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의약품의 ‘허가사항 외 사용(Off-Label-Use)’으로 인한 손해배상책임 - 의사의 책임을 중심으로
전병남 사법발전재단 2014 사법 Vol.1 No.28
When pharmaceutical manufacturers wish to make and sell drugs, they must obtain permission from the Ministry of Food and Drug Safety. Also, the manufacturers must indicate the permission's details on their pharmaceutical labels. When medical professionals such as doctors use a medicine beyond the permission from Ministry of Food and Drug Safety, the act is referred to as ‘off-label use.’ If a doctor engages in off-label use, it is regarded as an act of negligence, provided that there is no valid reason for such use. If the government fails to conduct administrative guidance for pharmaceutical manufacturers, despite being aware of their off-label use, it should be held liable for damages inflicted on citizens, despite the knowledge of their off-label use. If the manufacturers fail to warn customers of the danger of off-label use on their labels, they should be held liable for their products. If a pharmacist has prepared a medicine despite the doctor's prescription suggesting off-label use, the pharmacist should be held liable for the consequences. However, the most important thing is to prevent such consequences, as the lives and health infringed by off-label use can never be fully compensated, no matter who takes responsibility. 의약품 제조업자가 의약품을 제조·판매하기 위해서는 식약처의 허가를 받아야 하고, 또한 그와 같은 허가사항을 의약품 첨부문서에 기재하여야 한다. 의사 등이 식약처의 허가사항 외로 의약품을 사용하는 것을 ‘허가사항 외 사용(Off-Label-Use)’이라고 한다. 의사가 의약품을 허가사항 외로 사용하는 경우에는, 허가사항 외로 사용할 수밖에 없는 특단의 합리적인 이유가 없는 한 과실이 추정된다. 국가는 의약품 제조업자 등이 허가사항 외로 사용하는 것을 알면서도 행정지도를 하지 아니하여 국민에게 손해가 발생한 경우에는 책임을 져야 한다. 의약품 제조업자는 첨부문서에 허가사항 외 사용으로 인한 위험성을 경고하지 아니한 경우에는 제조물책임을 진다. 약사는 의사가 발행한 처방전에 허가사항 외 사용을 의심할 수 있는 내용이 기재되어 있음에도 이를 확인하지 아니하고 조제하였다면 역시 손해배상책임을 진다. 그러나 위와 같이 손해가 전보되더라도 허가사항 외 사용으로 인하여 침해된 생명과 건강까지도 원상회복되는 것은 아니므로, 이를 예방하기 위한 노력이 필요하다.
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전병남 대한의료법학회 2010 의료법학 Vol.11 No.1
Medical Dispute Arbitration Law had been debated on its legislation several times since Korean Medical Association's submission of the bill to the National Assembly in 1988, eventually in December, 2009, passed the National Assembly Standing Committee and was laid before the Legislation and Judiciary Committee, and thus its legislation is now near at hand. During the long process, it has provided a hot issue with our society. And yet, Medical Dispute Arbitration Law has differed considerably in legislative content depending on the main body of proceeding the enactment, which subsequently was given the mixed comments of ‘Act on Malpractice-related Damage Relief’ or ‘Medical Indemnity Act', and this legislative bill also cannot be free from this debate. It is desirable that medical disputes between doctors and patients be resolved through conciliation between the parties concerned. But, because reaching a compromise is difficult owing to deep emotional conflicts between the parties, difficulties in investigating a cause and requiring a high amount of settlement money, etc., it is inevitable to seek a resolution by third party intervention. By the way, such an arbitration by third party is based on the compromise of the interested parties and thus has a limitation of not being able to satisfy both parties completely. Therefore, the legislative bill made for arbitration of medical disputes between the parties will have to prepare an institutional system for the parties to easily understand and accept. Also, problems occurred in the legislative bill will have to be corrected through an in-depth discussion in order for the legislative bill to work as an effective system.
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감기약 콘택600 제조물책임사건에 관한 민사법적 고찰 - 대법원 2008.2.28. 선고 2007다52287 판결 -
전병남 대한의료법학회 2009 의료법학 Vol.10 No.1
While the medical supplies have positive functions such as extending lifespan, recovering health, and preventing diseases, they also cause unexpected tragic consequences due to their side effects, and the magnitude of such damage inevitably increases due to the mechanism of mass production, mass distribution, and mass consumption of those medical supplies. Therefore, needless to say, the optimal way to prevent or reduce such damage is rather through medical supply manufacturers' producing non-defective products, or through the government's controlling production and sales of medical supplies with more aggressive exercise of regulatory authority on medical supply manufacturers, than through a remedy by a legal relief after using medical supplies. In this case, although the victim died due to the defect of the cold medicine, 'Contac 600', the drug company's responsibility to cover damages was not recognized because a defect could not be found in the then-manufacturing process. Thus, while pharmaceutical companies are gaining economic profits by producing and selling a medical supplies, if they do not take any remedy measures for the victims of their products' side effects, the victims have to use medical supplies under their own responsibility of taking a risk, and they have to accept the full damage of the potential consequence. Therefore, to remove such absurdity and contradiction, and to practically remedy the victim of medical supplies' side effects, the pharmaceutical side effects remedy project pending in the pharmaceutical affairs law needs to be actively implemented.
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전병남 대한의료법학회 2014 의료법학 Vol.15 No.2
의료진의 주의의무 위반으로 인한 손해배상책임을 묻기 위해서는 의사의 주의의무위반, 손해의 발생, 주의의무위반과 손해발생 사이의 인과관계가 존재한다는 점이 각 입증되어야 한다. 그러므로 의사의 주의의무 위반이 있다고 하더라도, 인과관계가 입증되지 하지 않는 경우에는 손해배상책임이 인정되지 않음은 당연하다. 그런데 의사의 주의의무 위반이 일반인의 수인한도를 넘어설 만큼 현저하게 불성실한 진료를 하였다고 평가할 정도에 이르렀을 경우에는, 그 자체로 불법행위를 구성하여 손해배상책임을 인정한다고 하더라도 일반인의 정의 관념이나 법질서에 반하지는 않을 것으로 생각된다. 다만, 수인한도를 좁게 설정하는 경우에는 환자의 성실한 진료를 받을 이익 또는 기대가 부당하게 침해될 수 있고, 반대로 수인한도를 넓게 설정하는 경우에는 손해배상책임의 확장으로 인하여 의사의 진료위축이 초래될 수 있다. 따라서 환자의 진료 받을 이익과 의사의 진료권이 모두 충족될 수 있도록 합리적인 조화가 필요하다. In order to account for whether a doctor should indemnify damages resulted from violation of duty of care, the fact that a doctor violated duty of care, that damages were incurred, and the link between violation of duty of care and damages incurred, respectively, should be verified. So even though a doctor violated duty of care to patients, he or she will not bear the responsibility to indemnify damages unless it is not verified. If a doctor’s negligence in medical practices is assessed that obviously unfaithful medical practice far exceeds the limit of admission of a patient, it will not go against people’s general perception of justice or law and order to constitute a medical malpractice itself as an illegal action that will require liabiliy for damage. However, when the limit of admission is set too low, a patient’s benefit and expectation of proper medical treatment can be violated. In contrast, if the limit of admission is set high, it can leave too little room for doctors’ discretion for treatments due to a bigger risk of indemnification for damages. Thus, a reasonable balance that can satisfy both benefit and expectation of patients and doctors’ right to treatment is needed.
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