药品试验数据保护义务国内实施的制度困境与解决--以药品获取为视角

发布时间：2018-04-24 07:40

本文选题：药品试验数据 + 独占保护　；参考：以药品获取为视角

【摘要】：发达国家通过签订FTA等方式使包括中国在内的部分发展中国家接受了药品试验数据独占保护义务。这些发展中国家在实施义务的国内立法中,无论从数据保护条件与范围、申请程序与实施还是保护例外与限制等方面看均存在制度缺失。通过有关国家试验数据独占立法与药品获取相关度指数测算、分析和比较,揭示了发展中国家试验数据独占保护立法在平衡药品获取和数据保护方面存在的困境。发展中国家应摆脱欧美发达国家数据保护立法模式给本国立法带来的消极影响,借鉴其他可借鉴的发展中国家之立法经验,从自身需要和药品获取的角度出发理解和实施药品试验数据保护义务。
[Abstract]:Some developing countries, including China, have accepted the exclusive protection obligation of drug test data through the signing of FTA and other developing countries. In the domestic legislation of the implementation of the obligations, the developing countries have a lack of system in terms of the conditions and scope of data protection, application procedures and implementation, protection exceptions and restrictions. Through the calculation of the relative index of legislation and drug acquisition by the relevant national test data, the analysis and comparison revealed the difficulties in the balance of drug acquisition and data protection in developing countries. The developing countries should get rid of the legislation mode of the data protection legislation of the developed countries in Europe and the United States to bring to their legislation. The negative effect is to learn from the legislative experience of other developing countries and to understand and implement the obligation of drug test data protection from the point of view of its own needs and drug access.

【作者单位】：浙江财经大学法学院;
【基金】：教育部人文社科青年基金项目《创新药品研发的知识产权激励机制研究——以药品试验数据保护为视角》(15YJC820007) 国家自然科学基金项目《激励众包网络化创新的知识产权制度研究》(71573222)
【分类号】：D923.4

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