• The Korean Society of Law and Medicine
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• v.10 no.1
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• pp.363-388
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• 2009

i) Das deutsche Arzneimittelgesetz(AMG) vom 24. 8. 1976 hat neben der Einf$\ddot{u}$hrung des Zulassungsverfahren f$\ddot{u}$r Arzneimittel anstelle des bisherigen Registrieungsverfahrens vor allem auf dem Gebiet des Haftungsrechts eine bedeutende Neuerung gebracht: die Gef$\ddot{a}$hrdungshaftung f$\ddot{u}$r den pharmazeutischen Unternehmer. Gem$\ddot{a}{\ss}$ $\S$84 AMG ist der pharmazeutische Unternehmer zum Schadensersatz verpflichtet. wenn infolge der Anwndung eines Arzneimittels ein Mensch get$\ddot{o}$tet oder K$\ddot{o}$rper oder die Gesundheit eines Menschen nicht unerheblich verletzt wird. Pharmazeutischer Unternehmer ist, wer das Arzneimittel unter seinem Namen in Verkehr bringt. ii) Die Ersatzpflicht des pharmazeutisches Unternehmers besteht jedoch nur in zwei F$\ddot{a}$llen: a) Das Arzneimittel hat bei bestimmungsgemm$\ddot{a}{\ss}$em Gebrauch sch$\ddot{a}$dliche Wirkungen, die $\ddot{u}$ber ein nach den Erkenntnissen der medizinischen Wissenschaft vertretbares Ma$\ss$ hinausgehen($\S$84 Abs. 1 Satz 2 Nr. 1 AMG). b) Der Schaden ist infolge einer nicht den Erkenntnissen der medizinischen Wissenschaft entsprechenden Kennzeichnung, Fachinformarion oder Gebrauchsinformation eingetreten($\S$84 Abs. 1 Satz 2 Nr. 2 AMG). iii) Mit dem 2. Schadensersatzrechts$\ddot{a}$nderungsgesetz ist, dem Konzept von $\S$6 Umwelthaftungsgesetz folgend, eine gesetzliche Kausalit$\ddot{a}$tsvermutung eingef$\ddot{u}$hrt worden. Ist das angewendete Arzneimittel nach den Gegebenheiten des Einzelfalls geeignet, den entstandenen Schaden zu verursachen, so soll vermutet werden, da$\ss$ das Arzneimittel auch den konkreten Schaden beim Anwender verursacht hat($\S$84 II AMG). Der pharmazeutische Unternehmer hat dann diese Vermutung zu wiederlegen. iv) Gem$\ddot{a}{\ss}$ $\S$94 AMG hat der pharmazeutische Unternehmer f$\ddot{a}$r seine Haftpflicht Deckungsvorsorge entweder durch eine Hafpflichtversicherung oder eine Freistellungs- oder Gew$\ddot{a}$hrleistungsverpflichtung eines Inl$\ddot{a}$ndischen Kreditinstituts zu treffen. v) Aber koreanisches Arzneimittelgesetz hat keine Gef$\ddot{a}$hrdungshaftung f$\ddot{u}$r Arzneimittelschaden. Es gibt nur Gefahrdungshaftung des Hersteller aufgrund des Produkthaftungsgesetzes, das auf das Arzneimittel Anwendung findet. Ich glaube, in Zukuft soll koreanisches AMG die Gef$\ddot{a}$hrdungshaftung f$\ddot{u}$r den pharmazeutischen Unternehmer regeln.

• KDI Journal of Economic Policy
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• v.18 no.3_4
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• pp.3-61
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• 1996

소비자 보호 및 효율적 자원배분, 기업의 안전증진 유인제공, 제도의 국제적 조화를 위하여 제조물책임법(製造物責任法) 제정의 필요성이 제기되고 있다. 현재 제조물로 인한 사고는 민법(民法)에 의하여 보상받고 있으나 그 입증책임이 과중하고, 현재 우리나라 생산물배상책임보험(生産物賠償責任保險)이 전체 손해보험에서 차지하는 비중은 0.1%에 불과(미국 10%)하여 그 비용이 아직 미미하므로 제조물책임법제(製造物責任法制) 도입의 안전증진효과가 경제적 손실보다 클 것으로 예상된다. 법제정시의 기본방향은 소비자에게 단순히 보상을 제공하는 법제가 아닌, 기업의 책임과 제품결함이 밀접히 연관되어 배상(賠償) 및 사고억제(事故抑制)의 유인과 효과를 극대화하는 것이어야 한다. 추정규정의 도입은 소비자(消費者) 피해구제(被害救濟)를 용이하게 하지만, 디자인 및 경고결함(警告缺陷)과 결합되면 제조자가 제품사고의 모든 가능성에 대해 완벽한 정보를 가지지 않는 한 제조자의 책임이 되어 제조물책임(製造物責任)의 불확실성(不確實性)을 높이고, 결과적으로 기업에게 절대책임(絶對責任)을 부과하게 되어 제품개발과 혁신을 위축시키는 등의 부정적(否定的) 영향을 초래할 위험이 크다. 따라서 결함의 추정은 인정하지 않아야 하며, 제품개발 및 혁신을 도모하기 위해 개발위험항변(開發危險抗辯)은 인정되어야 한다. 손해배상액(損害賠償額) 상한(上限)을 두지 않는 것이 경제적으로 효율적이고 연대책임을 인정하여 유통업자의 안전제고유인(安全提高誘因)도 강화하는 것이 효과적이다. 중소기업을 포함한 모든 기업에게 입법후 1년 정도의 준비기간(準備期間)을 주는 것이 바람직할 듯하며, 배상책임보험(賠償責任保險)은 의무화하지 않는 것이 경제적으로 효율적이다. 기계, 전자, 운송용기기, 건설, 화학, 식 의약품, 가스제품, 완구, 운동용구 등이 영향을 크게 받을 것으로 예상되지만 법제이용(法制利用)의 편의가 개선되기 전에는 소송의 증가는 미미하리라 예상된다.

• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.43-67
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• 2011

Humankind history is faced with one gigantic turning point due to development of Living genetically Modified Organisms. Food production by means of LMO is on the acceleration in an effort to solve the shortage of food problems. Food is also used as alternative energy source. Use of LMO product is not only limited to food and energy, but is actively utilized in various fields of medicines. This paper is first to check out the state of biomedicine developed and associated problems from industries that use LMO, after which we made an attempt on legislative approach to find out means of relief, through examples of such laws legislated for the sufferer from the adverse effect of the biomedicine. As for the liable subject to bear the responsibility for compensatory damage in a way of relieving the victim owing to adverse effect of biomedicine, those who manufactured and sold biomedicine and who are related to the damage to the victim due to the accident and medical doctors and pharmacists who prescribe and administer the medicine in question have been looked into. Accidents involving medicines and medical supplies could take place without reason for imputation on part of the liable subjects or fault of the victim, in which case the victim can't receive damage compensation from any of both parties. When such accidents happened turn out to be no fault accidents, introduction of damage relief measures might have to be reviewed against side effects of medicine and medical supplies as no fault compensation in order for actual relief to be possible. Talking about technicality of legislation, we can suggest a method of strengthening the accountability of manufacturer for stereotypical agenda on biomedicines by newly legislating special regulation with an issue that resists claim on risks associated with the development of medicine and incorporating the same into Manufactured Product Liability Law. After all, when an accident happens associated with biomedicine, the damage will be done to the consumer. And the consumer will be exposed to fatal danger even without the time to cope with potential risks associated with medicine and medical supplies they take. Therefore, it is necessary to protect the potential victim by having the manufacturer of biomedicines bear the liability of medical risks.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.