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Legal aspects of end-of-life decisions in Italy: the penal relevance of the limitation of treatment in the terminally ill and the problem of causality by omission

Fabris, E. P.*; Piccinni, M.

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European Journal of Anaesthesiology: February 2008 - Volume 25 - Issue - p 58-65
doi: 10.1017/S0265021507003328
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Abstract

Introduction

H. Jonas already posed the problem of suspending life-support treatment in 1978. In an essay entitled ‘The Right to Die,' first published that year in the journal Hastings Center Report, he wrote: ‘How strange that nowadays we should speak of the right to die when throughout the ages all talk about rights has been predicated on the most fundamental of all rights - the right to live' [1].

Once over his initial ‘wonder,' the author identified the extent of the ‘novel problem' in these terms: ‘medical technology, even when it cannot cure or relieve or purchase a further, if short-term lease on a worthwhile life, can still put off the terminal point of death beyond the point where the patient himself may value the life thus prolonged, or even is still capable of any valuing at all. This often marks a therapeutic stage where the line between life and death wholly coincides with that between continuance and discontinuance of treatment, in other words where the treatment does nothing more than keep the organism going, without in any sense being ameliorative let alone curative. This case of the hopelessly suffering or comatose patient is only the extreme in a spectrum of medical knowledge which, allied to the institutional power of hospitals, backed by the law, creates situations in which it becomes a question whether the rights of the typically powerless (and somehow captive) patient are observed or violated, including the right to die' [2].

The philosopher's perspective on the issue is extremely topical and raises further issues for any judge called upon to determine what possible judicial importance should be given to the doctor's omission or so-called therapeutic obstinacy in the delicate area of medical intervention at the so-called ‘confines of life'.

The first question, when trying to define a doctor's legal responsibility in possible failure to treat and, even before when establishing when, effectively, medical intervention may be considered as failing to offer the due treatment, may be formulated in the form: what are a doctor's duties when managing an end-of-life situation?

In this sense, the problem should be analysed from the more general perspective of the legal relationship between doctor and patient.

Undoubtedly the doctor is invested to a position of safeguarding [3] the goods, life and individual safety of the patient, regardless of whether the therapeutic relationship initiates as private-sector treatment or in the public services.

In each case, it is in the context of the relationship of cure that the doctor's position of guardian and the consequent obligations for intervention take on legal relevance.

As a consequence, such obligations are founded on, and meet their limit in, respecting the needs of the person who is ill [4].

This means that whenever a doctor is a party in a relationship of cure, he has the obligation to do all that is within his power to restore the patient's state of health or in any case to avoid further damage deriving from the illness, should it not be adequately treated; when a cure is not possible, he is held to do all that is within his power to avoid or, in any case, delay the final outcome of death.

Only by clarifying - through a correct interpretation of the obligation to act referred to in Article 40 of the Penal Code - up to what point the doctor is obliged to undertake all that is technically possible for the prolongation of biological life and at what point, instead, this is superseded by an obligation to abstain from therapeutic treatment, albeit technically possible - with the consequent necessity of recurring to all the palliative cures useful for the reduction of psychophysical suffering - can one find constructive agreement and avoid intolerable discrepancies between medicine and law.

To such an end, the need to interpret the penal regulations in a teleological manner comes into consideration, in view of their continual and inevitable adaptation both to new problems, coming from social evolution, and to renewed conceptions of the values that constitute the object they protect.

From the point of view of social evolution, it is necessary to give due consideration to the problems involving developments in medical science [5].

While for renewed conceptions of values, it is not possible to ignore the influence that the Constitution of the Republic exerts on the system of penal regulations.

The Constitution radically changed the structure of the relationship between the individual and the state, placing the person at the centre, in a formulation, which, for this very reason, is distinguished as being ‘personalistic'.

Articles 2 and 3 of the Constitution recognize the inviolable rights of man as the priority values on which the entire structure of the legal system is based. And among such rights there are the right to life, the right to health, as well as the right to moral and personal freedom and that is, substantially, to dignity.

The right to health is specifically acknowledged in Article 32 of the Constitution, an obligatory reference whenever facing the problem of disposability of the goods of life and individual safety in the area of health treatment, in that it contributes to defining the limits within which the health worker takes on the position of guardian of those goods, health and life, which are in the possession of the patient. In particular, the second paragraph of the Article foresees that health treatment may only be imposed in exceptional cases, reserving the legislature's exclusive power to define new crimes and with the absolute limit of respect for the human person; respect for the person must, however, be read in the sense of respect for his dignity [6].

The first fundamental consequence of a correct interpretation of the above-mentioned constitutional regulation is the personalistic imposition, which the constitutional legislator intended to give to the right to health and the clear and definitive recognition of the freedom of the subject to refuse treatment, this being so even in cases of great seriousness where abstention from therapies may lead to the cessation of life [7].

It is to be derived from such an assumption that therapeutic treatment, especially in elective medicine, must not be enacted without the consent of the patient. The patient may, therefore, dissent and given such dissent the doctor is not authorized to use impositions or extraordinary methods to force the patient to be treated [8].

The principle of the autonomy of the patient, besides finding undisputed recognition in the Constitution, is, today, also consolidated in the areas of professional and general ethics.

In this sense, the activity carried out by medical Societies which have expressed themselves on this theme, showing a discrete awareness of their own professional and social responsibility, is particularly interesting [9].

But it is above all reflections on bioethics which have imposed a new conception of the doctor-patient relationship in medical practice. This emerges from the different versions of the Professional Ethics Codes for Medicine of the last decades [10]. In particular, there is a striking attempt to combine the (more and more emphasized) freedom and autonomy of the doctor, and the traditional principles of benefit and non-harmfulness, with respect for the freedom and autonomy of the patient, which is given further definition.

Even in the latest version, of 16 December 2006, there are several provisions in which the spaces for autonomy of the person-patient are exemplified and strengthened, and it is interesting to note how this often comes about through reference to the dignity of the person.

An exemplary proposition is found in Article 38 of the Professional Ethics Code for Medicine, latest version, which in paragraph I, with reference to the ‘autonomy of the citizen,' reads: ‘The doctor must adhere, within the area of the autonomy and independence which characterises his profession, to the freely expressed will of the person in cure and must act with respect for the dignity, the freedom and the autonomy of the same.'

The principle of autonomy, ever more consolidated from the standpoint of general and professional ethics, does not always find equally mature reflection in the juridical field.

There are, in fact, important regulatory references - one may think, on the one hand of the fundamental Convention on Human Rights and Biomedicine [11] and, on the other, of the more recent Charter of Fundamental Rights of the European Union [12] - which recognize ‘patient consent' as ‘a basic principle on which the doctor's activity must be based and in any case be subject to,' even though they have not yet produced shared conceptions, either in the doctrine or in jurisprudence [13], especially with respect to putting the principle itself into effect and to its effective implementation through concrete codification.

The point emerged with all its tragic consequences [14] in the recent affair that involved Pier Giorgio Welby. The defense of the doctor brought before the civil courts for a case under Article 700 of the Civil Proceedings Code was the following: ‘though not denying his beingobliged by law to respect the willof Mr. Welby, and therefore his obligation to detach the lung ventilator, under sedation, having found that such action broughtdanger to life”…when the patient was sedated, and therefore, “unable to decide” “there had come to bear, “in relation to the risk to life, the obligation toproceed immediatelyto reattach the same lung ventilator with the scope ofreestablishing breathing.” ' [15]

The civil court judge, to whom the request had been made, correctly notes that in the Italian system there are no existing regulations that expressly address the problem of the doctor-patient relationship regarding issues concerning the end-of-life.

Starting from such considerations, rather than seeking a possible answer at the level of principle, the judge comes to a conclusion that cannot be shared from a juridical point of view: though recognizing, in fact, the ‘principle of self-determination and informed consent' in all its wide-ranging application, including the right to refuse treatment [16], he concludes by stating that ‘Since a right can only be said to be effective and safeguarded if the code positively stipulates the possibility of compulsory execution of the expressed will, in the instance of non-executed spontaneous fulfilment of the request of the possessor who intends to use his will, it is observed that, in the case under examination, the right of the plaintiff to request the interruption of assisted breathing and detachment of the artificial breathing apparatus, subject to the administration of terminal sedation, must be held valid according to the standard of the observation here above, but it concerns a right not concretely safeguarded by the code. In fact, one may not speak of safeguards if thereafter what is required of the plaintiff must always be left to the total discretion of whatsoever doctor to whom the request is made, to his individual conscience, to his subjective interpretation of the facts and the situations and to his own ethical, religious and professional convictions.'

In the setting of penal law, the State Prosecutor decided to conclude investigations into the noted episode with a request to dismiss the case, correctly motivated by the assumption that no charge could be moved against someone who, given the physical impossibility of the patient, had materially undertaken detachment of the breathing apparatus, in so much as the action undertaken, which was limited to putting into effect the patient's right to refuse medical intervention no longer lived as a cure but rather as damaging in himself, cannot be considered against the law [17]. The judge for the preliminary investigation refused the request to dismiss the case and imposed formulation of charges for the crime of homicide, foreseen and punished under Article 580 of the Penal Code.

The problem is certainly complex, in that it requires the balancing of values of particular importance, from health, to life itself, to self-determination, including the necessary reference to dignity. In any case, what appears out of the question is the impossibility of qualifying homicidal - without provoking an inevitable conflict between ordinary penal law and the constitutional law - the conduct of the doctor who acts in accordance with the effective content of his obligation as guardian of the will of the patient who himself, though still in exclusive possession of his own goods [18], requests the interruption of therapeutic interventions no longer felt to be ‘beneficially' curative, but rather as damaging [19].

The cases in which, as in the episode reported, the fully conscious and aware patient expresses refusal of a therapy or dissent regarding its prolongation, the doctor must stop without there being the possibility of his being charged with liability for omission under Article 40 of the Penal Code.

‘Not impeding an event is the equivalent of causing it' only in as far as there is the juridical obligation to impede it; if the dissent obviates this obligation, there is no longer omission in the conduct of the doctor and he has not committed a penally relevant act.

A different argument is to be made for the vast category of subjects in a situation of great psychophysical weakness, completely unable to take decisions or in any case prevalently under the effects of distress and fear and therefore necessarily entrusted to the care of the doctor and, where possible, of relatives [20].

The solution to the problem for such patients is still to be found, also taking into account the need to give new foundations to the judicial categories. It is not possible, on such a new and complex theme as this, to think of using the same categories set up when the problems did not have the same entity and the drama they have taken on today, and when medicine did not have the possibility of so extensively effecting human life.

Besides, the difficulty of coming to satisfactory solutions, also on a juridical level, derives not only from a certain attitude in the medical setting but also from the lack of serious debate leading to the formation of public opinion on the question [21].

It is necessary, instead, to stimulate reflection on the principle, which must be behind decisions in the so-called ‘limit' or ‘borderline' situations, by addressing the question of what the right ‘costs' are to have the patient ‘pay' for the mere prolongation of his biological life.

The reply to the question can be found by making use of a correct balance between the benefit, which may reasonably be expected, and the sacrifices, which are, however, necessary to impose. Such a balance is made taking into account the criteria of good clinical practice and these, if the patient is of sound mind, include the careful consideration of his will; if, instead, the subject is not sound of mind, the terms of reference, in the present state of regulations, cannot but be objective. On balancing such criteria, it is possible to sustain that the limit is to be found when there is a clearly excessive disproportion between the therapy and the expected results.

In difficult decisions on the borderline between life and death, the objective of keeping the patient alive is to be reconciled with the control of suffering and with the guarantee of dignity in death.

For the defence of life not to descend to mere running of a biological item, it must be conducted in a reasonable way, avoiding the application of excessively disproportionate therapies that end up being transformed into a mere lengthening of the process of death.

The criterion to use is, therefore, that of the appropriateness of a treatment, taking into account its effective utility and its proportion with respect to the expected benefits; and it is clear that, as well as to the probability of success, such appropriateness is directly proportional to the increase in the quality and quantity of life and inversely proportional to the burdens and suffering of the patient.

When a therapeutic treatment is not justified on the basis of the criterion of clinical appropriateness indicated above, the doctor should interrupt it or avoid undertaking it, continuing due assistance to the patient with all the palliative cures available.

The limitation of treatment in such a case, far from being considered the cause of the death of the patient, is, instead, the obvious consequence of the recognition of its inefficacy and incapacity to modify the prognosis for that patient in an effective way; as the need to avoid every excess of treatment that harms individual dignity.

While it is true that the goods called life is a fundamental value safeguarded by the juridical regulations, it is also true that it is necessary to ask about the value of such goods.

The reply to such a question is that it is not possible to separate life as a set of biological functions from the human being in his entirety, as a person having his own dignity [22]. The law cannot but safeguard this goods in such a personalistic way and must, therefore, balance the mere prolongation of biological life with the dignity of the person, placing a limit on the suffering and the manipulations to which a patient is subjected. Besides, the Professional Ethics Code prohibits undertaking or continuing a treatment when inappropriate because of its excess, this being defined as ‘therapeutical obstinacy' and proposed as the very limit which the doctor must not pass [23].

Having identified the general principle, what remains to be established is who is to take the decisions in a single given case, who must evaluate, concretely, when treatment can no longer be considered therapy but has become therapeutic obstinacy and thus a mere prolongation of the process of death, bringing about an unjustified addition to the suffering of the patient.

Certainly the responsibility for such a decision for an incapacitated patient without a legal representative lies with the doctor.

However, the role relatives may take in facilitating the decision cannot be undervalued since they are recognized as the natural protectors of patients, though still taking into account the real situation of the single patient, as is required by the principle of good clinical practice.

It is frequently claimed, instead, that relatives have no say, since either the subject who owns the goods is capable of self-determination, putting a limit on the action of the doctor, or the patient is incapacitated and the doctor alone must decide. This assumption cannot be shared given the fact that the juridical regulations invest the relatives with an obligation of solidarity and cure with respect to their kin in situations of incapacity. On this question, it is sufficient to reflect that there is the possibility of hypothesizing penal responsibility for abandoning the incapable (Article 591 Penal Code), rather than mere omission of assistance (Article 593 Penal Code), in cases of omitted intervention regarding a relative in a situation of danger.

This question, which is usually presented as a juridical problem, also poses questions at other levels, that is, at the level of professional and ethical responsibility. When facing situations that do not have (and cannot have!) preconstituted solutions and for which it is necessary to start from the concrete case and thence come to a discussion on the legality of the choices adopted by the doctor, it is, in fact, indispensable to have an interdisciplinary vision, and to have and open and reflective disposition.

Above all, it is necessary to overcome the problem of ‘worrying about the possible legal consequences' which risks ‘contaminating' the doctor's decision.

For terminal patients, or in any case those with a seriously compromised clinical situation, the doctor must make a choice in relation to which there is an inevitable fear of possible penal consequences, both in the case of suspension of ‘extraordinary' treatment or not starting it, and in the case of insisting with the same, beyond every predictable efficacy.

If not meant honestly, the duty of prolonging life within the limits of the ‘possible' risks coming into conflict with the duty of cure, meaning the ‘duty to take care of' the patient, to respect his dignity, to relieve suffering as much as possible, and to weigh the means used, which must be the most adequate for the specific needs of that specific patient, seen as a unique and unrepeatable subject.

Faced with the apparent conflict between the two normally converging duties - saving life and taking care of the patient - the doctor's decision cannot be subject to a pervasive fear of the Draconian rules of the penal regulations, for which hastening death of a patient who would, anyway, have come to this point is the equivalent of causing it.

Instead, the doctor's decision must be correctly motivated by the need to fulfil the duty of cure and for this to be adequate in its scope, following the criteria of good clinical practice; if the doctor decides, therefore, to interrupt therapies that act as a mere prolongation of biological life and continue with palliative cures, the causal nexus between the omission of health treatment and the anticipation of death is to be excluded, just as, even with express provisions within the regulations, a nexus is excluded when hastened death is the consequence of pain therapy commensurate with the seriousness of the situation of suffering of the patient.

The problem is still that of the limit beyond which therapy is no longer found justified or, conversely, when care taking (e.g. pain therapy) knowingly brings about the choice to shorten life. The juridical solution for such hypotheses must necessarily be coherent with the regulations of good clinical practice, which is sometimes supported by legal documentation (as for pain therapy) but for the most part is the fruit of a scientific knowledge and professional ethics considerations, which are currently also used as Guidelines, meant as orientation and not as imperative rules.

Before heading towards the conclusion, some last points are provided believed to be useful.

Above all, it is necessary to bring clarity to the position of the doctor in emergency situations.

In these hypotheses, the prevalent doctrine bases the legality of the doctor's intervention on the justification of the state of necessity [24]. It also stresses how ‘in transforming intervention from a duty to a mere facultative act the state of necessity lends itself badly to regulating a situation in which the doctor finds himself taking on an obligation of protection of the goods, both of health and of life, of a patient temporarily unable to take decisions and therefore to safeguard his own goods. In such a hypotheses, the only guardian for the regulations is the doctor who, in this capacity, is obliged to intervene.' [25]

So it is more useful in cases of ‘medically verified urgency' to recur to the justification of fulfilment of duty under Article 51 of the Penal Code [26].

However, to avoid the doctor's finding himself having to undertake apparently ‘schizophrenic' [27] behaviour, it is necessary to repeat that, in the albeit remote hypothesis in which it has been possible, previously, to ascertain a clear and cogent manifestation of the will of the patient to not proceed or to interrupt life-support therapy, the doctor's duty ceases [28], and instead, the curer's guide becomes the duty not to insist with a therapy that the patient, immediately prior to his initial state of incapacity, had legitimately refused.

The second point, which is worth mentioning, is the case of experimentation.

Often, in end-of-life situations consolidated therapies are not available and for the doctor there may arise the problem of having to choose whether or not to include a patient in a research protocol.

On this topic, it is necessary to recall that where medical science no longer has any certainty, it is the duty of the scientific community to promote the goods of health of the population of patients by setting up experimental protocols, and of the single doctor to include patients in these studies when it is opportune and always inside the limits of ‘therapeutical obstinacy' [29].

But how is the choice of whether or not to include a patient into an experimental protocol to be made, especially when the person is incapable [30] of expressing his own consent?

Although not being able to explore such a delicate theme in this place, it may be recalled how the principles of reference, which must guide the doctor-experimenter's choice, are the same as those mentioned above, with special attention due to the particular vulnerability of the subject involved in the experimentation.

In other words, research must always be part of a project that takes charge of the patient and the latter can never be sacrificed to the common interest [31].

In conclusion, the doctor's activity in terminal situations must adhere to two principles: interruption/abstention of useless and/or disproportionate cures and assistance given to the dying person, also through the use of palliative medicine [32].

A reasoned decision, plausible at a scientific level, which is transfused into documentation that allows reconstructing the clinical profile of the patient - as evidence of the decisional process, also shared with relatives seen as natural protectors of the patient and possible testimony of a will which he is no longer able to express directly - certainly cannot be exposed to becoming the object of censure at a judicial level, and all the less so in instances in which the judicial decision is also inspired by a correct interpretation of the regulations found on the values, which the same regulations are responsible for protecting.

In this sense one cannot but agree with the observations that H. Jonas made in the essay quoted at the beginning of this paper: ‘In defense of the right to die one must therefore restate the authentic vocation of medicine, to free both the doctor and the patient from their current slavery. The new phenomenon, resulting from the combination of the impotence of the patient and the power of the techniques which, under public vigilance, delay death, require such restatement. On this question one may, I believe, agree, that safeguard through medicine has to do with the integrity of life, or at least with the situation in which life is still desirable. Keeping its flame alive, not its embers burning, is medicine's real task, for which reason it should also be the custodian of its extinguishing; indeed it is certainly not the imposition of suffering and humiliation which only serve for the undesired prolongation of extinction. In what way a similar declaration of principle may be translated into operative jurisprudence is, in itself, certainly a difficult subject; no matter how well we do our task, we shall always be, because of its very nature, in a shadow area where tortured decisions have to be taken in the single case. But once the principle is established, hope grows that the doctor returns to being at the service of man and not a tyrannical and at times tyrannised master of the patient' [33].

References

1. In H. Jonas, The Right to Die, in Hastings Center Report, 1978, n. 4; now in Id, Tecnica, medicina ed etica. Prassi del principio responsabilità, Einuadi, 1997, 185. The author continued: ‘Effectively, every other right which has ever been taken into consideration, claimed, conceded or denied, may be seen as an extension of this primary right, since every specific right regards the activation of some power, the access to some need, or the satisfaction of some aspiration of life.'
2. Ibidem, 187.
3. Cfr., for an understanding of the problem of liability through omission, G. Fiandaca, voce ‘Omissione (Diritto penale)', nel Digesto IV ed., Disc. pen., VIII, Utet, 1994, 556 s.; G. Grasso, Il reato omissivo improprio: la struttura obiettiva della fattispecie, Giuffrè, 1983, 233; F. Viganò, Stato di necessità e conflitti di doveri. Contributo alla teoria delle cause di giustificazione e delle scusanti, Giuffrè, 2000, 498 ss. With specific reference to the relationship between the doctor and the patient, cfr. E. Palermo Fabris, Diritto alla salute e trattamenti sanitari nel sistema penale. Profili problematici del diritto all'autodeterminazione, Cedam, 2000, 173 ss., and spec. 178 ss., which is also suggested for further bibliographical references.
4. On stressing the importance not only of the limits, but also the very foundation of the right to be cured and the corresponding duty to cure through widening the possibilities of expressing the individual's personality, in the sense of carrying them out and expanding them, see among others P. Zatti, Infermità di mente e diritti fondamentali della persona, in Pol. del dir., 1986, n. 3, 430 ss.
5. See Jonas's considerations quoted at the start.
6. For a more detailed analysis, see Palermo Fabris, op. cit., 2000, spec. 1-45, which is also suggested for further bibliographical references. More recently, for some reflections on Articles 2 and 3 of the Italian Constitution and on the concept of dignity inherent in our system of constitutional values, cfr. S. Rodotà, La vita e le regole, Feltrinelli, 2006, 16 ss.
7. The current Professional Ethics Code also seems oriented in this manner as seen, for example, in Articles 13, 16, 35, 36, 38, 39, 51 and 53.
8. Thus Article 35 Professional Ethics Code, latest version, under the heading ‘Acquiring consent' establishes: ‘The doctor must not undertake diagnostic and/or therapeutic action without acquiring the explicit and informed consent of the patient. […] However, given documented refusal of a person able to take decisions, the doctor must desist from consequent diagnostic and/or curative action, as no medical treatment against the will of the individual is permitted. The doctor must intervene, using his knowledge and conscience, regarding patients unable to take decisions, respecting the dignity of the person and the quality of life, avoiding any therapeutical obstinacy, taking into account the previous will of the patient.' Italics for parts added or emended with respect to the previous version. In this sense, see the considerations contained in the supreme court judgement Cass., Sez. IV pen., 10.10.2001, imp. Cicarelli, in Cass. pen., 2002, II, 1346 ss.
9. For an analysis in the European setting see the document of E.A.P.C., Task force sull'etica, Eutanasia e suicidio assistito dal medico, tr. it. in Rivista italiana di Cure Palliative, 1 (2004), 42-46. In the Italian context particular merit is deserved by the work of the S.I.A.A.R.T.I., of which, in particular, see two documents edited by the Commission of Bioethics: Raccomandazioni per l'ammissione e la dimissione dalla terapia intensiva e per la limitazione dei trattamenti in terapia intensiva, in Minerva Anestesiol, 2003, vol. 69, 111-118 e Le cure di fine vita e l'Anestesista- Rianimatore: quale approccio al malato morente? in Minerva Anestesiol, 2006, vol. 72, 1-23.
10. It may be useful to note that since 1989 when the National Council and the National Federation decided the transformation of the Study Commission - set up for the previous revision of the Professional Ethics Code of 1978 - into a Permanent Commission, there have been continual adjournments to the Ethics Code. In fact, the National Council already approved a new code in 1995, soon substituted by that of 3rd October 1998, and then by the latest version of 16th December 2006.
11. In the ‘Convention of the Council of Europe for the protection of the rights of man and the dignity of the human being with respect to the application of biology and medicine: Convention on the rights of man an biomedicine,' signed at Oviedo on 4th April 1997, and ratified in Italy by the law of 28th March 2001, no. 145, a ratification which, however, with a serious delay, has not yet been deposited with the Council of Europe. In particular, Chapter II treats the problem of consent (Articles 5-9) starting from the statement made in Article 5 of the general rule under which medical intervention may only be undertaken after the individual involved has expressed his free and informed consent.
12. This refers to the document signed in Nice on 7th December 2000 and transfused into the Preamble of the future European Constitution, in which the first heading concerns ‘dignity.'
13. It is sufficient to mention the divergence in interpretation based on two exemplary judgements over about ten years. In Corte D'Assise Firenze, 18.10.1990, imp. Massimo, in Dir. fam. e pers., 1991, 978 ss., condemning the doctor for premeditated homicide it was stated that: ‘the doctor can do nothing without the consent of the patient or even against the patient's will, which, besides, corresponds to a personalistic principle with respect to individual freedom and to a form of the doctor-patient relationship which the defence council of the aggrieved civil party has well identified in the figure of the patient as the possessor of his own fundamental rights and therefore as a man-person man-value and not as man-thing, man-means, subject to being used, also in an objectionable manner, and for ends which are often accompanied by the false cover of scientific progress or utility to the collectivity.'In some more recent sentences, though recognizing the validity of similar claims, there is seen the need of redimensioning the amplitude of the principle of consent. (See, for example, Cass., sez. IV pen., 12 luglio 2001, imp. Barese, in Cass. pen., 2002, 517 ss., con nota di Iadecola e in Riv. it. med. leg., 2002, 865 ss., con nota di Fiori, La Monaca, Albertacci e Cass., Sez. I pen., 11.07-2002, imp. Volterrani, in Cass. pen., 2003, 1945 ss.). In the Volterrani case, the Corte di Cassazione, in fully absolving the doctor, states: ‘the will of the subject involved in a juridical and penal setting in particular has a decisive role only when it is expressed in a negative form.' As regards explicit dissent, it is seen that in cases where the doctor has the duty to abstain from treatment - even when faced by explicit dissent on the part of the patient - are, anyway, ‘exceptional'. One also reads: ‘Actually, health care practice, and especially surgery, regardless of the hypothesis in which goes beyond the purpose of safeguarding health correctly understood, is always constrained, not to say forced. […] It seems valid, then, to envisage the existence of a general state of necessity and, so to speak, ‘institutionalised', intrinsic - that is, ontologically - to therapeutic activity.'
14. The extended sense of the expression is used - G. Calabresie P. Bobbit, Scelte tragiche, tr. it., Giuffrè, 1986 - to refer to the hypothesis where the solution of the case requires the sacrifice of one of the values (though fundamental) in question and inherent to the same possessor.
[15] Trib. Roma, ord. 16/12/2006, cit., c.vo. agg.
16. Trib. di Roma, ord. 16.12.2006, states: ‘The jurisprudence of the Corte di Cassazione (Supreme Court) and the Constitutional Court have brought out the magnitude of this principle, in the sense that whatsoever act invading the physical sphere, either of a therapeutic or a non-therapeutic nature, cannot take place without, or against, the consent of the interested person, in that ‘physical inviolability' constitutes the essential ‘nucleus' of the personal liberty itself, while, the imposition of a specific health treatment can be justified only if foreseen by a law which prescribes it as a function of the safeguard of the general interests and not a safeguard of individual health and providing, however, it guarantees respect for the ‘dignity' of the individual (Article 32 Constitution).'
17. See the Public Prosecutor's request not to proceed, refused by the judge of the European Union, which was reported in E, Vinci's article in La Repubblica newspaper on 7th March 2007. The Public Prosecutor states: ‘In the case in point, it can be claimed that there is the right of the patient not to undergo undesired medical treatment,' not being able to sustain that ‘such a right safeguarded by the Constitution would find a limit in the superior need of safeguarding human life which, under Italian law, constitutes an inviolable right.'
18. Palermo Fabris, Diritto alla salute, cit., 180 ss. Also see ivi for further bibliographical references.
19. In the episode under consideration it is worth mentioning a notable difference between the conduct of the health worker who limits himself to not administering therapy refused by the patient and that of the health worker who acts to interrupt therapy already undertaken. The problem has been faced in part by the doctrine itself with reference to disconnecting the artificial breathing apparatus and - though with the intention of being a meditated intervention on the theme on the part of the penal legislation - resolved in the sense that ‘detaching the artificial breathing apparatus - irrespective of a naturalistic perception of the actions of the doctor - gives rise to an omission of therapy imposed by the refusal of the patient, while the protraction of life support would give rise to an illegitimate forced treatment.' As espressly in S. Seminara, Riflessioni in tema di suicidio e di eutanasia, in Riv. it. dir e proc. pen., 1995, p. 695; also see F. Stella, Il problema giuridico dell'eutanasia: l'interruzione el'abbandono delle cure mediche, in Riv. it. med. leg., 1984, 1012; G. U. Nannini, Il consenso al trattamento medico: presupposti teorici e applicazioni giurisprudenziali in Francia Germania e Italia, Giuffrè, 1989, 504 ss.
20. The preliminary results of a recent study carried out by Giviti on 3648 patients who died in 84 Italian intensive care units, which admitted 21 428 patients in 2005 are particularly interesting. The initial quantitative data indicate that when admitted to intensive care more than 80% of the patients taken into consideration were not considered able to express valid consent to the treatment plan (among the reasons identified there are: ‘altered consciousness, conditions of extreme stress, anesthesis'). In only a very small number of cases (8%) was there available ‘a formal previous testimony of the patient's will'. As in the Press Statement of 19/10/2006 to be found in the site http://www.giviti.marionegri.it/FineVita.asp
21. To have an idea of the complexity of the problem, see for example the story regarding Eluana Englaro. The issue, which has now been protracted for several years, concerns the request of the patient's father, nominated as guardian, to suspend treatment on his grown daughter who has been in a persistent vegetative state since 1992. The case has seen a succession of numerous judicial acts (the latest decision is, currently, that of the Milan Court of Appeals, decree 16.12.2006, in Guida al dir., 2007, n. 1, 39 ss.). The work of a ministerial commission instituted by Ministerial Decree on 20/10/2000 by the then Minister of Health Veronsesi (the report of the workgroup on artificial nutrition nand hydration treatment of persons in a state of irreversible loss of consciousness may be found at www.globius.org/documenti/nutrizione.htm), in a deliberated opinion of the National Bioethics Committee of 30th September 2003, L'alimentazione e l'idratazione di pazienti in stato vegetativo persistente. Despite 15 months now having passed a solution still seems a long way off. The difficulties of deciding in these cases emerge with the very opinion of the CNB quoted. As well as its content, its method is also striking - unusual for the authoritative organ - according to which a document was decided upon without its having received a consistent majority of votes. What is defined as ‘An integrative note' contains the signatures of some 13 components against this final text.
22. Of particular significance there are Articles 1, 2 and 3 contained in part I, Charter of the European Union, 2000, quoted regarding, not by chance, ‘human dignity.' Only after the proclamation of the inviolability of human dignity (Article 1) is the right to life stated (Article 2) and the right to physical and psychological integrity, in the setting of which the duty to respect the ‘free and informed consent' of the patient is specified (Article 3).
23. Cfr. Articles 16 and 39, Professional Ethics Code, latest version.
24. Cfr. on this question G. Iadecola, Potestà di curare e consenso del paziente, Cedam, 1998, 99; R. Riz, Il consenso dell'avente diritto, Cedam, 1979, 348 ss.
25. Così Palermo Fabris, op. cit., 222 s.
26. For a deeper discussion see ibidem, 201 ss. e 222 ss.
27. See again the Welby case in the civil courts and the presentation of the doctor treating him, quoted above.
28. As in F. Giunta, Il consenso informato all'atto medico tra principi costituzionali e implicazioni penalistiche, in Riv. it. dir. e proc. pen., 2001, 380 ss.; Palermo Fabris, op. cit., 201 ss.; Viganò, Stato di necessità e conflitti di doveri, cit., 10 ss. But see also, P. Veneziani, I delitti contro la vita e l'incolumità individuale, nel Trattato di diritto penale. Parte speciale, diretto da G. Marinucci e E. Dolcini, I delitti colposi, t. II, Cedam, 2003, 319, which, though, places itself in an intermediate position regarding the penal relevance of ‘informed consent.' Also in the case that the justification of a state of need is operative, the ability of the doctor to choose between the goods in question concerning the same possession would cease when the owner himself had indicated which goods should prevail. Besides the cited authors, see also Albeggiani, Profili problematici del consenso dell'avente diritto, Milano, 1995, 78 ss.
29. Experimentation then becomes concretely expressed in Article 32 of the Constitution. Cfr. for an interpretation in this sense, G. Tognoni, La sperimentazione clinica: le condizioni minime di eticità, in Bioetica, 1996, 13 ss. and more recently recente G. Marsico, La sperimentazione umana: diritti violati/diritti condivisi, Franco Angeli, 2007, spec. 77 ss., where it is stated: ‘Participation in research/experimentation is therefore a right in as much as it is the expression of health assistance, which is transformed into a health project, where there are not adequate responses to the needs and the right to health risks being unfulfilled.' (p. 79).
30. As the Helsinki Declaration itself is codified the international scientific community has decided the question of whether, despite the lack of realtime informed consent of the patient to proceed with experimentation on the same in a positive way. On the problem of carrying out research on vulnerable subjects, see from ult. Marsico, op. cit., spec. 157 ss, which also suggested for further bibliographical references.
31. Not only the principles found right from the Introduction to the Helsinki Declaration - cfr. points 4, 5, 6, 8 - but also directive 2001/20/CE on the application of good clinical practice in carrying out clinical experimentation of drugs for clinical use, instituted in our law by the legislative directive 24th June 2003, no. 211, must be interpreted in this sense.
32. Article 39 Professional Ethics Code, latest version, stresses the connection between the appropriateness of the treatment and ‘the safeguarding, as far as it is possible, of the quality of life and the dignity of the individual person'; also containing the explicit invitation - in the case of a patient with a compromised state of consciousness - to avoid ‘every form of therapeutic obstinacy.'
33. Jonas, op. cit., 205, italics added.
Keywords:

TERMINALLY ILL; CESSATION OF TREATMENT; ETHICS; PHYSICIAN-PATIENT RELATIONS; LEGAL OBLIGATIONS

© 2008 European Society of Anaesthesiology