의약품 품목허가제도의 자기결정권, 보건권 침해 여부 - 약사법 제31조 제8항 등 위헌확인을 중심으로 - (Infringement on the Decision Right and Health Right of the Pharmaceutical Approval System - With an Emphasis on Ascertainment of Constitutional Violations by Paragraph 8, Article 31 of the Act on Phar)

서지정보

· 발행기관 : 이화여자대학교 생명의료법연구소
· 수록지 정보 : 생명윤리정책연구 / 7권 / 2호 / 89 ~ 113페이지
· 저자명 : 차승현

초록

In mid 2000’s, Korean society experienced a stem cell storm. Afterward, lots of patients suffering from incurable or obstinate diseases continued to put hope in curing their disease by stem cells. However, there have beencontroversy in the medical world over whether stem cell treatments can open a way to cure their disease. Meanwhile, there was a decision thatParagraph 8, Article 31 of the Act on Pharmaceutical Affairs isunconstitutional in last June. The decision turned down the claims of thepatients with incurable or obstinate diseases, and the concerned law wasaccepted for deliberation under the constitution to decide whether theconcerned law infringes on the freedom for the manufacturers of autologouscell theraphy products to choose jobs.
But the author of this paper thinks that the concerned law can infringeupon the right for the patients with incurable or obstinate diseases to makedecisions, and likes to re-compose the decision. The nature of the right forpatients to make decisions is permitting the patients to make importantdecisions for themselves without restrictions by anyone else. What matters inthis regard is whether the scope of exercising patients’ right to makedecisions themselves includes a decision which can endanger the right ofthe patients. In principle, regarding the scope of exercising the right formaking decisions, if the right is made by the individual after deliberation,the decision should be respected even though the decision endangers thedecision maker. Of course, because we live in a society, our standing needsto be adjusted. Therefore, if the self-determination endangers or harmsothers, it can be restricted.
Concerning the exercising of the self-determination of the patients withincurable or obstinate diseases as they want to use autologous cell theraphyproducts, the restriction on the self-determination is limited in that theexercising of the self-determination of the patients has no factor to harmothers. This paper tries to verify it by applying the “Weight Formula” of R. Alexy. Of course, this “Weight Formula” can have a value bias. However,this paper claims that a decision on the infringement upon basic rights canbe significant only when it is made in specific individual matters and that thevalue of the self-determination should be a priority over any supplementinglaw or regulation within the scope that the exercising of the right does notharm others.

영어초록

In mid 2000’s, Korean society experienced a stem cell storm. Afterward, lots of patients suffering from incurable or obstinate diseases continued to put hope in curing their disease by stem cells. However, there have beencontroversy in the medical world over whether stem cell treatments can open a way to cure their disease. Meanwhile, there was a decision thatParagraph 8, Article 31 of the Act on Pharmaceutical Affairs isunconstitutional in last June. The decision turned down the claims of thepatients with incurable or obstinate diseases, and the concerned law wasaccepted for deliberation under the constitution to decide whether theconcerned law infringes on the freedom for the manufacturers of autologouscell theraphy products to choose jobs.
But the author of this paper thinks that the concerned law can infringeupon the right for the patients with incurable or obstinate diseases to makedecisions, and likes to re-compose the decision. The nature of the right forpatients to make decisions is permitting the patients to make importantdecisions for themselves without restrictions by anyone else. What matters inthis regard is whether the scope of exercising patients’ right to makedecisions themselves includes a decision which can endanger the right ofthe patients. In principle, regarding the scope of exercising the right formaking decisions, if the right is made by the individual after deliberation,the decision should be respected even though the decision endangers thedecision maker. Of course, because we live in a society, our standing needsto be adjusted. Therefore, if the self-determination endangers or harmsothers, it can be restricted.
Concerning the exercising of the self-determination of the patients withincurable or obstinate diseases as they want to use autologous cell theraphyproducts, the restriction on the self-determination is limited in that theexercising of the self-determination of the patients has no factor to harmothers. This paper tries to verify it by applying the “Weight Formula” of R. Alexy. Of course, this “Weight Formula” can have a value bias. However,this paper claims that a decision on the infringement upon basic rights canbe significant only when it is made in specific individual matters and that thevalue of the self-determination should be a priority over any supplementinglaw or regulation within the scope that the exercising of the right does notharm others.

참고자료

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