| BackgroundDrug safety concerns the health and life safety of people, economic development and social stability, as well as the image of the nation and the government. As an essential part of public safety, drug safety has been under high concern both at home and abroad. To a certain extent, it has become an important indication of economic development, the improvement of people’s livelihood and social progress, also it become one of the indicators of the country’s soft power. With the rapid development of medical industry, drug safety in our country enters the stage with higher risk possibility and obvious contradiction. In recent years, fake and inferior drugs have become a serious problem, and drug safety accidents have occurred one after another, which seriously threatens the health and life safety of people, and discloses the problems and weak link of our country’s drug safety. To strengthen the construction of law enforcement ability is the urgent requirement of guaranteeing the safety and effect of drug, promoting the healthy development of medical economy, and protecting government image. At present, the construction of law enforcement system for drug lags behind, the grassroots law enforcement power is weak, and the law enforcement ability for drug could not adapt to the need of supervision. Therefore, it is the urgent matter to explore the problems in drug inspection system, and put forward strategies for constructing law enforcement ability. Many studies on drug safety supervision have been done by domestic scholars, but most put emphasis particularly on unilateral experience introduction, or elaboration from perspectives of economy or law. Few studies aim at the basic investigation and study of the construction of law enforcement system for drug safety, and there have been no study on comprehensive and systematic research of drug law enforcement ability.Under such background, this paper applies theories related to supervision, and from the perspective of law enforcement ability, studies the present conditions of law enforcement system for drug in our country, systematically analyzes the core elements and present construction status of law enforcement ability, and put forward suggestions on law enforcement construction through the situation analysis.Research purposeThe ultimate purpose of this research is:with the construction of grassroots law enforcement system as the main point and main line, to study the present status of system and ability construction, explore the factors influencing the construction of law enforcement ability, and put forward suggestions on its construction. The specific purpose includes:to analyze the core elements of drug law enforcement; to analyze and compare the characteristics and advantages of foreign drug supervision system to draw on their experience; to analyze the present status of drug supervision system in our country and its influence on the construction of law enforcement ability; to analyze the present status and requirement of law enforcement ability for drug; to make SWOT analysis of the construction of law enforcement ability for drug and puts forward suggestions on its construction.Research methodsThe study makes comprehensive use of literature review and comparative analysis method, qualitative and quantitative multiple argumentations, consultation from experts, normative analysis, SWOT analysis, gaming analysis, and HACCP analysis. The research data come from literature review, opinion collection, questionnaire, and site investigation. Research tools mainly comprise Inspection Organization Questionnaire, Law Enforcement Officer Questionnaire, and Opinion Questionnaire. The investigation of organization applies general investigation, while law enforcement officer investigation and expert investigation choose respondents through mechanical sampling.139copies of valid questionnaires,445copies of law enforcement officer questionnaires, and77copies of expert questionnaires are collected. The qualitative data are collected through opinion questionnaires, interviews and seminars. Statistical analysis methods include descriptive analysis, single factor analysis, factor analysis, data envelope analysis, applying softwares of epidata3.1, SPSS17.0, and Max DEA5for data input and statistical analysis.Primary findings1. Analysis of organization and personnel’s core abilityThe core elements of inspection organization fall into two categories:"structure" ability and "process-result" ability. Each category further falls into several subcategories. The "structure" ability includes system resource, organizational resource, human resource, financial resource, information resource, technical resource and environmental resource. The "process-result" ability is primarily represented in functional ability, including the usual supervision and inspection, product sampling inspection, investigation and dealing with case, complaints handling, emergency response, information management, propaganda, training and scientific research.The first5of33qualities and abilities in terms of the importance sequence investigated on law enforcement officers are:laws and regulations, use of law enforcement document, sense of evidence and collection ability, professional competence and the sense of administration by law. These five qualities and abilities can be taken as the core elements essential for the ability of law enforcement officers. Among the five core elements, except the sense of administration by law with4.09points (5-point system) graded by themselves, the other four elements have points between3.7-3.9graded by themselves. This proves that the core qualities and abilities of law enforcement officer need improving. Five "common factors" come out through factor analysis to extract the quality factors:sense of image, assistance ability, site response ability, character features and law enforcement knowledge ability. These five abilities are the primary indexes in measuring the comprehensive quality and ability of law enforcement officers.2. The influence of system on law enforcement abilityAmerican FDA puts emphasis on the construction of law enforcement ability, is a highly efficient and scientific mode worthy of use for reference. The abolition of vertical management in drug supervision system of our country brings some adverse impacts on the construction of law enforcement ability, which is strikingly represented in the point that the insufficient financial allocation for grass roots could not meet the needs of law enforcement after hierarchical management is applied. The fund shortage has become the bottleneck in the construction of law enforcement ability. Law enforcement system for drug consists of too many management hierarchies, which goes against improving management efficiency. The organization does not have powerful authority independence, and the exertion of line authority is limited, which impact the linkage within inspection system and the exertion of overall efficiency. The inspection organization does not have clear function positioning, the hierarchies do not have clear division of authority, and does not keep smooth relationship with normal supervision.3. Law enforcement agency and network constructionThe construction of inspection organization is not standard, lacking nationwide guideline. The organizational mode is not unified, with lower hierarchy in grassroots organization, part of the officers do not manage as civil servants, mismatching their administrative functions. The network construction of grassroots law enforcement agency is not sound.44.2%of the towns (subdistricts) have established law enforcement agency for drug,65.60%of the villages (communities) have information clerks. The construction of organization is not sound. Contract-based employees take up most proportion, and the comprehensive ability of staff could not meet the need of law enforcement. Both of them impact the ability of sustainable development. The poor running of the construction of "two networks" for drug in rural area is primarily caused by the lack of long-acting system for appropriation, and the root cause is insufficient policy supporting force.4. Human resourceThe shortage of frontline law enforcement officer is quite apparent. Over90%of organizations are short of human resource, and nearly1/3of them are in serious shortage. The authorized size of organizations at city level and county level of the whole province is about3,243, And about0.35authorized inspectors for every ten thousand people in the province. Actually there are2,460personnel, the average for each organization being17.70, and3.89of which are drug inspectors, only equivalent to1-2enforcement teams. The grassroots law enforcement teams are relatively young, but their educational qualifications are at relatively low level, with lower specialization degree. Professionals of drug and law are in urgent need, and complex types of personnel with multidisciplinary knowledge fall short. Law enforcement officers are better at laws and regulations on drug and document writing, but their mastery of knowledge on identifying fake drug, the technique to collect evidence by investigation, and expertise on drug are not enough, and their comprehensive quality still needs to be improved. The training force is inadequate, also the training content does not highlight law enforcement practice, and the training mode needs to be innovated.5. Fund guarantyMost revenues of inspection organization are from financial allocations. Among the rest revenue, the financial rebate takes about1/4of the total revenue, which indicates that the financial rebate is an important source of appropriation of law enforcement agency. Among the appropriation expenditures, basic expenditure takes89.89%of the total expenditure, while the expenditure on project takes quite little percentage:the expenditure on investment projects takes only1.41%. This makes it clear that the expenditure on personnel and usual public expenditure take up most of the organization’s expenditure, while the investment projects take up quite little percentage, and the appropriation for office conditions and purchasing vehicles and equipment is limited, which has become an important factor restricting the construction of organization ability. The financial allocations of the organization take up84.42%of the expenditure, which indicates that the financial allocations along could not meet the need of inspection organization. Therefore, more financial allocations are in need.6. Infrastructure and law enforcement equipmentOrganizations with independent office place take up79.70%of the total in the province, only16.53%of which have property rights. The overall equipment allocation rate of office equipment is57.42%. Actually4,325sets are in need, and the shortage percentage is48.39%. The allocation rate of network equipment is only33.81%, and that of inspection network system is only15.83%. The overall vehicles allocation rate is39.98%, allocation rate of evidence collection tools is25.67%. The resource allocation shortage is increasingly large when it goes down to grass roots. According to the contrast between the standard demand and actual demand, in applying the current2005-2010edition of Law Enforcement Equipment Standard in practice, it is appropriate to calculate law enforcement team by four people, some equipment standards need to be revised.7. Performance of organization functionsThe organization achieves fine performance in its usual supervision and inspection, product sampling inspection, and investigation and dealing with case, while the function for complaints handling, emergency response, information management, training and scientific research need to be strengthened.8. Relative efficiency of law enforcement agenciesAs a whole, about2/3grassroots organizations have relative efficiency of DEA-inefficiency, and county-level organizations have higher percentage of ineffective DEA than that at city level. Through the analysis of the ideal value of investment index of low-efficient organization, it is found that93inspection organizations could reduce the investment in law enforcement resource by about50%, which indicates these inspection organizations have overabundant investment in law enforcement resource, but inadequate output. The resource allocation is irrational, and the utilization degree is not high.Conclusions and suggestionsPrimary conclusions:1. The abolition of vertical management in drug supervision system of our country brings adverse impacts on law enforcement ability, which is primarily represented in:insufficient financial allocations becoming the bottle neck restricting the construction of law enforcement; decreased linkage efficiency between hierarchies, and weakened overall efficiency of law enforcement.2. The core elements of inspection organization’s ability include system resource, organizational resource, human resource, financial resource, information resource, technical resource, environmental resource and functional ability.3. The inspection organization construction is not standard, the organization does not have clear function positioning and powerful authority independence, and the hierarchies do not have clear division of authority, which impact the overall law enforcement efficiency of the system. The fee of grassroots network construction is insufficient, the network is not sound and the sustainable development ability is weak.4. Human resource for law enforcement falls short, and the comprehensive quality of personnel needs to be improved. The training should be strengthened. Infrastructure and law enforcement equipment fall short.5. The core elements essential for the ability of law enforcement officers consist of laws and regulations, use of law enforcement document, sense of evidence and collection ability, professional competence, and the sense of administration by law. The comprehensive qualities and abilities of law enforcement officer is composed of five factors:sense of image, assistance ability, site response ability, character features and law enforcement knowledge ability.6. The inspection organization achieves fine performance in its usual supervision and inspection, product sampling inspection, and investigation and dealing with case, but the function for complaints handling, emergency response, information management, training and scientific research need to be strengthened. Most organizations have low relative efficiency and resource underutilization.Suggestions:1. Under the current framework, inspection organizations should actively strive for policy support, give full play to the advantages of one’s own, mitigate the adverse impact brought by hierarchical management, to improve law enforcement ability in a comprehensive way.2. Nationwide guideline for inspection organization construction should appear publicly to strengthen construction of grassroots organization, to improve the standard and treatment of organization and personnel, and to form a national unified normative inspection system.3. It ought to lay stress on function construction. Strengthen line authority through evaluation, award, and supervision, to create a situation with linkage between hierarchies of law enforcement and regional inspection forming a "chess game."4. Law enforcement network for rural and community grass roots should be constructed sound to realize omnibearing supervision and seamless coverage of drug safety.5. The construction of human resource should be strengthened, replenish law enforcement force by the proportion of1-1.5officers for every ten thousand permanent population, strengthen training, and put forth effort to improve the comprehensive quality and core ability of law enforcement officer.6. It ought to establish sound long-acting fund guaranty system, strive for project appropriation, drive the construction of infrastructure, and improve ability by project.7. It is needed to strengthen the construction of organization operational mechanism, optimally allocate resources to improve the resource utilization efficiency.Innovations and LimitationsThis study is new in that it is the first to do comprehensive and systematic research of the system and ability construction of drug law enforcement agency in our country. The findings could be reference for strengthening the construction of national drug inspection system. The specific points are:1. In terms of research angle:with the study of the present status of the construction of law enforcement system for drug as the main line, the paper analyzes the present status of ability and the demands from the perspective of ability construction, which is significant for improving the ability of inspection organization and drug safety guarantee.2. In terms of research contents and methods:the stduy makes comprehensive use of many management theories to make multi-dimensional analysis from perspectives of framework and system; organization and function; organization and individual; internal conditions and external environment. qualitative analysis is combined with quantitative analysis for mutual corroboration and multiple argumentations to make comprehensive analysis of the present status of law enforcement ability. It is the first to apply DEA analysis to evaluate the efficiency of law enforcement agency for drug. It is the first empirical study of the core elements of the quality and ability of law enforcement officer.3. In terms of findings:the first-hand survey data on grassroots law enforcement system for drug provide objective evidence for understanding the present condition of grassroots law enforcement. The paper explores and analyzes the factors influencing ability construction, and puts up with strategies on strengthening ability construction, which provides reference for deepening system reform and improving law enforcement ability for drug.Limitations of the study and the prospect:1. In terms of research content:limited by the study time, it does not do precise research on standard of allocating resources like human resource and equipment of inspection organization, the index of ability construction needs further exploration so as to better instruct practice.2. In terms of findings:in recent years, drug supervision system has undertaken frequent reforms. The suggestions put forward in this study on system and organization construction to strengthen ability construction need to be checked and revised referring to the new reform under way. |
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