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55 Food & Drug L.J. 343 (2000)
International Harmonization of Human Tissue Regulation: Regulatory Control over Human Tissue Use and Tissue Banking in Select Countries and the Current State of International Harmonization Efforts

handle is hein.journals/foodlj55 and id is 369 raw text is: The International Harmonization of Human Tissue Regulation: Regulatory Control Over Human Tissue Use and Tissue Banking in Select Countries and the Current State of International Harmonization Efforts BARBARA INDECH* I. INTRODUCTION Human tissues play a critical role in modem medicine, particularly in this era of biotechnology.' Beyond immediate therapeutic uses, e.g., transplantation, tissues (unlike organs) may be stored for an indefinite time period in traceable and often coded form and later used for biomedical research purposes,' teaching, quality control in healthcare, and the manufacture and production of therapeutic and diagnostic aids.' Both living donors and cadavers serve as sources of human tissue. However, whether procured from a living or deceased donor, subjected to sophis- ticated tissue engineering4 or used in transplantation in its unprocessed, basic form, human tissue is no longer limited by national borders. Keeping pace with the global- ization of the marketplace, the increasingly international scope of human tissue use presents new challenges in cross-border disease control.' In response, the regulatory authorities of several industrialized countries, along with consumer and industry leaders * Ms. Indech is an LL.M. candidate in International and Comparative Law at the Georgetown University Law Center (GULC). The author currently is the Regulatory Counsel for the Office of Policy and Regulations, Center for Veterinary Medicine, Food and Drug Administration (FDA). The views expressed in this article do not necessarily reflect the views of FDA. The author wishes to thank Professor Linda Horton of GULC and the FDA for her assistance. 'For the purposes of this paper, human tissues are defined as constituent parts of the human body including, but not limited to, bones, skin, heart valves, tendons, corneas, arteries, veins, dura mater, and cells intended for grafting. While fetal tissue generally falls within the scope of this definition, this paper does not address the myriad of ethical considerations associated with the use of human fetal tissue. Whole organs, blood, and blood products (including fetal cord blood) are deemed beyond the parameters of this definition. See, e.g., Robin Elizabeth Margolis, Should Human Tissue Transplants be Regulated?, HEALTHSPAN, Dec. 1992, at 17. 2 This paper does not examine the ethical and legal aspects of human tissue stored in biological banks for medical research purposes, including DNA examination. Some ethics questions generated in this area do bear mentioning, including: 1) to what extent should biomedical storage be allowed, and what use of such material is permissible; 2) must the donor give consent for such preservation and use, and to what degree must the donor be informed of any use (i.e., must donor consent be secured for every different use of his/her tissue, even years after donation); 3) may old biomaterials which were retrieved without donor consent (i.e., residual tissues from sur- gery) be used for research purposes; 4) who is the owner of the biomaterial-the person who donated the tissue, the research institution, the individual researcher, society as a whole; 5) as a corollary, should human tissue, an intrinsic part of the human body, even be considered as property; and 6) to what degree must confidentiality be maintained. In essence, the protection of a donor's autonomy, privacy, and human dignity must be balanced against the fundamental societal interests of freedom of research and efficiency of medical care. Where DNA analysis of a donor's tissue may reveal his genetic profile and future health and by extension relevant medical information on his biological family, yet another ethical consideration is what obligation, if any, researchers bear to inform the donor of any genetic concerns (i.e., diseases or disease markers) discovered. See Linda Nielsen, Legal and Ethical Aspects of Further Use of Human issue, 20 EuR. J. HEALTH L. 109, 109-110, 112 (1995). 3 Introduction: Human Tissues; Health Care and the Rights of Patients, 2 Eui. J. HEALTH L. 101, 101-02 (1995). 1 In tissue engineering, human cells or tissues may be combined with biodegradable synthetic polymers to create a neo-tissue. 5 Linda Horton, MutualRecognition Agreements and Harmonization, 29 SEroN HALL. L. REv. 692, 693 (1998).

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