后TRIPS时期药品试验数据保护研究

发布时间：2018-03-07 20:54

本文选题：药品试验数据　切入点：生物药品试验数据　出处：《大连海事大学》2017年硕士论文　论文类型：学位论文

【摘要】：药品是一类特殊的商品,其与人类健康、社会安定及环境保护等重大问题息息相关。世界上绝大多数国家的政府部门对医药产品上市进行管制,以确保药品的安全性及有效性。在制药企业进行药品的上市申请时,政府相应部门均要求其提交药品试验数据,以证明该药品经过临床试验,证明该药品的安全有效。因此,制药企业提交的新药品的药品试验数据包含巨大的商业价值。在1995年生效的《与贸易有关的知识产权协定》(Agreement On Trade-Related Aspects of Intellectual Property Rights,以下简称 TRIPS 协定)第 39 条第 3 款中,首次在多边贸易协定中对数据信息进行保护。要求各成员国药品监管部门对制药企业提交的数据信息进行保护以防不正当的商业使用或泄露。但TRIPS协定仅对药品试验数据进行原则性的最低限度保护。这就使得在TRIPS协定产生后的后TRIPS时期中,各成员国的国内立法以及国家之间签订的自由贸易协定中对药品试验数据采取了更为全面的保护。本文首先在第一章是药品试验数据进行概述及TRIPS协定对药品试验数据的规定,为了突出后TRIPS时期药品试验数据保护的必要性,即本文的写作价值。在第二章对后TRIPS时期的药品试验数据高标准的保护进行论述,主要体现出后TRIPS时期的药品试验数据保护不仅在原有TRIPS协定的基础上对解释进行扩大,还细化保护类型以及形成了几种对应的药品试验数据保护模式。在后TRIPS时期还对一种特殊药品进行数据保护,就是第三章主要写的生物药品试验数据保护。通过对生物药品与化学药品的区别来说明生物药品试验数据保护的必要性,以及在后TRIPS时期发达国家与发展中国家对生物药品试验数据的立法发展,及在最新的多边贸易协定中首次对生物药品试验数据进行单独规定。第四章是前文通过对后TRIPS时期的药品试验数据保护的更高标准、更全面的保护后,我国在这种高标准保护药品试验数据的环境下,如何进行国内立法以及国际规则制定的建议。最后得出结论,在后TRIPS时期,药品试验数据普遍采取了高标准保护,并且保护的更为全面。我国在这种高标准的背景下,不仅要选择自己适合的药品试验数据保护制度,并且还要将我国的特色药品——中医药品向全世界推广,形成我们自己的特色药品试验数据保护模式。并且可以参与国际上的药品试验数据保护规则的制定。
[Abstract]:Medicine is a special kind of commodity, which is closely related to human health, social stability and environmental protection. Most government departments in the world regulate the marketing of pharmaceutical products. In order to ensure the safety and effectiveness of the drug. When a pharmaceutical company applies for the listing of a drug, the corresponding government department requires it to submit the drug test data to prove that the drug has passed clinical trials and that the drug is safe and effective. Drug testing data submitted by pharmaceutical companies for new drugs contain significant commercial value. Article 39, paragraph 3, of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which entered into force on 1995, For the first time, data information is protected in multilateral trade agreements. Drug regulatory authorities in member countries are required to protect data submitted by pharmaceutical companies against improper commercial use or disclosure. But the TRIPS agreement only covers drugs. There is a minimum level of principled protection of the test data. This makes it possible for the post-#en1# period after the TRIPS protocol to emerge, The domestic legislation of each member country and the free trade agreement signed between the countries have taken more comprehensive protection to the drug test data. The first chapter of this paper is the summary of the drug test data and the provisions of the TRIPS agreement on the drug test data. In order to highlight the necessity of drug test data protection in post TRIPS period, that is, the writing value of this paper, in the second chapter, the protection of high standard drug test data in post TRIPS period is discussed. It mainly reflects that the data protection of drug test in the post-#en0# period not only expands the interpretation on the basis of the original TRIPS agreement, It also details the types of protection and forms several corresponding data protection models for drug testing. In the post-#en0# period, a special drug is also protected by data. That is, the third chapter focuses on the protection of experimental data on biological drugs. The differences between biological drugs and chemicals are used to illustrate the necessity of data protection in biological drug trials. And the development of legislation in developed and developing countries on the experimental data of biological drugs in the post-#en0# period, And for the first time in the latest multilateral Trade Agreement, a separate provision is made for biopharmaceutical test data. Chapter 4th is the result of a higher standard of data protection for drug testing in the post-#en0# period, a more comprehensive protection, In the environment of protecting drug test data with high standard, how to carry on the domestic legislation and the suggestion of international rule making in our country. Finally, it is concluded that in the post-#en0# period, the drug test data generally adopt the high standard protection. And the protection is more comprehensive. Against this background of high standards, our country should not only choose its own suitable data protection system for drug testing, but also popularize our country's characteristic medicine, traditional Chinese medicine, to the whole world. To form our own unique drug test data protection model. And to participate in the international drug test data protection rules.
【学位授予单位】：大连海事大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D997.1

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