生物資料庫生物檢體與個人資料的國際傳輸──對我國法制之分析與建議

Transborder Flows of Biological Materials and Personal Data of Biobanks: An Analysis of and Suggestions for Taiwan’s Law

生物資料庫在進行生物檢體與資料之處理或利用時，可能涉及向生物資料庫外之傳輸活動。我國人體生物資料庫管理條例對於國際傳輸議題高度重視，採取相當嚴格的管制立場。惟條文留下解釋上的疑難，與國際規範相較亦有不易索解之處。本文之目的，即在藉由國際間發展之借鏡與我國規範之解構分析，為法律解釋適用的疑問尋求可能的回答，亦為未來法制改革提供方向。
本文認為，我國對生物資料庫生物檢體與資料之國際傳輸的管制規定，有逾越追求管制目的之必要範圍的疑慮，值得在立法上再行檢討。而在現行法的解釋適用上，本文建議，若將對資料與生物檢體衍生物之許可審查標的，解釋為係生物資料庫對國際傳輸事務的整體規劃，較能兼顧管制目的與憲法價值。在此架構下，主管機關之審查，即著重在生物資料庫之作業程序規範與要求申請使用人遵循之契約條款是否充分，得以確保生物檢體衍生物與個人資料獲得適當之保護。

Biobanks may transfer biological materials and personal data to third countries when they process or use collected biological materials and personal data. Taiwan’s Human Biobank Management Act pays close attention to and strictly regulates transborder flows. Yet, interpreting and applying the provisions encounters a couple of thorny questions. Moreover, it is difficult to find the rationale behind the provisions if we compare the provisions with the related international development. The purpose of this paper is to seek potential answers to the questions regarding the interpretation and application of the provisions and provide the direction for the future legal reform.
This paper argues that the regulation over the transborder flows of biological materials and data of biobanks under the Human Biobank Management Act probably has gone beyond the necessary limit to pursue the end of the regulation and should be reconsidered by the legislature. As for the interpretation and application of the current provisions, this paper suggests that the subject matter of the review and permit of the competent agency could be interpreted as the whole scheme of a biobank for addressing transborder transfers. This interpretation makes the provisions relatively consistent with the end of the regulation and the spirit of the constitution. Under this interpretation, the review of the competent agency would focus on the sufficiency of biobanks’ standard operating procedures (SOPs) and contracts with applicants in ensuring adequate protection of biological material derivatives and personal data.