이종이식 임상적용에서의 인권침해 요소에 관한 법적 고찰
A Legal Study on the Human Rights Violations of Xenotransplantation Clinical trials
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Clinical transplantation of animal tissues and organ into humans, so called xenotransplantation, is an alternative way to supply transplant organs. It carries with it a currently unquantifiable risk of the transmission of viruses from the animal to the human recipient. Therefore, the following would be necessary in order to monitor the health status of recipients: life-long surveillance, waiver of the right to withdraw consent, consent of their sexual partners, restrictions of travel, post-mortem examination, and so on. However, these conditions are violations of their human rights. Because it would be essential for recipients to personally comply with public safety measures, specific laws need to be enacted. To protect society in the event of emerging infectious diseases, governments must devise a legally effective means of ensuring compliance with such safeguards. This article argues that legislation implementing a xenotransplantation surveillance system should withstand constitutional scrutiny. Since the fundamental rights of recipients would be violated, the legal adequacy of such violations must be considered under existing constitutional doctrines.
Abstract
Clinical transplantation of animal tissues and organ into humans, so called xenotransplantation, is an alternative way to supply transplant organs. It carries with it a currently unquantifiable risk of the transmission of viruses from the animal to the human recipient. Therefore, the following would be necessary in order to monitor the health status of recipients: life-long surveillance, waiver of the right to withdraw consent, consent of their sexual partners, restrictions of travel, post-mortem examination, and so on. However, these conditions are violations of their human rights. Because it would be essential for recipients to personally comply with public safety measures, specific laws need to be enacted. To protect society in the event of emerging infectious diseases, governments must devise a legally effective means of ensuring compliance with such safeguards. This article argues that legislation implementing a xenotransplantation surveillance system should withstand constitutional scrutiny. Since the fundamental rights of recipients would be violated, the legal adequacy of such violations must be considered under existing constitutional doctrines.
참고문헌 (53)
- Bach F. H., "Uncertainty in Xenotransplantation : individual benefit versus collective Risk", Nature Medicine, 4(2) (1998)
- "Commission Directive 2003", 63, 83, pp.EC의 개정본) Part IV, Advanced Therapy Medicinal Products
- Cooper D. KC., "Xeno : The Promise of Transplanting Animal Organs into Humans" (2000), Oxford University Press
- Denner J., "The inter national xenotransplantation association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-chapter 5 : Strategies to prevent transmission of porcine endogenous retroviruses", Xenotransplantation, 16(4) (2009)
- Vandrpool HY, "Informed consent and xenotransplantation clinical trials", Xenotransplantation, 16(4) (2009)
- Hering B. J., "Prolonged diabetes reversal after intraportal xenotransplantation of wild-type porcine islets in immunosuppressed nonhuman primates", Natural Medicine, 12(3) (2006)
- HRC Gene Technology Advisory Committee, "Guidelines Preparation of Applications Involving Clinical Trials of Xenotransplantation in New Zealand", ~ (2007)
- HRC Gene Technology Advisory Committee, NZ, "Guidelines for Preparation of Applications Involving Clinical Trials of Xenotransplantation in New Zealand", ~ (2007)
- The IXA Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet Products in Type 1 Diabetes, "International Xenotransplantation Association", ~ (2009)
- Issa N. C., "Absence of replication of porcine endogenous retrovirus and porcine lymphotropic herpesvirus type 1 with prolonged pig cell microchimerism after pig-to-baboon xenotransplantation", Journal of Virology, 82(24) (2008)
- Chapman LE, "Xenotransplantation, Xenogeneic Infections, Biotechnology, and Public Health", Mount Sinai Journal of Medicine, 76(5) (2009)
- Monique A. Spillman, "“Clinical Trials of Xenotransplantation”, : Waiver of the Right to Withdraw from a Clinical Trial Should Be Required", 100 YEARS OF TRANSPLANTATION, ~ (2007)
- National Health Committee, "National Health Committee’s Advice on Living Cell Technologies Application for Xenotransplantation Clinical Trials in New Zealand", ~ (2008)
- Patrik S. Florencio, "Legal Enforcement of Xenotransplantation Public Health Safeguards", Journal of Law, Medicine & Ethics, 32 (2004)
- Public Health Service, U.S, "Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation", ~ (2001)
- Robert Sparrow, "Xenotransplantation, consent and international Justice", Developing World Bioethics, 9(3) (2009)
- Rood P. P., "Islet Xenotransplantation : are we really ready for clinical trials?", American Journal of Transplantation, 6(6) (2006)
- Edwards SJ, "Research Participation and the Right to Withdraw", Bioethics, 19(2) (2005)
- Stoye J. P., "The dangers of xenotransplantation", Letter to Nature Medicine, 1(11) (1995)
- Report on the State of the Art in the Field of Xenotransplantation, "The Committee of Ministers of the Council of Europe", ~ (2003)
- U.S. Department of Health and Human Services Secretary’s Advisory Committee on Xenotransplantation, "Informed Consent in Clinical Research Involving Xenotransplantation", ~ (2004)
- Report on the State of the Science in Xenotransplantation, "U.S. Department of Health and Human Services, Food and Drug Administration", ~ (2004)
- United Kingdom Xenotransplantation Interim Regulatory Authority, "Xenotransplantation Guidance", ~ (2006)
- Valdes-Gonzalez R., "No evidence of porcine endogenous retrovirus in patients with type 1 diabetes after long-term porcine islet xenotransplanta", Journal of Medical Virology, 82(2) (2010)
- WHO, "First WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials" (2008)
- (미국 SACX)이종이식의 피험자동의서에 관한 보고서, "국립독성연구원", 국립독성연구원, ~ (2004)
- 이영애, "이화여자대학교 생명의료법연구소, “이종이식 임상시험 규제 마련을 위한 공청회”", 자료집, ~ (2010)
- 권영설, "에이즈(AIDS)와 그 公法的 對應", 미국헌법연구, (8) (1997)
- 김나경, "후천성 면역결핍증(AIDS)의 문제구조와 법정책 -‘치료’와‘예방’이념의 대립과 조화 -", 저스티스, (109), pp.316~341 (2009), 한국법학원
- 너필드생명윤리위원회, "동물에서 인간으로의 이식: 이종이식의 윤리적 문제" (2007), 이화여자대학교 생명의료법연구소
- 모효정, "사회여론 수렴방법으로서의 시민 합의회의:이종이식 문제를 중심으로", 생명윤리정책연구, 3(1), pp.91~109 (2009), 생명의료법연구소
- 모효정, "이종이식 용어집" (2012), 이화여자대학교 생명의료법연구소
- 박균성, "과학기술위험에 대한 사전배려원칙의 적용에 관한 연구", 행정법연구, (21), pp.143~163 (2008), 행정법이론실무학회(行政法理論實務學會)
- 박수헌, "이종이식에 따른 평생추적관찰을 강제하기 위한 미국의 규제법적 방안", 공법연구, 37(1), pp.259~288 (2008), 한국공법학회
- 박수헌, "이종이식의 법적 문제와 규제", 생명윤리정책연구, 2(1), pp.45~64 (2008), 생명의료법연구소
- 박재현, "충분한 설명에 근거한 동의", 경희의학, 22(1) (2006)
- 박정규, "이종장기이식의 현황과 전망", 대한이식학회, 23(3) (2009)
- 생명윤리용어집편찬위원회, "생명윤리용어집" (2012), 생명윤리정책연구센터
- 세계의사회, "헬싱키 선언-서울 개정본", ~ (2008)
- "식약청 고시, "생물학적 제제 등 허가 및 심사에 관한 규정"", ~ (2007)
- 식품의약품안전청, "이종이식제제의 범위 및 원료 동물에 대한 가이드", ~ (2006)
- 식품의약품안전청, "이종이식제제의 전임상 및 임상시험에 대한 가이드", ~ (2006)
- 식품의약품안전청, "이종이식제제의 품질관리 및 이식 후 감염관리에 대한 가이드", ~ (2006)
- 안규리, "Xenotransplantation 가능한가?", Reproductive & Developmental Biology, 36(2) (2012)
- 양지예, "이종이식연구를 위한 단일법 제정에 대한 검토", 한국의료법학회지, 18(2), pp.145~176 (2010), 한국의료법학회
- 이정은, "국내 돼지에서 분리한 내인성 레트로 바이러스 gag 유전자의 분자 생물학적 특성 분석", Journal of Bacteriology and Virology, 36(3), pp.185~194 (2006), 대한미생물학회
- 이형석, "생명윤리와 사전동의(Informed Consent)", 의생명과학과 법, 7 (2012)
- 정규원, "바이오장기 이식에 있어서 환자의 동의", 법학논총, 28(2), pp.27~40 (2011), 법학연구소
- 정규원, "이종이식, 수인성 감염", 법학논총, 24(1), pp.31~46 (2007), 법학연구소
- 정규원, "피검자의 동의 - 이해를 중심으로 -", 법학논총, 22(2), pp.209~224 (2005), 법학연구소
- 정규원, "피검자의 동의- 자발성을 중심으로 -", 법학논총, 23(1), pp.1~22 (2006), 법학연구소
- 최상회, "인폼드 컨센트(Informed Consent)의 법리구조", 법학연구, (33), pp.111~134 (2009), 한국법학회
- 바이오장기의 윤리적 고찰 및 산업적 발전방안 연구, "한양대학교 산학협력단", 과학기술부, ~ (2006)