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정용익(Jeong, Yong-Ik) 원광대학교 법학연구소 2011 圓光法學 Vol.27 No.3
Procuration system is defined to be an institution that another person presents or accepts an expression for the principal so that the effect of law happens on the principal. In addition, in the case of representation of mandate, it is an expansion of private autonomy in the sense that one, with own intention, lets the third person commit a legal act and receives an effect. In the case of legal representation, the legal incompetent commits a valid legal act through a legal representative, and it has a function of supplementing private autonomy. However, it can be considered as an expansion of private autonomy in the respect that it creates a legal effect to the principal, for the principal on the premise of the intention of the principal. Merely, in the case of legal representation, it is considered to be different because the right of representation is granted under the law. All procuration system should not deviate from this original and characteristic. It is called an abuse of the right of representation when a representative works for himself or the third person, not for the principal who entrusts the right of representation. A number of theories exist for the case that the representative's action which corresponds to this happens. On the other hand, it causes another problem if procuration system, which is administered within a certain system, is able to fail to speak for the principal's opinion and profit. Procuration system is not always such in charter procedure, but it is considered somewhat meaningful because there exists a very unique phase, which is hardly found in general administration of procuration system. Charter procedure is commonly the most complicated among the administrative procedures, so the procuration system upon it seems to have a very peculiar characteristic. Other than the basic point that procuration system is managed for the principal himself, there might be various purposes such as stabilization of foreign relationship, effective management of related procedures, and etc. On charter procedure, procuration procedure seems to excessively emphasize the effectiveness of administrative procedure, among those several purposes. It is seen from the considerable amount of contents managed in charter procedure, other than the same points with civil law and the Civil Proceedings Act.Especially, about the management of comprehensive mandate system and appointment of sub-agent, the system is thought to be working for the comfort of representative more than for the effectiveness of procedure.Also, not a few of the contents, which regulate the unique produration system about charter procedure, are managed only with the basis related to the enforcement regulation format. Although it does not mean that these respect aught to be prescribed under the law, it needs a change, considering the fact that the recent tendency of legislation is trying to arrange legal basis as much as possible. Also, a problem of interpretation occurred while trying to include excessively complicated procedural term as a regulation.Though this originates in the complexity that the charter procedure carries, it is also a problem of legislation technology. Due to this kind of vagueness on regulations, the guidelines, which are only internal manuals, are sometimes understood as a bible. It needs to be stipulated more clearly.A national recognition of charter procedure is that it is difficult and complicated. Of course it is to create a new right by a certain procedure; therefore, it might be more complicated than other administrative procedures. However, it needs to be considered that the complexity originates from the systematic defect under management. About the charter procedure, procuration system is administered uniquely, and at some point, it needs to grope for more constructive plan for people. Further details are to be examined and learned, but some issues can be discussed as indications. First, it needs an impro
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후발의약품 진입 후 신약 보험약가 인하와 손실 배분의 정의(正義)
박성민(Park, Sungmin),정용익(Jeong, Yongik),신혜은(Shin, Hyeeun) 한국정보법학회 2017 정보법학 Vol.20 No.3
현행 특허법, 약사법 그리고 국민건강보험법 하에서, 신약 제약회사는 특허도전에 성공한 후발의약품 진입으로 인한 신약 보험약가 인하에 관하여 (추후 그 특허가 무효가 아니라는 판단이 확정되더라도) 후발의약품 제약회사나 국가 등으로부터 손실 을 보전받기 어렵고, 신약 특허권자 등의 판매금지 신청에 따라 후발의약품이 판매금지를 당하였을 때 사후적으로 그 판매금지가 잘못된 것임이 확인되어도, 국민건강보험공단이 신약 제약회사에게서 손실을 회복할 수 없다는 결론에 도달하였다. 하지만해석론적으로 본고와 다른 해석이 불가능하지 않아서 법적 안정성과 예측가능성이 저해되는 상황이다. 이는 특허권의 유동적 권리성이라는 현실적인 한계 때문에 혁신에 대한 보상과 의약품 접근성 제고의 요구를 조화시키려는 특허법, 약사법, 국민건강보험법이 의도한배분적 정의가 왜곡된 것이다. 그러므로 후발의약품의 조기 진입 이후의 부당한 신약 보험약가 인하에 대하여는 국민건강보험공단이 신약 제약회사에게 손실보상을 하고 후발의약품 진입 지연으로 인한 신약 보험약가 인하 지체에 대하여는 신약 제약회사가 국민건강보험공단에게 그로 인하여 얻은 망외의 이익을 반환하도록 하는 입법적개선이 필요하다고 생각한다(제1안). 그러나 만약 그러한 입법적 개선을 통한 교정에행정비용이 과도하게 소요된다면 차선책으로서 법령에서 정한 절차에 따라 행한 행위에 대하여는 책임을 부담하지 않음을 명확히 하는 입법이 필요하다(제2안). We have studied and concluded that under the current patent act, pharmaceutical affairs act and national health insurance act, original pharmaceutical company is not able to receive the compensation for the loss of original medicine upper price limit lowering after the market entry of follow-on medicine which succeeded in patent challenge, from the follow-on pharmaceutical company or the state, and vice versa. That is to say, when follow-on medicine is prohibited to sell according to approval-patent linkage system, National Health Insurance Service(the insurer of Korean national health insurance) is not able to receive the compensation for the loss from the original pharmaceutical company. However the different interpretation from us is not impossible. There is the problem of legal stability and possibility of forecast. This issue is caused by the realistic limitation of probabilistic patent. It distorts the distribution justice under the patent act, pharmaceutical affairs act and national health insurance act. Therefore we suggest the legislative improvement that rectify the distortion through compensation from the one which gets benefit to the one which gets loss. However, if the correction by the legislative improvement requires too much administrative cost, then, as a second way, we suggest the legislation that clarifies original pharmaceutical company or follow-on pharmaceutical company which follows the process of the pharmaceutical affairs act is not responsible for the loss above.
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KCI
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