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의약품 품목허가제도의 자기결정권, 보건권 침해 여부 : 약사법 제31조 제8항 등 위헌확인을 중심으로
차승현 이화여자대학교 생명의료법연구소 2013 생명윤리정책연구 Vol.7 No.2
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 been controversy in the medical world over whether stem cell treatments can open a way to cure their disease. Meanwhile, there was a decision that Paragraph 8, Article 31 of the Act on Pharmaceutical Affairs is unconstitutional in last June. The decision turned down the claims of the patients with incurable or obstinate diseases, and the concerned law was accepted for deliberation under the constitution to decide whether the concerned law infringes on the freedom for the manufacturers of autologous cell theraphy products to choose jobs. But the author of this paper thinks that the concerned law can infringe upon the right for the patients with incurable or obstinate diseases to make decisions, and likes to re-compose the decision. The nature of the right for patients to make decisions is permitting the patients to make important decisions for themselves without restrictions by anyone else. What matters in this regard is whether the scope of exercising patients’ right to make decisions themselves includes a decision which can endanger the right of the patients. In principle, regarding the scope of exercising the right for making decisions, if the right is made by the individual after deliberation, the decision should be respected even though the decision endangers the decision maker. Of course, because we live in a society, our standing needs to be adjusted. Therefore, if the self-determination endangers or harms others, it can be restricted. Concerning the exercising of the self-determination of the patients with incurable or obstinate diseases as they want to use autologous cell theraphy products, the restriction on the self-determination is limited in that the exercising of the self-determination of the patients has no factor to harm others. 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 can be significant only when it is made in specific individual matters and that the value of the self-determination should be a priority over any supplementing law or regulation within the scope that the exercising of the right does not harm others.
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