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標題: | 生物遺傳資源保護的替代途徑 Alternative Pathways of Biogenetic Resources Protection |
作者: | Yi-Chia Ke 柯一嘉 |
指導教授: | 陳俊宏(Jiun-Hong Chen) |
關鍵字: | 生物多樣性公約,遺傳資源,傳統知識,蚓激酶, Convention on Biological Diversity,genetic resources,traditional knowledge,fibrinolytic enzyme, |
出版年 : | 2021 |
學位: | 博士 |
摘要: | 臺灣目前並無任何現行法律規範生物遺傳資源及傳統知識的取得、移轉及利用。在有效的法律保護制度妥善建立前,較實際的作法應該是找尋其他替代途徑來保護我們珍貴的遺傳資源及傳統知識。透過科學實驗及遺傳資源保存機構的政策分析,結果顯示生物多樣性公約 (Convention on Biological Diversity)及相關公約的架構及實行尚無定論。 首先,傳統知識與遺傳資源間的關係並不明確。依照蚓激酶實驗,使用者可以利用中國大陸的傳統知識及臺灣特有種蚯蚓治療心血管疾病及營利,進而引發法庭選購 (Forum Shopping)的問題。原產國 (Country of Origin)的意義也存在問題。如果使用者在中國大陸取得入侵種的南美洲蚯蚓並用來制造心血管疾病藥物時,哪個國家才是原產國就存在問題。再者,若是不同國家裡的多個社群獨立發展出相同的傳統知識,這些國家或社群是否應該共同決定及同意取得及惠益分享並不明確。 生物多樣性的保護及創新發展間的平衡也需要兼顧。審查涉及遺傳資源或傳統知識的專利或其他智慧財產權時,應該要求較高的新穎性或創造以避免生物剽竊或其他對生物多樣性的不法使用。同時,應該要設立像著作權管理組織的特定機構,來負責監控遺傳資源及傳統知識的使用,為傳統知識持有者或遺傳資源提供者,洽談契約及收取費用。「顯著」、「相關」或「重要貢獻」等法律概念應該要考慮。若是使用遺傳資源的程度,不是很顯著或相關,例如病毒的疾病偵測,那麼惠益分享原則的適用應該受到限制。 幾個替代的保護途徑也應該被採用,包含:(1)藉由電腦程式鑑別生物剽竊;(2)檢視傳統知識以創造有價值的智慧財產權;及(3)使用材料轉移契約。首先,為了防止通過智慧財產權壟斷遺傳資源或傳統知識,必須要在公開專利系統資料庫,進行生物剽竊鑑別。在龐大的專利資料庫中,利用電腦程式,偵測生物剽竊是較為有效率的方式。經過生物剽竊案例的收集後,還可以監控慣於利用專利進行生物剽竊的機構或公司。其次,對於漢族及原住民等之臺灣多元社群的醫療植物進行交叉檢測,至少七種植物是被多數社群認定有療效共識,並且也被證明含有醫療用途之生物有效成份。若有臺灣的權責機構取得相關的智慧財產權,將可以適當實施生物多樣性公約的規定,並公平地及平等地分享惠益。再次,為了便利每天的學術、商業交易、生物產品製造及藥品臨床使用等各種目的之遺傳資源交換,可以利用材料轉移契約,去規範遺傳資源的利用及傳播。即使某個國家未簽署生物多樣性公約,或是採用相關的公約,使用者在簽署材料轉移契約後,就應依照契約法的拘束,必須遵守該契約裡的條款。 臺灣獨特的植物相、動物相及多元社群,讓它擁有極為豐富的遺傳資源及有高度醫療用途價值的傳統知識,但也面臨嚴重的生物剽竊挑戰。為了完全解決所有生物剽竊問題,應該持續致力於建立有效率的保護措施及國內法律制度。 Currently, no effective domestic laws or regulations guide the access, transfer or utilization of genetic resources (GR) and traditional knowledge (TK) in Taiwan. It is more realistic to seek alternative pathways to secure our valuable GR and TK before the well establishment of an efficient legal protection system. Through scientific experiments and policy analysis of GR institutions, the results suggest that the framework and implementation of Convention on Biological Diversity (CBD) and its relevant conventions have not been completely determined yet. It is unclear how TK should be associated with GR. According to the earthworm fibrinolytic enzyme experiments, users may commercialize an endemic earthworm species of Taiwan by utilizing the Mainland China TK to cure cardiovascular and cerebrovascular diseases, and the issue of forum shopping will occur. The meaning of “the country of origin” is problematic as well. It is not clear which country is the “country of origin” when a user acquires the invasive earthworm species from South America in China to manufacture the medicine for the cardiovascular and cerebrovascular diseases. In addition, if multiple communities in different countries have independently developed the same TK, it is not clear whether these counties or communities should jointly or severally decide and agree with the access and benefit sharing (ABS). Balance of biodiversity and innovation is also required. The scrutiny of patent or other intellectual property rights (IPR) involving any GR or TK should request a higher novelty or inventive step to avoid bio-piracy or any misappropriation of biodiversity. Certain institution should be established to undertake the management obligations like copyright collective management organizations, including monitoring the utilization of GR or TK, negotiating agreements and collecting fees for TK holders or GR providers. Certain legal concepts, such as “significant”, “relevant” or “material contribution”, should be considered. If the utilization of GR, such as virus used for disease detection, is not “significant” or “relevant”, the application of ABS should be limited. Alternative protection approaches to protect GR and TK are proposed, including (1) identifying bio-piracy with the assistance of computer software; (2) screening the TK to invent valuable intellectual property, and (3) utilizing material transfer agreement. First, to prevent the monopoly of GR or TK through IPR systems, it is essential to identify bio-piracy in publicly accessible data systems. Utilizing software to detect bio-piracy would be a more feasible approach due to the abundance of patent databases. After collecting bio-piracy cases, we may further monitor the institutions or companies which are used to conduct bio-piracy by patent application. Second, through the cross-examination of the medical plants among multiple communities in Taiwan, including the indigenous people and Han people, seven species are within the consensus among the communities and have been proved to contain bioactive materials for medical uses. If a competent institution in Taiwan may acquire the relevant IPR, it may obtain a better position to implement the CBD rules and distribute the benefits fairly and equitably. Third, to facilitate the numerous transfers of GR every day for the purposes of academic research, commercial transactions, bio-product manufacture and pharmaceutical and clinic uses, material transfer agreement (MTA) may be employed to regulate the utilization and distribution of GR. Even if the country does not ratify CBD or adopts its relevant conventions, the users signing the MTA are obligated to obey the relevant rules stipulated in it subject to contract law. With its unique flora and fauna and diverse communities, Taiwan has extremely rich GR and valuable TK for high potential medical uses, which face serious bio-piracy challenges. Alternative approaches with immediate effect to protect our GR and TK is necessary. We still need to continuously dedicate ourselves to establish an efficient protection system and domestic legislation to eventually solve all bio-piracy problems. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/61293 |
DOI: | 10.6342/NTU202100806 |
全文授權: | 有償授權 |
顯示於系所單位: | 生命科學系 |
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