Earticle

초록

영어

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.

목차

I. 서
 II. 바이오신약의 현행법적 문제점
  1. 약사법상 의약품
  2. 바이오신약에 관한 현행법적 규정
  3. 바이오신약에 대한 문제점
 III. 바이오신약에 대한 책임법리의 적용
  1. 일반책임법리의 적용
  2. 제조물책임
  3. 책임주체에 따른 책임
  4. 위험책임법리 적용의 검토
 IV. 결
 참고문헌
 ABSTRACT

키워드

저자

• 문상혁 [ Moon, Sang Hyuk | 법학박사, 성균관대학교 법학연구소 선임연구원 ]

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  의료법학 [THE KOREAN SOCIETY OF LAW AND MEDICINE]

• 간기

  계간

• pISSN

  1229-8069

• 수록기간

  2000~2025

• 등재여부

  KCI 등재

• 십진분류

  KDC 517 DDC 613