藥品試驗數據保護：從「TRIPS協定」到「TPP協議」

The Protection of Drug Test Data: From TRIPS to TPP

藥品試驗數據專有權是有別于專利權的新型知識產權。對其施加保護俱有積極和消極影響，需要在利益平衡基礎上尋求合理適度的制度架構。實踐中，「TRIPS協定」為藥品試驗數據保護確立了最低標準，但以「TPP協議」為代表的區域貿易機制卻進行了超出「TRIPS協定」標準的擴張。對此，我國應保持高度警惕，堅持在「TRIPS協定」多邊規則基礎上進行國內立法調整，並通過適時加入「TPP協議」談判，來提高規則制定的國際話語權，防止藥品試驗數據保護擴張的蔓延。Drug test data exclusivity, which is different from patent right, is a new type of intellectual property. The protection of data exclusivity has both positive and negative effects and we should seek to build a reasonable and proper system based on interest balance. In practice, TRIPS Agreement has established minimum standards for drug test data protection, but regional trade mechanism represented by TPP Agreement has built the highest TRIPS-Plus standards. In this regard, China should maintain a high degree of vigilance. We should insist on the adjustment of domestic legislation based on multilateral rules of TRIPS Agreement. In order to enhance the international power of discourse and prevent the spread of drug test data protection's expansion, China should timely participate in the TPP Agreement negotiations.