| In recent years,there has been continuous outbreaks of emerging infectious diseases globally. Ebola Haemorrhagic Fever, MERS, Zika Virus, as we ll as zoonosis such as Highly Pathogenic Avian Influenza and Anthrax, due to their strong transmission capability, rapid spread speed, wide range of infection and severe infection harm has become the important and focused area of global health security, which also attracts the attention from international community. As an important technology platform to carry out high pathogenic pathogen res earch, testing and other experimental activities, high- level biosafety laboratory mainly includes BSL-3 and BSL-4. Developed countries and the world’s military powerful countries have increased the scale and investment in their high- level biosafety laboratory construction, leading to a trend of noticeable expansion in these laboratories globally. However, as the number of high- level biosafety laboratories increasing, the biosafety issues become gradually demonstrated and more and more severe. Although most developed countries has high level of laboratory biosafety management, which have equipped with corresponding biosafety laboratory technologies and products, and developed a series of safety guidelines or technical standards, however, recently many countries still witness multiple laboratory safety risks, for instance, management mess, lack of safety measures,and imperfect supervision. There have been increasingly safety issues resulting from a fast growth of the global biotechnology and rapid expansion of high- level biosafety laboratory. The excess biodefense research directly gives rise to surging risks in laboratory biosec urity, and frequent incidents in high- level biosafety laboratory. Hence, the international communities are questioning and worrying about the biosafety of the high- level pathogenic microbiology laboratories in countries.Challenged by a global biosafety environment with traditional bioterrorism threat, frequent high- level biosafety laboratory accidents, and emerging infectious disease prevalence, China is facing an extremely severe situation in the biodefense and response to infectious disease. For a long time, insufficient attention has been given to the construction and development of high- level biosafety laboratories, especially BSL-4 laboratories, in China. As of today, C hina has not yet truly built and put into use the first BSL-4 laboratory that will form a defense research strength, let alone a considerable gap in the relevant core equipment and technology as well as safety supervision mechanism compared with the international advanced level, which has seriously restricted China’s scientific experiment and research on Ebola virus, Marburg virus, Lassa fever virus and other potent virus. O nce the above pandemic diseases entered China, our basic research on these high-risk pathogens would almost be equal to zero in the absence of BSL-4 laboratory, just remaining at the diagnosis level, and unable to take effective measures for response, prevention and control. So it implies great significances to build and accelerate developing our BSL-4 laboratory, carry out studies independently on infectious disease prevention and control as early as possible; strengthen standard management and operation of high- level laboratories, through fully understanding the construction and growth trend of foreign BSL-4 laboratories, absorbing and learning their sophisticated experiences. That also represents a significant topic relating to China’s biological defense strength enhancement.Mainly from the intelligence research perspective, several science research methods such as literature review, expert consultation, bibliometrics and visualization analysis, patent citation analysis, comparative analysis, summary analysis are integratively used in this research. Around “soft and hard strength†such as country distribution and development, key equipment, facilities and core technology, and safety supervision and operation of foreign BSL-4 laboratories, it undertakes a comprehensive and systematic study, deeply analyzing and summarizing foreign BSL-4 laboratories in terms of characteristics, operation mechanism, existing problems, and experiences and lessons worth learning, which is aimed to investigate the technology advantages and sophisticated management s ystem in current international advanced BSL-4 laboratories. On the basis of these work, combining with China’s demand status, current technical bottleneck and challenges faced, the study aims to provide intelligence clues and propose some suggestions for our country and our military in construction and development of BSL-4 laboratories.The research is mainly divided into 6 parts as follows:The first part is theoretical analysis and definition of basic concepts of biosafety laboratory, mainly differentiating the concepts theoretically including biosafety and biosecurity, laboratory biosafety and laboratory biosecurity and etc. This part compares and analyzes the classification of biosafety laboratories by WTO and important countries; analyzes and summarizes the definition of BSL-4 laboratory as well as explains its working principle and classification and compares the advantages and disadvantages between BSL-4 laboratory type in terms of biosafety cabinet and positive-pressure protective clothing.The second part is a research on the currently overall development situation and growth trend of fo reign BSL-4 laboratories, this part in-depth analyzes the background for the steadily increasing number of BSL-4 laboratories in construction. It focuses on the analysis and summary of key selected locations of important foreign BSL-4 laboratories; systematically researches national and regional distribution of global BSL-4 laboratories, nature of the agency responsible for, category and number of employees, laboratory sources of funding, invest ratio analysis and major research content; analyzes the number of published literatures by public BSL-4 laboratories, and conducts bibliometrics and visualization analysis, to reveal the hot contents, pathogens, leading scientists, institution cooperation, important conference and future development trend of the currently foreign advanced BSL-4 laboratories; and investigates the information related to the historical evolution and research areas of three key BSL-4 laboratories: Robert E.Shope laboratory of University of Texas, Galveston Laboratory of Medical School of University of Texas, and Coordinating Center for Infectious Diseases of Centre for Disease Control and Prevention.The third part is an in-depth study on the key equipment and core technology of BSL-4 laboratory, which represent a “hard power†for the construction and operation of BSL-4 laboratory. Mainly based on the literature study with a combination of expert advice, it reviews and summarizes the number of key equipment and core technology in building and effectively operating BSL-4 laboratory, as well as conduct a patent visualization analysis on eight equipments such as High-efficient Particulate Air Filtration, by using Derwent patent database; and draws conclusions from six modules covering total number and trend of patent, patent application country/region, patent holder, patent citation relationships, hot topics of technology, technology category/ keyword evolution. The findings show that currently, the U.S., France and other developed European countries dominate an absolute technological advantage and product prevalence in this field, while C hina, ranking among top countries around the world in terms of number of patent applications, stil l facing technical bottlenecks in multiple key equipment technologies, and lacking certification and accreditation standards, and practical tests for the independently-developed products. This part also presents some major foreign R&D companies with stronger competitiveness.The fourth part focuses on a comparative analysis on the laws, regulations and standard system stipulated by WTO, the United States, United K ingdom, Russia and other countries on Laboratory Biosafety. It investigates the sa fety supervisionary agency and mechanism for the BSL-4 laboratories in the U.S. NSABB is an advisory committee which is responsible for providing advice, guidance and leadership on biosafety supervision to the relevant federal departments and agencies’ high- level biosafety laboratory and dual-use research. Strengthening the U.S. Security Working Group, Control of Biological Agent Plan, Personnel Reliability Program and Behavioral Health Screening Program all represent important mechanism of examining BSL-4 laboratory practitioner qualification and exercising safety supervision. This part also makes an analysis on the management and training given to the BSL-4 laboratory employees, and in-depth analysis of recent typical incidents occurred in BSL-4 laboratories, which lead to conclusion that the human factor is the most major reason causing the laboratory accide nts in direct or indirect way. Corresponding to and complementary for the third part, this one is regarded as the “soft power†for the construction and operation of BSL-4 laboratory. So studying foreign well-established laws and regulations and standards system as well as advanced safety supervisionary experience will offer references and implications to an effective operation of China’s BSL-4 laboratory.The fifth part analyzes the construction and development of the BSL-4 laboratories in C hina. It exp lores the situation and demand for China’s BSL-4 laboratory construction deeply. Such factors as bioterrorism defense, prevention and control of sudden outbreaks of infectious diseases, and establishment of high-risk pathogen research platform require C hina to accelerate developing BSL-4 laboratory. This part reviews the progress of building China’s high biosafety laboratories, and analyzes the problems and challenges of C hina’s BSL-4 laboratory development, especially the bottlenecks for "key equipment and technology" and "management mechanism" of the BSL-4 laboratory. Also, it summarizes the construction of laws, regulations and standard system related to China’s biosafety laboratories.The sixth part concludes the analysis and proposes recommendations. It summarizes the general features of foreign BSL-4 laboratories and useful experience in advanced technology and management mechanism, coupled with the main problems in overbuilding and lacks supervision for private authorities. It further makes an analysis on multi-challenges from regulation, technology, funding and management for China’s construction and development of BSL-4 laboratories, and proposes the following enlightenments and suggestions by integrating the country’s reality:(1) recognizing the situation, and intens ifying layout and planning;(2) carefully selecting location, and encouraging a public participation;(3) increasing financial capabilities, and overcoming technical bottlenecks;(4) perfecting laws and regulations, and strengthening safety management;(5)intensifying personnel training, and conducting a strict safety supervision. This aims to provide powerful intelligence support for China’s further developing and optimizing BSL-4 laboratory. |
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