- Email: [email protected]
End-of-life, euthanasia, and assisted suicide: An update on the situation in France
revue neurologique 172 (2016) 719–724
Available online at
ScienceDirect www.sciencedirect.com
General review
End-of-life, euthanasia, and assisted suicide: An update on the situation in France R. Aubry a,*,b Axe « E´thique et progre`s me´dical », Inserm CIC 1431/neurosciences inte´gratives et cliniques, EA 481, university Bourgogne Franche-Comte´, 2, place Saint-Jacques, 25000 Besanc¸on, France b CHRU de Besanc¸on, 2, boulevard Fleming, 25030 Besanc¸on, France a
info article
abstract
Article history:
On February 2, 2016, the French parliament adopted legislation creating new rights for the
Received 5 June 2016
terminally ill. The text modifies and reinforces the rights of patients to end-of-life care and
Accepted 27 September 2016
strengthens the status of surrogate decision makers. Under the new regulations, advance
Available online 21 October 2016
directives become legally binding though not unenforceable. Two types of advance directives are distinguished depending on whether the person is suffering or not from a serious
Keywords:
illness when drafting them. The attending physician must abide by the patient’s advance
Law
directives except in three situations: there is a life-threatening emergency; the directives are
End-of-life
manifestly inappropriate; the directives are not compatible with the patient’s medical
Patient’s right
condition. There is no time limit on the validity of advance directives. They are to be
Advance directives
written in concordance with a model elaborated by the French superior health authority.
Sedation
This model takes into account the person’s knowledge (or not) of having a serious illness when drafting his/her advance directives. In all likelihood, physicians will be called upon to help patients elaborate their advance directives. The law also has a provision for a national registry – potentially the shared medical file – to be designed as a reference source to facilitate storage, accessibility and safety of advance directives. The law introduces the right to continuous deep sedation until death in three specific situations: (i) at the patient’s request when the short-term prognosis is death and continuous deep sedation is the only alternative for relieving the patient’s suffering or one or more otherwise uncontrollable symptoms; (ii) at the patient’s request when the patient chooses to withdraw artificial lifesustaining treatment and such withdrawal would be rapidly life-shortening and susceptible to cause unbearable suffering; (iii) when the patient is unable to express his/her wishes and the collegiate medical decision is to withdraw aggressive futile life-sustaining treatment; continuous deep sedation is mandatory when the patient presents signs of suffering or when the patient’s suffering cannot be evaluated due to the patient’s cerebral or cognitive state. The law stipulates prior control of such practices, implying the development of a new type of collegiate procedure for medical decision-making. Satisfactory application of this new law will depend greatly on the implementing decrees. It will also depend on the implementation of a genuine policy for the development of palliative care. Professional
* Correspondence. E-mail address: [email protected]. http://dx.doi.org/10.1016/j.neurol.2016.09.007 0035-3787/# 2016 Elsevier Masson SAS. All rights reserved.
720
revue neurologique 172 (2016) 719–724
guidelines will be needed. Several issues relevant to the field of neurology remain unresolved or are introduced by the new regulations. Further in-depth reflection and research are need. # 2016 Elsevier Masson SAS. All rights reserved.
1.
Introduction
French legislation on end-of-life care was recently changed when the parliament adopted law no 2016-87 on February 2, 2016, creating new rights for patients and persons at the end of their life. This article offers us the opportunity to explain the changes this new law imposes and to discuss the implications for neurology. Beyond an explanation of this specific law, we will explore the topic of end-of-life care and its relationships with the questions of euthanasia and assisted suicide of persons suffering from advanced-stage neurological disease (brain tumor or neurodegenerative disease) or brain damage.
2.
Semantic definitions
In this context, it is important to carefully define the words used to describe these sensitive questions concerning the end of life.
2.1.
2.3.
Euthanasia
According to commonly accepted definitions, euthanasia is an action designed to voluntarily terminate the life of a person who has a severe incurable disease that is performed at the request of that person and with the objective of ending a situation the person considers intolerable1. Individual persons may express simultaneously their desire to die and their refusal (or their psychological incapacity) to terminate their life themselves – irrespective of any context by which a disease state would prevent them from taking the necessary action – or their preference that a physician, at their request, should execute the lethal act instead of themselves. Euthanasia remains a penal offence in France.
2.4.
End-of-life sedation
Pharmacologically-assisted suicide
Assisted suicide consists in giving a person the means necessary for suicide. In this situation, after delivery, the lethal product is self-administered by the person committing suicide. The only voluntary action producing the lethal effect is made by the person who can, within his/her private sphere, terminate his/her own life. The person in possession of the lethal product is free to decide against self-administration. Although assisted suicide necessarily involves the intervention of an outside person (prescription, authorization), the responsibility for the final action is fully born by the person who requests assistance. It must be noted that the notion of assisted suicide is fraught with tension because of the opposing notion of duty to assist a suicidal person. Pharmacologically assisted suicide remains a penal offence in France.
2.2.
becomes ‘‘medically assisted suicide’’, to perform the act he/ she cannot perform alone. Assisted suicide remains a penal offence in France.
Assisted suicide
The notion of assisted suicide is based on the precondition that a person has the will to voluntarily terminate his/her own life but not the concrete means to do so. This type of situation is common in neurology where certain patients with a neurological disability – e.g. tetraparesia, tetraplegia, or locked in syndrome – are unable to terminate their own life even though they decide independently to do so. In this context, the person asks a third party, who can be a healthcare professional, in which case the term
‘‘Sedation is the search through medication for diminished vigilance, even to loss of consciousness. Its goal is to diminish, or eliminate, the perception of a situation that for the patient is intolerable despite the fact that all of the available means appropriate for this situation have been proposed but have not achieved the desired relief2’’. Sedation is a medical act. It can be intermittent (temporary sedation) or continuous. The depth of sedation may vary (vigilant sedation/coma). Sedative treatments, used to obtain relief, diminish vigilance or consciousness in a dose-dependent manner. These treatments alter both cognitive function and communication, which may be desired but which is necessarily questionable because communication with one’s close family and friends is of utmost importance, especially at the end of life.
1
This definition was retained by the CCNE (French governmental consultative advisory council on bioethics issues [Comite´ consultatif national d’e´thique]) in its opinion no 121: End of life, personal autonomy, will to die [Fin de vie, autonomie de la person, volonte´ de mourir]. July 1, 2013. 2 Consensus opinion. Sedation for distress in the terminal phase and in specific and complex situations [La se´dation pour de´tresse en phase terminale et dans les situations spe´cifiques et complexes] [2].
revue neurologique 172 (2016) 719–724
In all cases, before administering sedation in the terminal phase, a concerted consultation is required to examine its possible effects3.
3. French law no 2016-87 of February 2, 2016 creating new rights for patients and for persons at the end of life French law no 2016-87 of February 2, 2016 is a prolongation of the law no 2005-370 of April 20, 2005 (called the Le´oneti law) relative to patients’ rights at the end of life. The new law reinforces existing patients’ rights and adds new rights. It was promulgated after nearly 4 years of reflection with public and parliamentary debates.
3.1.
Reinforcing existing patients’ rights
The right to terminate one’s existence without aggressive and futile therapy is confirmed. If a therapeutic act is ‘‘futile, or disproportionate, or has no other effect than to sustain life artificially, it may be suspended or not undertaken, in compliance with the patient’s will’’. Persons at the end of life have the right to die without suffering, in all circumstances, even in the most complicated situations. ‘‘Everyone has the right to die with dignity, with the best possible relief of suffering. Healthcare professionals implement all means available to guarantee this right. The physician institutes analgesic and sedative treatments to relieve the suffering of patients with very advanced-stage or terminal illnesses, even if such treatments can have a lifeshortening effect’’. The right to have one’s wishes respected is reinforced. French legislation instituted the legal status of the personne de confiance, i.e. the surrogate decision maker or healthcare proxy, in 2002. The legal status of this person was consecrated in 2005 and is reinforced in the present law. The personne de confiance expresses the will of the sick person, and statements made by the personne de confiance take precedent over those of other people. The attending physician has the obligation to ensure that patients are informed of the possibility of designating a personne de confiance. Patients designate their personne de confiance using a written document that is cosigned by the designated person. In this document, the patient states the duration of the mandate. Under judicial guidance, a person under legal guardianship can now draft advance directives.
3.2.
Advance directives become legally binding
The new law instituted several changes concerning advance directives that affect their validity, their impact on medical decision-making, their content, their scope and their conservation: 3
Reference made to the notion of shared deliberation expressed in the European Council bioethics committee (DH-BIO). Guide sur le processus de´cisionnel relatif aux traitements me´dicaux dans les situations de fin de vie : European Counsel, Strasbourg, May 2014.
721
the law distinguishes two types of advance directives depending on whether the person has a serious disease or not at the time the directive is written; attending physicians are now required to consider advance directives as the expression of the will of patients who are no longer able to express their desires. Before this law, such directives were consultative. Under the new regulations, advance directives become legally binding though not unenforceable. The physician is required to abide by the directives except in three situations: there is a life threatening emergency, the directives are manifestly inappropriate, the directives are not compatible with the patient’s medical condition. In situations other than life threatening emergency, non-application of advance directives must now emanate from a collegial decisionmaking process. Such decisions will be made – a decree and/or professional guidelines are expected to detail this point – after concerting with at least one other physician who is qualified to evaluate the concerned pathology and who has examined the patient. This second opinion will be recorded on the patient’s medical chart; the field of application is broadened. Advance directives now express a person’s will relative to his/her end of life and the conditions under which treatments or medical interventions are to be pursued (a notion not present in the earlier law), limited, discontinued, or refused; the former law limited the validity of advance directives to 3 years. The new law does not make any stipulation as to the duration of the validity of the directives. This change can probably be explained by the fact that the length of time during which certain patients with neurodegenerative diseases may survive lasts for long periods measured in years; to be applicable, directives must be precise: the new law states that they must be written in compliance with a model elaborated by the French superior health authority (HAS4). This model takes into account the fact that when writing the directives the person is aware or not of having a serious illness; ensuring that all patients have written advance directives is not a primary objective. The goal is for advance directives to be used as an instrument of dialogue helping the person with a terminal disease anticipate his/her own end of life and express as accurately as possible his/her personal decisions [1]; healthcare professionals, especially attending physicians, will be called upon to help the patient draft his/her advance directives. The IGAS5 was assigned a specific mission concerning advance directives [2] and considers that primary care physicians have an obligation to assist patients who want to draft their advance directives. According to the IGAP, this accompanying assistance is a medical consultation; 4
HAS: French Superior health authority [Haute Autorite´ de la sante´]. 5 IGAS: French Inspectorate general for social affairs [Inspections ge´ne´rales des affaires sociales].
722
revue neurologique 172 (2016) 719–724
in the same line as the Council of Europe recommendations, and in accordance with several European jurisprudence decisions and the Conseil d’E´tat decision Vincent Lambert of June 24, 20144, in the event that the patient has not made any advance directive, the attending physician seeks directives from the personne de confiance, or by default, from close relatives or friends (Art. L.1111-12article 12); in order to ensure direct access to advance directives, a Conseil d’E´tat decree will be promulgated, after consultation with the National committee on information and freedom, to define the conditions of validity, confidentiality, and conservation of advance directives in a national registry. As stated in the law, this ‘‘registry’’ serving as a reference for storage, access, and safety of advance directives could in fact, according to the IGAS report cited above, be a shared medical file managed by the CNAMTS6 and the ASIP7, as described by the framework law on modernization of the healthcare system.
4. Introduction of a new right: the right, under certain conditions, to continuous deep sedation Professional guidelines, validated by several learned societies and the French superior health authority (HAS), have been available for several years5. The law details three exceptional circumstances under which the physician has the obligation, in order to avoid patient suffering, to institute an exceptional type of sedation: continuous deep sedation until death: at the request of the patient when death is eminent (i.e. within a short time-span to be defined by professional guidelines, probably a few hours or days) and continuous deep sedation is the only means by which the patient can be relieved of suffering or one or more otherwise uncontrollable symptoms; at the request of the patient when he/she chooses to discontinue treatments sustaining life artificially, this discontinuation necessarily leading to short-term fatal outcome and potentially inducing intolerable suffering; when the patient cannot express his/her will and the physician, after a collegial decision-making process, discontinues futile aggressive life sustaining treatment; continuous deep sedation is necessary when the patient presents signs of suffering, or when the patient’s suffering cannot be assessed due to the patient’s cerebral or cognitive status, this concerning brain injured patients of all ages, but also patients with very advanced-stage cognitive disorders.
The law provides that continuous deep sedation, in situations where such sedation is mandatory, should be combined with analgesic treatment and the withdrawal of all life-sustaining treatments. It is to be noted that under these circumstances, continuing artificial nutrition and hydration is to be considered as unwarranted unreasonable obstinacy. It is obvious that in these three exceptional situations, death is an inevitable short-term outcome, with or without sedation. A quite different reflection is required when the life expectancy of a person with a serious incurable illness is measured in weeks. In this situation, if sedation is necessary to relieve refractory symptoms, such sedation, according to professional guidelines5, should be modulated, i.e. not necessarily deep, but sufficient to provide symptom relief. According to the law’s provisions, an a priori control is required before implementing these practices. This control is performed within the framework of a new type of collegial process that will be the object of upcoming implementation decrees. The patient’s attending physician will ensure that the conditions are met for continuous deep sedation after concerting with the members of the care team, if there is one, and the justified opinion of at least one other physician called in as a consultant. Satisfactory application of this new law will depend greatly on the implementing decrees on advance directives and continuous deep sedation until death. Satisfactory application will also depend upon the implementation of a genuine policy for the development of palliative care. A priori, the implementation of the four areas of action of the Plan8 for accompanying and palliative care (CNAMTS) should facilitate this national policy. The Plan’s areas of action are: patient education to enable patient-centered decision making; professional training, research and knowledge transfer on palliative care; home care: favoring palliative care in the patient’s home, including patients residing in social and medicosocial institutions; guaranteed access to palliative care: reducing inequality of access to palliative care. Finally, proper use of this law will also largely depend upon the professional guidelines to be established. The law provides for an annual government report to Parliament – before the vote on draft legislation for Social Security funding9 – on implementation of the law and the plan. This regulatory and financial provision is necessary to ensure proper implementation of the law.
8
6
CNAMTS : French national healthcare fund for salaried employees [Caisse nationale de l’assurance maladie des travailleurs salarie´s]. 7 ASIP: French Agency for shared information systems in health [Agence des syste`mes d’information partage´s de sante´].
Announced on December 3, 2015, this plan for 2016–2015 has a budget of 190 million Euros. The objective is to create one palliative care bed per 100,000 inhabitants, 6 new palliative care units and 30 new mobile palliative care teams in 2016, as well as to develop training and research and create a university curriculum. 9 Article 14 for the law no 2016-87 of February 2, 2016.
revue neurologique 172 (2016) 719–724
5. For neurology, what are the implications of this new legislation? 5.1. Certain questions remain unanswered and will require in-depth work and research
723
no one can predict. Consequently, an advance directive cannot be construed as an end in itself; it is simply a means by which seriously ill individuals can express their desires about their final journey. Advance directives can be revised at any time, which means that all sick persons should be invited regularly to rethink their directives as their disease evolves.
Questions concerning advance directives are: Questions concerning sedation are: one might wonder about the intrinsic value of advance directives depending on whether they are drafted by a person suffering from a severe illness or not. While it might appear reasonable, or desirable, to anticipate future events when one has a serious illness or perceives oneself as a ‘‘sick person’’, questions arise when it comes to one’s capacity to project into a future life-terminating state that might develop outside any context of illness, e.g. survival despite severe alteration of consciousness after head trauma or stroke, or cardiac arrest. The law does not distinguish between these two types of directives despite the fact that in its opinion statement no 121, the CCN10, the national governmental consultative advisory council on bioethics issues, distinguished two possible types of anticipation depending on the circumstances. The first type of directive, termed ‘‘anticipated statement of will’’, is written outside a context of illness, and is designed basically to expose one’s desires in terms of living environment and mode of treatment. For individuals with a serious or potentially fatal disease, directives serve as a tool to facilitate dialogue between caregivers and the sick person. They are designed to anticipate medical decisions, taking into account disease progression and the different options as they develop; there is a risk that advance directives could be underused or misused because of certain insufficiencies involving time, availability, or caregiver training in communication skills for complex situations. There is a risk such directives would become – and unfortunately this is already the case in many situations – simply another administrative form that is proposed but not always completed with adequate care. There could also be a paradoxical effect, i.e. anticipated directives becoming legally binding even when not issuing from a progressive collective process of elaboration. Under these situations, it is most likely that many healthcare professionals would lack sufficient commitment, meaning that very few patients would draft advance directives. Before advance directives can become truly invested as an opportunity to aid the seriously ill along their personal journey, healthcare professionals (especially physicians) will need education in communication skills for complex situations. The ability to implement such skills must be recognized as a genuine act of care; it must also be kept in mind that for many patients, drafting advance directives is a difficult, potentially impossible, task. There is no reason that a sick person must write advance directives. One’s capacity to anticipate necessarily limits one’s ability to foresee the future that, by definition, 10 CCNE [Comite´ consultatif national d’e´thique]. Avis 121 [Fin de vie, autonomie de la personne, volonte´ de mourir, 1er juillet 2013]. End of life, personal autonomy, will to die. July 1, 2013.
when reference is made to the possible use of continuous deep sedation ‘‘as requested by the patient in order to avoid suffering’’ or ‘‘when the patient presents suffering refractory to treatments’’ (Article L. 1110-5-2), isn’t there the possibility that this could lead to the belief that sedation can treat suffering? Letting individuals believe that suffering is a symptom that can be controlled by a drug is simplistic and dangerous. Of course, continuous deep sedation may be considered as a coma equivalent; that as such it induces a state of unconsciousness; but it does not suppress psychic life and probably does not suppress suffering. On the grounds that we are eliminating suffering, we must not satisfy ourselves with eliminating its expression; according to the law, this continuous deep sedation until death can be implemented in the patient’s home, in a healthcare institution, or in a nursing home, raising certain questions concerning feasibility, surveillance and followup. The appropriate medications are generally reserved for their anesthetic effect, meaning that in this context they are to be used for other purposes. At the least, professional guidelines for good clinical practices are needed; accepting to implement continuous deep sedation until death for a person who alleges refractory existential suffering or for a person who wants to avoid all suffering while waiting for death will raise questions for certain physicians concerning the legitimacy of the request. Nevertheless, it is important to always ask the following question: what gives a doctor the authority to oppose the request of a person who knows he/she is going to die within a very short time and who wants a drug-induced coma and the interruption of potentially life-sustaining treatments? as was mentioned in the preceding chapter, the law states that when the short-term prognosis is death a patient has the right to have continuous deep sedation until death implemented at his/her request. ‘‘Short-term’’ will have to be defined, here again via professional guidelines. In practice, we do not know how to maintain continuous deep sedation beyond a few hours or days. And fundamentally, what is the signification of an ‘‘end-of-life’’ that lasts for several days or weeks? finally, while it is essential to carefully differentiate between sedation and euthanasia, we must be vigilant concerning the use of this right to sedation. A priori, continuous deep sedation does not cause death but is designed to make more bearable this ultimate moment of existence. But a utilization that is not adapted to this objective, or the use of increasingly high doses, may accelerate the advent of death. As we can see in neighboring countries, the risk of deviating towards euthanasia-sedation is far from theoretical [3].
724
revue neurologique 172 (2016) 719–724
5.2. End-of-life of persons with neurodegenerative disease or severe brain damage The paradox of progress is that it produces, correlatively, situations of complex survival including periods of ‘‘long dying’’ that raise questions concerning the meaning of ‘‘endof-life’’. Current advances, and especially perspectives for the treatment of neurodegenerative diseases, should oblige us to anticipate new end-of-life configurations. As has been seen in the field of oncology over the last 15–20 years, it is quite possible that the corollary of progress in neurology (cure for neurological diseases or survival with sequelae having little impact on quality-of-life) will be, in certain cases, long-term survival of totally dependent persons with severely altered cognitive capacity. These situations raise, and will inevitably continue to raise, the question of the sense of such survival: in this context and considering future developments, it can be expected that persons will formulate advance requests for assisted suicide or euthanasia. Thus, medicine can contribute paradoxically to the generation of long periods of terminal survival that raise the question of the ultimate sense of life. It is in this context that healthcare professionals will be confronted with a question of transgression: will we, should we, come to the
point where we interrupt lives that we will have contributed to prolong? Let us hope that the development of an ethical reflection and its integration into medical training and practices will help each of us ponder the validity of instituting a treatment simply because we know how to, when the final effect would question the sense of life itself.
Disclosure of interest The author declares that he has no competing interest.
references
[1] CCNE. End of life, personal autonomy, will to die [Fin de vie, autonomie de la person, volonte´ de mourir]. Opinion no 121; 2013. [2] Blanchet V, Viallard ML, Aubry R. Se´dation en me´decine palliative : recommandations chez l’adulte et spe´cificite´s au domicile et en ge´riatrie. MEDPAL 2010;9:59–701. [3] Mattelhauer X, Aubry R. Pratique de la se´dation aux PaysBas : preuve du de´veloppement des soins palliatifs ou de´rive euthanasique ? Med Palliat Soins Support Accompagnement Ethique 2012;11:133–41.
Available online at
ScienceDirect www.sciencedirect.com
General review
End-of-life, euthanasia, and assisted suicide: An update on the situation in France R. Aubry a,*,b Axe « E´thique et progre`s me´dical », Inserm CIC 1431/neurosciences inte´gratives et cliniques, EA 481, university Bourgogne Franche-Comte´, 2, place Saint-Jacques, 25000 Besanc¸on, France b CHRU de Besanc¸on, 2, boulevard Fleming, 25030 Besanc¸on, France a
info article
abstract
Article history:
On February 2, 2016, the French parliament adopted legislation creating new rights for the
Received 5 June 2016
terminally ill. The text modifies and reinforces the rights of patients to end-of-life care and
Accepted 27 September 2016
strengthens the status of surrogate decision makers. Under the new regulations, advance
Available online 21 October 2016
directives become legally binding though not unenforceable. Two types of advance directives are distinguished depending on whether the person is suffering or not from a serious
Keywords:
illness when drafting them. The attending physician must abide by the patient’s advance
Law
directives except in three situations: there is a life-threatening emergency; the directives are
End-of-life
manifestly inappropriate; the directives are not compatible with the patient’s medical
Patient’s right
condition. There is no time limit on the validity of advance directives. They are to be
Advance directives
written in concordance with a model elaborated by the French superior health authority.
Sedation
This model takes into account the person’s knowledge (or not) of having a serious illness when drafting his/her advance directives. In all likelihood, physicians will be called upon to help patients elaborate their advance directives. The law also has a provision for a national registry – potentially the shared medical file – to be designed as a reference source to facilitate storage, accessibility and safety of advance directives. The law introduces the right to continuous deep sedation until death in three specific situations: (i) at the patient’s request when the short-term prognosis is death and continuous deep sedation is the only alternative for relieving the patient’s suffering or one or more otherwise uncontrollable symptoms; (ii) at the patient’s request when the patient chooses to withdraw artificial lifesustaining treatment and such withdrawal would be rapidly life-shortening and susceptible to cause unbearable suffering; (iii) when the patient is unable to express his/her wishes and the collegiate medical decision is to withdraw aggressive futile life-sustaining treatment; continuous deep sedation is mandatory when the patient presents signs of suffering or when the patient’s suffering cannot be evaluated due to the patient’s cerebral or cognitive state. The law stipulates prior control of such practices, implying the development of a new type of collegiate procedure for medical decision-making. Satisfactory application of this new law will depend greatly on the implementing decrees. It will also depend on the implementation of a genuine policy for the development of palliative care. Professional
* Correspondence. E-mail address: [email protected]. http://dx.doi.org/10.1016/j.neurol.2016.09.007 0035-3787/# 2016 Elsevier Masson SAS. All rights reserved.
720
revue neurologique 172 (2016) 719–724
guidelines will be needed. Several issues relevant to the field of neurology remain unresolved or are introduced by the new regulations. Further in-depth reflection and research are need. # 2016 Elsevier Masson SAS. All rights reserved.
1.
Introduction
French legislation on end-of-life care was recently changed when the parliament adopted law no 2016-87 on February 2, 2016, creating new rights for patients and persons at the end of their life. This article offers us the opportunity to explain the changes this new law imposes and to discuss the implications for neurology. Beyond an explanation of this specific law, we will explore the topic of end-of-life care and its relationships with the questions of euthanasia and assisted suicide of persons suffering from advanced-stage neurological disease (brain tumor or neurodegenerative disease) or brain damage.
2.
Semantic definitions
In this context, it is important to carefully define the words used to describe these sensitive questions concerning the end of life.
2.1.
2.3.
Euthanasia
According to commonly accepted definitions, euthanasia is an action designed to voluntarily terminate the life of a person who has a severe incurable disease that is performed at the request of that person and with the objective of ending a situation the person considers intolerable1. Individual persons may express simultaneously their desire to die and their refusal (or their psychological incapacity) to terminate their life themselves – irrespective of any context by which a disease state would prevent them from taking the necessary action – or their preference that a physician, at their request, should execute the lethal act instead of themselves. Euthanasia remains a penal offence in France.
2.4.
End-of-life sedation
Pharmacologically-assisted suicide
Assisted suicide consists in giving a person the means necessary for suicide. In this situation, after delivery, the lethal product is self-administered by the person committing suicide. The only voluntary action producing the lethal effect is made by the person who can, within his/her private sphere, terminate his/her own life. The person in possession of the lethal product is free to decide against self-administration. Although assisted suicide necessarily involves the intervention of an outside person (prescription, authorization), the responsibility for the final action is fully born by the person who requests assistance. It must be noted that the notion of assisted suicide is fraught with tension because of the opposing notion of duty to assist a suicidal person. Pharmacologically assisted suicide remains a penal offence in France.
2.2.
becomes ‘‘medically assisted suicide’’, to perform the act he/ she cannot perform alone. Assisted suicide remains a penal offence in France.
Assisted suicide
The notion of assisted suicide is based on the precondition that a person has the will to voluntarily terminate his/her own life but not the concrete means to do so. This type of situation is common in neurology where certain patients with a neurological disability – e.g. tetraparesia, tetraplegia, or locked in syndrome – are unable to terminate their own life even though they decide independently to do so. In this context, the person asks a third party, who can be a healthcare professional, in which case the term
‘‘Sedation is the search through medication for diminished vigilance, even to loss of consciousness. Its goal is to diminish, or eliminate, the perception of a situation that for the patient is intolerable despite the fact that all of the available means appropriate for this situation have been proposed but have not achieved the desired relief2’’. Sedation is a medical act. It can be intermittent (temporary sedation) or continuous. The depth of sedation may vary (vigilant sedation/coma). Sedative treatments, used to obtain relief, diminish vigilance or consciousness in a dose-dependent manner. These treatments alter both cognitive function and communication, which may be desired but which is necessarily questionable because communication with one’s close family and friends is of utmost importance, especially at the end of life.
1
This definition was retained by the CCNE (French governmental consultative advisory council on bioethics issues [Comite´ consultatif national d’e´thique]) in its opinion no 121: End of life, personal autonomy, will to die [Fin de vie, autonomie de la person, volonte´ de mourir]. July 1, 2013. 2 Consensus opinion. Sedation for distress in the terminal phase and in specific and complex situations [La se´dation pour de´tresse en phase terminale et dans les situations spe´cifiques et complexes] [2].
revue neurologique 172 (2016) 719–724
In all cases, before administering sedation in the terminal phase, a concerted consultation is required to examine its possible effects3.
3. French law no 2016-87 of February 2, 2016 creating new rights for patients and for persons at the end of life French law no 2016-87 of February 2, 2016 is a prolongation of the law no 2005-370 of April 20, 2005 (called the Le´oneti law) relative to patients’ rights at the end of life. The new law reinforces existing patients’ rights and adds new rights. It was promulgated after nearly 4 years of reflection with public and parliamentary debates.
3.1.
Reinforcing existing patients’ rights
The right to terminate one’s existence without aggressive and futile therapy is confirmed. If a therapeutic act is ‘‘futile, or disproportionate, or has no other effect than to sustain life artificially, it may be suspended or not undertaken, in compliance with the patient’s will’’. Persons at the end of life have the right to die without suffering, in all circumstances, even in the most complicated situations. ‘‘Everyone has the right to die with dignity, with the best possible relief of suffering. Healthcare professionals implement all means available to guarantee this right. The physician institutes analgesic and sedative treatments to relieve the suffering of patients with very advanced-stage or terminal illnesses, even if such treatments can have a lifeshortening effect’’. The right to have one’s wishes respected is reinforced. French legislation instituted the legal status of the personne de confiance, i.e. the surrogate decision maker or healthcare proxy, in 2002. The legal status of this person was consecrated in 2005 and is reinforced in the present law. The personne de confiance expresses the will of the sick person, and statements made by the personne de confiance take precedent over those of other people. The attending physician has the obligation to ensure that patients are informed of the possibility of designating a personne de confiance. Patients designate their personne de confiance using a written document that is cosigned by the designated person. In this document, the patient states the duration of the mandate. Under judicial guidance, a person under legal guardianship can now draft advance directives.
3.2.
Advance directives become legally binding
The new law instituted several changes concerning advance directives that affect their validity, their impact on medical decision-making, their content, their scope and their conservation: 3
Reference made to the notion of shared deliberation expressed in the European Council bioethics committee (DH-BIO). Guide sur le processus de´cisionnel relatif aux traitements me´dicaux dans les situations de fin de vie : European Counsel, Strasbourg, May 2014.
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the law distinguishes two types of advance directives depending on whether the person has a serious disease or not at the time the directive is written; attending physicians are now required to consider advance directives as the expression of the will of patients who are no longer able to express their desires. Before this law, such directives were consultative. Under the new regulations, advance directives become legally binding though not unenforceable. The physician is required to abide by the directives except in three situations: there is a life threatening emergency, the directives are manifestly inappropriate, the directives are not compatible with the patient’s medical condition. In situations other than life threatening emergency, non-application of advance directives must now emanate from a collegial decisionmaking process. Such decisions will be made – a decree and/or professional guidelines are expected to detail this point – after concerting with at least one other physician who is qualified to evaluate the concerned pathology and who has examined the patient. This second opinion will be recorded on the patient’s medical chart; the field of application is broadened. Advance directives now express a person’s will relative to his/her end of life and the conditions under which treatments or medical interventions are to be pursued (a notion not present in the earlier law), limited, discontinued, or refused; the former law limited the validity of advance directives to 3 years. The new law does not make any stipulation as to the duration of the validity of the directives. This change can probably be explained by the fact that the length of time during which certain patients with neurodegenerative diseases may survive lasts for long periods measured in years; to be applicable, directives must be precise: the new law states that they must be written in compliance with a model elaborated by the French superior health authority (HAS4). This model takes into account the fact that when writing the directives the person is aware or not of having a serious illness; ensuring that all patients have written advance directives is not a primary objective. The goal is for advance directives to be used as an instrument of dialogue helping the person with a terminal disease anticipate his/her own end of life and express as accurately as possible his/her personal decisions [1]; healthcare professionals, especially attending physicians, will be called upon to help the patient draft his/her advance directives. The IGAS5 was assigned a specific mission concerning advance directives [2] and considers that primary care physicians have an obligation to assist patients who want to draft their advance directives. According to the IGAP, this accompanying assistance is a medical consultation; 4
HAS: French Superior health authority [Haute Autorite´ de la sante´]. 5 IGAS: French Inspectorate general for social affairs [Inspections ge´ne´rales des affaires sociales].
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in the same line as the Council of Europe recommendations, and in accordance with several European jurisprudence decisions and the Conseil d’E´tat decision Vincent Lambert of June 24, 20144, in the event that the patient has not made any advance directive, the attending physician seeks directives from the personne de confiance, or by default, from close relatives or friends (Art. L.1111-12article 12); in order to ensure direct access to advance directives, a Conseil d’E´tat decree will be promulgated, after consultation with the National committee on information and freedom, to define the conditions of validity, confidentiality, and conservation of advance directives in a national registry. As stated in the law, this ‘‘registry’’ serving as a reference for storage, access, and safety of advance directives could in fact, according to the IGAS report cited above, be a shared medical file managed by the CNAMTS6 and the ASIP7, as described by the framework law on modernization of the healthcare system.
4. Introduction of a new right: the right, under certain conditions, to continuous deep sedation Professional guidelines, validated by several learned societies and the French superior health authority (HAS), have been available for several years5. The law details three exceptional circumstances under which the physician has the obligation, in order to avoid patient suffering, to institute an exceptional type of sedation: continuous deep sedation until death: at the request of the patient when death is eminent (i.e. within a short time-span to be defined by professional guidelines, probably a few hours or days) and continuous deep sedation is the only means by which the patient can be relieved of suffering or one or more otherwise uncontrollable symptoms; at the request of the patient when he/she chooses to discontinue treatments sustaining life artificially, this discontinuation necessarily leading to short-term fatal outcome and potentially inducing intolerable suffering; when the patient cannot express his/her will and the physician, after a collegial decision-making process, discontinues futile aggressive life sustaining treatment; continuous deep sedation is necessary when the patient presents signs of suffering, or when the patient’s suffering cannot be assessed due to the patient’s cerebral or cognitive status, this concerning brain injured patients of all ages, but also patients with very advanced-stage cognitive disorders.
The law provides that continuous deep sedation, in situations where such sedation is mandatory, should be combined with analgesic treatment and the withdrawal of all life-sustaining treatments. It is to be noted that under these circumstances, continuing artificial nutrition and hydration is to be considered as unwarranted unreasonable obstinacy. It is obvious that in these three exceptional situations, death is an inevitable short-term outcome, with or without sedation. A quite different reflection is required when the life expectancy of a person with a serious incurable illness is measured in weeks. In this situation, if sedation is necessary to relieve refractory symptoms, such sedation, according to professional guidelines5, should be modulated, i.e. not necessarily deep, but sufficient to provide symptom relief. According to the law’s provisions, an a priori control is required before implementing these practices. This control is performed within the framework of a new type of collegial process that will be the object of upcoming implementation decrees. The patient’s attending physician will ensure that the conditions are met for continuous deep sedation after concerting with the members of the care team, if there is one, and the justified opinion of at least one other physician called in as a consultant. Satisfactory application of this new law will depend greatly on the implementing decrees on advance directives and continuous deep sedation until death. Satisfactory application will also depend upon the implementation of a genuine policy for the development of palliative care. A priori, the implementation of the four areas of action of the Plan8 for accompanying and palliative care (CNAMTS) should facilitate this national policy. The Plan’s areas of action are: patient education to enable patient-centered decision making; professional training, research and knowledge transfer on palliative care; home care: favoring palliative care in the patient’s home, including patients residing in social and medicosocial institutions; guaranteed access to palliative care: reducing inequality of access to palliative care. Finally, proper use of this law will also largely depend upon the professional guidelines to be established. The law provides for an annual government report to Parliament – before the vote on draft legislation for Social Security funding9 – on implementation of the law and the plan. This regulatory and financial provision is necessary to ensure proper implementation of the law.
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CNAMTS : French national healthcare fund for salaried employees [Caisse nationale de l’assurance maladie des travailleurs salarie´s]. 7 ASIP: French Agency for shared information systems in health [Agence des syste`mes d’information partage´s de sante´].
Announced on December 3, 2015, this plan for 2016–2015 has a budget of 190 million Euros. The objective is to create one palliative care bed per 100,000 inhabitants, 6 new palliative care units and 30 new mobile palliative care teams in 2016, as well as to develop training and research and create a university curriculum. 9 Article 14 for the law no 2016-87 of February 2, 2016.
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5. For neurology, what are the implications of this new legislation? 5.1. Certain questions remain unanswered and will require in-depth work and research
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no one can predict. Consequently, an advance directive cannot be construed as an end in itself; it is simply a means by which seriously ill individuals can express their desires about their final journey. Advance directives can be revised at any time, which means that all sick persons should be invited regularly to rethink their directives as their disease evolves.
Questions concerning advance directives are: Questions concerning sedation are: one might wonder about the intrinsic value of advance directives depending on whether they are drafted by a person suffering from a severe illness or not. While it might appear reasonable, or desirable, to anticipate future events when one has a serious illness or perceives oneself as a ‘‘sick person’’, questions arise when it comes to one’s capacity to project into a future life-terminating state that might develop outside any context of illness, e.g. survival despite severe alteration of consciousness after head trauma or stroke, or cardiac arrest. The law does not distinguish between these two types of directives despite the fact that in its opinion statement no 121, the CCN10, the national governmental consultative advisory council on bioethics issues, distinguished two possible types of anticipation depending on the circumstances. The first type of directive, termed ‘‘anticipated statement of will’’, is written outside a context of illness, and is designed basically to expose one’s desires in terms of living environment and mode of treatment. For individuals with a serious or potentially fatal disease, directives serve as a tool to facilitate dialogue between caregivers and the sick person. They are designed to anticipate medical decisions, taking into account disease progression and the different options as they develop; there is a risk that advance directives could be underused or misused because of certain insufficiencies involving time, availability, or caregiver training in communication skills for complex situations. There is a risk such directives would become – and unfortunately this is already the case in many situations – simply another administrative form that is proposed but not always completed with adequate care. There could also be a paradoxical effect, i.e. anticipated directives becoming legally binding even when not issuing from a progressive collective process of elaboration. Under these situations, it is most likely that many healthcare professionals would lack sufficient commitment, meaning that very few patients would draft advance directives. Before advance directives can become truly invested as an opportunity to aid the seriously ill along their personal journey, healthcare professionals (especially physicians) will need education in communication skills for complex situations. The ability to implement such skills must be recognized as a genuine act of care; it must also be kept in mind that for many patients, drafting advance directives is a difficult, potentially impossible, task. There is no reason that a sick person must write advance directives. One’s capacity to anticipate necessarily limits one’s ability to foresee the future that, by definition, 10 CCNE [Comite´ consultatif national d’e´thique]. Avis 121 [Fin de vie, autonomie de la personne, volonte´ de mourir, 1er juillet 2013]. End of life, personal autonomy, will to die. July 1, 2013.
when reference is made to the possible use of continuous deep sedation ‘‘as requested by the patient in order to avoid suffering’’ or ‘‘when the patient presents suffering refractory to treatments’’ (Article L. 1110-5-2), isn’t there the possibility that this could lead to the belief that sedation can treat suffering? Letting individuals believe that suffering is a symptom that can be controlled by a drug is simplistic and dangerous. Of course, continuous deep sedation may be considered as a coma equivalent; that as such it induces a state of unconsciousness; but it does not suppress psychic life and probably does not suppress suffering. On the grounds that we are eliminating suffering, we must not satisfy ourselves with eliminating its expression; according to the law, this continuous deep sedation until death can be implemented in the patient’s home, in a healthcare institution, or in a nursing home, raising certain questions concerning feasibility, surveillance and followup. The appropriate medications are generally reserved for their anesthetic effect, meaning that in this context they are to be used for other purposes. At the least, professional guidelines for good clinical practices are needed; accepting to implement continuous deep sedation until death for a person who alleges refractory existential suffering or for a person who wants to avoid all suffering while waiting for death will raise questions for certain physicians concerning the legitimacy of the request. Nevertheless, it is important to always ask the following question: what gives a doctor the authority to oppose the request of a person who knows he/she is going to die within a very short time and who wants a drug-induced coma and the interruption of potentially life-sustaining treatments? as was mentioned in the preceding chapter, the law states that when the short-term prognosis is death a patient has the right to have continuous deep sedation until death implemented at his/her request. ‘‘Short-term’’ will have to be defined, here again via professional guidelines. In practice, we do not know how to maintain continuous deep sedation beyond a few hours or days. And fundamentally, what is the signification of an ‘‘end-of-life’’ that lasts for several days or weeks? finally, while it is essential to carefully differentiate between sedation and euthanasia, we must be vigilant concerning the use of this right to sedation. A priori, continuous deep sedation does not cause death but is designed to make more bearable this ultimate moment of existence. But a utilization that is not adapted to this objective, or the use of increasingly high doses, may accelerate the advent of death. As we can see in neighboring countries, the risk of deviating towards euthanasia-sedation is far from theoretical [3].
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5.2. End-of-life of persons with neurodegenerative disease or severe brain damage The paradox of progress is that it produces, correlatively, situations of complex survival including periods of ‘‘long dying’’ that raise questions concerning the meaning of ‘‘endof-life’’. Current advances, and especially perspectives for the treatment of neurodegenerative diseases, should oblige us to anticipate new end-of-life configurations. As has been seen in the field of oncology over the last 15–20 years, it is quite possible that the corollary of progress in neurology (cure for neurological diseases or survival with sequelae having little impact on quality-of-life) will be, in certain cases, long-term survival of totally dependent persons with severely altered cognitive capacity. These situations raise, and will inevitably continue to raise, the question of the sense of such survival: in this context and considering future developments, it can be expected that persons will formulate advance requests for assisted suicide or euthanasia. Thus, medicine can contribute paradoxically to the generation of long periods of terminal survival that raise the question of the ultimate sense of life. It is in this context that healthcare professionals will be confronted with a question of transgression: will we, should we, come to the
point where we interrupt lives that we will have contributed to prolong? Let us hope that the development of an ethical reflection and its integration into medical training and practices will help each of us ponder the validity of instituting a treatment simply because we know how to, when the final effect would question the sense of life itself.
Disclosure of interest The author declares that he has no competing interest.
references
[1] CCNE. End of life, personal autonomy, will to die [Fin de vie, autonomie de la person, volonte´ de mourir]. Opinion no 121; 2013. [2] Blanchet V, Viallard ML, Aubry R. Se´dation en me´decine palliative : recommandations chez l’adulte et spe´cificite´s au domicile et en ge´riatrie. MEDPAL 2010;9:59–701. [3] Mattelhauer X, Aubry R. Pratique de la se´dation aux PaysBas : preuve du de´veloppement des soins palliatifs ou de´rive euthanasique ? Med Palliat Soins Support Accompagnement Ethique 2012;11:133–41.