의료행위의 상업화와 법적 한계에 관한 서론적 고찰

박은경,김기영 경북대학교 법학연구원 2011 법학논고 Vol.0 No.35

Eine Reihe vereinzelt schon langer diskutierter Phänomene aus dem Bereich ärztlichen Handelns beginnt, sich zunehmend unter einem neuen Begriff zu versammeln. Maßnahmen der wunscherfüllenden Medizin können, soweit sie nicht der Heilung von Defekten dienen, sondern (nur) der Asthetik, dem Wunsch des Patienten nach Verschonerung, “Anti-Aging”-Behandlungen, soweit sie nicht gesundheitlich indiziert sind, oder Maßnahmen der Lifestyle-Medizin,auch im Bereich der Fortpflanzungsmedizin solche Maßnahmen, die nicht notwendig zur Erfüllung des Kinderwunsches sind, sondern daruber hinausgehen. Ein weiteres typisches Begleitphänomen der Wunschmedizin ist deren umfassende Kommerzialisierung. Dieses Thema befasst sich mit der rechtlichen Problematik zur solche Maßnahmen. Dabei soll von der Dogmatik des Heileingriffs ausgegangen werden. Die Heilbehandlung ist noch immer als “Prototyp” ärztlichen Handelns anzusehen. Im Übrigen ist darauf hinzuweisen, der Arzt könne nicht verpflichtet sein, die Gesundung des Patienten als Erfolg der Behandlung oder Operation zu schulden. In der Literatur findet sich das Argument, dass dem Arzt aufgrund seines altruistischen Handelns beim Heileingriff Haftungserleichterungen zugestanden werden, dass der Arzt nicht mehr altruistisch, sondern mangels Indikation “merkantilistisch” handele und daher auch eine strengere Haftung gerechtfertigt sei. Zu bedenken ist, dass die Annahme eines Werkvertrags zum verschuldensunabhängigen Einstehenmüssen des Arztes für den Erfolg des Wunscheingriffs führen würde. Es wird abschließend festgestellt, der Wunscheingriff unterscheide sich vom Heileingriff dadurch, dass das Element der “Indikation” und damit auch der ”Heilzweck“ gänzlich fehlen. Daher ist es grundlegend wichtig, zunächst den Begriff der “Indikation” zu klären, weil ihm insgesamt eine entscheidende Bedeutung im Zusammenhang mit der Zulässigkeit und der Rechtfertigung ärztlicher Eingriffe beizumessen ist. 오늘날 의료행위의 발전이 장래의 삶을 보다 나은 방향을 계획하고자 하거나라이프스타일에 영향을 줄 수 있는 상황이 가능하게 된다면, 인간은 이러한 의료행위를 적극적으로 활용하여 자신의 외모나 신체적 능력을 개선하고자 할 것이다. 즉 단순한 치료를 넘어 개인의 능력이나 외모의 강화를 도와주게 되는 의료행위는 향후 의료시장에서 중요한 비중을 차지하게 될 수 있다. 최근 환자의 다양한 개인적 희망을 충족하는 것과 같은 의료행위개념의 확대는 현대적인 의미에서 “새로운” 인간으로서 삶의 질이나 방식을 가능하게 된다는 점에서 긍정적인평가를 내릴 수 있다. 그러나 다른 한편으로는 환자의 개인적인 가치관이나 기대와 일치되는 의료행위를 하여야 한다는 점에서 전통의 의료행위보다는 법률적책임을 강화시켜야 한다는 논의도 제기되고 있다. 이 논문에서는 먼저 희망의료행위(침습)와 전통적 의미에서 치료적 침습은 사실적 측면, 즉 시행시에 구별할 수 없다는 점이 명백하고 당사자의 동기, 의학적적응성이 없는 경우와 같은 침습은 침습의 시행과 관련하여 개별적인 환자의 그와 같은 신체적 예측불가능성에 해당하는 점은 달라지지 않는다는 점을 근거로위임계약으로서의 법적 성격을 여전히 가진다는 점을 설명하고 있다. 다음으로 의학적 적응성이 없는 성형수술, 문신 및 피어싱에 대해 의학적으로적응성이 있는 추가적 진료에 대해 비용부담의 문제뿐만 아니라 보험급여의 대상과 관련하여 앞으로도 문제가 될 것으로 전망하기 때문에 논의의 필요성을 제기하고 있다.

의료행위의 규율목적과 전문직업성과의 조화를 위한 해석과제

김봉철,김기영 원광대학교 법학연구소 2022 의생명과학과 법 Vol.28 No.-

이 논문에서는 의료법의 개념에서 도출되는 의료행위에 대한 국가의 규제를 검토한 다음, 이에 따라 의료행위에 대한 과잉규제와 소위 ‘보건위생상의 위험’이라는 개념으로 규율하고 있는 역사적 연원과 의료행위의 요건에 대해 고찰하고, 의사의 전문직업성의 관점에서 의료행위 본래의 본질에 대한 재검토를 하고자 하고 있다. 이러한 논의를 바탕으로 전통적인 의료행위의 요건인 의학적 적응성과 치료목적 등을 고려한 요건과는 달리 의료행정상의 목적으로 ‘일반 공중위생상의 위험’을 개념을 사용하여 실질적으로 의료행위개념에 대한 확대경향에 대해 비판적 고찰을 하고 있다. 이와 관련하여 특히 문신행위에 대한 의료행위성을 인정하고 있는 통설과 판례에 대한 비판적 입장을 제시하고 있다. 뿐만 아니라 의료행위의 중요한 요소로서 의학적 적응성과 치료목적에 대한 환자의 자기결정권에서 한계를 설정할 수 있는 진료권의 범위와 한계를 강조하고 있다. 또한 국민건강보험법상의 요양급여 부당이득징수처분에 대해 의사의 실질적인 진료행위에 대해 의료행위의 본질적 요소가 갖추어져 있고 진료를 하였다는 점이 인정된다면 국민건강보험법상 요양기관이 부정되지 않을 수 있다는 최근 사례와 민사책임영역에서 의료행위의 본질적인 요소인 요양지도의무나 판례에서 제시하고 있는 지도설명의무의 강화도 이러한 관점에서 해석하고 의사의 재량권과 진료권이 어느 정도로 영향을 미치고 있는지를 살펴보고 있다. 마지막으로 의료에 대해 필요한 법적 통제가 의사와 환자 사이의 관계를 완전히 법적 규범화로 확대하는 것은 바람직하지 않고, 환자와 의사의 구성요소로서의 신뢰관계를 회복할 수 있도록 본연의 의료행위의 개념과 전문직업성과 조화를 꾀하도록 해야 한다고 결론을 맺고 있다.

무의미한 연명치료 중단 등의 기준에 관한 재고 - 대법원 2009.5.21 선고 2009다17417사건 판결을 중심으로 -

문성제 대한의료법학회 2009 의료법학 Vol.10 No.2

According to a case of Supreme Court's Sentence No. 2009DA17417 (May 21, 2009), the Supreme Court judges that ‘the right to life is the ultimate one of basic human rights stipulated in the Constitution, so it is required to very limitedly and conservatively determine whether to discontinue any medical practice on which patient's life depends directly.’ In addition, the Supreme Court admits that ‘only if a patient who comes to a fatal phase before death due to attack of any irreversible disease may execute his or her right of self-determination based on human respect and values and human right to pursue happiness, it is permissible to discontinue life-sustaining treatment for him or her, unless there is any special circumstance.’ Furthermore, the Supreme Court finds that ‘if a patient who is attacked by any irreversible disease informs medical personnel of his or her intention to agree on the refusal or discontinuance of life-sustaining treatment in advance of his or her potential irreversible loss of consciousness, it is justifiable that he or she already executes the right of self-determination according to prior medical instructions, unless there is any special circumstance where it is reasonably concluded that his or her physician is changed after prior medical instructions for him or her.’ The Supreme Court also finds that ‘if a patient remains at irreversible loss of consciousness without any prior medical instruction, he or she cannot express his or her intentions at all, so it is rational and complying with social norms to admit possibility of estimating his or her own intentions on withdrawal of life-sustaining treatment, provided that such a withdrawal of life-sustaining treatment meets his or her interests in view of his or her usual sense of values or beliefs and it is reasonably concluded that he or she could likely choose to discontinue life-sustaining treatment, even if he or she were given any chance to execute his or her right of self-determination.’ This judgment is very significant in a sense that it suggests the reasonable orientation of solutions for issues posed concerning withdrawal of meaningless life-sustaining medical efforts. The issues concerning removal of medical instruments for meaningless life-sustaining treatment and discontinuance of such treatment in regard to medical treatment for terminal cases don't seem to be so much big deal when a patient has clear consciousness enough to express his or her intentions, but it counts that there is any issue regarding a patient who comes to irreversible loss of consciousness and cannot express his or her intentions. Therefore, it is required to develop an institutional instrument that allows relevant authority to estimate the scope of physician's medical duties for terminal patients as well as a patient's intentions to withdraw any meaningless treatment during his or her terminal phase involving loss of consciousness. However, Korean judicial authority has yet to clarify detailed cases where it is permissible to discontinue any life-sustaining treatment for a patient in accordance with his or her right of self-determination. In this context, it is inevitable and challenging to make better legislation to improve relevant systems concerning withdrawal of life-sustaining treatment. The State must assure the human basic rights for its citizens and needs to prepare a system to assure such basic rights through legislative efforts. In this sense, simply entrusting physician, patient or his or her family with any critical issue like the withdrawal of meaningless life-sustaining treatment, even without any reasonable standard established for such entrustment, means the neglect of official duties by the State. Nevertheless, this issue is not a matter that can be resolved simply by legislative efforts. In order for our society to accept judicial system for withdrawal of life-sustaining treatment, it is important to form a social consensus about this issue and also make proactive discussions on it from a variety of standpoints.

독일법상 의약품의“허가사항외 사용 (Off-Label-Use)”

김기영(Kim Ki-Young) 한국법학원 2010 저스티스 Vol.- No.117

허가받지 않은 의학적 적응성에 의약품을 사용하는 것을 “허가사항외 사용 (Off-Label-Use)”라고 하고 오랫동안 의료계에서 많이 이루어지고 이에 따라 여러 법영역에서 법적으로 문제가 제기되어 왔지만 국내에서 이에 대한 연구는 부족한 실정이다. 우리나라 약사법이 허가기준이나 사용범위를 규정함으로써 의약품의 남용이나 부작용을 방지하기 위한 법임에도 “허가사항외 사용”은 전반적으로 금지하고 있지는 않다. 이는 약사법 등의 규정이 의사의 치료의 자유를 배제하는 것은 아니기 때문이다. 뿐만 아니라 유럽연합의 VO 724/2004에 따르면 기존의 약이 효과가 없는 만성질환자나 중대한 질병을 앓고 있거나 또는 그 질병이 치명적인 경우나 이미 허가받은 의약품으로 진료하는 것이 만족스러운 결과를 가져 오지않는 경우에는 의약품의 “허가사항외 사용”도 인정할 수 있다고 한다. 독일 의약품법 (AMG) 제8조 제2항에 따르면 “허가사항외 사용”은 허가된 의약품의 특성이 있고 치료적 결과가 현재의 의료수준으로 달성하기 어려운 경우에는 허용될 수 있다고 규정하고 있다. 비용부담자를 위해 비용편익분석에 따라 허가받지 않은 약이 유리하다고 할지라도 허가된 의약품에 우위를 두어야 한다. 본 연구에서 독일의 논의를 중심으로 의료적 필요성과 일치되는 개념과 법적 논의를 위해서 근거를 살펴보고 “허가사항외 사용”이 허가사항과 달리 사용되는 경우의 사례들을 중심으로 살펴보고 구별하고 있다. 또한, 건강보험법상의 요양급여의 대상이 되는지 여부에 대한 사례와 독일의 법정건강보험시스템에 따라 이러한 위험을 어떻게 관리하고 있는지 살펴보고 있다.

연구논문 : 의사의 치료행위에 대한 형법적 의의

최호진 ( Ho Jin Choi ) 단국대학교 법학연구소 2006 법학논총 Vol.30 No.2

Die Strafrechtliche Bedeutung von arztlichen Heilbehandlung ist aber noch nicht expilzit darauf eingegangen, worauf ihre Straflosigkeit gestuetzt werden kann. Dauber setzen sich zwei Meinungen auseinander eine betrifft die Tatbestandmassigkeit, andere die Rechtswidrigkeit der Koperverletzung. Die Rechtsprechung erblickt in jedem arztlichen Heileingriff, der die korperliche Unversehrtheit nicht nur unerheblich beeintrachtigt, eine tatbestandsmassige Korperverletzung. Rechtfertigung durch Einwilligung, mutmassliche Einwilligung oder Notstand notwendig. Die herrschende Lehre ist hingegen der Ansicht, dass jede zu Heilzwecken vorgenommene Behandlung nach den Regeln der arztlichen Kunst schon tatbestandlich keine Korperverletzung ist. Fur die Strafloskeit der arztlichen Heilbehandlungs der Aufsatz folgendes; Die Behandlung muss zu Heilzwecken indiziert sein, was haufig eine Abwagung zwischen verschiedenen Methoden und Risiken voraussetzt. Die Behandlung muss lege artis, dh unter Beachtung der anerkannten arztlichen Kunstregeln durchgefuhrt werden. Die lex artis ist zwar weder mit einer bestimmten Schulmedizin gleichzusetzen. Die Behandlung muss eine Einwilligung des Patienten sein. Einwilligungsberechtigt ist grundsatzlich der Patient selbst, frei von Willensmanglen sein. Daher ist sie unwirksam, wenn sie durch Zwang oder Drohung, durch arglistige Tauschung, wieetwa uber den Zweck einer Punktion oder eines blossen Placebos erlangt wurde. Die Einwilligung des Patienten setzt grundsatzliche eine arztliche Aufklarung voraus.

무의미한 연명의료의 중단과 존엄사의 제 문제

문성체 ( Seong Jea Moon ) 법조협회 2009 法曹 Vol.58 No.6

Modern medicine started from struggles for overcoming a variety of incurable diseases and has made steady and successful efforts to liberate human being from suffering of diseases, but involves unprecedented side effects as well, including those related to holistic medicine primarily for terminal diseases. On the one hand, the advancement of medical science and technologies has its own implications in a sense that it contributed to prolonging the life of patients. On the other hand, physical and mental pain patients feel has robbed terminal patients of even their own dignity. In this context, patients` self-determination right for death of dignity is to give a chance to terminal patients to opt for liberate themselves from overplus of pain. And this study focuses primarily on discussing how to resolve potential conflicts concerned with those issues of life. In order to respect the self-determination of patients, American judicial precedents and legislation has permitted patients` right to deny any medical treatment for prolonging life, i.e. passive euthanasia(easy death) since 1970`s, to the certain extent allowable legally. In particular, Oregon Death with Dignity Act has acknowledged that terminal patients may commit physician-assisted suicide. Such a physician-assisted suicide of patients becomes a new way of death which has been never discussed in terms of active euthanasia since 1990`s. Unlike passive euthanasia in which physician administers lethal dose of medicine to a patient for the purpose of his death, the active euthanasia is a mean for patients to use such lethal dose of medicine as prescribed by physician at their option for suicide. Crucial difference between active and passive euthanasia can be determined by whether ultimate behavior causing death of a patient is committed by physician or the patient himself. Thus, it is found that active euthanasia has faced relatively low objections against legitimation of physician-assisted suicide of patients in a sense that ultimate behavior to cause death of a patient is attributed to the patient himself, so it is easier for active euthanasia to attribute the death of a patient to his own responsibility than passive euthanasia, and the former also has relatively low risk of misuse or abuse in comparison with the latter. In reality, it is obvious that physician-assisted suicide of patients is an issue unacceptable among the public, since physician`s behavior for active euthanasia may face other legal responsibilities such as aiding and abetting suicide as provided in criminal law. However, there have been proposed needs for exemption from any legal responsibility for physician-assisted suicide of terminal patients in respect of their self-determination right, as mentioned above. In order reflect such needs and perspectives on local legislation, the Oregon state(USA) has newly established and enforced the Oregon Death with Dignity Act. The ultimate purpose of this study is to address historical backgrounds concerned with legislation of the Oregon Death with Dignity Act as well as major legal contents in said act to examine the issues about death of dignity, which may be pointed out in terms of hospice medicine in the future, and thereby consider potential problems concerned with death of dignity.

무의미한 연명의료의 중단과 존엄사의 제 문제

문성제 법조협회 2009 法曹 Vol.58 No.6

Modern medicine started from struggles for overcoming a variety of incurable diseases and has made steady and successful efforts to liberate human being from suffering of diseases, but involves unprecedented side effects as well, including those related to holistic medicine primarily for terminal diseases. On the one hand, the advancement of medical science and technologies has its own implications in a sense that it contributed to prolonging the life of patients. On the other hand, physical and mental pain patients feel has robbed terminal patients of even their own dignity. In this context, patients' self-determination right for death of dignity is to give a chance to terminal patients to opt for liberate themselves from overplus of pain. And this study focuses primarily on discussing how to resolve potential conflicts concerned with those issues of life. In order to respect the self-determination of patients, American judicial precedents and legislation has permitted patients' right to deny any medical treatment for prolonging life, i.e. passive euthanasia(easy death) since 1970's, to the certain extent allowable legally. In particular, Oregon Death with Dignity Act has acknowledged that terminal patients may commit physician-assisted suicide. Such a physician-assisted suicide of patients becomes a new way of death which has been never discussed in terms of active euthanasia since 1990's. Unlike passive euthanasia in which physician administers lethal dose of medicine to a patient for the purpose of his death, the active euthanasia is a mean for patients to use such lethal dose of medicine as prescribed by physician at their option for suicide. Crucial difference between active and passive euthanasia can be determined by whether ultimate behavior causing death of a patient is committed by physician or the patient himself. Thus, it is found that active euthanasia has faced relatively low objections against legitimation of physician-assisted suicide of patients in a sense that ultimate behavior to cause death of a patient is attributed to the patient himself, so it is easier for active euthanasia to attribute the death of a patient to his own responsibility than passive euthanasia, and the former also has relatively low risk of misuse or abuse in comparison with the latter. In reality, it is obvious that physician-assisted suicide of patients is an issue unacceptable among the public, since physician's behavior for active euthanasia may face other legal responsibilities such as aiding and abetting suicide as provided in criminal law. However, there have been proposed needs for exemption from any legal responsibility for physician-assisted suicide of terminal patients in respect of their self-determination right, as mentioned above. In order reflect such needs and perspectives on local legislation, the Oregon state(USA) has newly established and enforced the Oregon Death with Dignity Act. The ultimate purpose of this study is to address historical backgrounds concerned with legislation of the Oregon Death with Dignity Act as well as major legal contents in said act to examine the issues about death of dignity, which may be pointed out in terms of hospice medicine in the future, and thereby consider potential problems concerned with death of dignity. 서울서부지방법원 2008가합6977사건 판결에서 무의미한 연명의료장치의 제거를 청구한 원고들의 주장을 받아들임으로써 무의미한 연명의료와 관련된 소극적 안락사에 대한 사회적 논의를 야기하였다. 현대 의료기술의 발전은 치유 불가능한 말기환자들에게 있어 생명연장이 가능하게 되었다는 점에서는 큰 의미를 부여할 수 있으나, 연명만을 위한 무의미한 의료를 통하여 환자들이 받는 육체적·정신적인 고통은 생명연장의 기쁨보다 인간으로서 존엄마저 상실시킬 수 있음이 지적됨에 따라, 환자들에게 스스로 고통으로부터 해방할 수 있는 선택권을 부여해야 한다는 주장이 제기되기에 이르렀는데 이것이 바로 소극적 안락사와 존엄사의 제 문제이다. 제 외국의 경우 치유 불가능한 말기환자에 대하여 치료중단으로 인한 소극적 안락사를 인정하려는 추세이며, 존엄사는 유일하게 미국 오리건 주에서 존엄사법을 제정하여 시행하고 있다. 우리나라 2008가합6977 판결은 무의미하게 연명만을 위한 의료에서 나타나는 문제에 대한 해결의 대한 방향성을 제시하였다는 점에서 매우 의미 있는 판결이다. 그러나 본 판결이 우리 사회에서 보다 설득력을 갖기 위해서는 의료와 환자의 자기결정권의 갈등의 문제를 어떻게 조화시키느냐에 따라 그 방향성이 정해질 것으로 본다. 이 같은 문제의식을 가지고 본 연구는 치유 불가능한 환자와 의료상의 제 문제를 중심으로 무의미한 연명의료장치의 제거와 환자의 자기결정 및 의사표시에 관한 제반문제를 검토하고 미국 오리건 주의 존엄사법의 주요 내용과 그 이후의 동향을 살펴보았다.

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