Preliminary instructions

Gonzalo Herranz
department of Humanities Biomedical, University of Navarra
Session in the course on "Law 41/2002 and the implementation of patients' rights".
Pamplona, September 5, 2003

Index

A. Legal aspects of Ip.

1. Legal background: agreement of Oviedo, General Health Law.

2. Social and ethical background.

3. The contents of article 11 of Law 41/2002.

4. Most significant aspects of the autonomic legislations.

B. Ethical and ethical aspects.

1. Ethical standards on PI.

2. Conflicts that PIs raise at the ethical-legal frontier.

Introduction

I would like to comment on article 11, on Advance Directives (Ip)¹of Law 41/2002, which forms part of its extensive Chapter IV, devoted to strengthening respect for patient autonomy and consolidating the internship of informed consent to medical interventions. The article 11 confers on the patient the capacity to grant Ip, that is, the right to decide, in advance and for a future in which he/she would not be in a position to express his/her wishes personally, on the medical treatments he/she wishes, or does not wish, to receive, and also on the destination of his/her body or organs after his/her death.

In this way, the Law validates the patient's right to self-determination in anticipation of circumstances in which the disease can eclipse, temporarily or definitively, his or her conscience and freedom, and thus extends to moments of incapacity the patient's right to decide for himself or herself.we are thus faced with a new way of exercising patient autonomy, which has legal and ethical implications of great interest and scope.
It can already be taken for granted that PIs will not be reduced to the role of mere living wills to govern medical decisions at the end of life, but will be applied over time to other areas of health care. We will have to wait and see whether, in Spain, PIs will catch on in the medical internship and become social use. In the immediate future, those involved in the law and ethics of medicine will have plenty of food for thought at subject : suffice it to consider the sometimes surprising developments that the Autonomous Communities are giving to their particular legislation.

In this exhibition I will deal successively with the following points:

A. Legal aspects of Ip.

1. Legal background: agreement of Oviedo, General Health Law.

2. Social and ethical background.

3. The contents of article 11 of Law 41/2002.

4. Most significant aspects of the autonomic legislations.

B. Ethical and ethical aspects.

1. Ethical standards on PI.

2. Conflicts that PIs raise at the ethical-legal frontier.

A. Legal aspects of Ip.

1. Legal background: The agreement of Oviedo and the General Health Law.

In its exhibition of motives, Law 41/2002 attributes some illustrious antecedents to PI. In its purpose to reinforce and give a special attention to the right to patient autonomy, it tells us that it has taken from loan of the agreement Relative to Human Rights and Biomedicine (agreement of Oviedo) the figure of the patient's previously expressed wishes as an element of particular value in the field of informed consent. Earlier, in the same paragraph, we had already been told that the Ip comes to fill in certain provisions that the General Health Law had enunciated as general principles.

The agreement of Oviedo. The article 9 of this agreement states that "The wishes previously expressed with respect to a medical intervention by a patient who, at the time of the intervention, is not at status able to express his or her will, will be taken into consideration". This brief text, of calculated generality, was sufficient to outline the most essential features of the Ip, an outline on which, according to article 1 of agreement, national legislators should be inspired to develop their own domestic legislation.

The comments that the explanatory report of agreement makes to this article 9 are equally brief, although it must be recognized that they have left a deep imprint on the derived legislations. They point out that the wishes previously expressed by a person must be taken into account, which does not mean that they must necessarily be complied with. This does not mean that they must necessarily be complied with. Setting them aside would be justified, for example, if they had been expressed a long time before the intervention and, in the meantime, scientific advances had taken place that, to a certain extent, invalidated them. This, however, does not exempt the physician from diligently checking whether, despite the evolution of medical techniques, the patient's wishes are still valid and appropriate to the actual status .

The General Health Law. Law 14/1986 does not deal at any time with PI. Its cardinal article 10, on the rights that everyone has before the health administrations, when considering the status of incapacity of the patient to exercise free choice among the options presented to him by the manager doctor in his case, limits itself to pointing out in its section 6, b, that when the patient is not capable of making decisions, the exercise of free choice is transferred to his family members or persons close to him.².

2. Social and ethical background.

In fact, legally, socially and ethically, PIs have antecedents that go back many years and illustrate the social motives that led to their introduction at internship and the philosophical arguments that have been put forward in their favor and against them. As is logical, only a very brief treatment of such antecedents can be given here.³.

The idea of the Ip was born in the United States, when the living will was proposed in 1969, as a parallel to the ordinary will.⁴. The first legislation that recognized the right to express Ip through living wills was the Natural Death Act, passed in California in 1976. The trend to issue Ip was growing there, thanks, above all, to the influence of some high-profile court cases. In 1983, the President's Commission recommended the use of Ip's as the best procedure way to involve the potentially incapacitated patient in future decisions about his or her own treatment.⁵. Finally, in 1991, the Patient's Self-determination Act was enacted, requiring all patients admitted to federal health care facilities to voluntarily declare their PIs. It is curious that, in contrast to opinion polls revealing a massive predisposition in favor of PIs, only 10% of patients admitted to hospitals agree to submit or prepare their PIs.⁶.

Logically, the progressive introduction of the idea of informed consent in the ordinary clinical internship has had a stimulating effect on the diffusion of Ip. The knowledge dissemination of the Principles of Bioethics, with its special emphasis on the principle of autonomy, paved the way for the general acceptance of Ip in hospitals.⁷. Ultimately, informed consent and Ip have the same underlying motivation and respond to the same statement of core values assertion of individual autonomy. The only difference is that Ip responds to the wish of a patient who is able to determine his or her medical care in a yet undetermined future, whereas informed consent refers to an immediate medical intervention.

Finally, it should be noted that some organizations promoting euthanasia have played an important role in the popularization of PIs. Associations for voluntary euthanasia or for the right to die are among the most important disseminators of different models of living wills that, in some cases, come dangerously close to the request for compassionate death .⁸. These same associations offer the interested parties information packs to help them overcome the ethical-medical or legal difficulties they may encounter in drawing up or asserting these documents.⁹. There is no doubt that as long as legislation prohibits euthanasia, PIs will remain aloof from any connection with it. There is no lack of authors who rationally argue that euthanasia and genuine Ip belong to two separate cultural and ethical worlds.¹⁰.

And, paradoxically, even those who oppose euthanasia and its legalization have offered models of living wills that, invoking the Christian ethic of absolute respect for life and acceptance of death, reject disproportionate or irrational treatment.¹¹.

3. The contents of article 11 of Law 41/2002.

The article consists of five sections that are not preceded by any introductory clause.

The section 1 contains the definition that the legislator himself gives us of the Ip, with precise specifications on the subject who expresses them, the circumstances in which they are to be applied, and the purposes (decisions on care and treatment, destination of the body and its organs after death, acceptance or refusal of treatment to which they are directed). It reads as follows: "By means of the advance directive document, a person of legal age, capable and free, expresses his will in advance, with the purpose of having it fulfilled when he reaches situations in whose circumstances he is not capable of expressing it personally, on the care and treatment of his health or, once death has occurred, on the destination of his body orits organs".

This section also defines the figure of the patient's representative, who is invested by the grantor with the triple function of being the patient's spokesperson, as interlocutor with the physician or healthcare team, interpreter of the contents of the Ip, and procurator of its fulfillment.The grantor of the document," he says, " may also designate a representative to serve, if necessary, as his interlocutor with the physician or health care team to ensure compliance with the advance directive".

The validity and operability of the PIs are conditioned to their being expressed in a document: without a written document it is not possible to speak of PI.¹². The idea is reiterated in section 2, which concludes that the Ip "must always be in writing". Moreover: section 4, satellite of section 1, when dealing with the freedom that the grantor enjoys to revoke - and, logically, to modify - his Ip, indicates that this must be done in writing. "Advance directives may be freely revoked at any time with a written record". The unavoidable condition of the Ip being a written document distances it from informed consent, which can be merely verbal, while at the same time raising, as will be seen below, certain ethical perplexities.

The section 2 transfers to the Autonomous Communities the power to determine the formalities, requirements and administrative mechanisms for the Ip to become effective and guarantee its application. It states that: "Each health service will regulate the appropriate procedure so that, when the case arises, compliance with the prior instructions of each person is guaranteed". Regional law thus takes on a special role in the development and in the internship of the Ip.

The section 3 takes care, on the one hand, of the legal and ethical correctness of the contents and specific applications of the Ip. It says to this effect purpose: "Prior instructions contrary to the legal system, to the "lex artis", or those which do not correspond to the factual situation foreseen by the person concerned at the time of their expression, shall not be applied". It therefore requires that the PIs and their objective contents be in accordance with the legal system and with the internal morality of medicine. This condition gives the clinical management of the Ip an exceptional intensity and richness, as it demands from physicians and jurists a work of interpretation that must simultaneously take into account the loyalty owed to the patient and the fair and full compliance with the law and the ethical and scientific professional standards that make up the state of the art of the moment. Moreover, the physician himself must demand of himself, and must ensure before the patient's representative, that the PIs are applied to the factual assumptions that the grantor had foreseen at the time of expressing them. It requires a great deal of reflection and ethical sensitivity, in cases of conflict, to analyze and judge the Ip's of agreement with the mind and foresight of the grantor and to try to bring them into line, as far as possible, with the ethical-professional and legal norms. The physician or the health care team has the power to disregard, to reject the Ip that, in their opinion, are not in accordance with the law, the lex artis or do not correspond to the factual situation foreseen by the grantor. This is a power that cannot be exercised in a discretionary manner. There is a qualified moral duty to give more respect to the patient, now incapable, who drafted the Ip, by virtue of his special vulnerability. One cannot distort the purposes for which his or her PIs were conceived, nor abuse medical power to render them ineffective or apply them to circumstances different from those for which they were intended. Very prudently, section 4 imposes on the physician the duty to justify rationally and transparently the reasons for his conduct when he disregards the Ip. The Law states: "The patient's medical record will contain a reasoned record of the annotations related to these provisions".

The section 5 and last of article 11 refers to the creation, at the Ministry of Health and Consumer Affairs, of a National Registry of Ip. agreement It reads as follows: "Inorder to ensure the effectiveness throughout the national territory of the advance directives expressed by patients and formalized in accordance with the provisions of the legislation of the respective Autonomous Communities, a National Registry of advance directives will be created in the Ministry of Health and Consumer Affairs, which will be governed by the rules to be determined by regulation, prior to agreement of the Interterritorial committee of the National Health System". This is a cautious provision, but it will force us to set up a registration and access system that is efficient and resistant to failure and fatigue.

4. Most significant aspects of regional legislation.¹³

a. Autonomous regulations prior to Law 20/2000 of Catalonia.

The enactment, on December 29, 2000, of Law 20/2000 of the Generalitat de Catalunya, introduced for the first time in Spain a regulation of IPs. The Catalan law marks a watershed between before and after. It can even be said that it triggered a legislative cascade on IP in the Autonomous Communities. There are very few that have not already legislated on subject.

The regulations prior to the Law of Catalonia do not properly deal with PI. They are mere transcriptions or, at most, rudimentary developments of section 6, b of article 10 of the General Health Law, which contrast sharply with the modern treatment, well articulated and ordinarily sufficient, of the Law of Catalonia and subsequent laws. It is to be hoped that, in the immediate future, under the obligatory influence of article 11 of the Basic Law 41/2002, the autonomic legislations that have not been updated will adapt to the contents of the State's rule .

The almost physical imprint of the section I have just quoted from the General Health Law can be seen in the three pre-Catalan laws. Law 1/92, of July 2, 1992, on the Health Service of the Principality of Asturias, and Law 8/2000, of November 30, 2000, on Health Regulation of Castile-La Mancha offer an almost identical text. When dealing with the right of the citizens (Asturias) or of the persons included in the scope of this Law (Castilla-La Mancha) to freely choose among the options offered by the physician, they state that in the event that the patient is not capable of making decisions, this right will correspond to his/her relatives or persons close to him/her (Asturias) or to his/her relatives, close persons or legal representative (Castilla-La Mancha). Law 11/1994, of July 26, 1994, on Health Care Management in the Canary Islands, which contains in its article 6 a long list of citizens' rights before the Canary Islands Health System, transfers this same right to the patient's relatives, and, in the event that these do not exist or cannot be located, they must go to contact with the judicial authority.

    b. Law 21/2000 of the Generalitat de Catalunya and its article 8.

The Preamble of the Catalan Law does not hide the fact that the introduction of the figure of what it calls advance directives, as a specific manifestation of patient autonomy, is undoubtedly the most outstanding novelty of the new legislative text, the first of its kind in Spain. At subject de Ip, the Law, although new, is not revolutionary, but innovative, prudent and moderate. On the one hand, and from agreement with the Preamble, the extension of the new figure seems to be limited to the internship and to the legal recognition of "what is commonly known as living wills or biological wills". On the other hand, according to article 9 of the agreement of Oviedo, advance directives should be understood not as a strict order dictated by the patient, but as an element of financial aid that the patient contributes to the decision making process.

Essentially, this article has served as a mold for the 11 of the Basic Law 41/2000, so it is not necessary to comment on it in detail. The Basic Law reproduces the essentials of the Law of Catalonia: the definition of PI, the institution of the representative, the invalidity of PIs that contain rules contrary to the legal system, the good clinical internship or that do not correspond to the foreseen factual assumptions.

The most significant differences are as follows:

Firstly, the state rule leaves to the Autonomous Communities and their health services the determination of the conditions of reliability, efficacy, guarantee of application and use of PI. In contrast, the Catalan rule establishes the modalities (before a notary, before three qualified witnesses) in which the document must be granted. These criteria have set a precedent and have been taken into account in loan in the internship totality of the subsequent autonomic legislations.

Secondly, the state rule , perhaps trusting in the efficiency and automatisms of the central registry that will be created with the support of the committee Interterritorial, says nothing about the submission to the doctor or the health institution of the Ip document. The Catalan Law imposes on the grantor, his relatives or his representative the duty to submit the Ip document to the health center where the person is treated, which will incorporate it into the patient's clinical history. This criterion has been included in internship in all subsequent regional regulations.

Although the Law of Catalonia does not make reference letter to an Ip Registry, in fact in mid 2002 a centralized registry was already operating in that Autonomy.¹⁴. In addition, the committee of Bioethics of Catalonia, organ advisor of the Generalitat in the subject, has published some Considerations on the Advance Directives Document and has presented an indicative document model .¹⁵.

    c. Standards after December 2000.

It is not possible to refer here to the details of the PI contained in the autonomous regulations that followed in the wake of the Law of Catalonia. Applying the chronological order of their enactment, the following are those differentiating features that seem to me to be worthy of mentioning accredited specialization.

Galicia

The article 5 of Law 3/2001, of May 28, presents, in subject of Ip, an almost literal coincidence with the article 8 of the Law of Catalonia. The only significant difference is that the Galician Law does not include the figure of the representative as interlocutor and advocate of the patient's Ip, which is a striking omission.

Extremadura

The section 5 of article 11 of Law 10/2001, of June 28, recognizes the right to the expression of PI, in terms that are a slightly simplified version of those contained in article 8 of the Law of Catalonia. However, it exempts conformity with the lex artis or good clinical internship as a necessary element for the validation of PIs. Nor does it establish a regional registry of PIs.

Madrid

In the Preamble of Law 12/2001, of Health Regulation of the Community of Madrid, the use of the term Advance Directive is justified, in preference to Advance Directives or Living Wills, because of its consistency with the agreement of Oviedo and with the State Law 41/2002, then in parliamentary procedure.

The rules and regulations included in the article 28, on Ip, reiterates in abbreviated form that of the article 8 of the Law of Catalonia, with the significant difference of not pronouncing on the way of formalizing the document: it demands that the Ip be expressed in writing and that in an irrefutable way it is recorded that they have been granted in the required conditions, but without specifying the procedures (notarial or before witnesses) that the Catalan rule introduces. Neither does reference letter make reference to the existence of an Autonomous Registry of Ip.

Aragon

Law 6/2002, of April 15, 2002, on Health in Aragon, reiterates in its article 15 and without substantial changes the Catalan rules and regulations on Ip. It presents, however, an important novelty: the requirement, expressed in section 5 of article, that each hospital center must have a Commission in charge of assessing the content of such wills. In line with this provision, on May 6, 2003, the Government of Aragon published Decree 100/2003 approving the Regulations for the organization and operation of the Registry of Advance Directives. The Regulation includes, along with a detailed regulation of the Registry, a article 5 which regulates the structure and functions of the Commission which, in each health center, will be in charge of assessing the Advance Directive Documents knowledge. It will be made up of three or more members, appointed by the Director of the center, at least one of whom will have training accredited in Clinical Bioethics and another will be graduate in law or graduate with accredited knowledge of health legislation. The function of these Commissions will be the evaluation of the PI Documents that are presented in the Health Centers or that are sent to them by the Registry. If, in the opinion of the Commission, the content of a Document could imply a violation of the legislation in force, of Medical Ethics, of the good clinical internship or that it does not correspond exactly with the eventuality that was foreseen at the time of issuing it, the Commission will take the agreement decision that it should not be taken into account. The Commission's decision must be recorded in the patient's medical record.

The performance of this new institution will need to be closely monitored. It can obviously facilitate the work of physicians in interpreting the contents of Ip documents, but it may give rise to conflicts that are not difficult to imagine.

La Rioja

Law 2/2002, of April 17, 2002, on Health in La Rioja, includes the rules and regulations on Ip in section 5 of its article 6, rules and regulations which essentially coincides with that of the Law of Catalonia. However, it presents some differences with the latter. It makes the Ip document valid not before the physician manager, but before the Public Health System of La Rioja, which thus assumes a peculiar guardianship function, conditional on the document being registered in the Registry of Wills attached to the competent Regional Ministry in subject health. This seems to close the way to Ip's that are presented by the patient or his/her representative directly to the health center or physician. The formalization process is also peculiar: only Ip's formalized by means of a notarial document, in the presence of three qualified witnesses, are recognized as valid.

Navarre

The Foral Law 11/2002, of May 6, 2002, was amended, once the Basic Law 41/2002 had been enacted, by means of the Foral Law 29/2003, of April 4, 2003. The rules and regulations on Ip did not have to be modified, since the Foral Legislative considered the content of article 9 of the Foral Law of 2002 to be in accordance with the State rule .

This article reproduces the general ideas of the rule of Catalonia, although it presents some additions that deserve comment. In the first place, it grants to the capable minor the condition of a capable subject to grant an Ip. Secondly, it lists a series, somewhat rhetorical, of situations to which the Ip can be directed: "so that, in the case of critical, vital and irreversible situations with respect to life, suffering is avoided with palliative measures, although the vital process is shortened, life is not artificially prolonged by means of disproportionate or extraordinary technologies and treatments, nor is the process of death delayed abusively and irrationally". Thirdly, it adds "the best scientific evidence available" to the three disabling criteria of the Catalan rule . And it adds, enigmatically, that "the Health Administration will adopt the necessary measures to guarantee the advance will of the patient contained in the document".

It is interesting to note that a Foral Decree 140/2003, of June 16, 2003, has been enacted to regulate the Registry of Advance Directives, which will fulfill the functions of a archive to which citizens can entrust their Ip documents and at the same time facilitate, through the use of appropriate technologies, access to them by health professionals who have to provide attendance health care to the interested parties.

Cantabria

Law 7/2002, of December 10, 2002, on Health Regulation in Cantabria, which in its Preamble declares itself to be tributary to the State Law and to some regional laws, presents two singular features.

One is the radicalization of the right to the issuance of Ip. Indeed, section 1 of article 34 establishes that "the Username of the Autonomous Health System, of legal age and with full capacity to act, has the right to absolute respect for his/her previously expressed will, in those cases in which the circumstances of the moment prevent him/her from expressing it in a staff, current and conscious manner". This strong character of the Ip is reinforced in section 5 of the same article which states that "the declarations of will expressed in advance will be binding, once registered in the Register of Wills attached to the competent Regional Ministry in subject of health, which will be regulated by regulation".

The other establishes, at section 3 of the same article 34, that a document subject will be put into circulation by the competent Regional Ministry at subject for health, which will be offered to users and which will include, among other things, the possibility of refusing not only treatments that temporarily and artificially prolong life and life-sustaining interventions, but also the request for sedation and/or analgesia in terminal cases. Fortunately, these potentially intimidating rules are tempered by the inclusion in section 6 of the reassuring clause that advance directives incorporating provisions contrary to the legal system or to good clinical practice internship cannot be taken into account.

Basque Country

Law 7/2002, of December 12, 2002, on Advance Health Care Directives is a very detailed document, which includes an expanded Ip model , in which it is possible to declare vital objectives and personal values in order to help interpret them and make better clinical decisions when the time comes.

It also broadens the exclusion criteria to be able to act as the patient's representative; it details that the Ip can be circumscribed in its object to certain diseases, present or future, and include provisions regarding the medical interventions desired or refused; it accepts, in addition to the formalization made before a notary or before three specially qualified witnesses, the one made before the public official or employee in charge of the Basque Registry of Advance Directives. It specifies the conditions for modification, substitution and revocation, which must follow the same procedure as the original document, since only the content of the last document granted can be taken into account. The lex artis is not accepted as a criterion for the rejection of the Ip, although it establishes that instructions regarding medical interventions that the grantor wishes to receive when they are contraindicated for his/her pathology will be deemed not to have been given.

The Basque Registry of Advance Directives will act in accordance with the principles of confidentiality and interconnection with other similar registries. The Registry may be in charge of sending the PI document to the health centers.

Valencia

Law 1/2003, of January 28, 2003, on Patient Rights and Information, dedicates its article 17 to PI. It confers the right to issue them to the emancipated minor. It states that the document must be respected by healthcare professionals, but admits the possibility that compliance with it may give rise to conscientious objection, a circumstance that the administration will remedy so that the will of the patients can be fulfilled. It leaves open the possibility of establishing by law other procedures for formalizing the advance directives document, in addition to having it notarized or witnessed by three witnesses. In the event that the grantor modifies, extends, specifies or cancels his or her will at any time, this must be recorded in writing or undoubtedly, and the last action of the grantor will be valid. The Department of Health will create a centralized registry to be developed by regulation.

Balearic Islands

Law 5/2003, of April 4, 2003, of Health of the Balearic Islands, dedicates its article 18 to the Ip. It excludes from the criteria for invalidation of the Ip the non-conformity with the lex artis or the good clinical internship . It establishes that the centers will provide information and models of advance directives. And it establishes the creation of an official registry of Ip, which will be governed by criteria of preservation of privacy and confidentiality of the data incorporated.

Castilla-León

The article 30 of Law 8/2003, of April 8, on the Rights and Duties of Persons in Relation to Health contains a brief rules and regulations of the Ip, which entrusts the details to a future regulation of the registration formulas and of the procedure to guarantee compliance with the Ip and which will be in accordance with the basic state rules and regulations . It leaves open the possibility of formalizing the Ip documents "before staff at the service of the Administration designated by the competent Regional Ministry in subject of Health, under the conditions to be determined by regulation". It seems to close the way to the issuance of Ip by mature minors, since it states that Ip can only be granted by persons of legal age, capable and free.

B. Ethical and ethical aspects.

1. Ethical standards on PI.

Many national and international medical organizations have already made statements on PIs.

In Europe, the Declaration of the Permanent committee of European Doctors on living wills/Ip, adopted during the Plenary Session held in 1993 in Cascais, was of particular relevance.¹⁶. In this Declaration, the Permanent committee considered that there were many social, cultural and religious factors that created very varied legal and professional contexts in Europe, and that it was therefore premature to propose a definitive document. Nevertheless, it seemed timely to publish the Declaration in order to establish some general principles and recommendations. In essence, the Declaration stated that there should be no connection between Ip and euthanasia; that no longer able patients have the same rights with respect to health care as able ones; that physicians should promote the best interests of their patients; that Ip's are a valid statement of the patient's wishes for when he or she is no longer capable, that in principle they should be honored once they have been interpreted by the physician with loyalty and good professional judgment, but that when faced with Ip's, physicians cannot be forced to act against their conscience; that it is the patient's task to make his or her Ip's known to those who are responsible for ensuring that they are honored; and, finally, that the voice of the medical profession should be heard in the preparatory discussions for legislating on subject .

The Code of Medical Ethics and Deontology of the Spanish Medical Association (Organización Medica Colegial de España)¹⁷ establishes in its article 27.2 the ethical criteria for futile interventions and Ip. After pointing out to the physician not to undertake or continue hopeless, futile or obstinate diagnostic or therapeutic actions, and urging him to take into account the patient's explicit will to refuse life-prolonging treatment so that he can die with dignity, the article continues: "And when his [the patient's] condition does not allow him to make decisions, the physician will take into consideration and value the previous indications made by the patient and the opinion of the responsible related persons".

One of the most mature documents on subject comes from Germany. It is a guideline from the Federal Medical Chamber to assist physicians with regard to the Ip of their patients. It discusses the different modalities of PI, their contents, the clinical situations for which they are intended, the medical interventions they may affect, and the traits that shape the personality. An important place in these guidelines is occupied by the advisory role of the physician, the specification of the points, circumstances and moments in which the PIs should be confirmed or modified, and some recommendations on conservation and submission. An important element of the guidelines is the invitation to physicians to take the lead in subject and not to abandon this important aspect to the pressures of activists.¹⁸.

2. Conflicts posed by PIs at the ethical-legal frontier.

    a. Ascertaining the legitimacy of the Ip.

Before granting effectiveness to an Ip, the physician must conclude that there are no serious reasons to doubt its validity. To do so, he must judge whether the patient drafted them under the proper conditions of mental and psychic lucidity. The task is facilitated both in the case where the PIs are presented personally by their holder to the physician, as well as in the case of those issued before a notary, who must be assumed to have the necessary skill to judge the capacity of the subjects to conclude business deals or grant wills.¹⁹.

But the physician cannot take as good some PIs that are presented to him by third parties without having diligently ascertained whether, at the time of issuing them, the holder of the PIs was capable of making those particular decisions; whether he did so free of external or internal, invalidating influences; whether he was sufficiently informed to make that decision; whether he intended his PIs to be applied to the status and present circumstances. This obliges the physician to review the patient's medical history; to question with intelligence, sagacity and confidence the patient's representative; to contact the attending physician. The potential complexity of this status reveals the convenience that the patient should discuss with his physician everything related to his Ip.

It has been proposed, in order to save this status, that it is essential to establish a system (of certification or authentication) of the document, to guarantee the identity and capacity of the holder of an Ip; with a mandatory registration procedure that can operate in real time and that can be accessed from all medical centers. The registry, at least national in scope, should be consulted when a patient who is not in a position to consent is being treated.²⁰.

    b. Events that cause the Ip to come into effect: twilight situations.

The effectiveness of the PIs is conditioned by the unavoidable circumstance that the holder is not capable of personally expressing his will, that he has lost the capacity to determine himself. Only then do the PIs become operative, can they come into effect. With the capable patient, communication prevails staff, direct, however imperfect it may be.

Judging when this happens can pose serious problems, since it is not always a matter of diagnosing unequivocal situations of coma, persistent states of unconsciousness. There are very frequent clinical pictures in which the patient's ability to express himself is transiently lost, is on Fail because of the physician's intervention, or fluctuates. Medication-induced sedation or delirium are not uncommon. It is therefore a difficult task to judge the moment when the patient passes from the state of consciousness to a twilight period, to determine when he/she appears to be able to make transcendental decisions and when he/she is no longer able to do so, to estimate the reversibility of the incapacitating states. Clinical prudence, the internal morality of medicine that leads to granting the benefit of the doubt in order to favor the life and interests of the patient, restrains the physician from putting into effect some Ip. Under these conditions, abandoning treatment to please a PI could lead to the catastrophic status of a patient who survives with increased damage because, in order to please his PIs, the physician had not initiated or had suspended a beneficial treatment. The prevailing professional view is that never can a PI prohibit physicians from providing the most appropriate palliative treatment available.²¹.

Fortunately, and wisely, the Law has left to the physician's judgment the responsibility of deciding when Ip can be performed, and has allowed him to put his social commitments - to respect life and alleviate suffering - and his good professional judgment before the automatism of mechanically applying Ip.

    c. To take into account or not to take into account.

This is not the only judgment that the law entrusts to the good discretion of the physician. The latter may or may not take them into account.

The PIs suffer, in a certain way, from a congenital weakness, inherited from Oviedo's agreement that conceives them as an adjuvant element in decision making, so that, as stated in point 62 of its explanatory report , "the taking into consideration of previously expressed wishes does not necessarily mean that they must be followed". It is logical, because to take into account is to keep in mind, to consider. And to consider, to take into consideration, is to think, to reflect on something with attention and care, not to execute it at all costs.

The PIs make the patient's voice and wishes present before the physician, but the imperative force of these is logically limited by factors as strong and important as conformity with the legal system, with the good clinical internship and with the coincidence with the factual situation.
There is no lack of regulations, however, that confer a hypothetical binding force on the PI, such as that of Cantabria, or that introduce them by the hand of the Administration or the Registry in order to enforce them, as if they were an order, in the decision-making process. The imperative meaning, linked to the patient's status as an order, has been linked to the use, in the United States, of the legal-clinical language of treatment orders (not only active, but also aggressive) and, above all, of non-treatment orders, linked to the prevalence in American culture of the almost absolute principle of autonomy.²².

In any case, however, it is highly doubtful that PIs can ever be enforced with mandatory legal force. Although judgments have been handed down in the United States and Canada against physicians who have failed to perform Ip's on their patients, in Europe the scarce and underdeveloped case law does not allow conclusions to be drawn.²³.

We must not forget that PIs were born precisely to avoid technological abuses in the final days of life, to exclude futile treatments. They should not favor attitudes of exalted autonomism, of arrogant self-determination of I do with my life what I want. It is important that the implementation of PI, the legislation and regulations for their application, as well as the jurisprudence that will shape them, favor in everyone a sense of "sensible" predetermination, of considered autonomy: that is what they were born for.

d. Prepared forms vs. personalized writings.

Several autonomous community legislations are considering the possibility of Ip's being formalized on the counterfeit of certain standard forms, given the advantages that these formats could offer both for their incorporation into the Registry and for their computerized transmission. In fact, as already mentioned, the committee of Bioethics of Catalonia has offered to the public a model of Ip with instructions for its use.

Ip models abound and there is no shortage of those who are enthusiastic about forms that are both sturdy and adaptable.^{24 25}. But the mere possibility that filling out a form is appropriate for submitting PIs is strongly rejected by those who consider individualized documents to be more authentic and personal. They attribute many disadvantages to the use of forms: uncertainty that their impersonal language is not only not fully understood by the signatory, but is inappropriate to capture the specificity that Ip's should have. There is evidence that many patients are intimidated by the abstruse language of technical medicine, as they are by the technicalities of formal legal style. In addition, many elderly people are accustomed to signing, when invited to do so, documents whose content they do not understand²⁶. The preparation of Ip's through a dialogue between doctor and patient is defended as a valid alternative. It has even been argued that this doctor/patient communication, when it crystallizes into what has come to be called a "value story", is much more authentic and informative about the patient's wishes and desires.²⁷.

It is necessary to wait and see what happens once the Autonomous Communities have legislated on the practical aspects of Ip.

e. Maintenance, revocation, modification.

It may often happen that PIs are written and recorded, only to be forgotten. An effective factor of invalidation is the long time elapsed between the date of essay and the date of application. The agreement of Oviedo indicates this in point 62 of its explanatory report .

It is a general opinion that PIs should be reviewed. The grantor is free to do so periodically or not. It has been suggested that at least a ratification of the document or, if appropriate, a revision, should be made every 5 years, for example, following a simple mechanism for the registration of the ratified or modified document. The regulatory rules and regulations should have procedures to make effective the revocation or modification of PIs in emergent situations, such as hospital admission, immediate internship of a high-risk intervention, or simply when the patient whispers in someone's ear that he or she has changed his or her mind about his or her PI.

As rightly pointed out by de Lorenzo, the requirement that PIs must be written in a document to be valid can be obstructive and counterproductive. The possibility of adding an authorized transcript of a verbal order from the patient should be allowed.

One aspect that can create confusion is the existence of copies of documents that are no longer valid and that may have remained on file in the medical records or on the instructions computer. If the patient distributes copies to different people (doctors, relatives or companions, lawyers, priests), he/she should keep track of them in order to collect the expired copies and replace them with new ones. It is therefore necessary that the PIs are clearly dated, as only the most recent variant is legally effective.

    f. The great absentee: the right to the spiritual financial aid .

In contrast to the usual presence, in national or international legal and professional determinations on Ip, of religious care among the elements to be included in Ip, neither in Law 41/2002 nor in any of the autonomous community laws does accredited specialization appear any reference to religious care.
Perhaps this omission is a legacy of article 10 of the General Health Law, in which the right to receive, or reject, religious attendance is conspicuously absent, which is a striking exception. This right appears in the internship totality of patients' bills of rights, although it has often been relegated to the bottom of the list. For many patients, PIs are not complete without their desire for religious and sacramental care, especially the sacrament of the sick, even in the precarious circumstances of loss of capacity in which PIs become operative.

In my opinion, this absence is regrettable. There is a tendency to emphasize time and again that PIs are a manifestation of autonomy, even strong autonomy. But PIs are established for situations of need, they are a request from financial aid rather than a dry and unappealable mandate. They always presuppose that individuals and social groups are always in need of help from others. The terminal status , the main field of application of PI, is incompatible with moral foreignness, with speaking different languages, with social disconnection. The doctor/patient relationship that presents its Ip presupposes the recognition of the freedom of each one, doctor and patient, to live his or her own life. And although this situation will not always allow them to become "moral friends", it does bring them closer to the condition of "moral acquaintances".

The condition of "moral acquaintances" can not only open dialogue and negotiation on the technical aspects of medicine: it authorizes, with exquisite respect for freedom staff, to suggest the inclusion of the religious dimension in that very special testament which are the Ip.