論消費者基因檢測之法律爭議及應有規範

The Legal Disputes and Appropriate Regulations of Direct-to-Consumer Genetic Testing

林珮慈(Pei-Tzu Lin)

指導教授 ： 王立達 ； 林欣柔

國立交通大學/管理學院/管理學院科技法律學程/碩士(2012年)

https://doi.org/10.6842/NCTU.2012.00022

摘要

隨著基因體醫學研究及相關檢測工具的發展，已有越來越多的商業公司對一般消費者提供基因檢測服務。此類由一般民眾透過非醫療管道直接取得之基因檢測服務統稱為消費者基因檢測（direct-to-consumer genetic testing，簡稱DTC基因檢測），DTC基因檢測的問題癥結在於檢測內容涉及高度專業的基因及疾病機轉，且依目前研究所知對於檢測結果的解釋不確定性高，尤其它非以傳統醫療診斷為目的，因此排除醫療提供者的參與，單純由檢測服務提供者與消費者直接建立買賣契約關係，且服務又涉及隱私性及道德性極高的個人基因資訊。有鑑於此，美國及英國等相關單位相繼對DTC基因檢測服務之管制提出建言，而美國食品藥物管理局（Food and Drug Administration）也擬將DTC基因檢測納入規範管理。本文將檢視DTC基因檢測的法律爭議，並藉由探討國際相關組織之立法建議、現行相關法律規範，尋求DTC基因檢測可能適用的法律管制工具，以於公眾權益保護及商業創新發展間取得平衡機制。

關鍵字

基因檢測 ； 基因檢測服務 ； 消費者基因檢測

並列摘要

With the advance of genomic medical research and related testing tools, growing numbers of commercial companies provide genetic testing services to the public. Such genetic testing services directly accessed by the general public through non-medical channels are collectively known as the direct-to-consumer genetic testing (referred to as DTC genetic testing). The crux of DTC genetic testing’s disputes is concerning the highly complicated correlation between genes and diseases, and the improbable interpretation of test results with current knowledge. Especially for its non-medical diagnostic purposes, thus excluding the participation of health care providers, the sales agreement is established only by the service providers and consumers. Moreover, the genetic testing involves personal genetic information of high privacy and ethic concerns. For this reason, the related organizations of the United States and the United Kingdom have proposed the suggestions on DTC genetic testing regulation. The U.S. Food and Drug Administration is also planning the regulation of DTC genetic testing into the standard management. This paper will examine the legal disputes of DTC genetic testing, legislative proposals of international organizations, and the existing legal norms. Finally, we will try to seek out the appropriate legal control tools to strike the balance between protecting the public interests and developing the innovative business.

並列關鍵字

Genetic Test ； Genetic Testing Service ； Direct-to-Consumer Genetic Testing Service

參考文獻

1. Bloss, Cinnamon S., Nicholas J. Schork & Eric J. Topol, Effect of Direct-to-Consumer Genomewide Profiling to Assess Disease Risk, 364 N Engl J Med 524 (2011).

2. El, Carla G van, & Martina C Cornel, Genetic Testing and Common Disorders in a Public Health Framework: Recommendations of the European Society of Human Genetics, 19 European Journal of Human Genetics 377 (2011).

3. European Society of Human Genetics, Statement of the ESHG on Direct-to-Consumer Genetic Testing for Health-Related Purposes, 18 European Journal of Human Genetics 1271 (2010).

4. Godard, Be’atrice, Helena Kaariainen, Ulf Kristoffersson, Lisbeth Tranebjaerg, Domenico Coviello & Se’gole`ne Ayme’, Provision of Genetic Services in Europe: Current Practices and Issues, 11 European Journal of Human Genetics Suppl 2 S13 (2003).

5. Hogarth, Stuart, Gail Javitt, & David Melzer, The Current Landscape for Direct-to-Consumer Genetic Testing: Legal, Ethical, and Policy Issues, 9 ANN. REV. GENOMICS AND HUMAN GENETICS 161 (2008).