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[药品注册档案中的数据独占性以及以色列在知识产权保护方面的国际地位]

[Exclusivity of data in drug registration files and Israel's international status with regard to intellectual property rights protection].

作者信息

Lipschitz Yoel, Tamir Orly, Shemer Joshua

机构信息

The Israeli Center for Technology Assessment in Health Care, The Gertner Institute for Epidemiology and Health Policy Research, Tel Hashomer.

出版信息

Harefuah. 2004 Dec;143(12):845-8, 912.

Abstract

Protecting intellectual property rights encourages creativity and innovation, which are key measures for research and development of new drugs and also promotes the introduction of drugs to new markets. Over the past years, many countries have enacted laws implementing the protection of data in drug registration files. Until recently, Israel has not provided any form of data protection. Current moves focus on new legislation granting exclusivity in the marketing of innovative drugs. Although controversial, this legislation aims to secure balance in Israel between the innovative pharmaceutical companies and the public's interest in competitive generic drugs.

摘要

保护知识产权能够鼓励创新,而创新是新药研发的关键举措,同时也有助于推动药品进入新市场。在过去几年里,许多国家都颁布了法律,对药品注册档案中的数据予以保护。直到最近,以色列都未提供任何形式的数据保护。目前的举措聚焦于一项新立法,该立法赋予创新药物在市场销售方面的独占权。尽管这项立法存在争议,但它旨在确保以色列在创新制药公司与公众对具有竞争力的仿制药的利益之间达成平衡。

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