Is the Croatian Medical Law in Harmony with the International Comparative Standards on the Right to Self- Determination? The Example of Jehovah’s Witnesses Patients

Are Jehovah’s Witnesses (JW) outstanding patients? One might answer in the affirmative. Is not their refusal of blood transfusions, a treatment traditionally considered as a life-saving treatment, problematic both from the medical and legal viewpoint? However, traditions are not everlasting. Both modern medical science and legal standards have greatly improved during the last two decades. Over the last few years, JW medical choice has become standard treatment for many physicians specialized in bloodless surgeries. From the legal standpoint, laws and case-law worldwide have been moving in the same direction: a patient endowed with discernment has the absolute right to choose the treatment he/she deems the most appropriate according to his/her own personal values. In light of this evolution worldwide, JW patients have become ordinary patients. Since this is not the case in Croatia yet, this article seeks to put the Croatian legislation in harmony with the international standards by using the example of JW. It does so by answering five fundamental questions: 1) Should a JW patient be forced to undergo a blood transfusion against his or her will? 2) Should a JW patient be forced to undergo a blood transfusion in an emergency situation where life is at risk, and the patient is unconscious? 3) Can a doctor refuse to treat a JW patient because the patient refuses to accept a treatment deemed lifesaving? 4) Can a doctor be held liable for respecting a JW patient’s wishes if the patient dies? 5) Can a doctor be held liable for overriding a JW patient’s wishes and administering a blood transfusion by force?

The notion of informed consent lies at the very heart of the relationship between doctors and patients since a valid consent is a legal condition for a medical treatment. Legal and medical publications have acknowledged that "the study of issues related to the refusal of consent is inspired, to a considerable extent, by the position of Jehovah's Witnesses on blood transfusion". 1 At the same time, these issues about patients who are Jehovah's Witnesses who wish to be treated with medical and surgical strategies that avoid allogeneic blood transfusion 2 have been described as one of the most sensitive and problematic existing in the legal system. 3 The first reason is that doctors and/or judges believe 4 they are confronted with conflicting rights which are of fundamental nature: the right to life on the one hand and the right to personal autonomy and freedom of religion on the other hand. The second reason is that this conflict cannot be resolved through a fair-balance test which results in a consensual middle-road approach guaranteeing both rights. In such cases, between doctor's will and patient's rights, only one can be satisfied to the detriment of the other.
Comparative legal experience worldwide has shown, however, that a methodic approach can be implemented to legally resolve any challenging situation and bring about a stable and peaceful relationship for the mutual benefit of both doctors and patients.
This article aims at answering the main questions arising from situations where Jehovah's Witnesses patients are to be treated. As for the scientific approach, intentionally we do not delve into any moral, philosophical or wishful thinking applicable to these cases. Instead, we have chosen a case-study approach for two main reasons. First, our purpose is to help doctors and lawyers who read this article find clear and practical answers to their questions pertaining to patients who are Jehovah's Witnesses. Both in common law and a continental law system, any legal issue finds its fulfillment and realistic conclusion in the interpretation of the legal rules by the highest domestic judicial bodies. So, our choice was made to approach the issue from the standpoint of what the law is internationally, and not what it could or should be. Second, both lawyers and doctors have published numerous articles on doctorspatients' relationships and informed consent over the last twenty years and, despite some discrepancies, they have reached a common understanding of the main issues of informed consent. 5 However, with regard to patients who are Jehovah's Witnesses, lawyers' and doctors' opinions do not always reflect the legal standards applicable to these cases 6 . Perhaps this is because, for those authors, it appears illogical and irrational for patients to prioritize their religious beliefs over their own life. For these reasons, we will focus on the majoritarian predominant judicial approach established by the Supreme Courts in democratic countries where the goal is to develop and maintain the highest standards of human rights' protection. In addition to references to the case-law of Supreme Courts from around the world, the study relies on the well-established case-law from the American courts at the Federal and State level, and the jurisprudence of the European Court of Human Rights, which follow a common denominator. By offering this wide jurisprudential sample, this study analyzes the currently applicable rules in democratic countries, which could serve as a guide for similar future situations occurring in Croatia. 7 We will compare these standards with the relevant legislation in Croatia and identify any deficiencies in the law. 8 5 Among the vast literature on the issues of patients' rights and informed consent, see in the English-speaking literature: Maclean, Alasdair (2013). Autonomy, Informed Consent and Medical Law: A Relational Challenge, Cambridge University Press; in the French-speaking literature: Guillod, Olivier (1986). Le consentement éclairé du patient: autodétermination ou paternalism? Neuchâtel, Université de Neuchâtel; in the German-speaking literature: Spickhoff, Andreas (2018). Medizinrecht, Munich, C. H. BECK; in the Italian speaking literature: Brazzini, Sara, Muià, Pier Paolo (2018). La legge sul consenso informato e le DAT. Diritti del paziente e doveri del medico, Padova, Primicerieditori; in the Spanish-speaking literature: Luelmo, Andres Dominguez, (2007). Derecho sanitario y responsabilidad médica. comentarios a la Ley 41/2002, de 14 de noviembre, sobre derechos del paciente, información y documentación clínica, Valladolid, LEX NOVA. 6 There is no valid reason to treat cases of patients who are Jehovah's Witnesses differently from other patients. As stated by Sobolewski, P. (2019), 137: "The legal system, however, should not attach other legal effects to an objection made by a Jehovah's Witness from those made by a person of any other religion. The religion of the patient, therefore, should not affect in any way the effectiveness of his or her statements in the course of treatment. The medical doctor may not demand that the patient give reasons for his or her objection, and if the patient does not give any reasons, the medical doctor should not judge them. (…) Taking into consideration the religion of the patient while judging the effectiveness of his or her refusal (or harm caused by the refusal) is a breach of the constitutional principles of privacy and equality." 7 Ideally, this comparative approach should have put in perspective judicial decisions from Croatian courts with those International standards. However, there are presently no judicial decisions in Croatia concerning patients who are Jehovah's Witnesses yet. Besides, the Croatian legislation appears problematic in itself. So, we will confine our study to a comparison between these international judicial standards and the Croatian relevant legislation.
We have identified five main questions which can be set in the following order: 1) Should a JW patient be forced to undergo a blood transfusion against his or her will? 2) Should a JW patient be forced to undergo a blood transfusion in an emergency situation where life is at risk, and the patient is unconscious? 3) Can a doctor refuse to treat a JW patient because the patient refuses to accept a treatment deemed life-saving? 4) Can a doctor be held liable for respecting a JW patient's wishes if the patient dies? 5) Can a doctor be held liable for overriding a JW patient's wishes and administering a blood transfusion by force? I will answer these questions, first, by explaining the current democratic standards applicable worldwide and, second, comparing them to the legislative state in Croatia.

1) Should a JW patient be forced to undergo a blood transfusion against his or her will?
Since the 2010 judgment from the ECHR Jehovah's Witnesses in Moscow v. Russia, the answer to this question is a clear "no".
In Resolution 1859 (2012), the Parliamentary Assembly of the Council of Europe reiterated that under Article 8 of the European Convention on Human Rights (right to privacy), "flow the principles of personal autonomy and the principle of consent." Treatment decisions of a capable adult patient "when clearly expressed, must prevail even if it signifies refusal of treatment: no one can be compelled to undergo a medical treatment against his or her will." Supreme Courts worldwide would eventually acknowledge consent as defined by Judge Benjamin Cardozo near the beginning of the twentieth century that "every human being of adult years and sound mind has a right to determine what shall be done with his own body." However, there existed some doubt as to whether State interests could override this right in the extreme circumstance where doctors believed transfusions were the only intervention that would prevent a fatal outcome. In these cases, physicians often felt entitled to ignore the patient's will.
In the USA, for instance, there was room for doubt as the case-law had set an approach based on a balance of interests according to which "the right to refuse medical treatment, (…) is not absolute. Hence, in cases of JW patients who do not wish to die but to remain alive and be treated in harmony with their conscience 11 , courts have repeatedly emphasized the supremacy of the patient's right to bodily self-determination. 12 Among the four interests, the protection-of-third-parties argument was most probably the one subjected to strongest debates, especially in case of pregnant women or parents whose life was at risk. Indeed, JW patients "just make a choice of medical procedures". In this regard, their position toward medical act and their relation to doctors is no different from any other patient such as, for instance, a patient allergic to a certain antibiotic who refuses that drug, a patient with cancer who prefers a more risky but less invasive method of treatment contrary to the recommendation of the doctor, a person who does not wish to be kept alive if he falls in a persistent vegetative state or a parturient who refuses a medical termination of pregnancy although her life is at risk.
It is so because, as a matter of fact, "Surgeries cannot be viewed generally. Each surgery has its own specificities relating to manner of its performance, pursuant to the standards of the medical profession. Subsequently, the manner in which surgery alleviates, rectifies the damage or heal the patient depends on his or her general and specific state of health, current treatment of the condition for which the surgery is indicated, possible treatment of other diseases, certain medication which prevents coagulation, the patient's behavior toward his or her own health (i.e. alcohol or drug addiction), or his or her health discipline, etc ." 20 Otherwise said, every patient, every medical act, every doctor, and every context is unique. It would, therefore, run counter any sense of logic to force a patient to be molded in what doctors consider a standard procedure. The reality shows that quality doctors do not practice off-the-shelf medicine but rather tailor treatments based on the patient's age, medical history, and health status while respecting the will of patients.
A lucid conclusion is: "if each patient is allowed to refuse a single procedure within the medical treatment and further receives treatment in accordance with his or her wishes and preferences, appropriately medically suiting his or her state of health, then also the patient refusing blood and blood products because of his or her beliefs, should receive the appropriate procedure to which he or she consented." 21 "The patient's perspective of his or her own interests should be respected by the surgeon. The ethical principle of respect for autonomy captures what is at stake clinically. The surgeon should acknowledge and accept the integrity of the competent patient's values and beliefs, whether or not the surgeon agrees with them, and should provide the patient with an adequate amount of information ." 22 This obviously shifts the issue to the main question of the patient's capacity to consent. Thus, both in a common law and in a continental law system, the question 20 Roksandić Vidlička, S. et al. (2017) is therefore not whether JW patient can be forced to receive a certain treatment, but whether the patient is capable of understanding to choose his treatment. 23 This means that when a physician is confronted with a refusal of treatment of a conscious patient, he must follow a three-steps-approach as required by the ECHR: "Firstly, one of the central issues in determining the validity of a refusal to undergo medical treatment by a patient is the issue of his decision-making capacity. 24 Secondly, except for unconscious patients who have expressed their will through a legal representative or an advanced medical directive, such a decision should be based on the patient being provided with sufficient information, and any medical intervention should have the patient's informed consent. 25 Thirdly, the patient's decision should reflect his free will, failing which the decision to consent or to refuse to consent to treatment will not be valid ." 26 This three-steps-assessment is generally limited to adults. However, because this review is carried out in concreto and based on the unique character of each individual, courts worldwide have also in some circumstances extended it to minors, if found mature enough 27 "to understand the state of their health, the scope of the medical act to 23 In an expert case study entitled "The legitimacy of the refusal of blood transfusion by Jehovah's Witnesses: Human dignity, religious freedom and existential choices," Luís Roberto Barroso, currently judge at the Supreme Federal Court in Brazil explains: However, [the need of ] patient's consent to an operation or to other [treatment] is based on the right to self-determination where each individual can determine the course of his own life (his life-style, or, the values he places before his own life). So, if a patient's consent is limited by an obligation to sign a form in order to be treated, the right to self-determination is, as a result, also limited by such obligation: which it should not. "For this to be valid, the right holder must be civilly capable and have the sound judgment to express it. Therefore, in addition to capacity, the right holder must be fit to express his will, which would exclude persons in a mentally altered state, whether due to a traumatic situation, the use of psychoactive drugs, or to being under the effect of medications that significantly impede or prevent cognition. For the consent to be deemed unequivocal, it must be strictly personal, explicit and current. 2) Should a JW patient be forced to undergo a blood transfusion in an emergency situation where life is at risk while unconscious?
Article 16, paragraph 1, of the Croatian Act on the Protection of Patients' Rights states that: "The patient shall have the right to consent or to refuse a particular diagnostic procedure or treatment, except in case of an urgent medical intervention, the lack of which would put at risk the patient's life and health or cause permanent damage to their health." This exception of "an urgent medical intervention" has been understood by some to indicate that doctors are allowed to ignore the patient's right to consent or refuse treatment when the life of the patient is at risk.
However, if this exception is interpreted in this way, it will contradict the abovementioned principles. The right to personal autonomy is not conditional. The physician's obligation to respect the will of a patient remains the same, whether in an emergency situation or in case of elective surgery. The only difference in an emergency situation results from the fact that a patient is oftentimes unconscious when admitted to hospital. However, firstly, this is not always the case. And secondly, even if the patient were unconscious, this does not release doctors from searching for and respecting the patient's will before becoming unconscious. Doctors shall find whether the patient prepared advanced medical directives or appointed a legal representative to decide in his name. 30 Article 9 of the Oviedo Convention on Bioethics unambiguously states that "The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account." In this regard, Articles 18 and 19 of the Croatian Act on the Protection of Patients' Rights 31 also do not meet the legal requirements set out within the Council of Europe. It must be noticed that the principle covers not only pre-operative and intra-operative situations involving unconscious patients, but also post-operative situations. In the Supreme Court of Carolina case Harvey v. Strickland, the patient received elective surgery, and his surgeon knew that the patient was one of Jehovah's Witnesses and that he would not consent to blood transfusions. After his surgery, when the patient was unconscious, complications arose, and the surgeon obtained 'consent' to transfuse him from Mr. Harvey's mother, who was not one of Jehovah's Witnesses. Even though the blood issue arose in Mr. Harvey's case post-operatively, the principle of the doctor's honoring his patient's known wishes is the same, The Court made it clear: "A patient's wishes against medical treatment or intervention, when made known to a physician prior to surgery, must be followed by the attending physician ." 34 The European Court also emphasized this obligation weighing upon doctors in the well-known Lambert v. France case where the European Court had to decide whether the French authorities would violate the right to life (Article 2) by interrupting the administration of palliative care to a patient in a neuro-vegetative state. Focusing on the most decisive issue in this case, the European Court held that "it is the patient who is the principal party in the decision-making process and whose consent must remain at its centre; this is true even where the patient is unable to express his or her wishes ." 35 As for Supreme Courts worldwide, they have, for the wide majority of them, emphasized the obligation to respect the patient's wishes even in an emergency situation by obliging doctors to determine what these wishes were.
For example, the Supreme Court of Poland held that "the patient's medical directive prepared in advance in case of a coma, which consists of one's wish to be treated by a 33 Fosmire v. Nicoleau, (1990 Some have opposed the view that between the signing of the advanced medical directive and the very treatment in case of emergency, specific circumstances may have influenced the will of the patient. However, if the choices expressed in the directive have been expressed by a competent adult and are consistent with the way of life and beliefs of the person, it can hardly be argued that there would be a sudden change in the approach of the person. Besides, such an opinion would render useless the signing of any advanced directive whose aim is precisely to express, clarify, and set the will of the patient for any future circumstances. 39

3) Can a doctor refuse to treat a JW patient because of his/her refusal to accept a treatment deemed life-saving?
The answer depends on the circumstances, and the reasons adduced for such a refusal.
As it is common in many countries, doctors have the right to refuse to perform certain treatments asked for. However, such refusals are strictly regulated. Actually, there is only one motive that can justify a refusal to treat a patient according to his wishes. It is an appeal of conscience. 40 Article 20 of the Croatian Act on Medical Profession states: "A medical doctor is entitled to an appeal of conscience on the grounds of ethical, religious or moral principles or beliefs and decline to provide diagnostics, treatment and rehabilitation services to the patient, if this is not in contradiction to the rules of the profession or if it does not cause lasting harmful effects to the health of the patient or jeopardize their life. They shall inform the patient of their decision in due time and refer them to another doctor of the same specialization." This appeal of conscience is valid if it fulfills several requirements. First and foremost, it must be based on an authentic motive of conscience. It would be difficult for instance for a doctor to refuse to treat a Jehovah's Witness patient for the sake of right to life, if at the same time, this doctor practices or condones abortions or accepts to treat a cancer patient without recourse to chemotherapy although this might prove to be life-saving. Such refusal must, in principle, be consistent with the ethics and practice of the doctor.
Second, that conscientious objection must be based on the doctor's individual choice. In some instances, the refusal to treat JW patients simply originates from the hospital administration, which imposes a general directive on all the doctors practicing in the hospital. Such refusal is based on institutional policy and is not grounded on the personal ethics of the doctor. A collective conscience constitutes a contradiction. The expression of a conscientious choice is only of individual nature. Besides, such institutional policy directives are also harmful to doctors as they could result in forcing a certain practice on a doctor who otherwise might have treated the patient according to his wishes.
Third, this conscientious objection must be justified and proportionate. For instance, some doctors have dismissed a JW patient for a diagnostic or a simple treatment where the risk of blood loss was close to zero, such as the insertion of a catheter, a nasal septoplasty, or a knee arthroscopy. Such a refusal was obviously excessive because the very motive on which the conscientious refusal is based, that is, the risk of life-endangering bleeding, is extremely unlikely.
40 See, for instance, Takeda: "Of course, this does not obligate a doctor to comply with patient's requests on what treatment to be administered, including an application for absolute non-blood-transfusion. Whether a doctor should comply with a request for absolute non-blood-transfusion treatment or not wholly depends on the doctor's own ethics as well as on how he views the matter of life and death. Aside from this duty of explanation, which we are going to take up later, a doctor should administer treatment according to his own conscience, and a patient cannot force a doctor to adopt any treatment against his conscience".
Fourth, even when the preceding requirements are met, the doctor must still fulfill two other legal requirements. On the one hand, there is an obligation to inform the patient and the hospital management in due time. Hence, it would certainly be unlawful to dismiss a patient the very day of the surgery, as it has unfortunately happened in some circumstances. On the other hand, the doctor must refer the patient to another doctor of the same specialization who is willing to treat the patient according to his wishes. 41 This obligation, which oftentimes tends to be forgotten, is all the more natural as it goes in harmony with the respect for the patient and the principle of life. Indeed, it would be contradictory for a doctor who refuses to treat a JW patient because his conscience puts greater emphasis on the survival of the patient, to subsequently get rid of the patient without providing him any help, which could endanger his very life.
So, depending on the circumstances, doctors may have a right to refuse to treat a patient. However, due to the importance of the right to personal autonomy of patients and the commitment taken by doctors with "great humbleness and awareness of [their] own frailty" 42 to take care of patients who might disagree with their approach, such a right is limited by the strict requirements explained above.

4) Can a doctor be held liable for respecting a JW patient's wishes if the patient dies?
The answer is no, for a simple reason. A doctor cannot be held liable for obeying the law. As explained above, to respect a patient's choice constitutes respect for a fundamental right, the right to self-determination, and personal autonomy. It would, therefore, be unlawful to punish a doctor for ensuring the implementation of the fundamental right to personal autonomy, even if the patient were to die.
The situation would certainly be different if a doctor were to help a person to commit suicide or to hasten its death through the withdrawal of medical treatment because deprivation of life is not protected by any legal provision. However, as clearly stated by the European Court in relation to JW patients: "In so far as the domestic judgments can be understood to consider that the refusal of a blood transfusion is tantamount to suicide, in the Court's view, this analogy does not hold, for the situation of a patient seeking a hastening of death through discontinuation of treatment is different from that 41 "States are obliged to organize the health services system in such a way as to ensure that an effective exercise of the freedom of conscience of health professionals in the professional context does not prevent patients from obtaining access to services to which they are entitled under the applicable legislation." R. R. v. Poland, Application no. 27617/04, ECHR 2011 (extracts

"
The printed form of the previously expressed refusal often states that the signatory releases the doctor, the healthcare institution and the hospital staff from any liability for the risks arising out of refraining from administering a blood transfusion to the patient (a liability exclusion clause is thereby included). Due to the complexity of a medical treatment program which may involve many separate surgical procedures, which may not be unrelated to one another, it is understood that blood transfusion and the liability resulting from its administration or omission is just one issue among many. Furthermore, as in the case of consent, the doctor is exposed to complaints of providing inadequate information or inappropriate treatment, which necessitated the transfusion of blood. Finally, a physician who is not specialized in methods alternative to blood transfusions should extend the liability exclusion clause so as to include assumption of risk, in the case the doctor does not have sufficient experience and has informed the patient of this. " Kyriakaki, E. N. (2016)

5) Can a doctor be held civilly and/or criminally liable for overriding a JW patient's wishes and administering a blood transfusion by force?
The answer to this question is yes, although sometimes difficult for courts to apply. 50 On the one hand, it is logical that disrespecting fundamental principles renders one liable to civil and/or criminal punishment. Otherwise, what would be the meaning of the right to personal autonomy if a doctor could disrespect it without being held accountable for its violation? On the other hand, doctors have always enjoyed a positive reputation, which makes it difficult for judges or juries to punish someone who disregarded the will of another individual driven by the imperious motive of trying to save his life. Such contradiction makes the answer to this question challenging de facto. However, legally and practically speaking, a doctor who transfuses a patient against the patient's expressed wishes could be held civilly and/or criminally liable. After defining consent as required for medical treatment in 1914, Justice Cardozo added, "and a surgeon who performs an operation without his patient's consent commits an assault." 51 If judges and juries make it clear that administering a certain treatment by overriding a patient's wishes is unlawful and entails legal consequences, they set a clear limit to a doctor's power to control the lives of individuals which is conducive to a certain form of humility in line with their Hippocratic oath. Besides, such limits protect individuals from being subjected to additional harm as mere objects of treatment. Indeed, such violation is not only viewed by a JW patient as a spiritual rape, but it has also sometimes given rise to negative medical consequences, such as blood-borne infections or acute traumatic reactions that can lead to death 52 . 52 In this regard, judges will have to evaluate every situation on a case by case basis. If doctors are in principle to be held liable for overriding a patient's will, they might be able to reduce the extent of their liability in the light of several criteria. It might depend on the doctor's efforts to find out the patient's medical choice, the degree of emergency, the degree of patient's discernment, the degree of clarity of patient's medical choice, and to what extent the treatment was beneficial to the patient's health.
53 See, for instance, Malette, and Perkins v. Lavin (1994) 648 N.E.2d 839 (Ohio Court of Appeal, U.S.). Both of these cases affirmed the civil liability of doctors who transfused Jehovah's Witnesses patients against their will. In Malette, the Ontario Court of Appeal said that a doctor's "honest and even justifiable belief that the treatment was medically essential did not serve to relieve him from liability for the battery resulting from his intentional and unpermitted conduct." In Perkins v. Lavin, the Ohio Court of Appeals said "Battery not only protects individuals from harmful contact but protects them from any offensive contact: 'A harmful or offensive contact with a person, resulting from an act intended to cause the plaintiff or a third person to suffer such a contact, . . . is a battery.' of treatments) is legally binding for a medical practitioner and relieves him of the criminal or civil responsibility, whereas in the case of administering it -makes it illegal." 54

Conclusion:
We must leave the credit to the Superior Court of Pennsylvania in re Duran for having rightly summed up the opposing interests between JW patients and doctors: "it is a difficult thing to decline potentially life-saving treatment for a loved one, rendered mute by her condition, on the basis of her devotion to religious beliefs. Nevertheless, absent evidence of overarching state interests, the patient's clear and unequivocal wishes should generally be respected." 55 Today, medical research and science are showing that the liberal use of blood transfusions results in worse patient health outcomes and that use of medical and surgical treatment strategies that avoid blood transfusion result in superior clinical and economic outcomes. 56 In the context of this medical research and science, the strengthening of fundamental principles toward the absolute recognition of patients' will, the juncture between JW patients' and doctors' conscience has never been so close to forming a mutual bridge of understanding and cooperation. Similar to what has taken place over the last ten years in countries where the right to personal autonomy has received full protection, there is also hope in Croatia that this sensitive issue will soon be part of the past. At least, as we could see in this article, we have now at our disposal well-established and convincing legal rules which can help doctors, patients, and judges to methodically resolve any opposing interests in this field for the benefit of all parties.