論藥品資料專屬保護之不引據義務——以加拿大拜爾案為中心

Exploring the Concept of Non-Reliance Obligation under Pharmaceutical Data Exclusivity Regime with Emphasis on the Implications of Bayer v. Canada

資料專屬保護制度，旨在保障藥商為取得新藥上市許可所有新藥安全性與有效性之試驗資料免受他人不公平之商業使用。此等新興的智慧財產保護形態首見於北美自由貿易協定第1711條，加拿大據此採取資料專屬保護制度，然對於該制度下要求衛生主管機關不得引據研發藥廠所提試驗資料，何謂「不引據」或「非依賴」之概念，引發拜爾案對此問題之熱烈爭議。因此，本文擬就加拿大拜爾案所涉資料專屬保護之法令，探討「不引據」概念在資料專屬保護制度下之可能解釋及其意涵，分析寬嚴不同之解釋對研發藥廠與學名藥廠利益之消長，並尋求平衡藥品研發創新與公共健康價值之可能解釋，提供我國藥事法第40條之2解釋適用之參考。

Data exclusivity is designed to protect undisclosed clinical data from disclosure and unfair commercial use for a certain exclusive peri-od of time. Generated by innovators, such test data are submitted to the health authority for the examination of the safety and effectiveness of a new drug before marketing. Data exclusivity is granted to the innovators for their considerable efforts put forth in generating those test data. Generally, no one can rely on those submitted data for a subsequent application for a new drug approval. Such new type of intellectual property firstly appeared in Article 1711 of the North American Free Trade Agreement, and was incorporated under Article 39.3 of the TRIPS Agreement and subsequent bilateral free trade agreements. However, the concept of “unfair commercial use” has never been clearly defined un-der the TRIPS Agreement, and the meaning of “non-reliance” has been interpreted differently from country to country. As a leading case on data exclusivity, the Canadian case, Bayer v. Canada, offered useful resources to clarify the issues surrounding the meaning of “non-reliance”. This study attempts to explore the concept of “non-reliance” under the pharmaceutical data exclusivity regime based on Bayer v. Canada. This study suggests a possible compromised interpretation of “non-reliance” with a view to balance pharmaceutical innovation and public health, and argues that Article 40-2 of the Pharmaceutical Affairs Act is consistent with the above compromised interpretation. This study also proposes several options for amendments.