Abstract France enacted the Claeys–Leonetti law in 2016, becoming one of the first countries to legalize terminal sedation as a medico-legal practice in the world. The focus of this short paper is to highlight the limitations imposed by Claeys–Leonetti on the doctor to fulfil his or her ethical duties under the Hippocratic oath to act ‘for the benefit of my patient’ but to act only according to the ‘wishes of the patient’, to eliminate all forms of pain and suffering. A legislative commentary will be provided for the first five pertinent articles followed by proposals for reform. INTRODUCTION On 2 February 2016, France enacted a law permitting terminal sedation, popularly known as the Claeys–Leonetti law.1 Claeys–Leonetti was a response to an unsatisfactory first law, also known as the Leonetti Law of 2005, which already dealt with patients at end of life with a refractory condition, but which was considered, after extensive parliamentary discussions, to be inadequate in dealing with the wishes of patients in the final stages of life with respect to the ‘limitation and discontinuation of treatment and sedation for a symptom that has remained refractory until death’.2,3 With the enactment of Claeys–Leonetti, France became one of the first countries to legitimate the practice of terminal sedation in the world.4,5,6 Finally, under Claeys–Leonetti, the doctor must now act in accordance with the wishes of his patient rather than act solely for the benefit of his patient.7 This paper’s focus is to highlight that what is in accordance with ‘the wishes of the patient’ is not always ‘for the benefit of the patient’. It is therefore important to define these phrases in the context of Claeys–Leonetti and the Hippocratic Oath. ‘The Wishes of the Patient’ Defined under Claeys–Leonetti Under Claeys–Leonetti, the pertinent provisions prioritize a patient’s right to decide on matters relating to terminal sedation and unreasonable obstinacy for the absolute avoidance of pain, while in effect displacing a doctor’s obligations to fulfil his or her ethical obligations under the Hippocratic Oath to act for the benefit of the patient, thus allowing a doctor to only oblige the wishes of the patient, as mandated by Claeys–Leonetti. ‘For the Benefit of the Patient’ as Defined under the Hippocratic Oath The medical profession must swear and abide by the Hippocratic Oath, formulated by the Greek physician, Hippocrates. Contrary to popular belief, the popular phrase ‘first do no harm’ (or Primum non nocere) does not exist in this oath. A similar phrase exists in one of the Hippocrates works called ‘Of the Epidemics’ in which the exact expression is ‘to do good or to do no harm’. In the Hippocratic Oath itself, however, the exact wording is: I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous.8 The words ‘deleterious’ and ‘mischievous’ could in this context be considered synonyms as they seem to mean the same thing, that is, to avoid any injurious acts to the patient. THE ARTICLES Claeys–Leonetti is divided into 14 Articles. The focus of this paper is to highlight the limitations imposed by Claeys–Leonetti on a doctor’s ethical obligation to act for the benefit of the patient. Therefore, this paper will comment on the first five Articles, which relate to this objective. Article 1 A Patient’s Right to Painless Medical Intervention; A Doctor’s Obligation to Offer Painless Medical Intervention Everyone has the right to have a dignified end of life and the best possible relief9 of suffering. Health professionals must use all means at their disposal to ensure that this right is respected. Commentary This Article’s indisputable legislative intent is patient autonomy and the patient’s right to the avoidance of pain and suffering. As such, the standard required of health professionals here is not to act ‘for the benefit of the patient’ as mandated by the Hippocratic oath but ‘for the wishes of the patient’ as mandated by Claeys–Leonetti to avoid all pain and suffering. Article 2 A Patient’s Right to Refrain from Unreasonable Obstinacy; A Doctor’s Obligation to Refrain from Unreasonable Obstinacy The acts mentioned in Article 1, i.e. that medical professionals must use all means at their disposal to ensure a patient has full access to his or her right to painless medical intervention, [acts mentioned in Article 1] must not be implemented or prosecuted when they result from therapeutic relentlessness. When treatments appear unnecessary, disproportionate or when they have no other effect than the mere artificial maintenance of life, they may be suspended or not undertaken, in accordance with the patient’s wishes and, if the patient is unable to express his or her own choice, following a collegiate procedure defined by regulation. Artificial nutrition and hydration constitute treatments that may be stopped in accordance with the first paragraph of this article. Commentary This Article’s indisputable legislative intent is to permit the cessation of useless treatments. Also called ‘Acharnement therapeutique’, it describes the situation where treatment should only be continued in proportion to the expected benefit to the patient. Consequently, treatments that do not procure the expected benefits (or, worse, put the patient in a worse condition) or treatments that ‘will act solely to artificially prolong life should not be started or should be discontinued’.10,11 Nothing in this Article mentions whether treatment may cease if it is not for the benefit of the patient, only if it is the wish of the patient. Again, the standard here is not ‘for the benefit of the patient’ as mandated by the Hippocratic oath but ‘for the wishes of the patient’ as mandated by Claeys–Leonetti. As such, the standard here to follow is not ‘for the benefit of the patient’ as mandated by the Hippocratic oath but ‘for the wishes of the patient’ as mandated by Claeys–Leonetti. Article 3 A Patient’s Right to Request Terminal Sedation; A Doctor’s Obligation to Offer Terminal Sedation This Article allows patients, in order to avoid suffering and therapeutic relentlessness, to request deep and continuous sedation, causing an alteration of consciousness maintained until death, with associated analgesia and cessation of all life-sustaining treatments, in the following situations: (1) When a patient with a serious and incurable condition whose life prognosis in the short term suggests suffering that is resistant to treatment12; (2) When the decision of a patient with a serious and incurable condition to stop treatment is life-threatening in the short term and is likely to cause unbearable suffering. This Article also provides that where the patient is unable to express his or her will regarding the refusal of therapeutic relentlessness in treatment mentioned in Article 2, the doctor may stop life-sustaining treatment, [and] apply a deep and continuous sedation causing an alteration of consciousness maintained until death, together with analgesia. This Article further states that the procedure for deep and continuous sedation together with analgesia provided for in this Article shall be implemented according to the collegial procedure defined by regulation, which allows the health care team to verify beforehand that the conditions of application provided for in the preceding paragraphs are fulfilled. Finally, at the request of the patient, deep and continuous sedation may be performed at home, in a health facility or institution referred to in Article L.1 (1) (6) I of the Code of Social Action and Families. The entire procedure followed is recorded in the patient’s medical file. Commentary This Article specifically talks about terminal sedation as a right to be requested by a patient, who is already suffering from a serious and incurable medical condition but who specifically is also suffering from a refractory condition and is likely to suffer unbearable pain when treatment is stopped. Here, the indisputable legislative intent is to offer terminal sedation as an option to avoid suffering and therapeutic relentlessness. While this Article mandates that patient suffering should be avoided at all cost, there is no mention of whether terminal sedation should be offered if it is for the benefit of the patient, only that it should be offered if it is the wish of the patient to alleviate pain and suffering. This paper notes, nonetheless, that this Article does pay very careful attention to the type of patients who can request to be kept sedated until death, that is, patients already suffering from a ‘serious and incurable condition’, which could safely be interpreted to mean patients who have arrived irreversibly at the end of life. In addition, the Article also specifies that in addition to having arrived irreversibly at the end of life, such patients must also be those who suffer refractory conditions (that is conditions that are not responding to treatments) and be likely to encounter unbearable suffering when treatments are stopped. Even so, nothing in this article mentions whether the treatments should be abandoned and terminal sedation should begin if it is not for the benefit of the patient, only if it is the wish of the patient. As such, the standard here to follow is not ‘for the benefit of the patient’ as mandated by the Hippocratic oath but ‘for the wishes of the patient’ as mandated by Claeys–Leonetti. Article 4 A Patient’s Right to Painless Treatment and Care; A Doctor’s Obligation to Offer Painless Treatment and Care Everyone has the right to receive treatment and care for the alleviation of suffering. This must be, in all circumstances, foreseen,13 taken into account, evaluated and processed. The doctor must put in place all the analgesic and sedative treatments to respond to the refractory suffering of the patient in the advanced or terminal phase, even if they may have the effect of shortening life. He or she must inform the patient (without prejudice to the fourth paragraph of Article L. 1111–12) the person of trust provided for in Article L. 1111–16, the family or, failing that, a close relative of the patient.14,15 The procedure followed is recorded in the medical file. A patient must be informed by health professionals of the possibility of being cared for at home, as long as the patient’s condition allows. Commentary This Article is perhaps most clearly the one where the obligation of the doctor to do what is for the benefit of the patient is ignored by Claeys–Leonetti. Here, the indisputable legislative intent is to allow the medical profession to make accessible to a patient any and all treatment and care to avoid pain and suffering. The sole objective of the medical profession must be the avoidance of pain and suffering for the patient, by means of compiling and implementing medical intervention in the form of treatment and care that must take into account the avoidance of pain. Nothing in this article mentions whether efforts of the medical team to offer medical intervention in the form of both treatment and care to avoid pain and suffering is in the best interests of the patient, only that such treatment should be offered as a right to the patient who wishes for it. Furthermore, the article elaborates that even if the efforts to avoid pain and suffering by the medical team for the patient have the effect of shortening the life of the patient, such treatment should still be offered to the patient as a right if the latter so wishes. This stands in violation of the ethical obligations of the medical team to do what is for the benefit of the patient as mandated by the Hippocratic oath. As such, the standard here is not to follow what is ‘for the benefit of the patient’ as mandated by the Hippocratic oath but ‘for the wishes of the patient’ as mandated by Claeys–Leonetti. Article 5 A Patient’s Right of Refusal of Treatment; A Doctor’s Obligation to Offer the Right of Refusal of Treatment (1)Everyone has the right to refuse or not to receive treatment. The follow-up care of the patient by the doctor remains guaranteed,16 in particular, for palliative care and support. (2)The doctor has the obligation to respect a patient’s choices after informing the patient of the consequences of such choices and their seriousness. If, by a choice to refuse or interrupt any treatment, the patient would put his or her life in danger, the patient must be asked to reiterate his decision within a reasonable time. The doctor may seek the view of another member of the medical profession. The entire procedure is recorded in the patient’s medical file. The doctor safeguards the dignity of the dying person and ensures the quality of his end of life by providing the palliative care mentioned in Article L. 1110–10.17 (3)A decision to cause death cannot be reached without having respected the collegial procedure mentioned in Article 2 and the directives or, failing that, without consulting the confidential person provided for in Article L. 1111–618 or, failing that, without consulting the family or relatives. The reasoned decision limiting or stopping treatment is entered in the medical file. Commentary Section 1 of this Article simply ensures that the medical team must provide assurance that the right of a patient to refuse treatment must be respected. Furthermore, under section 2, this Article imposes an obligation upon the medical team to inform the patient of the serious consequences of the latter’s decision to exercise his or her choice regarding the refusal to stop treatments. Where there is a serious risk of danger to life, the medical team has the obligation only to ‘reiterate’ or double check with the patient about his or her wishes; however, there is no obligation imposed on the doctor to do what is for the benefit of the patient, even where there is a serious risk to life. The medical team has the option to consult with another doctor but this is not mandatory as indicated by the words ‘can call on another member’, nor is there a statement as to what the medical team must do following such a consultation. This is a serious flaw in this Article, where the doctor must act only as a medical advisor for the patient to be able to make a sound decision, but where the patient does not, the doctor must let the decision stand and has no obligation to do what is for the benefit of the patient as mandated by the Hippocratic oath. As such, the standard here, is not to follow what is ‘for the benefit of the patient’ as mandated by the Hippocratic oath but ‘for the wishes of the patient’ as mandated by Claeys–Leonetti. CONCLUSION The legislative intent of Claeys–Leonetti is, undeniably, clear: the avoidance of all pain and suffering, for patients at end of life with a refractory condition. Nonetheless, while granting the right to a suffering patient, a right in humanity, to die with dignity, to die a peaceful death, unadulterated by pain and suffering, this law concurrently seems to have taken away the right of a doctor to do his or her job as a doctor, to strive for the benefit of the patient but obliges the doctor to act only for the wishes of the patient. As such, this paper concludes that Claeys–Leonetti has succeeded as a human rights advocate for the patient, but has seriously failed with respect to the rights of the doctor to fulfil his or her ethical obligations under the Hippocratic Oath. Proposals for Reform: A Standard that Weighs the Rights of the Patient against the Ethical Obligations of the Doctor This paper urges the drafters of Claeys–Leonetti to reconsider the wording contained in Articles 1–5 so as to include, while maintaining the rights of a patient to the best alleviation of pain, to also concurrently allow doctors to do their jobs and fulfil their ethical obligations towards the patient. Public Health Law in France is very strict with respect to treatment and care for end of life patients. A doctor in fact cannot administer anything harmful to his patient and must abandon useless treatments also. This is also clearly stated in the French code of medical ethics where under Article 37: A doctor must at all times do his or her best to alleviate pain and suffering by the means most appropriate to a patient’s condition, and provide moral support to the patient. However, he or she must refrain from undertaking any investigation or treatment that appears unreasonable in the circumstances, and may limit or withdraw treatment that appears of no benefit, is disproportionate, or the only aim or effect of which is to prolong life artificially.19 While it is true that the version of the Hippocratic oath in France states that the doctor must do everything in his power to alleviate pain and suffering, such a requirement, this paper argues, is in fact not in line with the original textual meaning of the Hippocratic oath ‘to abstain from whatever is deleterious and mischievous’. One cannot deny the point that in situations where the patient refuses treatment, when treatments are clearly still needed but refused and abandoned due to the wishes of the patient for the sake of alleviating pain and suffering, it is in fact an injury to the patient because treatment is still possible but is discontinued because of the patient’s wishes. Hence, the title of this article: Patient’s Orders. ‘continuous palliative sedation’ means care that is offered as part of palliative care and consists in administering medications or substances to an end-of-life patient to relieve their suffering by rendering them unconscious without interruption until death ensues. Footnotes 1 Legifrance – Le service public de l’accès au droit ‘Law Number 2016–87 of 2nd February 2016’ <https://www.legifrance.gouv.fr/eli/loi/2016/2/2/AFSX1507642L/jo/texte> (31 December 2017). 2 A De Nonneville and others ‘End-of-Life Practices in France under the Claeys–Leonetti Law: Report of Three Cases in the Oncology Unit’ (2016) Case Rep Oncol 9, 650–4. 3 Ibid (see n 1). 4 G Nicolas and A Réglier Mort et droit de la santé: les limites de la volonté (LEH Édition Bordeaux 2016) 117. 5 Légis Québec ‘Bill 52, An Act Respecting End of Life Care’ <http://legisquebec.gouv.qc.ca/en/pdf/cs/S-32.0001.pdf> (31 January 2018). 6 It is important to mention another significant country that legalized terminal sedation in 2014. Quebec enacted terminal sedation in 2014. Under S-32.0001, Title II, End of Life Care, Chapter 1, 3(5), the Act states as follows: ‘continuous palliative sedation’ means care that is offered as part of palliative care and consists in administering medications or substances to an end-of-life patient to relieve their suffering by rendering them unconscious without interruption until death ensues. 7 MR Shmerling ‘First, Do No Harm’ (14 October 2015) <https://www.health.harvard.edu/blog/first-do-no-harm-201510138421> (10 January 2018). 8 Ibid (see n 7). 9 In the original text in French, the word used is ‘apaisement’. 10 Ibid (see n 2). 11 J Vincent and others ‘[“Piece”] of Mind: End of Life in the Intensive Care Unit Statement of the Belgian Society of Intensive Care Medicine’ (2014) J Crit Care 29, 174–5. 12 In the original text in French, the phrase used is ‘la souffrance réfractaire du malade’. 13 In the original legal text, the word used is ‘prévenue’. 14 In the original legal text, the article simply refers to ‘la personne de confiance’. 15 In the original legal text, the article simply refers to ‘la famille ou, à défaut, un des proches du malade’. 16 In the original legal text, the article uses the term ‘assure par le médecin’. 17 In the original legal text, the article simply refers to ‘soins palliatifs’. 18 In the original legal text, the article simply refers to ‘la personne de confiance’. 19 Conseil National de l’Ordre des Médecins <https://www.conseil-national.medecin.fr/> (3 February 2018). © The Author(s) 2018. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact firstname.lastname@example.org
Statute Law Review – Oxford University Press
Published: Mar 14, 2018
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