【作者】 吴晓明；

【导师】 李士雪；

【作者基本信息】 山东大学 ， 社会医学与卫生事业管理， 2013， 博士

【摘要】 研究背景药品安全关系到人民群众的身体健康和生命安全,关系到经济发展和社会稳定,关系到国家和政府的形象。药品安全是公共安全的重要组成部分,国内外高度关注。一定程度上,药品安全已经成为衡量经济发展、民生改善和社会进步的重要标志,成为国家的重要软实力。伴随着医药产业的迅速发展,我国药品安全处于风险高发期和矛盾凸显期。近些年来,假冒伪劣药品问题突出,药品安全事件接连发生,对人民群众健康乃至生命安全造成严重威胁,也暴露出我国药品安全存在的问题和薄弱环节。加强执法能力建设是保障药品安全有效、促进医药经济健康发展以及维护政府形象的迫切要求。当前,药品执法体系建设滞后,基层执法力量薄弱,执法能力远不能满足监管工作需要。因此,探索药品稽查体系存在的问题,提出执法能力建设的策略建议成为当务之急。国内学者对药品安全监管进行了不少研究,但大多侧重于单方面实践经验介绍,或侧重于经济、法律等角度的阐述,针对药品安全执法体系建设的基础调查研究少,未见对药品执法能力的全面系统研究。本文在此背景下,综合运用监管有关理论,从执法能力的视角,研究我国当前药品执法体系建设情况,系统分析药品执法能力核心要素及执法能力建设现状,通过形势分析,对执法能力建设提出策略建议。研究目的本研究总的目的是：以基层药品稽查体系建设研究为重点和主线,研究药品执法体系和能力建设现状,探索执法能力建设的影响因素,提出执法能力建设的策略建议。具体目的是：分析药品执法能力核心要素；研究国外药品监管体制特点和优势,找出可借鉴之处；分析我国药品监管体制现状及其对执法能力建设的影响；分析药品执法能力建设现状及需求；对药品执法能力建设进行SWOT分析,提出药品执法能力建设的策略建议。研究方法本研究综合运用文献法与比较分析法、定性定量多重论证、专家咨询法、规范分析法、SWOT分析法、博弈分析及HACCP分析等方法进行分析。研究资料来源于文献复习、意见征询、自填问卷和现场调查。研究工具主要有《稽查机构调查表》、《执法人员调查表》和《意见征询表》。机构调查采用普查方式,执法人员调查和专家意见征询采取机械抽样选择调查对象。回收机构调查表139份、执法人员调查表445份、专家意见征询表77份。定性资料通过意见征询、访谈和专题讨论获得。统计分析方法包括描述性分析、单因素分析、因子分析、数据包络分析等,采用epidata3.1、SPSS17.O、MaxDEA5软件进行数据录入、统计分析。主要研究结果1.机构和人员能力核心要素稽查机构能力核心要素分为“结构”能力和“过程-结果”能力两大类,每类再分为若干小类。其中,“结构”能力包括制度资源、组织资源、人力资源、财力资源、信息资源、技术资源、环境资源等。“过程-结果”能力主要体现为职能能力,具体包括日常监督检查、产品抽验、案件查办、投诉举报处理、应急、信息管理、宣传、培训及科研等。执法人员对33项素质能力选项的重要性排序,前5位的是：法律法规、执法文书使用、证据意识和收集能力、专业知识能力、依法行政意识。此5项素质能力为执法人员必备的能力核心要素。5项能力核心要素中,除了依法行政意识自评分(5分制)为4.09分,其余4项自评分均在3.7-3.9分之间,说明执法人员的核心素质能力方面尚有待提高。利用因子分析方法对素质因子进行提取,得到5个“公因子”,分别为：形象意识、辅助能力、现场应对能力、品格特征和执法知识能力,这5项能力为决定执法人员综合素质能力的主要指标。2.监管体制对执法能力的影响美国FDA药品监管体制模式高效科学,重视执法能力建设,值得借鉴。我国药监系统取消垂直管理后,给执法能力建设带来一些不利影响。突出表现在分级管理后,基层的财政拨款数量不能满足执法工作需要,经费不足成为制约执法能力建设的瓶颈。药品稽查体系管理层次较多,不利于管理效率的提高。机构职权独立性不强,职能职权发挥受限,影响了稽查系统上下联动和整体效能的发挥。稽查机构职能定位不清,上下级之间职权划分不明,执法与日常监管关系不理顺。3.执法机构和网络建设情况稽查机构建设不规范,缺乏全国性的建设指导意见。机构模式不统一,基层机构的级别相对较低,部分人员未参照公务员管理,与所承担的行政职能不相称。基层执法网络不健全,44.2%的乡镇(街道)成立了药品执法机构,65.60%的村(社区)有专门人员。机构建设不完善,聘用人员占较大比例,人员综合素质能力达不到执法要求,影响了可持续发展能力。农村药品“两网”建设运行欠佳的首要原因是经费投入缺乏长效机制,根本原因是政策支持力度不够。4.人力资源情况一线执法人员数量不足问题较为突出,超过90%的机构人力资源不足,近1/3的严重不足。全省市级和县级机构共有执法人员编制数约3243名,每万人口编制数约为0.35名。实有执法人员2460名,每个机构平均17.70名,其中,药品稽查人员有3.89名,仅相当于1-2个执法小组。基层执法队伍较年轻化,但学历层次相对偏低,人才专业化程度低,药学和法律等专业人才紧缺,具有多学科知识的复合型人才缺乏。执法人员药品法律法规知识和文书写作掌握的较好,对药品识假知识、调查取证技术及药品相关专业知识掌握的不够,综合素质能力有待提高。培训力度不够,培训内容没有突出执法实务,培训模式有待创新。5.经费保障情况稽查机构经费收入大部分为财政拨款,财政返还款约占收入总额的1/4强,说明财政返还款是执法机构的重要经费来源。经费支出中,基本支出占支出总额的89.89%,项目支出比例相对较少,投资类项目支出仅占1.41%,说明人员支出和日常公用支出占机构经费支出的绝大部分。投资类项目比例非常小,办公场所建设和车辆、设备等购置经费受到限制,成为机构能力建设的重要制约因素。机构财政拨款收入占支出比例为84.42%,说明仅靠财政拨款不能满足稽查机构经费需求,需要加大财政拨款额度。6.基础设施、执法装备情况全省具有独立办公场所的机构占机构总数的79.70%,其中,只有16.53%的为产权房。办公设备总体配备率为57.42%,实际需要4325台,缺口比例为48.39%。网络设备配备率仅有33.81%,稽查信息平台系统配备率仅为15.83%。全省各类执法用车总体配备率为39.98%,取证装备总体配备率为25.67%。越往基层,资源配备缺口相对较大。根据标准需求与实际需求的对比,现行的2005-2010版《执法装备标准》实际应用中,执法小组以4人计算为宜,有的执法装备标准需要修订。7.机构履行职能情况机构日常监督检查、产品抽验、案件查办等职能开展情况较好,投诉举报、应急、信息管理、培训及科研工作职能有待加强。8.执法机构的相对效率总体上,约2/3的基层机构相对效率为DEA无效,县级机构DEA无效的比例明显多于市级。对低效率机构投入指标的理想值分析发现,93个稽查机构的执法资源投入可降低比例约为50%,说明这些稽查机构执法资源投入过剩、产出不足,存在资源配置不合理、利用程度不高的问题。结论与建议主要结论：1.药监系统取消垂直管理后对执法能力产生不利影响,主要体现在：财政拨款不足成为制约执法能力建设的瓶颈；辖区上下级联动效率降低,执法整体优势减弱。2.稽查机构能力核心要素包括制度资源、组织资源、人力资源、财力资源、信息资源、技术资源、环境资源及职能能力。3.稽查机构建设不规范,职能定位不清,职权独立性不强,职能职权发挥受限,影响系统整体执法效率。基层网络建设投入不足,网络尚不健全,可持续发展能力较弱。4.执法人力资源数量不足,人员综合素质有待提高,培训需要加强。机构基础设施和执法装备缺口较大。5.执法人员能力核心要素为法律法规、执法文书正确使用、证据意识和收集能力、专业知识能力、依法行政意识5项。执法人员综合素质能力可归纳为形象意识、辅助能力、现场应对能力、品格特征和执法知识能力5项。6.稽查机构日常监督检查、产品抽验、案件查办等职能开展情况较好,投诉举报、应急、信息管理、培训及科研工作职能有待加强。多数机构相对效率较低,资源利用不足。建议：1.在现有体制下,稽查机构积极争取政策支持,充分发挥自身优势,消减分级管理带来的不利影响,全面提升执法能力。2.从国家层面出台稽查机构建设指导意见,加强基层机构建设,提高机构规格和人员待遇,形成全国统一规范的稽查体系。3.注重机构职能建设,通过考核、奖励、督导等机制,强化职能职权,打造执法上下联动、区域稽查“一盘棋”的格局。4.健全农村和社区基层执法网络,实现药品安全全方位监管,无缝隙覆盖。5.加大人力资源建设力度,按每万常住人口配备1-1.5名执法人员的比例充实执法力量。强化培训,着力提高执法人员综合素质和核心能力。6.建立健全经费保障长效机制,并积极争取项目经费,以项目促能力,推动机构基础设施建设。7.加强机构运行机制建设,优化资源配置,提高资源利用效率。创新与不足本研究的创新之处在于首次对我国药品执法机构体系和能力建设进行了较为全面系统的研究,研究结果可为加强全国药品稽查体系建设提供参考依据,具体为：1.研究角度方面,从执法能力的视角,以药品稽查体系建设现状研究为主线,分析能力现状和需求,对于提高稽查机构能力、保障药品安全具有重大现实意义。2.研究内容和方法方面,综合运用管理理论,从体制、体系；组织、职能；机构、个体；内部条件、外部环境等多维度,采取定性定量有机结合,相互印证,多重论证,全面分析执法能力现状。首次利用DEA分析法对药品执法机构进行效率评价。首次对药品执法人员素质能力核心要素进行实证研究。3.研究结果方面,基层药品稽查体系的一手基础调查资料,为全面了解基层执法现状提供了客观依据。对能力建设的影响因素进行了探讨,综合提出加强能力建设的策略,为深化体制改革、提高药品执法能力提供参考。本研究的不足之处与研究展望：1.研究内容方面,因研究精力所限,未对稽查机构人力、设备等资源配置标准进行精细研究,对能力建设的评价指标有待深入探讨,以更好地指导实践。2.研究结果方面,近年来药监系统改革频繁,本研究提出的有关能力建设的策略建议,有待结合正在进行的新一轮改革进行检验、修订。更多还原

【Abstract】 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.更多还原