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| On International Legislation Development and Chinese Institutional Arrangement of Exclusive Right of Drug Data |
| Liu Xin |
| (Center for Studies of Intellectual Property Rights, Zhongnan University of Economics and Law, Wuhan 430073, China) |
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Abstract 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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Received: 05 January 2023
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