Earticle

초록

영어

(Background) Recent biotechnological breakthroughs are shedding new lights on various ethical and legal issues about human biological material. Since Rudolph Virchow, a German pathologist, had founded the medical discipline of cellular pathology, issues centering around human biological materials began to draw attention. The issues involving human biological materials were revisited with more attention along with series concerns when the human genome map was finally completed. Recently, with researches on human genes and bioengineering reaping enormous commercial values in the form of material patent, such changes require a society to reassess the present and future status of human tissue within the legal system. This in turn gave rise to a heated debate over how to protect the rights of material donors: property rule vs. no property rule. (Debate and Cases) Property rule recognizes the donors' property rights on human biological materials. Thus, donors can claim real action if there were any bleach of informed consent or a donation contract. Donors can also claim damages to the responsible party when there is an infringement of property rights. Some even uphold the concept of material patents overtaking. From the viewpoint of no property rule, human biological materials are objects separated from donors. Thus, a recipient or a third party will be held liable if there were any infringement of donor's human rights. Human biological materials should not be commercially traded and a patent based on a human biological materials research does not belong to the donor of the tissues used during the course of research. In the US, two courts, Moore v. Regents of the University of California, and Greenberg v. Miami Children’s Hospital Research Institute, Inc., have already decided that research participants retain no ownership of the biological specimens they contribute to medical research. Significantly, both Moore and Greenberg cases found that the researcher had parted with all ownership rights in the tissue samples when they donated them to the institutions, even though there was no provision in the informed consent forms stating either that the participants donated their tissue or waived their rights to ownership of the tissue. These rulings were led to huge controversy over property rights on human tissues. This research supports no property rule on the ground that it can protect the human dignity and prevent humans from objectification and commercialization. Human biological materials are already parted from human bodies and should be treated differently from the engineering and researches of those materials. Donors do not retain any ownership. (Suggestions) No property rule requires a legal breakthrough in the US in terms of donors' rights protection due to the absence of punitive damages provisions. The Donor rights issue on human biological material can be addressed through prospective legislation or tax policies, price control over patent products, and wider coverage of medical insurance. (Conclusions) Amid growing awareness over commercial values of human biological materials, no property rule should be adopted in order to protect human dignity but not without revamping legal provisions. The donors' rights issue in material patents requires prospective legislation based on current uncertainties. Also should be sought are solutions in the social context and all these discussions should be based on sound medical ethics of both medical staffs and researchers.

목차

I. 연구의 배경
 II. 인체 유래 물질의 법적 특수성과 법적 지위
  1. 서설
  2. 재산권 개념의 유연성(flexibility)과 한계
  3. 인체에 대한 재산권 인정 여부에 관한 연혁적 검토
  4. 인체 유래 물질에 대한 재산권성 인정 여부
 III. 재산권 부정설에 입각한 인체 유래 물질의 쟁점 검토
  1. 의의
  2. 인체 유래 물질이 권리의 객체인가?
  3. 인체 유래 물질이 민법상 물건인가?
  4. 시료 제공 계약의 성질은 어떠한가?
  5. 시료 제공자의 권리 구제는?
 IV. 결론
 참고문헌
 ABSTRACT

키워드

인체 유래 물질 재산권 시료 이송 계약 물질 특허 무어 판결 그린버그 판결 human biologic material property rule genetic engineering material transfer Moore case Greenberg case.

저자

• 이웅희 [ Ung Hee Lee | 서울내과외과원장, 의학박사 ]

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