药品上市审批对于药品安全有效性数据的专门审查要求，造就了涉及药品数据的独特知识产权保护机制。基于药品数据获取的高昂投入及其对于药品仿制与后续创新的重要价值，美欧发达国家在世界范围内率先建立了药品数据保护机制，其逐渐成为一项国际性的法律规则。无论是美欧发达国家的立法，还是相关国际法律规则，对于药品数据的知识产权保护都呈现从商业秘密模式向专有权机制转变的立法格局。产业利益驱动无疑是其中的一个重要诱因，但归根结底是源自药品数据专有权有效兼顾原研发药企经济利益与社会公众健康权益的制度优势。鉴于此，在药品数据专有权保护的国际趋势下，我国应从本土药品产业激励创新与规范仿制的基本诉求出发，以必要的内部限制与外部监管明确药品数据专有权的法律边界，并通过药品数据动态化公示平台的设置与药品数据付费使用模式的创设，建构起与药品专利制度有机衔接的数据专有权保护机制。
The special review requirements for drug safety and effectiveness data in drug marketing approval create a unique exclusive right protection mechanism for drug data. It can be seen that the initial purpose of the exclusive right to drug data is to compensate the pharmaceutical enterprises for the extra-long time cost and high economic investment in the process of producing data for the pre-marketing safety and effectiveness of drugs, such as toxicity analysis, animal experiments and clinical experiments, rather than to stimulate drug research and development. Therefore, the TRIPS Agreement adopts the trade secret protection mode of prohibiting unfair commercial use of drug data. However, developed countries, led by the United States, have established an exclusive right protection mechanism for drug data through the signing of regional FTAs, like the TPP Agreement and the CPTPP Agreement, in order to fully meet the interests of pharmaceutical enterprises, and avoid the "free ride" behavior of free use of original drug data in the administrative approval of generic drug listing. From the behavior regulation of unfair competition in the market to the exclusive right narrative, drug data has gradually possessed the property right attribute and monopoly power similar to patent technology, and has evolved into another institutional tool for the developed countries in the United States and Europe to carry out international trade strife against the vast number of developing countries in need of medical treatment, in addition to the patent mechanism.#br#The current international legislative pattern of the intellectual property protection of drug data has been changed from the trade secret model to the exclusive right mechanism, which is undoubtedly the result of the benefit drive of the drug industry to a large extent, and it is very likely to further aggravate the imbalance of drug supply between developed and developing countries worldwide. On the one hand, once a pharmaceutical enterprise has an absolute control and complete monopoly of the supply of relevant drugs on the basis of exclusive right, it will inevitably lead to the problem that the realization of the most basic life and health rights of the public is subject to the pharmaceutical enterprise. On the other hand, pharmaceutical enterprises need to recover their research and development investment through high-profit production and operation under the guarantee of market monopoly rights.#br#In view of this, by untangling the development process of the protection mechanism of intellectual property rights of drug data, this paper clarifies the international legislative motivation for the generation of the exclusive right of intellectual property rights of drug data, and explores how to deal with the relationship between the development and use of drug data in the protection of the exclusive right of intellectual property rights of drug data, and how to coordinate the conflict of interests between the original research pharmaceutical enterprises and the generic pharmaceutical enterprises, as well as between developed countries and developing countries. The epidemic of COVID-19 has shrouded the world in the shadow of viruses. Drug data sharing has become an urgent need for the current epidemic prevention. How to achieve a reasonable design of the exception mechanism for the protection of exclusive intellectual property right in drug data has also attracted much attention.#br#As a major developing country, China has taken the lead in epidemic prevention and control and achieved remarkable results, but it must be acknowledged that the lack of resource control over key drug data has also hindered China's timely response to public health crises. Thus, it is necessary to make reference to the international legislative trend of drug data protection and encourage drug research and development with high levels of data protection. On this basis, it is pivotal to establish a data exclusive right protection mechanism linked with the drug patent system, starting from the basic demands of encouraging innovation and standardizing imitation of the local pharmaceutical industry by defining the legal boundary of the exclusive right of drug data with necessary internal restrictions and external supervision, and building the dynamic publicity platform of drug data and the use payment of drug data.#br#
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