本文選題：藥品試驗數(shù)據(jù) + 獨占保護　； 參考：以藥品獲取為視角

【摘要】：發(fā)達國家通過簽訂FTA等方式使包括中國在內(nèi)的部分發(fā)展中國家接受了藥品試驗數(shù)據(jù)獨占保護義務(wù)。這些發(fā)展中國家在實施義務(wù)的國內(nèi)立法中,無論從數(shù)據(jù)保護條件與范圍、申請程序與實施還是保護例外與限制等方面看均存在制度缺失。通過有關(guān)國家試驗數(shù)據(jù)獨占立法與藥品獲取相關(guān)度指數(shù)測算、分析和比較,揭示了發(fā)展中國家試驗數(shù)據(jù)獨占保護立法在平衡藥品獲取和數(shù)據(jù)保護方面存在的困境。發(fā)展中國家應(yīng)擺脫歐美發(fā)達國家數(shù)據(jù)保護立法模式給本國立法帶來的消極影響,借鑒其他可借鑒的發(fā)展中國家之立法經(jīng)驗,從自身需要和藥品獲取的角度出發(fā)理解和實施藥品試驗數(shù)據(jù)保護義務(wù)。
[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.

【作者單位】： 浙江財經(jīng)大學(xué)法學(xué)院;
【基金】：教育部人文社科青年基金項目《創(chuàng)新藥品研發(fā)的知識產(chǎn)權(quán)激勵機制研究——以藥品試驗數(shù)據(jù)保護為視角》(15YJC820007) 國家自然科學(xué)基金項目《激勵眾包網(wǎng)絡(luò)化創(chuàng)新的知識產(chǎn)權(quán)制度研究》(71573222)
【分類號】：D923.4

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1 張志聰;藥品試驗數(shù)據(jù)保護制度淺析[D];中國社會科學(xué)院研究生院;2015年

2 周宇浩;我國藥品試驗數(shù)據(jù)法律保護研究[D];復(fù)旦大學(xué);2013年

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本文編號：1795745