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Neonatal euthanasia: Lessons from the Groningen Protocol
Seminars in Fetal & Neonatal Medicine 19 (2014) 296e299
Contents lists available at ScienceDirect
Seminars in Fetal & Neonatal Medicine journal homepage: www.elsevier.com/locate/siny
Review
Neonatal euthanasia: Lessons from the Groningen Protocol A.A. Eduard Verhagen* Department of Pediatrics, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands
s u m m a r y Keywords: Neonatal euthanasia Palliative care Neonatal intensive care Ethics Medical law
Decisions about neonatal end-of-life care have been studied intensely over the last 20 years in The Netherlands. Nationwide surveys were done to quantify these decisions, provide details and monitor the effect of guidelines, new regulations and other interventions. One of those interventions was the Groningen Protocol for newborn euthanasia in severely ill newborns, published in 2005. Before publication, an estimated 20 cases of euthanasia per year were performed. After publication, only two cases in five years were reported. Studies suggested that this might be partly caused by the lack of consensus about the dividing line between euthanasia and palliative care. New recommendations about paralytic medication use in dying newborns were issued to increase transparency and to improve reporting of euthanasia. New surveys will be needed to measure the effects of these interventions. This cycle of interventions and measurements seems useful for continuous improvement of end-of-life care in newborns. © 2014 Elsevier Ltd. All rights reserved.
1. Introduction The Groningen Protocol for newborn euthanasia in severely ill newborns was devised to regulate the practice of neonatal euthanasia and make it more transparent. Its publication immediately generated an international controversy and forced doctors to analyze the differences between the existing approaches in palliative care that are common in many countries, such as withholding and withdrawing of life supportive treatments or the administration of high doses of narcotics to relieve suffering, and the Dutch approach of administering lethal medication with the purpose of ending life. Almost 10 years have passed since its publication. What were the effects of the protocol on end-of-life practice? What can be learned form the Groningen Protocol? 2. End-of-life practice in patients who are suffering In the early 1980s some doctors in The Netherlands began reporting that they had performed euthanasia in adult patients to end suffering. In the preceding decade, the results of polls investigating the public and professional opinions concerning euthanasia had shifted from almost balanced to strongly in favor of euthanasia. The prosecuting office decided to charge some of these doctors to produce clarity about the grounds on which euthanasia might be justified as well as to specify the requirements of due care * Tel.: þ31503612470. E-mail address: [email protected]. http://dx.doi.org/10.1016/j.siny.2014.08.002 1744-165X/© 2014 Elsevier Ltd. All rights reserved.
with which a doctor had to comply [1,2]. Around that time, reports by political and medical bodies were issued reflecting the existing views on euthanasia. This made it easier for the Supreme Court to conclude that a doctor, who, in a case of euthanasia, complies with the criteria of due care, may successfully invoke the justification of necessity (conflicts of duties). Later verdicts have confirmed the legality of euthanasia, and the criteria of due care formulated by the court were subsequently incorporated into the Euthanasia law (2002). This law applies to all legally competent persons of 12 years and older. At the same time that euthanasia was being legalized, serious efforts were made to establish national standards surrounding medical decisions about end-of-life care. The first study was carried out in 1990, and every five years follow-up studies were conducted to ‘monitor’ changes in medical end-of-life practice by reporting frequency and other characteristics of decisions to withhold or withdraw life-supportive treatments (LSTs), use of medication that could potentially hasten death, consultation, reporting, palliative sedation, and euthanasia [2e7]. In the early 1990s, several case reports about termination of life in newborns were published, and in 1991 the Dutch Pediatric Association issued an influential report about end-of-life decisions in newborns [8e10]. Similar to the developments regarding adult euthanasia, governmental reports were issued and professionals and the public appeared to be in favor of allowing at least some form of life-ending measures for newborns with extreme suffering. The general prosecutor decided to prosecute two doctors who reported that they had performed newborn euthanasia. The
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prosecutor’s main reason was to secure legal clarification. The judgments in the two court cases in 1996 were similar in their confirmation that newborn euthanasia may be justified if the doctor acts in accordance with the applicable requirements of due care, as formulated in the verdicts, and reports what s/he has done to the prosecutorial authorities.
withdrawing LST in 95% of cases [17,18]. In ~60% of cases, this concerned unstable babies with an inevitable death, whereas the remaining 40% occurred in stable newborns for quality of life reasons. Only one case of unreported euthanasia was identified. An international comparative study reported similar results in 2010 [17].
3. A protocol for newborn euthanasia: the Groningen Protocol
5. Life-shortening by physicians: euthanasia or palliative care?
In the 1995 and 2001 national studies, special attention was given to end-of-life decisions in the care of newborn babies [11,12]. Based on these data, it was estimated that at least 15e20 cases of neonatal euthanasia took place every year. At that time, not many details about those cases were available, except that the babies did not have any LST(s) that could be withheld or withdrawn. A group of doctors at the University Medical Center Groningen wanted to know more details about these babies and reviewed all neonatal euthanasia cases that were reported to the prosecuting authorities from 1997 to 2005. They reported that only three cases per year were actually reported, and that they concerned term, stable babies suffering from severe and untreatable congenital malformations [13]. The data from this review, combined with the criteria of due care from the court cases and expert opinions, were used to develop an approach to identify situations in which neonatal euthanasia might be appropriate. Full transparency of end-of-life practice was sought. The New England Journal of Medicine published this protocol, known as ‘the Groningen Protocol for Neonatal Euthanasia’ (GP), in 2005 [14]. The protocol describes five major criteria that make euthanasia permissible: (1) diagnosis and prognosis must be certain; (2) hopeless and unbearable suffering must be present; (3) a confirming second opinion by an independent doctor must be obtained; (4) both parents must give informed consent; and (5) the procedure must be performed carefully, in accordance with medical standards.
The results of these follow-up studies sparked discussion within the medical and legal professions about the use of paralytic medication in dying babies. It appeared from the study results that some doctors administered this medication, always in combination with appropriate doses of opioids, to stop the prolonged gasping or to hasten death in dying babies on parental request. These doctors did not consider their action to be euthanasia but rather adequate symptom management and part of palliative care [19,20]. Those cases were, for that reason, never brought to the committee. Critics argued that, although the GP was created for another type of clinical situation (stable babies with excruciating suffering who have no LST that could be withdrawn), the action, the aim, and the medication were similar to euthanasia, and the GP should therefore be applied and reported. Those in favor of the argument that treating signs such as gasping in moribund patients is part of good palliative care state that, first, there is no alternative treatment that could take away the signs or alleviate potential suffering, or both; second, these patients were moribund, which means they were dying and death was imminent. It seems very unlikely that gasping in the dying state serves the infant any purpose. Moreover, the sight of their newborn gasping for breath can be a source of acute and long-term stress and anxiety for parents. In this situation, granting a parental request to stop the gasping by hastening their newborn's death with paralytic medication and sedatives will increase the parents' comfort and may contribute positively to their grief process and should therefore be regarded as acceptable medical practice [21e25]. At this point, the Dutch Medical Association (KNMG) asked a multidisciplinary group of experts to address the problem of differentiating newborn euthanasia and palliative care. They reasoned that a more detailed description of the dividing line between euthanasia and palliative care was crucial in view of the intended transparency of end-of-life care. After all, the consequences of either action are very different and may influence the doctor's willingness to report honestly what s/he has done. A case of neonatal euthanasia needs to be reported and reviewed post hoc to assess whether the physician fulfilled the due care criteria. If the criteria are not fulfilled, the doctor risks prosecution for homicide. Medical decisions leading to neonatal death in the context of palliative care are seen as normal medical practice and have no legal consequence [26,27].
4. Effects of the Groningen Protocol The publication of the GP and its endorsement by the Dutch Pediatric Association made the reporting of neonatal euthanasia in theory much easier because the requirements for due practice and the legal position of the doctor were made much clearer. The government contributed by transforming the GP into formal governmental regulation [15]. In addition, the reporting procedure became easier to follow because the revised version required the initial reporting to a multidisciplinary committee of experts (consisting of ethicists, doctors and legal people) instead of the local prosecuting office. This committee has been in place since 2007. In the five years following the GP, euthanasia had decreased from 15 to two cases. The two cases were babies with lethal epidermolysis bullosa. For congenital malformations, euthanasia decreased from 15 to 0 cases [16]. Both cases were reviewed post hoc and were considered to have been handled appropriately, and nobody was prosecuted. Those who are in favor of the GP argue that the decreased incidence of euthanasia is the effect of more transparency and clear regulation resulting in appropriate control of end-of-life practice. There is increasing evidence, however, that the transformation of the healthcare system (antenatal screening policy became a part of routine antenatal care in 2007) was probably the most important reason for increased elective terminations and less euthanasia [16]. Recent studies have evaluated end-of-life practice. One large follow-up study, describing end-of-life decision-making after the GP in the 10 Dutch neonatal intensive care units (NICUs), reported that the main mode of death was by withholding and/or
6. New recommendations for end-of-life care The multidisciplinary group formulated general recommendations about end-of-life decision-making and care in very sick newborns, based on a thorough analysis of medical policy statements from past reports, scientific publications, ethics, and the law [28,29]. In the discussion about the decision to withdraw LSTs, the group's report focuses on several specific treatments, among them withdrawal of respiratory support. Step by step, the report describes the clinical course of events that usually occurs around the time of withdrawal of the ventilator. Recommendations are made about communication with the parents and about treatment of signs and suffering in the dying newborn. The use of paralytic
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medications, always used with sedatives and analgesics, is discussed in great detail. According to the group, administration of paralytic medications is permitted if the aim is to stop prolonged gasping during ventilator withdrawal and to end a protracted dying process of several hours or more, which only adds to the suffering of the parents. This situation may occur in very rare situations when even state-of-the-art palliative sedation is insufficient to relieve pain and suffering, and despite the medical team's careful preparation involving the parents. The group ultimately concludes that this practice should be regarded as ‘good medical practice’, but they recommend that, in view of the ongoing debate about its legality, all cases must be reported for review to maintain full transparency and accountability. The significance of this conclusion is that it expresses the current opinion of the medical profession. In the Dutch legal system, judicial decisions are based primarily on the medical profession's opinion if detailed formal legislation is absent. A substantial proportion of the recommendations of the multidisciplinary group correspond with, and refer to, the evidencebased Guideline for Pediatric Palliative Care that was issued by the Dutch Pediatric Association in 2013 [30]. The ultimate goal of this clinical guideline was to improve palliative care for children and create indicators to measure the quality of care. The guideline has three chapters: symptom management, decision-making, and organization of care. In the chapter about decision-making, much attention is given to the medical, ethical, and legal aspects of decision-making and to the role of parents and patients in this context. Among the topics in this chapter are the recommendations about palliative sedation and euthanasia in newborns, all in line with the KNMG document discussed above, and in older children. The position of euthanasia in the guideline is that of a last-resort option, if no other reasonable palliative treatments are available and the newborns' parents (or a child aged 12 years) request it. The authors of the guideline note that there is a discrepancy in the available scientific studies and other sources of knowledge about newborn euthanasia, and in the lack of knowledge and guidelines about euthanasia in older incompetent infants and children. This note was echoed among the professional and public media and coincided with the decision in Belgium to remove the age limit in the euthanasia law and make it applicable to competent children of all ages. The minister of health, who was recently asked to clarify her position on euthanasia in minors, has indicated that she supports both the pediatric association's efforts to examine the current end-of-life practice in children aged 1e12 years in more depth, as well as their initiatives to secure and promote implementation of the pediatric palliative care guideline [31]. This support is likely to result, ultimately, in new regulations for children, based in large part on new scientific data about the clinical practice of palliative care in children <12 years.
Surveys of end-of-life practice have provided details about the frequency and dimensions of newborn euthanasia and have made it plausible that underreporting by doctors occurs. This led to regulation of practice through the GP, and resulted in the initiative by the medical profession to propose new recommendations about the dividing line between euthanasia and palliative care, especially in the context of dying newborns, and to clarify the definition of euthanasia. This development suggests that scientific data can be powerful stimuli to bring about changes in clinical practice. For many years, substantial efforts were made to make the practice of newborn euthanasia fully transparent and to regulate it. In contrast, the developments toward making high quality pediatric palliative care available have only recently started to accelerate, as illustrated by the publication last year of a national guideline for pediatric palliative care. The order of events, however, may seem illogical to many readers. Neonatal euthanasia has always been very rare and has become even more unusual in the last 10 years. This is in sharp contrast to pediatric palliative care, which involves several thousand pediatric patients with life-limiting diseases in The Netherlands. These patients and their families would immediately benefit from improvements in availability and quality of pediatric palliative care. However, the Dutch have started to regulate and define the complex end-point of unsuccessful palliative care (euthanasia) first, and from that point, retroactively, started to reorganize, define and improve the preceding steps in palliative care. Although this may seem counterintuitive, and most other countries choose their end-of-life care priorities differently, this approach seems to work for the Dutch. At this point, both areas are receiving increased attention from doctors, the public, and politicians with the goal of achieving optimal end-of-life care for ill children and their families.
Practice points The goal of the Groningen Protocol (GP) is to achieve transparency in end-of-life care. Euthanasia is a legal option for newborns who suffer intolerably. Acceptance of the GP has actually decreased euthanasia cases to <1 per year. Clear definitions are needed to distinguish palliative care from euthanasia. Repeated surveys allow monitoring of changes in end-oflife care.
7. Concluding remarks: what can be learned?
Research directions
This paper describes the most important developments in newborn end-of-life practice that have resulted in publication of the Groningen Protocol and the evolution that has occurred since endorsement by pediatricians in The Netherlands. The legal and medical developments in end-of-life care and euthanasia in newborns show much similarity with those in adults. Legality of both adult and newborn euthanasia was established after a long period of case reporting by the medical profession, and court cases. Comparative studies and repeated national surveys were performed to monitor changes in end-of-life care, every five years. This approach seems to work for The Netherlands and allowed us to demonstrate that legalization of (newborn) euthanasia does not necessarily lead to widespread misuse, as was widely predicted by opponents of decriminalization of euthanasia.
Refining quality indicators for neonatal end-of-life care. The role of parental suffering in physicians' end-of-life decision-making. End-of-life care and treatment of suffering in children aged 1e12 years. Implementation of neonatal palliative care guidelines in the NICU.
Conflict of interest statement None declared.
A.A. Eduard Verhagen / Seminars in Fetal & Neonatal Medicine 19 (2014) 296e299
Funding sources None. References [1] Griffiths J, Weyers H, Adams M. Euthanasia and law in Europe. Oxford/Portland, OR: Hart Publishing; 2008. [2] Hessing DJ, Blad JR, Pieterman R. Practical reasons and reasonable practice: the case of euthanasia in The Netherlands. J Soc Issues 1996;52:149e68. [3] Van Der Maas PJ, Van Delden JJ, Pijnenborg L, Looman CW. Euthanasia and other medical decisions concerning the end of life. Lancet 1991;338:669e74. [4] van der Maas PJ, van der Wal G, Haverkate I, de Graaff CL, Kester JG, Onwuteaka-Philipsen BD, et al. Euthanasia, physician-assisted suicide, and other medical practices involving the end of life in the Netherlands, 1990e1995. N Engl J Med 1996;335:1699e705. [5] Onwuteaka-Philipsen BD, van der Heide A, Koper D, Keij-Deerenberg I, Rietjens JA, Rurup ML, et al. Euthanasia and other end-of-life decisions in the Netherlands in 1990, 1995, and 2001. Lancet 2003;362:395e9. [6] van der Heide A, Onwuteaka-Philipsen BD, Rurup ML, Buiting HM, van Delden JJ, Hanssen-de Wolf JE, et al. End-of-life practices in the Netherlands under the Euthanasia Act. N Engl J Med 2007;356:1957e65. [7] Onwuteaka-Philipsen BD, Brinkman-Stoppelenburg A, Penning C, de JongKrul GJ, van Delden JJ, van der Heide A. Trends in end-of-life practices before and after the enactment of the euthanasia law in the Netherlands from 1990 to 2010: a repeated cross-sectional survey. Lancet 2012;380:908e15. [8] Orlowski JP, Smith ML, Van Zwienen J. Pediatric euthanasia. Am J Dis Child 1992;146:1440e6. [9] Visser HK, Aartsen HG, de Beaufort ID. Medical decisions concerning the end of life in children in The Netherlands. Am J Dis Child 1992;146:1429e31. [10] Nederlandse Vereniging voor Kindergeneeskunde. Doen of laten. Grenzen van het medisch handelen in de neonatologie. [To treat or not to treat? Limits for life-sustaining treatment in neonatology.]. Utrecht: Den Daas; 1992. [11] van der Heide A, van der Maas PJ, van der Wal G, de Graaff CL, Kester JG, e LA, et al. Medical end-of-life decisions made for neonates and infants in Kolle the Netherlands. Lancet 1997;350:251e5. [12] Vrakking AM, van der Heide A, Onwuteaka-Philipsen BD, Keij-Deerenberg IM, van der Maas PJ, van der Wal G. Medical end-of-life decisions made for neonates and infants in the Netherlands, 1995e2001. Lancet 2005;365: 1329e31. [13] Verhagen AAE, Sol JJ, Brouwer OF, Sauer PJ. Actieve levensbeeindiging bij pasgeborenen in Nederland, analyse van alle meldingen van 1997/'04. [Deliberate termination of life in newborns in The Netherlands; review of all 22 reported cases between 1997 and 2004]. Nederlands tijdschrift voor geneeskunde 2005;149:183e8. [14] Verhagen E, Sauer PJ. The Groningen protocol e euthanasia in severely ill newborns. N Engl J Med 2005;352:959e62.
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[15] Annual report 2007 (Jaarverslag 2007). Den Haag Commitee on Late Termination of Pregnancy and Termination of Life in Newborns (Commissie Late Zwangerschapsafbreking en levensbeeindiging bij pasgeborenen); 2007. [16] Verhagen AA. The Groningen Protocol for newborn euthanasia; which way did the slippery slope tilt? J Med Ethics 2013;39:293e5. [17] Verhagen AA, Dorscheidt JH, Engels B, Hubben JH, Sauer PJ. End-of-life decisions in Dutch neonatal intensive care units. Archs Pediat Adolesc Med 2009;163:895e901. [18] Verhagen AA, Janvier A, Leuthner SR, Andrews B, Lagatta J, Bos AF, et al. Categorizing neonatal deaths: a cross-cultural study in the United States, Canada, and the Netherlands. J Pediatr 2010;156:33e7. [19] Verhagen AA, Dorscheidt JH, Engels B, Hubben JH, Sauer PJ. Analgesics, sedatives and neuromuscular blockers as part of end-of-life decisions in Dutch NICUs. Archs Dis Child 2009;94:F434e8. [20] Dorscheidt JH, Verhagen E, Sauer PJ, Hubben JH. Medication regimes in the context of end-of-life decisions in neonatology: legal considerations with regard to Dutch NICU-practice. Med Law 2013;32:215e29. [21] McHaffie HE, Laing IA, Parker M, McMillan J. Deciding for imperilled newborns: medical authority or parental autonomy? J Med Ethics 2001;27:104e9. [22] Kuhse H. Response to Ronald M Perkin and David B Resnik: the agony of trying to match sanctity of life and patient-centred medical care. J Med Ethics 2002;28:270e2. [23] Rushton CH, Terry PB. Neuromuscular blockade and ventilator withdrawal: ethical controversies. Am J Crit Care 1995;4:112e5. [24] Perkin RM, Resnik DB. The agony of agonal respiration: is the last gasp necessary? J Med Ethics 2002;28:164e9. [25] McHaffie HE, Lyon AJ, Hume R. Deciding on treatment limitation for neonates: the parents' perspective. Eur J Pediatr 2001;160:339e44. [26] Dorscheidt JH. Assessment procedures regarding end-of-life decisions in neonatology in the Netherlands. Med Law 2005;24:803e29. [27] Dorscheidt JHHM. Levensbeeindiging bij gehandicapte pasgeborenen naar huidig Nederlands recht. Levensbeeindiging bij gehandicapte pasgeborenen Strijdig met het non-discriminatiebeginsel?. Den Haag: SDU; 2006. p. 183e269. [28] Royal Dutch Medical Association (KNMG). Medische beslissingen rond het levenseinde bij pasgeborenen met zeer ernstige afwijkingen [Medical end-oflife decisions in newborns with severe handicaps]. Utrecht: KNMG; 2013. [29] Willems DL, Verhagen AAE, Wijlick E. Infants' Best Interests in End-of-life Care for Newborns. Pediatrics 2014;134. ePub ahead of print, http://dx.doi.org/10. 1542/peds.2014-0780 (accepted for publication). [30] Dutch Pediatrc Association (NVK). Richtlijn Paliuatieve Zorg voor Kinderen. [Clinical Guideline for Pediatric Paliative Care.]. Utrecht: Dutch Pediatric Association (NVK); 2013. [31] De Minister van Justitie en de Staatssecretaris van Volksgezondheid Welzijn en Sport. Regeling centrale deskundigencommissie late zwangerschapsaf€indiging bij pasgeborenen. breking in een categorie 2-geval en levensbee [Establishment of a central committe of experts for late term abortion in category 2 case and termination of life of newborn babies.]. Staatscourant; 2007. p. 8e10.
Contents lists available at ScienceDirect
Seminars in Fetal & Neonatal Medicine journal homepage: www.elsevier.com/locate/siny
Review
Neonatal euthanasia: Lessons from the Groningen Protocol A.A. Eduard Verhagen* Department of Pediatrics, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands
s u m m a r y Keywords: Neonatal euthanasia Palliative care Neonatal intensive care Ethics Medical law
Decisions about neonatal end-of-life care have been studied intensely over the last 20 years in The Netherlands. Nationwide surveys were done to quantify these decisions, provide details and monitor the effect of guidelines, new regulations and other interventions. One of those interventions was the Groningen Protocol for newborn euthanasia in severely ill newborns, published in 2005. Before publication, an estimated 20 cases of euthanasia per year were performed. After publication, only two cases in five years were reported. Studies suggested that this might be partly caused by the lack of consensus about the dividing line between euthanasia and palliative care. New recommendations about paralytic medication use in dying newborns were issued to increase transparency and to improve reporting of euthanasia. New surveys will be needed to measure the effects of these interventions. This cycle of interventions and measurements seems useful for continuous improvement of end-of-life care in newborns. © 2014 Elsevier Ltd. All rights reserved.
1. Introduction The Groningen Protocol for newborn euthanasia in severely ill newborns was devised to regulate the practice of neonatal euthanasia and make it more transparent. Its publication immediately generated an international controversy and forced doctors to analyze the differences between the existing approaches in palliative care that are common in many countries, such as withholding and withdrawing of life supportive treatments or the administration of high doses of narcotics to relieve suffering, and the Dutch approach of administering lethal medication with the purpose of ending life. Almost 10 years have passed since its publication. What were the effects of the protocol on end-of-life practice? What can be learned form the Groningen Protocol? 2. End-of-life practice in patients who are suffering In the early 1980s some doctors in The Netherlands began reporting that they had performed euthanasia in adult patients to end suffering. In the preceding decade, the results of polls investigating the public and professional opinions concerning euthanasia had shifted from almost balanced to strongly in favor of euthanasia. The prosecuting office decided to charge some of these doctors to produce clarity about the grounds on which euthanasia might be justified as well as to specify the requirements of due care * Tel.: þ31503612470. E-mail address: [email protected]. http://dx.doi.org/10.1016/j.siny.2014.08.002 1744-165X/© 2014 Elsevier Ltd. All rights reserved.
with which a doctor had to comply [1,2]. Around that time, reports by political and medical bodies were issued reflecting the existing views on euthanasia. This made it easier for the Supreme Court to conclude that a doctor, who, in a case of euthanasia, complies with the criteria of due care, may successfully invoke the justification of necessity (conflicts of duties). Later verdicts have confirmed the legality of euthanasia, and the criteria of due care formulated by the court were subsequently incorporated into the Euthanasia law (2002). This law applies to all legally competent persons of 12 years and older. At the same time that euthanasia was being legalized, serious efforts were made to establish national standards surrounding medical decisions about end-of-life care. The first study was carried out in 1990, and every five years follow-up studies were conducted to ‘monitor’ changes in medical end-of-life practice by reporting frequency and other characteristics of decisions to withhold or withdraw life-supportive treatments (LSTs), use of medication that could potentially hasten death, consultation, reporting, palliative sedation, and euthanasia [2e7]. In the early 1990s, several case reports about termination of life in newborns were published, and in 1991 the Dutch Pediatric Association issued an influential report about end-of-life decisions in newborns [8e10]. Similar to the developments regarding adult euthanasia, governmental reports were issued and professionals and the public appeared to be in favor of allowing at least some form of life-ending measures for newborns with extreme suffering. The general prosecutor decided to prosecute two doctors who reported that they had performed newborn euthanasia. The
A.A. Eduard Verhagen / Seminars in Fetal & Neonatal Medicine 19 (2014) 296e299
297
prosecutor’s main reason was to secure legal clarification. The judgments in the two court cases in 1996 were similar in their confirmation that newborn euthanasia may be justified if the doctor acts in accordance with the applicable requirements of due care, as formulated in the verdicts, and reports what s/he has done to the prosecutorial authorities.
withdrawing LST in 95% of cases [17,18]. In ~60% of cases, this concerned unstable babies with an inevitable death, whereas the remaining 40% occurred in stable newborns for quality of life reasons. Only one case of unreported euthanasia was identified. An international comparative study reported similar results in 2010 [17].
3. A protocol for newborn euthanasia: the Groningen Protocol
5. Life-shortening by physicians: euthanasia or palliative care?
In the 1995 and 2001 national studies, special attention was given to end-of-life decisions in the care of newborn babies [11,12]. Based on these data, it was estimated that at least 15e20 cases of neonatal euthanasia took place every year. At that time, not many details about those cases were available, except that the babies did not have any LST(s) that could be withheld or withdrawn. A group of doctors at the University Medical Center Groningen wanted to know more details about these babies and reviewed all neonatal euthanasia cases that were reported to the prosecuting authorities from 1997 to 2005. They reported that only three cases per year were actually reported, and that they concerned term, stable babies suffering from severe and untreatable congenital malformations [13]. The data from this review, combined with the criteria of due care from the court cases and expert opinions, were used to develop an approach to identify situations in which neonatal euthanasia might be appropriate. Full transparency of end-of-life practice was sought. The New England Journal of Medicine published this protocol, known as ‘the Groningen Protocol for Neonatal Euthanasia’ (GP), in 2005 [14]. The protocol describes five major criteria that make euthanasia permissible: (1) diagnosis and prognosis must be certain; (2) hopeless and unbearable suffering must be present; (3) a confirming second opinion by an independent doctor must be obtained; (4) both parents must give informed consent; and (5) the procedure must be performed carefully, in accordance with medical standards.
The results of these follow-up studies sparked discussion within the medical and legal professions about the use of paralytic medication in dying babies. It appeared from the study results that some doctors administered this medication, always in combination with appropriate doses of opioids, to stop the prolonged gasping or to hasten death in dying babies on parental request. These doctors did not consider their action to be euthanasia but rather adequate symptom management and part of palliative care [19,20]. Those cases were, for that reason, never brought to the committee. Critics argued that, although the GP was created for another type of clinical situation (stable babies with excruciating suffering who have no LST that could be withdrawn), the action, the aim, and the medication were similar to euthanasia, and the GP should therefore be applied and reported. Those in favor of the argument that treating signs such as gasping in moribund patients is part of good palliative care state that, first, there is no alternative treatment that could take away the signs or alleviate potential suffering, or both; second, these patients were moribund, which means they were dying and death was imminent. It seems very unlikely that gasping in the dying state serves the infant any purpose. Moreover, the sight of their newborn gasping for breath can be a source of acute and long-term stress and anxiety for parents. In this situation, granting a parental request to stop the gasping by hastening their newborn's death with paralytic medication and sedatives will increase the parents' comfort and may contribute positively to their grief process and should therefore be regarded as acceptable medical practice [21e25]. At this point, the Dutch Medical Association (KNMG) asked a multidisciplinary group of experts to address the problem of differentiating newborn euthanasia and palliative care. They reasoned that a more detailed description of the dividing line between euthanasia and palliative care was crucial in view of the intended transparency of end-of-life care. After all, the consequences of either action are very different and may influence the doctor's willingness to report honestly what s/he has done. A case of neonatal euthanasia needs to be reported and reviewed post hoc to assess whether the physician fulfilled the due care criteria. If the criteria are not fulfilled, the doctor risks prosecution for homicide. Medical decisions leading to neonatal death in the context of palliative care are seen as normal medical practice and have no legal consequence [26,27].
4. Effects of the Groningen Protocol The publication of the GP and its endorsement by the Dutch Pediatric Association made the reporting of neonatal euthanasia in theory much easier because the requirements for due practice and the legal position of the doctor were made much clearer. The government contributed by transforming the GP into formal governmental regulation [15]. In addition, the reporting procedure became easier to follow because the revised version required the initial reporting to a multidisciplinary committee of experts (consisting of ethicists, doctors and legal people) instead of the local prosecuting office. This committee has been in place since 2007. In the five years following the GP, euthanasia had decreased from 15 to two cases. The two cases were babies with lethal epidermolysis bullosa. For congenital malformations, euthanasia decreased from 15 to 0 cases [16]. Both cases were reviewed post hoc and were considered to have been handled appropriately, and nobody was prosecuted. Those who are in favor of the GP argue that the decreased incidence of euthanasia is the effect of more transparency and clear regulation resulting in appropriate control of end-of-life practice. There is increasing evidence, however, that the transformation of the healthcare system (antenatal screening policy became a part of routine antenatal care in 2007) was probably the most important reason for increased elective terminations and less euthanasia [16]. Recent studies have evaluated end-of-life practice. One large follow-up study, describing end-of-life decision-making after the GP in the 10 Dutch neonatal intensive care units (NICUs), reported that the main mode of death was by withholding and/or
6. New recommendations for end-of-life care The multidisciplinary group formulated general recommendations about end-of-life decision-making and care in very sick newborns, based on a thorough analysis of medical policy statements from past reports, scientific publications, ethics, and the law [28,29]. In the discussion about the decision to withdraw LSTs, the group's report focuses on several specific treatments, among them withdrawal of respiratory support. Step by step, the report describes the clinical course of events that usually occurs around the time of withdrawal of the ventilator. Recommendations are made about communication with the parents and about treatment of signs and suffering in the dying newborn. The use of paralytic
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medications, always used with sedatives and analgesics, is discussed in great detail. According to the group, administration of paralytic medications is permitted if the aim is to stop prolonged gasping during ventilator withdrawal and to end a protracted dying process of several hours or more, which only adds to the suffering of the parents. This situation may occur in very rare situations when even state-of-the-art palliative sedation is insufficient to relieve pain and suffering, and despite the medical team's careful preparation involving the parents. The group ultimately concludes that this practice should be regarded as ‘good medical practice’, but they recommend that, in view of the ongoing debate about its legality, all cases must be reported for review to maintain full transparency and accountability. The significance of this conclusion is that it expresses the current opinion of the medical profession. In the Dutch legal system, judicial decisions are based primarily on the medical profession's opinion if detailed formal legislation is absent. A substantial proportion of the recommendations of the multidisciplinary group correspond with, and refer to, the evidencebased Guideline for Pediatric Palliative Care that was issued by the Dutch Pediatric Association in 2013 [30]. The ultimate goal of this clinical guideline was to improve palliative care for children and create indicators to measure the quality of care. The guideline has three chapters: symptom management, decision-making, and organization of care. In the chapter about decision-making, much attention is given to the medical, ethical, and legal aspects of decision-making and to the role of parents and patients in this context. Among the topics in this chapter are the recommendations about palliative sedation and euthanasia in newborns, all in line with the KNMG document discussed above, and in older children. The position of euthanasia in the guideline is that of a last-resort option, if no other reasonable palliative treatments are available and the newborns' parents (or a child aged 12 years) request it. The authors of the guideline note that there is a discrepancy in the available scientific studies and other sources of knowledge about newborn euthanasia, and in the lack of knowledge and guidelines about euthanasia in older incompetent infants and children. This note was echoed among the professional and public media and coincided with the decision in Belgium to remove the age limit in the euthanasia law and make it applicable to competent children of all ages. The minister of health, who was recently asked to clarify her position on euthanasia in minors, has indicated that she supports both the pediatric association's efforts to examine the current end-of-life practice in children aged 1e12 years in more depth, as well as their initiatives to secure and promote implementation of the pediatric palliative care guideline [31]. This support is likely to result, ultimately, in new regulations for children, based in large part on new scientific data about the clinical practice of palliative care in children <12 years.
Surveys of end-of-life practice have provided details about the frequency and dimensions of newborn euthanasia and have made it plausible that underreporting by doctors occurs. This led to regulation of practice through the GP, and resulted in the initiative by the medical profession to propose new recommendations about the dividing line between euthanasia and palliative care, especially in the context of dying newborns, and to clarify the definition of euthanasia. This development suggests that scientific data can be powerful stimuli to bring about changes in clinical practice. For many years, substantial efforts were made to make the practice of newborn euthanasia fully transparent and to regulate it. In contrast, the developments toward making high quality pediatric palliative care available have only recently started to accelerate, as illustrated by the publication last year of a national guideline for pediatric palliative care. The order of events, however, may seem illogical to many readers. Neonatal euthanasia has always been very rare and has become even more unusual in the last 10 years. This is in sharp contrast to pediatric palliative care, which involves several thousand pediatric patients with life-limiting diseases in The Netherlands. These patients and their families would immediately benefit from improvements in availability and quality of pediatric palliative care. However, the Dutch have started to regulate and define the complex end-point of unsuccessful palliative care (euthanasia) first, and from that point, retroactively, started to reorganize, define and improve the preceding steps in palliative care. Although this may seem counterintuitive, and most other countries choose their end-of-life care priorities differently, this approach seems to work for the Dutch. At this point, both areas are receiving increased attention from doctors, the public, and politicians with the goal of achieving optimal end-of-life care for ill children and their families.
Practice points The goal of the Groningen Protocol (GP) is to achieve transparency in end-of-life care. Euthanasia is a legal option for newborns who suffer intolerably. Acceptance of the GP has actually decreased euthanasia cases to <1 per year. Clear definitions are needed to distinguish palliative care from euthanasia. Repeated surveys allow monitoring of changes in end-oflife care.
7. Concluding remarks: what can be learned?
Research directions
This paper describes the most important developments in newborn end-of-life practice that have resulted in publication of the Groningen Protocol and the evolution that has occurred since endorsement by pediatricians in The Netherlands. The legal and medical developments in end-of-life care and euthanasia in newborns show much similarity with those in adults. Legality of both adult and newborn euthanasia was established after a long period of case reporting by the medical profession, and court cases. Comparative studies and repeated national surveys were performed to monitor changes in end-of-life care, every five years. This approach seems to work for The Netherlands and allowed us to demonstrate that legalization of (newborn) euthanasia does not necessarily lead to widespread misuse, as was widely predicted by opponents of decriminalization of euthanasia.
Refining quality indicators for neonatal end-of-life care. The role of parental suffering in physicians' end-of-life decision-making. End-of-life care and treatment of suffering in children aged 1e12 years. Implementation of neonatal palliative care guidelines in the NICU.
Conflict of interest statement None declared.
A.A. Eduard Verhagen / Seminars in Fetal & Neonatal Medicine 19 (2014) 296e299
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