바이오의약품 사고로 인한 피해구제법리 - 제조물책임법리를 중심으로 -

Abstract

Humankind history is faced with one gigantic turning point due to development of genetically modified organisms. Food production by means of GMO is on the acceleration in an effort to solve the shortage of food problems. Food is also used as alternative energy source. Use of GMO 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 GMO, 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.