Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
Current controversy
When ethical reform became law: the constitutional concerns raised by recent legislation in Taiwan Yi-Chen Su Correspondence to Professor Yi-Chen Su, Bachelor Program of Biotechnology and Graduate Institute of Biotechnology, National Chung Hsing University, 250 KuoKuang Rd, Taichung 40227, Taiwan; [email protected] Received 24 May 2013 Revised 8 July 2013 Accepted 29 September 2013 Published Online First 16 October 2013
ABSTRACT In an effort at ethical reform, Taiwan recently revised the Hospice Palliative Care Law authorising family members or physicians to make surrogate decisions to discontinue life-sustaining treatment if an incompetent terminally ill patient did not express their wishes while still competent. In particular, Article 7 of the new law authorises the palliative care team, namely the physicians, to act as sole decision-makers on behalf of the incompetent terminally ill patient’s best interests if no family member is available. However, the law fails to provide guidance as to what constitutes the patient’s best interests or what specific procedures the treating physicians should follow, and so has raised constitutional concerns. It may be difficult to translate ethical reform into law but it is not impossible if essential requirements are carefully followed. First, there must be substantial nexus between the purpose of the statute and the measures provided under the statute. Second, advocates need to convince the public that futility or waste has amounted to a public health emergency so as to justify lower procedural requirements. Third, a remedy or compensation should be available if the surrogate decisions have not been appropriately made. Fourth, minimum procedural safeguards are necessary even though the statute is intended to reduce the procedural burdens of making surrogate decisions on behalf of incompetent patients who lack family members and did not express their wishes while still competent.
BACKGROUND
To cite: Su Y-C. J Med Ethics 2014;40:484–487.
484
Most healthcare systems face the challenge of increasing demands for healthcare within limited financial budgets. Healthcare cost control in the context of end-of-life and palliative care is frequently considered a principal candidate for cost containment.1 Some have argued that waste or futile use of medical resources does not fulfil end-of-life treatment goals and have urged ethical reform.1 However, medical ethical reform based on futility should not violate the constitution. Ethics debates on medical issues seldom involve the constitution. Nonetheless, the constitution must be considered when advocates seek to enforce their views on medical ethics through state actions such as legislation. The medical community in Taiwan persuaded the government to remove the arguably burdensome legal procedure required for the termination of incompetent patients’ life-sustaining treatment based on futility and waste.2 However, the new law, as the embodiment of the medical community’s collective view, has raised constitutional concerns. Before the latest amendment to the Hospice Palliative Care Law in 2013, termination of
life-sustaining treatment in Taiwan required the approval of the hospital ethics committee in addition to the unanimous consent of the patient’s family members.3 The law also provides that at least one-third of hospital ethics committees should be composed of medical, ethics and legal experts together with prominent community leaders.3 As a government official stated when the latest amendment was being considered, hospital ethics committees do not meet regularly, which “often makes the committee’s decision untimely, even if two physicians had confirmed that the patient was terminally ill and the family members had agreed to terminate the life support”.4 The statute therefore needs to be revised as there could be a delay of 2–3 months between the decision and the withdrawal of treatment.4 Taiwanese medical community leaders issued a consensus statement in September 2011, singling out haemodialysis, ventilator use and extracorporeal membrane oxygenation (ECMO) as the three major futile and wasteful treatments. The consensus called for further revision to the Hospice Palliative Care Law, only amended in January 2011, to allow less stringent procedures for the discontinuation of incompetent patients’ life-sustaining treatment to avoid waste.2 However, the evidence does not suggest that haemodialysis, ventilator use or ECMO in Taiwan is particularly excessive or wasteful. In 2000, for instance, 29.6% of cancer patients used a ventilator within 1 month of their death, slightly reducing to 26.5% in 2010.5 Furthermore, 499 (44.3%) of the 1126 patients in Taiwan who received ECMO in 2010 were alive after the treatment. The average length of hospital stay for patients given ECMO was 22.5 days and the average duration on ECMO was 4.3 days, which was approximately 19% of the overall inpatient days. On average, ECMO treatment accounts for 19% of these patients’ medical expenses.6 In fact, the average time on ECMO in Taiwan is similar to that in other countries, which ranges from 5 to 10 days.7 8–10 In addition, a study in the USA suggested that ECMO can also be used to treat patients with cardiac arrest and profound shock and showed that 21% of patients who otherwise would have died survived after the treatment.11 Futility or waste is often used to justify unilateral decisions by physicians to withhold or withdraw life-sustaining treatment.12 A US study showed that 80% of physicians reported unilaterally withholding or withdrawing life-sustaining treatment that they considered futile, sometimes without the knowledge or consent of the patient or despite the patient’s objections.13 Therefore, a procedural approach would better support sound decision-
Su Y-C. J Med Ethics 2014;40:484–487. doi:10.1136/medethics-2013-101599
Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
Current controversy making by facilitating agreement among parties holding different positions.12 Nonetheless, procedural approaches, such as referral to hospital ethics committees, may be open to the charge of bias in the hospital’s favour.14 The Taiwanese medical community and Department of Health officials sought to enforce their views on ethical reform via legislation. In particular, the consensus statement issued by the medical community urged the reallocation of medical resources to prevent waste.2 However, this approach may result in unilateral decisions in the hospitals’ interests if the decisionmaking is not guided appropriately.
THE HOSPICE PALLIATIVE CARE LAW AMENDMENT The Hospice Palliative Care Law in Taiwan was amended in response to the medical community’s opinions and in light of the soaring National Health Insurance System deficit arguably caused by the provision of much unnecessary or futile treatment.2 Palliative care can be generally defined as “the prevention or treatment of pain, dyspnoea, and other kinds of suffering in terminally ill patients”.15 Article 7 of the revised Hospice Palliative Care Law, effective since January 2013, authorised the palliative care team, namely the physicians, to take medical decisions on behalf of incompetent terminally ill patients who did not express their wishes while still competent and who have no family member, regarding the termination of life-sustaining treatment in accordance with the patient’s best interests.16 Nonetheless, the law provides no guidance as to what constitutes the patient’s best interests or any procedures or guidelines for the treating physicians except the requirement that two physicians should have confirmed that the patient is terminally ill prior to the medical team’s decision to terminate life-sustaining treatment. On the other hand, under the new law, if a terminally ill patient has expressed their wishes regarding the termination of life-sustaining treatment while they were still competent, these wishes should be honoured; if the patient did not state their wishes, the next of kin are authorised to make the decision.16 However, no specific procedures are laid down in the statute in the event of conflict among family members with the same degree of relationship to the patient except that the government official mentioned above asserted that “the disagreement among family members is irrelevant as long as one family member with the same degree of relationship as the opposing members to the patient has signed the written consent”.4 Notably, the law only allows family members and the palliative care team to serve as the patient’s surrogate decision-maker, reflecting the emphasis on family unity and medical doctors’ high social status in Taiwanese culture. Compared with the previous 2011 revision of the statute, which took over a year to pass through the legislature, the latest revision enacted in January 2013 took less than 50 days. It is therefore not surprising that there is uncertainty regarding the composition of the “team” as mentioned in the statute and how it differs from the “hospital ethics committee” as prescribed in the earlier version. However, according to the statement by the Department of Health official, the team could be composed solely of the two physicians who had previously confirmed that the patient was terminally ill.4 It is clear from the legislative history that the new law intended the treating doctors to take the decision to withdraw or withhold treatment if the patient was incompetent and no family members were available. The original draft of Article 7 provided that “the treating physician” may take the decision in accordance with the patient’s best interests.4 The “treating physician” in the draft was later replaced with the words the “team Su Y-C. J Med Ethics 2014;40:484–487. doi:10.1136/medethics-2013-101599
providing palliative care” in response to the legislators’ concerns.4 In addition, legislators also questioned whether, in cases of potential conflicts of interest, the patient’s human rights or medical autonomy were adequately protected by a decisionmaking hierarchy based solely on the family member’s degree of relationship to the patient.4 In effect, in contrast to the previous situation, the new law excluded legal experts, ethicists and prominent community leaders from participating in the decision-making process. Decisions can be made solely by a palliative care team consisting only of the two physicians who previously confirmed the terminal illness, while the statute provides no guidance as to what constitutes the patient’s best interests. The law raised constitutional concerns because of its ambiguous nature and implications for human life. Constitutional concerns raised when ethical reform is translated into law include violation of the right to life, the right to equality, personal freedom and due process. The Council of Grand Justices (the Constitutional Court in Taiwan) addressed these issues in its No. 701 and No. 690 opinions, respectively.
SUBSTANTIAL NEXUS The differential treatment of persons involving a fundamental right such as the right to life is subject to a higher standard of judicial scrutiny. The Council of Grand Justices addressed this issue in its No. 701 opinion. American constitutional jurisprudence has a similar principle. The No. 701 opinion concerns differential tax treatment for expenses for long-term care services provided by different medical facilities. In this case, the statute being challenged stated that tax could only be deducted for medical expenses paid to some healthcare facilities but not to others similarly certified. The differential treatment was challenged for violating the equal right to life under the Taiwanese constitution. The Grand Justices stated that this issue was subject to a higher level of scrutiny as it concerns a person’s right to life. In other words, differential treatment should be supported by the constitution and there must be substantial nexus between the differential treatment and the purpose of the regulations.17 In that case, the Grand Justices stated that the classification does not contribute to tax avoidance or fraud as the tax authority can conduct audits, but does adversely effect the right to life of patients receiving long-term care and so violates the constitution.17 The rationale of the No. 701 opinion is analogous to the American notion that classification affecting fundamental rights can be justified only if necessary in the state’s interests.18 Under Article 7 of the Taiwanese Hospice Palliative Care Law, terminally ill incompetent patients who have not expressed their wishes are treated differently depending on whether or not they have family members. For the statute to be valid there must be substantial nexus between the stated purpose of the statute and the measures provided under the statute. As stipulated in Article 1, the purpose of the statute is to “respect the wishes of terminally ill patients and protect their rights”.19 However, differential treatment does not fulfil the purposes of the statute since the patients did not express their wishes and there is no guidance regarding the patient’s best interests for medical teams making surrogate decisions. Alternatively, in addition to respecting patients’ wishes, the government should promote the statute in order to alleviate the pain and suffering of terminally ill incompetent patients. However, the obstacle remains unless the government can convince the court that protecting incompetent patients from inhumane or excessive medical treatment is a compelling state interest sufficient to survive heightened constitutional scrutiny. 485
Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
Current controversy PUBLIC HEALTH EMERGENCY A hearing, which may be in the form of a hospital ethics committee, is generally required before government action or an act authorised by the statute affecting a person’s life, property or freedom. One way to reduce the rigid procedural requirements beforehand without violating the due process guaranteed under the constitution, is to convince the court that the statute concerns the protection of public health. The Council of Grand Justices addressed this issue in the No. 690 opinion. During the SARS (severe acute respiratory syndrome) outbreak in 2003, a medical doctor refused to be compulsorily quarantined in a hospital and as a result his medical license was suspended. Subsequently, the doctor challenged the compulsory quarantine as a violation of his personal freedom and as being outside the scope of the necessary dispositions allowed under the Communicable Disease Control Act.20 In the No. 690 opinion, the Grand Justices stated that compulsory quarantine, as a disposition necessary to prevent the spread of communicable diseases, did not violate the due process requirement for the protection of bodily freedom, even if the statute at issue did not provide a maximum length of quarantine and the compulsory quarantine was not ordered by a court. The No. 690 opinion is analogous to the US Supreme Court’s decision in North American Cold Storage Co. v. City of Chicago. In that case, the Supreme Court stated that a notice or hearing is not necessary before the seizure and destruction of food unfit for human consumption; it is within the legislature’s discretion to enact laws in relation to public health and to determine whether a hearing is needed beforehand.21 Unlike the SARS epidemic or food unfit for human consumption, futility or waste is not considered a public health emergency but does consume scarce medical resources. The allocation of medical resources is considered a public health issue in many countries.22 Also, as health costs have contributed to a large and increasing share of US bankruptcies,23 futile or excessive treatment may amount to a public health emergency in the future.
REMEDY OR COMPENSATION Even if lower procedural requirements are applied, for instance where futility or waste is recognised as a public health issue, a remedy or compensation should be available in case of abuse of the decision-making process. In the absence of a guardian appointed by the court or the relevant authority on behalf of the patient’s interests, the statute would fail in a constitutional challenge as it lacks provision for a remedy or compensation. In the No. 690 opinion, the Grand Justices cautioned that “prompt remedies and an adequate compensation system should be established for persons and their families disputing the compulsory quarantine” and the authorities “should promptly review the Communicable Disease Control Act”.20 Similarly in North American Cold Storage Co. v. City of Chicago, the US Supreme Court stated that, although it is not necessary for a party to have a hearing in advance, the right to have it cannot be deprived and can be claimed upon a trial in an action for the destruction of their property.21 Under the Hospice Palliative Care Law, once a surrogate decision for the termination of life-sustaining treatment has been made by medical staff, no remedy or compensation is available for the patient since in most situations the patient dies. Reducing the procedural requirement so that no remedy or compensation is available directly conflicts with the Grand Justices’ instruction. 486
Therefore, a non-surrogate guardian neutral in the decisionmaking process must be appointed beforehand as otherwise there will be no one to act on behalf of the incompetent patient. Alternatively, if no guardian is appointed, the law should allow interested parties to commence court proceedings to review the decision if they have reasonable grounds to believe that the decision-making process has been abused, as in the case of gross negligence or a decision solely based on the healthcare provider’s financial interests. However, the simple appointment of a non-surrogate guardian is insufficient to meet minimal procedural safeguards for the protection of human life under the constitution.
MINIMAL PROCEDURAL SAFEGUARDS The Grand Justices in Taiwan have yet to address to what extent the procedural safeguards ensure surrogate decisions for the termination of life support for incompetent patients do not violate their constitutional rights. The issue has been discussed more extensively in US courts and legislation. In the USA, the State of Tennessee recognised that “every person has the fundamental and inherent right to die naturally with as much dignity as circumstances permit and to accept, refuse, withdraw from, or otherwise control decisions relating to the rendering of the person’s own medical care”, including palliative care.24 The court in San Juan-Torregosa v. Garcia confirmed that the right to refuse unwanted treatment “belongs to every person, and does not distinguish between those who are competent and those who are not”.24 Nonetheless, procedural safeguards must be in place to guarantee that the surrogate decision is in accordance with the incompetent patient’s values, such as the requirement for a higher burden of proof concerning the incompetent patient’s wishes regarding the withdrawal of treatment in Cruzan v. Director of Missouri Health Dept.25 Moreover, a statute providing procedures for the termination of life-sustaining treatment should be very specific.26 At a minimum, the surrogate should be someone familiar with the patient’s values. As the US Uniform Health-Care Decisions Act has recommended, as a last resort those making healthcare decisions for the patient should be those who know the patient’s values if no one higher in the decision-making hierarchy is available.27 In situations where terminally ill patients cannot make decisions and lack surrogates, Luce and Alpers agreed that physicians may forego life-sustaining treatment for patients, but only if they base their actions as formal surrogates should, on their best understanding of what the patients themselves would want.15 Nonetheless, in an ordinary setting, physicians may not know the patient’s values. In fact, the US Uniform Health-Care Decisions Act expressly excluded the owners, operators or employees of the health institution at which the patient is receiving care from making surrogate decisions unless they are also the patient’s family members.27 Similarly, the New York State Family Health Care Decisions Act allows physicians to serve as the sole decision-makers withholding life-sustaining treatment for patients without surrogates only if the patient’s death is imminent irrespective of whether or not treatment is provided, and the provision of life-sustaining treatment in such a situation would violate accepted medical standards.28 In assessing the patient’s best interests as general guidance in decision-making, the New York statute provides that the consideration should at least include the dignity and uniqueness of each person, and values that a reasonable person in the patient’s circumstances would probably hold.29 However, a decision in Su Y-C. J Med Ethics 2014;40:484–487. doi:10.1136/medethics-2013-101599
Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
Current controversy accordance with the patient’s best interests is insufficient to justify the termination of the patient’s life support under the New York statute. Additional requirements are needed, for instance in the situation where the provision of life-sustaining treatment would reasonably be deemed inhumane or extraordinarily burdensome under the particular circumstances.29 In a constitutional challenge, the Taiwanese Hospice Palliative Care Law would most likely fail because it does not provide minimum procedural safeguards. Alternatively, the Taiwanese government could revise the law to include the following procedural safeguards: (1) procedures appointing non-surrogate guardians other than family members on behalf of the patient’s interests before the team makes its decision; (2) provisions excluding attending physicians from being the sole decisionmaker; (3) provisions defining the composition of the “team” to include members to oversee the decision-making; and (4) provisions defining the patient’s best interests specifically regarding the decision to terminate the patient’s life-sustaining treatment.
2
3 4 5
6
7 8
9
10
CONCLUSION Examination of the legislation in Taiwan and its constitutional implications reveals how difficult it is to translate ethical reform into law. However, it is not impossible if the essential requirements are carefully followed. First, there must be substantial nexus between the purpose of the statute and the measures provided under the statute. Second, advocates need to convince the court and the public that futility or waste has amounted to a public health emergency so as to justify lower procedural requirements. Third, a remedy or compensation should be available if the surrogate decision involves gross negligence or is based solely on the healthcare provider’s financial interests. Finally, minimum procedural safeguards are necessary even if the statute is intended to reduce the procedural burdens of making surrogate decisions on behalf of patients who have no family member and did not express their wishes while still competent.
11
12 13
14 15
16 17 18 19 20 21 22
Acknowledgements The author appreciates the reviewers’ invaluable comments and generous assistance.
23
Competing interests None.
24 25 26 27
Provenance and peer review Not commissioned; externally peer reviewed.
REFERENCES 1
Jennings B, Morrissey MB. Health care costs in end-of-life and palliative care: the quest for ethical reform. J Soc Work End Life Palliat Care 2011;7:300–17.
Su Y-C. J Med Ethics 2014;40:484–487. doi:10.1136/medethics-2013-101599
28 29
Chang C. Twenty-two percent of patents were brain-dead even after using ECMO. China Times 5 September 2011. http://health.chinatimes.com/contents.aspx? cid=5,68&id=14170 (accessed 15 May 2013). Taiwan’s Hospice Palliative Care Law of 2011. Art 7 (repealed). Legislative Yuan. Committee records. Legislative Yuan Gazette 2012;102 (1):1596–652. Bureau of National Health Insurance. The ratio of cancer patients using CPR within one month before their death reduced 60% in the past 11 years and the use of palliative care increased 5 times during the same period. News Release 13 October 2012. http://www.bhp.doh.gov.tw/BHPnet/Web/News/News.aspx? No=201210150002 (accessed 15 May 2013). Bureau of National Health Insurance. ECMO saved 499 patients last year. News Release 29 June 2011. http://www.nhi.gov.tw/information/NewsDetail.aspx? No=947&menu=9&menu_id=544 (accessed 15 May 2013). Jefferson University Hospitals. ECMO at Jefferson. http://www.jeffersonhospital.org/ tests-and-treatments/ecmo (accessed 15 May 2013). Intermountain Primary Children’s Medical Center. Let’s talk about ECMO 2009. http://intermountainhealthcare.org/ext/Dcmnt?ncid=520408193 (accessed 15 May 2013). Great Ormond Street Hospital for Children. Extracorporeal membrane oxygenation (ECMO). http://www.gosh.nhs.uk/medical-conditions/procedures-and-treatments/ ecmo/ (accessed 15 May 2013). Glenfield Hospital. Information for relatives if allocation is to ECMO. http://cesar. lshtm.ac.uk/ecmo.pdf (accessed 15 May 2013). University of Pennsylvania. Penn medicine research study suggests new role for ECMO in treating patients with cardiac arrest and profound shock. News Release 17 May 2013. http://www.uphs.upenn.edu/news/News_Releases/2013/05/ecmo/ (accessed 15 May 2013). Winkler EC, Hiddemann W, Marckmann G. Evaluating a patient’s request for life-prolonging treatment: an ethical framework. J Med Ethics 2012;38:647–51. Asch DA, Hansen-Flaschen J, Lanken PN. Decisions to limit or continue life-sustaining treatment by critical care physicians in the United States: conflicts between physicians’ practices and patients’ wishes. Am J Respir Crit Care Med 1995;151(2 Pt 1):288–92. Burns JP, Truog RD. Futility: a concept in evolution. Chest 2007;132(6):1987–93. Luce JM, Alpers A. Legal aspects of withholding and withdrawing life support from critically ill patients in the United States and providing palliative care. Am J Respir Crit Care Med 2000;162(6):2029–32. Taiwan’s Hospice Palliative Care Law of 2013. Art 7. Taiwan’s Judicial Yuan Interpretation No. 701 (2012). San Antonio Independent School District v. Rodriguez, 411 US 1 (1973). Taiwan’s Hospice Palliative Care Law of 2013. Art 1. Taiwan’s Judicial Yuan Interpretation No. 690 (2011). North American Storage Cold Co. v. City of Chicago, 211 US 306 (1908). Liss P. Hard choices in public health: the allocation of scarce resources. Scand J Public Health 2003;31(2):156–7. Himmelstein DU, Thorne D, Warren E, et al. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med 2009;122(8):741–6. San Juan-Torregosa v Garcia. 80 SW3d 539 (Tenn Ct App 2002). Cruzan v Director of Missouri Health Dept. 497 US 261 (1990). In re Appointment of a Guardian for CK. 819 NYS2d 847 (NY Sur 2006). Uniform Health-Care Decisions Act §5(c), (f), (i). http://www.uniformlaws.org/ shared/docs/health%20care%20decisions/uhcda_final_93.pdf (accessed 15 May 2013). N.Y. Public Health Law §2994-g.5(b). N.Y. Public Health Law §2994-d.4, 5.
487
Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
When ethical reform became law: the constitutional concerns raised by recent legislation in Taiwan Yi-Chen Su J Med Ethics 2014 40: 484-487 originally published online October 16, 2013
doi: 10.1136/medethics-2013-101599 Updated information and services can be found at: http://jme.bmj.com/content/40/7/484
These include:
References Email alerting service
Topic Collections
This article cites 8 articles, 2 of which you can access for free at: http://jme.bmj.com/content/40/7/484#BIBL Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Articles on similar topics can be found in the following collections Hospice (110)
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
Current controversy
When ethical reform became law: the constitutional concerns raised by recent legislation in Taiwan Yi-Chen Su Correspondence to Professor Yi-Chen Su, Bachelor Program of Biotechnology and Graduate Institute of Biotechnology, National Chung Hsing University, 250 KuoKuang Rd, Taichung 40227, Taiwan; [email protected] Received 24 May 2013 Revised 8 July 2013 Accepted 29 September 2013 Published Online First 16 October 2013
ABSTRACT In an effort at ethical reform, Taiwan recently revised the Hospice Palliative Care Law authorising family members or physicians to make surrogate decisions to discontinue life-sustaining treatment if an incompetent terminally ill patient did not express their wishes while still competent. In particular, Article 7 of the new law authorises the palliative care team, namely the physicians, to act as sole decision-makers on behalf of the incompetent terminally ill patient’s best interests if no family member is available. However, the law fails to provide guidance as to what constitutes the patient’s best interests or what specific procedures the treating physicians should follow, and so has raised constitutional concerns. It may be difficult to translate ethical reform into law but it is not impossible if essential requirements are carefully followed. First, there must be substantial nexus between the purpose of the statute and the measures provided under the statute. Second, advocates need to convince the public that futility or waste has amounted to a public health emergency so as to justify lower procedural requirements. Third, a remedy or compensation should be available if the surrogate decisions have not been appropriately made. Fourth, minimum procedural safeguards are necessary even though the statute is intended to reduce the procedural burdens of making surrogate decisions on behalf of incompetent patients who lack family members and did not express their wishes while still competent.
BACKGROUND
To cite: Su Y-C. J Med Ethics 2014;40:484–487.
484
Most healthcare systems face the challenge of increasing demands for healthcare within limited financial budgets. Healthcare cost control in the context of end-of-life and palliative care is frequently considered a principal candidate for cost containment.1 Some have argued that waste or futile use of medical resources does not fulfil end-of-life treatment goals and have urged ethical reform.1 However, medical ethical reform based on futility should not violate the constitution. Ethics debates on medical issues seldom involve the constitution. Nonetheless, the constitution must be considered when advocates seek to enforce their views on medical ethics through state actions such as legislation. The medical community in Taiwan persuaded the government to remove the arguably burdensome legal procedure required for the termination of incompetent patients’ life-sustaining treatment based on futility and waste.2 However, the new law, as the embodiment of the medical community’s collective view, has raised constitutional concerns. Before the latest amendment to the Hospice Palliative Care Law in 2013, termination of
life-sustaining treatment in Taiwan required the approval of the hospital ethics committee in addition to the unanimous consent of the patient’s family members.3 The law also provides that at least one-third of hospital ethics committees should be composed of medical, ethics and legal experts together with prominent community leaders.3 As a government official stated when the latest amendment was being considered, hospital ethics committees do not meet regularly, which “often makes the committee’s decision untimely, even if two physicians had confirmed that the patient was terminally ill and the family members had agreed to terminate the life support”.4 The statute therefore needs to be revised as there could be a delay of 2–3 months between the decision and the withdrawal of treatment.4 Taiwanese medical community leaders issued a consensus statement in September 2011, singling out haemodialysis, ventilator use and extracorporeal membrane oxygenation (ECMO) as the three major futile and wasteful treatments. The consensus called for further revision to the Hospice Palliative Care Law, only amended in January 2011, to allow less stringent procedures for the discontinuation of incompetent patients’ life-sustaining treatment to avoid waste.2 However, the evidence does not suggest that haemodialysis, ventilator use or ECMO in Taiwan is particularly excessive or wasteful. In 2000, for instance, 29.6% of cancer patients used a ventilator within 1 month of their death, slightly reducing to 26.5% in 2010.5 Furthermore, 499 (44.3%) of the 1126 patients in Taiwan who received ECMO in 2010 were alive after the treatment. The average length of hospital stay for patients given ECMO was 22.5 days and the average duration on ECMO was 4.3 days, which was approximately 19% of the overall inpatient days. On average, ECMO treatment accounts for 19% of these patients’ medical expenses.6 In fact, the average time on ECMO in Taiwan is similar to that in other countries, which ranges from 5 to 10 days.7 8–10 In addition, a study in the USA suggested that ECMO can also be used to treat patients with cardiac arrest and profound shock and showed that 21% of patients who otherwise would have died survived after the treatment.11 Futility or waste is often used to justify unilateral decisions by physicians to withhold or withdraw life-sustaining treatment.12 A US study showed that 80% of physicians reported unilaterally withholding or withdrawing life-sustaining treatment that they considered futile, sometimes without the knowledge or consent of the patient or despite the patient’s objections.13 Therefore, a procedural approach would better support sound decision-
Su Y-C. J Med Ethics 2014;40:484–487. doi:10.1136/medethics-2013-101599
Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
Current controversy making by facilitating agreement among parties holding different positions.12 Nonetheless, procedural approaches, such as referral to hospital ethics committees, may be open to the charge of bias in the hospital’s favour.14 The Taiwanese medical community and Department of Health officials sought to enforce their views on ethical reform via legislation. In particular, the consensus statement issued by the medical community urged the reallocation of medical resources to prevent waste.2 However, this approach may result in unilateral decisions in the hospitals’ interests if the decisionmaking is not guided appropriately.
THE HOSPICE PALLIATIVE CARE LAW AMENDMENT The Hospice Palliative Care Law in Taiwan was amended in response to the medical community’s opinions and in light of the soaring National Health Insurance System deficit arguably caused by the provision of much unnecessary or futile treatment.2 Palliative care can be generally defined as “the prevention or treatment of pain, dyspnoea, and other kinds of suffering in terminally ill patients”.15 Article 7 of the revised Hospice Palliative Care Law, effective since January 2013, authorised the palliative care team, namely the physicians, to take medical decisions on behalf of incompetent terminally ill patients who did not express their wishes while still competent and who have no family member, regarding the termination of life-sustaining treatment in accordance with the patient’s best interests.16 Nonetheless, the law provides no guidance as to what constitutes the patient’s best interests or any procedures or guidelines for the treating physicians except the requirement that two physicians should have confirmed that the patient is terminally ill prior to the medical team’s decision to terminate life-sustaining treatment. On the other hand, under the new law, if a terminally ill patient has expressed their wishes regarding the termination of life-sustaining treatment while they were still competent, these wishes should be honoured; if the patient did not state their wishes, the next of kin are authorised to make the decision.16 However, no specific procedures are laid down in the statute in the event of conflict among family members with the same degree of relationship to the patient except that the government official mentioned above asserted that “the disagreement among family members is irrelevant as long as one family member with the same degree of relationship as the opposing members to the patient has signed the written consent”.4 Notably, the law only allows family members and the palliative care team to serve as the patient’s surrogate decision-maker, reflecting the emphasis on family unity and medical doctors’ high social status in Taiwanese culture. Compared with the previous 2011 revision of the statute, which took over a year to pass through the legislature, the latest revision enacted in January 2013 took less than 50 days. It is therefore not surprising that there is uncertainty regarding the composition of the “team” as mentioned in the statute and how it differs from the “hospital ethics committee” as prescribed in the earlier version. However, according to the statement by the Department of Health official, the team could be composed solely of the two physicians who had previously confirmed that the patient was terminally ill.4 It is clear from the legislative history that the new law intended the treating doctors to take the decision to withdraw or withhold treatment if the patient was incompetent and no family members were available. The original draft of Article 7 provided that “the treating physician” may take the decision in accordance with the patient’s best interests.4 The “treating physician” in the draft was later replaced with the words the “team Su Y-C. J Med Ethics 2014;40:484–487. doi:10.1136/medethics-2013-101599
providing palliative care” in response to the legislators’ concerns.4 In addition, legislators also questioned whether, in cases of potential conflicts of interest, the patient’s human rights or medical autonomy were adequately protected by a decisionmaking hierarchy based solely on the family member’s degree of relationship to the patient.4 In effect, in contrast to the previous situation, the new law excluded legal experts, ethicists and prominent community leaders from participating in the decision-making process. Decisions can be made solely by a palliative care team consisting only of the two physicians who previously confirmed the terminal illness, while the statute provides no guidance as to what constitutes the patient’s best interests. The law raised constitutional concerns because of its ambiguous nature and implications for human life. Constitutional concerns raised when ethical reform is translated into law include violation of the right to life, the right to equality, personal freedom and due process. The Council of Grand Justices (the Constitutional Court in Taiwan) addressed these issues in its No. 701 and No. 690 opinions, respectively.
SUBSTANTIAL NEXUS The differential treatment of persons involving a fundamental right such as the right to life is subject to a higher standard of judicial scrutiny. The Council of Grand Justices addressed this issue in its No. 701 opinion. American constitutional jurisprudence has a similar principle. The No. 701 opinion concerns differential tax treatment for expenses for long-term care services provided by different medical facilities. In this case, the statute being challenged stated that tax could only be deducted for medical expenses paid to some healthcare facilities but not to others similarly certified. The differential treatment was challenged for violating the equal right to life under the Taiwanese constitution. The Grand Justices stated that this issue was subject to a higher level of scrutiny as it concerns a person’s right to life. In other words, differential treatment should be supported by the constitution and there must be substantial nexus between the differential treatment and the purpose of the regulations.17 In that case, the Grand Justices stated that the classification does not contribute to tax avoidance or fraud as the tax authority can conduct audits, but does adversely effect the right to life of patients receiving long-term care and so violates the constitution.17 The rationale of the No. 701 opinion is analogous to the American notion that classification affecting fundamental rights can be justified only if necessary in the state’s interests.18 Under Article 7 of the Taiwanese Hospice Palliative Care Law, terminally ill incompetent patients who have not expressed their wishes are treated differently depending on whether or not they have family members. For the statute to be valid there must be substantial nexus between the stated purpose of the statute and the measures provided under the statute. As stipulated in Article 1, the purpose of the statute is to “respect the wishes of terminally ill patients and protect their rights”.19 However, differential treatment does not fulfil the purposes of the statute since the patients did not express their wishes and there is no guidance regarding the patient’s best interests for medical teams making surrogate decisions. Alternatively, in addition to respecting patients’ wishes, the government should promote the statute in order to alleviate the pain and suffering of terminally ill incompetent patients. However, the obstacle remains unless the government can convince the court that protecting incompetent patients from inhumane or excessive medical treatment is a compelling state interest sufficient to survive heightened constitutional scrutiny. 485
Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
Current controversy PUBLIC HEALTH EMERGENCY A hearing, which may be in the form of a hospital ethics committee, is generally required before government action or an act authorised by the statute affecting a person’s life, property or freedom. One way to reduce the rigid procedural requirements beforehand without violating the due process guaranteed under the constitution, is to convince the court that the statute concerns the protection of public health. The Council of Grand Justices addressed this issue in the No. 690 opinion. During the SARS (severe acute respiratory syndrome) outbreak in 2003, a medical doctor refused to be compulsorily quarantined in a hospital and as a result his medical license was suspended. Subsequently, the doctor challenged the compulsory quarantine as a violation of his personal freedom and as being outside the scope of the necessary dispositions allowed under the Communicable Disease Control Act.20 In the No. 690 opinion, the Grand Justices stated that compulsory quarantine, as a disposition necessary to prevent the spread of communicable diseases, did not violate the due process requirement for the protection of bodily freedom, even if the statute at issue did not provide a maximum length of quarantine and the compulsory quarantine was not ordered by a court. The No. 690 opinion is analogous to the US Supreme Court’s decision in North American Cold Storage Co. v. City of Chicago. In that case, the Supreme Court stated that a notice or hearing is not necessary before the seizure and destruction of food unfit for human consumption; it is within the legislature’s discretion to enact laws in relation to public health and to determine whether a hearing is needed beforehand.21 Unlike the SARS epidemic or food unfit for human consumption, futility or waste is not considered a public health emergency but does consume scarce medical resources. The allocation of medical resources is considered a public health issue in many countries.22 Also, as health costs have contributed to a large and increasing share of US bankruptcies,23 futile or excessive treatment may amount to a public health emergency in the future.
REMEDY OR COMPENSATION Even if lower procedural requirements are applied, for instance where futility or waste is recognised as a public health issue, a remedy or compensation should be available in case of abuse of the decision-making process. In the absence of a guardian appointed by the court or the relevant authority on behalf of the patient’s interests, the statute would fail in a constitutional challenge as it lacks provision for a remedy or compensation. In the No. 690 opinion, the Grand Justices cautioned that “prompt remedies and an adequate compensation system should be established for persons and their families disputing the compulsory quarantine” and the authorities “should promptly review the Communicable Disease Control Act”.20 Similarly in North American Cold Storage Co. v. City of Chicago, the US Supreme Court stated that, although it is not necessary for a party to have a hearing in advance, the right to have it cannot be deprived and can be claimed upon a trial in an action for the destruction of their property.21 Under the Hospice Palliative Care Law, once a surrogate decision for the termination of life-sustaining treatment has been made by medical staff, no remedy or compensation is available for the patient since in most situations the patient dies. Reducing the procedural requirement so that no remedy or compensation is available directly conflicts with the Grand Justices’ instruction. 486
Therefore, a non-surrogate guardian neutral in the decisionmaking process must be appointed beforehand as otherwise there will be no one to act on behalf of the incompetent patient. Alternatively, if no guardian is appointed, the law should allow interested parties to commence court proceedings to review the decision if they have reasonable grounds to believe that the decision-making process has been abused, as in the case of gross negligence or a decision solely based on the healthcare provider’s financial interests. However, the simple appointment of a non-surrogate guardian is insufficient to meet minimal procedural safeguards for the protection of human life under the constitution.
MINIMAL PROCEDURAL SAFEGUARDS The Grand Justices in Taiwan have yet to address to what extent the procedural safeguards ensure surrogate decisions for the termination of life support for incompetent patients do not violate their constitutional rights. The issue has been discussed more extensively in US courts and legislation. In the USA, the State of Tennessee recognised that “every person has the fundamental and inherent right to die naturally with as much dignity as circumstances permit and to accept, refuse, withdraw from, or otherwise control decisions relating to the rendering of the person’s own medical care”, including palliative care.24 The court in San Juan-Torregosa v. Garcia confirmed that the right to refuse unwanted treatment “belongs to every person, and does not distinguish between those who are competent and those who are not”.24 Nonetheless, procedural safeguards must be in place to guarantee that the surrogate decision is in accordance with the incompetent patient’s values, such as the requirement for a higher burden of proof concerning the incompetent patient’s wishes regarding the withdrawal of treatment in Cruzan v. Director of Missouri Health Dept.25 Moreover, a statute providing procedures for the termination of life-sustaining treatment should be very specific.26 At a minimum, the surrogate should be someone familiar with the patient’s values. As the US Uniform Health-Care Decisions Act has recommended, as a last resort those making healthcare decisions for the patient should be those who know the patient’s values if no one higher in the decision-making hierarchy is available.27 In situations where terminally ill patients cannot make decisions and lack surrogates, Luce and Alpers agreed that physicians may forego life-sustaining treatment for patients, but only if they base their actions as formal surrogates should, on their best understanding of what the patients themselves would want.15 Nonetheless, in an ordinary setting, physicians may not know the patient’s values. In fact, the US Uniform Health-Care Decisions Act expressly excluded the owners, operators or employees of the health institution at which the patient is receiving care from making surrogate decisions unless they are also the patient’s family members.27 Similarly, the New York State Family Health Care Decisions Act allows physicians to serve as the sole decision-makers withholding life-sustaining treatment for patients without surrogates only if the patient’s death is imminent irrespective of whether or not treatment is provided, and the provision of life-sustaining treatment in such a situation would violate accepted medical standards.28 In assessing the patient’s best interests as general guidance in decision-making, the New York statute provides that the consideration should at least include the dignity and uniqueness of each person, and values that a reasonable person in the patient’s circumstances would probably hold.29 However, a decision in Su Y-C. J Med Ethics 2014;40:484–487. doi:10.1136/medethics-2013-101599
Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
Current controversy accordance with the patient’s best interests is insufficient to justify the termination of the patient’s life support under the New York statute. Additional requirements are needed, for instance in the situation where the provision of life-sustaining treatment would reasonably be deemed inhumane or extraordinarily burdensome under the particular circumstances.29 In a constitutional challenge, the Taiwanese Hospice Palliative Care Law would most likely fail because it does not provide minimum procedural safeguards. Alternatively, the Taiwanese government could revise the law to include the following procedural safeguards: (1) procedures appointing non-surrogate guardians other than family members on behalf of the patient’s interests before the team makes its decision; (2) provisions excluding attending physicians from being the sole decisionmaker; (3) provisions defining the composition of the “team” to include members to oversee the decision-making; and (4) provisions defining the patient’s best interests specifically regarding the decision to terminate the patient’s life-sustaining treatment.
2
3 4 5
6
7 8
9
10
CONCLUSION Examination of the legislation in Taiwan and its constitutional implications reveals how difficult it is to translate ethical reform into law. However, it is not impossible if the essential requirements are carefully followed. First, there must be substantial nexus between the purpose of the statute and the measures provided under the statute. Second, advocates need to convince the court and the public that futility or waste has amounted to a public health emergency so as to justify lower procedural requirements. Third, a remedy or compensation should be available if the surrogate decision involves gross negligence or is based solely on the healthcare provider’s financial interests. Finally, minimum procedural safeguards are necessary even if the statute is intended to reduce the procedural burdens of making surrogate decisions on behalf of patients who have no family member and did not express their wishes while still competent.
11
12 13
14 15
16 17 18 19 20 21 22
Acknowledgements The author appreciates the reviewers’ invaluable comments and generous assistance.
23
Competing interests None.
24 25 26 27
Provenance and peer review Not commissioned; externally peer reviewed.
REFERENCES 1
Jennings B, Morrissey MB. Health care costs in end-of-life and palliative care: the quest for ethical reform. J Soc Work End Life Palliat Care 2011;7:300–17.
Su Y-C. J Med Ethics 2014;40:484–487. doi:10.1136/medethics-2013-101599
28 29
Chang C. Twenty-two percent of patents were brain-dead even after using ECMO. China Times 5 September 2011. http://health.chinatimes.com/contents.aspx? cid=5,68&id=14170 (accessed 15 May 2013). Taiwan’s Hospice Palliative Care Law of 2011. Art 7 (repealed). Legislative Yuan. Committee records. Legislative Yuan Gazette 2012;102 (1):1596–652. Bureau of National Health Insurance. The ratio of cancer patients using CPR within one month before their death reduced 60% in the past 11 years and the use of palliative care increased 5 times during the same period. News Release 13 October 2012. http://www.bhp.doh.gov.tw/BHPnet/Web/News/News.aspx? No=201210150002 (accessed 15 May 2013). Bureau of National Health Insurance. ECMO saved 499 patients last year. News Release 29 June 2011. http://www.nhi.gov.tw/information/NewsDetail.aspx? No=947&menu=9&menu_id=544 (accessed 15 May 2013). Jefferson University Hospitals. ECMO at Jefferson. http://www.jeffersonhospital.org/ tests-and-treatments/ecmo (accessed 15 May 2013). Intermountain Primary Children’s Medical Center. Let’s talk about ECMO 2009. http://intermountainhealthcare.org/ext/Dcmnt?ncid=520408193 (accessed 15 May 2013). Great Ormond Street Hospital for Children. Extracorporeal membrane oxygenation (ECMO). http://www.gosh.nhs.uk/medical-conditions/procedures-and-treatments/ ecmo/ (accessed 15 May 2013). Glenfield Hospital. Information for relatives if allocation is to ECMO. http://cesar. lshtm.ac.uk/ecmo.pdf (accessed 15 May 2013). University of Pennsylvania. Penn medicine research study suggests new role for ECMO in treating patients with cardiac arrest and profound shock. News Release 17 May 2013. http://www.uphs.upenn.edu/news/News_Releases/2013/05/ecmo/ (accessed 15 May 2013). Winkler EC, Hiddemann W, Marckmann G. Evaluating a patient’s request for life-prolonging treatment: an ethical framework. J Med Ethics 2012;38:647–51. Asch DA, Hansen-Flaschen J, Lanken PN. Decisions to limit or continue life-sustaining treatment by critical care physicians in the United States: conflicts between physicians’ practices and patients’ wishes. Am J Respir Crit Care Med 1995;151(2 Pt 1):288–92. Burns JP, Truog RD. Futility: a concept in evolution. Chest 2007;132(6):1987–93. Luce JM, Alpers A. Legal aspects of withholding and withdrawing life support from critically ill patients in the United States and providing palliative care. Am J Respir Crit Care Med 2000;162(6):2029–32. Taiwan’s Hospice Palliative Care Law of 2013. Art 7. Taiwan’s Judicial Yuan Interpretation No. 701 (2012). San Antonio Independent School District v. Rodriguez, 411 US 1 (1973). Taiwan’s Hospice Palliative Care Law of 2013. Art 1. Taiwan’s Judicial Yuan Interpretation No. 690 (2011). North American Storage Cold Co. v. City of Chicago, 211 US 306 (1908). Liss P. Hard choices in public health: the allocation of scarce resources. Scand J Public Health 2003;31(2):156–7. Himmelstein DU, Thorne D, Warren E, et al. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med 2009;122(8):741–6. San Juan-Torregosa v Garcia. 80 SW3d 539 (Tenn Ct App 2002). Cruzan v Director of Missouri Health Dept. 497 US 261 (1990). In re Appointment of a Guardian for CK. 819 NYS2d 847 (NY Sur 2006). Uniform Health-Care Decisions Act §5(c), (f), (i). http://www.uniformlaws.org/ shared/docs/health%20care%20decisions/uhcda_final_93.pdf (accessed 15 May 2013). N.Y. Public Health Law §2994-g.5(b). N.Y. Public Health Law §2994-d.4, 5.
487
Downloaded from http://jme.bmj.com/ on June 25, 2015 - Published by group.bmj.com
When ethical reform became law: the constitutional concerns raised by recent legislation in Taiwan Yi-Chen Su J Med Ethics 2014 40: 484-487 originally published online October 16, 2013
doi: 10.1136/medethics-2013-101599 Updated information and services can be found at: http://jme.bmj.com/content/40/7/484
These include:
References Email alerting service
Topic Collections
This article cites 8 articles, 2 of which you can access for free at: http://jme.bmj.com/content/40/7/484#BIBL Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Articles on similar topics can be found in the following collections Hospice (110)
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
