RICERCA ITALIANA     

New frontieres in the medicine criminal law: comparing the italian to foreign experience

Università degli Studi di Firenze

Abstract

Nowadays, the medical activity (therapeutic, experimental, aesthetic and so on) is the object of a philosophical, ethic and especially criminal law consideration. So, many institutes of criminal law are involved in medical activity, like causality, fault, omission, complicity etc.
This research wants to investigate two groups of arguments; the first, traditional, concerning the problem of justification of the medical profession and its liability; the second, in the forefront, concerning the bioethics considerations of the beginning and the end of life and the clinical experimentation., when law and reflection are not yet developed.
The Unit of research of Pisa will deal specifically with the topics of the causation, relationship and the subjective criteria required to the ascription of criminal responsibility. The Unit of research of Siena, will develop the part of the study related to the legal grounds and judicial basis of the medical-surgical profession.
The Unit of research of Bologna will direct its scientific work to the complex matter of legal regulations on the field bioethics considerations of the beginning and the end of life, like euthanasia and medically assisted procreation. At last, the unit of research of Firenze will focus its activity on the analysis of clinical experimentation.
The operative Units of Pisa and Siena, will investigate the tendencies of jurisprudence and the doctrinal positions emerged in the scientific literature in Italy as well as in several foreign legal systems selected as terms of comparison. The operative Units of Bologna and Firenze realized the lack of a clear discipline regulating the matter, in Italy as well as in several foreign systems, and the questionable use of the criminal law (ex: the recent Italian law concerning the medical assisted procreation). On the contrary, some fields, as the clinical pharmacologic experimentation, are characterized in that is fragmentary and incomplete discipline, both from the statute law sources point of view and from the secondary ones. Each single Unit of research will turn its attention, not only to the domestic experience, but also – in the considered field – to the models of discipline as provided within the main foreign legal orders: in particular, the foreign systems under review will be those European countries belonging to the E.U. area, like for instance France, Spain and Germany, and those referring to the common law area, above all United States of America. The comparison will lead to the evaluation of the common features, traits and standards or differences emerging in the legal systems considered. This comparative evaluation will base the analysis of criminal law of medicine in its wholeness, directed to formulate, in a de iure condendo perspective, proposals of reform of the matters considered. <<<

Principal Investigator

Fausto Biagio GIUNTA Università degli Studi di FIRENZE

Research Objectives

The research, given the lack – within the scientific literature – of global studies analyzing the medicine criminal law in a comparative perspective as well as with the purpose of proposing notions and models de iure condendo, aims to pursue goals of cognitive as well as of proposal order. As for the cognitive order aims, they first of all regard to the general field of medicine criminal law, in all its implications: that is, from the traditional features, concerning the legal grounds for defences, the causation relationship between medical activity and event, cooperation and negligence, etc., to the new frontiers questions, like that of clinical experimentation and of bioethics limits to the beginning and end of life.
Secondly, the goal of the research will be the comparative analysis of the discipline regulating the matter in Italy as well as in several foreign legal systems selected and assumed as terms of comparison, according to the traditional distinction between civil law and the common law countries. The research will focus on the comparison between the Italian regulations and those of the above mentioned foreign countries, aiming to underline what are – if any - the common standards and patterns in the development of the provisions regulating this matter.
As to the comparison of the Italian model of discipline on clinical experimentation with foreign national legal systems within the civil law tradition, the Unit will focus his analysis particularly on some of the major countries of the European Union area, like France, Spain and Germany. At this stage, in fact, the main purpose of the research will be to check if and to what extent the single national legal systems bound together under the European Union legislation have receipt, enforced and applied the EU legal instrument on the subject – like, for instance, the Directive 2001/20/CE of 4 April 2001, relating to the "approach to the legal and administrative provisions and regulations of the Member States about the application of good clinical practices in the conduct of clinical trials in human" – and more in general those fundamental international law instrument like the Oviedo Convention. The main interest for the comparison with the U.S. law on the matter is especially rooted into the technologic and scientific undisputable leadership of northern American clinical sciences and experimental practice.
As to the proposal aims, the research will focus – in a de iure condendo perspective – the question of the opportunity of intervention techniques of criminal law rules and instruments, with regard to the traditional matters concerning the responsibility ascription criteria and more in general the offender mens rea, as well as to the above mentioned frontier fields. Speaking of the former, it will be studied the specific questions of the contents and the limits of medical personnel individual criminal responsibility, and the corresponding right of compensation granted to the patient-victim. About the latter, a particular attention will be devoted to underline the possible trends and models of reform of the discipline of frontiers medical activity like clinical experimentation, studied both as clinical experimentation properly said and as drug experimentation, or affecting those bioethics fields relating to criminal law issues like the principle of precaution, the experimental practice of xenotransplantation, and the debate concerning euthanasia. <<<

Timescale

24 months

National and international background

Having raised quite recently, in the last years, the interest towards the relationship between medical activities and their criminal implications have progressively grown to be a fundamental point of discussion for the Italian and foreign legislator as well as for the courts and the judiciary. Besides the traditional notions of criminal law involved in this case – think, for instance, to causation, defenses and mens rea – to the medicine criminal law affects also several aspects of "new frontiers" matters, like drug experimentation and bioethics.
The reason for a research into the legal grounds of permissibility of medical conducts – and thus, into the grounds of medic defences – resides clearly in the two-dimensional nature of the medical profession that, on one hand, is perceived as intrinsically advantageous, being finalized in the physiology of its activity in curing illness, and in preserving an interest of constitutional relevance, on the other hand, in each instance, demonstrates the essential element of the potential abuse of power which justifies the involvement of penal law. This happens for example, in consequence of a surgical intervention, even without destroying tissues, because the simple surgical incision and its anaesthesia - both entailing a more or less wide range of post-operative pains - determine an alteration of the physical and mental state of the patient; but it is evident that similar alterations can occur even after bloodless medical interventions, as in the case of invasive diagnostic procedures, of pharmacological treatments with side-effects, and of psychiatric treatments. The accompanying invasiveness of the medical treatment, together with the inability to eliminate inherent risks in a medical procedure even when performed in the most scrupulous respect of the leges artis, help to understand why, from the first judicial sentences, criminal law, and even more directly, civil law, have limited the involvement of the doctor only to cases in which exists the valid consent of the patient. Not so much as to protect the liberty of auto-determination of who undergoes it, as to avoid that a third person can freely interfere with the integrity of health, understood in the widest sense of residual healthfulness and in the interest of not accelerating the pathologies already present or leading to a worsening of the clinical patient profile.
In line with the "traditional" conception of the relationship between doctor and patient, not at all discussed by a generic and unspecific reference to consent, revolved around the duties of the health worker, who was obligated to profess his or her art with an altruistic intent, interpreting according to his or her conscience, but in absolute solitude, the good of the patient, relegated to the role of beneficiary, who underwent passively the altruistic action willingly. Only with the gradual affirmation of the idea that consent to the medical treatment must be "informed", was the transfer made from a so-called paternalism, where the doctor fulfilled a duty to cure by exercising an unconditional power to choose a therapy together with its concrete administration, scrutinised only under its conformity to scientific principle, to a philosophy so-called "personalised", in which the accurately informed patient, exercises his or her right to decide if and in what manner of therapy in consideration of costs and possible therapeutic benefits. To sum, the theses that continue to occupy the field are – as seen – essentially that of a matrix prevalently judicial that weighs upon the principle of informed consent as the cause to preclude the non-judicial nature of the fact, and that of a matrix prevalently doctrinal, that recognizes the activity of the physician as basically objective, supported by the authorization given by the State in which the physician practices for the social utility which distinguishes such practice (see art. 51 Italian criminal code), and identifies in the informed consent the subjective condition of legitimacy, in the absence of which a medical treatment assumes a connotation of arbitrariness.
The ascription of criminal responsibility to the medic as a consequence of the noxious events resulted from his activity involves the fundamental notions of criminal law. In particular, the relation cause /effect – in the specific sector of omissive criminal conducts – plays a very important role in this field. Speaking of which, it seems appropriate to review how, that is through which criteria, the jurisprudence of the superiors courts (like the Italian Corte di Cassazione) have evaluated the presence of causality in this field of relevant conducts. According to the recent decision of the Corte di Cassazione, Sezioni Unite, the presence of scientific laws, that permit to cover the explanation of the events is only the first step in the research of the causal action. In addiction to the scientific laws, it is necessary to analyse the circumstances of the concrete case, in order to check if the scientific laws are suitable to the facts hic et nunc considered. In a first moment it is necessary to find a scientific explanation of the event, so that we can say that an action was the cause of an event when, according to scientific laws expressing a probability near to the highest rate after the realization of this activity can follow the verification of that event. But it cannot be neglect also a second moment of the proceeding, that is the control on the possibility of application of that rule to the circumstances of the concrete case. This second moment is the so-called verification of reasonable reliability that is more difficult when the laws express a law level of probability. On the contrary, when the scientific laws are universal, the check is very simple, because judge has only to control the correspondence between the content of the law and the elements of the concrete case. For these reasons, also scientific laws that express a law probability can be adapted to the case hic et nunc.
Besides the relationship of causation, another critical factor within the medic relevant criminal conducts can be the subjective elements or mens rea required for these patterns of offences. In this field of criminal responsibility it is admitted a very low standard of mental liability, namely that governing by the rules of art. 43 c.p., particularly the rules of the negligence, imprudence and unskilfulness. As to the last one, the tendency of Italian judges is to adapt the so called "model agent" to the different types of doctors, distinguishing between generic and specialized doctors. This approach is gone beyond the traditional rule of the "grave fault" drawn from art. 2236 c.c., that limited the responsibility of the doctor to the cases of grave dolus or fault, by affirming that the rules of the "special difficulty of the case" has to be adapted to the concrete circumstances, avoiding any form of automatism or privilege for medical responsibility, that can be charged also in case of weak fault. The most important control concerns the correspondence between the real characteristics of the concrete agent and the ones of the so called model agent. If criminal responsibility has to be personal, it is not possible to request superior standards of knowledge, than the ones, the accused really has. Like to the question of the causality, also the subject of the fault has to be analysed in the perspective of the personality of criminal responsibility. From this point of view, the subject of criminal responsibility of the doctor becomes a very privileged observatory for the study of the fundamental principles of the whole criminal law.
As said above, besides to the traditional aspects of criminal law involved in this matter, there are some belonging to the new frontiers of modern medical sciences.
Scientific knowledge's evolution has perceptibly increased people's life and health expectancy.
Take as an example the significant results obtained by biomedicine as new drugs and vaccines' production, innovative diagnostic tools for genetics pathologies and biotechnologies, clinical and pharmaceutical trials, predictive medicine, medically assisted procreation, pre-natal therapy, etc.
According to the general opinion, the above-mentioned areas cannot be considered as "free of law" space, that is zones that, because of their prevailing and adsorbing ethic, philosophical and religious dimension, have to remain free from any legal regulation. On the contrary, nowadays, with always greater insistence, is recognized as necessary and timely a legal regulation of beginning and end of life's bioethics, regulation that comprises punishments suitable to prevent effectiveness. Of course, this makes necessary the settlement of this research with some typical characteristics of the modern criminal law: first of all, it should be regulated punishment's laicism, punishment that doesn't run the risk of give up in front of the moral dimension of phenomenon. At the same way, the complex of guaranty's principles, typical of criminal law, cannot be renounced; among these stands out punishment's delimitation of the unique cases where there is the necessity to protect juridical properties not defendable with efficacy in other way. One of the most relevant difficulties of the criminal law's intervention in this item is the relatively hard identification of a material offence to values such as genetic identity, right to procreation and freedom of care and treatment in the medical field. The offence profile is not only a result of scientific progress but, at the same time, it is an effect of moral and ethical choices. This double-faced problem of the offence represent a very peculiar subject for legislation science, for scholars and for physicians too. At present, such a very debated approach has been focalized on fields as euthanasia, medically assisted procreation, abortion and clinical trials on human embryo. Furthermore, these items, object for plans of law's reform, have been deeply discussed in the public opinion such as in the academic literature. The most important examples are the proposals to renew Italian Criminal Law Code (Progetto Pagliaro, 1992; Progetto Grosso, 2001) and, even more, to regulate euthanasia and medically assisted procreation, that has been, in fact, recently disciplined by law (Legge 40/2004). Moreover, the Oviedo Treaty, signed in 1997, and the farther law interventions by international community demonstrate the existence of an international trend toward regulation in the bioethics field.
Another fundamental part of the modern medical activity – and in particular the part of medical research more connected to the scientific progress – is clinical experimentation, whose aim is to search for new therapies to be applied to the traditional pathologies, that is those already known to the medical sciences, as well as to emerging or still undiscovered ones. As a legally regulated activity, clinical trial nowadays faces three major questions: what are its legal sources and how to discern their nature and contents; what are the conditions and limits under which its undertaken can be regarded to as lawful or authorised; and, what are the criminal nature consequences arising in the case of injury or death. As to the legal sources of clinical experimentation, it must first considered that this field of law is characterized in that is fragmentary and incomplete, partly because of it is the result of the inconsistent stratification of different sources over the time, and partly because of the unwillingness of the legislator to set out an organic and general discipline on the matter, due to the complexity of moral implications at stake. Having said that, the fundamental notions of the legal discipline on clinical experimentation can be found on several levels of the Italian legislation, from the higher – represented by the Constitution and the European Union legal instruments – to the lower, like for instance the regulations provided by the government. At the constitutional level, the provision contained in the Italian Constitution referring to the scientific research activity (art. 9) is the result of the balance between the principle of its social utility – upon which is based the policy of prompting scientific research enterprises hold by the same constitutional Charter – and the individual fundamental rights, like that to health provided by articles 2 and 32 of the same Constitution. The main European Union legal instruments dealing with this topic are the Directive 2001/20/CE of 4 April 2001, regarding the "approach to the legal and administrative provisions and regulations of the Member States about the application of good clinical practices in the conduct of clinical trials in human" and the guidelines of the good clinical practice of 17 July 1996. In this context, the Declaration of Helsinki of June 1964, providing for the ethical principles applying to the medical research involving human beings, the EU Charter of Fundamental Rights of December 2000 and the Oviedo Convention also should be mentioned. Within the domestic legislation, it must be underline that the primary sources (statute law) on the matter are extremely rare, and the few enacted have been passed by the Parliament with the main purpose to enforce international treaties already signed and ratified. This is the case, for instance, of the Parliament law number 145 of 2001, which enforces both the Oviedo Convention and the Additional Protocol of 12 January 1998, n. 168 forbidding human clonation. Numerous are, indeed, the secondary sources – like those government acts or executive regulations labelled as "decreto del Presidente della Repubblica" (d.P.R.) or "decreto ministeriale" (d.m.) – in particular on the field of clinical experimentation and investigation of drugs. In this context, a fundamental role is played by the Institutional Review Boards, whose competences embrace a very large spectrum, going from the power to conduct ethical evaluation on the clinical experimentation activity in general, to that to release technical advices, in particular in the specific field of clinical pharmacological investigation. The IRB technical advices, and more in general the power of authorize patterns of experimentation conducts attributed to this institution, are extremely relevant to the purpose of the research, and therefore they will be subject to a deep analysis, since they can constitute the legal grounds of defence for the medical personnel which can prove to have conformed its conduct to those suggested by the IRB. The research will end with some conclusive remarks on the edge-practice of the so called xenotransplantation, that is the not human source organs – most of times, of suine nature – transplant in human beings. In particular, lacking an express specific discipline on this sector of experimental transplantations, it will be investigated if and to what extent, the principle of precaution – affirming, as provided by art. 174 of EU Treaty, that in case of doubt of noxious or dangerous to the community consequences resulting from clinical and experimental practice it should be disposed its moratoria, so allowing the medical sciences to reach a sufficient degree of knowledge on all the consequences and implications of this kind of practice – can apply to this matter. <<<