moral dilemmas occurring in biomedicine, such those that we have examined in the aforementioned examples. Because, there, not only the doctor is standing between conflicting choices of critical moral importance, but also he/she is facing a persisting demand of his/hers conscience for making the right choice.
In such cases the law should, at least, respect the difficult personal position, by avoiding authoritarian orders. We can plainly understand the reason on which such a respect is based, since in a democratic society, no collective interest or moral attitude, even expressed by the law, can overthrow the freedom of conscience. It is precisely this last fundamental freedom that needs to be maintained in ethically critical instances occurring in the life not only of a doctor but also of any individual.
Although not authoritarian, the law in biomedicine can effectively promote a socially desirable conduct, by using "permissive" rules, backed not by sanctions but merely by motives. In that sense, a rule permitting, for instance, therapeutic cloning and offering administrative or financial support to the labs interested is more likely to persuade a scientific team to focus its interest on this particular use of the method and, thus, avoid its use for reproductive purposes.
Certainly, it is not always easy to find appropriate motives for guiding the conduct of interested persons in biomedicine. Socially desirable patterns are pretty vulnerable, when both sides (doctors and persons undergoing treatment) have strong reasons to behave differently. For giving an example, a well-known legal and also deontological rule in IVF prohibits the selection of the embryo's sex on the basis of preimplantation tests, unless for preventing sexually linked diseases11. However, selecting the embryo's sex serves also social desires of the future parents. Are there, really, adequate motives for preventing this kind of selection? In such cases the answer is difficult. Yet if we are not able to imagine motives discouraging parents for demanding children of determined sex, and labs for offering this kind of service, perhaps we have reach the limits of legal regulation. Regardless of this prohibition's correctness, only rules of deontology and, eventually, the moral attitudes of the persons involved are in place to ensure the socially desirable pattern. Unless making known in public this pattern, a legal rule declaring it is deprived of any other force, even if it threatens violators with strict sanctions.
2. Bridging deontology with the general principles of law
The other aim of the law in biomedicine should be to bring in close relation professional deontology and the general principles of law, in order to establish a "unified" regulation in that field.
Since deontology is referring to the moral attitudes of professionals, its rules determine a wide area of possible personal choices, and they often use, for that, a pretty general wording. Even if deontology plays a vital role in biomedicine, the risk of having completely different choices in similar cases weakens the certainty and predictability of the regulation as a whole and, eventually, its efficacy. For avoiding that, we have to "bridge" deontology with the legal system, which, by contrast, is characterized by a significant degree of certainty.
Special legislation in biomedical matters should "transfer" deontology in legal documents, showing the way that these matters correspond to particular aspects of fundamental legal values, such as the human dignity, the protection of human life, the right to personal freedom, the right to privacy, the right to procreation, the right to health etc.
Both the UNESCO's Declaration on the Human Genome and the Oviedo Convention illustrate clearly this point. In these documents, for instance, the deontological "informed consent" principle is connected with particular legal rights (for example, the aforementioned "right not to know"12) and with detailed processes that ensure its applicability in practice13. Furthermore, these documents establish a logical order of rules, starting from the most general rule of the human dignity respect14. In that order, biomedical practices are connected with legal notions, like the equal protection principle15, or fundamental rights, like the right to research16. Via these notions, they are connected furthermore with a whole legal theory and jurisprudence structured not in the last few years but during a long period of time. This characteristic ensures certainty in regulation, since it is based on a stable tradition of law.
A firm connection of deontological rules with the general principles of law is critical in the legal practice, for covering normative uncertainties and gaps, emerging from the application of deontology in specific cases. A judge wants to know, for instance, if there are legal limits to the informed consent principle or to the principle of medical confidentiality.
Both principles (and deontology as a whole) preserve a good professional practice, and thus their application cannot be treated as independent of the socially accepted system of fundamental legal rights and values. A dangerous experimental intervention is not always justified on the basis of the patient's informed consent, not only because the quality of this information or the circumstances of the consent may be proved disputable (and therefore unaccepted from the deontology's point of view), but moreover because there is an absolute legal limit in biomedical experimentations emanating from the legal principle of human dignity. In the same way, the deontological demand of preservation of medical confidentiality should not be understood as binding, when the legal right to health of another person demands immediate action, i.e. in HIV/AIDS cases, and probably in some serious genetic diseases. Yet not only the officials, but also the practitioners should be informed about the legal implications and limits of professional deontology. In this respect, a legislation making clear this connection between the two normative orders, and thus preventing possible uncertainties is more than necessary.
Conclusion
By its nature, modern biomedicine constitutes a field of coexisting legal and deontological rules, stemming from different needs. On the one hand, as biomedical questions are closely related to the fundamental principles of social life, do not concern only some specialists, but eventually affect every one of us. Therefore, the law seeks to define a socially acceptable measure of the new applications, that is, to adjust the rapid development of technology and science to our social values.
On the other hand, critical questions in biomedicine raise dilemmas of conscience to the doctors, and researchers involved. For dealing with these dilemmas, medicine and scientific research have developed special patterns of deontology, which are rules of professional ethics, freely adopted by professionals themselves.
Since both kinds of rules regulate the same object, there is always a likelihood of conflict between them, or at least a situation of uncertain regulation. This is the reason that we need a balance, for maintaining as far as possible the benefits of both regulatory orders, namely the force of deontology in persuading those who exercise biomedicine and the "unified" force of law in regulation. In this paper, we examined a model of such a balance, supposing that legal regulation may be proved more effective in biomedicine on two particular conditions.
According to the first of them, the law needs to use permissive rather than dictative forms, by avoiding sanctions and offering motives for encouraging desirable social conducts. The second condition requires from biomedical legislation to connect deontology with the general principles of law, provided especially in the Constitution and the international documents on human rights.
Under these conditions, the law can cover normative gaps, occurring where provisions of deontology have a vast content, in order to achieve an effective and clear social function, characterised by the highest possible degree of certainty.
NOTES
* Research Member, Hellenic National Bioethics Commission, Athens.
1 See, for example, Art. 1 of the UN Declaration on Human Rights, and Art. 1 of the European Convention on Human Rights.
2 See the l. no 35/1988.
3 See the Human Fertilization and Embryology Act, 1990.
4 See the l. 94-653, 94-654 (1994).
5 Embryonenschutz Gesetz, 1990.
6 Though not accepted by several member States of the Council of Europe, including Germany and the UK.
7 See the relevant Council of Europe's Convention 108/1981 and the EU Directive 95/46.
8 See the EU Directive 2001/20. An additional protocol to the Oviedo Convention on biomedical research is also under preparation.
9 See the recent Greek l. 3089/2002 (new Art. 1455 of the C.C.).
10 European Society on Human Reproduction and Embryology.
11 See Art. 14 of the Oviedo Convention.
12 See Art. 10 para. 2 of the Oviedo Convention.
13 See Art. 16, 17 of the Oviedo Convention, regarding biomedical research.
14 See Art. 2 of the UNESCO Declaration and Art. 2 of the Oviedo Convention.
15 See Art. 3 and Art. 11 of the Oviedo Convention.
16 See Art. 12 (b), 14, 15 of the UNESCO Declaration and Art. 15 - 18 of the Oviedo Convention.
Copyright 2004. Greek Legal and Medical Conference