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《与贸易有关的知识产权协定》(TRIPS)-plus对药品可及性的影响:以泰美自由贸易协定为例的研究

Impact on access to medicines from TRIPS-Plus: a case study of Thai-US FTA.

作者信息

Kessomboon Nusaraporn, Limpananont Jiraporn, Kulsomboon Vidhaya, Maleewong Usawadee, Eksaengsri Achara, Paothong Prinya

机构信息

Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kean 40002, Thailand.

出版信息

Southeast Asian J Trop Med Public Health. 2010 May;41(3):667-77.

Abstract

This study assessed the impact of the Thai-US Free Trade Agreement (FTA) on access to medicines in Thailand. We first interpreted the text of the sixth round of Thai-US negotiations in 2006 on intellectual property rights (IPR). The impact was estimated using a macroeconomic model of the impact of changes in IPR. The estimated impact is based on a comparison between the current IPR situation and the proposed changes to IPR. The FTA text involves the period of patent extension from the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS Agreement). The provisions involve the period of patent extension, which have to do with compensation for delays in patent registration and/or drug registration, data exclusivity that would result in a delay in generic drug entry, and the enforcing role of the Thai Food and Drug Administration of patent linkages. As a worst case scenario for this single provision, a 10 year patent extension would be given to compensate for delays in patent registration and/or drug registration. The impact on access to medicine, in the year 2027, would be: 1) A 32% increase in the medicine price index, 2) spending on medicines would increase to approximately USD 11,191 million, (USD1 = THB 33.9 on September 2, 2009), and 3) the domestic industry could loss USD 3.3 million. These results suggest there would be a severe restriction on the access to medicines under the TRIPS-Plus proposal. IPR protection of pharmaceuticals per the TRIPS-Plus proposal should be excluded from FTA negotiations.

摘要

本研究评估了泰美自由贸易协定(FTA)对泰国药品可及性的影响。我们首先解读了2006年泰美第六轮知识产权谈判的文本。使用知识产权变化影响的宏观经济模型来估计其影响。估计影响基于当前知识产权状况与提议的知识产权变更之间的比较。自由贸易协定文本涉及《与贸易有关的知识产权协定》(TRIPS协定)规定的专利延长期限。这些规定涉及专利延长期限,这与专利注册和/或药品注册延误的补偿、会导致仿制药进入延迟的数据独占性以及泰国食品药品管理局在专利关联方面的执行作用有关。作为这一单一规定的最坏情况,将给予10年的专利延长以补偿专利注册和/或药品注册的延误。到2027年,对药品可及性的影响将是:1)药品价格指数上涨32%,2)药品支出将增至约11.191亿美元(2009年9月2日,1美元=33.9泰铢),3)国内产业可能损失330万美元。这些结果表明,根据TRIPS-plus提案,药品可及性将受到严重限制。TRIPS-plus提案中对药品的知识产权保护不应纳入自由贸易协定谈判。

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